Podcast The Life Science Rundown

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EPISODE #001 A Look at FDA's Pandemic Inspections Q&A Guidance

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The FDA Group’s CEO, Nick Capman, breaks down the FDA’s Q&A guidance on drug and biologic inspections during the pandemic, pointing out the important takeaways manufacturers should consider and prepare for. Read our blog post for a written breakdown of the key takeaways. We've also written on FDA's more recent guidance outlining its expectations for resuming normal manufacturing operations during the pandemic. Read that post here. Need expert quality system remediation assistance? Learn more and get in touch.

Resources:

EPISODE #002 Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher Smith

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The FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 40 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations. 

Learn how PAIs are planned and conducted, how to prepare for them, and where to go to find helpful resources your team can utilize.

Need expert help with PAI preparation? Contact us to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP Auditing services here.

Resources:

Episode #003 What RA/QA/Clinical Leaders Should Expect From the FDA in 2021

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The FDA Group’s CEO, Nick Capman, sits down with Ben Locwin, Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more.

Ben has extensive experience working with the FDA and international regulatory officials. His project work includes Pre-IND, NDA, Ph1-3, and marketed/post-market drug products, as well as PMA and 510(k) medical devices. Ben has trained FDA inspectors within their headquarters and has participated in the design of the FDA's Global Quality Metrics Initiative.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started.

EPISODE #004 Clinical Outsourcing & Insourcing: Selecting the Right Model or Mix

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The FDA Group’s CEO, Nick Capman, sits down with Mark Shapiro, a Partner with biopharmaceutical consulting firm Pharma Initiatives, to discuss outsourcing and insourcing models in the current clinical R&D environment, and what to consider when selecting the right model or mix of models for a project.

Download the corresponding white paper and put these insights into practice: A Modern Guide to Clinical Operations Resourcing.

Mark is widely recognized as an expert on the business of clinical research and is frequently quoted in the press, including Outsourcing Pharma, PharmaVoice, and CenterWatch. His comments have also been featured in the New York Times and Raleigh News & Observer on topics pertaining to the business of drug development. His focus at Pharma Initiatives is growth and innovation strategies in clinical research, development, and medical affairs. He has led strategic planning, growth, and change management initiatives at many pharmaceutical, biotech, and clinical research organizations. 

Prior to joining Pharma Initiatives, Mark was SVP, Operations at a global CRO, where he was responsible for an operations team of about 500 drug development professionals in more than 30 countries, and a portfolio of more than 100 active clinical trials. He was previously a management consultant at Campbell Alliance in the Clinical Development and Medical Affairs Practice, where he worked with many global CROs and biopharma companies on R&D innovation strategy. Mark is a pharmacologist, holds an MBA from Duke University’s Fuqua School of Business, and has received numerous certifications in clinical research, regulatory affairs, and healthcare management.

Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started.

EPISODE #005 What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden Administration

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The FDA Group’s CEO, Nick Capman, breaks down the key points in a recent Morgan Lewis article laying out what to expect for the FDA's regulation of medical devices and digital health under the Biden administration.
 
Read the full Morgan Lewis piece here.
 
Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started.

EPISODE #006 FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine Scams

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The FDA Group’s CEO, Nick Capman, discusses the federal effort to thwart COVID-19 vaccine scams.

From FDA.gov:

"The FDA’s dedicated COVID-19 Fraudulent Products Task Force continues to monitor the market, including online, for fraudulent COVID-19 products, and the Operation Quack Hack initiative continues to leverage agency expertise and advanced analytics, resulting in the removal of hundreds of unlawful products from the marketplace. To date, the agency has uncovered nearly 1,300 fraudulent products, sent more than 160 warning letters, issued more than 270 abuse complaints to domain registrars, and sent more than 290 requests to various marketplaces to remove listings for fraudulent COVID-19 products.

The FDA will continue working with its state and federal partners to take appropriate action against bad actors who prey upon people seeking a COVID-19 vaccine in the midst of this global pandemic. The agency has gone to great lengths to ensure that the authorized vaccines available to the public are safe and effective."

Read the full article here.

EPISODE #007 Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, Director of Health Care, GAO

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The FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a formidable pandemic-induced inspection backlog, and what measures the agency may take to address it.

Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public policy and public affairs at Sam Houston State University, Troy University, and the Georgian Institute of Public Affairs.

Over the past year, Mary and her team at the GAO have published two FDA-focused reports:

EPISODE #008 Quality Management Review: Benchmarking Quantitatively!

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The FDA Group’s CEO, Nick Capman, sits down with Tobias Kuners of Koenders, Managing Consultant at Tob Management, to discuss his integrated approach to implementing and interpreting qualitative and quantitative metrics in the GMP and non-GMP sides of a life science business.

Tobias has worked with Biogen, Ipsen, Thermo Fisher, Kite Pharma, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led the design, engineering, and construction of multiple facilities to meet cGMP requirements. He performs audits, identifies gaps, and develops remediation plans, working within organizations to assist with deviation investigations and CAPA implementation and to develop scientific, risk-based solutions. 

EPISODE #009 FDA's Domestic Biopharma Inspections Return to Normal

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From Endpoints News:

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, according to FDA acting commissioner Janet Woodcock.

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said. The return to normalcy will be welcomed by industry, which has grappled with a growing backlog of mostly surveillance inspections, although some of those delayed inspections have also delayed the approval of new drugs.

According to a report from FDA in May, an estimated 68 applications (including 48 for human drugs) have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of March. The agency said it postponed nearly 8,000 non-mission-critical surveillance inspections in 2020 due to the pandemic.

Surveillance inspections are routine inspections that monitor conformance to FDA requirements to identify quality problems and adverse trends, but unlike others, they’re planned in advance by applying established risk factors and statutory inspection frequency mandates.

Read the full article here.

EPISODE #010 Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for Industry

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Product sampling and remote records requests accounted for most import alerts and drug GMP warning letters over FDA's fiscal year 2021. They may play a key role post-pandemic.  
 
As remote records reviews conducted during the pandemic accounted for a growing share of warning letters, experts have advised the industry to prepare for remote FDA oversight to continue even after routine site inspections resume and the pandemic recedes.  
 
The FDA, which historically relied solely on on-site inspections as a basis for drug adulteration warning letters, only based 28% of warning letters issued in the first 11 months of fiscal year 2021 on-site inspections, with 62% based on sample testing and 10% on remote records reviews.  
In this episode, we sit down with former FDA professional, Larry Stevens, RAC, to talk about how inspection alternatives may become a permanent facet of FDA's oversight program and what companies may want to consider doing to prepare accordingly.  
 
FDA official: Growing number of enforcement actions stem from inspection alternatives: https://www.raps.org/news-and-articles/news-articles/2021/11/fda-official-says-increasing-number-of-enforcement (RAPS)   
 
About Larry Stevens, RAC:
Larry has held almost every field position within FDA during his 21-year career with the Agency. He has over 18 years of experience in the medical device industry, rising from an RA Manager to Vice President of RA/QA/Clinical for major class III device manufacturers. He specializes in planning, creating, and auditing quality systems as well as creating clinical plans, including protocol development, case report form development, and implementing and managing clinical trials. He also assists in design control to meet FDA requirements. Larry is a professional speaker who regularly trains on all aspects of FDA requirements while offering practical, successful solutions to FDA problems.  

EPISODE #011 FDA Revives Its Proposed Quality Metrics Program for Pharma


The FDA Group's Nick Capman discusses the recent news that the FDA is once again returning to its quality metrics program for pharma manufacturers.

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