Science and Law
26th October 2014

Effective Use of Science and Regulations in Pharmaceutical Litigation

In this webinar we covered critical principles related to the scientific and regulatory framework as they pertain to drug and medical device litigation for seasoned in house and outside counsel. Examples of topics that were covered in this webinar included:

Effective Use of Science and Regulations in Pharmaceutical Litigation

On October 14th, Innovative Science Solutions organized a webinar with Momentum Events, entitled:

Working the Science and Regulations Harder to Win Your Drug and Device Case

In this webinar we covered critical principles related to the scientific and regulatory framework as they pertain to drug and medical device litigation for seasoned in house and outside counsel. Examples of topics that were covered in this webinar included:

  • safety signaling and pharmacovigilance

  • epidemiological and randomized controlled trial study design
  • risk management principles
  • causality assessment
  • the strategic role of regulatory guidelines and compliance

The webinar focused on the role of clinical studies and other forms of clinical data in helping defend pharmaceutical and medical device products under attack. The goal was to link best practices related to fundamental principles with real world examples. The presentations aimed to provide clear guidance and examples drawn from the presenters’ experience as consulting and testifying experts in pharmaceutical and medical device cases over the course of the last two decades.

Click below to download the slides and a recording of this webinar.

A short biographical summary of each of the speakers is provided below 

John Clark, MD, MSPH

Dr. Clark has worked as a medical expert in health care product development and monitoring for 25 years, with a focus on safety signaling, product complaint analysis, risk management, safety surveillance, AERS and MAUDE Database analyses, dictionary management, clinical trials, pharmacoepidemiology and marketing/outcomes research. He has been a subject matter expert consultant for the new FDA Adverse Event Reporting System (FAERS) and MedWATCHplus projects, and is currently an Associate Professor (Teaching) at Temple University in Philadelphia. Dr. Clark has consulted with corporations and defense counsel on mass tort and complex litigation for the past three decades. Dr. Clark is currently the President and Chief Medical Officer at PCSglobal, a pharmaceutical, biotechnology and medical device industries consulting company specializing in risk-reduction services. He is Board Certified in both internal and preventive medicine. 

April Zambelli-Weiner, Ph.D., M.P.H.

Dr. April Zambelli-Weiner is a Senior Epidemiologist and Biostatistician with over 16 years of experience in providing scientifically rigorous research and consulting services to diverse clients in both the public and private sectors, including NIH, CDC, and Fortune 500 companies. She has supported the science and testified in drug and device cases for both plaintiffs and defendants. Dr. Zambelli-Weiner’s areas of expertise include epidemiological methods, post-market surveillance, pharmacovigilance, biostatistics, chronic diseases, clinical immunology, human genetics and genetic epidemiology, and environmental health and she possesses extensive experience studying health outcomes across the lifespan, from birth defects, asthma, and rare pediatric cancers to Huntington’s disease, cardiovascular disease, neurological impairments, aging and injury, among others. Dr. Zambelli-Weiner has extensive experience in all phases of epidemiologic, health services and outcome research including the design, conduct and analysis of data from large multi-site population based studies, retrospective databases, administrative claims databases and registries.

David H. Schwartz, Ph.D.

A “scientific detective,” Dr. Schwartz is a modern day Sherlock Holmes when it comes to analyzing how science and law interact. He has helped clients in complex litigation by providing strategic and tactical support when winning depends on making sure the science is well explained and fits perfectly into the parameters defined by the law. Dr. Schwartz is a founding member of Innovative Science Solutions, LLC and currently heads up their Science Support to Counsel practice. He helps clients defend and support FDA-regulated products (as well as other healthcare and consumer products) in the courts, the regulatory arena, and the market place. With a talent for communicating complex scientific information, Dr. Schwartz has become a go-to for lawyers, business professionals, and financial and investment firms. Dr. Schwartz specializes in providing strategic and tactical support to counsel in legal cases involving complex scientific issues. He has played a lead role in winning multi-billion dollar legal cases for clients. With the sheer weight of the scientific data he’s able to collect, evaluate, and present as evidence, he’s helped counsel win cases before going to trial, saving ISS clients time and money.

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