Biologics Summit

a Controlled Release Society and
IPEC-Americas joint program

Dates/Locations

Part 1: May 4, 2026 (co-located with Excipient World Conference & Expo, Nashville, TN)

Part 2: July 6, 2026 (co-located with CRS Annual Meeting & Exposition, Lisbon, Portugal)

Biologics Summit Part 1
Bridging Excipient Standards with CGT & Biologics Raw Materials
May 4, 2026, 8 AM - 5 PM

Abstract

This full-day program will highlight the growing intersection between excipient management and the raw and starting materials community within biologics and advanced therapies. Led by Basak Clements (Biomatria), Lili Belcastro (BMS, USP), and Nigel Langley (gChem), the session will explore how IPEC-Americas’ organizational framework and resources can be extended to support this evolving space.

Goals and Learning Objectives

Understand the similarities in material management principles between excipients and raw/starting materials.
Identify regulatory gaps in the raw materials space, particularly in advanced therapies.
Explore how IPEC standards, subject matter experts, and knowledge base can be adapted to support raw material oversight.

Sub-topics Covered

Regulatory frameworks and their limitations for raw materials.
Case studies demonstrating overlap in excipient and raw material control.
Strategic opportunities for IPEC-Americas to expand its role.

Takeaways
Attendees will gain insight into how existing excipient standards can be applied to raw materials, fostering improved regulatory alignment and industry collaboration. They will leave with actionable ideas for integrating IPEC resources into their raw material strategies.

Preliminary Program Schedule

8:00 - 8:05	Opening Remarks		Biologics Summit Chairs: -Basak Clements, biomatria -Nigel Langley, gChem -Lili Belcastro, BMS
8:05 - 8:45	Opening Keynote	"Developing Next-Generation Delivery Systems to Unlock the Full Potential of RNA Therapeutics"	Orn Amarsson, Axelyf
8:45 - 9:30	Formulation and Excipients	"Use of DMSO in Cell and Gene Therapies"	Rachael Atlee, Akron Bio
8:45 - 9:30	Formulation and Excipients	"Dynamic Water Sorption Analysis to Determine Microbial Stability of Excipients"	Arther Zeng, J&J
9:30 - 9:45	Break	Networking and Coffee
9:45 - 11:15	Raw Material Regulatory Perspectives	"Bringing Consistency to Complexity: ISO 20399-4 and the Future of Ancillary Materials"	Dawn Henke, Standards Coordinating Body
		USP BIO4 Updates	Rebecca Potts, USP
		Panel Discussion: "Raw Materials - Enabling Drug Development through Collaboration and Standardization - a Multi-Stakeholder Perspective"	Panel Participants: -Dawn Henke, SCB -Rebecca Potts, USP -Janeen Skutnik-Wilkinson, Lilly -Magali Hickey, Beren Therapeutics -Ravi Kumar, University of Alabama -Fatima Agha, Sartorius
11:15 - 12:00	Supplier Innovation Session	Coming Soon!	Rishi Pimentel, gChem
		"Beyond LNPs: Redefining Nucleic Acid Delivery with Pre-Formed Vesicles"	Ian Villamagna, Sartorius
		Viral Vector Technologies	David Bohonak, MilliporeSigma
		Coming Soon!	TBD, InVitria
12:00 - 1:00	Lunch
1:00 - 1:30	Raw Material Qualification	"Material and Supplier Qualification Streamlining"	Basak Clements, biomatria
1:30 - 2:45	Raw Material Variability	"Stress Tested: How Sterilization and Freeze–Thaw Leave Biochemical Fingerprints in Serum Lots"	Andrew Schaefer, Eurofins
		"Media Fingerprinting for Quality Assessment: Linking Composition to Performance"	Remy Collier, Sartorius
		"Beyond Packaging: A Lifecycle Approach to E&L Risk in Excipients, Raw Materials, and Formulation"	Antonio Scatena, Gateway Analytical
2:45 - 3:00	Break	Coffee and Networking
3:00 - 3:45	Raw Material Safety	Fireside Chat: "Material Safety & Toxicology"	Speakers: -Teresa Wegesser, Amgen -Ron Filler, Drug Development Consultants, LLC Moderator: -Lili Belcastro, BMS
3:45 - 4:00	Biologics Summit Wrap Up		Biologics Summit Chairs: -Basak Clements, biomatria -Nigel Langley, gChem -Lili Belcastro, BMS
4:00 - 4:15	Break
4:15 - 5:00	Closing Keynote	"4.5"	Eric Berg, Amgen

Background

The mission of the Biologics Summit is to bring stakeholders together around a scientific challenge/unmet need via a forum that lends itself to equal participation from academia and industry.

The Biologics Summit is a Controlled Release Society (CRS) and IPEC-Americas collaboration. CRS is the home for experts dedicated to delivery science, including delivery scientists, engineers, clinicians, and technical professionals. CRS members are creating the future of delivery science and technology through fundamental delivery research, development, regulatory science, and clinical translation. IPEC-Americas is a non-profit 501 (c) (6) organization whose members are finished drug manufacturers, ingredient suppliers, distributors, and industry consultants.