Quality Systems

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.
He can be contacted at bdrapeau@gxpframe.com for any consulting or advisory needs. 

Articles

Agentic AI changes the question from what a model can produce to what a system is allowed to decide.

Pharma's Next AI Problem Is Authority

Pharma's AI ROI gap isn't strategy or tech; it's the missing workforce qualification step every other regulated capability requires.

Pharma's AI ROI Problem Isn't a Tech Problem but a Qualification Problem

Partha Anbil is at the intersection of the Life Sciences industry and Management Consulting. He has over 30+ years of experience in Life Sciences. He is also a Life Sciences industry advisor at MIT, his alma mater. He held senior leadership roles at WNS, IBM, Booz & Company, Symphony, IQVIA, KPMG Consulting, and PWC. Mr. Anbil has consulted with and counseled Health and Life Sciences clients on structuring solutions to address strategic, operational, and organizational challenges. He is a diplomat/fellow at MIT CSAIL. He is a healthcare expert member of the World Economic Forum (WEF). He was a member of the IBM Industry Academy, a very selective group of professionals inducted into the academy by invitation only, the highest honor at IBM.

Deepak Manjarekar is a veteran Data & AI leader with over three decades of experience driving business transformation through data. As Head of Coforge's Global Data HBU, he leads the company's Data & AI growth strategy, building on leadership roles at Mphasis and KPIT, where he successfully scaled high-growth data businesses.

A phased playbook for moving life sciences data warehouses to a compliant, AI-ready cloud Lakehouse, balancing GxP rigor with faster insights.

From Warehouse to Lakehouse: A Life Sciences Playbook for Regulated, AI-Ready Data Modernization

Vice President – Business Development
LGM Pharma

Checking in at 2026's midyear mark, LGM Pharma's Mike Stenberg revisits his 2025 predictions on inspections, onshoring, GLP-1 delivery, and AI adoption.

From Predictions to Reality: Mike Stenberg Assesses Pharma Manufacturing's First Half of 2026

The future of compliant AI is not better content generation. It is better control over what happens next.

Can Governance-by-Design Make AI Compliant in Pharma? (Part II)

Henrik Johanning is CEO and specialist, Genau & Co, Denmark. He is also a member of Pharmaceutical Technology Europe’s Editorial Advisory Board.

Epista's Henrik Johanning revisits his 2026 predictions on QRM, Annex 1, AI governance, and regulatory convergence: What's tracking, what isn't.

Mid-Year Check-In: Are Henrik Johanning's Pharma Manufacturing Predictions Holding Up?

A warning letter, a hard look at why “a human reviews it” doesn’t settle anything, and one company’s argument that accuracy was never the real problem.

Is Compliant AI in Pharma Even Possible? The Search for an Honest Answer

FDA’s CNPV pilot aims to speed drug reviews but raises questions about safety trade-offs, resource strain, and unclear incentives for sponsors.

The Regulatory Crucible: Risk, Resource Drain, and the Hidden Trade-Offs of the CNPV Pilot Program

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Videos

Frank Romanski of Lonza Capsugel dives into the excipient side of manufacturing and the emerging prevalence of digitalization.

Regulatory, cGMP, and CDMO Challenges: A CPHI Conversation with Lonza Capsugel, Part Two

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

Regulatory Oversight and Compliance