日期： 2026 年 7 月 8 日, 星期三
时间： 10:00 - 11:00am ET
概述
The path to IND is no longer just about completing required studies, it’s about building a differentiated, investor-ready development strategy that maximizes probability of success. In today’s competitive environment, biotech companies must make smarter decisions earlier, leveraging modern regulatory flexibility, integrated evidence strategies, and predictive approaches to accelerate development while preserving capital.
This webinar will explore how companies can strategically plan their journey to IND through strong commercial and development planning, Totality of Evidence (ToE) and Weight of Evidence (WoE) approaches, New Approach Methodologies (NAMs), and Model-Informed Drug Development (MIDD). Attendees will gain practical insights into building leaner, more efficient development programs, leveraging regulatory flexibility, and creating the evidence packages needed to support both regulatory and investor confidence.
Key learning objectives:
Discover how emerging biotech companies can build IND-ready and investor-ready development programs by integrating, scientific, regulatory, and commercial considerations early, reducing development risk, leveraging regulatory flexibility, and accelerating progress toward key value inflection points.
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Fran Brown, PhD
Senior Vice President, Global Head, Drug Development Science从药物早期发现到报批和上市后，Fran 在全球战略性和运营性药物开发方面拥有超过 25 年的经验。她在战略性药物发现和开发方面拥有广泛的知识，尤其侧重于发展策略和模型引导的药物开发 (MIDD) 的应用。
Colin Callaghan, RPh, MBA
Senior Director, Program LeadershipColin has 33 years in the pharmaceutical industry primarily in multi-disciplinary drug development leadership roles, including 25 years with early development/early-stage programs.
At Certara, Colin leads numerous programs in Oncology, CNS, Infectious Disease and Global Health therapeutic areas and supports biotech companies with their funding initiatives. Prior to Certara, Colin worked for very large (Pfizer, Wyeth-Ayerst), mid-size (Celldex), and start-up (Kolltan, Iterum, Maxwell BioSciences) pharmaceutical companies as well as consultant firms (Deloitte and Lachman Consultants) in drug development, business operations and process improvement roles. He earned an undergraduate degree in Pharmacy from Rutgers University and an MBA degree from the University of North Carolina – Wilmington.
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