BioTech IQ

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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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!

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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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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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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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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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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!

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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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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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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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