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57 minutes | Oct 1, 2021
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.https://www.tonixpharma.com/
29 minutes | Sep 21, 2021
#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.https://validustherapeutics.com/
55 minutes | Sep 1, 2021
#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.
52 minutes | Aug 11, 2021
#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.https://www.boltbio.com/ https://www.globenewswire.com/news-release/2021/06/02/2240329/0/en/Genmab-and-Bolt-Biotherapeutics-Announce-Oncology-Research-and-Development-Collaboration.html
38 minutes | Jul 16, 2021
#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. https://wefunder.com/brazenbio/https://www.linkedin.com/company/brazenbio/https://www.brazen.bio
47 minutes | Jul 9, 2021
#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. https://twitter.com/onquality_rxhttps://www.linkedin.com/company/onquality-pharmaceuticals-ltd/https://www.onqualityrx.com/
60 minutes | Jun 25, 2021
#22 Regulatory Affairs Strategy w/Dr. Jethro Ekuta - VP, Global RA
Dr. Ekuta helps to educate us on the function of regulatory affairs by sharing an acronym he calls RCI. Regulatory Requirements, Compliance, and Interaction. He shares how regulatory affairs professionals can had value to companies at all stages of the process, pre-clinical to post-market. Dr. Ekuta is currently the VP of Global Regulatory Affairs with Alexion Pharmaceuticals and is an accomplished RA and pharmacovigilance executive. Learn some of his secrets to regulatory strategy.
36 minutes | Jun 11, 2021
#21 Research and Development Tax Credits
Let's talk a little bit of tax and financial strategy! On this episode we have guests Derick Van Ness, a tax/financial strategist and owner of Big Life Financial and Justin Maxwell, President of Small Business Incentive Consultants. They discuss in further detail section 41 of the IRS tax code which cover R&D tax credits.
50 minutes | May 7, 2021
#20 Can longevity really be extended? Eric Leire, MD - CEO GenFlow Biosciences
Dr. Leire discusses some of his background and the amazing things that GenFlow Biosciences are doing to develop gene therapies that slow or reverse aging in humans an dogs.
48 minutes | Apr 8, 2021
#19 Bing Du, MD - Senior Director, Global Patient Safety - BeiGene, Ltd.
Dr. Du shares how he was chosen to study medicine in China and how he immigrated to the United States for a research fellowship. He subsequently went into industry and drug safety. We discuss some of the details and nuances of the medical case review side of drug safety.
44 minutes | Mar 18, 2021
#18 Ed Tucker, MD, MBA - Chief Medical Officer - Mirum Pharmaceuticals
Dr. Tucker shares insight from his career on leadership to team building. He also discusses some of the the great things Mirum is doing to fight rare liver diseases in children.
48 minutes | Feb 24, 2021
#17 Patti Engel - CEO of Engage Health Discusses Rare Disease
Patti started in the Rare Disease space back when it wasn't as well known. Her career led her to founding Engage Health a company that is helping to solve some of the unique challenges faced with patient recruitment in Rare Disease.
50 minutes | Feb 14, 2021
#16 Amy Baxter, MD, FAAP, FACEP - Founder and CEO of Pain Care Labs
Dr. Baxter practiced pediatric emergency medicine which led her to discover a common challenge people face; fear of needles and needle pain. She went on to develop a medical device called Buzzy. This has now evolved into another device called VibraCool that can be used to help people deal with pain. An interesting fact, Dr. Baxter was a guest season 5, episode 8 of Shark Tank. She actually turned the sharks down. And has continued find success in growing Pain Care Labs. Her device is also used in many clinical trials by multiple well pharmaceutical companies. Listen to hear the whole story!https://shop.paincarelabs.com/
45 minutes | Jan 30, 2021
#15 David Chonzi, MD - Global Head of PVE with Instil Bio
Dr. Chonzi started his career in pharma/biotech as a drug safety physician learning both pre and post-market PV. Since then he has gained a large amount of experience helping companies develop their PV/drug safety function in the pre NDA and the NDA submital stages of the clinical trial process. In this episode of BioTech IQ he shares detailed insight into pharmacovigilance in the pre-market phases the clinical trial process.
47 minutes | Jan 21, 2021
#14 Juliana Oliveira, MD, PhD - VP Clinical Development, Viking Therapeutics
Dr. Oliveira discusses some of her background and uses her wealth of knowledge in drug development to discuss the development of a phase III clinical trial.
34 minutes | Dec 5, 2020
#13 Jo Bhakdi - Founder and CEO of Quantgene
Quantgene has combined precision genomics, machine learning, and a new perspective to detect cancers at early stages. By doing this they have brought one of the biggest needle movers to the market for beating cancer, catching it at an early enough stages for treatments to be effective. Jo discusses some of the science, approach, and system his company is taking to advance a new model for early cancer detection. Join us for the full episode!
47 minutes | Nov 23, 2020
#12 James Kirwin - COO SFA Therapeutics and Experienced Clinical Operations Expert
James Kirwin has worked for some of the most well-known and successful large pharma organizations and successful start-up biotech firms. He has been on the front lines and cutting-edge of clinical operations strategy and has been directly part of multiple treatments on market today. Join us for a discussion on the other critical half of drug development: Clinical Operations.
53 minutes | Nov 14, 2020
#11 Michelle McGuinness - Pharmaceutical Compliance Partners
Michelle has as a long and successful history leading compliance, quality assurance, and regulatory affairs. She discusses the difference between QA and Regulatory Affairs and how they affect both clinical trials and commercialization. Michelle also shares part of the story about her father who suffered from CADASIL syndrome, a rare disease that has no treatment, and how that inspired her throughout her career to make key decisions in her life. She has worked for well both well-known generics companies such as Mylan and big pharma companies such as AstraZeneca and Sanofi. Join for the journey and to learn a few things on along the way!
41 minutes | Nov 7, 2020
#10 Aleisha Dobbins, PhD, MBA - QA and GCP Consultant
Aleisha shares how she became an expert consultant in helping clients with GCP Auditing, building functioning QA operations, and getting them inspection ready. All critical functions to not only manufacturing but running successful clinical trials as well.
49 minutes | Oct 31, 2020
#9 Salah Kivlighn, PHD - The Kivlighn Group
Dr. Kivilghn is a senior Pharmaceutical and biotech executive with a rare blend of science and business acumen. Dr. Kivlighn discusses what drove him into the industry, controversial challenge trials, and how having a science background contributed to successfully commercializing multiple drugs. Some of those drugs include Losartan (Cozaar®), a market-leading antihypertensive drug becoming a $3.5B franchise (Merck & Co.) and RotaTeq®, a required vaccine for children in the US, resulting in an $800M franchise (Merck & Co.)Very interesting insights shared!
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