Strengthen CMC Strategy to Prevent Downstream Delays

Many CMC challenges that emerge during manufacturing originate much earlier in development. They are decisions made months earlier, in cell line development, process design or formulation, without a clear picture of what they would cost downstream. By the time the consequences show up, the options for fixing them are expensive, time-consuming and need regulatory approvals. This webinar gives biologics teams the real-world perspective and practical frameworks to make those decisions with confidence.

The session examines where CMC strategy most commonly breaks down. Across cell line development, process design, formulation, analytics, manufacturing and tech transfer, there are recurring decision points that teams underestimate. The strategic implications are rarely made visible early enough, and by the time they surface, the cost of course-correcting is already high.

The featured speakers will share lessons from more than 25 years of CMC experience, including recurring development patterns, decisions that initially appeared low risk and early indicators that distinguish programs positioned to scale from those likely to stall. The session will connect these strategic insights with structured, stage-appropriate development pathways.

Different programs have different needs. A team racing to first-in-human has fundamentally different CMC priorities than one preparing for a phase transition or optimizing an underperforming process. The webinar will show how to match CMC strategy to program stage and goals, and how structured development frameworks can translate strategic thinking into practical development paths.

Whether attendees are developing an initial CMC strategy, preparing for technology transfer or restoring momentum to a stalled program, this session will provide practical guidance for making informed decisions and reducing downstream risk.

Register for this webinar to learn how CMC strategy can reduce costly rework, development delays and manufacturing risk.

Speakers

Xiao-Ping Dai, PhD, Chief Technical Officer, Alveus Therapeutics

Xiao-Ping Dai, PhD, is CTO and Head of Technical Operations at Alveus Therapeutics, with over 25 years of experience in biopharma and biotech. Her expertise spans end-to-end CMC leadership from discovery to commercialization across biologics, cell and gene therapies, small molecules and oligonucleotides. She contributed to the commercial development and success of Opdivo, Yervoy, Reblozyl and Izervay.

Prior to Alveus, Xiao-Ping Dai served as SVP and CTO at IVERIC bio, leading late-stage CMC development, NDA filing and the commercial launch of Izervay. She previously held roles as Chief Technologist at WuXi Advanced Therapies, Senior Director of Biologics Development and Manufacturing at Celgene Corporation and spent over 12 years in leadership and technical roles at Medarex/BMS and Regeneron Pharmaceuticals.

She is also Founder and Principal of Expedite Bio, LLC, a consulting firm specializing in end-to-end pharmaceutical CMC development strategies.

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Dr. Ellen Higernberg, Director, Business Development, ProBioGen

Dr. Ellen Hilgenberg is Director of Business Development at ProBioGen, working with biotech and biopharma companies navigating CMC strategy and CDMO partnerships across early- to clinical-stage programs.

She holds a PhD in Immunology from Humboldt University of Berlin, with her doctoral research conducted at the German Rheumatism Research Center and postdoctoral research completed at the Max Delbrück Center in Berlin. Her scientific grounding and CDMO experience give her a sharp perspective on how early CMC decisions shape program outcomes.

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