Our “Meet the Expert” series introduces you to our team of experts around the world. This “behind the curtain” view will help you get to know who we are on a professional and personal level, and highlight how our colleagues work together on our higher purpose to improve patient health and safety throughout the complete product lifecycle.
Meet the Expert: Roger Williams, MD, Expert Consultant and Partner
What do you do at ProPharma Group?
I am a Senior Expert Consultant and former Chief Executive Officer and Chair of the Council of Experts at the US Pharmacopeial Convention. I directed the Office of Generic Drugs in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration and served as Deputy Center Director. While at CDER, I directed the Office of Pharmaceutical Science, which evolved into the Office of Product Quality.
I am an expert in clinical pharmacology and have been board certified in clinical pharmacology and internal medicine. My experience allows me to serve as an expert witness for law firms who represent clients either as defendants or plaintiffs based on my understanding of the United States regulatory system for drugs under the Federal Food Drug & Cosmetic Act. I have been, or am involved in, cases of antitrust, patent litigation, disputes between pharmaceutical companies, disputes between a company and a branch of the government, and ‘failure to warn’ cases where plaintiffs claim harm due to a drug where the harm is not listed in the label.
What are the qualifications of an expert witness?
Expert witnesses are well-qualified subject matter experts with regulatory or scientific backgrounds that provide the requisite expertise to support a legal case. Experts should be thoughtful, well-spoken, and impartial since they are providing information to help all parties understand complex regulatory or scientific issues.
It also is important for experts to stay within their area of expertise since an expert can be disqualified if they do not have the required expertise. Litigation can take a long time working with one or more courts and at times many lawyers, starting with legal statements, productions of records, fact witnesses, expert witnesses, depositions for both types, and then a trial.
As an expert witness, what is the most important way to support clients?
The most important thing is communication. Stay in touch with counsel continuously throughout the production of an expert report and follow-on activities. Counsel will make sure that the expert report serves their client’s purpose, and that subsequent testimony proceeds in the interest of their client. Day-to-day communication helps facilitate the overall process.
What’s the one thing you wish potential clients knew about ProPharma Group Regulatory Sciences?
ProPharma Group Regulatory Sciences has experienced experts, including experts who previously worked at the Food and Drug Administration, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency, and the European Medicines Agency, as well as executives from the biopharmaceutical and medical device industries.
These experts can provide consultation and expert testimony support to law firms on issues such as antitrust violations, patent infringement, product liability, supply chain failures, and business disputes.
How do you support ProPharma Group’s mission and higher purpose of improving the health and safety of patients?
I help clients understand complex regulatory and scientific issues. My thorough understanding of the United States regulatory system for drugs under the Federal Food Drug & Cosmetic Act allows me to serve as an impartial expert in support of legal litigation.
