The Life Science Rundown

How 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 structured data that demands consistent master data, controlled vocabularies, and traceable lineage
Start with scope and pain points, not a boil-the-ocean exercise — pilot governance in one or two high-value use cases, then scale
Data ownership belongs in the business, not IT — IT facilitates, but stewards and business owners should be accountable for their data
Tools support governance but don't replace it — get the people and process foundation right before selecting platforms
AI reliability depends on governed data — without standardized inputs and clear provenance, models produce unreliable or unexplainable outputs
Tie governance to business outcomes people are already measured on — submission cycle time, audit readiness, right-first-time metrics — or compliance won't stick
About Cary SmithsonCary Smithson is Managing Partner and Owner of LeapAhead Solutions, Inc., where she leads a consulting practice focused on IT strategy, data governance, and business process consulting for life sciences. She leads the DIA RIM Working Group and the DIA RIM Intelligent Automation Team and co-authored the DIA RIM eBook. With experience spanning large consulting firms (Grant Thornton, PharmaLex), enterprise technology organizations (OpenText), and her own practice, Cary has served clients including Regeneron, Bristol-Myers Squibb, Johnson & Johnson, Daiichi Sankyo, Bayer, and BeiGene. She is a recognized thought leader who regularly presents at industry conferences on regulatory information management, intelligent automation, and AI adoption in life sciences.
About The FDA GroupThe 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/

How 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 adaptability—build organizations that absorb and anticipate change rather than resist it
Separate innovation from execution with intentional gates for when new approaches are ready to implement
Document your assumptions so you can revisit decisions effectively when circumstances change
Failure is a process problem, not a personal one—root cause analysis should improve systems, not assign blame
Data is the common language that aligns scientists, regulators, and stakeholders
Everyone is a leader in cell therapy—manufacturing and QC teams hold patient lives in their hands
About Nelly Viseux
Nelly Viseux is Vice President of Cell Therapies Development, Manufacturing, Supply & Quality at Regeneron, leading a 100-person organization supporting autologous cell therapy programs. She has over 20 years of biotechnology experience spanning large pharma (Shire, Biogen, Baxter) and startups, working across cell and gene therapies, biologics, and nanoparticles. Her accomplishments include building a Phase 1 cell therapy manufacturing facility that achieved 100% cGMP success and first IND submission within two years. She holds a Ph.D. in Biochemistry and Molecular Biology from University of Lille and is a member of the Society for Immunotherapy of Cancer and the American Society of Gene & Cell Therapy.
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/

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/