Life Science Compliance Update

May 13, 2016

Pharmaceutical Summit on Business & Compliance Issues in Managed Markets

The Pharmaceutical Summit on Business and Compliance Issues in Managed Markets is set to take place June 8 through June 9, 2016, at the Grand Hyatt in Washington, D.C.

The conference opens on the morning of June 8, 2016, with a preconference workshop, with an introductory workshop that provides an overview of the United States payment systems for pharmaceuticals.

Day One officially starts at 1:00 pm on June 8, 2016, with a welcome by Susan Dentzer, which leads into a presentation by Robert Dubois, MD, PhD, on how to develop and use value-based frameworks for pharmaceuticals and guiding standards for how to implement those frameworks.

The afternoon continues, including a keynote presentation by Gregg Shapiro, the Assistant United States Attorney for the US Attorney's Office in the District of Massachusetts, on a prosecutor's perspective on enforcement actions. Day One ends with a panel on compliance and legal considerations within the managed markets business, with presentations by Blake Bolinger, the Director of US Pharmaceuticals, Compliance and Ethics, at Bristol-Myers Squibb; Jennifer McGee, the interim chief compliance officer and senior compliance counsel at Otsuka Pharmaceutical Development and Commercialization, Inc; Ronald Wisor, a partner at Hogan Lovells; and Seth Lundy, a partner at King and Spalding.

Day Two starts with two different tracks: Track A will discuss 340B program considerations and attendees will hear from Anthony Greco, a Director of Pharmaceutical & Life Sciences Advisory Services at PwC; Ray Schroeder, a Director of Pharmaceutical & Life Sciences Advisory Services at PwC; and Aaron Vandervelde, the Managing Director of the Berkeley Research Group. Track B attendees will hear about real world evidence and implications to value-based contracting, presented by Mark DeWyngaert, the managing director of Huron Life Sciences.

The morning continues with several other track options, including: legal and regulatory challenges regarding risk-sharing arrangements in the journey to value-based care, how to optimize contract operations through technology and harness insights through analytics to drive strategy and compliance, and what some of the strategic precursors are that are necessary for value-based contracting approaches to take hold.

Day Two closes out with a discussion on the future of the United States pharmaceutical marketplace, including PhRMA's perspective and how to manage communications between manufacturers and payers.

If you are interested in attending this conference, those who register by May 20, 2016, can qualify for the $200 Early Bird discount. Registration information can be found here.

May 04, 2016

CBI Forums on Transparency & Aggregate Spend

The Annual Forums on Transparency and Aggregate Spend are coming up. The 7th Annual West Coast Forum on Transparency & Aggregate Spend will be held May 18-19, 2016 at the Westin in San Diego, CA. The 10th Annual Forum on Transparency & Aggregate Spend will be held August 15-17, 2016, at the Ritz-Carlton in Washington, D.C.

West Coast Forum on Transparency & Aggregate Spend

This annual forum is the only West Coast Forum that is dedicated to the strategies and tactics to accelerate the effectiveness of organization transparency initiatives. This year's forum will feature presentations on: managing the process of changing your vendor, understanding how to capture spend in foreign countries after your firm expands or acquires, proving ROI on your transparency reporting initiative by optimizing systems and processes.

This year's schedule includes several general sessions on a variety of topics. The first session in the main conference focuses on how to improve your process for data remediation, and is presented by Elizabeth Schwartz, the Director of U.S. External Reporting and Transparency, Global Operations, at Johnson & Johnson Health Care Compliance and Privacy.

Day Two starts out with concurrent working groups, each on different topics, including: identifying high-risk areas and impactful competitor activity using transparency data, overcoming the pitfalls involved in working with third-parties, and identifying opportunities to improve communications with physicians and teaching hospitals. The conference ends with a keynote speech on how to ensure transparency of fair market value and a live polling benchmarking survey.

Attendees can save $300* on registration fees if they register by May 17, 2016, and use promo code AGGWPL.

East Coast Forum on Transparency & Aggregate Spend

This annual forum features solution-oriented sessions, working groups, and topic intensives on topics such as: how to use data analytics to assess compliance risk; how to enhance systems for data remediation and validation; how an Open Payments audit would look, including FCPA issues and off-label indications; and some of the differences between EFPIA and U.S. transparency regulations.

The forum starts on Monday, August 15, 2016, with two pre-conference workshops: one on transparency reporting for medical device, supplies, dental manufacturers and distributors; and the other focusing on the impact of the EFPIA Disclosure Code and Open Payments reporting on U.S. and European meetings and event management.

The forum continues the next day with a CMS keynote address on Open Payments and a panel discussion on understanding trends in recent enforcement targets. Day two closes out with a panel discussion on how to structure and initiate a global transparency compliance program and a keynote speech presenting a progress report of the implementation of EFPIA disclosure code and June 2016 publication results.

Day three rounds out the forum, where the morning session offers ten concurrent sessions (working groups and topic intensives) for attendees, who select five to attend. The topics covered include: transparency disclosure guidelines around the world; how to implement metrics and monitor to ensure compliance; how to ensure the accuracy and completeness of data; and how to make 2017 a more user-friendly experience when reporting 2016 Open Payments data.

Attendees can save $400* on registration fees if they register by May 17, 2016, and use promo code AGGPOL.

*Discount expires 5/17/2016; applies to standard rates only and may not be combined with other offers or applied to an existing registration.

February 09, 2016

Biosimilars Clinical Studies and Analytical Similarity Summit – Update on Biosimilars

This year, Pharma IQ, a division of the International Quality and Productivity Center, will be hosting the Biosimilars Clinical Studies and Analytical Similarity Summit, March 21 through the 23, in Boston, Massachusetts. Attendees to the Summit will receive key insights from industry thought leaders into some of the biggest challenges in the analytical and clinical phases of biosimilar drug development.

This Summit boasts a full agenda spanning all three days, starting with Pre-Conference events on March 21 at 9:00 am. The Pre-Conference workshop day consists of three workshops with a wide range of topics: Compare, Contrast and Comply with US and EU Regulations that Govern Biosimilar Product Development; Establishing Structural Comparability with Effective Preclinical Characterization Methods; and Effective Clinical Study Design for Detecting Differences Between Biosimilar and Innovator Products Among Sensitive Populations.

Day One of the Summit gets off to a roaring start at 9:00 am with a keynote address given by Professor Andrea Laslop, the Head of Scientific Office at the Austrian Agency for Health & Food Safety, on the future of biosimilar approval in Europe. They keynote is followed by three discussions: one on the unique bioanalytical testing and clinical testing strategies for proving safety and efficacy; one on the legal and regulatory implications of "similarity" and "interchangeability"; and a third one on biosimilars regulations in the US market and where we are headed from here, presented by our very own Thomas Sullivan. The afternoon closes out with discussions on how to leverage the FDA's "Totality of Evidence" methodology for using foreign reference products, and how to reduce or eliminate nonclinical toxicity studies from biosimilar development programs.

Day Two of the Summit again begins with a keynote address, this time a regulatory update on Health Canada's new guidance for subsequent entry biologics, presented by Agnes V. Klein, M.D., the Director CERB, Biologics and Genetic Therapies Directorate, at Health Canada. Dr. Klein and Professor Laslop come together mid-day on Day Two to host a regulatory question and answer session, focused on similarities and differences in the market authorization of biosimilars, including regulatory, policy, and guidance background. Day Two ends with a presentation by Michael Retsky, a research associate with the Department of Environmental Health at the Harvard T.H.Chan School of Public Health, on the difficulty of using biosimilars in oncology and what can be done about it.

If you are interested in attending the Biosimilars Clinical Studies and Analytical Similarity Summit, you can register here. Those who register by February 19, 2016, could receive up to $400 off registration costs.


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