Biopharma CMC/Regulatory Relationships In a Global Market

By Matthew Pillar, Editor, Bioprocess Online

You’re not alone. Scores of biopharma quality, regulatory, and CMC professionals before you have wrestled with the mantle of streamlining their chemistry, manufacturing, and controls initiatives with ever-evolving global regulatory requirements. It’s one of biopharmas biggest challenges, but getting an invitation to the struggle is an honor, a privilege offered only to those with clinically- and commercially-viable assets. While few walk away unscathed, many become quite adept at efficiently navigating the labyrinth. Fortunately, a handful of those who’ve skinned their knees before you—then gotten back on their feet to meet the challenge—are willing to share what they’ve learned and how they’ve applied those learnings in their organizations.

On August 9 at 11 AM ET, I’m bringing three veterans of the biopharma CMC and regulatory landscape together for a Bioprocess Online Live! virtual discussion on the topic (free registration is here). All three of them are among the willing—willing to share the best practices they’ve learned, how they institutionalized those practices, and the mistakes they’ve seen (and made) along the way.

During our Regulatory Harmonization Meets CMC Realities Bioprocess Online Live! session, I’ll be addressing questions—both mine and those from our live audience—to:

• Olga Braem, Ph.D., Head of CMC at Kyowa Kirin North America
• Steve Chamow, Ph.D., Senior VP of CMC at Alira Health
• Stefanie Pluschkell, Ph.D., former executive director at Pfizer and founder & CEO at InScope Coaching & Consulting LLC

During the course of the conversation, we’ll delve into:

• The “path of most resistance” strategy of meeting the most stringent global jurisdiction’s regulatory requirements in expectation that your CMC strategy will then check the boxes in every region you apply —and where that strategy breaks down.
• Which guidelines—ICH and otherwise—demand the most CMC attention.
• What CMC and other business changes incite regulatory engagement—from new asset acquisitions to changes in raw materials, equipment, consumables to supply chains and vendor/supplier engagements—and how to clear the regulatory hurdles those changes create.
• Which development activities are nearly impossible to get “undone” and how to get them right the first time.
• What “unsophisticated” looks like in the context of IND preparedness, and the avoidable mistakes our panelists have seen throughout their careers.
• What “tracking” CMC/regulatory people, functions, time, and expense looks like and why it’s important.
• The pace of global regulatory harmonization and convergence, and what’s on the horizon.

We’ll also be taking plenty of questions from our audience, and being a part of that audience costs nothing. Don’t miss an opportunity to learn from the best without paying the bill. Register here.