September 24-25, 2026 | Hyatt Regency, New Brunswick, NJ

2026 Speakers

Patrick Day, Principal Consultant, Lachman Consultants

FDA Inspection Trends and Top Citations: A Focus on Facilities and Engineering

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Dhaval Desai, Director of Regulatory Affairs & Supply Chain, Zydus Pharmaceuticals

From Approval to Availability: Strengthening the Regulatory-Supply Chain Connection

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Romit Jani, Senior Director of Formulation Development, Solaris Pharma

From Formulation Development to Manufacturing Readiness: Working with CDMOs on Complex Product

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Eric Langer, President and Managing Partner, BioPlan Associates, Inc.

The Biomanufacturing Capacity Crunch: Where CDMO Demand Is Still Outrunning Supply

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Vice President, Reliant Life Sciences

The New Rules of Pharma Outsourcing

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Director, Regulatory Affairs, Amneal Pharmaceuticals

Before FDA Pushback: Using Regulatory Intelligence to De-Risk CMC Submissions

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Gil Roth, President, Pharma & Biopharma Outsourcing Association (PBOA

25 Years of Pharma Outsourcing: From CMOs to Strategic Partners

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Michael Spangler, Principal Consultant, Spangler Consulting

Check Before You Choose: Making CDMO References Calls

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David H. Windley, CFA, CPA, Managing Director, Jefferies LLC

Demand Cometh Before the Fall

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