The Best Of BioTech IQ podcast artwork

PODCAST · science

The Best Of BioTech IQ

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!

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    A Journey From Investment Banker To The CEO Of A Biotech Developing Cancer Therapy With Bryan Kobel

    Bryan Kobel decided to pursue a career in biotech after seeing its massive opportunities to change the world. He sits down with Ammon Rivera to share how he translated his background as an investment banker into his role as the CEO of TC BioPharm, a company that develops cancer therapy. He opens up about finding his purpose in this space that allows him to save lives and molds him into a compassionate leader. Bryan also talks about their allogenic Gamma Delta T Cell therapy platform, which involves injecting isolated Gamma Delta T Cells to treat cancer-stricken patients. He explains how they are continuously evolving this method to make it cost-effective and easily accessible to underserved and economically disadvantaged individuals. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Biotech Chief People Officer Discusses How To Build Company Culture

    Science will only get you so far in biotech. No matter how ingenious your products are, you will never succeed as a company if you don’t have all the pieces if business development in place. And there is no greater piece than the people piece. As the Chief People Officer of Biomea Fusion, Naomi Cretcher knows that company culture is what is going to make or break her company’s success. Despite everything that went on with COVID and with a recession looming, Naomi is confident that investing on their talent pool with pay off in terms of company success. She joins Ammon Rivera in this episode to tell us what it takes exactly to build an excellent company culture in a biotech company and why the act of building one will give any business its biggest ROI. Tune in! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Qualigen Therapeutics: How To Develop An Oncology Therapeutics Pipeline From A CMO's Perspective With Tariq Arshad, MD

    There isn’t a cure for cancer yet, but if everyone can come together, we may find that cure sooner rather than later. One biotech company that is trying to solve cancer is Qualigen Therapeutics. With their oncology therapeutics pipeline, they could be onto something with their leading asset QN-302.  Join Ammon Rivera as he talks to the Chief Medical Officer of Qualigen Therapeutics, Tariq Arshad, MD, about where they are right now in their therapeutics pipeline. Learn why cancer is the greatest injustice and how Tariq is fighting to stop it. Find out more about their research in Qualigen Therapeutics when it comes to killing these cancer cells. Let's all come together and stop cancer. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Qualigen Therapeutics: How Do You Develop A Successful Therapeutics Pipeline In Oncology With Amy Broidrick

    Qualigen Therapeutics is a biotechnology company that develops novel therapeutic products to treat adult and pediatric patients with rare cancers. A leading name in the industry, they have decided to build a therapeutics pipeline within the last few years. In this first episode of a three-part series featuring top executives of Qualigen Therapeutics, Ammon interviews Amy Broidrick, the firm’s President and Chief Strategy Officer. She shares what she brings to the table in the company’s transition from a preclinical stage company to a brand new business venture. She also talks about her deep love for market research, her career’s pivotal and most fulfilling moments, and how she deals with negativity. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Mapping The Human Immune System: Using AI To Change Drug Development With Noam Solomon

    AI has gone so far as to potentially change drug development, and these developments have the potential to make a difference in people’s lives. On this episode of BioTech IQ, Ammon interviews Noam Solomon, the CEO of Immunai. Immunai is developing an AI platform that leverages big data, single cell multiomics, and machine learning to bridge the gap between casual immunology and translational disease biology. Their platform is mapping the human immune system at an unprecedented level of granularity, allowing them to identify the right targets to go after. In this interview, Noam shares his knowledge on reprogramming the immune system for better diagnosis and treatment. He shares his amazing team and how they make patient’s lives easier and meaningful. Tune in to learn more about immunotherapies! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Going Beyond The Current Standard Of Care For Anxiety, Depression, And CNS Disorders With Shawn Singh

    Social anxiety disorder is the third most common mental health disorder. Over 23 million Americans alone are affected by it. This disorder can continue to grow into depression and drug abuse, so it's very important to catch it early so it can be stopped. But how can it be stopped? Shawn Singh, the CEO and Director of VistaGen Therapeutics, and his team are creating a nasal spray to help people with social anxiety disorder. Just like an inhaler for asthma, this nasal spray can do for social anxiety. Join Ammon Rivera as he talks to Shawn Singh about the PH94B nasal spray. Find out how it works and how far along they are in the process. If they get approved, VistaGen has the opportunity to be the first FDA-approved acute treatment for adults with social anxiety disorder. Discover how VistaGen is going beyond the current standard of care for anxiety, depression, and CNS disorders.  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Harnessing the Innate Immune System By Developing Three Types of iPSC-Derived Natural Killer Cells With Daniel Teper

    Companies in the biotech space are making contributions to help find a cure for cancer. Today’s guest is no exception. In today’s episode, Ammon Rivera sits down with Daniel Teper, Co-Founder and CEO of Cytovia Therapeutics, to talk about the unique technology they’re using to develop a treatment for cancer. Daniel discusses how they’ve developed three types of iPSC-Derived Natural Killer Cells and are now targeting unmet needs in treating hepatocellular carcinoma (HCC). There is a lot of disruptive innovation coming from the biotech industry. Daniel also discusses how the field is dealing with worsening market conditions amidst recent news of a special purpose acquisition with Isleworth Healthcare Corporation. There’s much to learn from this episode, both in medicine and economics. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Cell Cycle Therapy: Understanding The Cell Cycle Biology To Treat Cancer With Spiro Rombotis

    Cell cycle biology is key to understanding cancer. You have to hit the cancer cells early before they become smart and adapt. There is a stage in the cell cycle called mitosis. This is where, if done right, can cause cancer cells to suicide. This is where the biotech company, Cyclacel comes in with all their research into the cell cycle of cancer. Join Ammon Rivera as he talks to Spiro Rombotis about some of Cyclacel's cell cycle therapies. Spiro is the CEO of Cyclacel. His mission is to use cell cycle biology to treat cancer and other serious diseases. Ammon and Spiro go over the use of Cyclin-dependent Kinase and its role in the cell cycle. Spiro also talks about Cyclacel's pipeline and drug candidates. They also go through discussion strategy, the drug approval process, and what it means to fail fast. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Can Lineage Cell Therapeutics Proprietary Cell-Based Therapy Platform Change Treatment Development?

    Have you ever thought about having replacement parts for your body? It sounds like science fiction, but it’s now as real as the eyes you’re using to read this, thanks to cell-based therapy. Brian Culley is one of the leaders in this field. He is the CEO of Lineage Cell Therapeutics, a company developing treatments for multiple indications based on their proprietary cell-based therapy platform. Leveraging in-house manufacturing, they are attacking multiple indications from ophthalmology to immuno-oncology. In this episode, Brian joins Ammon Rivera to explain what their strategy is, where they are currently in the development process, and where they’re going from there. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Global Tensions And Supply Chains And Their Effect On Biotech. Guillermo Morales, PhD, CEO Of Innoventyx

    The biotech industry has been bombarded with disruptions in recent years, from a global pandemic to rising global tensions. How are they dealing with the supply chain issues and how else has it impacted the industry? In this episode, Ammon Rivera sits down with two-peat guest, Guillermo Morales, PhD, CEO of Innoventyx. Guillermo makes us privy to the issues brought on by COVID-19 and the geopolitical tensions such as the Russia-Ukraine conflict. He also discusses intellectual property in greater depth and why it’s important to act fast when patenting your product. Moving from Latin America to the United States, Guillermo also shares his experience learning and re-learning the science in both languages and how it impacts communication. Don’t miss out on their enlightening conversation by tuning in! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Can Hepion Pharmaceuticals Develop the First Treatment Approved For NASH? With Robert Foster, Pharm D, PhD

    On this episode of BioTech IQ, Ammon Rivera interviews Robert Foster Pharm D, PhD, CEO of Hepion Pharmaceuticals. Robert brings 30 years of experience to this discussion and shares with us details of his background that led him to where he is today. We also discuss Hepion Pharmacetuicals current clinical trials to development treatments targeting chronic liver diseases including NASH, cancer, and chronic hepatitis virus infection. A quarter of the people in the US have fatty livers and of those, about a fifth will likely develop NASH. It’s a big problem that affects a lot of people. The company’s lead drug candidate, Rencofilstat, reduces liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH. Tune in to learn more about their pharmaceutical development process and other possibilities with the drug in terms of treatment. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    How Is Translational Genomics Reducing Background Noise In Multi-Disease Detection? With Aiguo "Adam" Zhang

    Some of the main problems with sequencing in identifying mutations are its cost and the time it takes. Fortunately, with the rapid growth of technology, revolutionary products that simplify processes are being made. One of those is from DiaCarta, a diagnostics company using translational genomics and molecular precision technology to develop ways of detecting disease. In this episode of BioTech IQ, Ammon Rivera interviews its CEO, Adam Zhang. Their patented technology reduces the "background noise" in testing, allowing for the detection of the "bad actor." Join in to learn the processes behind their work, what this means to the future of testing and treating diseases, and where the company is headed. Don't miss out! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    Addressing One Of The World’s Biggest Drivers Of Disease: Inflammation With Jim Woody, M.D., Ph.D. - CEO 180 Life Sciences

    TNF is a protein that contributes to inflammation. Anti-TNFs can be used to stabilize this and stop the inflammation. It’s used for diseases like arthritis and psoriasis. Discover how clinical trials are done so these medicines and anti-TNFs can be utilized. Join Ammon Rivera as he talks to M.D., Ph.D. and CEO of 180 Life Sciences, Jim Woody about anti-TNFs and the trial process behind them. Jim’s goal is to address one of the biggest drivers of disease – inflammation. Learn more about Jim’s career as a venture capitalist. Find out why trials need to be uniform and randomized. And, discover what it takes to run a biotech company today. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #35 Can Biomea Change the World with Irreversible Drugs and Covalent Bonds? Thomas Butler, CEO - Biomea Fusion

    Tom shares with us some of his journey and how that led him to co-found Biomea Fusion. We discuss some of the science behind irreversible drugs and covalent bonding. Using their fusion system there is greater potential for high selectivity, deep inactivation of target, and a greater therapeutic window.https://biomeafusion.com/https://thebiotechiqpodcast.com/podcast/ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #33 Reducing friction at Clinical Trial Start-Up - Sam Searcy, CEO of CliniStart

    CliniStart launched to provide innovative tech-enabled solutions focused on global investigator contracts, budgets, and payments. And they did all of this just as the COVID-19 pandemic was hitting. This gave them an opportunity to shift and adapt. In this episode we address the challenges causing friction at during clinical trial start-up and what it takes to launch a start-up company.https://clinistart.com/ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #32 People, the most valuable asset a business has. Brenda Sousa - Chief HR Officer

    On this episode we have Brenda Sousa, previously the Chief Human Resources Officer with Constellation Pharmaceuticals. Brenda shares with us part of her backstory and entry into the world of Biotech. We discuss people, culture, the function of HR, and how the industry requires a unique yet similar approach. Ammon also shares past experiences with Brenda and gets her take on them.#BiotechIQ #Biotech #Drugdevelopment #Recruiting #Staffing Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #31 Managing CRO relationships and unique business models - Stewart Hallet - COO SFJ Pharmaceuticals

    In this episode of BioTech IQ Ammon interviews Stewart Hallet the COO of SFJ Pharmaceuticals, a specialty pharmaceutical company with a unique business model. The discussion touches on a number of things in clinical operations including working with CROs, leadership, and resourcing. #BioTechIQ #ClinicalOperations #DrugDevelopment #Podcasts Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #30 Brazen Bio Part II - Live and In Person!

    Co-founders Shawn Carbonell and Brent Witgen discuss the progress of the 1st cohort (BRZN1) as they are well into the Brazen Bio program. We also get the chance to interview one of the founders currently in the program. We discuss what he is working on and what his experience has been in the program. Do you have a project that needs acceleration? Then don't hesitate, go to brazen.bio and get your application in for the next cohort. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #29 Why do we resist? Applying clinical psychology to clinical trials. Kathleen Starr, PhD - EVP Behavioral Insights, Syneos Health

    Kathleen shares fantastic insights on understanding behavioral psychology and how it applies to successful clinical trials. We had a great conversation that touched on increasing diversity in trials to understanding our own behavior and how we can potentially understand patients better. This can be applied in a way to close the gap between intention and action. Kathleen co-authored a Book called "Why We Resist: The Surprising Truths about Behavior Change: A Guidebook for Healthcare Communicators, Advocates and Change Agents" You can check it out at the link below. PSA: I have no sponsorships or financial agreements to promote the book. I figured since I read it and talked about it on the show people might want to check it out.https://www.amazon.com/Why-Resist-Surprising-Healthcare-Communicators/dp/057854766X Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #28 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/ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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/ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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 Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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 Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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/ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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.  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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.  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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/ Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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.  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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.  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #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! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #8 Rolf Linke, MD - Chief Medical Officer - SFJ Pharmaceuticals

    Dr. Linke shares his wealth of global drug development knowledge by discussing clinical trials and interacting with US, European, Chinese, and other regulatory agencies! Dr. Linke also shares his career progression and what drove some of the decisions he made that led to his current role. Being the Chief Medical Officer located in Germany with the company headquartered in California, you can bet he gets his share of travel and late nights. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #7 Gwen Nichols, MD - Chief Medical Officer - The Leukemia & Lymphoma Society

    A trained Oncologist and physician scientist Dr. Nichols discusses what she has seen from working as an academic in research on the front lines as a principal investigator to transitioning into pharma and now in the non-profit setting. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #6 Doniel Jackson, MD - Head of Drug Safety and Pharmacovigilance - MEI Pharma

    Doniel Jackson, MD is a 24+ year Drug Safety and PV veteran in the pharmaceutical industry. Dr. Jackson and I discuss aspects of Drug Safety and Pharmacovigilance and how it is a critical part to successful submission, registration, and post-marketing.  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #5 Gurdyal Kalsi, MD - Chief Medical Officer - Asklepion Pharmaceuticals

    Dr. Kalsi shares some insight on the difference between vaccine clinical trials vs. rare disease vs. oncology. While practicing medicine, experiences working as a principal investigator drove Dr. Kalsi to pursue a medical degree in pharmaceutical medicine and join the industry. Over 20 years later Dr. Kalsi shares some of what he's learned. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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    #4 Ross O. Youngs - Founder and CEO of Biosortia Pharmaceuticals

    Through an interesting turn of events Biosortia discovered they had access to large amounts of Aquatic Microbiome. With a broad range of capabilities they are able to extrapolate this into drug discovery. Ross believes that Biosortias ability to mine microbiome on such a large scale will change drug discovery in the coming years.  Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

  45. 4

    #3 Dana Dornsife - CEO Lazarex Cancer Foundation

    When Dana's brother-in-law was diagnosed with pancreatic cancer she helped her family discover the power of access to clinical trials. That led her founding Lazarex Cancer Foundation, a non-profit organization that helps people find clinical trials and deal with the costs associated. Dana has literally worked to induce change on how the FDA views reimbursements to patients from pharma companies and her foundation is doing some amazing things to further diversity. Listen for the whole story! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

  46. 3

    #2 Guillermo Morales - CEO Innoventyx

    Dr. Morales discusses how COVID-19 affects the clinical trial supply chain, IP Strategy, and transitioning from pre-clinical to clinical. Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

  47. 2

    #1 Steven Norton - Chief Drug Development Officer - Elevar Therapeutics

    Steve discusses adapting to COVID-19, hiring, and the challenges of drug development Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

  48. 1

    Coming Soon: Biotech IQ

    On August 14, 2020, Identifyd Life Sciences launches, Biotech IQ hosted by Ammon Rivera. A podcast that interviews those at the cutting edge and front lines of drug development. Ammon interviews people from all aspects of biotech and pharma! Hosted by Simplecast, an AdsWizz company. See pcm.adswizz.com for information about our collection and use of personal data for advertising.

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ABOUT THIS SHOW

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!

HOSTED BY

Podgo

Frequently Asked Questions

How many episodes does The Best Of BioTech IQ have?

The Best Of BioTech IQ currently has 48 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.

What is The Best Of BioTech IQ about?

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...

How often does The Best Of BioTech IQ release new episodes?

The Best Of BioTech IQ has 48 episodes. Check the episode list to see recent publication dates and frequency.

Where can I listen to The Best Of BioTech IQ?

You can listen to The Best Of BioTech IQ on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.

Who hosts The Best Of BioTech IQ?

The Best Of BioTech IQ is created and hosted by Podgo.
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