BioTech IQ

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.

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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!

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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

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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

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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_rx
https://www.linkedin.com/company/onquality-pharmaceuticals-ltd/
https://www.onqualityrx.com/

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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.

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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. 

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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.

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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.

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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. 

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