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PODCAST

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!

science life sciences

All Episodes

29:22

#27 How do you effectively manage the CMC process?...

The Best Of BioTech IQ ·

2021/09/21

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

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54:41

#26 How do you know the right path of development?...

The Best Of BioTech IQ ·

2021/09/01

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

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52:22

#25 Potential Tumor Immunity? Grant Yonehiro, CBO -...

The Best Of BioTech IQ ·

2021/08/11

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

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38:09

#24 A fellowship program for biotech founders? Meet:...

The Best Of BioTech IQ ·

2021/07/16

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

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47:26

#23 Targeting treatment related toxicities - Michael...

The Best Of BioTech IQ ·

2021/07/09

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/

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59:29

#22 Regulatory Affairs Strategy w/Dr. Jethro Ekuta -...

The Best Of BioTech IQ ·

2021/06/25

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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36:06

#21 Research and Development Tax Credits

The Best Of BioTech IQ ·

2021/06/11

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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49:46

#20 Can longevity really be extended? Eric Leire, MD...

The Best Of BioTech IQ ·

2021/05/07

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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48:18

#19 Bing Du, MD - Senior Director, Global Patient...

The Best Of BioTech IQ ·

2021/04/08

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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43:56

#18 Ed Tucker, MD, MBA - Chief Medical Officer -...

The Best Of BioTech IQ ·

2021/03/18

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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47:36

#17 Patti Engel - CEO of Engage Health Discusses Rare...

The Best Of BioTech IQ ·

2021/02/24

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.

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49:49

#16 Amy Baxter, MD, FAAP, FACEP - Founder and CEO of...

The Best Of BioTech IQ ·

2021/02/14

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

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44:52

#15 David Chonzi, MD - Global Head of PVE with Instil...

The Best Of BioTech IQ ·

2021/01/30

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.

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47:09

#14 Juliana Oliveira, MD, PhD - VP Clinical...

The Best Of BioTech IQ ·

2021/01/21

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.

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34:18

#13 Jo Bhakdi - Founder and CEO of Quantgene

The Best Of BioTech IQ ·

2020/12/05

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!

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46:55

#12 James Kirwin - COO SFA Therapeutics and...

The Best Of BioTech IQ ·

2020/11/23

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.

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52:39

#11 Michelle McGuinness - Pharmaceutical Compliance...

The Best Of BioTech IQ ·

2020/11/14

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

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40:34

#10 Aleisha Dobbins, PhD, MBA - QA and GCP Consultant

The Best Of BioTech IQ ·

2020/11/07

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.

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49:11

#9 Salah Kivlighn, PHD - The Kivlighn Group

The Best Of BioTech IQ ·

2020/10/31

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

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51:44

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

The Best Of BioTech IQ ·

2020/10/23

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.

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48 results

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