Heidi Wang

Chief Executive Officer (CEO)
OBI Pharma
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Dr. Heidi Wang is an experienced drug developer with more than 30 years of global pharmaceutical and biotech industry experience. With deep expertise in Oncology, Virology, Immunology, etc., Heidi has a proven record of working or leading teams to obtain approvals for 9 New Molecule Entities, many were first-in-class drugs, as well as more than 30 supplemental applications worldwide.  

Heidi had a long career at Bristol Myers Squibb Company (BMS, a Fortune 500 company), leading teams in the US headquarter and in multiple countries, including China. Other than delivering new drug approvals globally, Heidi had a chance to transform BMS’ processes and mindset to optimize company’s portfolio acceleration, enable global simultaneous submissions and approvals of life saving medicines, and shape company’s 2030 China strategy, etc.

After joining OBI Pharma as the CEO, Heidi changed the company’s culture, grew talent, encouraged an “inclusive” mindset, reshaped the portfolio with a laser focus on Antibody-Drug-Conjugate (ADC) assets, and drove the development of unique ADC platforms that are likely “best-in-class”. 
Heidi’s twin passions are to bring new medicines to patients worldwide and to give back. Hence, she shaped both BMS and OBI Pharma’s global drug development strategy and processes, converted colleagues’ mindset to think globally from early stages of clinical development, enabled acceleration in submissions and approvals, and ensured success in reimbursement and commercial areas. She volunteers as a mentor and advisor to colleagues and organizations in the US and Taiwan to give back to the community.  
Heidi received her B.S. degree from Fu-Jen University in Taiwan. After receiving her M.S. and Ph.D. degrees in Molecular Biology and Virology from University of Notre Dame in Notre Dame, IN, USA, Heidi had postdoctoral training in Cancer Biology at the Cold Spring Harbor Laboratory in New York, USA.

Speech title & Synopsis

Challenges and Opportunities of ADC Drug Development: Regulatory Considerations

Antibody−drug conjugates (ADCs) are targeted immunoconjugate molecules that integrate the potency of cytotoxic drugs with the selectivity of monoclonal antibodies while minimizing damage to healthy cells and reducing systemic toxicity. Their design allows for higher doses of the cytotoxic drug to be administered, potentially increasing efficacy. ADCs are currently among the most promising drug modalities in the fight against cancer, with efforts to expand their applications for non-oncological indications and in combination therapies. 
Despite successes in the past 20 years, development of effective ADCs with broad therapeutic window remains challenging due to the complexity of conjugation technologies and the instability of the linkers. ​
In this presentation, I will describe the challenges and opportunities of developing the next generation of ADCs from a regulatory perspective.  Considerations from CMC/manufacturing, preclinical, and clinical will be interwoven with relevant guidance from major health authorities.  Further, to ensure smooth reviews and approvals of Investigational New Drug Applications, key aspects that are unique to ADC development will be discussed. Insight on dosing optimization strategy, pharmacokinetics and pharmacodynamics assessment, clinical trial designs, etc., will be shared to guide in the success of potential Biologics License Applications.