Peer AI - Medical Writing Platform for FDA Submissions - Life Sciences Today Podcast Episode 63

Peer AI - Medical Writing Platform for FDA Submissions - Life Sciences Today Podcast Episode 63

We’re excited to be back for another episode of the Life Sciences Today Podcast [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/] by Healthcare IT Today. My guest today is Anita Modi, Co-Founder and CEO at Peer AI [https://getpeer.ai/]. Peer AI is a medical writing acceleration tool for pharma/biotech regulatory teams, now repositioning as a “submission platform.” The authoring piece is the real product — the orchestration and prediction layers are newer and almost certainly less mature. The April 14, 2026, press release announcing they’re “now a platform” is the tell: two weeks ago, they were a document-drafting tool, and the Command Center + query prediction capabilities are fresh additions being marketed ahead of their maturity curve. The core wedge is medical writer productivity on large clinical documents for IND/NDA/BLA submissions. Every single attributed quote on their site is from a medical writer, head of medical writing, or regulatory VP — not from CMOs, not from heads of regulatory strategy, not from CEOs. That’s diagnostic. The buyer is a Head of Medical Writing at a mid-to-large biotech or pharma who is drowning in CSR and protocol drafts and can justify a tool that cuts 40-day drafts to 17. Check out the main topics of discussion for this episode of the Life Sciences Today podcast: * Tell us about your journey to Peer AI. * You started with medical writing being your primary customers, but are you moving up the chain now? * How do you create value for your customers? * A 2014 survey found that the average delay for resubmissions took 435 days. Have things gotten better on their own by now? * Do medical writers not write code anymore? Are they just writing specs for what they want to see as the end result? * In your new version, you talk about predicting queries. Tell me about that, how is it working? * How do you create value? * Unlike other startups, the budget is already on the table for you. What is that like? * What is your business model? How do you charge your customers? * Do you primarily work with drugs, or do you work with device companies as well? * What are three things you want to do for your customers in the next nine months? * Let’s say I’m a specialty CRO in Philadelphia who specializes in neurodegenerative diseases. I have 10 medical writers on my staff, and I want to fire all of them and hire you. Could I do that? * What is the biggest anti-pattern in your industry? Subscribe [https://dannylieberman.com/] to Danny’s newsletter to get strategic patterns for life science leaders building a defensible business. Be sure to subscribe to the Life Sciences Today Podcast on your favorite podcasting platform: * Apple Podcasts [https://podcasts.apple.com/us/podcast/life-sciences-today/id1801767332] * Spotify [https://open.spotify.com/show/1qlQQbaRm3jl3S34WshlkR] * iHeartRadio [https://iheart.com/podcast/270042330/] * Amazon Music [https://music.amazon.com/podcasts/dc745588-e430-4669-9863-ec601439b0a7/life-sciences-today] * Pandora [https://www.pandora.com/podcast/life-sciences-today/PC:1001099557] * YouTube [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2] Along with the popular podcasting platforms above, you can Subscribe to Healthcare IT Today on YouTube [https://www.youtube.com/channel/UCdEOObR3ZwgRNrwEjEsx3yg?sub_confirmation=1].  Plus, all of the audio and video versions will be made available to stream on Healthcare IT Today [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/]. As a former pharma-tech founder who bootstrapped to exit, I now help TechBio and digital health CEOs grow revenue—by solving the tech, team, and go-to-market problems that stall your progress. If you want a warrior by your side, connect with me on LinkedIn [https://www.linkedin.com/in/dannylieberman/]. If you work in Life Sciences IT, we’d love to hear where you agree and/or disagree with our takes on health IT innovation in life sciences. Feel free to share your thoughts and perspectives in the comments of this post, in the YouTube comments [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2], or privately on our Contact Us [https://www.healthcarescene.com/contact-us/] page. Let us know what you think of the podcast and if you have any ideas for future episodes. Thanks so much for listening!

Thirty Years of Free Therapy: Sanofi's Rare Humanitarian Program - Life Sciences Today Podcast Episode 62

We’re excited to be back for another episode of the Life Sciences Today Podcast [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/] by Healthcare IT Today. My guest today is Bonnie Anderson, Head of Humanitarian Programs, Rare Diseases at Sanofi [https://www.sanofi.com/en]. For more than 30 years, Sanofi’s Rare Humanitarian Program [https://www.foundation-s.sanofi.com/en/our-commitments/humanitarian-aid-medicine-donations] has provided free enzyme replacement therapy to patients with lysosomal storage disorders — Gaucher, Fabry, Pompe, ASMD, MPS I and II — in countries where no reimbursement pathway exists. What started in 1991 with a single drug for a single disease has grown to cover six diseases across 100+ countries, with more than 3,600 patients treated and over 1,000 patients active today. In this conversation we talk about what it actually takes to sustain patient access at this scale: how a physician in a country with no reimbursement initiates a request, how the program builds local diagnostic and treating capacity alongside the drug donation, and what changed in 2023 when Sanofi moved the review and approval workflow off spreadsheets and onto Bonterra’s grants management platform — cutting approval turnaround to under 36 hours. We also talk about what three decades of humanitarian access have taught Sanofi about running programs that outlast portfolio changes, M&A, and generational staff turnover. Check out the main topics of discussion for this episode of the Life Sciences Today podcast: * For someone who has never heard of the program, paint the picture — who is the patient, what disease do they have, and what would happen to them without this? * The program started in 1991 with Genzyme for Gaucher disease. What was the original decision inside Genzyme that created it, and does that still hold today? * Walk me through what happens from the moment a treating physician in a country like India or Egypt identifies a patient they think might qualify, through to the first infusion. Where does the physician meet the program? * The program is case-by-case, country-by-country. What does “case-by-case” actually mean in practice — what are the criteria, and what kinds of requests don’t get approved? * How does the program think about long-term commitment to a patient across decades of pharma portfolio changes and M&A? * One of the things that stood out in the Orphanet paper is that the program builds local clinical infrastructure — advisory boards, training, diagnostics — not just drug logistics. Why was that decision made early, and what does it look like in a country today? * Thirty years in, what does the program look like? Is it still there? Has it wound down? Has it evolved into something else as local capacity matured? * Before 2023, the review and approval workflow ran on email, spreadsheets, and PDFs. What did a bad week look like back then, and what was the moment you knew the manual process couldn’t scale? * You moved to Bonterra’s grants management platform in 2023. Approval turnaround is now reportedly under 36 hours. What does that delta mean for a patient and their physician? * A grants management platform wasn’t originally built for medical access programs — it’s CSR software. Why was that the right shape for this workflow, versus a purpose-built managed access platform? * What do you think about the cyber and privacy architecture of a program that crosses that many borders? * What is the biggest anti-pattern in your industry of humanitarian access? Subscribe [https://dannylieberman.com/] to Danny’s newsletter to get strategic patterns for life science leaders building a defensible business. Be sure to subscribe to the Life Sciences Today Podcast on your favorite podcasting platform: * Apple Podcasts [https://podcasts.apple.com/us/podcast/life-sciences-today/id1801767332] * Spotify [https://open.spotify.com/show/1qlQQbaRm3jl3S34WshlkR] * iHeartRadio [https://iheart.com/podcast/270042330/] * Amazon Music [https://music.amazon.com/podcasts/dc745588-e430-4669-9863-ec601439b0a7/life-sciences-today] * Pandora [https://www.pandora.com/podcast/life-sciences-today/PC:1001099557] * YouTube [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2] Along with the popular podcasting platforms above, you can Subscribe to Healthcare IT Today on YouTube [https://www.youtube.com/channel/UCdEOObR3ZwgRNrwEjEsx3yg?sub_confirmation=1].  Plus, all of the audio and video versions will be made available to stream on Healthcare IT Today [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/]. As a former pharma-tech founder who bootstrapped to exit, I now help TechBio and digital health CEOs grow revenue—by solving the tech, team, and go-to-market problems that stall your progress. If you want a warrior by your side, connect with me on LinkedIn [https://www.linkedin.com/in/dannylieberman/]. If you work in Life Sciences IT, we’d love to hear where you agree and/or disagree with our takes on health IT innovation in life sciences. Feel free to share your thoughts and perspectives in the comments of this post, in the YouTube comments [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2], or privately on our Contact Us [https://www.healthcarescene.com/contact-us/] page. Let us know what you think of the podcast and if you have any ideas for future episodes. Thanks so much for listening!

Building Companies at the Edge of Science and Market - Life Sciences Today Podcast Episode 61

We’re excited to be back for another episode of the Life Sciences Today Podcast [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/] by Healthcare IT Today. My guest today is Jennifer Ernst, Co-Founder and CEO at Valion Bio [https://valionbio.com/] (formerly Tivic Health). Ernst has built companies at the intersection of breakthrough science and market opportunity — from Xerox PARC’s open innovation lab to printed electronics to bioelectronic medicine. As Co-Founder of Valion Bio, she took a handheld neuromodulation device from idea to FDA clearance in three years for under $3M, took the company public on Nasdaq, and executed a bold pivot into biopharmaceuticals.  In this episode, we dig into the hardest question in neuromodulation today: getting FDA approval is like base camp at Everest, and getting paid is reaching the summit — how do you get from base camp to the summit? And Ernst shares her remarkable journey from Xerox PARC to pioneering bioelectronic medicine — and what it really takes to build a business in neuromodulation. Check out the main topics of discussion for this episode of the Life Sciences Today podcast: * I think you’re the only person I know in the Life Sciences industry who has done devices and technology, and then pivoted from devices to biologics. Tell us about your journey. How did you make those transitions? * Is Valion Bio in good hands now that you’ve transferred over? * How many products does the company have in the portfolio right now? * For neuromodulation, getting FDA approval or doing a pivotal trial is like base camp at Everest — to get to market, you need to get all the way to the summit. How do you go from the base camp to the top of Everest? * The discourse in the public, on social media, and in the industry is that recruiting is a big problem. This seems to be true for certain areas of oncology, but not true for anything related to what you have done and chronic conditions. What do you think of that? * I saw an article out of the Weizmann Institute that claimed that they didn’t like Chinese Medicine, but Traditional Chinese Medicine has its own take on the body’s electrical signals. What do you think? * What do you think is the biggest anti-pattern in the neuromodulation/neuroscience space today? * What is next for you? Subscribe [https://dannylieberman.com/] to Danny’s newsletter to get strategic patterns for life science leaders building a defensible business. Be sure to subscribe to the Life Sciences Today Podcast on your favorite podcasting platform: * Apple Podcasts [https://podcasts.apple.com/us/podcast/life-sciences-today/id1801767332] * Spotify [https://open.spotify.com/show/1qlQQbaRm3jl3S34WshlkR] * iHeartRadio [https://iheart.com/podcast/270042330/] * Amazon Music [https://music.amazon.com/podcasts/dc745588-e430-4669-9863-ec601439b0a7/life-sciences-today] * Pandora [https://www.pandora.com/podcast/life-sciences-today/PC:1001099557] * YouTube [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2] Along with the popular podcasting platforms above, you can Subscribe to Healthcare IT Today on YouTube [https://www.youtube.com/channel/UCdEOObR3ZwgRNrwEjEsx3yg?sub_confirmation=1].  Plus, all of the audio and video versions will be made available to stream on Healthcare IT Today [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/]. As a former pharma-tech founder who bootstrapped to exit, I now help TechBio and digital health CEOs grow revenue—by solving the tech, team, and go-to-market problems that stall your progress. If you want a warrior by your side, connect with me on LinkedIn [https://www.linkedin.com/in/dannylieberman/]. If you work in Life Sciences IT, we’d love to hear where you agree and/or disagree with our takes on health IT innovation in life sciences. Feel free to share your thoughts and perspectives in the comments of this post, in the YouTube comments [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2], or privately on our Contact Us [https://www.healthcarescene.com/contact-us/] page. Let us know what you think of the podcast and if you have any ideas for future episodes. Thanks so much for listening!

How AI is Replacing the Microsoft Word Protocol - Life Sciences Today Podcast Episode 60

We’re excited to be back for another episode of the Life Sciences Today Podcast [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/] by Healthcare IT Today. My guest today is Scott Chetham, Co-Founder and CEO at Faro Health [https://farohealth.com/]. In this episode, I sit down with Chetham to explore why the clinical trial industry is still designing $100M+ studies in Microsoft Word — and what’s finally being done about it. Chetham shares his journey from the Gold Coast of Australia to the heart of San Diego’s biotech scene, and how two decades of hands-on clinical development experience led him to build an AI platform that can do in 60 minutes what previously took five experts three weeks. From a published Merck study showing $130M in cost avoidance to becoming the first company to automate study builds directly into Veeva, Faro Health is quietly becoming the backbone of protocol design for 6 of the top 10 pharma companies. We also dig into the future of vertical integration in drug development — from molecule discovery all the way through automated clinical monitoring. Check out the main topics of discussion for this episode of the Life Sciences Today podcast: * What is an Australian doing in the US, working in clinical development? How did that happen? * Tell us what you’re doing at Faro Health. * Who are your sponsors, and how do you create value for them? * How do you capture value? What is your business model? * What’s your superpower? * What are three things you want to do for your sponsors in 2026? * I’ve been thinking about vertical integration, on and off, for the past ten years. How great would that be? * What is the biggest anti-pattern in the industry? Subscribe [https://dannylieberman.com/] to Danny’s newsletter to get strategic patterns for life science leaders building a defensible business. Be sure to subscribe to the Life Sciences Today Podcast on your favorite podcasting platform: * Apple Podcasts [https://podcasts.apple.com/us/podcast/life-sciences-today/id1801767332] * Spotify [https://open.spotify.com/show/1qlQQbaRm3jl3S34WshlkR] * iHeartRadio [https://iheart.com/podcast/270042330/] * Amazon Music [https://music.amazon.com/podcasts/dc745588-e430-4669-9863-ec601439b0a7/life-sciences-today] * Pandora [https://www.pandora.com/podcast/life-sciences-today/PC:1001099557] * YouTube [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2] Along with the popular podcasting platforms above, you can Subscribe to Healthcare IT Today on YouTube [https://www.youtube.com/channel/UCdEOObR3ZwgRNrwEjEsx3yg?sub_confirmation=1].  Plus, all of the audio and video versions will be made available to stream on Healthcare IT Today [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/]. As a former pharma-tech founder who bootstrapped to exit, I now help TechBio and digital health CEOs grow revenue—by solving the tech, team, and go-to-market problems that stall your progress. If you want a warrior by your side, connect with me on LinkedIn [https://www.linkedin.com/in/dannylieberman/]. If you work in Life Sciences IT, we’d love to hear where you agree and/or disagree with our takes on health IT innovation in life sciences. Feel free to share your thoughts and perspectives in the comments of this post, in the YouTube comments [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2], or privately on our Contact Us [https://www.healthcarescene.com/contact-us/] page. Let us know what you think of the podcast and if you have any ideas for future episodes. Thanks so much for listening!

Israeli Medtech: Innovation Without an Ecosystem? - Life Sciences Today Podcast Episode 59

We’re excited to be back for another episode of the Life Sciences Today Podcast [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/] by Healthcare IT Today. My guest today is Shai Policker, Co-Founder and Managing Partner at Edge Medical Ventures [https://edgemed.vc/]! I sit down with Policker to challenge a provocative thesis: that Israeli medtech is trapped in a cycle of underfunding, walking-dead companies, and missed commercialization opportunities. I bring the data — $5.6B raised by 41 US medtech companies in 15 months, zero Israeli — and argue that the Israel Innovation Authority’s habit of writing small checks keeps entrepreneurs in perpetual poverty rather than building a self-sustaining ecosystem. Policker pushes back with a counter-model: Edge VC’s venture studio approach, which starts from validated unmet needs sourced from large medical device corporations, builds companies from scratch, and bridges Israeli innovation to US commercial operations through a first-of-its-kind partnership with the state of New Jersey. The result: Israeli R&D capital efficiency meets American go-to-market expertise. Our conversation covers the IAA’s evolving funding programs, why US investors still see Israel as a premier innovation hub, and what it actually takes to cross the ocean without crashing into the wall. Check out the main topics of discussion for this episode of the Life Sciences Today podcast: * Tell me about your journey. * Break it down for our audience – when you say ‘a venture studio’, ‘we’re more of a VC’, and ‘we’re more hands on’, what does that mean? * Were you with the Israel Innovation Authority (IIA) for a while? * How much money are you managing right now? * My controversial opinion is that as a citizen of Israel, I would like my government investing more in the ecosystem and less in helping VC’s make more money. I know you don’t agree with this – so what is your view? * Would Israel as a country be better off if the government was creating commercialization infrastructure? * What is, in your opinion, the biggest anti-pattern in the Israeli medtech industry? Subscribe [https://dannylieberman.com/] to Danny’s newsletter to get strategic patterns for life science leaders building a defensible business. Be sure to subscribe to the Life Sciences Today Podcast on your favorite podcasting platform: * Apple Podcasts [https://podcasts.apple.com/us/podcast/life-sciences-today/id1801767332] * Spotify [https://open.spotify.com/show/1qlQQbaRm3jl3S34WshlkR] * iHeartRadio [https://iheart.com/podcast/270042330/] * Amazon Music [https://music.amazon.com/podcasts/dc745588-e430-4669-9863-ec601439b0a7/life-sciences-today] * Pandora [https://www.pandora.com/podcast/life-sciences-today/PC:1001099557] * YouTube [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2] Along with the popular podcasting platforms above, you can Subscribe to Healthcare IT Today on YouTube [https://www.youtube.com/channel/UCdEOObR3ZwgRNrwEjEsx3yg?sub_confirmation=1].  Plus, all of the audio and video versions will be made available to stream on Healthcare IT Today [https://www.healthcareittoday.com/category/life-sciences-today-podcasts/]. As a former pharma-tech founder who bootstrapped to exit, I now help TechBio and digital health CEOs grow revenue—by solving the tech, team, and go-to-market problems that stall your progress. If you want a warrior by your side, connect with me on LinkedIn [https://www.linkedin.com/in/dannylieberman/]. If you work in Life Sciences IT, we’d love to hear where you agree and/or disagree with our takes on health IT innovation in life sciences. Feel free to share your thoughts and perspectives in the comments of this post, in the YouTube comments [https://www.youtube.com/playlist?list=PLNoGlaOHbDm2E8rWvMHSqtShowaKQJqV2], or privately on our Contact Us [https://www.healthcarescene.com/contact-us/] page. Let us know what you think of the podcast and if you have any ideas for future episodes. Thanks so much for listening!