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IP in Healthcare Conference 2019 (Manchester), 'The Importance of Integrating Regulatory and Patent Exclusivity When Approaching the U.S. Pharmaceutical Market'

Speakers: Raymond A. Miller and N. Nicole Stakleff

3/14/2019
9:00 AM-2:30 PM (GMT)
IP in Healthcare Conference 2019 (Manchester), 'The Importance of Integrating Regulatory and Patent Exclusivity When Approaching the U.S. Pharmaceutical Market'

Raymond A. Miller, a partner and member of the Leadership Team of the Health Sciences Department of Pepper Hamilton, and N. Nicole Stakleff, a partner with Pepper Hamilton, a member of the Health Sciences Department and a member of the firm's Executive Committee, will be speaking at the HGF IP in Healthcare Conference 2019 taking place in Manchester, England on March 14, 2019. Mr. Miller and Ms. Stakleff will be presenting the following panel at 10:15–10:55 (GMT):

The Importance of Integrating Regulatory and Patent Exclusivity When Approaching the U.S. Pharmaceutical Market

The U.S represents about one-half of the world’s pharmaceutical market by sales and about 25 percent of these sales are by generics. The U.S. uses a series of incentives to reward and encourage research and development while also stimulating a robust generic market to drive down the cost of important therapies. This balancing act is accomplished in part by the crucial interplay of patent monopolies granted by the USPTO and data and market exclusivity granted by the FDA.

Understanding the interplay and independence of these "exclusivities" will be crucial to the development of any innovator that views the U.S. as a viable market. Mr. Miller and Ms. Stakleff bring decades of experience in guiding the development of exclusivity strategies that have permitted companies to advance their drug in the clinic and ultimately obtain approval and access to the U.S. markets. They will discuss a wide range of topics, including ways to maximise patent term for new chemical entities and ways to strategize and protect pharmaceuticals that are being revived or repurposed after initial clinical development or approval.

Location

Alderley Park
Manchester,
England

Additional Information

Other Dates
March 19 - London, England

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