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Access to Reimbursement in Pharma’s New Healthcare Paradigm
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LES New Jersey Chapter Meeting

2/25/2015
When: Wednesday, February 25, 2015
6:00 PM – 9:00 PM
Where: Basking Ridge Country Club
185 Madisonville Road
Basking Ridge, New Jersey  07920
United States

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LES-NJ Chapter and BioNJ Joint Meeting

DATE & TIME
Wednesday, February 25, 2015
6:00 PM – 9:00 PM

LOCATION
Basking Ridge Country Club
185 Madisonville Road
Basking Ridge, NJ 07920
http://www.baskingridgecc.com

TITLE
Access to Reimbursement in Pharma’s New Healthcare Paradigm

DESCRIPTION
FDA approval to market is no longer the smooth pathway to market success.  Our US-based health system now parallels European markets, in which approval, therapeutic impact and pricing are intertwined considerations – but unique market obstacles.  While the importance of payers’ views toward innovative drugs has been building —especially for oncology drugs and orphan indications—pricing innovation has become a flashpoint after Gilead breakthrough treatment cures for HCV—Solvadi and Harvoni.  The introduction of Abbvie Viekira Pak further heightened stakes for formulary acceptance. 

The result: an increasing need for early and ongoing dialogue with payers to gain formulary inclusion on optimal terms.

Key issues include:
  • Defining the position of your innovative therapy early on in the treatment pathway is critical to ensure optimal coverage by payers.
  • In addition to demonstrating long-term economic value, it is important to frame the evidence in relation to the impact on insurers annual budgets.
  • Harnessing patient advocacy groups to demonstrate the value of your innovative therapy early in the course of the disease/condition.
This LES-NJ/BioNJ panel discussion will explore avenues to address health outcomes and treatment pathways early in the development of innovative therapies to achieve formulary acceptance and market success.  The speakers who have decades of experience with policy, pricing and reimbursement issues both US and ex-US will engage in an interactive discussion with the audience. 

Intro of Panelists by Ruth Plager, President, ZenithBIO 
“We’ve come a long way since the early ‘80’s when I first introduced a pharmacoeconomic strategy to gain formulary acceptance for an older Pfizer antibiotic.  In today’s environment, payers have become the first stakeholder group to be considered in evaluating the potential for a new therapy. Our distinguished panelists—all have decades of expertise in the biopharma industry focusing on the full range of critical reimbursement issues.” R. Plager

PANELISTS
Gil Bashe, Executive Vice President and Practice Chair, Makovsky Health
Paul Gallagher, President, Compass Strategic Consulting: Pricing & Reimbursement 
William (Bill) Gerth, W. C. Gerth & Associates, Consultancy in Market Access/Health Policy
Moderator, Ruth Plager, President, ZenithBIO Business Development Consultancy

SCHEDULE 
Cocktail Reception - 6:00pm - 7:30 (Open Bar, Hors d'oeuvres)
Program - 7:30pm - 9:00 (Coffee & Dessert) 
Dress Code:  Business or Business Casual 

COST & CANCELLATION POLICY
$50 LES and BioNJ Members in advance (received by 12:00 Midnight EST, Monday, Feb. 23rd) 
$60 Non-Members in advance (received by 12:00 Midnight EST, Monday, Feb. 23rd)

$60 LES and BioNJ Members at the door (cash and checks only)
$70 Non-Members at the door (cash and checks only)

Cancellations made after 12:00 Midnight EST, Monday, Feb. 23rd, cannot be reimbursed, but substitutions are welcome! 

Register by Fax or Mail:  
Use the PDF form on the registration page and follow instructions for credit card payment or paying by check. Use one form per person.

Please note: Due to recent changes in the LES registration system, all advance registrations for this meeting will end on Monday, Feb. 23rd at 12:00 Midnight EST 

If you have any problems registering online or if you’ve missed the deadline, please contact:

Butler Cooper
Chapter Relations Manager
Licensing Executives Society
1120 Route 73, Suite 200
Mount Laurel, NJ  08054
(856)380-6870 Direct
bcooper@les.org
http://www.lesusacanada.org

Leadership Team for LES-NJ
Chapter Chair, Linda Webb (973)292-5001 Ext. 232 
Chapter Co-Chair, Lori Waldron (973)643-5158
Chapter Co-Chair, Daisy Rivera-Muzzio (973)903-1809
+++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++

Gil Bashe, Executive Vice President and Practice Chair, Makovsky Health
Gil has been at the forefront of introducing innovative drugs and devices, including introducing the first biotherapeutic for the treatment of cancer as well as many of the nation’s noted orphan drug therapies.  A former pharma sector lobbyist and executive in some of the world’s largest integrated marketing and PR consultancies, he has led Makovsky Health, cited by the Holmes Report as the nation’s #1 health PR firm, for more than 12 years.  He was also charged with leading teams in order to overcome CMS and payer formulary hurdles to secure Part D coverage for Niaspan.  An advocate for the voice of the patient, he is a national access-to-care counselor on therapies for cardiovascular, cancer, neurologic and women’s health therapies.  He serves on the Galien Foundation and the American Academy of Pain Medicine Foundation advisory boards and is chair-elect of the American Heart Association Founder’s Affiliate.

Paul Gallagher, President, Compass Strategic Consulting: Pricing & Reimbursement 
Paul has a 35-year career in healthcare that is characterized by its breadth and extensive experience in the development and commercialization of innovations. During 16 years at Ciba-Geigy, Merrell Dow, and Wyeth-Ayerst, Paul held positions of increasing responsibilities in marketing research, product management, sales management and executive marketing management. From 1984 to 1988, he was Vice President of Global Marketing for Ayerst International.  

In 1994 Paul Gallagher founded Compass Strategic Consulting, Inc. In its 21 years, Compass has moved from specializing in a full range of business development services in the life sciences to one predominantly focused on global market access intelligence and strategies. Compass provides pricing and reimbursement assessments and strategies, primarily for pipeline products, in the pharma, biotech, and diagnostic sectors. Clients include biopharma companies, from emerging to top ten, and venture funds.  

Paul has presented at national conferences on the US Affordable Care Act, orphans drugs and biosimilars. He is Co-chair of the CT Chapter of LES (Licensing Executives Society).

William (Bill) Gerth, W. C. Gerth & Associates, Consultancy in Market Access/Health Policy
Bill has 36 years of global pharmaceutical industry experience in sales, marketing, outcomes research, health economics, pricing/reimbursement, and market access. He spent 11 years at Schering-Plough and 19 years at Merck & Co., most recently as Global Access Team Leader.  W. C. Gerth & Associates, L.L.C.  was founded in 2009. that provides insights and tools that bridge science and market access/health policy.

Bill is a pioneer in developing, integrating, aligning, implementing, and communicating Outcomes Research strategic plans/programs in all phases of clinical and market development.  He has directed initiatives across many therapeutic areas including: oncology, central nervous system disorders, virology (vaccines), pulmonary/respiratory, cardiovascular, and infectious diseases.  

Bill has collaborated with investigators, health technology agencies, and public health authorities in the Americas (North, South, & Latin), Europe, and the Pacific Rim Region.  He has authored a number of peer-reviewed publications on burden-of-illness, health-related quality of life, cost-effectiveness, and health policy.  He has been instrumental in obtaining optimal positioning of products in formularies, reimbursement listings, and treatment guidelines resulting in a positive impact on patient access and market penetration around the world.

Ruth Plager - President, ZenithBIO Business Development Consultancy 
Ruth’s track record of adding value to the positioning, partnering and ultimate successful commercialization of innovative therapies is built on 30 years of commercial and business development experience both within Pfizer, Syntex International (Roche) and Enzon combined with more than a decade of consulting to dynamic biopharmaceutical companies on both coasts. 

Given the current healthcare environment, where pricing has become a dominant force in the use of newly approved innovative products, Ruth’s early track record is notable: in the early ‘80’s she  introduced a pharmacoeconomic strategy to achieve formulary acceptance of an older, premium priced antibiotic. This strategy was rapidly adopted throughout Pfizer and then the industry.

Currently, in addition to gaining the perspective of KOLs, line physicians and patients, the biopharma industry is challenged to work with payers early on to ensure that their approach to outcomes research for an innovative product will meet the payers’ goals. 

ZenithBIO’s (ZB) insightful assessments coupled with our business development network impact the strategic positioning of assets which in turn translate to an increase in the value of innovative discovery platforms, technologies and therapies for biopharmaceutical companies. 

Ruth’s network is further enhanced by her involvement in the Licensing Executives Society Life Science Sector and the development of more than a dozen Health Care related workshops for annual LES meetings, Biotech Showcase, and the Life Science Summit.
  
Prior to joining the industry, Ruth spent a year in cancer research at the Weizmann Institute of Science in Israel and held positions in Medical Education Agencies.