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In partnership with Fierce Biotech

Summary

In today’s high-stakes biotech environment, the difference between success and failure often lies in early strategic decisions leading up to IND submission and into First-in-Human trials. With constrained capital and sharpened investor expectations, companies must align science, strategy, and investment readiness from the very start.

This webinar presented by Certara in partnership with Fierce Biotech explores how forward-thinking biotech leaders are integrating early development strategies, asset evaluation, and venture planning sooner to build stronger, model-informed programs, attract funding, and accelerate outcomes while managing risk.

Through real-world examples and expert insight, we’ll uncover the early development choices that determine long-term outcomes, and how a strategic, data-first approach helps biotech innovators bring the right drug to the right patient, faster.

Key Learning Objectives:

The goal and objective are for participants to:

  • Identify the most common strategic pitfalls that lead to early-stage failure and how to avoid them
  • Understand how early, integrated decision-making improves development outcomes and investor confidence
  • Learn best practices for evaluating therapeutic potential and program risk with clarity and confidence
  • See how early strategic planning connects science, funding, and commercialization for lasting success

Speakers:

Fran Brown, PhD

Senior Vice President & Head of Drug Development Science
Certara Drug Development Solutions

Dr. Fran Brown is a highly respected professional with proven leadership skills and 28 years of broad experience within pharmaceutical development and due diligence. She has extensive experience with strategic and operational global drug development from early discovery to filing and post-marketing. This experience spans multiple therapeutic areas, small molecules and biologics, global regulatory requirements and registration pathways. She possesses a broad knowledge of product development and portfolio management, with a special focus on development strategy, regulatory interactions and product filings.

Her past appointments include leadership roles within large Pharma as well as in small biotech organizations including head of clinical pharmacology, clinical leader, project development leader, head of clinical operations and due diligence asset assessment. She has over 10 years of experience in providing consulting advice to the pharmaceutical industry and non-profit Global Health Organizations ranging from individual project support, to strategic TA strategy and development planning, portfolio management and corporate transformation. She joined Certara in 2017 and is currently the SVP of Drug Development Science within Integrated Drug Development.

Max Vargas, PhD, MBA

Vice President, Evidence & Access Strategy Certara Drug Development Solutions

Max brings both scientific training and experience in healthcare product development that are important for evidence-based value and access strategies for pipeline and marketed products. Leading a team of analysts and focusing on projects involving late stage, launch, and due diligence efforts, Max’ experience cuts across all major therapeutic areas and care settings with special emphasis on CV / metabolic, oncology, gene therapies, ophthalmology, GI, and dermatology. Max and team have designed successful pricing and contracting strategies for products at launch and throughout the life cycle. He also leads projects focusing on managed markets communications strategies.