Robert Dormer to Speak at ACI Orphan Drugs and Rare Diseases ConferenceNovember 20, 2012
Hyman, Phelps & McNamara’s Robert A. Dormer will be speaking at the American Conference Institute’s upcoming conference, “Orphan Drugs and Rare Diseases – Maximizing Opportunities and Overcoming Stumbling Blocks in the Designation and Development Process.” The conference will take place on November 28th and 29th at the Hyatt Regency in Boston, Massachusetts. The conference is designed to give practitioners the complete picture of the orphan drugs and rare diseases landscape, including evolving laws and regulations, commercial implications, patent considerations, and the international framework. Among other things, speakers, including Mr. Dormer, will discuss strategies to offset potential risks inherent to orphan drug development including:
- Understanding and factoring in the unique incentives, including favorable exclusivity, pricing, and tax benefits, for companies who decide to pursue designation;
- Replenishing product pipelines in the face of the patent cliff through novel therapies;
- Preparing for eventual pharmacovigilance and labeling issues downstream as designation takes off;
- Designing clinical trials endpoints and proving safety and efficacy in a smaller population; and
- Protecting orphan drug status and keeping competitors at bay.
To view the conference brochure and register for the conference see here. FDA Law Blog readers may obtain a $200 registration discount by using code FDALB 200.