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Home / Resources / Webinar / Unlock Global Regulatory Success: Overcoming Early Drug Development Challenges [APAC Webinar]

Unlock Global Regulatory Success: Overcoming Early Drug Development Challenges [APAC Webinar]

Live webinar

Webinar times:

10am Japan & Korea Feb 20th

9am China Feb 20th

8pm US ET Feb 19th

Navigating early drug development is critical to ensuring the long-term success of therapeutic candidates. This webinar explores key strategies to overcome common challenges, with expert insights from APAC and US perspectives.

We will begin by addressing the importance of understanding therapeutic potential, emphasizing the early selection of biomarkers to validate mechanisms of action and support dose-response relationships. Insights into biomarker incorporation during First-in-Human (FIH) study design will highlight their role in decision-making and regulatory support.

Learn how to effectively prepare an IND package for submission to the FDA by integrating Model-Informed Drug Development (MIDD) approaches, especially for novel modalities. Discover how biomarker-driven strategies can accelerate drug development timelines while increasing confidence in advancing through clinical phases.

Whether you’re navigating the FDA, EMA or other regulatory landscapes, this session will provide actionable guidance for global regulatory success in early drug development.

Key Learnings:

  • Understanding Therapeutic Potential: Emphasizing the early selection of biomarkers to validate mechanisms of action and support clinical development.
  • Regulatory Strategy Development: Highlighting the importance of formulating a robust regulatory strategy early in the development process to ensure global success.
  • Overcoming Common Challenges: Providing expert insights into common hurdles in early drug development and offering strategies to overcome them.

Register
Speakers
Tong Zhu
Tong Zhu, PhD, FCP
VP, Global Head, Clinical Pharmacology & Translational Medicine Certara Drug Development Solutions
Dr. Tong Zhu has over 25 years of experience specializing in translational medicine, early development, and clinical pharmacology. She has a wealth of knowledge in pharmaceutical research and development. She was responsible for leading Astellas’ Primary Focus strategy in Mitochondria Biology by working globally to help identify and develop innovative drugs targeting mitochondrial biology. In almost 14 years at the company, she held various leadership positions in its Clinical Pharmacology & Exploratory Development division. Before her time at Astellas, Dr. Zhu held positions with increasing responsibilities at Abbott Global Pharmaceutical Research and Development (now AbbVie) on Clinical Pharmacology and Pharmacometrics teams. 
Mayumi Hasegawa
Mayumi Hasegawa, PhD
Vice President, Certara Drug Development Solutions
Dr. Hasegawa has over 20 years of drug development experience focused on the areas of clinical pharmacology, pharmacometrics and specializes in development for Asia Pacific regions (APAC; Japan-Korea-Taiwan). Dr. Hasegawa has experience in both early and late development programs across therapeutic areas of Oncology/Immunology, Rheumatoid Arthritis and Cardiovascular.  She has extensive regulatory interaction experience with health authorities including FDA, EMA and PMDA and has supported multiple filings and accountability for Clin Pharm-related scientific issues with global health authorities.
Kevin Hershberger
Kevin Hershberger, BPharm, MBA
Vice President, Certara Drug Development Solutions
Kevin brings over 25 years of experience in the pharmaceutical industry primarily in project leadership roles and provides integrated program management (integrated plans, Target Product Profiles, and financial planning clients, including fund raising, business development, client presentations, and vendor selection.  He has held leadership and management roles at Brighton Biotech, deCODE Genetics, Parke-Davis, Pfizer and Takeda.