Regulatory Articles
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Gap Analysis Fundamentals To Maintain Forward Progress
9/16/2020
Gap analysis—defined as the process of reviewing all the available information for a candidate product to assess current development status, identify potential gaps in information, and the subsequent steps required to develop a strategy to fill those gaps a fundamental and ongoing exercise. In a recent The Business Of Biotech podcast Dr. Valenzuela, CEO at Andes Biotechnologies, was joined on the podcast by Cristian Hernández-Cuevas, COO at Andes. Their collective reflections and advice on gap analysis execution provides real-world guidance for the leaders of emerging biopharma organizations.
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CMC Considerations For First In-Human Studies
9/16/2020
Dr. Edith Perez, Chief Medical Officer and Dr. Nathan Ihle, VP of CMC and Quality at Bolt Biotherapeutics, Inc. share their collective advice for emerging biotech leaders who are new to first-in-human studies.
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The Relationship Between GMP And CMC - And The Team That Ties It Together
9/16/2020
While GMP adherence might seem like a prescriptive series of boxes that biopharmaceutical producers are responsible for checking off, there’s a bit more strategy involved as it relates to a company’s overarching CMC (chemistry, manufacturing, and controls) strategy.
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The Data Quality & Master Files Challenge For FDA Submissions
9/16/2020
From its beginnings in 2016, Celularity Inc.’s Dr. Robert Hariri knew his company would face a particularly acute challenge with the FDA. The company’s therapeutic approach—the development of medicine from allogeneic placental-derived cells—is entirely dependent on its ability to do something that had never been done before: accomplish the at-scale harvest and preservation of healthy, postpartum fetal stem cells from maternity wards far-and-wide.
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Is It Time To Leave The Biotech Incubator?
6/8/2020
Kavitha Iyer Rodrigues, founder of Zumutor Biologics, Inc. offers experience-based insight into maximizing the value of incubation time, and knowing when it’s time to spread your wings and step out of the nest.
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Building An All-Star Biotech Team
6/8/2020
Building your biotech team isn’t easy, but it’s central to your value. In fact, Roivant Sciences founder and CEO Vivek Ramaswamy believes people are the most important ingredient for launching a biopharma company. Here he shares more about why finesse, not formula, should drive your hiring decisions.
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Finding Biotech Funding In Volatile Times
6/8/2020
Dr. Ben Zeskind founded Immuneering in 2008 as the economy spiraled into the Great Recession. Here, Zeskind tells us how he adjusted his fundraising strategy to build the foundation of a thriving company.
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Pitching Your Biotech To Investors
6/8/2020
Early-stage biopharmas find themselves in an increasingly crowded field of companies seeking capital, and the noisier the crowd gets, the harder it is to differentiate your science, your people, and your value proposition. Unless you’re extremely lucky or the spouse or offspring of a billionaire, successfully producing investor dollars from the story of your science, people, and value proposition is going to require a pitch deck and tireless energy to present it. Multi-time biotech founder Leslie Williams has been down this road more than once, and she’s got plenty of candid advice on building a pitch deck and preparing for the pitching process.
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Linking Biotech Value Creation And The Exit Strategy
6/8/2020
Dr. Francois Nader has taken multiple biotechs from non-factor to multi-billion-dollar exits. Here, Dr. Nader discuss the business side of biopharma, and more specifically, why it's important for emerging biopharma leaders to launch with the end in mind and what that means in the contexts of building company valuation and maximizing the exit.
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Soluble Versus Insoluble Expression In Microbial Fermentation
Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?