Shareholder Mercedes Meyer, Ph.D. gave two presentations at the American Conference Institute’s (ACI) summit on Biosimilars and Innovator Biologics on June 2 and 3 in Boston.
The first presentation, “Innovator Strategies in a Biosimilar Era: Managing Competition, Driving Innovation, and Maintaining Market Position,” explored the legal, regulatory, and commercial challenges that the innovator biologics community faces. Additional topics included:
- Developing next-generation biologics with improved efficacy or new indications
- Actively managing IP to extend exclusivity
- Engaging in robust clinical trials to solidify the safety and efficacy profile of the original drug
- Exploring new therapeutic areas with high unmet medical needs
Mercedes’ second presentation, “Ethical Considerations in Biologics & Biosimilars: Addressing Fairness, Access, and Innovation,” discussed the ethical responsibilities of those in the biologics and biosimilars industry. The session also touched on:
- Balancing fair market competition in BPCIA litigation while ensuring patient access to affordable treatments
- Addressing the role of pricing strategies, formulary decisions, and exclusivity periods in shaping healthcare equity
- Mitigating the risks of biased data sets in clinical research and ensuring diverse patient representation
- Upholding ethical standards in patent litigation, including challenges to evergreening and anti-competitive practices
- Examining professional responsibility and ethics in legal practice, including access to PTAB representation and emerging regulatory considerations
You can read more about this event by clicking here.
