Business Of Biotech

We love to hear from our listeners. Send us a message. Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK has a few BTDs under its belt. Dr. Gupta is VP of Medicine Development at GSK and Dr. Ganeshan is formerly VP of Global Regulatory Affairs there, having recently joined Gilead as Head of Regulatory for Oncology. On this episode, we go deep on how to apply for--and win--breakthrough therapy designation with two women who couldn't be more qualified for the discussion.Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. Maintaining therapeutic integrity through cryopreservation and super cold supply chains have challenged, and continue to vex, biologics producers. On this episode of the Business of Biotech, Celyad Oncology Head of Cell Therapy Manufacturing Thomas Lequertier shares best practices for the cryopreservation of cell therapies while minimizing cell degradation, maintaining their integrity on the journey from the lab to the patient, and what the future holds for cold chain biologic therapy logistics. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. Revolo Biotherapeutics has entered phase 2 clinical studies of two molecules for autoimmune or allergic diseases that act to reset the immune system “upstream,” or ahead of the inflammatory cascade. On this episode of the Business of Biotech, Revolo CEO Jonathan Rigby shares the outsourced manufacturing strategy behind the endeavor, why it's so important to avoid immune suppression and how the therapies work to avoid it, and how the company managed to raise a $53 million Series B to fund development in the midst of a raging global pandemic.Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. As Leyden Labs Founder & CEO Koenraad Wiedhaup puts it, we breathe in galaxies of viruses on a daily basis. As those viruses multiply and mutate, our approach to mitigating their risks is largely reactive. That's why his new company is busy developing a prophylactic approach to protecting populations from a host of influenza and coronaviruses via a self-administered intranasal spray. Learn how the company came to be, how its development efforts were buoyed by a recent $40 million series A investment, and why Wiedhaup believes intranasal prophylactics are ready to play a role in prevention of the next pandemic on this episode of the Business of Biotech podcast.Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. Special-purpose acquisition companies, or SPACs, are all the rage as start-up financing vehicles go, and they're particularly well-suited for emerging biopharma companies. On this episode of the Business of Biotech, we dig deep into the advantages, limitations, and potential pitfalls of the SPAC with a man who was executing SPAC deals before SPAC deals were cool. Whether you're a biotech investor or a biopharma leader looking to acquire or be acquired, you'll want to tune in to this episode for insight into the special-purpose acquisition company strategy.Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. As leaders at Diamyd Medical made plans to manufacture clinical supply of therapies aimed at preserving and restoring insulin production in Type 1 diabetes patients, outsourced production was on the table. Then, the company doubled down on its intentions and built out its own manufacturing facility. On this week's episode of The Business of Biotech, Diamyd Medical President & CEO Dr. Ulf Hannelius tells us all about the therapies his company is developing, plus the why and the how behind the company's choice to manufacture them in-house. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. Kite Pharma Global Head of Technical Operations Chuck Calderaro joins the Business of Biotech for a conversation on a dichotomy in the CAR T-cell supply chain: the inherent source material advantages and subsequent logistical challenges associated with the distribution of cell therapies. Calderaro discusses the implementation of manufacturing automation at Kite, the manufacturing hurdles that remain, and reflects on the company's autologous and allogeneic roadmaps. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. When is the appropriate time for a new life sciences company to wind up the PR machine? What's the difference between public and investor relations, and how do they complement each other? What's newsworthy? What's not? What are the latest tools of the trade in an increasingly social-driven PR practice? What results should you expect, and how are those results measured? On this episode of the Business of Biotech, we address these questions with  physician and professor-turned public relations practitioner extraordinaire Matt Middleman, M.D. , founding partner and CEO at LifeSci Communications, LLC.Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. When the pandemic hit, Solis Biodyne found its manufacturing capacity stretched to its limit. In short order, it doubled, and then tripled, its manufacturing capacity. Then it doubled, and then tripled, its workforce. Meanwhile, it adopted a host of new platforms to serve the demand of its clients. Drs. Kadri Artma and Angela Vassa join this episode of the Business of Biotech to take us behind the scenes and tell us the scale up story that's allowing the renowned producer of reagents to the life sciences industry to meet market demands.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. BridgeBio has a whopping  18+ pre-clinical to clinical-stage candidates in its pipeline representing an impressive array of modalities and targets. It boasts a couple of commercial wins under its belt. The company is no stranger to developing business strategies for success. Central to that success are partnerships with scientists and researchers to fuel pipeline expansion. On this episode of The Business of Biotech, BridgeBio Chief Business Officer Michael Henderson, M.D. walks us through the formula behind the company's academia-led growth strategy. Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/