Optimizing Late-Stage Clinical and Commercial Development: The Benefits and Challenges of Bridging the Gap

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Tuesday, February 03, 2015

The landscape for the development and commercialization of drugs and devices is becoming increasingly complicated by regulation and constrained by economic pressures. As a result, today’s pharmaceutical, biotech, and device companies must fine-tune their clinical development programs to ensure that the products with the best chances for success are prioritized. At the same time, companies have clear motivations to optimize both the development and commercialization timeframes in order to accelerate regulatory and marketplace acceptance. This calls for an unprecedented level of inter-company cooperation between teams that often have dramatically different perspectives, training, skill sets, and even lexicons. To achieve accelerated clinical and commercial development — particularly during the timeframe surrounding product approval and launch — clinical researchers and product marketers must be increasingly in sync, and must strive to balance science and strategy.

This webinar provides invaluable perspectives and relevant examples of the opportunities and challenges facing those industry professionals with a stake in planning, generating, and communicating the real-world value of drugs and devices. Creative, compliant, and compelling solutions will be presented to many of the vexing challenges companies face in recruiting for clinical trials, in designing persuasive late stage research initiatives, and in communicating the value of products to key stakeholders.

Presenters from industry and Continuum Clinical will share their experiences in:

  • The development of mechanisms connecting observational “real world” registries to and from distinct outreach campaigns to recruit patients for clinical trials.
  • The creation of strategic plans guiding the development of evidence of product value by leveraging the respective expertise in Clinical Operations, Health Economics, Medical Affairs, Market Access, and Product Management.
  • The inventorying of critical stakeholders demanding data on the cost-effectiveness and budget impact associated with innovative products and technologies.

Case studies will be presented to further demonstrate the unique solutions available to those willing to help their organizations advance. In addition, findings from an industry survey will be presented revealing additional opportunities for improving synergies between scientific and strategic processes.

Viewers will take away vital new perspectives and tools that can be used to achieve the levels of accelerated clinical and commercial development and cooperation that are critical to success in today’s environment.

Speakers

Jeff Trotter, President, Continuum Clinical

Jeff Trotter, President, Continuum Clinical has enjoyed a diverse career in the healthcare industry spanning the past 30 years. As an entrepreneur, researcher, consultant, and innovator, Jeff has been a pioneer in the evolving health economics and an outcome research community, and is an industry leader in the design and implementation of research studies generating “real world” evidence.

Having engineered the acquisition of his internationally known research and consulting firm, Ovation Research Group, Jeff has been in executive management with other global clinical research organizations. He has spoken widely in front of varied industry audiences and has published over 50 original articles and research papers, including a book for the American Hospital Association, The Quest for Cost-Effectiveness in Healthcare: Achieving Clinical Excellence While Controlling Cost, and is currently co-editing another book on Observational Research.

Message Presenter

Neil Weisman, Executive Vice President, Patient Recruitment, Continuum Clinical

Neil Weisman heads up Continuum Clinical’s Patient Recruitment practice, formerly Blue Chip Patient Recruitment. An experienced and innovative healthcare marketing professional, Neil is dedicated to helping Pharmaceutical and biotech companies bring new therapies to market faster and more efficiently by accelerating clinical trial enrolment. With more than 15 years of experience, Neil is responsible for developing the strategic direction of all domestic and global campaigns and overseeing a team of dedicated patient recruitment and clinical enrollment specialists for a wide variety of clients.

Message Presenter

Jeff Kent, Senior Vice President, Medical Affairs and Health Outcomes, Horizon Pharma

Dr. Jeffrey Kent is a graduate of Franklin and Marshall College and the Jefferson Medical College in Philadelphia where he received his M.D. degree. He completed a residency in Internal Medicine at Thomas Jefferson University Hospital and a fellowship in Gastroenterology and Hepatology at Rush Presbyterian St. Luke’s Hospital in Chicago.

He served as a full-time faculty member for several years in the Department of Internal Medicine and the Division of Digestive Diseases at Rush Medical College and Rush Presbyterian St. Luke’s Hospital. While at Rush Dr. Kent was heavily involved with clinical practice, educating medical students, residents, and follows, and developed extensive experience with Phase II-IV clinical trials. Following his experience at Rush, he served as Associate Medical Director for the Evanston Hospital Clinical Pharmacology Unit, a Phase I clinical trials facility and gained experience with first-inman and ADME studies.

In 1999, Dr. Kent joined Searle (now Pfizer) and served in various capacities in Research and Development including the Global Director for valdecoxib (Bextra) development before joining Abbott Labs as a Global Medical Director for Immunosciences in August 2003. In 2005, Dr. Kent became the Global Project Head for Medical Affairs in Immunology within Abbott Global Pharmaceutical Research and Development. In this capacity, he had global Medical Affairs responsibility for HUMRIA across the Rheumatology, Dermatology, and Gastroenterology therapeutic areas. In 2011, Dr. Kent joined Astellas Pharmaceuticals as Executive Director, Medical Affairs and in May 2012, Dr. Kent became Senior Vice President, Medical Affairs and Clinical Outcomes for Horizon Pharma.

Message Presenter

Elaine Ferguson, Executive Vice President, Medical Communications, Continuum Clinical

Elaine Ferguson heads up Continuum Clinical’s Medical Communications practice and is based in the U.K. Her healthcare experience spans two decades and combines expertise across clinical practice, research, academia and industry. Elaine specialises in facilitating collaboration between the healthcare community and industry across all stages of a product’s development from clinical trial participation to stakeholder communications and disease area education. Most recently, Elaine led the global medical communications network for inVentiv Health including a team of more than 180 individuals across 8 markets.

Elaine’s work has been recognised for numerous industry awards most notably in facilitating partnership programmes between industry and thought leaders to provide high quality and relevant medical education across clinical skills, professional development and service design. Elaine has also designed programmes to support local access to new technologies through collaborations with payers, healthcare professionals and industry.

As an avid psychologist, Elaine applies behavioural economics research and cognitive science to unearth insight as a foundation for strategies to improve health outcomes and bridge clinical development with real-world needs.

Message Presenter

Who Should Attend?

Professionals with interests in: Clinical Operations, Patient Recruitment, Medical Affairs, Health Economics & Outcomes Research, Product, Brand or Marketing Management.

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Continuum Clinical

Continuum Clinical is a healthcare research and communications company. With roots extending back over thirty years, Continuum Clinical brings together a unique blend of world class experience in key disciplines, including: post-approval research, marketing, communications, health economics, and outcomes research.

Continuum Clinical has three businesses — Patient Recruitment and Retention for clinical trials; the design and execution of Late Stage (peri- and post-approval studies and health economics and outcomes research); and Medical Communications services. By offering three related services, Continuum Clinical provides a unique blend of resources and perspectives, proven expertise, and innovative solutions that ensure key development and commercial activities are optimized and full leveraged for achieving overall strategic goals.

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