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Biotech—it's complicated. A successful product launch requires grit, determination, and clear direction. But let’s be real, the path to launch isn’t a straight one. There are curves, hard turns, and dead ends. Here’s the good news, you don’t have to navigate the complexities alone. Welcome to The Emerging Biotech Leader, where we help biotech leaders maximize the value of their therapeutics from clinical development to product launch.
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In this episode of The Emerging Biotech Leader, Chief Business Officer Kim Kushner and Dr. Carrie Brownstein, SVP Medical at SSI Strategy are joined by Dr. Chrystal Louis, Chief Medical Officer at TScan Therapeutics, to discuss how different professional experiences shape leadership approaches in the biotechnology sector. Dr. Louis brings extensive…
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As biotech innovation accelerates across therapeutic areas organizations face complex strategic decisions about their future. In this episode of The Emerging Biotech Leader, former EMA Director Dr. Thomas Lönngren offers insights into the market dynamics and organizational requirements that will define success in 2025. Several key themes emerged fr…
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When does a biotech need a Chief Medical Officer? "If you're asking, you probably needed one yesterday," suggests Dr. Benit Maru in this straight-talking episode of Emerging Biotech Leader. The SSI Strategy medical lead breaks from convention, arguing that early-stage organizations - particularly those in rare disease or novel modalities - can't af…
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Have you ever wondered what makes a great biotech CMO? In this episode of the Emerging Biotech Leader, Dr. Steven Zelenkofske shares the practical, hard-earned insights he’s gained from his five CMO positions and multiple board roles, offering straightforward advice on how CMOs can step in early, build strong executive relationships, and drive clin…
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The relationship between biotech leadership and their boards is evolving, particularly as private equity takes a larger role in the industry. In this episode of the Emerging Biotech Leader, Nick Amigone from Amulet Capital Partners offers a unique perspective on building effective board relationships from the private equity vantage point. The conve…
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How can biotech CEOs and their boards foster strong, trusting relationships that drive effective decision-making and long-term success? In this episode of Emerging Biotech Leader, host Kim Kushner explores this critical question together with Don de Bethizy. Don is a seasoned life sciences executive with over 30 years of experience, having served a…
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In this episode of "The Emerging Biotech Leader" podcast, host Ramin Frahood speaks with Helen Kargaryani, VP Global Head of Quality/Quality Services at SSI Strategy. With over 30 years of experience in the pharmaceutical and biotech industries, Helen shares her expertise on quality and risk management. Risk management in these industries is a crit…
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This episode offers critical insights on leveraging risk management as a strategic advantage in medical device development. In a conversation with Ramin Farhood, Bijan Elahi, with over 30 years of experience, provides a roadmap for integrating safety considerations into innovation pipelines, potentially accelerating time-to-market and enhancing com…
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The latest Emerging Biotech Leader podcast tackles the important topic of patient-focused drug development, offering valuable insights for the biotech industry. Our host Kim Kushner engages in an insightful dialogue with Dr. Laurie Smaldone-Alsup, SVP Regulatory Science at SSI Strategy, who brings years of hands-on regulatory experience to the conv…
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On this episode of Emerging Biotech Leader, Kim Kushner sits down with Edward M Kaye, M.D., CEO and director of Stoke Therapeutics, to talk about his work in rare disease drug development. Throughout their conversation, Ed describes the challenges of first-in-class drug development. He explains the importance of understanding diseases thoroughly an…
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Summary: In this episode, host Kim Kushner is joined by Dr. Chantal van Gils, a leading expert in evidence and value strategy at SSI Strategy. Building on the previous podcast discussion with Christian Howell of Cognito, this episode delves into three key themes:1) differing evidentiary requirements for medical devices versus pharmaceuticals, 2) th…
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This episode features an interview with Christian Howell, Chief Commercial Officer at Cognito Therapeutics, a biotech company pioneering a neurotechnology approach to treat Alzheimer's disease. Christian draws on his diverse background spanning the military, medical device giant Medtronic, and now the biotech industry. The conversation covers Cogni…
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Episode Overview: In this podcast interview, Ramin Farhood hosts Dr. Thomas Lönngren, an expert in drug regulation, approval, and market access. Thomas has an impressive career spanning over three decades, including a transformative tenure as the executive director of the European Medicines Agency (EMA). He currently serves as a strategic advisor, …
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In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhood interview Keith Gottesdiener, President and CEO of Prime Medicine. They discuss Keith's unconventional career path, which spans roles as a physician, research scientist, drug development leader at Merck for over 16 years, and entrepreneurial biotech CEO at R…
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In this engaging episode of the Emerging Biotech Leader podcast, Kim Kushner, Ramin Farhood, and Jackie Levine discuss the key lessons learned from the previous conversation with Dr. Dan Bloomfield, CMO at Anthos Therapeutics. The trio focuses on the challenges biotech companies face when building organizations with evolving goals, the important ro…
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In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhad speak with Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. Dan generously shares insights from his diverse career that has spanned academia at Columbia University, over a decade at big pharma giant Merck across multiple leadership roles, and…
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In this episode of the Emerging Biotech Leader podcast, hosts Kim Kushner and Ramin Farhad are joined by Bob Honigberg to further discuss the considerable challenge of achieving bold missions in healthcare. Building on their discussion from Episode 28 where they interviewed Cleerly Health founder Dr. Jim Ninh, the episode provides useful perspectiv…
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"I believe that we can eradicate heart attacks from this world...If we can leverage these tools to accomplish those three goals, whether it's in coronary heart disease, valvular heart disease, myocardial disease, et cetera, et cetera, I think that's going to not be a slight improvement. I think it's going to be a game changer in terms of improving …
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“I think outcomes for a lot of people means meeting milestones. So hitting that next clinical milestone, CMC milestone, et cetera, and that's, I think, one way of looking at it. Still, it's also about the culmination of outcomes and achieving something greater than bringing together one discipline and one win." ~ Adriana Valenciano, SVP, SSI Strate…
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“Getting a drug to market is a change journey. The whole process is a change journey. And we pass through so many different stages and gates on the way there: we need to adapt almost regardless of circumstances, even if everything goes according to plan, we have to shift.” Johan Stromquist, President, NDA Group As the quote above alludes, launching…
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“The reality is that the earlier one thinks about and invests in a safety process and a safety system, the more dividends that early thinking pays downstream.” Dr. Greg Fiore Harvard-Trained Physician. McKinsey Consultant. Startup Advisor. These are just a few of the titles that describe our next guest, Dr. Greg Fiore. As one might imagine, with th…
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“Safety doesn't live outside of you. It's not a yellow ribbon that you wear in hospitals that says, ‘it's patient safety week.’ It's not a sign in your office that says, ‘this is patient safety month.’ It's a consequence of how we approach our work on a day-to-day and hour to hour basis. And it's by definition, therefore, an emergent property of wh…
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“It's not always smooth sailing or a straight line path. So being able to address those different inflection points, being able to resource accordingly, flex in, flex out, and really focus on ‘what are the most important priorities?’ Make sure you're addressing those, the ‘must haves’ versus the ‘nice to haves.’” Jacqui Levine, Vice President, SSI …
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“You're actually able to make a difference, not just at your local level or your regional level, but much more on a global level. You know, you may be one of the lucky few that is able to get involved in guideline development and those guidelines are then applicable across the world.’” Benit Maru, Senior Vice President, SSI Strategy “Should I stay …
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“I will always have deep empathy for patients and want to do the best that I can, but I feel very satisfied that I'm driving development of OHB 607, which has the potential to change the trajectory. So, I don't have to sit and remind myself why I'm doing that–there are patients on the other end.” Victoria Niklas How can you break into biotech from …
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“There are clear distinctions, as we've talked about, between device and pharma from a medical affairs perspective. I think they each require this special touch and strategic medical affairs plan, but I think what we're also converging on is that they’re almost more similar than we think.’” Leah Damesek, Vice President of Medical Affairs, SSI Strat…
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“My primary advice is to get comfortable with discomfort right away and open your mind to how your particular skill set can benefit patients on this tremendously big scale.’” Shon Chakrabarti MD MPH, Vice President, and General Manager Chronic Venous Therapies, Inari Medical. Episode 19 of the Emerging Biotech Leader commemorates a milestone. This …
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“A lot of the work is in asking ‘how do we distill this down into the simplest, most digestible narrative that feels obvious when you hear it back?’” Kim Kushner, Chief Business Officer, SSI Strategy. Episode 18 of the Emerging Biotech Leader welcomes a new voice to the show: Kate Goldstein, Senior Vice President of SSI. Fresh off the heels of Epis…
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“I won't say that we had this all planned out because when I started, it was just a crazy idea that we were excited about, but it ended up working out really well where we're trying to create a new class of medicine with digital therapeutics or with prescription digital therapeutics.” Scott Xiao, Co-Founder and CEO, Luminopia. What’s possible when …
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“You may not have the resources as a CMO, especially with smaller biotech companies, but you have to be resourceful.” Ramin Farhood, Senior Vice President, SSI Strategy Every guest on the Emerging Biotech Leader builds on the insights from our previous contributors while also adding their own unique best practices, analogies and experience. In that…
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“The expansions of your expertise and your external network are two key fundamental things that one should be focusing on as you think about developing your career towards a CMO pathway.” Dr. Christopher Morabito, Astria Therapeutics. Welcome to this week’s Emerging Biotech Leader recap. In our previous Episodes, we touched on the topic of careers …
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In Medical Affairs, timing is everything. If we had to summarize this next Episode of the Emerging Biotech Leader in one sentence, it would be “a deeper dive on both the impact and importance of Medical Affairs,” inspired by our interview with Rachel Couchenour in Episode 13. But that single sentence alone wouldn’t convey the robust takeaways and m…
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“I've found that it's usually not the ‘what’ or the ‘how’ that will get me where I need to go with a Senior leader. It's the why. They want to understand the why behind it.” Rachel Couchenour, VP, Global Medical Affairs, Travere Therapeutics. Working cross-functionally. Some would call it a skill. Others would say it’s a talent. For our guest on Ep…
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“The good news and the bad news are the same news.” Rik Reppe, VP Digital, Acquis Consulting Group We are excited to announce a new service, Digital-Led Biotech Strategy, in partnership with Acquis Cortico-X. Through this service, our clients will get access to medical, business, and digital experts to maximize theraputic value through a digital-le…
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“The best leaders that I've seen are the ones that realize that it’s always “go, go, go,” and they need to move fast. But they still consciously take time to think, to pause a little bit and have a more of a multi-dimensional view of what's happening, as opposed to always being at a fast pace, moving forward and getting things done.” Ramin Farhood,…
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“I don't know any other leader that's had that type of prior steps in their careers. It almost feels like you need pieces of all those things to actually be a leader, you know, soldier, lawyer, investment banker. I'm sure they all came in handy.” Doug Locke, SSI CEO. Some biotechs are created from research and academia. Others are born from firstha…
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“Digital impacts our lives all the time in every way, including in medicine.” Jen Seda, M.D. The day of digital medicine is here. And while software and digital apps can be created rapidly, historically, the healthcare ecosystem has implemented change at a much slower pace. This contrasting combination, or tension as today’s episode describes it, p…
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As everyday consumers, we interact with AI (Artificial Intelligence) daily. Whether unlocking the home screen of our phones via facial recognition, using voice commands to send a text, or interacting with a chat tool when shopping online, AI adoption is continuous. But what is the role of AI in today’s healthcare? And how will AI impact medicine an…
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Digital biomarkers have opened up a series of questions worth contemplating as both newer and more mature biotechs evaluate the following: Are we measuring things correctly? What's inefficient about our clinical development process? What should we be thinking about to innovate for the future? And how do we democratize access to clinical trials and …
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Biomarkers themselves have been a part of medical research for decades. However, digital biomarkers have become increasingly important to the modern clinical development process. While the term “digital biomarker” is prevalent in discussions around investment, clinical trials, and measuring patient outcomes, a variety of questions surrounding digit…
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What does it take to launch a new class of medicine? When launching a new therapeutic, many unknowns exist, but some principles remain constant. By looking to past experiences and staying lean, emerging biotechs can derisk their organizations while hitting milestones by taking an agile team-building approach. Today’s guest is Adriana Valenciano, Se…
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What if there were a way to genetically engineer fungi species and transform them into human therapeutics to help with neurological disorders? Today’s guest, Dr. Usman (Oz) Azam, just launched a biotech, Empyrean Neurosciences, that is genetically modifying fungi to create therapeutics. Biotech is hard enough as it is, but what does it take to pion…
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Securing funding as an early-stage biotech is no easy feat. There are a few key strategies that help differentiate a funding thesis. What separates burgeoning initiatives from those that fail? Join today’s guest, co-founder, and CEO of SSI Strategy, Doug Locke, whose experience in entrepreneurship, investing, and advising biotechs and startup compa…
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When most people think about the path to becoming a CEO, they conjure up a straight climb up the corporate ladder, rung by rung. But that’s not the only way. In fact, a few detours along the way can provide you with valuable tools that broaden your perspective and launch you into executive roles at a young age. This was the case for Niren Shah, CEO…
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At biotech companies, things often evolve at light speed, and the natural tendency of a Chief Medical Officer (CMO) can be to try and manage every detail. But it’s a superhuman task, especially when powerful egos are in play. This episode of The Emerging Biotech Leader features: Dr. Ramin Farhood, Vice President of Medical Affairs, SSI Strategy Kim…
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Being Chief Medical Officer at an emerging biotech company can feel like draining the ocean with a dixie cup. No CMO can fulfill the duties of the medical office alone. Building a solid team is critical. In this episode, SSI Strategy’s hosts Dr. Ramin Farhood, Vice President of Medical Affairs, and Kim Kushner, Senior VP, spoke with Dr. Suku Nagend…
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Biotech—it's complicated. A successful product launch requires grit, determination, and clear direction. But let’s be real, the path to launch isn’t a straight one. There are curves, hard turns, and dead ends. Here’s the good news, you don’t have to navigate the complexities alone. Welcome to The Emerging Biotech Leader, where we help biotech leade…
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If you own a small business in California, you could get COVID grants up to $25 thousand dollars! On May 13, Governor Gavin Newsom proposed adding $1.5 billion dollars to a program providing grants of up to $25 thousand dollars to small business owners, which will help many more business owners to receive this grant. This relief program had $2.5 bi…
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Do you receive Social Security or Supplemental Security Income benefits? Then it’s important to make sure that you and your family are getting the stimulus money that you’re eligible for by filing your 2020 taxes immediately even if you do not normally file. Once you file your taxes, you will get all EIPs that you are eligible for through what is k…
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Governor Gavin Newsom plans to triple the state’s investment in the Golden State Stimulus by expanding the stimulus to middle-class families. Once his proposal gets approved, 2 out of every 3 Californians will be eligible for the new $600 and extra $500 stimulus checks if you qualify. This total of nearly 12 billion dollars of potential direct cash…
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