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Summary

In today’s capital-constrained biotech landscape, early development is no longer just a scientific milestone—it’s the defining moment that shapes a company’s long-term success. This webinar will uncover how integrating modeling and simulation, regulatory foresight, and commercial strategy from the very beginning can dramatically reduce risk, accelerate timelines, and increase investor confidence.

Join experts from Certara as they share actionable strategies for designing smarter, fundable development programs that not only meet scientific and regulatory standards but also align with business goals and funding expectations. Whether you are advancing your first asset or building a pipeline, you’ll gain insights to strengthen both your development plans and your investor positioning.

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Key Learning Objectives:

Understand the critical inflection point of early development and how strategic decisions at this stage impact risk, speed, and investor readiness.

Identify ways to integrate modeling, regulatory strategy, and commercial insights to design development programs that are both scientifically rigorous and commercially fundable.

Recognize what investors and partners look for in early-stage biotech companies—and how to build confidence through data credibility, scenario planning, and aligned strategies.

Speakers:

Colin Callaghan, RPh, MBA, Senior Director, R&D Program Leadership at Certara
Colin Callaghan, RPh, MBA

Director, Program Leadership, Certara

Maximilian Vargas, PhD, MBA, Vice President, US Access Strategy at Certara
Max Vargas, PhD, MBA

Vice President, Evidence & Access Strategy, Certara

Moderator:

Kevin Hershberger, BPharm, MBA

Vice President, Nonclinical Development Sciences, Certara

Register now