👋🏻 It’s been a minute, so I wanted to remind you who is behind the writing! My name is Annicka, I am an industry biotech scientist (experience in analytical development and CMC regulation), I got my PhD in Bioengineering studying AAV gene therapies, and I have also been an online science communicator since 2020.

That combination is why I try to go a layer deeper than most biotech news — not just what happened, but what it means mechanistically and regulatorily. I love making fit-for-purpose figures that help bring it all together, hence the tagline: Part newsletter, part textbook. All biotech.

Thank you so much for being here.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #3!

• 2026 may be a record-breaking M&A year for the biotech space ➡️

• A new recombinant protein therapy for autoimmune kidney disease, IgAN ➡️

• Another GLP-1 landscape expansion toward a slow-release implantable device ➡️

• Advancing domestic manufacturing through the FDA PreCheck Pilot Program ➡️

• A physicians take on if you really need 8 hours of sleep ➡️

• Bonus (paid): Market Exclusivity (6th of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: The biotech space is buzzing with merges & acquisitions (M&As) this year, with over 45 deals at a value of around $135B*! In all of 2025, which was actually one of the better years recently, total deal value was $133B. If the second half of this year is as busy, 2026 may be a record year for deals. And what’s more, there is quite a bit of diversity amongst both what is being purchased, and by whom. Let’s break down the M&A 2026 surge into 3 takeaways:

1. The buyer pool has broadened to include more mid-size companies. This is likely on the tail of biotech valuation starting to rebound (but still being much less than the 2020-2021 peak), giving companies that have been outpriced the last few years, an window of opportunity to acquire with their cash reserves.

2. There is diversity in purchased assets. So far this year, oncology is around 33% of total deal value, with immunology-based therapeutics coming in around 29% and neurology-focused drugs around 14%. The remainder cover women’s health, rare disease, and infectious disease.

3. Finally, it is becoming more common to see deals structured to include Contingent Value Rights (CVRs) into deal structures. Essentially, when buyer and seller don’t necessarily agree on the risk profile of a certain early-stage asset, you can put in the deal that money will be tied to certain program milestones. For example, Apellis shareholders will receive $41 per share upfront (from Biogen), plus up to an additional $4 per share based on annual sale goals of their macular degeneration therapy, Syfovre.

A few more sips: Endpoints News covered the first half of 2026 (45 deals at $125B) but since reporting, Vertex acquired Crinetics Pharma for $10B! So, we’re already over the 2025 deal total!

2. From the Bench

The Tea: There is a new therapy on the market for IgA nephropathy (IgAN), an kidney autoimmune disease caused by the buildup of abnormal antibodies in the kidneys. Vera Therapeutics was awarded approval of Trutakna, a recombinant protein therapy that works by reducing the production of these abnormal IgA antibodies, slowing disease progression.

IgAN therapies on the market today, have left room for improvement, with many patients still seeing loss of kidney function over time. Most similar to Trutakna is Otsuka, which was approved by the FDA just last year. While Otsuka targets one important protein in the pathway that leads to abnormal antibody buildup (APRIL), Trutakna targets two (APRIL & BAFF).

The data from the Phase 3 study showed that there was a significant reduction in the protein-to-creatinine ratio which is a strong indicator of kidney function. The group taking Trutakna showed a 45.7% reduction from baseline while the placebo group showed only a 6.8% reduction.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: The GLP-1 space is rapidly evolving as companies compete to find safer, more effective, or more convenient options for patients. Toward the goal of improving convenience… Novo Nordisk, which produces the oral semaglutide Wegovy, just announced a partnership with medtech company, Vivani Medical, to evaluate, and potentially help advance, Vivani’s slow-release implantable GLP-1 system.

Vivani has a proprietary NanoPortal platform technology designed to remain stable in the body and release medication over an extended period of time. The platform can be custom designed per molecule and has demonstrated efficacy using larger molecules and peptides. The therapy is loaded within the device reservoir and slowly released through custom-size nanotubes on the ends of the device.

Vivani has been working on a semaglutide device, NPM-139, and they plan to initiate a Phase 1 trial comparing it to Wegovy injections this year.

A few more sips: On their website, Vivani discusses ‘The Goldilocks Effect’ of nanotube pore size. The ratio of molecule size to pore size is critical for determining release kinetics.

4. The Rulebook

The Tea: The FDA announced the first seven companies participating in their PreCheck Pilot Program, aimed to aid in the readiness of new domestic manufacturing facilities for therapies of unmet needs.

Participants get to engage with the FDA both for building out the manufacturing facility & for the drug application. Pre-submission FDA meetings will provide technical guidance for getting the facility operational and try to identify issues before they potentially delay a submission.

The following companies are the pilot participants:

Amneal Pharma, Cellares Corp., Eli Lilly, FUJIFILM Biotech, Kriya Therapeutics, Kyowa Kirin, and Regeneron.

5. The Human Side

The Tea: In this New York Times opinion piece, Dr. McCormick, a primary care physician, takes us through why the long-held recommendation of 8 hours of sleep is too simplified.

“Both sleep and insomnolency, when immoderate, are bad.” - Hippocrates

While sleep is, of course, biologically very critical, we know that individual needs will vary greatly. Like with all guidelines, they are meant to provide useful guidance that covers the majority, but never fully cover all the nuance. I enjoyed that this piece summarized the general holes to look out for in epidemiology studies, historical sleep patterns we can learn from, as well as what we can observed from other cultures that live differently.

Biotech Term of the Week

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• Influenza treatment generic approved by the FDA in time for fall Flu season! ➡️

• Building muscle in muscular dystrophy with epigenetic-based therapy ➡️

• A new lung ex-vivo perfusion system may lead to more accepted organs ➡️

• 8 new members of the advisory committee set to meet on peptides in July ➡️

• The similarities between early-career scientists & professional football players ➡️

• Bonus (paid): Orphan Drug Designation (5th of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: The FDA has approved the first generic for the single-dose influenza treatment, XoFluza (baloxavir marboxil).

Most people are familiar with Tamiflu for influenza treatment — but unlike Tamiflu, XoFluza (made by Genentech) is a single-dose treatment and generally better tolerated. But up until now, it’s been quite a bit more expensive (and often not covered by insurance), and therefore harder to find and lesser known.

Norwich Pharmaceuticals obtained FDA approval for it’s generic version, which will provide a lower cost alternative for the upcoming flu season!

A few more sips: Tamiflu (oseltamivir) and XoFluza (baloxavir) work by blocking specific steps in the influenza virus lifecycle. Oseltamivir works by stopping newly made viruses from releasing from the cell. It inhibits the neuraminidase protein on the virus surface which acts as the final rope cutter. Baloxavir inhibits a key protein in the viral RNA polymerase (a cap-dependent endonuclease) that is necessary for viral replication.

2. From the Bench

The Tea: A gene silencing drug successfully harnessed epigenetics to help muscular dystrophy patients gain muscle mass.

Epicrispr Biotechnologies, based in the Bay Area, announced that in a Phase 1/2 trial EPI-321 lead to an average increase in lean muscle of about 0.8 pounds in 3 patients that have facioscapulohumeral muscular dystrophy (FSHD).

EPI-321 is an AAV-based gene therapy carrying the genetic code for what they call their Gene Expression Modulation System (GEMS) — a DNA-binding protein, a guide RNA, and a modulator protein. In the case of this therapy the system recognizes the Dux4 gene, which is turned off in normal cells but remains on in patients with FSHD. Their delivered modulator is designed to add methyl groups to Dux4, acting as an off-switch for expression.

Note that the system isn’t changing the sequence of DNA at all, but rather changing the chemical groups attached to the genome - this is epigenetics!

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: A new workflow for pre-transplant lung evaluation has become possible following the recent premarket approval of the LungFX device, developed by Lung Bioengineering.

The LungFX is an ex-vivo lung perfusion system (EVLPs), allowing donated lungs to be perfused in a controlled environment so they can be be properly assessed prior to being accepted by a transplant center for a recipient. But what’s different about this? EVLPs aren’t new. But the infrastructure required to house the device and run it properly, has been limiting. The current EVLP workflow requires a transplant center commit to an organ prior to evaluation.

A drawback to this system is that if the transplant center does not accept the lung, there may not be enough time to transport somewhere else.

The LungFX system is set up to run in two centralized hub facilities (Maryland and Florida) where the lungs are evaluated, and then offered up to transplant centers prior to transporting.

This provides more transplant centers the opportunity to accept before time runs out. It also reduces the burden of multiple facilities housing the infrastructure for EVLP. Finally, if EVLP is concentrated in just a few facilities, you could make an argument for the quality of work being better.

4. The Rulebook

The Tea: The FDA just added the names of 8 new members of the Pharmacy Compounding Advisory Committee (PCAC) that will meet in July to discuss loosening peptide restrictions.

The PCAC is responsible for evaluating the 503A Bulk Drug Substance List which determines which ingredients compounding pharmacies can legally use. The July meeting is set to cover BPC-157, KPV, TB-500, MOTS-C, Emideltide (DSIP), Semax, and Epitalon.

When the announcement of the new members was made, it was met with a lot of concern for bias and lack of expertise (very reminiscent of the concern with the changes to the Advisory Committee for Immunization Practices or ACIP). Several of the members are known to sell or promote peptides.

Back in April we covered RFK Jr. openly hinting at his preference to make peptides more accessible, as well as the FDA announcement to reevaluate several Category 2 substances.

A few more sips: A reminder that none of the 7 peptides have FDA approval that provides a solid indication for use or proof of safety or efficacy. But below is a table summarizing what they are promoted for in the wellness space.

5. The Human Side

The Tea: As the FIFA World Cup is in full swing, this piece is a fun read. In this opinion piece in Nature Career Columns, Sarah Blackford, an academic career consultant, reflects on the similarities between early-career scientists and professional athletes.

“At the early-career stage, both professional footballers and academic researchers are driven by the kind of passion and talent that can demand sacrifices in home life, leisure and personal time. For players, this means long hours at the training ground dreaming of a winning goal in the national league or on the international stage. For researchers, it means hopes for a breakthrough discovery or highly cited paper.” - Sarah Blackford

Biotech Term of the Week

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• mRNA-based flu vaccine recommended by FDA advisory committee ➡️

• A CAR-T therapy milestone hit with first solid-tumor approval ➡️

• Dexcom’s OTC continuous-glucose monitor expands to children ➡️

• Denali Therapeutics makes gains by selling their Priority Review Voucher ➡️

• How do you feel about genetic screening in infants? An opinion piece. ➡️

• Bonus: Commissioner’s National PRV (4th of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: The mRNA vaccine platform is expanding with the FDA’s vaccine advisory committee unanimously recommending Moderna’s mFlusiva (mRNA-1010) for adults over 50 this past week. The FDA has now committed to make a decision by August 5th.

mFlusiva is an mRNA-based vaccine similar to that of the Moderna and Pfizer COVID-19 vaccines. A lipid nanoparticle encapsulates three mRNAs that each encode for the hemagglutinin (HA) glycoproteins of influenza A-H1N1, A-H3N2, and B-Victoria. The Phase 3 trial data was published in NEJM last month and showed that the the mRNA-based vaccine reduced the risk of influenza-like illness by 26.6% relative to the standard-dose vaccine it was compared to! This bump in efficacy combined with the added technology benefit of quicker seasonal pivots, may be a game changer for protecting against seasonal strains.

A few more sips: In February it was announced that the agency would not even review the application because they felt that the clinical data did not have a sufficient control arm — they wanted Moderna to compare the new mRNA-based flu vaccine against a currently approved high-dose flu vaccine, instead of a standard-dose. The high-dose flu vaccine is currently what’s recommended for adults over 65. Moderna had revealed that the agency, while hoping for the high-dose comparator, also noted that they would accept the standard dose in the Phase 3 study. The reversal in February left the industry confused. The recommendation by the VRBPAC indicates this concern no longer exists.

2. From the Bench

The Tea: A new CAR-T therapy milestone has been achieved with the first solid-tumor CAR-T therapy approved in China! There are around a dozen approved CAR-T therapies globally but they are for cancers like leukemia, lymphoma, and multiple myeloma, not solid-tumors, which account for a large portion of cancers.

CARsgen, a biotech company headquartered in China, has been developing satri-cel, which is a CAR-T therapy that uses a patient’s own T-cells, after being engineered to recognize a protein known as Claudin 18.2 (CLDN18.2), to treat specific CLDN18.2+ gastric and stomach cancers. Satri-cel’s Phase 2 data, which consisted of patients that had all failed at least 2 prior treatment plans, demonstrated a subtle but meaningful increase in survival (~8 months vs 5.5 months).

I enjoyed this summary on Instagram by Dr. Yasmin Mohseni who works in CAR-T research.

A few more sips: A particular challenge of solid-tumor CAR-T therapy is identifying a target antigen that is not also on healthy tissue. The discovery of CLDN18.2 is an incredibly important advancement for this reason. It is minimally expressed in normal tissue but upregulated in gastric and gastroesophageal junction adenocarcinomas (GEAs).

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: We have another FDA approval to discuss (the theme of this week, it seems)! Stelo, made by Dexom, is now the first over-the-counter continuous glucose monitor for children.

Stelo was approved for use in adults in 2024 and is a way to better inform people about how daily lifestyle and diet choices impact their glucose levels. It’s a small, waterproof, device placed on the back of the arm that can be worn for up to 15 days at a time. A small flexible wire is inserted by the applicator into the arm’s subcutaneous tissue, and near real-time glucose values (up to 15 min old) are displayed on the paired phone application. Interstitial blood glucose levels are measured by the wire biosensor, and readings are transmitted via a Bluetooth transmitter.

With this new pediatric clearance, the hope is for the device to be a useful tool in managing prediabetes in children over 2 years old, but who are not using insulin.

4. The Rulebook

The Tea: Denali Therapeutics has sold a previously awarded priority review voucher (PRV) for $195M!

P.S. This bounces nicely off last week’s Biotech term of the Week (where we discussed what a PRV is and how to get one).

Denali Therapeutics is a Bay Area biotech company focused on developing drugs that can cross the blood-brain-barrier (BBB). They were awarded a PRV earlier this year, with the approval of AVLAYAH, an enzyme replacement therapy for pediatric Hunter syndrome treatment. It has not yet been announced who the buyer is. Denali will use it for their clinical pipeline which includes therapies for Sanfilippo syndrome, dementia, Pompe disease, and Alzheimer’s.

A few more sips: Denali has developed a proprietary TransportVehicle (TV) platform that is designed to help large molecules cross the BBB. The TV platform uses engineered Fc domains that bind to native transport receptors (e.g. transferrin, CD98). Target therapies are ferried through the BBB by the specialized transporter.

5. The Human Side

The Tea: The NIH is funding a study to genetically screen 30,000 infants for a panel of different conditions that are able to be treated within the first year of life. This opens up the potential for parents to take early action to prevent or slow-down disease. In this NYT opinion piece, Dr. Daniela Lamas, a physician and mother, walks us through how she thinks about infant genetic screening. She lands on the side of knowledge is power but also understands the hesitancy.

“At the core of our hesitation is a concept called genetic exceptionalism — the idea that genetic information is uniquely dangerous, uniquely frightening, uniquely deserving of protection. For decades this has been a foundational assumption in medical ethics. It has shaped consent laws, insurance protections and the way doctors decide what to tell patients and what to withhold. The question worth asking now is whether that exceptionalism still serves us.” - Dr. Lamas

In her piece she walks us through her experience as a new mother but also earlier infant screening datasets that, to the surprise of some, show that receiving genomic results didn’t increase parental anxiety as much as expected. Dr. Lamas is a proponent of genetic screening but, importantly, building a system that is ready to support it (genetic counseling, parental leave, trained pediatricians, etc.).

Biotech Term of the Week

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• Competition in the oral medication for Psoriasis space ➡️

• Using ultrasound to deliver RNA/DNA using microbubbles ➡️

• A more discreet insulin bolus batch for meal-time dosing ➡️

• First approved active sunscreen ingredient in over 25 years ➡️

• Biopharma may be losing out on early AI talent to big tech ➡️

• Bonus (paid): Priority Review Vouchers (3rd of FDA Encouraging Innovation series)➡️

1. Story I’m Watching

The Tea: Psoriasis treatment, which for years has been dominated by frequent antibody injections, is moving toward a future with more oral medication options with the introduction of small-molecule and peptide drugs. Last week, data for a new oral psoriasis candidate, zasocitinib (made by Takeda) demonstrated superiority over the first-in-class drug Sotyktu (made by BMS).

So we’re all on the same page, psoriasis is an immune-mediated chronic disease that results in inflammation and the build up of skin cells causing patchy, red, and itchy skin. Treatment strategies include blocking cytokine signaling (yellow: small-molecule enzyme inhibitors), blocking cytokine binding (green: receptor antagonists), and neutralizing cytokines (blue: monoclonal antibodies).

Zasocitinib is a small-molecule TYK2 inhibitor, stopping the activation of the downstream pathway after cytokine binding. Recent Phase 3 results of the LATITUDE head-to-head study showed that with zasocitinib, “more than 35%” of trial patients showed clearer skin compared to only 14% with Sotyktu (in quotes because data came from a press release). Of note, people taking zasocitinib started to show better improvement as early as 8 weeks, which is meaningful for patients.

2. From the Bench

The Tea: SonoThera just raised $125M for their ultrasound-based gene therapy pipeline. The top two candidates they are pushing toward the clinic are for Duchenne Muscular Dystrophy (DMD) and autosomal dominant polycystic kidney disease.

Most gene therapies you hear about are utilizing a lipid-based nanoparticle or a virus shell to deliver the genetic cargo. In the case of SonoThera, they are utilizing ultrasound to deliver their DNA or RNA alongside microbubbles that carefully disrupt the cell membrane, making it so the nucleic acid can get to the target.

SonoThera isn’t the first to develop ultrasound-based technology for drug delivery. They are among the first to combine the technology with RNA/DNA delivery. Insightec is a medtech company that has developed a precision ultrasound technology that can target highly specific regions of the body paired with MRI. Lotus Neuro is a brand new biotech startup that peeled off of Insightec to develop the technology for delivering to the brain and crossing the blood brain barrier.

A few more sips: Ultrasound delivery has a few potential advantages. One, unlike with viral vectors, the size of the genetic payload is not as limited. For example, when using AAV, there is only 4.2kb space to put your therapeutic gene. Two, redosing is safer with microbubble delivery. Using AAV as an example again, after the first dose, the body will produce anti-AAV antibodies, making future doses less effective (or not possible). Delivery with microbubbles doesn’t produce a lasting immune response.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Meal-time dosing of insulin is getting easier for patients looking to move away from the standard pen injector. CeQur, a Swiss company, just got two new FDA clearances expanding the use of their CeQur Simplicity insulin patch. On the tails of this success, they also announced raising $100M in seed funding for moving the expansion to commercialization.

What is it? A slim, water-proof, and convenient insulin bolus patch that gives 2U of insulin with the quick squeeze of two side buttons. Up until this week it had only been cleared for use for 4 days at a time, but the latest clearance extends that to 7 days. It also opens the door for a version that gives 1U dosing, which gives better bolus precision for users.

While syringes, pens, and pumps are able to deliver variable amounts of insulin depending on the situation, they are less discreet, less convenient and can require a lot of training. This fills a gap for some Type 1 and Type 2 diabetes patients who are looking for a simple meal-time bolus system.

4. The Rulebook

The Tea: The FDA has approved the first new UV filter in over 25 years — bemotrizinol or BEMT. If you’ve purchased sunscreen while abroad, it’s very likely you’ve already used it. Because it’s such an excellent UV filter, BEMT has been approved in Europe since 2000 and even longer in many Asian countries.

So what was the road block in the U.S.? At a high-level, really strict data requirements. Maximal Usage Trials (MUsTs) are required for topical product NDAs in order to assess how much of the product is systemically absorbed. If the MUsT results find that absorption is over 0.5ng/mL, animal studies that assess reproductive toxicity and carcinogenicity are required. This level of data is not required for approval abroad, because sunscreens are regulated as cosmetics, not drugs.

BEMT, because it is a very bulky molecule, has low systemic absorption (around 0.1ng/mL). Therefore, it already didn’t trigger the animal study requirements. So, the reason it’s taken so long is honestly one of regulatory failure. The last few years we have seen several versions of laws, acts, and guideline updates to try and give the whole landscape a much-needed refresh. It’s very likely that the 2025 provisions in H.R. 5371, which pushed the FDA toward broader data acceptance for sunscreens, finally moved the needle on allowing approval based on the 25+ years of global post-market safety data.

A few more sips: If you’re interested in a recently updated overview of sunscreen, I’d highly recommend this post by .

Your Local Epidemiologist

Here comes the (sun)screen

Summer is close! While sunscreen may seem like an easy health decision, many people, especially younger and health-conscious ones, have questions. Sunscreen health advice and rumors are everywhere, and we’re seeing this reflected in national surveys…

Read more

a month ago · 558 likes · 56 comments · Dr Michelle Wong and Katelyn Jetelina

5. The Human Side

The Tea: In this opinion piece, we learn a tale of caution for pharma companies losing out on the next generation of AI talent to the more attractive salaries of big tech. Mazdak Abulnaga is a high-performing 33-year-old post-doc developing health and science related AI models. But when he, and others like him, are asked where they are headed, pharma isn’t top priority. Salaries not only tend to be lower but pharma has a ways to go when it comes to embracing AI and showing up in tech spaces as invested players.

Biotech Term of the Week

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Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• A peak into CEO-to-Worker salary ratios and insights➡️

• We hear about the measles vaccine but what about a new antibody treatment?➡️

• An tissue engineered heart muscle patch used for heart failure patients➡️

• Do blood pressure wearables get regulated as medial devices?➡️

• A physician-scientists take on the ‘reference paradox’ for job applications➡️

• Bonus (paid): Humanitarian Device Exemption (2nd of FDA Encouraging Innovation series) ➡️

1. Story I’m Watching

The Tea: Endpoint News has begun releasing parts of their biopharma employee salary report for 2025 and they reported the median biopharma salary (which they weighted for head-count of company) was $115.6k. That’s higher than the typical salary for an employee of an S&P500 company.

What struck me most was looking at the CEO-to-Worker salary ratios. ThermoFisher has the highest (1120) with the CEO making $79.9M. Novo Nordisk has the lowest (19.9) with the CEO making $3.5M.

I spent some time looking at the numbers, graphing them in ways that helped bring some stories to light, and coming up with groups I felt were insightful.

• Worker-Pay Leaders I defined as companies with a CEO-to-Worker ratio <100 and a median worker pay >$200k. You can see no CEOs make more than $25M in this category. Incyte just barely misses the grouping because while the median worker salary was quite high, the CEO made $32.1M.

• High Disparity Zone I defined as a CEO-to-Worker ratio >200. While the majority of companies in this group have higher bucketed CEO salaries, Revvity is unique for this category in that the CEO makes less than $15M. But because the typical median worker salary is so low, it makes it into this category.

Take a look at the graph and let me know what insights you find!

A few more sips: Portland, OR was the first place to pass a business tax surcharge based on CEO-to-Worker salary ratios. In San Francisco the ‘Overpaid CEO tax’ narrowly failed passing just last week. And in 2025, the Tax Excessive CEO Pay Act was reintroduced, aiming for the same kind of penalty system for high disparities between CEOs and workers.

2. From the Bench

The Tea: With the unfortunate resurgence of Measles, better understanding how vaccine-derived antibodies neutralize the virus (where exactly they bind) is important information for developing antibody therapies.

Real quick: It may surprise you when you realize that we don’t already have a Measles-specific treatment, but it’s because preventing infection of the highly contagious virus, through vaccination, is so effective. And with the disease being eradicated in the U.S. in 2000, efforts for a treatment weren’t prioritized and new technology hasn’t been applied. Back to the findings…

Researchers at La Jolla Institute for Immunology recently published their work characterizing antibodies from people who had been immunized and data showing what specific regions the antibodies recognize on two important viral surface proteins — hemagglutinin (H) and fusion (F). This kind of virus-to-antibody mapping work isn’t novel, but it fills important gaps in our understanding of Measles virus immunity. It opens the door to developing an antibody therapy that could be used for pre- or post-exposure therapy in high-risk groups if Measles cases continue to rise.

A few more sips: There is also work being done to develop antivirals against Measles! A lab at Georgia State University, in particular, recently published data on a broad spectrum drug targeting machinery of orthoparamyxoviruses (e.g. measles & parainfluenza). The work was funded by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institutes of Health (NIH). It has yet to be tested in humans but showed promise in animal studies.

A few more sips:

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Researchers in Germany have engineered a patch of heart muscle derived from stem-cells that shows potential in boosting weakened heart tissue in heart failure patients.

At late stages of heart failure, the heart loses its ability to effectively pump blood, and you see a significantly lowered left ventricular ejection fraction (LVEF). It is in those scenarios that a patient may be indicated for a left ventricular assist device (LVAD), which is literally a pump that is inserted into the ventricle of the heart that assists the heart in circulating blood throughout the body. (Fun fact: Yours truly worked as an LVAD tech part time during undergrad and it was a really fun job that exposed me to clinical care and retrospective research).

A total of 16 patients (who had heart failure and a LVEF less than 35%) received the engineered heart muscle patch and were followed up for 3 months. The heart wall showed an increase in thickness and the LVEF demonstrated a small improvement.

4. The Rulebook

The Tea: Earlier this year the updated FDA guidance that relaxed regulation on wearables (low-risk devices) “intended for only general wellness”, which has opened the floodgates for companies to offer blood pressure readings.

“FDA may consider certain products that use non-invasive sensing (e.g. optical sensing) to estimate, infer, or output physiologic parameters (e.g. blood pressure, oxygen saturation, blood glucose, heart rate variability) to be general wellness products when such outputs are intended solely for wellness uses…” - Guidance Doc

In just the last few months the list of wearables with this feature has skyrocketed — Whoop, Oura, Samsung, Pin Pulse, just to name a few (Apple sought FDA clearance for it’s feature). While some consumers may appreciate this added feature, many are skeptical that allowing devices to give this kind of information without regulation could result in patients not seeking accurate diagnostic measurements and proper care.

A few more sips: How does a wearable blood pressure measurement even work? Most of the devices repurpose the sensor used to measure heart rate but apply specific algorithms that try to use the readings to infer pulse volume and pressures. At the end of last year the American Heart Association published a statement warning against the lack of accuracy and precision in the cuff-less blood pressure tech.

5. The Human Side

The Tea: In this opinion piece by physician-scientist Bibek Aryal, he argues against the usefulness (and hinderance) of letters of recommendations for first round job applications.

His reasoning is two-fold: in a highly digital era, we no longer rely on letters from former employers to confirm skills, publications, or degrees. Second, it is a privilege (and something quite out of our control) to have mentors that will take the time (often again and again) to write recommendations.

Aryal isn’t anti-recommendation entirely, but suggests that they be only used for finalists.

Biotech Term of the Week

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Paid subscribers get the Biotech Term of the Week, where we break down biotech concepts, technologies, or terms you’ll encounter again & again in the industry. We’re starting a new series, and I’d love more readers to join us.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• Researchers get a standing ovation for pancreatic cancer data ➡️

• A gene editor for cholesterol reduction may change heart disease treatment➡️

• Sleep apnea detection using Apple watch sensors➡️

• Proposed change to grant review tighten criteria & shift priorities➡️

• The story of an American ER physician surviving Ebola➡️

• Bonus (paid): Grant Programs (1st of FDA Encouraging Innovation series)➡️

1. Story I’m Watching

The Tea: It’s likely you’ve heard (or seen videos) about the standing ovation earned by Phase III clinical trial results for pancreatic cancer drug, daraxonrasib, presented at the American Society of Clinical Oncology (ASCO) annual conference.

The trial showed that daraxonrasib, a small-molecule inhibitor made by California-based biotech Revolution Medicines, doubled the survival of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) compared to gold standard chemotherapy. While the median overall survival on chemo was only 6.6 months, those on the trial drug saw a median survival of 13.2 months.

A few more sips: Not being in this specific field myself, I immediately wanted to better grasp how this fits into the larger pancreatic cancer therapy picture. This gives context to the standing ovation.

It turns out that more than 90% of PDACs have a mutation in KRAS (part of the RAS family) that favors the ON state, driving lots of important cell pathways, including cell proliferation.

Small-molecule inhibitors that halt cell pathways, are not new, but it also turns out that KRAS has a particularly “smooth” binding domain and years of work in this space has yielded relatively few successes in blocking the pathway. Research in 2013 identified a “druggable” pocket which eventually led to the approval of two KRAS G12C (the particular mutation) inhibitors that try to lock KRAS in the OFF state — sotorasib and adagrasib. These two drugs, were celebrated upon their approval as well!

We also have a whole emerging modality called protein degraders that have been applied to the RAS pathway. The idea is to tag these proteins for the cell’s disposal machinery so they don’t even exist to propagate the cell proliferation pathways. In March, successful human data was reported on a degrader called setidegrasib, showing it could reduce tumors in lung and pancreatic cancer.

Finally, we get to daraxonrasib (which got the claps). Scientists at Revolution Medicines took the approach of blocking the binding site of RAS while in the ON state, preventing it from binding to proteins that are next steps in critical pathways (downstream signaling inhibition).

I hope this mini crash-course on KRAS and pancreatic cancer helps you understand the importance of the latest findings.

2. From the Bench

The Tea: While many gene therapies are targeting rare genetic diseases, Eli Lilly just released positive Phase 1 data for their gene editing drug, VERVE-102, in the heart disease space.

Besides not often hearing gene therapy and cardiovascular disease in the same sentence, what, in particular, is new about this? Well, we already know that inhibiting the PCSK9 gene in the liver results in reduced low-density lipoprotein (LDL) cholesterol, lowering risk of cardiovascular disease — currently, doctors can prescribe PCSK9 inhibitors in the form of an oral medication that needs to be consistently taken in order to see it’s long-term benefits to health.

VERVE-102 shifts the burden off the patient with a single IV dose that directly modifies the DNA in liver cells to perpetually turn-off (or lower expression of) the PCKS9 gene. The Phase 1b trial was tested in 35 individuals with hypercholesterolemia or premature coronary artery disease and in all but the lowest doses, there was a significant and lasting reduction in LDL.

A few more sips: I am not only looking forward to the future trial data on VERVE-102, but also VERVE-201, which uses the same platform technology but targets ANGPTL3 with the hopes of reducing both LDL cholesterol and triglyceride. That data isn’t expected until late next year or early 2028.

And while we’re talking about the line-up, I found it interesting that the earlier version of this drug (VERVE-101) showed liver toxicity and Lilly has said that their redesign of the lipid nanoparticle (LNP) carrier now minimizes that concern. The LNP now includes a particular sugar (GalNAc) that improves liver cell entry in a way that improves patient safety. VERVE-102 was already in their pipeline at the time of halting VERVE-101. An example of how an iterative pipeline can be beneficial.

Quick call back to issue No. 5 where we discussed another gene editor using LNPs (it was a split system with AAV carrying part too!) for the treatment of urea cycle disorders.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Apple recently released a sleep apnea feature on the Apple watch, which evaluates disruptions in breathing during sleep.

Sleep apnea, which affects an estimated 30 million people in the U.S., is defined by what is known as apnea-hypopnea events or the apnea-hypopnea index (AHI). Apple has developed a new algorithm that takes motion readings from the watch’s triaxial accelerometer sensor and identifies what it thinks are breathing disturbances that could be apnea-hypopnea events. The consumer can review breathing disturbance values in application, but they will also be sent a notification if the algorithm detects an elevated disturbance read over a 30-day period, suggesting they may want to be evaluated for sleep apnea. Apple revealed data on their design, implementation, and validation phases, which included thousands of participants, in a white paper.

A few more sips: When it comes to wearables and wellness values, the major question is whether or not the proxy for a true diagnostic test will hinder (or unnecessarily prompt) proper care. To address this, Apple states in it’s technical white paper, that they took a cautious approach. While specificity for the alert was 98.5% (meaning you are very unlikely to get an alert if you do not have sleep apnea), sensitivity only came in at 66.5% (meaning the device will not alert quite a large portion of people who do have sleep apnea).

4. The Rulebook

The Tea: Late last week the U.S. Office of Management and Budget (OMB), which oversees the federal budget, released a proposal to significantly revise the way federal research grants are approved and what they can fund.

Some of the larger proposed changes? Agency senior appointees would be required to review all grants (and have ultimate veto power), the President’s policy priorities would be prioritized, grants could be terminated at any time, and the rules for what grant money can be used for gets much tighter (for example, needing pre-approval for conference attendance & not covering journal fees).

In part, the aim is to reduce spending, but they also state that the changes would keep activities “consistent with law and policy”, hold recipients “accountable when they fail to meet relevant standards”, and “ensure that basic American principles of equality and equal opportunity are upheld”.

A few more sips: I found this article by incredibly helpful for breaking down the long list of proposed changes and what their implications are.

5. The Human Side

The Tea: Craig Spencer is an emergency medicine physician and public health professor at Brown University, but in this NYT piece he’s speaking as an Ebola survivor.

He contracted the virus during the outbreak of Zaire ebolavirus in West Africa between 2014 and 2016, which resulted in over 11,000 deaths and spread through 10 countries. Spencer carefully lays out why the current outbreak is so dangerous — from a geography riddled with violence, a species of ebolavirus with no vaccine or treatment, and a U.S. administration that has retreated from robust global humanitarian aid.

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🌐 You may notice posts now direct to thebiotechtea.com ☕ Nothing changes on your end — just excited to have a home outside of Substack URLs.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #2!

• A company quietly tapped by the govt for it’s Ebola antibody drug ➡️

• A enzyme replacement therapy not reliant on the pig industry ➡️

• First data in for the Doctronic prescription renewal pilot ➡️

• The FDA released framework for post-market assessment of foods ➡️

• The “academic sleuth” asks that scientists and journalists work together" ➡️

• Bonus (paid): FDA Encouraging Innovation series framework ➡️

1. Story I’m Watching

The Tea: As the Bundibugyo ebolavirus (BDBV) outbreak in the DRC and Uganda continues, an experimental antibody treatment has been quietly tapped by the U.S. government for potential use. According to a spokesperson at the Department of Health and Human Services, a small San Diego company, Mapp Biopharmaceutical, “has shipped doses [of it’s experimental antibody treatment, MBP134] for potential use in high-risk individuals”.

Very little information is known about the quantity of drug shipped, the grade of the material (research or clinical), under what conditions doses would be administered, and if more research is underway as we speak.

A few more sips: MBP134 is listed in their pipeline as a pan-Ebolavirus anti-viral antibody treatment but developed for Sudan ebolavirus (SUDV). It’s a mixture of 2 antibodies that were discovered from a survivor of the historic Zaire ebolavirus (EBOV) outbreak in West Africa between 2014 and 2016. They showed — in ferrets and monkeys — that the antibodies could potentially neutralize EBOV, SUDV, and BDBV.

You can also read more about it in this week’s Binding Brief written by !

2. From the Bench

The Tea: Many people who live with cystic fibrosis or pancreatic cancer have to take up to 40 (!) daily pills to deal with GI issues and poor nutrition absorption (known as exocrine pancreatic insufficiency). Pancreatic Enzyme Replacement Therapies (PERTs) may be used to introduce missing enzymes instead of taking pills, but current ones on the market are derived from pig pancreatic tissue (both an ethical and major supply chain problem).

Anagram Therapeutics is entering Phase 2 trials for a non-porcine PERT, ANG003, and Phase 1 results looked promising! This is a critical example of how drug development is holistic. You can’t just have a solid scientific basis if manufacturing runs into issues.

ANG003 contains 3 essential replacement enzymes:

• Lipase for better absorbing fats

• Protease for better absorbing proteins

• & Amylase for better absorbing carbohydrates

A few more sips: It turns out that the reason for the supply chain issue is that the upstream agricultural market is actually shifting toward leaner pigs, which is a problem for the production of PERTs. Higher-fat pigs produce more enzyme. I think it’s really interesting to see a conflict between what’s needed for food vs drugs. The optimization target for one industry inadvertently constrained the other.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Because we’ve covered this in previous issues, I wanted to follow-up! The first data report is in from the AI Doctronic Pilot Program that is renewing prescriptions in Utah.

So far, 72% of interactions resulted in a renewal (other 28% escalated to a physician). Of these, 91% had a result that agreed with the physician. In the mismatched 9% of interactions, the reviewing physician wanted more details or labs. When this happened, a second physician provided an opinion, and when you look at total number of cases that had a result agreeing with at least one physician, it was 97%!

Interestingly, in the 28% that escalated to a physician, 31% of them the reviewing physician thought they were being overly cautious - but we can all agree that extra caution is better than too little in a pilot like this!

A few more sips: The Utah Medical Board has expressed concern, but the state Office of Artificial Intelligence Policy (OAIP) clarified that all the interactions with patients in this phase of the project are being reviewed by a physician before the prescription renewal takes place. They require 250 patients in each of nine different medication classes before moving onto the second phase of the pilot where a physician will review after the renewal.

4. The Rulebook

The Tea: Earlier this month the FDA released a framework for monitoring the safety of food chemicals and additives once they have been approved. This is on the tails of a 2024 discussion paper outlining what a more systematic process would look like and a 2025 tool released to help guide what should be reviewed. So what does this post-market assessment for food chemicals look like? It starts with signal detection (looking for any potential concern) and they will use several approaches including an AI platform called Warp Intelligent Learning EnginE (WILEE) that scans a plethora of sources. The food additive will then be triaged and prioritized for potential action based on sufficiency of evidence and level of public health concern.

A few more sips: In the news release they also announced the first two additives being reassessed: butylated hydroxytoluene (BHT) and azodicarbonamide (ADA). BHT is an antioxidant used in fats and oils to increase shelf-life. ADA is a whitening agent and dough conditioner used in breadmaking.

5. The Human Side

The Tea: Lonni Besançon, an Assistant Professor of Visualization in Sweden, has become known as an “academic sleuth”, spending years investigating problematic work published during the pandemic and fighting for better and more transparent research practices. Earlier this month he wrote a column in Nature focusing on the importance of scientists and journalists garnering a much stronger relationship than what currently exists. In the column he shares a few words from when he spoke in a session at the World Conference of Science Journalists called ‘Cheats, sleuths, and journalists: How to cover misconduct in science’:

“In many cases, a journalist needs a lot more than a quick quote for an article that is more or less already written. Instead, they need involvement, critical feedback, context, suggestions of other papers to look at, deep analysis and more.” - Besançon

A few more sips: He, and other European researchers, have spent years trying to shine a light on the unethical research practices and lack of scientific rigor of one, Didier Raoult. While the concerns date back to the 2010s, he became prolific both in the media and in journals during the pandemic and is well known for his stance on hydroxychloroquine being an effective treatment against COVID-19. In 2024, their advocacy led to the retraction of 6 publications by the Raoult group.

Biotech Term of the Week

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This post covers:

• Fast Track Designation (FTD)

• Breakthrough Designation (BTD)

• Accelerated Approval Pathway

• Priority Review

Before going into this series I couldn’t quite make out some of the more subtle differences between the various options and this review solidified it for me. I distilled the key aspects (and differences) in a table, which I hope you find helpful!

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🗝️ Paid subscribers get the Biotech Term of the Week at $30/year (~$2.50/month). I try to keep it intentionally accessible, but if cost is ever a barrier, send me a message. A few people asked about expensing your subscription, so I put together a short email template you can send to your manager. Your support helps keep this brewing each week.

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Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• The current Ebola outbreak doesn’t have a vaccine, but do alternative exist? ➡️

• Startup takes a new approach to making mRNA tech more durable ➡️

• A simpler way to detect damage to blood vessels ➡️

• The FDA director resigns, ushering in Kyle Diamantas ➡️

• An appreciation piece for genomic pioneer, J. Craig Venter ➡️

• Bonus (paid): Priority Review (last of FDA expedited programs) ➡️

1. Story I’m Watching

The Tea: The latest Ebola outbreak in the Democratic Republic of the Congo (DRC), features a vaccine-less virus, Bundibugyo ebolavirus (BDBV), but the WHO is debating the use of other ebolavirus vaccines to combat the deadly disease spread.

Ervebo, made by Merck, is the only vaccine approved for use in humans and targets the most prevalent ebolavirus species to date, Zaire ebolavirus (EBOV). Ervebo is a live, attenuated virus vaccine. An Ebola envelope glycoprotein (think: spike protein) is placed within a weakened vesicular stomatitis virus (VSV) vector, resulting in specific EBOV immunity.

While EBOV and BDBV have distinctly different spike proteins, a 2011 paper in macaques showed some unexpected cross-protection. Data is very limited and risks are unknown, but the WHO is actively having conversations about the utility in deploying Ervebo as an emergency response to control the spread. Importantly, the two FDA-approved antibody treatments are also only for EBOV.

A few more sips: There are several papers exploring pan-Ebola protection (or at least cross-protection between species), but the large divergence of glycoproteins between species, combined with low research prioritization, has stunted success.

Besides the findings that Ervebo could potentially challenge BDBV in macaques, the next most promising research for BDBV protection is from 2013 and explored a blended strategy. Monkeys were given a shot with spike protein from the Sudan ebolavirus (SUDV) followed 2 weeks later by a shot with spike protein from EBOV. The SUDV vaccine has been tested in small clinical trials and there is a limited clinical-grade supply that is held by IAVI, who has already said they will give if requested.

2. From the Bench

The Tea: While mRNA technology certainly hits lots of headlines, a small start-up that just launched, ParcelBio, with the goal of improving mRNA durability in the cell, caught my attention. While short-lived protein expression is fit-for-purpose for things like vaccines, many other applications of mRNA therapy would benefit from more enduring expression.

David Weinberg and Chris Carlson, ParcelBio co-founders, think they’ve determined a more robust way of stabilizing mRNA delivery, driving higher and longer protein expression in cells. They’re focusing on engineering the untranslated 5’ and 3’ portions of the mRNA payload to recruit naturally occurring stabilizing proteins in the cell. They have named their technology Amplified and Prolonged EXpression mRNA (APEXm). They plan to present early data at this week’s ASGCT conference and I look forward to seeing it.

A few more sips: Weinberg and Carlson used to work at CircBio (which became Orbital, which was acquired by BMS last year). CircBio was also in the business of stabilizing mRNA delivery but their now-BMS owned platform does it by circularizing mRNA. ParcelBio is being very closed-lipped on their strategy but we can guess it is some combination of RNA regulatory optimization (secondary structure, protein recruitment, etc.).

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: There’s potentially a new blood-based test to detect early signs of heart and kidney disease by measuring glycocalyx signatures in red blood cells (RBCs).

Damage to the endothelial cell glycocalyx of microvessels is associated with a multitude of diseases and is currently measured by specialized imaging (called GlycoCheck).

But research published in Nature Communications earlier this month demonstrated that RBCs respond to damage to endothelial cells by showing their own glycocalyx changes. And since blood samples are easy to obtain in a clinical setting, a blood-based RBC glycocalyx assay would be simpler and more scalable.

4. The Rulebook

The Tea: In the wake of Marty Makary resigning as Director of the FDA last week, Kyle Diamantas, the former deputy commissioner of the Food part of the FDA has temporarily stepped in.

It’s thought that the final straw was Makary pushing back on Trump’s ask to approve fruit-flavored nicotine vapes (decreased risk for people who smoke but increased risk for people who do not).

Diamantas is a lawyer, not a scientist, bringing some concern about his knowledge for leading drug regulation during his stay. Fortunately, however, reports that day-to-day review hasn’t noticeably changed amidst the many changes to leadership in the past few weeks.

A few more sips: with Inside Medicine spoke with several agency employees and it wasn’t until Friday (resignation on Tuesday) that there was any internal announcement made about his departure. Instead, FDA employees heard the news through the media AND an ominous blank picture frame hanging on the wall of the headquarters lobby (check out his newsletter for more on this!).

5. The Human Side

The Tea: J. Craig Venter, a modern-day genomics pioneer, died earlier this month and STAT reporter, Matthew Herper, comments on his career in this appreciation piece. Harper notes that he first encountered Venter 25 years ago at the earlier part of his journalism career, when Venter was running Celara Genomics and racing the government-funded Human Genome Project. From the read you can tell that Venter was a bold character — enchanting some, upsetting others — but most agree that he had a very transformative role in genomics and synthetic biology.

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☕ We crossed 500 readers (just in time for the 10th issue!) and I am very humbled. Thank you for spending a few minutes here each week.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #3!

• Sanofi shows how a Priority Review Voucher can have pros and cons ➡️

• Approach to cancer therapy that targets tumor AND stroma ➡️

• Earlier Alzheimer’s diagnosis achievable with blood-based tests ➡️

• FDA announces one-day facility inspection pilot program ➡️

• An epidemiologist & scicommer talks about hantavirus misinformation ➡️

• Bonus (paid): Accelerated Approval Pathway (3rd of FDA expedited program series) ➡️

1. Story I’m Watching

The Tea: Sanofi is pulling an indication expansion of their Type 1 diabetes monocloncal antibody, Tzield, from the National Priority Review process after experiencing political interference.

The Director of the Center for Drug Evaluation and Research (CDER), Dr. Tracy Beth Høeg, appears to be pushing for the rejection of the expedited application, seemingly against the majority view of many career scientists. She is worried the risks outweigh the benefits in the late-stage group, but Sanofi has responded saying that no post-market analysis data from use in patients in previously approved indication groups has shown any causal relationships between serious AEs and the treatment.

Sanofi, pulling out of the Commissioner’s National Priority Review (CNPV) expedited review, doesn’t guarantee a clean approval through the normal review process, but it appears that they are hoping that leaving the spotlight (and taking some time) will result in a more favorable outcome.

A few more sips: Tzield (or Teplizumab) is already approved for early-stage Type 1 diabetes use in ages 1+ years. The application at hand is seeking approval for use in late-stage disease in 8+ years. It was one of the first nine to receive the CNPV voucher, granting a speedy 1 to 2 month review, for “aligning with national priorities”.

The CNPV voucher program has taken a lot of criticism since being announced — mostly for concerns about political interference: are career scientists still leading the decision process? High-level FDA-officials do not typically weigh in, but the high-profile nature of the voucher applications seems to draw their attention. Companies will have to weigh the benefits of the expedited review period against both the optics as well as the risk of interference.

2. From the Bench

The Tea: The Tea: What if the next generation of cancer therapies focuses just as much on the tumor microenvironment as the tumor itself?

Theolytics (a UK based biotech company) is building a pipeline aimed at killing tumor cells while also weakening the surrounding stroma, the network of cells that can help tumors survive and resist treatment. They are currently testing their oncolytic viral therapy, THEO-260 in two trials: OCTOPOD-IV (intravenously, UK and Spain), and OCTOPOD-IP (intraperitoneally or directly into the abdomen, US), with the latter dosing its first patient this week. Both trials are the first time THEO-260 has been given to patients, so I’ll be watching closely for early safety and efficacy data!

A few more sips: THEO-260 is an oncolytic adenovirus therapy for ovarian cancers that have already shown resistance to platinum-based chemotherapy treatments, serving a particularly vulnerable population. The edge? The virus was selected for its ability to kill both tumor cells and cancer-associated fibroblasts (CAFs), which can play a key role in treatment resistance. This is what may differentiate Theolytic’s approach from other exhausted ones in this target group.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Roche just got EU approval for its blood plasma Tau test, Elecsys pTau271 — an important step toward making Alzheimer’s screening faster and more accessible.

Today, gold standard Alzheimer’s diagnosis often involves a combination of cognitive assessments, brain imaging (PET and MRI), and invasive cerebrospinal fluid (CSF) tests looking for tau and amyloid-beta biomarkers. But many of these approaches are expensive, time-consuming, or difficult to access, making the time between first symptoms and diagnosis remarkably long.

In partnership with Eli Lilly, Roche has now developed two blood-based immunoassays: one for pTau181 (already available in the US) and now a newer assay targeting pTau271, which is thought to be a stronger and more specific Alzheimer’s signal. The Lumipulse device was actually the first blood-based test FDA approved, just last year. This shift toward faster, more scalable diagnosis could significantly improve care by identifying patients earlier in the disease process. Leqembi and Kisunla are two currently approved therapies targeting amyloid pathology, but without improved detection and diagnosis, millions of people are left untreated.

A few more sips: I was inspired to do a broad review of the current Alzheimer’s blood-based diagnostic tests. All but one are immunoassay-based tests (varying versions). Three tests are Lab Developed Tests (LDTs) meaning they can only be performed within certain validated labs or lab systems, unliked FDA approved tests which are themselves validated and can be performed in any lab that has the proper instruments.

Below is a table I made focused on differences in biomarkers tested for, type of platform technology used, and regulatory status. I also took a stab at giving them a complexity and scalability score. Let me know what you think and if this was helpful.

4. The Rulebook

The Tea: This week the FDA announced a pilot program for completing mini facility inspections that will allow the agency to cover more area in shorter time. Since April, they have already completed 46 of these one-day inspections at facilities that AI determined were low-risk based on product type and historical inspection findings. These abridged inspections do not replace full facility inspections and inspectors reserve the right to extend the inspection if there is any indication of an issue. They will continue throughout 2026.

“We are closely analyzing the operational and compliance data from these assessments—including trends in outcomes, risk signals, and investigator feedback to determine how this approach can enhance our broader inspectional strategy,” - FDA Associate Commissioner for Inspections and Investigations, Elizabeth Miller, Pharm.D.

If you’re looking for a longer read on this topic I’d recommend the following:

5. The Human Side

The Tea: Dr. is an expert epidemiologist and seasoned science communicator. In this perspective piece she reflects on how this past week (with the hantavirus outbreak) demonstrated that health and science misinformation now runs with robust infrastructure. The rumors and false claims that took the first years of the COVID-19 pandemic to fully form, now sprout from the dirt in a matter of hours, with the same underlying themes just attached to the latest relevant story.

“The individual claims almost matter less than the cycle itself: See a new disease. Distrust the official explanation. Assume a coverup. Mention ivermectin. Suggest a hidden profit motive. Repeat.” - Dr. Kat Wallace

I think she eloquently highlights that public health experts are now faced with two problems at once: the actual illness, disease, or contagion and the cyclical monetization scheme that churns out misinformation around it.

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• Biotech companies weight in on Mifepristone court ruling ➡️

• Harnessing the “jumping gene” system to turn cells into GLP-1 factories ➡️

• A migraine electrical nerve stimulation device approved for Hinge Health ➡️

• FDA’s new pilot to try and speed up clinical trial timelines ➡️

• A career built on developing genetics curriculums that reduce racism, ended ➡️

• Bonus (paid): Breakthrough Therapy Designation (2nd of FDA expedited programs) ➡️

1. Story I’m Watching

The Tea: You have likely seen headlines discussing the new wave of cultural and political conflict around Mifepristone. But while the conversation is often led by politicians, judges, and doctors on the matter, let’s dive into how pharma is responding.

Shortly after a federal appeals court in New Orleans challenged telehealth prescriptions and mail delivery of Mifepristone, two of the drug’s manufacturers (Danco and GenBioPro) filed emergency appeals.

The ask? Keep access to the drug unchanged unless new safety data supports a reversal.

The Supreme Court responded with a temporary “administrative stay”, pausing any court ruling just through May 11th.

While both companies are aligned, their appeals highlight different risks. Danco emphasizes the dangerous precedent this could set for courts playing a role in the drug approval system. GenBioPro focuses more on the possible downstream effect, noting how a sudden change driven by a single state could disrupt patient access nationwide.

A few more sips: While all drugs are monitored after approval, some, like Mifepristone, have an added safety layer called a REMS (Risk Evaluation and Mitigation Strategy). This means the FDA actively manages and adjusts prescription and distribution based on ongoing safety data. Overtime, REMS requirements have been adjusted as data becomes available. Most relevant to current events is 2023, when REMS data assessments, paired with shifts in patient care (thanks to the pandemic), eliminated the requirement to have in-person dispensing.

This current legal battle seeks to overturn this recent update without new supporting REMS data. And while courts have influenced access before (2021 waive of in-person requirements), the FDA still made the final regulatory decision after reviewing the data.

2. From the Bench

The Tea: A team of UC Berkeley scientists is aiming their “selfless jumping gene” technology at the weight-loss market. They are one of many companies trying to make GLP-1 drug delivery last longer in the body using gene therapy, reducing patient dosing.

Addition therapeutics has an RNA-lipid nanoparticle (LNP) platform coined PRINT (Precise, Rna-mediated, INsertion of Transgenes) that harnesses retrotransposon biology to turn cells into little factories that make whatever target gene you want.

By making your liver cells produce their own GLP-1 agonist long-term, you could eliminate the need for continuous injection (or oral dosing).

A few more sips: Transposable Elements (TEs or jumping genes) are segments of DNA in the genome that encode machinery like reverse transcriptases & integrases that allow them to be copy-pasted, increasing the number of DNA copies, which can increase protein expression.

PRINT is able to harness this copy-paste function but introduce a desired jumping gene into the cell (for example a GLP-1 agonist) AND direct it to a certain place (as to not disrupt important coding genes). From early data on the technology, it appears they are targeting highly repetitive ribosomal DNA (rDNA) coding regions that already exist in multiple places throughout the genome.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: While drugs still play a crucial role in patient care, treatment is increasingly becoming more multi-faceted. An example? Hinge Health just expanded its digital health platform for migraines by introducing an electrical nerve stimulation device (Enso) that pairs with their user-friendly software. In this case, their care is entirely drug-free.

While neuromodulation for migraines isn’t new, this integration of a device into a broader digital care platform, is. Their Migraine Care Program offers drug-free pain relief using the device, app-driven insights into environmental, lifestyle, and dietary factors that may be triggering migraines, and easily accessible expert guidance.

A few more sips: ENSO has been integrated into Hinge Health care for musculoskeletal pain for a few years. It is just recently that it’s FDA-cleared for migraine use. Hinge says 125 of their clients have already enrolled in coverage for their employees and it will be rolling out this month.

4. The Rulebook

The Tea: This week the FDA unveiled a plan to reduce delays in clinical trial data reporting by reviewing patient data real-time.

AstraZeneca and Amgen are two early guinea-pigs of the new pilot program. Two of their early phase clinical trials (for lymphoma and lung carcinoma, respectively), will be pushing data directly to a data platform built by AI company, Paradigm Health. The new real-time clinical trial (RTCT) workflow that Paradigm Health built in collaboration with the FDA, pulls data directly from electronic health records at trial sites, automatically evaluates pre-defined data points, and sends key safety or efficacy signals to both the sponsors and the FDA.

Typically, clinical trial data is batched from the trial sites and sent to the sponsors. From there it is analyzed and eventually reported to the FDA. Eliminating this step-wise process could significantly shorten the approval process for a drug. What we can see is a future where clinical trials operate more continuously.

A few more sips: But continuous clinical data doesn’t just accelerate trials. It fundamentally would change how the rest of development should operate. For CMC, it means shifting from a deadline-driven model to one of more constant readiness. Companies might find themselves in a pickle if the FDA is reviewing clinical data but the accompanying CMC documents aren’t ready. This will be a shift in culture.

5. The Human Side

The Tea: In this perspective piece we follow the remarkable story of Brian Donovan dedicating his career to building genetics education programs aimed at reducing racism.

Specifically, he hoped to combat “genetic essentialism”, the oversimplification of genetics that leads individuals to believe that racial differences are rooted solely in genetics. Donovan spent over 15 years building curriculums that emphasize genetic complexity to avoid rooting this dangerous biological misconception. Unfortunately, in the timeline, his work did not align with the administration’s priorities and the vast majority of the grants that kept is work going were cancelled resulting in him losing his position.

“I was shut down, not just financially, but culturally.” - Dononvan

While he plans now to pivot his career, he’s launched a website with the curriculum and he hopes he’s inspired the next wave of teachers.

A few more sips: Some of Donovan’s work was published in Science in 2024 and it indicated that his methods could have a positive impact in reducing racist ideas.

Biotech Term of the Week

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Breakthrough Therapy Designation

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Happy nearly May! I hope the weather is starting to warm up for you, like it is for me. I’m training to walk the 96-mile West Highland Way in August, so the better weather is perfect.

Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• A gene therapy that restores hearing… for free?! ➡️

• A new technology lowers cost for whole genome sequencing ➡️

• Chatbot renewing prescriptions has upset the medical board ➡️

• New RAPID coverage pathway aims to get devices to patients quicker ➡️

• Career advice for scientists encourages bridging disciplines ➡️

• Bonus (paid): Fast Track Designation (1st of FDA expedited program series)➡️

1. Story I’m Watching

The Tea: Regeneron just got approval for their gene therapy (Otarmeni) treating a rare genetic form of hearing loss (otoferlin deficiency), and surprised everyone with a $0 price tag!

For frame of reference, other one-time AAV-based gene therapy treatments like Luxturna or Zolgensma cost from nearly $1M to over $2M! But you’re likely thinking - this is too good to be true. And in part, it is. In a press release last week Regeneron announced that they will provide Otarmeni for free and reduce the cost of another one of their cardiovascular drugs in trade for 3 years relief from increased tariffs. And with only 20-50 babies being born with the genetic hearing condition, the tradeoff is likely very much in their favor. Realism aside, this is a huge win for the parents of affected patients.

A few more sips:

Otarmeni is a dual Adeno-associated virus 1 (AAV1) therapy with each AAV carrying half the OTOF gene. The two halves are spliced together to create a functional Otoferlin protein, which patients with the condition are missing. A cool feature is the promoter used to drive production. It is a proprietary promoter that only expresses in hair cells, meaning you will have minimal to no off-target expression of the gene.

A few more regulatory details that I found interesting. We know that Otarmeni was given priority approval because it was one of the first therapies awarded a Commissioner’s National Priority Voucher (CNPV) meaning it aligns with national priorities. They are simultaneously eligible for another voucher, a Rare Pediatric Disease Priority Review Voucher (PRV). This lets Regeneron ask for priority review on any future drug application OR they can sell it! And honestly they might be able to sell it for more than what they’ll spend on several years of Otarmeni.

2. From the Bench

The Tea: Element Biosciences recently unveiled a new technique for sequencing genomes (VITARI) and claims it will cost only $100 instead of the industry standard $200.

So what is the difference? At a very high level, most genome sequencing techniques build out copies of the template and, one-at-a-time, incorporate a base and read out the associated fluorescent signal (different colors for A, C, G, T). And for accuracy, each fragment of DNA is read many times, requiring many bases that emit fluorescence. This is expensive! Element Biosciences introduced VITARI which is based on avidity base chemistry (ABC). Instead of a 1:1 ratio of expensive fluorescent nucleotide to base sequenced, an avidite binds to multiple copies of the same next base at once, reducing cost.

A few more sips: I needed to give myself a mini crash-course on sequencing techniques and I wanted to share a comparison that helped me.

• Illumina sequencing is a well-known short-read system. Your genome is fragmented into very small pieces, they are amplified to create clusters of themselves, and each is read by sequencing by synthesis (SBS), meaning the polymerase is forced to stop after each base is added so the fluorescent signal can be captured. The many results per fragment are pieced together to give you a whole genome read.

• PacBio sequencing is a well-known long-read system. Your genome is fragmented into very large pieces, circularized, and a polymerase runs the circle over and over, continuously adding bases that give off fluorescent signal. This is known as Single Molecule Real-Time (SMRT). The repetitive long reads are compared to one another to resolve any conflicting areas.

• Element Bio uses polony technology combined with avidite chemistry. Your genome is fragmented into small pieces (like Illumina) but circularized (like PacBio). Each circularized small fragment is amplified repeatedly to create many connected copies (rolling circle amplification) but instead of single base incorporation snapshots, avidites come in and bind to several repeats of the target base in the polony, creating stronger signal each read.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The tea: The Utah Medical Licensing board is pushing back on AI renewing prescriptions without a doctor. A few weeks back we discussed how Doctronic is the first closed-loop AI system being used to renew prescriptions for patients, and it’s being tested exclusively in Utah.

But in a letter published Friday, the Medical Board noted that it was not given prior notice about the pilot and is asking for it to stop. The Utah Office of AI Policy already responded saying they did consult specialists (just not them), Phase 1 renewal decisions are entirely reviewed by human physicians, and that they are welcome to review the pilot data as it comes out. This is our reality! AI will become a part of many parts of our future, but the question is how we implement and validate.

A few more sips: The board is arguing that the chatbot is acting as someone “practicing medicine” and that the board is specifically designed to have oversight of that.

“There is a reason prescription refills require physician authorization.” - Utah Medical Licensing Board

Dr. Daniel Aaron, a law professor at the University of Utah recently wrote a JAMA opinion article on this topic.

4. The Rulebook

The Tea: CMS and FDA jointly announced the RAPID coverage pathway earlier this month - a means to expedite Medicare coverage of newly FDA approved Breakthrough Devices. The problem? Many devices are approved but then reimbursement decisions aren’t made for months to years, delaying patient use. Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage, requires that CMS now be a part of early discussions that happen between the device companies and the FDA. That way they are informed, earlier.

Important distinction: this isn’t for all devices, but breakthrough devices. These are devices that will improve treatment or diagnosis of a life-threatening or debilitating condition and either no alternatives exists, they offer major advantages over existing options, or availability is crucial for patients.

5. The Human Side

The Tea: I recently stumbled upon a Substack article by that, I thought, gave helpful career development advice for biotech scientists. They articulate that having the ability to bridge technical science with business decisions is a way to really differentiate yourself amongst talent. The 6 differentiating skills they highlight are:

• Be able to scan a paper and summarize it in 20 minutes or less.

• Understand basic business and financial basics.

• Know the basic pathways for regulatory approval.

• Practice your communication skills to a variety of audiences.

• Be literate in trial design and statistics.

• Place yourself in cross-functional positions so you understand values of each.

A few more sips: If this sounds interesting to you, the article goes on to highlight 4 tracks that help with this bridging. I’m in the middle of doing something like this right now with CMC regulatory! My company gives full-time employees the opportunity to do internal internships that allows you to grow into a new area while also supporting a project or need. I’ve been on a steep learning curve but am enjoying it and can already tell it is making me better equipped in the biotech space.

Biotech Term of the Week

Fast Track Designation

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Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #2!

• The frontrunner oral GLP-1 agonists are entering new indications ➡️

• A hole poked in the central dogma of biology ➡️

• OpenAI released a life-science reasoning model, GPT-Rosalind ➡️

• Erica Schwartz appointed the new CDC Director ➡️

• A pediatrician pushes back on vaccine skepticism as the majority opinion ➡️

• Bonus (paid): Biologics License Application (BLA) ➡️

1. Story I’m Watching

The Tea: As of a few weeks ago there are now two oral GLP-1 agonists on the market for weight-loss: semaglutide (Wegovy with Novo Nordisk) and orforglipron (Foundayo with Eli Lilly). But, as we know, these drugs aren’t just for weight-loss. The race to be approved for other indications is underway. Wegovy was approved for both weight-loss and reducing cardiovascular (CV) risk in December 2025. This week, Phase 3 trial results for Foundayo demonstrated it may have potential for diabetes treatment in addition to weight-loss.

A few more sips: In the trial (ACHIEVE-4), participants with obesity and type 2 diabetes were split into an arm taking Foundayo and an arm taking Insulin. Lilly reports that there was no increase in major adverse CV events but that A1C and body weight showed greater improvement in the Foundayo group. This is significant, when being compared to Insulin!

Fun fact: While the GLP-1 agonist landscape is largely peptides, Foundayo is unique in that it is a small molecule drug. If you hear that it may be more tolerable and can be taken without food or water… this is why!

2. From the Bench

The Tea: Researchers at Stanford recently published data that demonstrates an exception to the central dogma of molecular biology. They found a protein that is able to make a DNA sequence without having an RNA template! The central dogma dictates that DNA makes RNA makes Protein and that it is a unidirectional flow of information (meaning protein can’t be the template for DNA or RNA). Dr. Alex Gao, and team, discovered that a reverse transcriptase enzyme that functions to defend bacteria against phages does in fact make DNA by itself (a reversal of the established idea of information flow). Known as Drt3b, it is able to use its peptide sequence to specifically recruit nucleic acids in the sequence of ACACAC (polyAC) to create a single stranded DNA (ssDNA)!

A few more sips: This discovery opens a lot of doors. Prior to now, science understood that nucleic acid chemistry was required for building new nucleic acid strands. Specifically, tRNAs bring in nucleic acids based on the template codons. This discovery suggests that the shape and geometry of a protein active site is enough to recruit nucleic acids in a patterned order. The sequence here is rudimentary (a two-base pair repeat sequence) so I think it’s unlikely that we will find a protein that is able to create a long, sequence-complex peptide without a template. But time will tell!

For those interested in a little more detail about the Drt system in the paper. Drt3a does use an RNA template to make a polyGT ssDNA. It is Drt3b that makes the complementary polyAC ssDNA with no template at all. The two ssDNA sequences combine to form a double-stranded DNA (dsDNA) sequence.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: OpenAI just rolled out a reasoning model built for life science research, GPT-Rosalind, named after Rosalind Franklin. The model specifically aims to reduce the time between discovering a drug and treating patients, with tools designed for early research, trial design, regulatory document drafting, manufacturing optimization, and commercial launch and lifecycle management strategy. Rosalind is already being used by biotech companies like ThermoFisher, Amgen, Moderna, & Sanofi. Companies who are interested can request access and OpenAI will access eligibility and governance to make sure it is being used in a safe and controlled way.

A few more sips: On their website they show a few examples of science/research prompts they tested in Rosalind as well as their broad scope models GPT5, 5.2, and 5.4. Rosalind consistently scored higher. Check out this page if you are interested in seeing the prompts and some of the comparative responses.

🗳️ P.S. My survey results showed a potential interest in Bio[Tech] placing higher up in the newsletter. I’d like to get a larger feel for this here! Let me know!

4. The Rulebook

The Tea: President Trump has nominated Erica Schwartz to lead the CDC, and she will take the role if confirmed by the Senate. When I first started looking into Dr. Schwartz it seems clear she is qualified for this position. She has three degrees (a BS in Biomedical Engineering, an MS in Public Health, and an MD) and decades of relevant professional experience. She once served as Deputy Surgeon General and held several positions within the U.S. Coast Guard, including Chief Medical Officer and Chief of Preventative Medicine.

Her nomination is being met with mixed reactions, though. Many see her as a welcome return to more conventional public health expertise, while others, that align more with current HHS administration, feel this is a step backward in trying to reform vaccine policy. The decision to bring her in after a year of unconventional picks, could signal a change in direction. An article this week by pointed out that the senate confirmation could be pushed ‘til after the midterms. And her confirmation would be hanging in the balance.

A few more sips: This nomination comes after an unusually unstable period for CDC leadership. The agency has cycled through several leaders since President Trump took office, with only one making it through Senate confirmation (see graphic below). A high turnover rate like this undermines the agency’s ability to maintain continuity in purpose and provide steady guidance to the public. I am hopeful that with Dr. Schwartz’ strong qualification she will be confirmed and hold the position for some time.

5. The Human Side

The Tea: A recent Politico article suggested that most Americans doubt vaccine safety. Dr. David Higgins, a pediatrician and public health physician, firmly pushed back, arguing that this interpretation doesn’t hold up under closer scrutiny.

“One of the greatest threats to childhood vaccination is the normalization of skepticism, even though it isn’t actually the norm.” -

A few more sips: Dr. Higgins walks through how survey design and question framing can distort how public opinion is interpreted. In this case he showcases a particular question that made skepticism appear more widespread than it is. He also brings attention to a plethora of surveys and published research showing that vaccine support is actually quite resilient. There has been some slow decline in recent years, but not to the extent where we can say that the majority opinion is that vaccines aren’t safe.

Biotech Term of the Week

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Biologics License Application (BLA)

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Let’s get into this week’s cup of biotech tea. ☕If you only have time for one this week, I’d start with #2!

• Split messaging on peptide-based drug regulation ➡️

• A novel soft contact lens for the treatment of glaucoma ➡️

• AI-powered clinic tools partner with medical journals ➡️

• The new ACIP charter updates definition of qualified expert ➡️

• Seven stories of how early-onset cancer is uniquely hard ➡️

• Bonus (paid): critical process parameter➡️

1. Story I’m Watching

The Tea: In recent weeks, there has been a lot of confusion around what direction the Department of Health and Human Services (HHS) will take with regulating peptides.

In a recent podcast appearance, HHS Secretary RFK Jr. suggested there may be a move to loosen the regulation of some peptides to improve public accessibility. This hint at a potential shift in thinking was confirmed just yesterday with the release of an FDA document announcing the intent to re-evaluate a subset of peptides that have been restricted from compounding. At the same time, this sentiment contrasts with a February statement from the FDA announcing its intent to restrict the use of GLP-1 active ingredients in non-FDA-approved compounded drugs, citing safety concerns. GLP-1s are some of the most widely used peptide-based drugs today, so this move reflects a more cautious stance on them. Taking all this together, the current landscape feels somewhat split, and I will be carefully watching the next steps.

A few more sips: The recent podcast statement by RFK Jr. refers to something that was set in motion a few years ago. In 2023, about 19 peptides (mostly metabolic, immune, mood, and hormone modulators) were moved into Category 2 of the 503A bulk substances framework. Category 2 substances are considered to have significant safety risks or insufficient data and, importantly, are therefore not eligible for compounding by a pharmacy. This effectively limited access to many of the peptides that had been gaining popularity in wellness and performance spaces. The hot-off-the-press FDA announcement signals that several of these peptides (around 11) are being reconsidered.

2. From the Bench

The Tea: Researchers at the Terasaki Institute for Biomedical Innovation (led by Yangzhi Zhu) have developed a theranostic (diagnostic + therapeutic) soft contact lens for glaucoma, the second-leading cause of blindness. The device can continuously measure intraocular pressure (IOP) and responsively deliver a therapeutic.

Today, managing glaucoma relies on periodic IOP measurements in clinic and daily prescription eye drops to slow damage to the optic nerve. Dosing is adjusted over time based on those measurements. A wearable device that can both monitor IOP in real time and real-time and release drug as needed could significantly streamline treatment and improve adherence. The next steps are to initiate a clinical trial! I have a family member with a recent glaucoma diagnosis so I’ll be paying attention to enrollment sites.

A few more sips: The all-polymer theranostic smart contact lens (AP-TSCL) consists of three layers: two that store drug and sense changes in IOP, and a third that encapsulates the system components in a way that is compatible with blinking. As pressure changes, the curvature of the eye subtly shifts, compressing the drug reservoir and triggering release. This system was inspired by sea sponges and their natural networks of pores and microchannels. The AP-TSCL was made to mimic this mechanoactive (pressure-responsive) anti-swelling (controlled volume) structure that doesn’t require electronics.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: AI-powered tools to help clinicians are already here (ask your doctor next time!) and they are rapidly expanding to cover more of a physician’s workflow. This week, one such tool, Abridge, announced its partnership with NEJM and JAMA with the goal of expanding its scribe technology into the medical search space, helping physicians access information real time during patient visits. OpenEvidence is another example of one such tool, but it started in AI-assisted medical searching (and already has partnerships with journals like NEJM and JAMA), and is now expanding into scribing.

A few more sips: While these two are certainly not the only players, they highlight how quickly the space is evolving. These tools are already expanding beyond just note-taking or gathering helpful information during a patient visit. They are also moving into medical coding, insurance authorization, and integration with electronic health records.

4. The Rulebook

The Tea: A new charter was released for the Advisory Committee on Immunization Practices (ACIP), the panel that sets recommendations for vaccines, following the recent legal decisions that temporarily paused ACIP proceedings (call-back to our discussion of the AAP vs. HHS lawsuit from March). The update introduces two notable shifts:

1. Broader membership criteria: The previous charter emphasized expertise in vaccines, immunology, and pediatrics. The updated version expands the definition of qualified expert to include fields such as toxicology, pediatric neurodevelopment, and consumer perspectives.

2. Shift in framing: The charter puts greater emphasis on evaluating vaccine safety concerns.

A few more sips: It’s also helpful to understand the framework ACIP has historically used to evaluate evidence when making vaccine recommendations. GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) assesses the quality of a body of evidence based on factors like bias, indirectness, inconsistency, precision, and missing data, and rates it as high, moderate, low, or very low.

This is paired with EtR (or Evidence to Recommendation), which helps translate the evidence into a final recommendation by considering how it applies in real-world use (values of the population, implementation considerations, health economics, etc.). Together these frameworks help explain both the WHAT of the decision as well as the WHY.

5. The Human Side

The Tea: When the New York Times asked readers who had experienced early-onset cancer to write-in, more than 800 people responded. In this powerful piece, seven of those stories are shared in the patients’ own words. They describe the impact of diagnosis and treatment during a time of life that is often defined by building. Growing careers, exploring relationships, improving financial stability, and, for some, raising young children.

Cancer is never easy, but early-onset disease carries a different set of burdens. Understanding those challenges is important not just for empathy, but for how we think about treatment and support.

Biotech Term of the Week

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Critical Process Parameter (CPP)

non biotech synonym: crucial production setting

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Let’s get into this week’s cup of biotech tea. ☕ If you only have time for one this week, I’d start with #1!

• An organ-on-a-chip was sent to space on Artemis II ➡️

• A split-delivery AAV+LNP gene editing therapy ➡️

• Conflicting trial results for a cardiac occlusion device ➡️

• Updated Patient Preference Information guidelines ➡️

• Is our use of AI akin to the Greek myth of Narcissus? ➡️

• Bonus (paid): the make-or-break-it characteristics of a drug ➡️

1. Story I’m Watching

The Tea: The Artemis II mission to the moon (which had me absolutely entranced on Monday) has a biotech objective while traveling 250,000 miles away from Earth! Meet AVATAR (A Virtual Astronaut Tissue Analog Response), a thumb drive-sized organ-on-a-chip device used “to study the effects of increased radiation and microgravity on human health.” Each organ chip contains cells from the bone marrow of the Artemis II astronauts and they will be analyzed upon return to give insight into how space conditions affect people differently. There may also be information that can contribute to advancing personalized medicine on earth.

A few more sips: Bone marrow is extremely sensitive to radiation exposure and therefore very interesting to study in deep space. To make the chips, the astronauts donated platelets. Stem and progenitor cells were then purified out of the samples using magnetic beads that bind specifically to them. The cells were then loaded onto the chips with blood vessel cells and other supporting cells. NASA-funded scientists at Emulate, Inc. are behind the design of the organ-on-a-chip.

2. From the Bench

The Tea: Researchers at the Children’s Hospital of Philadelphia (CHOP) recently published a new split-delivery CRISPR approach for treating several urea cycle disorders (UCDs). In this system, lipid nanoparticles (LNPs) deliver the genetic instructions to produce the editing machinery, while adeno-associated virus (AAV) delivers the guide RNA that directs where the editing should occur. This split-delivery strategy allows for longer and more complex guide RNA packages that are difficult to chemically synthesize but important for making needed edits for certain UCDs.

The AAV + LNP therapy uses prime editing as opposed to base editing - two slightly different versions of CRISPR technology. While base editing is limited to making single-letter DNA changes, prime editing can make a broader range of changes, expanding the types of diseases that may be treatable.

A few more sips: You may have seen the story last year of Baby KJ receiving a world’s first personalized CRISPR gene therapy for his rare genetic liver disease. Dr. Rebecca C. Ahrens-Nicklas at CHOP led both that work and this latest proposal to the FDA. Earlier this year, the team published both the science and the pre-IND feedback they received for AAV + LNP approach.

If you’re interested in the FDA’s pre-IND feedback, you can read it here.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Two recent trials reached different conclusions about whether a left atrial appendage (LAA) occlusion device can safely replace non-vitamin K oral anticoagulants to reduce stroke risk in patients with atrial fibrillation. Devices like the Watchman FLX Pro (Boston Scientific) are currently approved in patients who can’t take anticoagulants, but not yet as an alternative for those who can. The larger trial found the device was noninferior (think similar) to anticoagulation therapy. The smaller trial found it was NOT noninferior (think not similar). Why the uncertainty? The total number of stroke events across both studies was low, leading to wide confidence intervals and less precise conclusions.

Quick call back to last week when we talked about the Lyme vaccine trial narrowly missing its endpoint because of low Lyme disease events!

A few more sips: The CHAMPION-AF trial was the one that concluded the device may be similarly safe to anticoagulation. While it was a larger trial (3000 enrolled), critics note that it was sponsored by Boston Scientific and they only used their Watchman FLX Pro device. We also see that the baseline risk of stroke in the patient population averaged somewhat low, potentially making the device appear more favorable.

Conversely, the CLOSURE-AF trial concluded anticoagulation is likely still the safest treatment. This study was not industry funded, used 2 different occlusion devices (Boston Scientific Watchman FLX Pro and Abbott Amplatzer), but only enrolled 900 patients. It’s population baseline risk of stroke averaged higher, also potentially impacting results.

Read this editorial piece for a deeper review on what to make of these conflicting results.

My first question was: why implant a device at all if anticoagulants already work? The authors note that expanding the indication allows physicians and patients another option to explore through shared clinical decision-making. It was also noted that many patients do not consistently take blood thinners, reducing their effectiveness.

4. The Rulebook

The Tea: This week the FDA released updated guidance on how patient input can be collected and used in medical device approval decisions which are regulated by the Center for Devices and Radiological Health (CDRH). This input - called Patient Preference Information (PPI) - captures how patients weigh benefits and risks of medical devices. While PPI has never been required, the FDA continues to emphasize its value in decision-making.

The biggest shift in this update? In 2016, PPI was primarily considered in select novel or higher-risk approval pathways (PMA, HDE, or De Novo). Now, the FDA is explicitly extending its use across the entire life cycle, including 510(k) submissions and even postmarket decisions.

As a quick frame of reference, the patient voice framework for drugs and biologics is called Patient-Focused Drug Development (PFDD).

A few more sips: An important reminder (that I needed to give myself when reviewing this): PPI is not used to approve something that’s unsafe. It’s used when risks are acceptable and patient opinion can help interpret risk/benefit analysis. It sits in the gray area between regulatory protection and patient autonomy. Here’s an example from the guidance showing how PPI may be used to inform a device decision:

A permanent, fully implantable hearing device under review shows higher risk of facial nerve injury than similar devices already on the market. PPI revealed that a sizeable group of patients highly valued the discreet design of the device and would be willing to accept the increased risk. In this example, the FDA may use that patient preference information to determine that the device’s benefits outweigh the risks for the intended population.

A great in-depth article by for those interested:

5. The Human Side

The Tea: In this opinion piece by Ezra Klein entitled ‘“I Saw Something New in San Francisco”, Ezra Klein walks us through a striking analogy between our collective obsession with AI and the Greek myth of Narcissus. He reminded me that the story doesn’t convey an obsession with self but with an extension of self in any material other than self. And what is AI if not that? We regularly warn each other of the selection bias that comes from using LLMs and that the way we frame our prompts creates a self-reinforcing loop akin to staring at our own reflection. A thought-provoking read as we continue into this new era.

A few more sips: Beyond the analogy, Klein describes how he sees us giving AI more and more access to both our work and our personal lives. It’s a double-edged sword. The more information AI has about something, the better it’s responses become. But he points out that the nature of that information might change if we know it has an audience.

“I know people who have been keeping a journal for years and now upload it into any new A.I. system they use. The journal has become, for them, not just a place to pour out their innermost thoughts, but a convenient package of context that can be used to make themselves known to new systems, and thus make the systems more useful to them. But that of course changes how they write in those journals: What was once private now has a reader.” - Ezra Klein

Biotech Term of the Week

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Reminder: The Biotech Term of the Week is where I break down one concept you’ll encounter again and again in biotech. Seeing it here makes it become clearer, more intuitive, and easier for you to speak about with confidence.

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Critical Quality Attribute (CQA)

non biotech synonym: make-or-break characteristic

While a product or drug can have dozens of qualities that are measured, a critical one is something that could directly impact patient safety or how well it works.

Officially, CQAs are defined in ICH Q8 as “physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality.”

These attributes are:

• continuously monitored throughout development, and

• given acceptable upper and lower bounds based on what is known (or predicted) not to impact safety or efficacy.

It’s important that they are defined early on in drug development so that you can carefully monitor any changes. This helps guide process understanding and risk-based decision-making.

Here are some examples of how process steps are tied to CQAs and why it’s important to control them early:

1. Does your ultra-filtration step reduce your concentration?

   1. Concentration is a CQA, so you’d want to control or adjust this step.

2. Does your antibody lose binding affinity after storage?

   1. Binding is a CQA, so you’d need to carefully evaluate stability temperatures and times.

3. Does a purification step fail to remove impurities?

   1. Certain residuals are CQAs, so that step may need to be replaced or another purification step added.

4. Does a candidate cell line lead to a less ideal glycosylation pattern?

   1. Post-translational modification may be a CQA, so a different cell line may need to be selected.

As you can see, once a CQA is defined, any part of the process that impacts it is carefully studied and tightly controlled. This leads directly into another term for a future week… a critical process parameter (CPP)!

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Let’s get into this week’s cup of biotech tea.☕ If you only have time for one this week, I’d start with #2!

P.S. Just click on the arrow, and you’ll jump to the section.

• Pfizer Lyme vaccine misses the mark but is applying anyway ➡️

• Semen-derived exosomes may have edge in ocular delivery ➡️

• Microneedle patch technology pivots to GLP-1 delivery ➡️

• The NIH continues to push toward non-animal models ➡️

• An Indian health influencer is demanding more GLP-1 data ➡️

• Bonus (paid): different types of drugs and what that classification is called ➡️

1. Story I’m Watching

The Tea: Pfizer’s Lyme vaccine (LB6V) narrowly missed its primary endpoint because there were too few Lyme cases but they are preparing to submit to the FDA anyway!

Despite enrolling thousands of patients in the VALOR study, the number of participants that developed Lyme disease was so low the confidence interval of the efficacy results went outside the predetermined passing range. Regardless, Pfizer has stated that they are preparing to seek approval, given how promising the results appeared to be. The vaccine was over 70% effective at reducing Lyme disease after 4 doses compared to placebo. I am particularly curious to see how CBER responds.

A few more sips:

• LB6V is a 6-valent recombinant protein vaccine targeting the surface protein (OspA) of the bacteria responsible for Lyme disease, Borrelia burgdorferi. You may see it referred to as VLA15 - this was its original name when it was initially developed by Valneva. LYMErix was a vaccine available for Lyme disease in the 90s but was discontinued in 2002. LB6V covers 6 relevant bacteria strains while LYMErix only covered 1.

• This took a big hit on Valneva’s stock while not doing much to Pfizer’s.

2. From the Bench

The Tea: Researchers in China recently discovered a potentially new, non-invasive way of delivering drugs to retinal cells (back of the eye). Get ready for it (it’s a little head tilting at first but stick with me). Zhao et. al wondered if the high penetration ability of sperm in a female reproductive tract could be translated to getting through the biologically complex back part of the eye (a known challenge in the field). Exosomes (lipid spheres) derived from pig semen (SEVs) were used to deliver a therapeutic payload to retinoblastoma cells through eye drops. The results were exciting. The SEVs were able to carefully navigate the tight-junctions (think narrow alleys between cells) of many of the ocular segments to deliver their payload without causing structural damage. This finding opens up the potential to further develop non-injection-based treatments for eye diseases!

A few more sips: One of the most valuable findings from this research was the evaluation of the unique peptide signature of the SEVs. Future work in this space will rely on reverse-engineering these exosomes and optimizing them further. Through proteomics they specifically looked into proteins associated with reproductive barrier penetration (PTGDS and ACRV1) and tight-junction regulation (like EGFR). Interestingly they did NOT find that higher amounts of reproductive barrier proteins in the SEVs resulted in better delivery of the therapy. They DID find that endothelial growth factor (EGF) likely plays a role in the exosome successfully transporting to the back of the eye.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: A classic story of rejection followed by pick-yourself-off-the-floor success. A few years ago, a startup named Vaxxess partnered with AstraZeneca (AZ) to see if mRNA vaccines could be delivered with their novel microneedle patch technology platform. AZ ended their partnership with Vaxxess last year. But instead of giving up, Vaxxess pivoted. They renamed themselves Terrestrial Bio and just got $50mil in Series C funding to deliver GLP-1s using their platform. First up? A Phase I trial to deliver Semaglutide through the patch, eliminating the less-than-ideal routine injection patients have to endure when on this medication.

A few more sips: The microarray used in their patch is soluble, dissolving into the body after removal. The pig pre-clinical data that landed them the recent success demonstrated that bioavailability was comparable to subcutaneous injection and they were able to achieve a slightly higher max concentration. Can you imagine how much this could change the GLP-1 scene if it works well?

4. The Rulebook

The Tea: The NIH continues to emphasize that it wants animal models as much a thing of the past as possible. Both to improve clinical predictability (as we know animal models often fail to translate well to humans) and for ethical reasons. This month they announced that they have invested $150 million to labs across the country, toward the infrastructure of implementing New Approach Methodologies (NAMs).

A few more sips: I spent quite a bit of time clicking through the NIH and FNIH websites until I felt like I had a decent understanding of all that’s going on around NAMs right now. Here’s the general pipeline as far as I can tell:

Keep an eye out for the announcement of the 3-year Reduction to Practice projects as well as efforts to define regulatory standards through the Validation & Qualification Network (VQN).

5. The Human Side

The Tea: Semaglutide just went-off patent in India and the country is about to be flooded with generics (estimates say 40 - 50)! If that wasn’t a recipe for disaster already, the BMI cut-off that the FDA set for using Semaglutide to reduce cardiovascular (CV) risk (BMI of 27) is too high for South Asian groups. But no Indian specific clinical data has been collected. An Indian health influencer and CEO/Founder of FITTR, Jitendra Chouksey, is demanding more from Indian Regulators and filed a court petition for more data last June.

“The drug patent in India has expired already and now GLP-1 drugs are 10-20x cheaper. No pharmacovigilance, no greivance redressal. What could possible go wrong? Best of luck to all the news channels, doctors, hospital formularies. Some serious money and damaged patients coming your way! 😇😀” - J. Chouksey

A few more sips: It is estimated that nearly half of at-risk Indian adults are below BMI 27. Compared to White populations, South and Southeast Asian populations accumulate visceral fat (increasing CV) younger and at lower BMIs. But the trial that set the BMI threshold, SELECT, enrolled over 10x more white participants than Asian. Indian regulators have not yet determined what their cut-off will be or if they plan to study it further. They are expected to respond to Jitendra’s concerns about the lack of Indian-specific clinical data at the Delhi High Court on May 21st. Diversity in trial design is critical for global markets.

Biotech Term of the Week

Helping you speak biotech.

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Modality

non biotech synonym: type of a drug

A modality is the type of medicine used to treat disease. Each type has a unique biological mechanism and structure. Here are some examples:

• Gene Therapies

• Cell Therapies

• Antibody Drug Conjugates

• Small-molecules

• Peptides

• RNAi Therapies

Many companies focus in on one, or a handful. Each comes with it’s own unique challenges, manufacturing process, and analytical requirements (tests that need to be done to characterize and release the batches). As science advances, the list of modalities just continues to increase. Sometimes an entire new modality is added. Other times a modality splits into two (or more) as the mechanism becomes more specific and defined. An example of this is with antibodies:

• Antibodies

  • monoclonal

  • bispecific

  • antibody-drug conjugates

  • nanobody

  • probody

  • …

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You’ll now see “The Tea” & “A few more sips” within each section. The first provides you the most important thing to know and the second a bit more detail if you’re interested!

Let’s get into this week’s biotech tea. ☕

1. Story I’m Watching

The Tea: The American Academy of Pediatrics (AAP) won a lawsuit against RFK Jr. reversing changes made to vaccine policy over the past year. A federal judge ruled that dismantling the original Advisory Committee on Immunization Practices (ACIP) and implementing new vaccine recommendations violated federal procedures.

While ACIP doesn’t directly shape biotech development, the ruling reinforces that following established procedure is essential to credible outcomes. This is a win for science!

A few more sips: Here is a nutshell timeline of the ACIP changes over the last year.

• June 2025: RFK Jr. replaces the ACIP committee with hand-picked members, raising concerns about anti-vaccine bias.

• January 2026: Major changes to the child vaccine schedule are announced, reducing the number of diseases covered from 17 to 11.

• March 2026: A federal judge rules in favor of the AAP lawsuit, reversing changes implemented since June 2025. You can listen to an interview with the lawyer behind the case here (conducted by ).

In the opening remarks, Judge Brian Murphy wrote:

“‘Science’, like law, ‘is far from a perfect instrument of knowledge’. - Carl Sagan. Nevertheless, science is still ‘the best we have’. ‘Procedure is to law what scientific method is to science.’”

2. From the Bench

The Tea: CytomX announced positive Phase I data for Varseta-M, a “masked” antibody-drug conjugate (ADC) in the treatment of late-stage colorectal cancer. Unlike traditional ADCs, these “masked” ones are designed to only bind to tumors, not healthy tissues. This “Probody” technology takes advantage of high concentrations of proteases in a tumor microenvironment to “unmask” the binding domain. In the image below you see a masking peptide cleaved in the presence of protease enzymes in tumor tissue, activating it.

A few more sips: I audibly gasped when I saw this because yours truly did her PhD on protease-activatable AAV gene therapies for ovarian cancer! My advisor, Dr. Junghae Suh, built an entire wing of her research with the goal of engineering a protease-cleavable sequence into the capsid protein of AAV, such that it blocked cell-binding unless it was cleaved - rescuing binding! Clearly I’m biased, but I think this is such a fun bioengineering approach. But back to CytomX! They have an entire pipeline with this Probody technology. It includes ADCs, T-cell bispecifics, and cytokines. I will be keeping an eye on what they do.

Message me if you have a recent science development you’d like to see featured!

3. Bio[Tech]

The Tea: Eli Lilly and Nvidia recently announced LillyPod, the largest supercomputer owned and housed by a pharma company!

*I was happy to hear that they plan to fuel it with renewable energy!

LillyPod will be used for things like digital twin modeling (read more about that below) but also molecular discovery research (designing new drugs) using their massive internal datasets from decades of research.

Eli Lilly reported that the use of AI and digital twin technology resulted in big increases in GLP-1 production last year and they are making moves to stay on top.

“We literally made more product last year than we possibly could have without AI.” - Diogo Rau, Lilly’s CIDO

A few more sips: Have you heard of a digital twin? It’s a digital mirror of a process or product that runs simulations to optimize performance. Think Manufacturing Sims. With a digital twin scientists can test far more design conditions or process parameters than would be practical manually. The simulations don’t always perfectly match reality, but they can narrow down on promising directions. For Eli Lilly, it ended up being really useful.

4. The Rulebook

The Tea: The FDA released a new guidance document that will make it easier and cheaper to develop biosimilar drugs.

A biosimilar is like a generic, in concept. Both are “off-brand” versions of the brand-name drug (reference product) once it is no longer protected by its patent. The major difference is that a generic is the term for an “off-brand” chemically synthesized small-molecule drug (like acetaminophen), whereas a biosimilar is an “off-brand” living cell produced biological drug (like an antibody therapy).

Biosimilars improve patient access by increasing options and potentially reducing cost. To date, 82 biosimilars have FDA approval.

A few more sips: The new Revision 4 guidance replaces the 2021 version. The update loosens requirements for the reference material that is used during development to allow the use of non-U.S.-licensed comparators without extensive bridging studies. For example, a company developing a Humira biosimilar could potentially use EU-authorized Humira in a study if they can analytically justify that it’s comparable. This update seems like a reasonable move to try and save time and money without sacrificing quality.

5. The Human Side

The Tea: In this thought-provoking piece, neurologist and medical ethicist Jason Karlawish uses surrealist art to help readers imagine what living with dementia might feel like. We all likely know or have known someone living with dementia or Alzheimer’s. The lessons learned from this article feel important to being able to step into their shoes.

A few more sips: His opinion piece does a wonderful job giving examples of patient experiences and how parts of them might feel like one does looking at surrealist art. A piece like the collaborative drawing Exquisite Corpse (above) forces viewers to interpret strange, fragmented images that blur the boundary between the conscious and unconscious. Karlawish suggests this experience mirrors what many dementia patients describe: disorientation, hallucinations, and altered sensory perception that can make the world feel uncanny and frightening.

“Perhaps surrealism — because it helps us feel what it is like to live with dementia and offers clever, subversive ways to live creatively with it — might make living with dementia not so unpleasant.” - Jason Karlawish

Biotech Term of the Week

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Route of Administration

Non-biotech synonym: how a drug is delivered

Every drug candidate can potentially be developed for multiple diseases. That may mean that the active ingredients are the same but the dosing will likely change and so may the way it’s delivered to the patient. Here are some of the most common routes of administration:

• Intravenous (think chemotherapy infusion)

• Oral (think acetaminophen pill)

• Intramuscular (think mRNA vaccine)

• Inhalation (think asthma inhaler)

• Transdermal (think nicotine patch)

Here are some less common routes of administration that can be used for delivery to particular tissues:

• Intrathecal (into the cerebrospinal fluid)

• Intravitreal (into the body of the eye)

• Intratumoral (into a tumor mass)

• Intracerebral (into brain tissue)

While we often think about the research and design of the drug itself, the way it is delivered can be equally important. If the drug doesn’t get to the part(s) of the body it needs to get to, it won’t be therapeutic.

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So without further ado…

Story I’m Watching

What caught my attention this week.

A little piece of my soul lights up when I see a positive AAV gene therapy readout. I studied AAV in my PhD and spent the first few years in industry working on AAV clinical candidates. This week Ultragenyx announced positive Phase 3 data for it’s AAV8 gene therapy drug for the treatment of a rare metabolic disease, ornithine transcarbamylase (OTC) deficiency.

OTC is an enzyme that helps prevent ammonia buildup in the liver.

The early readout indicated a statistically significant reduction of plasma ammonia compared to placebo (18%, p = 0.018). The second primary endpoint, a reduction in treatment burden, will not readout until next year.

While not the point of the Phase 3 trial, there were no big safety concerns, in line with the good safety profile from the Phase 1 and 2 trials. This is exciting to see, because AAV gene therapies have had a rocky start in the last decade, often because of off-target safety concerns. I look forward to seeing the final results next year!

From the Bench

An exciting science update.

Have you heard of the the Sec61 complex? It’s an important translocation channel protein in the endoplasmic reticulum (ER) membrane that mediates key steps of the secretory pathway of produced proteins. The French biotech company, Enodia Therapeutics, as well as California based Kezar Life Sciences are exploring drugs that modulate Sec61 to try and reduce the production of disease-relevant proteins. Kezar has a broader pipeline while Enodia is more Sec61 focused.

The news this week? Enodia is acquiring Kezar’s preclinical Sec61 program for $1 million. The molecule, KZR-540, selectively blocks PD-1 (another well-known anti-PD1, though not an Sec61 modulator, is Keytruda).

In January Enodia announced that they raised over $20 million to advance their work in this space with machine learning. It seems like the work to make these small molecule modulators specific to disease proteins may be possible but is very challenging.

Bio[Tech]

An advancement worth noting.

This news broke a little earlier this year but when I came across it again this week I knew I wanted to cover it. Doctronic, a New York based digital health startup, is running a pilot program in Utah to test a closed-loop AI agent that can independently refill patient prescriptions.

What is closed-loop? Think of it like a thermostat. Information is provided (temperature is read), decision is made (turn the heater on). Tools like CoPilot or ChatGPT are open-loop systems - they provide information but do not act on it.

Closed-loop AI systems in healthcare are proceeding with a lot of caution but companies like Doctronic and UpDoc believe they are the way for AI to truly transform healthcare workflows. Doctronic, outside this pilot in Utah, provides AI consultations for patients since January 2025. In a pre-print they recently released they found that with an n=500, the AI bot diagnosis agreed with a clinician only 81% of the time while the treatment plan matched 99% of the time.

The Rulebook

An important standard or regulatory development.

The United States Pharmacopeia (USP) has been busy! They released

• 6 new Reference Standards (hm maybe this week’s biotech term of the week)

• 11 Analytical Reference Materials

• and 46 Pharmaceutical Analytical Impurities.

What does this mean? Let’s start with a quick get-to-know-you of the USP. It’s a private, non-profit scientific organization that develops standards for companies to use to harmonize drug production. They develop both documents (recommendations) AND physical materials used as analytical controls with the goal of making drugs developed and tested in a more harmonized way. The idea is that consistency improves quality. Each new reference standard or impurity material helps analytical labs around the world confirm that medicines meet the same quality bar.

Importantly, the USP releases documents (recommendations) and material on a continuous basis. I want to draw attention to it so you better understand that standards like this exist for drug development.

The Human Side

A patient or scientist perspective worth highlighting.

Jenna Norton, is a health equity and public health scientist that has worked in the NIH as a program officer. She is currently on administrative leave.

In this opinion article, Jenna shares her experience being a whistleblower from within and encourages scientists to embrace activism. Last year she began speaking up internally about consequences to the cuts in funding and eventually moved to getting more public support. Did you hear about the Bethesda Declaration? It was an open letter organized by Jenna written to NIH Director Jay Bhattacharya. It was signed by hundreds of her colleagues as well as other non-NIH scientists, voicing concern.

“For about 80 years, most fields of science enjoyed bipartisan support, allowing scientists to cling to an “apolitical” fantasy. But the scientific community can no longer afford to avoid politics when science is under attack… Scientists can start to demonstrate authenticity by remaining resolute in our values: truth, accountability, freedom of ideas, open debate, transparency, and public good.” - Jenna Norton

Biotech Term of the Week

Helping you speak biotech.

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Reference Standard

non biotech synonym: calibration material

A reference standard, is a highly understood batch of drug that can be used to compare all other batches to. This is critical for maintaining consistency, and like discussed above (in The Rulebook), consistency improves quality. Some reference standards are manufactured by individual companies, some are created by the USP, and some are even made by the FDA.

An example you might find interesting: Labs at the FDA work to make large batches of the recommended Influenza antigens to use as important references for testing seasonal flu vaccine batches.

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Most of you probably know—but maybe some of you don’t—that I’ve worked as an industry scientist since 2019, after finishing my PhD. I’m part of an analytical development team at a large biotech company based in Boston. I love the work I do there.

Over time I’ve realized that the biotech industry can feel like a bit of a black box to people outside of it. My hope is that The Biotech Tea can help open that box—keeping those of you interested in biotech up to date on what’s happening, through the lens of a scientist who gets to see the inside.

A quick description of the newsletter - I’ve decided on 5 key pillars that will be covered each week and 1 bonus content for paid subscribers.

1. Story I’m watching: what caught my attention this week.

2. From the Bench: an exciting science update.

3. Bio[Tech]: an advancement worth noting.

4. The Rulebook: an important standard or regulatory development.

5. The Human Side: a patient or scientist perspective worth highlighting.

   and bonus for paid…

6. Biotech Term of the Week: helping you speak biotech.

As always, I appreciate you being here and hope that you find this perspective on science and public health updates to be helpful.

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So without further ado…

Story I’m Watching

What caught my attention this week.

Have you heard the names Şahin and Türeci before? If you follow any science communicators since the pandemic you likely have because they are some of the key scientists behind mRNA vaccine technology. They are co-founders of BioNTech, most well known for COMIRNATY, the COVID-19 mRNA vaccine developed with Pfizer. From their recent announcement it seems like these two remarkable innovators are looking to step away from late-stage development and commercialization (which is the usual bread and butter of larger companies) to go back to early-stage research (more a start-up or small-company focus).

“Özlem and I are ready to become pioneers once again.” - Şahin

Excitingly, they plan to start a new company focused on next-generation mRNA innovations. I will be watching for it to get started and look forward to seeing what comes out of it!

From the Bench

An exciting science update.

A paper published this week in Nature demonstrated a new method (dubbed INSTALL) for safely incorporating large sequences of DNA into genomes.

What’s new about it? Circular single stranded DNA (cssDNA) as opposed to double-stranded DNA (dsDNA).

And why does that matter? dsDNA detected in the cytoplasm of a cell triggers the innate immune system. cssDNA, on the other hand, is able to evade the cellular immune triggers.

The team behind this work was inspired by certain bacteria and viruses that are able to naturally insert cssDNA into double stranded genomes and they developed a method for doing so in human cells!

“This is beautiful work that addresses in an elegant way one of the big challenges with controlled DNA insertion into the genome,” Kiran Musunuru, M.D., Ph.D., co-founder of Verve Therapeutics and a scientist at the Children’s Hospital of Philadelphia and the University of Pennsylvania.

Bio[Tech]

An advancement worth noting.

Meet Spectris, a sensory stimulus device developed by Cognito, worn on the head for the treatment of Alzheimer’s Disease.

For some context: the only two treatments on the market for Alzheimer’s are from Eli Lilly (Kisunla) and Eisai/Biogen (Leqembi) - both targeting amyloid-β. Importantly, these are both pretty new to the market (within about 3 years) and nothing existed for treatment before.

So what about Spectris? Data from a 673 person randomized control trial is nearing completion and results should be in later this year. The company says they’d be looking to file through the de novo pathway hopefully later this year with it available to patients, assuming it is approved, by mid-2027.

I will be watching for the data and will report back when I hear!

The Rulebook

Am important standard or regulatory development.

Earlier this week the FDA announced the launch of a new adverse event look-up tool - AEMS, short for Adverse Event Monitoring System. The idea is to have a single streamlined dashboard for drugs, biologics, vaccines, cosmetics, and animal food. Reporting will need to transition to AEMS in the coming months and historical AE data will be migrated over.

What are my thoughts? If structured well, a centralized location for AEs would make data analytics easier. I think my concern lies with the both:

1. The data quality of the original databases

2. The quality of the data migration

I have been involved in some massive documentation migration initiatives at work (moving from an old document system to a new) and the effort was no small task. Historical data is often missing important metadata that makes it hard to properly categorize in new systems. We already know (from ample pandemic exposure) that VAERS reports can be entered by anyone, and the idea of cleanly migrating that data over sounds impossible.

The following paragraph from EndPoints News further suggests that data coming from VAERS will lead to data bias.

“The CDC began to include secondary reports in the database last year — instances in which a VAERS report for the same person, vaccine and dose came from a second independent source. The agency warned that these would show up as additional reports in the database, which could be misleading in a raw tally.”

I will be watching for more information!

The Human Side

A patient or scientist perspective worth highlighting.

I was thrilled to see this opinion piece by a dear friend and fellow scientist, Liz (Dr. Elisabeth Marnik), last month. Titled ‘I Grew Up Unvaccinated. Now I’m an Immunologist.’, Liz eloquently describes the perspective of her mother when she chose not to vaccinate her children. It’s a beautiful story meant to teach us about how important it is to communicate science with empathy.

“When I hear stories about children getting sick from measles, I feel angry. But not at the parents. I’m frustrated at those knowingly spreading false and misleading claims, and profiting from it. Shaming and dismissing parents who are confused and trying their best won’t change minds. Instead, it can drive people deeper into communities that validate their beliefs and create echo chambers filled with inaccuracy. We have to meet parents’ concerns with empathy. That’s where real change begins.” - Dr. Elisabeth Marnik

Biotech Term of the Week

Helping you speak biotech.

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RESIDUAL TESTING

non biotech synonym: looking for contaminants

When a batch of drug is made, it must go through a panel of tests to assess quality and consistency. This panel varies by drug depending on what it is an how it is made. “Residuals” are things that were introduced during the production process that aren’t intended in the final product but even after careful steps to remove, may exist in small amounts.

“process-related impurities that remain from manufacturing but should be removed or controlled before release”

Residuals can be things like solvents used during synthesis (e.g. ethanol, dimethylformamide) or reagents used during purification (e.g. enzymes, detergents). For biologics residuals expand into things that can come from the production cell line (e.g. host-cell protein, host-cell nucleic acid, endotoxins).

Regulatory agencies set clear limits on each residual based on known toxicity of the residual, dose of the drug in the patient, and the route of administration (how it will be delivered).

What’s my experience with residual testing?

I have helped oversee the development of residual DNA methods and have seen the development of residual protein methods. The goal for any method, but particularly for residual methods, is to develop something with incredible accuracy and precision with a very low threshold so we are able to pick up even the smallest amounts.

Importantly, not all DNA or protein is equal. If there is concern that a particular sequence or peptide may be present that has some known toxicity or mechanism of action, development groups (ahem analytical development) will design methods to look for them so risk assessments can be done early. Communication with regulatory agencies is fluid to set the right limits for residuals.

Here’s an article on residual testing if you’d like to read more.

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You could call me the queen of SparkNotes.

I’ve always loved finding the most concise language or structure to best remember a concept or theory. I like looking at a piece of work and using it as a tool for understanding or implementation. And for some reason, that seems to be the only way I can write now. When writing, I almost always start with an outline of information.

Introduction,

point number one,

point number two,

point number three,

conclusion.

Over the years it’s become clearer to me that, while my ability to write grammatically correct sentences is strong, I only really know one kind of writing - highly structured technical writing. Paired with a strong inclination to structure and consolidate information, I am finding it really difficult to write more narrative, creative pieces that tell a story to better connect with you. Most of the topics I tend to write about are also more technical by nature, but I know that with more experience I’d be able to talk about them in a more narrative way.

I rarely include emotion in my writing, and when I try, it feels exaggerated or unauthentic. I am hoping to learn how to better weave my messaging throughout a piece in a way that doesn’t feel like I turned an outline into paragraphs.

Admittedly, I really don’t write much, which is also probably part of the problem. When I do, it’s in small bits of time, at home, in a variety of locations that may not even be really that conducive to creativity. Right now I’m sitting outside in a lounge chair with a lap desk, in 40 degree weather, with a coat on, so I can keep Toulie (my sweet pup) company in our backyard. I’m fighting the urge to give up on a writing course (even though I just started) because I can’t tell if it will even help me and I’m feeling like I may be wasting some precious time. But I keep reminding myself that I’m being encouraged to write a one-page, single-space piece (as a part of this course) that will, at the very least, be writing practice. At most, it will be a poor writing piece compared to a much transformed piece in a few weeks.

So, for the next 2 months, I am hoping to write a few reflection pieces. I want to practice talking about things that aren’t just technical but include the personal. And for the record, this sounds so uncomfortable to me. But I also believe heavily in being bad at something before being good at it and I trust y’all to give me grace through this experience!

“Before you can be great, you’ve got to be good. Before you can be good, you’ve got to be bad. But before you can even be bad, you’ve got to try” - Art Williams.

I hope, by the end of the month, I will notice a difference - whether that’s a difference in the quality of my ability to write more narratively or just a difference in the amount of comfortability I have in doing it. (Hopefully both!)