The Uncomfortable Truth About CMC in 2025

Why JPM Conversations Matter Now More Than Ever

Your CMC strategy is probably obsolete. Yes, you read that right. In an industry obsessed with innovation, we're clinging to regulatory approaches from a bygone era. At JPM 2025, we need to have the difficult conversations no one's having.

The $2B Problem No One Wants to Acknowledge

Every year, pharma companies waste billions on outdated CMC practices. While we celebrate breakthrough therapies, our manufacturing and control strategies remain stuck in 2020. The cost? An estimated $2 billion in unnecessary delays, redundant testing, and missed opportunities.

AI Isn't Your Savior (But It Could Be)

Everyone's talking about AI in CMC, but let's be honest – most implementations are window-dressing. Real transformation requires uncomfortable changes to deeply entrenched processes.

At JPM, we'll explore how leading companies are actually revolutionizing their CMC approach, not just checking the AI box.

The Global Market Access Myth

Think your current CMC strategy will work for global expansion? Think again. Emerging markets are rewriting the rules, and the old playbook is becoming a liability. We'll reveal why traditional approaches are failing and what the new paradigm looks like.

Beyond Compliance: The New CMC Imperative

• Why "regulatory compliance" as we know it will be irrelevant by 2026
• The hidden cost of playing it safe in CMC development
• Why your competitors' CMC strategies are leaving you behind
• How regulatory agencies are quietly revolutionizing their expectations

The Conversations That Will Shape 2025

Join us at JPM to discuss:

• The end of platform CMC approaches (and why that's good news)
• Why your regulatory timeline is probably twice as long as it needs to be
• The controversial new approach to stability testing that's gaining traction
• How some companies are cutting CMC review times by 60%

Breaking the Silence

We'll host intimate, no-holds-barred discussions about:

• The real reasons CMC submissions fail (hint: it's not what you think)
• Why traditional CMC consulting is dead
• The uncomfortable truth about quality systems
• What regulatory agencies really want (but won't say publicly)

Take Action Now

The pharma industry is at a crossroads. The companies that adapt their CMC strategies now will dominate the next decade. Those that don't? Well, let's discuss that at JPM.

Ready for real change? Join us for an unvarnished look at the future of CMC. No sugar-coating. No buzzwords. Just straight talk about what's working, what's failing, and what's next.

[Schedule Your Session in Person on January 13-15 or Virtual now Enarke@enkrisi.com]

Because in 2025, CMC isn't just about compliance – it's about survival.

Maximizing Your JPM Healthcare Experience: The CMC Perspective

The JP Morgan Healthcare Conference represents a unique opportunity to align regulatory strategy with business objectives. Here's why our CMC regulatory discussion should be on your JPM agenda.

Strategic Value

Industry consolidation and technological advancement are reshaping CMC requirements. Understanding these shifts is crucial for:

• Optimizing development timelines
• Reducing compliance costs
• Accelerating market entry
• Building robust quality systems

Key Discussion Benefits

Our focused sessions will help you:

• Navigate complex regulatory changes affecting CMC in major markets
• Identify opportunities for streamlining submissions
• Understand impact of AI/ML on CMC documentation
• Network with industry leaders facing similar challenges

Business Impact

These discussions directly influence:

• Resource allocation decisions
• Technology investment strategies
• Risk management approaches
• Global expansion plans

Join us to transform regulatory challenges into competitive advantages.