Pharmacogenetics in Pain Management and the Use of Pharmacogenomics Methodologies in the Pharmacovigilance Evaluation of Medicinal Products

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • October 31, 2016

Evidence suggests that there is a genetic influence on the prevalence and processing of pain. Pharmacogenetics therapy in pain patients requires the consideration of two different genetic substrates to determine the outcome of pharmacotherapy. The first being the genetic contribution to a variety of different pain types and the second is the genetic influence on drug effectiveness and safety. Furthermore, due to gene-environmental interactions there exists large variability in responses to drug therapy, some of which are inherited or non-inherited characteristics of the genome. Such genomic variations have the potential to lead to subsets of patients with a different benefit/risk profile.

In this presentation Dr. Lynn Webster, Vice President of Scientific Affairs (Early Development Services), and Michael Marschler, Director of Safety and Risk Management, will discuss how pharmacogenetics can be integrated in clinical trials. The speakers will also outline post-marketing settings to achieve a personalized therapy and how considering missing information (potential risk(s)) of genomic variations can help to identify risk minimization measures to greatly reduce the risk of side effects and significantly increase the therapeutic benefit to the patients.

Speakers

Lynn R. Webster, M.D., F.A.C.P.M., F.A.S.A.M., Vice President of Scientific Affairs PRA Health Sciences and Past President, American Academy of Pain Medicine (AAPM)

Dr. Lynn Webster has dedicated more than three decades to becoming an expert in the field of pain management. He is the vice president of Scientific Affairs of PRA Health Sciences and past president of the American Academy of Pain Medicine. A leading voice in trying to help physicians safely treat pain patients, Dr. Webster actively works within the industry to develop safer and more effective therapies for chronic pain and addiction. He is board certified in anesthesiology, addiction, and pain medicine. Dr. Webster lectures extensively on the subject of preventing opioid abuse and criminal diversion in chronic pain patients and has authored more than 300 scientific abstracts, manuscripts, journal articles and a book entitled Avoiding Opioid Abuse While Managing Pain: A Guide for Practitioners, many of which are the basis for training physicians who are studying pain.

Dr. Webster has played an instrumental role in his industry as a strong advocate for safe and effective pain resolution methods. The Opioid Risk Tool (ORT), which he developed, is currently used and is the standard in multiple countries and thousands of clinics worldwide. He spends most of his time now developing safer and more effective therapies for chronic pain and campaigning for safer use of medications.

He received his doctorate of medicine from the University of Nebraska and later completed his residency at the University of Utah Medical Center’s Department of Anesthesiology. Dr. Webster has been quoted by multiple media sources, including in the Los Angeles Times and The Wall Street Journal, and has given over 250 presentations across the United States and internationally. He is the author of The Painful Truth: What Chronic Pain Is Really Like and Why It Matters to Each of Us (Webster Media LLC) and co-producer of the documentary The Painful Truth, to be released in 2016.

Michael Marschler, Director of Safety and Risk Management, PRA Health Sciences

Michael Marschler has over 15 years of Pharmacovigilance experience in the Pharmaceutical and CRO industries.

As Director Safety and Risk Management he is responsible for various aspects of PRA’s Safety and Risk Management Services. To ensure constant quality and regulatory compliance Michael was deeply involved in the development and improvement of SOPs and Work Instructions in the area of Aggregate Safety Reporting, PSMF and Risk Management. Michael joined PRA as Director Safety and Risk Management in September 2014.

Before joining PRA Michael worked as consultant Safety and Risk Management for different clients in the Pharmaceutical and CRO industries. During his consultant career he worked for various Pharmaceutical companies and provided different pharmacovigilance services to his clients, including but not limited to safety case management and reporting, conduction of global and local literature search, consulting regarding legislative requirements, set-up of pharmacovigilance systems and serving as deputy QPPV and Commissioner of the graduated plan. Michael had consultant overview for several PSMFs and RMPs as well as for Aggregate Safety Reports.

Michael Marschler provides leadership to his direct reports and to project teams and supports the development of client relationships. Within the scientific area he focuses on Pharmacogenomics (PGX) and is a personal member of ESPT – European Society of Pharmacogenomics and Personalized Therapy.

Who Should Attend?

  • “C-Level” Executives – CSO/CMO
  • Drug Developers in the CNS/Pain/Addiction Therapy fields
  • Epidemiologists
  • Heads of Global Clinical Development
  • Patient Recruitment and Retention professionals
  • Senior Physicians/ Prescribers of opioid medications
  • Clinical Trial Planning and Optimization

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