By Amit Dhawan, MD, and Michael Fronstin, Kantar Health
Pain is a large and growing market globally, affecting more than 1 billion people worldwide. It is a high-prevalence, low-diagnosis market and often results in extremely high unmet needs. As anyone who experiences pain, either chronically or acutely, can tell you, it is incredibly difficult to treat because everybody experiences it differently, and the many different types of pain add another layer of complexity.
An ethnic group is defined as a group of people who identify with each other based on intrinsic factors, such as genetic similarities due to common ancestry, and extrinsic factors, such as shared cultural experiences or environment. Therefore, one’s ethnicity is a fundamental aspect of life that defines a person, and that differentiates that person from others.
Ethnic differences have become important in the field of clinical drug development because they may impact the absorption, distribution, metabolism, or excretion (ADME) of drugs, and may be relevant to an understanding of a drug’s efficacy and safety.
Topics: patent law, Clinical Trials
Inter Partes Review (IPR), introduced by the America Invents Act (AIA), opens the door to another venue and procedure to challenge the validity of a patent. IPR on pharmaceutical patents is drawing increasing attention as an additional threat for a research-based (brand) pharmaceutical company facing or already involved in Hatch-Waxman litigation—the most common type of patent litigation between brands and generics seeking to market copies of branded products.
Hatch-Waxman litigation typically occurs between a brand company, which holds a New Drug Application (NDA) to sell a drug, and a generic, which files an Abbreviated New Drug Application (ANDA) requesting FDA approval to market a generic copy of the NDA holder’s drug.
Topics: Hatch-Waxman Litigation, Generics, patent law, Inter Partes Review
New York Pharma Forum (NYPF) has created this new blog as an opportunity for our members to share their ideas and viewpoints on topics that have a significant impact on the biopharma industry, both internationally 
and in the United States and Japan. Whether you are a seasoned pharma executive focused on expanding your company’s pipeline, a regulatory expert who helps pharma manufacturers resolve thorny regulatory issues or a researcher at a clinical research organization who is focused on discovering new clinical trial solutions, this blog will help connect you with important stakeholders in the industry.
Of course, this valuable new resource will not grow by itself. It will depend on thoughtful contributions by New York Pharma Forum members. This blog is by members, for members. We also expect it to be a good resource for non-members visiting our website.
