The Best Of BioTech IQ

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 accomplishe...

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 infor...

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.

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...

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.

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.

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...

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 phas...

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.

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 can...

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,...

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 througho...

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.

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 $3.5...

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 h...

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.

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.

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...

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 i...

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 an...

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.

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.

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.