Podcast The Life Science Rundown

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.

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.

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:

• Laboratory Safety: FDA Should Strengthen Efforts to Provide Effective Oversight: https://www.gao.gov/products/gao-20-594
• Drug Safety: FDA's Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog: https://www.gao.gov/products/gao-21-409t

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.

• Read his full column in Pharmaceutical Online: Quality Management Review: Benchmarking Quantitatively!

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. 

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.