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Enhanced Strategic FDA Collaboration: Working with CDER and CBER

Enhanced Strategic FDA Collaboration: Working with CDER and CBER

This podcast features a panel discussion from the 2025 Chief Medical Officer Summit 360° about how CMOs across indications can best support their regulatory teams and engage with the FDA and other regulators.

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Featured Podcasts

Best Practices and Potential Pitfalls Enriching Clinical Trials with PROs

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What CMOs Need to Know and Do When Preparing for Product Launch

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Strategies for CMOs to Scale Up Effectively as Their Biotech Companies Evolve

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Patient Engagement: Practical Approaches for Emerging Biotech CMOs

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CMO Misunderstandings about Clinical Operations and How to Improve

CMO Misunderstandings about Clinical Operations and How to Improve

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The CMO as a Translational Scientist

The CMO as a Translational Scientist
Transitioning from Early Stage to Registrational/Pivotal Stage Development

Transitioning from Early Stage to Registrational/Pivotal Stage Development
Maximizing Regulatory Interactions

Maximizing Regulatory Interactions
How CMOs Build a Network of Consultants

How CMOs Build a Network of Consultants
What CMOs Need to Know about Partnering with Hospitals & Clinical Research Sites

What CMOs Need to Know about Partnering with Hospitals & Clinical Research Sites
CMO Insights and Advice on Tailoring Your Pitch to Investors

CMO Insights and Advice on Tailoring Your Pitch to Investors
What CMOs Need to Know About Medical Affairs

What CMOs Need to Know About Medical Affairs
Interacting with Different Types of Investors as a CMO

Interacting with Different Types of Investors as a CMO
Developing Internal and External Communication Strategies

Developing Internal and External Communication Strategies
Financial Analyst Keynote: How CMOs can Support the Overarching Process of a Fundraising

Financial Analyst Keynote: How CMOs can Support the Overarching Process of a Fundraising
Prioritizing Development Programs that Align with Fundraising Catalysts

Prioritizing Development Programs that Align with Fundraising Catalysts
The Changing Environment Around Accelerated Approvals and Regulatory Pathways

The Changing Environment Around Accelerated Approvals and Regulatory Pathways
Biotech Financing Options and Their Implications

Biotech Financing Options and Their Implications
The First 90 Days as a CMO

The First 90 Days as a CMO
R&D Veteran on Leading a Biotech through Founding, IPO and Acquisition

R&D Veteran on Leading a Biotech through Founding, IPO and Acquisition
Building up a Company Through to Commercialization and Beyond

Building up a Company Through to Commercialization and Beyond
Best Practices for Cross Functional Communication Strategies for the CMO

Best Practices for Cross Functional Communication Strategies for the CMO
Managing the Partnership Between Big and Small Pharma

Managing the Partnership Between Big and Small Pharma
What Statisticians Wish They Could Tell Their Chief Medical Officers

What Statisticians Wish They Could Tell Their Chief Medical Officers
Biotech CMO-CEO Fireside Discussion on Working Through Challenges

Biotech CMO-CEO Fireside Discussion on Working Through Challenges
Building a Work Culture that Attracts and Retains Talent in Biotech

Building a Work Culture that Attracts and Retains Talent in Biotech
Positioning Yourself For Board Roles and What to Expect as a CMO in Biotech

Positioning Yourself For Board Roles and What to Expect as a CMO in Biotech
Taking on the CMO Role at Moderna and Looking to the Future of Biotech R&D

Taking on the CMO Role at Moderna and Looking to the Future of Biotech R&D
What CMOs Must Know About How Patient Engagement Supports the Entire Biotech

What CMOs Must Know About How Patient Engagement Supports the Entire Biotech

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