Scaling 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, risk management, QMS maturity, and regulatory expectations across the U.S. and EU. The conversation focuses on what actually prevents costly delays—and how disciplined communication and documentation make scaling achievable.

A few key takeaways:

• Early quality work should be right-sized, not commercialized prematurely

• Design space, material variability, and sensitivities must be understood and documented early

• FMEA works best when it evolves with the product—not when it’s treated as a one-time exercise

• FDA and EU requirements can diverge in ways that materially affect submission timing

• Clear documentation and regular, direct communication prevent avoidable delays

Jackie Klecker is Executive Vice President of Quality and Development Services at Lifecore Biomedical, a fully integrated CDMO with decades of experience supporting pharmaceutical drug products, medical devices, biologics, and APIs. She has led quality systems and development programs across multiple global manufacturing sites and brings deep expertise in FDA 21 CFR 210, 211, and 820, ISO 13485, EU GMP, and ICH Q7 environments. Her background spans chemical engineering, process development, validation, risk management, and cross-functional leadership.

About The FDA Group

The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠⁠https://www.thefdagroup.com/

The 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 remains critical in an AI-driven environment, and how organizations must move beyond reactive reskilling toward more intentional “pre-skilling” of future talent. Mike also reflects on the enduring importance of character, integrity, curiosity, and trust, arguing that these traits matter as much as technical competence in a highly regulated industry.

Nick and Mike examine the evolving role of professional organizations like ISPE in building global communities of practice, sharing knowledge across borders, and supporting lifelong learning. The conversation also addresses how learning itself is changing — from long-form training to bite-sized, modular education — and what leaders must do to engage a new generation of professionals with different expectations around purpose, speed, and technology.

Throughout the episode, Mike emphasizes a unifying theme: innovation and compliance are not opposing forces. When approached correctly, innovation strengthens quality, improves compliance, and ultimately enhances patient safety.

This episode is a must-listen for anyone responsible for building teams, modernizing operations, or preparing their organization for the future of pharmaceutical manufacturing and engineering.

About The FDA Group

The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: ⁠https://www.thefdagroup.com/

The 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 change within complex, matrixed organizations.

Nick and Chris explore what truly defines a quality-centric culture, how leadership and accountability shape it, and the practical, long-term steps required to sustain it.

In this conversation, Chris shares insights on:

• What “quality culture” really means—and how to make it visible at every level of an organization.

• The leadership behaviors that create alignment and consistency across global teams.

• How to embed compliance and continuous improvement into daily operations.

• Managing uncertainty, pressure, and change without losing focus on the patient.

• Practical methods for measuring and improving quality culture over time.

• Why humility and transparency are non-negotiable for sustainable performance.

About The FDA Group

The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

The 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 biotech companies can build regulatory resilience: strengthening governance, preparing for FDA interactions, improving documentation discipline, and integrating external partners without losing control.

He also breaks down how to evaluate vendors, structure joint governance, embed QA into outsourced workflows, and design audit-ready data flows that prevent institutional knowledge loss.

Topics discussed include:

• Why early regulatory infrastructure prevents costly rework

• Leadership behaviors that shape regulatory culture

• How to prepare for high-stakes FDA and ex-US health authority meetings

• The risks of “tribal knowledge” in fast-moving organizations

• A structured model for evaluating and managing external partners

• How small companies can stay inspection-ready with lean teams

One takeaway: External partners can be force multipliers or liabilities—the sponsor’s structure and oversight determine which.

About The FDA Group:

The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations.
https://www.thefdagroup.com/

The 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 technology developers to advance responsible, evidence-driven innovation.

In this conversation, Maria breaks down the reality behind AI in the regulatory ecosystem: what’s currently in use, how agencies are evaluating and validating tools, why risk-based tiers matter, and how the field is moving toward lifecycle oversight rather than one-time checks. She also highlights the ethical and equity considerations that must be embedded from the start and shares insights from global regulatory trends and DIA’s convening role.

Key topics discussed include:

• How regulatory agencies are already using AI internally for document-heavy workflows, safety surveillance, and information retrieval

• Why validation must focus on end-to-end workflow integrity, not just the model

• The emerging role of risk-based tiers for AI-enabled tools

• The importance of lifecycle control frameworks such as TPLC and PCCPs

• Global convergence themes around transparency, bias mitigation, and human accountability

• How agencies are preparing for increasing AI adoption—and what industry teams should be doing now

• DIA’s role as a neutral convener helping harmonize expectations and accelerate responsible innovation

About The FDA Group

The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

Coruna 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 sustains progress beyond the initial response—fostering transparency, prioritization, and a culture of accountability that prevents repeat findings.

Topics discussed include:

• The leadership posture that steadies teams during inspections and remediation

• How to stand up the four-room inspection model (Front, Back, Doc-QC, SME-Prep)

• Responding to 483s: when to push, when to accept, and how to align internally

• Data-integrity vulnerabilities and effective interim controls

• Balancing remediation with production demands

• Building transparency and accountability into quality culture

• Keeping systems current to avoid backsliding into repeat observations

About The FDA Group

The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/

The 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 compliance, structure cross-functional teams for consistent execution, and foster cultures that prioritize transparency, collaboration, and patient focus.

About The FDA Group
The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

The 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 represents a cultural and scientific shift toward safe, risk-based inclusion.

Read the draft guidance here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e21-inclusion-pregnant-and-breastfeeding-women-clinical-trials

Regina shares practical insights on:

• How physiologic changes in pregnancy alter drug absorption, distribution, metabolism, and elimination.

• The dangers of underdosing, overdosing, or avoiding treatment altogether in the absence of trial data.

• Why clinicians should avoid inappropriate substitutions (e.g., some NSAIDs) and instead rely on evidence-based dosing.

• How E21 encourages continued monitoring of participants who become pregnant during a trial rather than automatic withdrawal.

• The stepwise approach to lactation studies—starting with breast milk concentration, then estimating infant dose, and eventually assessing infant exposure and safety.

• The role of PK/PD modeling, nonclinical data, and real-world evidence in bridging evidence gaps.

• How sponsors can engage FDA early to align on inclusion triggers and maternal–fetal expertise.

  
  

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 makes a quality system truly “robust” in practice, and why culture, accountability, and simplicity matter as much as compliance.

Nick and Jeff also explore practical steps for keeping data integrity controls sharp, building efficient systems that don’t overburden teams, and fostering engagement so quality is seen as a partner, not just a policing function.

About The FDA Group: The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: https://www.thefdagroup.com/

The 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-by-step approach to identifying the right challenges, aligning AI projects with company strategy, piloting solutions with clear ROI, and managing change so teams embrace and sustain new tools.

Nick and Catherine also discuss the balance between innovation and regulation, how to keep humans in the loop, and why strong governance and explainability are essential to ensuring AI adds real value in GLP environments.

About The FDA Group: The FDA Group helps 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 on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations: ⁠https://www.thefdagroup.com/