Julien Willard, MD MPH
@julienwillard.com
Health economist | Ex-intelligence officer | 15+ yrs in life sciences strategy (ex-IBM, Accenture, World Bank) | Contrarian | linkedin.com/in/julienwillard/
When the FDA’s credibility is on the line and industry and patients are watching, Vinay Prasad’s back-and-forth only adds to the whiplash. The life scoences community can't afford it. endpoints.news/vinay-prasad...
Prasad returns to FDA, resuming head of CBER role
Vinay Prasad is back at the FDA, the latest move in his whipsaw tenure with the agency.
endpoints.news
August 9, 2025 at 5:00 PM
When the FDA’s credibility is on the line and industry and patients are watching, Vinay Prasad’s back-and-forth only adds to the whiplash. The life scoences community can't afford it. endpoints.news/vinay-prasad...
FDA just launched “PreCheck” — a new program to speed up U.S. drug manufacturing. Goal: get factories built faster with earlier FDA input on design, quality systems, and site inspections.
August 7, 2025 at 5:08 PM
FDA just launched “PreCheck” — a new program to speed up U.S. drug manufacturing. Goal: get factories built faster with earlier FDA input on design, quality systems, and site inspections.
The Sarepta case underscores challenges in leadership and communication within biotech. Vinay Prasad's insights reveal the complexities of navigating regulatory landscapes. Understanding these dynamics benefits future innovations in life sciences.
August 5, 2025 at 7:31 PM
The Sarepta case underscores challenges in leadership and communication within biotech. Vinay Prasad's insights reveal the complexities of navigating regulatory landscapes. Understanding these dynamics benefits future innovations in life sciences.
Novartis revolutionizes cholesterol management with Leqvio, an siRNA-based therapy. Administered twice a year in clinics, it ensures patient adherence by integrating into regular care. In trials, over 80% hit LDL-C targets. A game-changer for healthcare systems.
August 5, 2025 at 6:31 PM
Novartis revolutionizes cholesterol management with Leqvio, an siRNA-based therapy. Administered twice a year in clinics, it ensures patient adherence by integrating into regular care. In trials, over 80% hit LDL-C targets. A game-changer for healthcare systems.
AstraZeneca's Phase III results for BaxHTN show promise in reducing systolic blood pressure, while Mineralys advances lorundrostat for high-risk groups. Despite AstraZeneca's resource advantage, the true challenge lies in post-approval value maximization. Can Mineralys compete?
August 5, 2025 at 4:31 PM
AstraZeneca's Phase III results for BaxHTN show promise in reducing systolic blood pressure, while Mineralys advances lorundrostat for high-risk groups. Despite AstraZeneca's resource advantage, the true challenge lies in post-approval value maximization. Can Mineralys compete?
Sarepta keeps distributing ELEVIDYS for DMD despite FDA's informal pause request after three deaths linked to their gene therapy. This raises big questions: When do urgent needs outweigh safety? How much weight do informal FDA requests carry? Is this a strategic move or a risky gamble?
August 5, 2025 at 3:31 PM
Sarepta keeps distributing ELEVIDYS for DMD despite FDA's informal pause request after three deaths linked to their gene therapy. This raises big questions: When do urgent needs outweigh safety? How much weight do informal FDA requests carry? Is this a strategic move or a risky gamble?
Is Sanofi's $1.6B investment in Vicebio just about RSV/hMPV, or is it a strategic move to revolutionize combo vaccine development? Paying $1.15B upfront for a Phase 1 project suggests a focus on platform control. Could this reshape the future of immunization?
August 5, 2025 at 12:31 PM
Is Sanofi's $1.6B investment in Vicebio just about RSV/hMPV, or is it a strategic move to revolutionize combo vaccine development? Paying $1.15B upfront for a Phase 1 project suggests a focus on platform control. Could this reshape the future of immunization?
Thinking about how the FDA's focus on orphan drugs aligns with P4 medicine, yet reimbursement models still favor population health. With patent expirations looming, biopharma leans on quick revenue strategies. Until payment models evolve, P4 remains more concept than reality.
August 4, 2025 at 11:23 PM
Thinking about how the FDA's focus on orphan drugs aligns with P4 medicine, yet reimbursement models still favor population health. With patent expirations looming, biopharma leans on quick revenue strategies. Until payment models evolve, P4 remains more concept than reality.
America's shift from manufacturing to healthcare raises questions. Hospitals lead payrolls, yet productivity remains unseen. Despite high spending, life expectancy lags. We need new metrics focusing on real health improvements and scalable innovations, not just job numbers.
August 4, 2025 at 10:23 PM
America's shift from manufacturing to healthcare raises questions. Hospitals lead payrolls, yet productivity remains unseen. Despite high spending, life expectancy lags. We need new metrics focusing on real health improvements and scalable innovations, not just job numbers.
Seeing a dip in LinkedIn engagement? Not just you. I noticed delayed notifications and posts resurfacing weeks later. Checked for a shadowban—turns out, my content just isn't resonating. It's a challenge, but at least there's a tool to check visibility issues. Worth a look.
August 4, 2025 at 9:23 PM
Seeing a dip in LinkedIn engagement? Not just you. I noticed delayed notifications and posts resurfacing weeks later. Checked for a shadowban—turns out, my content just isn't resonating. It's a challenge, but at least there's a tool to check visibility issues. Worth a look.
Kendall Square's biotech scene is cooling down. LabCentral has open benches, a rare sight. Startups face no wait. The industry banks on biopharma thriving by 2026, but is optimism masking denial? Leadership stalls with short-term tactics, missing the personalized medicine shift.
August 4, 2025 at 8:23 PM
Kendall Square's biotech scene is cooling down. LabCentral has open benches, a rare sight. Startups face no wait. The industry banks on biopharma thriving by 2026, but is optimism masking denial? Leadership stalls with short-term tactics, missing the personalized medicine shift.
Biopharma's shift to late-stage focus is reshaping clinical research participation. Independent sites risk being sidelined. How will they adapt to the demands of Phase 3/4 trials? The landscape is changing, and resilience is key. What are your thoughts on this shift?
August 4, 2025 at 7:23 PM
Biopharma's shift to late-stage focus is reshaping clinical research participation. Independent sites risk being sidelined. How will they adapt to the demands of Phase 3/4 trials? The landscape is changing, and resilience is key. What are your thoughts on this shift?
Reading about the Senate report on pharma-backed telehealth raises more questions than answers. Are these prescription rates truly alarming without comparator data? Telehealth's growth is undeniable, but we need a deeper dive into its impact on patient care before jumping to conclusions.
August 4, 2025 at 5:23 PM
Reading about the Senate report on pharma-backed telehealth raises more questions than answers. Are these prescription rates truly alarming without comparator data? Telehealth's growth is undeniable, but we need a deeper dive into its impact on patient care before jumping to conclusions.
NIH limits grant submissions to six per year to enhance fairness and quality. While most submit fewer, high-output labs must now prioritize. This change targets review efficiency, not ambition. How will research teams adapt?
August 2, 2025 at 5:31 PM
NIH limits grant submissions to six per year to enhance fairness and quality. While most submit fewer, high-output labs must now prioritize. This change targets review efficiency, not ambition. How will research teams adapt?
Dr. Prasad steps down from FDA to focus on family, aiming to avoid distractions for the agency. His tenure brought key reforms, and Health and Human Services appreciates his contributions. Interesting to see how leadership changes impact ongoing efforts.
August 2, 2025 at 4:31 PM
Dr. Prasad steps down from FDA to focus on family, aiming to avoid distractions for the agency. His tenure brought key reforms, and Health and Human Services appreciates his contributions. Interesting to see how leadership changes impact ongoing efforts.
Just thinking about how the push for clean energy and a healthier environment is more than a trend—it's a fundamental human need. Investing in these areas isn't just profitable; it's essential for a better future. We've made seven investments so far, and more are coming.
August 2, 2025 at 3:31 PM
Just thinking about how the push for clean energy and a healthier environment is more than a trend—it's a fundamental human need. Investing in these areas isn't just profitable; it's essential for a better future. We've made seven investments so far, and more are coming.
Over 8 million Americans face neurodegenerative diseases like Alzheimer's and Parkinson's, yet effective treatments remain scarce. Investing in biotech could drive breakthroughs, offering hope and progress.
August 2, 2025 at 2:31 PM
Over 8 million Americans face neurodegenerative diseases like Alzheimer's and Parkinson's, yet effective treatments remain scarce. Investing in biotech could drive breakthroughs, offering hope and progress.
Biotech now demands understanding of economics and policy, not just biology. Navigating the IRA and pricing strategies has been challenging yet rewarding. Strategic insights often emerge here. Peter Kolchinsky's course sheds light on these intersections. Worth exploring.
August 2, 2025 at 1:31 PM
Biotech now demands understanding of economics and policy, not just biology. Navigating the IRA and pricing strategies has been challenging yet rewarding. Strategic insights often emerge here. Peter Kolchinsky's course sheds light on these intersections. Worth exploring.
Why do we keep saying investors just want to 'recoup' their investment in biotech? They aim for profit, not just breaking even. Let's shift the focus to the need for a return, not just covering R&D costs. It's about a broader portfolio investment strategy.
August 2, 2025 at 12:31 PM
Why do we keep saying investors just want to 'recoup' their investment in biotech? They aim for profit, not just breaking even. Let's shift the focus to the need for a return, not just covering R&D costs. It's about a broader portfolio investment strategy.
We often overlook the broader benefits of drugs when we focus only on their price. They boost productivity, ease caregiver strain, and drive scientific advances. By ignoring these, we risk delaying access and stifling innovation. Let's rethink how we measure value.
August 2, 2025 at 2:31 AM
We often overlook the broader benefits of drugs when we focus only on their price. They boost productivity, ease caregiver strain, and drive scientific advances. By ignoring these, we risk delaying access and stifling innovation. Let's rethink how we measure value.
Thinking about the 80% market adoption investors expect for new drugs. But what happens to the 20% left out? Their voices drive the push for price controls. Sustainable biotech investments can make medicines accessible to everyone.
August 2, 2025 at 1:31 AM
Thinking about the 80% market adoption investors expect for new drugs. But what happens to the 20% left out? Their voices drive the push for price controls. Sustainable biotech investments can make medicines accessible to everyone.
Why do critical drugs stay out of reach for those who need them most? Cambridge Associates' discussion with experts dives into this issue, exploring how to improve access and affordability without hindering innovation. Insightful thoughts on the market's challenges.
August 2, 2025 at 12:31 AM
Why do critical drugs stay out of reach for those who need them most? Cambridge Associates' discussion with experts dives into this issue, exploring how to improve access and affordability without hindering innovation. Insightful thoughts on the market's challenges.
Why is U.S. drug pricing so tangled? Market-based pricing, unique federal program rules, and regulatory ceilings all play a part. Manufacturers must strategize early to avoid access issues. Value-based models show promise, but fixed discounts still dominate.
August 1, 2025 at 11:31 PM
Why is U.S. drug pricing so tangled? Market-based pricing, unique federal program rules, and regulatory ceilings all play a part. Manufacturers must strategize early to avoid access issues. Value-based models show promise, but fixed discounts still dominate.
AI's getting closer to managing biotech funds. Companies should rethink communication strategies as people use AI to decode complex topics. Discussed Cidara Therapeutics' trial data with ChatGPT-3—insights are valuable for biotech firms and investors.
August 1, 2025 at 10:31 PM
AI's getting closer to managing biotech funds. Companies should rethink communication strategies as people use AI to decode complex topics. Discussed Cidara Therapeutics' trial data with ChatGPT-3—insights are valuable for biotech firms and investors.
Could AI soon manage biotech funds? Companies might need to rethink communication strategies as AI becomes key in interpreting complex data. I discussed Cidara Therapeutics' trial data with ChatGPT-3, and it made me wonder about the future impacts on biotech firms and investors.
August 1, 2025 at 9:31 PM
Could AI soon manage biotech funds? Companies might need to rethink communication strategies as AI becomes key in interpreting complex data. I discussed Cidara Therapeutics' trial data with ChatGPT-3, and it made me wonder about the future impacts on biotech firms and investors.