Hung-Chih Chang

About Hung-Chih Chang

Dr. Hung-Chih (Michael) Chang has more than twenty-five years of experience in the pharmaceutical development and manufacturing science of small molecules, biologics, and biologic-device combination products. In addition, Michael is highly interested in leveraging his deep scientific background and expanding his capability in the field of Regulatory Affairs CMC. In his current capacity as a Sr. Director, GRACMC-Emerging Markets, Eli Lilly and Company, Michael is responsible for establishing RACMC capability to enable parallel global-China clinical development and accelerate product registrations and launches in China. Part of his responsibilities also include developing regulatory strategies and innovative approaches to address submission challenges and regulatory-related issues. Prior to his current role, Michael was the Sr. Director of Biologics Drug Product Development leading a division of scientific staff to develop phase-appropriate formulations to support Ph1-3 trials, and commercialization for the biologics pipeline. The pharmaceutical scientists and process engineers in the division also wrote INDs and BLAs for regulatory filing. Furthermore, Michael oversaw the clinical and commercial formulation development for Emgality®, a mAb-device combination product approved for the preventive treatment of migraine and the treatment of episodic cluster headache.Before his role in Biologics development, Michael held both technical and management positions in the Small Molecule Organization. He and his team were responsible for the chemistry, solid dosage form, and process development to enable the manufacture of GMP drug substances and clinical trial drug products. While working in the Small Molecule Organization, Michael also spent three years as an expatriate in China and built CMC capabilities including process chemistry, analytical chemistry, and formulation development. His work enabled the manufacture of GMP API and drug product clinical material in China supporting Lilly’s FHD globally.Prior to joining Lilly, Michael was employed by Abbott Lab and his work concentrated in the development of parenteral-route sustained-release formulations for analgesics in supporting preclinical studies. Michael is not only an accomplished leader with a demonstrated record of leading scientific organizations to efficiently advance drug candidates to awaiting patients but is also very passionate about workplace safety. He often takes an active role in promoting health and safety culture in the workplace and serves as a workplace safety champion.

Experience

1. Vice President, Global Regulatory Affairs Cmc-asia Pacific

   Eli Lilly and Company

   Dec 2024 — Present · SG

   I’m excited to share that I’m moving to Singapore and starting a new position as Vice President, Global Regulatory Affairs CMC-Asia Pacific on January 1, 2025 at Eli Lilly and Company. Also, we are hiring the following Regulatory Affairs-CMC scientists in Singapore. Please join us if you are motivated to speed up the delivery of innovative medicines to awaiting patients. https://careers.lilly.com/us/en/job/R-70559/Sr-Scientist-Principal-Scientist-Sr-Principal-Scientist-Advisor-Sr-Advisor-GRA-CMC-Asia-Pacifichttps://careers.lilly.com/us/en/job/R-70430/Senior-Director-Executive-Director-Regulatory-Scientist-Global-Regulatory-Affairs-Asia-Pacific-Region

Education

• University of Iowa

  Ph.D., Pharmaceutics

  1990 — 1995

• Taipei Medical University

  MS, Pharmacokinetics

  1985 — 1987

• Taipei Medical University

  BS, Pharmacy

  1981 — 1985

• Indiana University - Kelley School of Business

  Executive Certification in the Business of Life Science,

  2013

Skills

• Bioavailability/Bioequivalence
• Highly Potent Compound & Containment
• Tech Transfer to Ct and Commercialization
• Enabled Formulations for Poorly Soluble Compounds
• Parenteral & Topical Formulations
• Drug Product Continuous Manufacturing Process
• Ind & Nda Submission
• Experience with Cmc Outsourcing Models
• Leading, Motivating & Developing People
• Project Planning & Management
• Solid Dosage Form Development
• Experience with CRO/CMO Management
• Budgeting and Resource Planning
• Effective Leadership in Diversified Culture