Increase your IQ and understanding of the Biotech industry by listening to interviews with key business leaders who have built successful companies and departments. We discuss everything from the science, clinical operations, clinical development, safety/PV and more! We address how each function plays an important role in the drug approval process. We also discuss the people that make up these departments. Get ready to hear about cutting edge development and the people who make it happen!
Vaccine Durability, Diversified Pipeline, Winning Strategy - Seth Lederman, MD - CEO Tonix Pharmaceuticals
Seth Lederman is the CEO of Tonix Pharmaceuticals and a physician scientist with a two decades of research experience. Prior to becoming an entrepreneur, he was an Associate Professor at Columbia University. Dr. Lederman’s groundbreaking research led to the discovery of the CD-40 ligand and its role in T cell helper function. Currently, Dr. Lederman oversees Tonix Pharmaceuticals and its diverse programs that are aimed to develop therapeutics for chronic CNS and immunologic conditions, that include indications like fibromyalgia, Covid-19 and Long Covid, amongst others. Dr. Lederman earned an AB from Princeton University in Chemistry and an MD from Columbia University's College of Physicians and Surgeons. Dr. Lederman trained in internal medicine and rheumatology at Columbia's Presbyterian Hospital.
#27 How do you effectively manage the CMC process? With Doug Looker, PhD
Doug Looker is the VP of Operations with Validus Cellular Therapeutics. Validus is using cellular therapy to target infections by fighting the biology of antimicrobial resistance by activating the biology of the mammalian immune system. Doug walks us the through the process of establishing the CMC process that will drive success at every stage of the clinical trial process. And we have a brief discussion on animals being used in trials.
During the recording and editing of this episode Doug was the VP of Preclinical Development and Manufacturing at Amicrobe, Inc. Therefore the intro does not reflect his currrent position.
#26 How do you know the right path of development? Mike Rea, CEO - IDEA Pharma
Mike is the CEO of IDEA Pharma and author of the Pharmaceutical Innovation Index. He just launched a new company, Protodigm, that’s mission is to act as a pharma/biotech skunkworks that can test and troubleshoot drug development and avoid failure by determining the best possible development paths. Here’s the release.
He is an expert on all things drug development and has positioned 8 of the 15 biggest drug launches of the last 5 years. Mike is a contributor to Fortune, STAT, and Endpoints and also hosts his own podcast. https://podcast.ideapharma.com/
Mike also refers to Protodigm as a next generation CRO.
#25 Potential Tumor Immunity? Grant Yonehiro, CBO - Bolt BioTherapeutics
Grant is the Chief Business Officer with Bolt BioTherapeutics. Bolt Bio recently went public in February this year and announced a partnership with Genmab. Grant talks business development strategy and helping to navigate Bolt through their recent milestones.
Bolt Bio focuses on the development of ISACs – immune-stimulating antibody conjugates – which are anti-cancer drugs comprised of two main parts: a tumor targeting antibody attached to an immune system stimulant. This stimulant activates both the innate and adaptive arms of the immune system, potentially turning a “cold” tumor environment into a “hot” one. Their lead therapeutic candidate, BDC-1001, targets HER2+ tumors and is currently in Phase 1/2 trials.
#24 A fellowship program for biotech founders? Meet: Brazen Bio
The founders of Brazen Bio discuss how their program is helping potential biotech founders prove their concepts and launch their company. Be Brazen!
Shawn Carbonell, MD, PhD quit his neurosurgery residency to found his first biotech startup a decade ago. He had invented and developed a first-in-class cancer drug which is currently in phase 1 clinical trial.
Brent Witgen, PhD had been in big pharma for the past decade, with direct involvement in over a dozen drug and device regulatory filings across multiple areas of human disease. He has built high-performing biotech teams in the US, EU, and Asia.
Together they have recently launched Brazen Bio to help biotech founders advance human health. Brazen Bio is building a turnkey incubator program with state-of-the-art laboratory access, including specialized equipment, technical support, expert advisors and accommodation. Based in LA they are planning to run the first cohort of founders through the program this year.
#23 Targeting treatment related toxicities - Michael McCullar - CEO OnQuality Pharmaceuticals
Mike discusses the advancements that OnQuality Pharmaceuticals is making toward to the treatment of toxicities caused by cancer treatments. Mike also shares with us the challenges and importance of strong leadership in our evolving workforce.