FDA Watch - Podcast Details

Shows

FDA Watch Insights on Evidence and Communication with FDA in Device Submissions Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates. You'll hear their thoughts on what's happening right now at FDA and in the medical device industry; whether companies should engage FDA early in the pre-submission process or make their case in the actual submission; common breakdowns in the submission process; the importance of real-world evidence and where companies can still fall short; holding FDA to a consistent standard after initial feedback; and much more. In our headlines segment, Wayne highlights these majo...

2026-05-0445 min

FDA Watch FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – FoodsIn the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Milli Hansen, Partner in Skadden's Mass Torts, Insurance and Consumer Litigation Group; Daniel Luks, Partner in Skadden's Mergers & Acquisitions Practice; and Douglas Stearn, Principal at Canal Row Advisors. Together, they discuss the latest developments in food regulation at FDA and at the state level; how companies may want to prepare for potential FDA and state enforcement actions and policy shifts in the coming year; how the regulatory environment impacts litigation; how regulatory uncertainty and litigation affect M&A deals...

2026-04-2043 min

The Life Science Rundown Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change ThatWhy are there over 400 phase three oncology programs but only one in dialysis? John Butler, who has spent over 30 years in the kidney disease space, breaks down the regulatory and reimbursement dynamics that have created a surge of innovation in rare kidney diseases while leaving dialysis patients behind, and what it would take to change that.John discusses how FDA clarity on endpoints transformed the rare kidney disease investment landscape, why the dialysis bundle makes innovation functionally impossible for providers, and how the Kidney Care Access Protection Act could be the first meaningful step toward a sustainable...

2026-04-1035 min

The Life Science Rundown Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ AckerWhat does it actually take to navigate global regulatory filings across the FDA, EMA, and PMDA, and why do so many programs stumble despite technically harmonized dossiers? AJ Acker draws on about 30 years of rare disease regulatory experience to break down the real differences between regions and the strategies that drive successful multi-regional approvals.AJ discusses why ICH compliance doesn't equal regulatory alignment, how Japan's evolving regulatory landscape creates both opportunity and complexity, and why the preparation that starts early in development (not at submission) is what determines whether a program achieves tight global approval timelines.

2026-03-3028 min

FDA Watch FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden's Global Cybersecurity and Data Privacy Practice; Michelle Gasaway, Partner in Skadden's Capital Markets Practice; and Carolyn Bruguera, Vice President and General Counsel at the Medical Device Manufacturers Association. Together, they discuss considerations for companies who manufacture, design and/or develop medical devices, including general wellness devices, regarding whether to submit a 510(k); how to proactively prepare for and anticipate complex regulatory, diligence and disclosure issues in preparing for a public offering, private...

2026-03-3036 min

FDA Watch FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – PharmaceuticalsIn this first part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Raquel Fox, Head of Skadden's U.S. ESG Practice and Co-Head of the firm's SEC Reporting and Compliance Practice; Kendall Ickes, Associate in Skadden's Intellectual Property and Technology Practice; and Tess Cameron, Managing Director on the Venture Team at RA Capital Management. Together, they discuss helping pharmaceutical and biotech industry clients navigate the uncertain regulatory environment; how FDA is expanding its scope of responsibility; staffing and policy changes at FDA and how they impact the review process...

2026-03-2349 min

The Life Science Rundown Navigating Regulatory Leadership Across Large and Small Life Science with Tammy SarnelliWhat actually changes for regulatory leaders when they move between large pharma and small biotech, and what stays the same? Tammy Sarnelli draws on over 35 years of experience across organizations of every size to break down the real differences in workload, risk tolerance, resource access, and culture.Tammy discusses how organizational silos create friction in large companies, why limited resources at small companies can actually accelerate decision-making, and how risk tolerance shapes not just strategy but the speed at which products move forward, especially in rare disease.A few of Tammy's key takeaways:Regulatory...

2026-03-1932 min

The Life Science Rundown Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary SmithsonHow should life science companies govern their data to meet increasingly structured regulatory submission requirements and actually get value from AI? Cary Smithson shares lessons from decades of helping organizations modernize their regulatory, quality, and R&D operations.Cary discusses why data governance has become urgent across three fronts — structured submissions, cross-functional interoperability, and AI reliability — and walks through the foundational steps companies should take, the organizational challenges they'll hit, and what measurable results look like when governance is done right.A few of Cary's key takeaways:Regulatory submissions are no longer just documents — they're...

2026-03-0528 min

FDA Watch FDA Reporter Roundtable: A View From the News Desk Wayne chats with Lizzy Lawrence, Lead FDA Reporter at STAT; Derrick Gingery, Executive Editor for U.S. Regulatory and Policy Insights at The Pink Sheet; and Sarah Karlin-Smith, Research Director at Public Citizen's Access to Medicines Program and former Reporter at The Pink Sheet. Together, they offer overarching themes surrounding FDA coverage today; how access to FDA decision-makers and frontline staff has changed recently; FDA's tendency to announce policies via video announcements and press releases instead of through official guidances; how reporters decide what gets media attention; how the absence of advisory committees has created reporting challenges; stories reporters...

2026-03-0253 min

The Life Science Rundown Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly ViseuxHow do you build an organization that can absorb change, learn from failure, and keep patients at the center—even when the science is uncertain? Nelly Viseux shares lessons from over 20 years in biotech and a decade leading cell and gene therapy development.Nelly discusses how she structured a 100-person CMC organization at Regeneron to balance innovation with operational execution, why documenting your assumptions is critical to managing risk, and what it really takes to maintain resilience when you're literally holding patient lives in your hands.A few of Nelly's key takeaways:Resilience is ad...

2026-02-0937 min

FDA Watch FDA's 2026 Food Priorities Wayne chats with David Lennarz, President of Registrar Corp., and Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition. You'll hear their thoughts on the Human Foods Program's 2026 priority deliverables; how the new food pyramid/dietary guidelines may impact food and nutrition policy; the state of FDA's focus on food dyes; the latest labeling and ingredient disclosure; the direction of infant formula following recent recalls; GRAS reform and general food safety oversight; and much more. In our headlines segment, Wayne highlights these...

2026-02-0955 min

FDA Watch FDA's Evolving Approach to Medical Device Reviews Wayne chats with Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on where the relationship between FDA and the device industry stands right now; factors that influence how reviewers assess risk, credibility, and readiness during submission reviews; the role of the TPLC approach at CDRH; FDA's elimination of the requirement that RWE submissions include identifiable patient-level information; practical changes sponsors can make to improve regulatory outcomes, without increasing time or cost; and much more. In our headlines segment...

2026-01-2650 min

The Life Science Rundown Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie KleckerScaling a product from preclinical development to commercial manufacturing is one of the most complex transitions life science teams face—and one of the easiest places to lose time and momentum.In this episode of The Life Science Rundown, host Nick Capman speaks with Jackie Klecker, Executive Vice President of Quality and Development Services at Lifecore Biomedical, about how sponsors and CDMOs can build robust, phase-appropriate quality systems without over-engineering early or under-preparing later.Drawing on decades of experience across pharmaceutical drug products, medical devices, APIs, and biologics, Jackie shares practical guidance on knowledge transfer, ri...

2026-01-1235 min

FDA Watch Inside FDA Pharma Policy Development Wayne chats with Rumi Young, Director of Regulatory Policy at Novo Nordisk, and Jamie Gamerman, Head of Regulatory Policy at UCB. You'll hear their thoughts on how FDA policy is developed and is evolving; how previous PDUFAs have changed the agency's policy agenda and how those commitments translate into guidance development; the most important scientific or technical inflection points driving FDA policy right now; what drives the development of new agency frameworks or programs; how companies internalize new FDA policies where disconnects may exist; FDA's efforts to balance scientific integrity with regulatory flexibility in policy development for issues such...

2026-01-1245 min

The Life Science Rundown Preparing the Workforce That Will Shape Pharma’s Future with ISPE President & CEO Mike MartinThe FDA Group's Nick Capman sits down with Mike Martin, President and CEO of ISPE, for a conversation on how the pharmaceutical industry must rethink workforce development amid rapid technological and cultural change.Drawing on nearly four decades of global experience in pharmaceutical engineering, operations, and manufacturing leadership, Mike shares his perspective on why the industry is entering a new industrial era — often referred to as Pharma 4.0 — and what that means for engineers, operators, and leaders at every level.The discussion explores how automation, robotics, and AI are reshaping day-to-day work, why deep technical expertise rema...

2026-01-0642 min

The Life Science Rundown How to Build (and Sustain) a Quality-Centric Culture with Chris MastersonThe FDA Group’s Nick Capman sits down with Chris Masterson, Senior Vice President of Quality and Chief Quality Officer at Tolmar, for a wide-ranging conversation about how to create and sustain a quality-centric culture that drives compliance, operational excellence, and long-term resilience in the biopharmaceutical industry. A microbiologist by training with more than 35 years of BioPharma leadership experience, Chris has led global quality organizations at Ipsen, Cubist (Merck), and now Tolmar, as well as his own consultancy. Across the U.S., Europe, and Asia, he has managed large CMO networks, established inspection-readiness programs, and led cultural ch...

2025-12-0943 min

The Life Science Rundown From Molecule to Market: A Commercial-Readiness Playbook for Biotechs with Carlos CarrilloThe FDA Group’s Nick Capman sits down with Carlos Carrillo, PhD, MSc, Senior Vice President of Regulatory Affairs & Quality Assurance at SAB Biotherapeutics. With nearly 30 years of experience across Operations, R&D, Regulatory Affairs, Quality Assurance, and Project Management, Carlos has led global regulatory strategy for small- and large-molecule programs from Phase 1 through launch. He has prepared IND/IMPD/CTA/CTR/BLA/MAA submissions across multiple regions, secured expedited designations, managed FDA and ex-US health authority meetings, and built RA/QA systems for growing biotech organizations.Carlos shares practical, experience-tested guidance on how small and mid-size bi...

2025-12-0248 min

The Life Science Rundown How Regulators Are Bringing AI Into Review (Without Losing Trust) with Maria VassilevaThe FDA Group’s Nick Capman sits down with Maria Vassileva, PhD—Chief Science & Regulatory Officer at the Drug Information Association (DIA)—for a grounded, forward-looking discussion on how regulators are actually using AI today, where the technology is going, and what life science organizations should be preparing for now.Maria draws on two decades of leadership across nonprofit, government-funded clinical research, and biomedical science programs—spanning patient registries, clinical trials, multi-stakeholder consortia, DEI initiatives, and regulatory strategy. As the head of DIA’s global science and regulatory portfolio, she works closely with regulators, industry sponsors, academia, and techno...

2025-11-1751 min

FDA Watch How Industry Is Adapting to FDA's Food Shifts Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You'll hear their thoughts on the current state of foods at FDA, concerns related to the agency's budget, impacts of the government shutdown on FDA and the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is adapting to evolving guidance on ultraprocessed foods, and much more. Read Sarah Sorscher's statement...

2025-11-1749 min

FDA Watch A Look at FDA's Drug Review Reset Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm's Pharmaceuticals and Biotechnology practice. You'll hear their thoughts on FDA's maintenance of its drug review process amid staffing cuts; the agency's new PreCheck program and how it may proceed; FDA's evolving stance on confirmatory evidence and accelerated approvals and how they could reshape how companies approach clinical trial designs or risk disclosures; agency budgets; ramped-up AI use at the agency and in industry; and much more. In our...

2025-10-2045 min

The Life Science Rundown A Playbook for FDA Inspections and Remediation with Jeff HinesCoruna Medical’s Vice President of Quality, Jeff Hines, joins host Nick Capman to share a leadership-driven playbook for navigating FDA remediation—without overwhelming teams or losing focus on long-term improvement.Drawing from nearly four decades in pharmaceutical quality, including more than 30 years at Eli Lilly, Jeff offers practical guidance for building calm, effective inspection environments and keeping people confident under pressure. He outlines the four-room model for inspection management, strategies for responding to observations, and proven methods for closing data-integrity gaps while daily operations continue.Jeff and Nick also explore the leadership mindset that sust...

2025-10-1652 min

The Life Science Rundown Leading Cross-Functional Teams from Concept to Commercialization with Marwan FathallahThe FDA Group’s Nick Capman speaks with Marwan Fathallah, President and CEO of DIA Global, for a wide-ranging discussion on what it takes to lead effectively across the life science product development cycle—from concept to commercialization.With nearly 30 years of leadership experience spanning pharmaceuticals, medical devices, and diagnostics, Marwan has held senior roles in R&D, regulatory, clinical, scientific affairs, and operations. He brings a rare, holistic view of how leadership, culture, and systems thinking come together to drive successful outcomes in complex, regulated environments.Their conversation explores how to balance innovation and comp...

2025-10-0646 min

The Life Science Rundown Breaking Down FDA’s E21 Draft Guidance: Including Pregnant and Breastfeeding Women in Clinical Trials with Regina AtimThe FDA Group’s Nick Capman speaks with Regina Atim, PharmD, pharmacist, maternal and perinatal health advocate, and founder of Clinicians Touch Healthcare Solutions. Regina brings deep expertise at the intersection of clinical practice, regulatory strategy, and maternal health innovation—including work on technologies to detect pregnancy-acquired cardiovascular disease.Their conversation explores FDA/ICH’s new E21 draft guidance, Inclusion of Pregnant and Breastfeeding Women in Clinical Trials. Regina explains why pregnant and breastfeeding women have historically been excluded from research, how that has left clinicians and patients with insufficient evidence, and why E21 re...

2025-09-2928 min

The Life Science Rundown Staying Ready for the FDA (When Inspections Are Less Predictable)The FDA Group’s Nick Capman speaks with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. With more than 25 years of pharmaceutical manufacturing experience spanning branded, generic, and OTC products, Jeff brings a deep perspective on sustaining inspection readiness across multiple sites while leading global quality teams.Jeff shares why inspections feel less predictable today—with more variability in inspector experience and a higher likelihood that minor issues become formal observations—and how leaders can respond without overreacting. He explains how to prepare documentation so that it’s understandable to any inspector, what mak...

2025-09-1928 min

The Life Science Rundown Building the Next-Gen Lab: AI in a GLP Environment with Catherine LunardiThe FDA Group's Nick Capman speaks with Catherine Lunardi, Founder and CEO of GenAIz. With nearly a decade leading GenAIz and prior leadership roles at GSK, CGI, and Héma-Québec, Catherine brings a seasoned perspective on how life science organizations can practically and compliantly deploy AI to build the next generation of labs.Catherine explains the biggest challenges labs face today—like fragmented data, manual processes, and costly compliance reviews—and how AI can help orchestrate data, surface anomalies, and accelerate insights without replacing the people at the center of science. She outlines a step-b...

2025-09-1938 min

The Life Science Rundown How to Build High-Performing Quality Teams with Marcus GesnerThe FDA Group's Nick Capman speaks with Marcus Gesner, Vice President of Global Quality at embecta. With more than two decades of leadership experience at companies including Boston Scientific, Olympus, Covidien, JUUL Labs, and others, Marcus brings a unique perspective to what makes a quality organization truly high-performing.Marcus shares why compliance is only the baseline “entry fee” for quality—and how high-functioning teams go further by protecting a company’s right to compete, preventing manufacturing and supply disruptions, enabling speed to market, and building trust across the business.He discusses the metrics that matter most (li...

2025-09-0849 min

FDA Watch FDA's Fight Against Ultraprocessed Foods Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on FDA's focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler's citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA's use of AI in food decision-making; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez Devices: FDA launces Regulatory Accelerator for digital health devices

2025-09-0844 min

The Life Science Rundown The 4 Cs of MedTech Leadership with Sean GallimoreThe FDA Group's Nick Capman sits down with executive consultant Sean Gallimore to break down what makes medtech leaders and teams truly effective. Drawing from decades of experience across medical devices, diagnostics, CROs, and industrial technology, Sean shares his practical framework for leadership—the 4 Cs: Strategic Clarity, Capabilities, Compliance, and Connectedness—and how each one directly impacts growth, culture, and execution.Listeners will learn how to:Pressure-test whether your strategy is actually winnable.Match organizational capabilities to goals (and pivot when they don’t).Use KPIs and OKRs to diagnose execution gaps.

2025-08-1854 min

FDA Watch Vaccines, Pharmaceutical Policy & FDA's Next Moves Wayne chats with Deb Autor, CEO of Healthcare Innovation Catalysts, and Paul Offit, M.D., Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at the Children's Hospital of Philadelphia. You'll hear their thoughts on vaccine development, policy, testing, and funding, including COVID vaccines; the new Commissioner's National Priority Voucher Program; the Sarepta gene therapy episode; leadership transitions at CDER and CBER; AI in pharmaceutical regulation; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Vinay Prasad back as CBER head after ousting

2025-08-1141 min

FDA Watch FDA's Past, Present & Future with John Taylor Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting veteran. Together, they discuss Taylor's pedigree; his perspective on the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency's increasing use of AI; what FDA's top priorities should be moving forward; and much more. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be...

2025-08-0748 min

The Life Science Rundown The Power (and Pitfalls) of Real-World Evidence with Dr. Manfred StapffThe FDA Group’s Nick Capman sits down with Dr. Manfred Stapff—physician, author, and founder of Candid Advisory Inc., a consultancy specializing in real-world evidence and clinical development—for a wide-ranging conversation about how real-world data is reshaping drug development, regulatory decisions, and public understanding of evidence.Dr. Stapff draws on decades of experience across medical affairs, clinical trials, and RWE analytics to explain why real-world evidence isn’t a replacement for randomized controlled trials—but a necessary complement. He outlines how to transform raw data into credible evidence, how the FDA is using RWE today, and why qu...

2025-07-2851 min

The Life Science Rundown Quality Is Not a Cost Center—It’s a Culture (with Dr. Kimberly Garko)The FDA Group's Nick Capman sits down with Dr. Kimberly Garko, Chief Technical Officer and 25-year life science veteran, for a deep dive into one of the most misunderstood concepts in the industry: the cost of quality.Dr. Garko shares why quality should be viewed not as a cost center but as a strategic investment—and how companies can embed that mindset into their culture, systems, and leadership practices. She outlines the difference between good and poor quality costs, explains how to build ROI-focused metrics, and offers practical ways to foster transparency, psychological safety, and proactive decision-making....

2025-07-1554 min

The Life Science Rundown Managing Royalties in Biotech, Pharma, and Medtech with David MarlinNicholas Capman of The FDA Group welcomes David Marlin, Co-Founder and CEO of Metacomet Systems, to explore the often-overlooked complexities of royalty management in life sciences.Drawing from his experience helping over 200 companies automate royalty payouts, David explains how biotech, pharma, and medical device firms struggle to manage licensing agreements as they scale. What starts as a simple once-a-year payment can quickly evolve into a tangled web of tiered rates, stacked IP, country-specific rules, and audit requirements.David breaks down where companies most often go wrong—managing rules in Excel, underestimating the operational burden, and la...

2025-06-0944 min

FDA Watch AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; and Dr. William Maisel, Vice President and Senior Medical Officer at Intuitive, and former Director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health at FDA. Together, they discuss the use of AI for clinical decision support, in regulation and pharmacovigilance functions, and in diagnostic and monitoring tools; AI's impact on advertising and promotion; what "AI washing" is and why...

2025-05-2739 min

The Life Science Rundown GMP Compliance in 503B Compounding Pharmacies with Jesse GillikanNick Capman talks with Jesse Gillikan, President of cGMP Validation, about the challenges compounding pharmacies face with GMP compliance in 2025. After helping over 100 pharmacies navigate FDA regulations since the 2013 Drug Quality and Security Act, Jesse shares candid insights about this industry transformation.The conversation reveals how compounders have moved from resistance to acceptance of GMP requirements, though major hurdles persist. For 503B facilities, the primary challenge isn't knowledge but cost, particularly testing expenses that might be manageable for pharmaceutical giants making millions of units but become prohibitive for compounders producing just thousands.Jesse highlights practical space constraints, with many...

2025-05-2024 min

FDA Watch The Latest in FDA's Focus on Foods Shelly and Wayne chat with Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You'll hear their thoughts on what incoming FDA Commissioner Dr. Marty Makary may be prioritizing in the food space, why it took FDA so long to ban Red Dye No. 3, the agency's "healthy" claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the...

2025-03-3152 min

The Life Science Rundown A Smarter Approach to Supplier Quality Audits with Thermo Fisher's David FestaNicholas Capman of The FDA Group welcomes David Festa, Director of Corporate Quality at Thermo Fisher Scientific, to explore whether pharmaceutical and medical device companies are auditing suppliers too frequently and with the right personnel.With over 25 years of experience in quality management and oversight of tens of thousands of suppliers, David advocates for a more strategic approach that balances quality, compliance, and business needs through "exception-based" auditing.Rather than rigidly adhering to calendar-based audit schedules, David suggests companies should assess suppliers based on performance metrics, risk factors, and the criticality of materials they provide...

2025-02-2841 min

FDA Watch Navigating FDA's Future: Janet Woodcock on the Evolving Regulatory Landscape Shelly and Wayne chat with Janet Woodcock, M.D., former FDA Principal Deputy Commissioner. Woodcock shares her expert insights on the agency's approach to navigating the current regulatory environment, the increasing role of artificial intelligence in FDA decision-making, and the future of the agency's staffing, resources, and regulatory frameworks. This episode and all future bonus episodes do not include the usual Headlines and Resource Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the...

2025-02-1739 min

The Life Science Rundown Mastering FDA and EMA Regulatory Meetings with Ashley PrestonNicholas Capman of The FDA Group welcomes Ashley Preston, SVP of Global Regulatory Affairs & Quality Assurance at BlossomHill Therapeutics, to discuss the critical elements of successful regulatory agency meetings. With over 20 years of experience in regulatory affairs and quality assurance, Ashley shares expertise on preparing for and executing effective interactions with FDA and EMA.While the FDA and EMA are both considered first-tier regulatory agencies, they handle meetings differently. FDA offers various meeting types with structured timelines, while EMA takes a more committee-based approach through the CHMP.FDA meetings include several key types, from pre-IND...

2025-02-1040 min

The Life Science Rundown Working with Chinese CROs: Benefits, Risks, and Best Practices with Harri JärveläinenNicholas Capman, CEO of The FDA Group, welcomes Harri Järveläinen, an independent consultant specializing in non-clinical and regulatory affairs, to discuss the realities of working with Chinese Contract Research Organizations. With over 20 years in the pharmaceutical industry—including experience with AstraZeneca and in Chinese biotech—Harri shares first-hand insights on selecting and managing Chinese CRO partnerships while addressing common misconceptions. Chinese CROs have evolved significantly over the past two decades. Initially focused on medicinal chemistry, they have expanded into full-service providers across all areas of preclinical development. Government support in the mid-2010s fueled rapid growth...

2025-02-0538 min

FDA Watch The New-Look FDA: What's on the Horizon? In this episode, Shelly and Wayne chat with Marc Scheineson, a former FDA Associate Commissioner and currently Senior Counsel in the Washington, D.C., office of Alston & Bird; and Steven Grossman, President of HPS Group, a policy and regulatory consulting firm, and author of "FDA Matters: The Grossman FDA report." You'll hear their thoughts on what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.'s role, staffing issues, funding, possible changes in standards for safety and efficacy, the fate of user fees, and more. This episode and a...

2025-01-2043 min

The Life Science Rundown The Smart Way to Adopt AI in Clinical Trials and Regulatory Affairs with Keith ParentThe FDA Group's Nicholas Capman welcomes Keith Parent, CEO of Court Square Group and RegDocs365, to discuss practical approaches to implementing AI in clinical trials and regulatory operations. With 30 years of experience managing infrastructure for life science companies, Keith offers insights on how organizations can effectively adopt AI while maintaining compliance. Discussion points include: Industry Adoption Patterns: Keith contrasts how large pharma companies are establishing AI centers of excellence for major cost-saving initiatives while smaller companies are experimenting with tools like ChatGPT. He emphasizes the importance of solutions that can scale from large to small organizations. ...

2024-11-2238 min

The Life Science Rundown Demystifying AI in Life Sciences Supply Chain with Jennifer ChewThe FDA Group's Nicholas Capman welcomes Jen Chew, Vice President of Solutions and Consulting at Bristlecone, to discuss how life sciences companies can effectively implement AI in their supply chain operations. Jen sheds light on a few practical approaches to AI adoption in an industry still adapting to post-COVID realities. Discussion points include: Strategic Implementation Approach: Jen emphasizes the importance of starting with simple, tactical applications before moving to complex strategic implementations. She advocates for a focused departmental approach rather than scattered company-wide experimentation. Data Quality and Regulatory Compliance: A major focus is placed on the...

2024-11-1439 min

The Life Science Rundown Streamlining Promotional Reviews in the Life Sciences with Annalise LudtkeThe FDA Group's Nicholas Capman welcomes Annalise Ludtke, Senior Manager of Marketing and Communications at Vodori. They explore the essential steps and challenges involved in bringing compliant marketing content to market in a regulated industry. Discussion points include: Bottlenecks and Feedback Challenges: Annalise details how differing team goals, particularly between marketing and regulatory, often lead to bottlenecks, making it essential to streamline feedback and improve claim management. Role of Claims Matrices and Version Control: Effective claims matrices and version control processes are critical for pre-approved content to ensure accuracy, avoid compliance delays, and...

2024-10-2535 min

The Passionate Workforce Podcast Expert Insights on FDA Regulations and Building a Passionate WorkforceIn this special cross-post episode of The Passionate Workforce Podcast, we’re excited to share Nick Capman’s recent conversation from Steve Ramona’s podcast, Doing Business with a Servant’s Heart. Nick delves into two critical topics: expertly navigating FDA regulations and building a passionate, high-performing workforce. Nick shares his deep experience in helping life sciences companies streamline their regulatory processes, prevent costly delays, and achieve smoother approvals. Shifting gears, the episode explores how business leaders can transform workplace culture by embracing bold strategies like profit-sharing and unlimited paid time off. Whether you're in the FDA-regulated industry...

2024-10-2428 min

The Life Science Rundown Navigating Supplier Audits in Japan with Derek WessmanThe FDA Group's Nick Capman sits down with Derek Wessman, a consultant based in Japan, to discuss the intricacies of conducting supplier audits in the Japanese life sciences industry. They explore the unique challenges and opportunities presented by Japanese suppliers and the cultural and regulatory nuances that impact auditing processes. Discussion points include: Language and Cultural Barriers: Derek explains how the significant language barrier and cultural differences can impact audit efficiency and effectiveness, often doubling the time required for audits. Strengths of Japanese Suppliers: The conversation highlights the strengths of Japanese suppliers, including...

2024-10-1727 min

The Life Science Rundown Small Lots, Big Risks: Rethinking Statistical Sampling in BiopharmaThe FDA Group's Nick Capman sits down with pharmaceutical scientist and consultant Gary Ritchie to discuss the intricacies of statistical sampling in biopharmaceuticals. They explore the limitations of the square root of n plus one sampling method, particularly for small lot sizes, and the advantages of more rigorous statistical approaches. Discussion points include: Limitations of Square Root of n + 1: Gary explains why this commonly used method is inadequate for small biopharmaceutical lot sizes, leading to potential risks in sample representativity and patient safety. Importance of Proper Sampling: Gary highlights the need...

2024-08-2918 min

The Life Science Rundown Quality Metrics that Matter with Kimberly WallbankThe FDA Group's Nick Capman sits down with quality management consultant Kimberly Wallbank to discuss the challenges and best practices of implementing effective quality metrics in the life sciences industry. Discussion points include: Quality vs. Quantity in Metrics: Kimberly emphasizes the importance of focusing on meaningful metrics rather than simply tracking throughput. Aligning Metrics with Business Goals: Kimberly discusses how to connect quality metrics to financial impacts and overall business objectives. Optimal Number of Metrics: Kimberly advises on starting with a few key metrics and gradually expanding, while regularly reassessing their...

2024-08-1941 min

The Life Science Rundown Applying AI in the Life Sciences with MasterControl's Matt LoweThe FDA Group's Nick Capman sits down with Matt Lowe, Chief Strategy Officer at MasterControl, to discuss the opportunities and challenges of implementing AI in the life sciences industry. Discussion points include: AI Applications in Life Sciences: Matt outlines the broad spectrum of AI applications, from early-stage drug discovery to post-market analysis of customer feedback and adverse events. Risk-Based Approach to AI: Matt emphasizes the importance of applying a risk-based approach to AI implementation, similar to other processes in the life sciences industry. Low-Risk, High-Value Use Cases: Matt provides examples of...

2024-07-1530 min

The Life Science Rundown Navigating FDA Regulations for SaMD AI and Machine Learning with Adam ForesmanThe FDA Group's Nick Capman sits down with Adam Foresman, Head of Quality & Regulatory Affairs at VideaHealth, to explore the intersection of AI, machine learning, and diagnostics within the FDA's regulatory environment. Adam brings over 15 years of experience in medical device design, quality management systems, and regulatory affairs, with a recent focus on AI in the dental diagnostic market. Discussion points include: The Regulatory Landscape for AI in Dental Diagnostics: Adam shares his insights on how AI and ML are becoming integral in dental diagnostics, aiding in identifying previously missed detections, enhancing patient education, and streamlining...

2024-05-1528 min

The Life Science Rundown Crafting Quality Systems for Each Phase of Drug Development with Carlos YuraszeckThe FDA Group's Nick Capman sits down with Carlos Yuraszeck, an accomplished leader in biopharmaceutical compliance, operations, and quality assurance, with a specialized focus on driving innovation and efficiency in cell therapy manufacturing. With over two decades of dedicated service in the biopharmaceutical industry, most recently serving as the Head of GMP Manufacturing at the Astellas Institute of Regenerative Medicine, Carlos provided profound insights into the pivotal role of phase-appropriate quality systems in managing drug development from research to commercialization. Our discussion focused on how these systems facilitate the rapid delivery of treatments to patients in urgent...

2024-04-3018 min

The Life Science Rundown Leading Through Transition: Strategic Insights from Novartis's Front LinesThe FDA Group's Nick Capman sits down with Stephen Poor, a physician-scientist with over 20 years of experience in the industry, mainly with Novartis — currently serving as Novartis's Global Program Clinical Head (Executive Director). They delve into the psychological and professional impacts of organizational changes, particularly focusing on identity and adaptation during times of transition, such as layoffs or department closures. Discussion points include: » Stephen's transition due to organizational shutdown and his journey through change. » Stephen's experiences and thought processes from realizing Novartis's exit from ophthalmology to starting a new job, focusing on id...

2024-04-0147 min

The Life Science Rundown Real Talk on Remote Leadership with Nick KlingensmithThe FDA Group's Nick Capman sits down with Nick Klingensmith, a four-time cancer survivor, motivational speaker, and mindset coach. They discuss the challenges of remote work, especially the disconnect between leadership, management, and frontline employees, and how it affects company culture and employee engagement. Key points discussed include: Klingensmith's journey from sales in the telecom and logistics industries to becoming a motivational speaker and coach, emphasizing resilience and overcoming obstacles. The fundamental disconnect in remote work environments, where leaders fail to engage effectively with their teams, leading to feelings of isolation and disconnection among employees. The...

2024-03-2944 min

The Life Science Rundown Audit and FDA Inspection Readiness Best Practices with Divya GowdarThe FDA Group's CEO, Nick Capman sits down with Divya Gowdar, Founder and CEO of NubGenix to discuss the pitfalls and lessons learned on the frontlines of audit and inspection readiness throughout the FDA-regulated industries. Discussion points include: The need for a formalized inspection readiness program, especially highlighted by challenges in accessing critical documents like quality manuals or SOPs in a timely manner. The complexities and confusion surrounding QMS integration post-merger or acquisition, emphasizing the importance of clear SOP adherence and SME identification. The strategic development of an inspection readiness playbook outlining detailed procedural actions for...

2024-02-1927 min

The Life Science Rundown Mastering the TMF: Ensuring GCP Compliance and Inspection Readiness with Donna DorozinskyThe FDA Group's CEO, Nick Capman, sits down with Donna Dorozinsky, founder and CEO of Just in Time GCP, to discuss key considerations for Trial Master File (TMF) management and GCP compliance. Discussion points include: The TMF's significance in capturing a study's complete story, including its challenges and achievements and its pivotal role in GCP compliance. The evolution of TMF structuring, the development of the TMF Reference Model for standardization, and its benefits for simplifying content integration across different organizations and vendors. Donna’s three components of a quality TMF: record quality, timeliness of filing, and co...

2024-02-0617 min

The Life Science Rundown The Startup's Guide to Setting Up Cell Therapy Manufacturing: Navigating Regulations, Resources and TimelinesThe FDA Group's CEO Nick Capman sits down with Mukesh Kumar, PhD, RAC, for a deep dive into the challenges of setting up GMP facilities for cell therapy startups. Discussion points include: » Common questions startups have around engaging with the FDA and determining costs and timelines for GMP facility setup and clinical trials. » Recommendations for engaging regulatory experts early and doing first-in-human manufacturing in-house rather than through a CMO to reduce costs and time. » The importance of educating oneself on regulations before meetings with experts or the FDA to get the mos...

2024-01-1840 min

The Life Science Rundown A Blueprint for Quality Culture with Vincent CafisoThe FDA Group's CEO Nick Capman, sits down with Vincent Cafiso for a deep dive into the nuances of quality culture within the life sciences sector. Vincent is a former FDA Investigator and industry expert who now helps firms with inspection readiness, compliance, quality assurance, and quality systems consulting expertise. Discussion points include: » The essence of quality culture being more than just adherence to procedures. It encompasses the actions, mindsets, and execution methods of employees—areas that are pivotal for inspection readiness and regulatory compliance. » The integral components of quality culture, including an emph...

2023-12-2053 min

The Life Science Rundown An FDA Inspection Survival Guide with Jonathan WacksThe FDA Group's CEO, Nick Capman, sits down with Jonathan Wacks to discuss ways to minimize the stress associated with FDA inspections. Jonathan is an experienced healthcare industry executive with a proven track record in startups and Fortune 500 companies. He has a strong background in international QA/RA, engineering, and project management, specifically with medical devices, electronic assemblies, and supply chain management. Discussion points include: » The importance of a robust QMS and the role of third-party audits in ensuring unbiased compliance assessments, and preemptively identifying compliance issues, underlining the need for thorough and h...

2023-12-1452 min

The Life Science Rundown Clinical Data Standards in Focus: SDTM Compliance with Sunil GuptaThe FDA Group's CEO Nick Capman, sits down with Sunil Gupta, a seasoned expert in pharmaceutical data, to shed light on the nuances of SDTM (Study Data Tabulation Model) compliance and its pivotal role in clinical trial processes. Sunil brings a wealth of experience from his three decades in the pharmaceutical industry, focusing on areas like SAS programming, submissions, and leveraging new technologies for clinical trials. Discussion points include: » The transition from manual processes to technology-enhanced procedures in clinical trials — specifically the shift towards automation and standardization. » An in-depth look at SDTM...

2023-12-1321 min

The Life Science Rundown The Link Between Quality Culture and QA Communication Pathways with David MarksThe FDA Group's CEO Nick Capman, sits down with David Marks to discuss the intricacies of Quality culture and QA communication pathways in the life sciences. David is a strategic advisor and experienced executive with a proven track record in establishing global Quality, Operational, Corporate Stewardship, Change Management, and Integration programs across biopharma and CROs. Discussion points include: » The crucial role of a Quality culture, especially in biopharma and clinical settings. David discusses how a strong Quality culture leads to proactive organizations, reducing the frequency of audits and audit findings. » The separation of Qu...

2023-11-151h 08

The Life Science Rundown Mastering Medical Device Supplier Management with Paul HakamakiThe FDA Group’s CEO, Nick Capman, sits down with Paul Hakamaki, Vice President of Quality at Anteris Technologies, to explore the nuances of supplier management in the medical device industry. Discussion points include: » Paul's journey from a supplier quality engineer to Vice President of Quality and his experience across various company sizes in the medical device sector. » The critical importance of supplier management in the medical device industry, highlighting the necessity for clear expectations, risk management, and fostering partnerships beyond mere transactional relationships. » A spectrum of supplier relationships, ranging from trans...

2023-11-0945 min

The Life Science Rundown Recent FDA Enforcement Trends with George ToscanoThe FDA Group’s CEO, Nick Capman, sits down with George Toscano, President & CEO of Toscano Consulting Group, to explore recent FDA enforcement trends and the nuances of the FDA inspection process, especially in light of the COVID-19 pandemic's impact on the industry. Discussion points include: » George's extensive background in the pharmaceutical, biologics, and medical device industries, highlighting his transition from an analytical development chemist to a consultant specializing in quality and regulatory work. » The emergence of new companies in the pharmaceutical space during the COVID-19 pandemic, particularly those producing hand sanitizers, and the...

2023-11-0337 min

The Life Science Rundown Growing Your Career in RA/QA with Jessica Smith Beaver, PhDThe FDA Group’s CEO, Nick Capman, sits down with Jessica Smith Beaver, PhD, President & CEO of Verinetics, to explore various career trajectories within the quality and regulatory space in the life science industry, the advantages and challenges of different paths, and the crucial role of personal reflection in career development. Discussion points include: » Dr. Beaver's journey from a pharmacist to a contributing scientist in the pharmaceutical industry, and her eventual transition into regulatory affairs and quality space. » The dilemmas faced by professionals in RA/QA roles, such as the decision to specialize or g...

2023-11-0153 min

The Life Science Rundown Drug Delivery System Innovation and Leadership with Steve KnowlesThe FDA Group’s CEO, Nick Capman, sits down with Steve Knowles, MB.BS, M.R.C.P., M.F.P.M., Chief Medical Officer at Halozyme, a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. They discuss advancements in drug delivery technology and the role of leadership in fostering innovation and addressing challenges in this field. Discussion points include: » Dr. Knowles's transition from a physician in the UK to Chief Medical Officer at Halozyme in San Diego. » The evolution in drug deli...

2023-10-2039 min

The Life Science Rundown Motivating Technical Teams in the Life Sciences: A Conversation with Rick BeattyThe FDA Group’s CEO, Nick Capman, sits down with Rick Beatty, Chief Science Officer and Senior VP of Quality and Regulatory at Robinson Pharma, the largest industry contract manufacturer in the U.S. They discuss: » Leadership philosophy, particularly the importance of focusing on employees’ success as a pathway to organizational achievement. » Rick's shift in leadership approach after training with Marshall Goldsmith, moving from a self-centered to a people-centered approach. » The generational gap in leadership styles, with older generations often struggling to understand the mindset of younger employees. » How scientif...

2023-10-0952 min

The Life Science Rundown Cross-Cultural Pharma: Mike Martin's Experiences from Puerto Rico to ChinaThe FDA Group’s CEO, Nick Capman, sits down with CAI's CEO, Mike Martin, BSME, MBA, PE, whose roles have spanned from designing facilities and systems to CEO, including experiences in device manufacturing, global project management, and regulatory insights. They discuss: » Mike's personal journey from growing up in Southern Indiana with a passion for math and science to leading major pharmaceutical projects around the world. » The importance of servant leadership in the pharmaceutical sector, emphasizing the success of team members over personal achievements. » The challenges and intricacies of navigating the regulatory lands...

2023-08-1440 min

The Life Science Rundown Courageous Leadership to Reinvent Our Healthcare SystemThe FDA Group's CEO, Nick Capman speaks with Cheryl Blasie, Ph.D., a healthcare consultant and advocate whose roles have spanned from entry-level Ph.D. Research Scientist to Vice President and Head of Quality at biotech and biopharma companies, including Program Management, Business Operations, and Patient Advocacy. They discuss: » Cheryl's personal journey from being a biotech industry veteran to becoming a healthcare advocate, driven by her own health challenges. » The need for courageous leadership in the healthcare sector to challenge the status quo and explore alternative treatment options beyond traditional allopathic medicine. ...

2023-07-2749 min

The Life Science Rundown The Critical Role of 'Hyper-Targeting' in Rare Disease Drug DevelopmentThe FDA Group’s CEO Nick Capman sits down with Dan Donovan, an expert in rare disease drug development, to explore the unique challenges and new opportunities presented in the rare disease space. They discuss: » The critical role of patient advocates and caregivers in conducting successful studies and applications for bringing a rare disease drug to market. » The financial and resource challenges faced in the field of rare diseases and drug development. » The potential for individuals to contribute to the rare disease sector, specifically through the Five Voices program. » Successful and unsuccessful attempts to bring rare disease drugs to market...

2023-07-1430 min

The Life Science Rundown A Journey into Life Sciences Investment: Strategies, Challenges, and Opportunities with Sal BuscemiThe FDA Group’s CEO Nick Capman sits down with seasoned investor Salvatore Buscemi to delve into the intricacies of investment in early-stage life science and device companies. They highlight key aspects such as: » The definition and role of 'family offices' in life science investments. » The importance of investors being prepared to lose their investment due to potential risks, highlighting that these investors should be aware of who they're investing alongside. » The mistakes founders often make when raising capital, notably misunderstanding the relationship-driven nature of the business, and the need to build trust before expecting monetary investments. » The significance of sta...

2023-06-0136 min

The Life Science Rundown Navigating Risk Management in Medical Devices with Brian DenseThe FDA Group's CEO, Nick Capman sits down with Brian Dense, a medical device consultant with over 30 years of experience across several parts of the industry, to discuss risk management for medical devices, emphasizing key points such as: » The importance of risk management in the medical device industry as it forms the basis of regulations and ensures safe and cost-effective products. » Different markets, including the European Union, Canada, and the United States, and their specific regulatory requirements. » The primary standard for risk management, ISO 14971, with the 2019 version designed to align with the EU MDR...

2023-05-1535 min

The Life Science Rundown The DEA, FDA & Controlled Substances: An Insider's Perspective with Former DEA Agent Dennis WichernThe FDA Group's CEO, Nick Capman sits down with former DEA agent Dennis Wichern to discuss the vital role of compliance for pharmaceutical companies dealing with controlled substances and the significance of adhering to DEA regulations. Key discussion points include: » The importance of strong compliance programs, record-keeping, and suspicious order monitoring systems, especially in light of the nationwide opioid lawsuits. » Common issues faced by DEA registrants, such as poor record-keeping and security, and the need for adequate security measures and compliant record-keeping systems. » The process of determining a buyer's legitimacy and the...

2023-04-2630 min

The Life Science Rundown A Deep Dive into Medical Device Regulatory Strategy with Regulatory Attorney Christine P. BumpThe FDA Group's CEO, Nick Capman, sits down with Regulatory Attorney Christine P. Bump to discuss the current regulatory landscape for medical devices and the importance of developing a thoughtful regulatory strategy. Discussion points include: » The three classifications of medical devices and the various regulatory submission types — each with different risk levels, required data, costs, and approval timelines. » The costs associated with FDA approval. » Why it's important to craft a regulatory strategy early, even at the product concept stage, to determine device functionality and anticipate FDA requirements. » The challenges that t...

2023-04-1138 min

The Life Science Rundown Lessons from a Medtech Entrepreneur: Ram Konduru on Fostering Teamwork and Personal Growth in LeadershipThe FDA Group's CEO, Nick Capman sits down with Ram Konduru, CEO of PrimeSoft Inc (North America & Europe) and Co-Founder of Coherence Health. Ram discusses his experience in leadership and management, highlighting the importance of having a common purpose and goal for a team. Ram and Nick also discuss the need for leaders to create strong bonds within their teams, provide opportunities for team members to bond, and be humble and relatable. Other discussion points include: » Ram’s personal growth journey as a leader, the impact of his mentors on his development, and the importance of...

2023-04-0329 min

The Life Science Rundown Unlocking Effective Leadership: A Conversation with MetaComet Systems President, David MarlinThe FDA Group's CEO, Nick Capman sits down with David Marlin, President of MetaComet Systems, a company specializing in royalty automation software. David shares his background, thoughts on leadership and management, and the importance of working towards a common goal. He emphasizes the value of joining peer groups, vulnerability, trust, and using the Entrepreneurial Operating System (EOS). He credits the concept of "letting go of the vine" for reducing stress and improving overall business performance. David also discusses: His transformation from a charismatic leader to a better listener and the pride he takes in his company's...

2023-03-2436 min

The Life Science Rundown Leadership, Management, and Enhancing Quality of Life: A Conversation with Dan Barker, CEO of WikimotiveThe FDA Group's CEO, Nick Capman sits down with Dan Barker, CEO of Wikimotive, to explore perspectives on management and leadership. Dan shares his unique professional journey and dives into the importance of vulnerability and constant learning in leadership and management, as well as discussing other topics, including: How management can be the 'easy' side of the equation, with leadership being about ensuring management systems are built and executed effectively. Dan's non-typical career path, from cabinet maker to marketer and eventually CEO. The importance of leadership and management in enhancing people's quality of life. How good leaders and...

2023-03-0930 min

The Life Science Rundown Navigating the 510(k) Process: A Q&A with Regulatory Consultant, Trey Thorsen, MS, RACThe FDA Group’s CEO, Nick Capman, sits down with Regulatory Consultant Trey Thorsen, MS, RAC, to answer some of the most frequently asked questions about navigating the 510(k) premarket notification process. Trey brings experience in Class I, II, and III devices, such as active implantables with MRI functionality, external therapeutic devices indicated for pain, devices that have software functionality, transvaginal catheter systems that evaluate fallopian tube patency, sterile and non-sterile wound care devices, compression devices, surgical booms, surgical lights and devices indicated for incontinence. He also has experience with 513(g)s, Pre-Subs and CFGs, UDI/GUDID im...

2023-02-0922 min

The Life Science Rundown The Future of Life Science Talent Acquisition: Securing In-Demand Skills in a Competitive MarketEarlier this year, Deloitte released its Global Life Sciences Outlook report, featuring a section devoted to "transforming the talent experience." The FDA Group's CEO, Nick Capman, sat down with Larry Stevens, RAC, to unpack some of Deloitte's findings and what they might mean for life science teams looking to innovate their workforce strategies and navigate a hyper-competitive specialized labor market. Read Deloitte's full report (PDF): https://www.deloitte.com/content/dam/assets-shared/legacy/docs/perspectives/2022/gx-lshc-dei-global-life-sciences-outlook-report.pdf Some key excerpts: Page 29: _____ "Life sciences companies are still optimizing v...

2022-11-2125 min

The Life Science Rundown FDA Revives Its Proposed Quality Metrics Program for PharmaThe FDA Group's Nick Capman discusses the recent news that the FDA is once again returning to its quality metrics program for pharma manufacturers. The agency’s focus on quality metrics began in 2015 and continued with a heavily revised draft guidance on submitting metrics data, including quality-related complaints. The guidance led to two FDA pilot projects in 2018. In a new update, FDA stressed that additional quality data can help both the FDA and the supply chain, which needs to have a better understanding of which manufacturers are going above and beyond the status quo. Cu...

2022-04-1807 min

The Life Science Rundown Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for IndustryProduct 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 ye...

2022-02-1421 min

Pelos Ouvidos da FDA Episódio 13 - Professor Alberto Jorge - Magistratura, Docência e Ciências CriminaisNo décimo terceiro episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Alberto Jorge para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-09-181h 13

Pelos Ouvidos da FDA Episódio 12 - Egressa Lívia Lemos - Direito Internacional, Refugiados e PesquisaNo décimo segundo episódio do podcast Pelos Ouvidos da FDA, convidamos a egressa da Faculdade de Direito de Alagoas Lívia Lemos para falar sobre seus anos no curso e a contribuição deste para a sua vida. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-08-311h 00

Pelos Ouvidos da FDA Episódio 11 - Professor Paulo Cordeiro - Docência, Magistratura e JustiçaNo décimo primeiro episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Paulo Cordeiro para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-08-2649 min

The Life Science Rundown FDA's Domestic Biopharma Inspections Return to NormalFor 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...

2021-08-0508 min

Pelos Ouvidos da FDA Episódio 10 - Professora Lavínia Cavalcanti - Mediação, Cultura da Paz e ComunicaçãoNo retorno do podcast Pelos Ouvidos da FDA, convidamos, no décimo episódio, a professora Lavínia Cavalcanti para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-07-311h 23

Pelos Ouvidos da FDA Episódio 9 - Professor Marcos Bernardes de Mello - Tradição, Docência e AdvocaciaNo nono episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Marcos Bernardes de Mello para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia Observação: Esse episódio foi gravado no dia 21/05/2021.

2021-07-231h 22

The Life Science Rundown Quality Management Review: Benchmarking Quantitatively!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: https://www.pharmaceuticalonline.com/doc/quality-management-review-benchmarking-quantitatively-0001 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 me...

2021-07-0226 min

Health Equity Forum A conversation with the FDA Chief Scientist: Learn about the Emergency Use Authorization (EUA) ProcessIn this episode, RADM Araojo discusses FDA’s Emergency Use Authorization process with RADM Denise Hinton, FDA’s Chief Scientist.

2021-06-0810 min

The Life Science Rundown Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health CareThe 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 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 poli...

2021-06-0331 min

Pelos Ouvidos da FDA Episódio 8 - Técnica Marluce Cunha - Legado e DesafiosNo oitavo episódio do podcast Pelos Ouvidos da FDA, convidamos a sra. Marluce Cunha, membra do corpo técnico da Faculdade de Direito de Alagoas, para uma conversa acerca dos seus anos na FDA. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-2153 min

Pelos Ouvidos da FDA Episódio 7 - Técnica Gilda Monteiro e o setor administrativo da FDANo sétimo episódio do podcast Pelos Ouvidos da FDA, convidamos a membra do corpo técnico Gilda Monteiro para falar acerca dos seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-2014 min

Pelos Ouvidos da FDA Episódio 6 - Professor Beclaute Oliveira - Arte, Filosofia e DireitoNo sexto episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Beclaute Oliveira para falar sobre seus anos como aluno e como docente da Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-192h 05

Pelos Ouvidos da FDA Episódio 5 - Professor George Sarmento - Direitos Humanos, Constituição e EducaçãoNo quinto episódio do podcast Pelos Ouvidos da FDA, convidamos o professor George Sarmento, atual coordenador do curso de Direito da Universidade Federal de Alagoas, para falar sobre seus anos como aluno, professor e sobre o início de seu trabalho na coordenação do curso. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-181h 49

Pelos Ouvidos da FDA Episódio 4 - Professora Juliana Jota - Meio Ambiente, Docência e PesquisaNo quarto episódio do podcast Pelos Ouvidos da FDA, convidamos a professora Juliana Jota para falar sobre seus anos como docente da Faculdade de Direito de Alagoas, além do seu período como coordenadora do curso. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-182h 02

The Life Science Rundown Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, Director of Health Care, GAOThe 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 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 publ...

2021-05-0731 min

The Life Science Rundown FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine ScamsThe FDA Group’s CEO, Nick Capman, discusses the federal effort to thwart COVID-19 vaccine scams. Read the full article on FDA.gov 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: www.thefdagroup.com.

2021-03-0908 min

The Life Science Rundown What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden AdministrationThe 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 mo...

2021-01-2808 min

The Life Science Rundown Clinical Outsourcing & Insourcing: Selecting the Right Model or MixThe 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 ha...

2021-01-1232 min

The Life Science Rundown What RA/QA/Clinical Leaders Should Expect From the FDA in 2021The 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...

2020-12-1643 min

The Life Science Rundown Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher SmithThe 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 35 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? Connect with The FDA Group to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP...

2020-11-1251 min

The Life Science Rundown A Look at FDA's Pandemic Inspections Q&A GuidanceThe 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. Links and Resources: Blog Post: 7 Key Takeaways from FDA's Pandemic Inspections FAQ Guidance Blog Post: Key Tak...

2020-11-1204 min