Michael McCaughan

Editor-in-Chief, FDC-Windhover’s Biopharma Group

Michael McCaughan is Editor-in-Chief of FDC-Windhover’s Biopharma Group, the leading publisher of news and information services for the pharmaceutical industry, including The Pink Sheet, IN VIVO, The RPM Report, PharmAsia News, and The IN VIVO Blog. McCaughan speaks frequently on regulatory and policy developments affecting the biopharmaceutical industry.

David A. Galardi

Pharm.D., Apogenics

David currently leads the marketing and corporate development initiatives of the company he co-founded, Apogenics Healthcare. Prior to forming Apogenics Healthcare he was Vice President of Corporate Development at a major specialty services distributor and specialty pharmacy provider. He was responsible for bringing the many brands of the company to the pharmaceutical and specialty physician marketplaces in a strategic fashion. He has represented various Fortune 100 companies at the senior and executive level.

David has worked as a Product Director at three major health plans, where he was responsible for a variety of clinical, quality and strategic sales functions. He has been a managed care pharmacy director responsible for all aspects of drug policy and was one of the first to implement a specialty drug program. He has developed successful programs for autoimmune, neurology, oncology and HIV disease management and has chaired various benefits coverage and health policy committees within a number of managed care organizations.

David has spoken at numerous national meetings for various professional societies and has been a national speaker in areas of oncology, neurology diseases autoimmune diseases and health policy. He has significant experience related to NCQA\HEDIS and outcomes management.

Jayson S. Slotnik

Associate, Washington, D.C.

Jayson Slotnik’s practice focuses on health care regulatory issues, with an emphasis on coverage, coding and reimbursement for devices, diagnostic tests, drugs, and biologicals under all parts of Medicare.

Prior to joining Hogan & Hartson, Jayson was Director of Medicare Reimbursement and Economic Policy at the Biotechnology Industry Organization in Washington, D.C. where he represented the industry in front of the Centers for Medicare and Medicaid Services, U.S. Congress, and other regulatory agencies. Jayson counseled companies of all sizes on an appropriate reimbursement strategy.

Before that, he spent several years as a health care regulatory associate where he focused on legal, regulatory, and federal legislative issues arising under Medicare, Medicaid, and the Federal Food, Drug and Cosmetic Act, and functioned as regulatory counsel to a managed care organization operating in nine states.

While attending law school, Jayson served as a judicial clerk for the Honorable Charles Day on the U.S. District Court for the District of Maryland. He also interned at the National Cancer Institute, National Institutes of Health where he drafted memoranda and reviewed licensing agreements on behalf of branch scientists.

Dennis Matheis

President, BCBS of MO

Dennis Matheis is the President of Alliance Blue Cross and Blue Shield in Missouri. He currently directs product and service innovation, underwriting and sales. Previously, he was Vice President and general manager of group business for the health plans.

Mr. Matheis has over 17 years of experience in the health insurance sector and has served in a variety of senior management positions. Prior affiliations include Advocate Health Partners in Chicago where he served as the Chief Executive Officer. In addition, he formerly served as President and general manager at Cigna HealthCare of Illinois and as President of Humana Health Plans of Kansas and Missouri. In addition, he was President of Health Partners of the Midwest located in St. Louis.

Mr. Matheis began his career in public accounting with Coopers & Lybrand.

CRAIG KEPHART

President, Chief Executive Officer and Director,
Centric Health Resources

Craig Kephart is a co-founder of Centric Health Resources, Inc. and key developer of the company’s business model for addressing the needs of individuals with rare chronic disorders. He has over 25 years of experience in the healthcare sector, beginning his career as a respiratory therapist in hospital settings as a clinician and administrator.

Mr. Kephart previously served with Express Scripts, Inc. as the Vice President of Specialty Distribution Services managing the Bayer Direct Program. While at Express Scripts, he also had management responsibilities in a variety of operational roles including reimbursement, pharmacy and specialty mail order pharmacy.

Prior corporate affiliations include Quantum Health Resources, Inc., where he was general manager of the St. Louis facility and later responsible for all national Alpha-1 programs as a corporate group marketing director.

Warwick Charlton, M.D., MBA

Chief Medical Officer

Dr. Charlton has more than 25 years of experience across a wide range of healthcare businesses and health service technologies. He has specialized expertise in product development, healthcare data, analytics and informatics. Dr. Charlton is a board-certified physician with broad clinical experience in managed care settings and private practice.

Warwick served as CMO and senior vice-president at Accordant Health Services, a disease management and specialty pharmaceutical fulfillment company. During his tenure he was directly responsible for the development and oversight of 15 rare, complex chronic disease management programs that provided direct services for 50,000 patients. As CMO and senior vice-president at Click-for-Care, he was responsible for the development of a comprehensive web-based patient care information technology and communication platform that provided disease management, health services and health content.

John W. Walsh

Chairman

John W. Walsh is the co-founder, President and Chief Executive Officer of the Alpha-1 Foundation based in Miami, Florida. The organization has gained international recognition and has raised more than $31 million to support Alpha-1 research and research-related projects. Currently, more than 60 academic institutions in North America and Europe have been awarded funding grants.

Mr. Walsh is also co-founder and President of AlphaNet, Inc., a not-for-profit disease management services company that provides comprehensive care exclusively for individuals with Alpha-1 Antitrypsin Deficiency. Presently, AlphaNet serves over 2,500 individuals with Alpha-1 in all 50 states, Puerto Rico and the Virgin Islands.

In the fall of 2004, Mr. Walsh partnered in the founding of Centric Health Resources, Inc. to better serve the needs of individuals with rare chronic disorders. As Chairman, he meets frequently with patient advocacy organizations, biotech and pharmaceutical companies, and related health care stakeholders.

Mr. Walsh’s contributions to pioneering collaboration in orphan drug development were officially recognized by the Food and Drug Administration in 2002 with the presentation of the Commissioner’s Special Citation. With an extensive background in business management and government relations, Mr. Walsh regularly testifies before Congress and health advisory groups as a patient advocate. He was diagnosed with the rare genetic disorder, Alpha-1 Antitrypsin Deficiency in 1989.

Robert A. Sandhaus, MD

Medical Director, AlphaNet
Traveling From: Denver, CO

Robert “Sandy” Sandhaus graduated from Haverford College in Pennsylvania with a degree in molecular biology.  He then received a PhD in cell biology and an MD from the State University of New York at Stony Brook.  He completed his residency in internal medicine at the Beth Israel Hospital in Boston and a pulmonary fellowship at the University of California San Francisco (UCSF).  He was then appointed to the UCSF medical faculty and subsequently joined the medical faculty at the University of Colorado School of Medicine in 1981 where he founded the Alpha1-Antitrypsin Deficiency Program at National Jewish Medical and Research Center in Denver and remains its director.

His research throughout his academic career has centered on the role of white blood cell enzymes in the prevention and promotion of lung disease.  This work led to a special clinical interest in patients with the genetic deficiency of alpha-1 antitrypsin.  In addition to his ongoing academic career, Dr. Sandhaus briefly left medical practice to work in research and development in the biopharmaceutical industry.  He ran clinical development programs at Cortech, NeXstar Pharmaceuticals, and Gilead Sciences.  Dr. Sandhaus has served on the Boards of Directors of the Alpha-1 Association, the Alpha-1 Foundation, AlphaNet, and the Osteogenesis Imperfecta Foundation.  For the past five years, he has been the Executive Vice President and Medical Director of AlphaNet and the Clinical Director of the Alpha-1 Foundation.

He is board certified in internal medicine, pulmonary disease, and critical care medicine.  He lives in Bow Mar, Colorado.

Diane Dorman

Vice President for Public Policy
National Organization for Rare Disorders (NORD)

Ms. Dorman is the Vice President for Public Policy for the National Organization for Rare Disorders (NORD) and leads NORD efforts in its relationship with the federal government and Congress. She is the primary DC representative for more than 25 million Americans who have one of the 6,000 to 7,000 known rare diseases. Her overriding mission is to improve the plight of patients with rare diseases and increase incentives for the development of orphan drugs, devices, and diagnostics.

Since joining NORD in October 2000, Ms. Dorman’s advocacy has been instrumental in the passage of two new public laws and she has been influential in the adoption of numerous programs, regulations and guidance that touch the lives of patients with rare diseases.

On behalf of NORD and coalitions in which NORD participates, Ms. Dorman leads education and outreach programs to gain policymaker support for increased research into rare diseases and greater development of orphan products. She sits on the Board of Directors of the Alliance for a Strong FDA, as well as the International Conference on Rare Diseases and Orphan Drugs (ICORD). Ms. Dorman is also one of the founding members of the Alliance for Drug Safety and Access (ADSA), and was appointed to the Membership Committee of the U.S. Pharmacopeia.

She is responsible for ensuring that patients continue to have access to life-saving orphan therapies through Medicare, Medicaid and private insurance. She also serves as NORD’s primary liaison to the Food and Drug Administration, the National Institutes of Health, and the Center for Medicare and Medicare Services, as well as the pharmaceutical, biotechnology, and medical device industries. Most recently, Ms. Dorman has been appointed as a consumer representative to the Medicare Evidence Development Coverage Advisory Committee.

Ms. Dorman develops and maintains relationships with other healthcare voluntary agencies and patient groups. She provides technical assistance and legislative analysis to NORD’s member agencies on government-related matters, as well as the training of staff and volunteers of member organizations. Her leadership efforts have led to introduction and passage of the Rare Diseases Act (P.L. 107-281), and the Rare Diseases Orphan Product Development Act (P.L. 107-281). She was also influential in the introduction of House Concurrent Resolution 147, commemorating the 20th Anniversary of the Orphan Drug Act.

Wendy S. White

Founder & President, Siren Interactive

Wendy White has been Founder and President of Siren Interactive Corporation since August 1998, dedicated to helping biopharmaceutical clients use the power of the Internet to establish trust relationships with patients, caregivers, and healthcare professionals through education, support, and service. She previously served as Account Manager of VideOcart (1991-1993), and Consultant for William M. Mercer (1985-1991). Wendy authors a popular blog on marketing therapies for rare diseases and is an outgoing public speaker. As the mother of a child with a rare disorder, she is intensely interested in patient empowerment and the role of the Internet in providing self-education and support. She led global Internet Initiatives and eStrategy for the Healthcare Businesswomen's Association (HBA) and is currently President of the HBA Chicago Chapter. For several years, Wendy served on the board of the Thrive Counseling Center and continues to advise the organization on an informal basis. Wendy received the 2008 President's Award from the Healthcare Businesswomen's Association (HBA), the 1996 New Media Invision Award (Comdr), and the 1995 Gold Hugo Award (Chicago Film Fest).

David Sirois

Dr. Sirois earned the DMD, PhD in Neuroscience, and completed a Fellowship in Oral Medicine from the University of Pennsylvania. He is the Associate Dean for Graduate Education and Professor of Oral and Maxillofacial Pathology, Radiology and Medicine at NYU College of Dentistry, Professor of Neurology at NYU School of Medicine, and a Diplomat of the American Board of Oral Medicine. His clinical and research areas of interest include oral dermatology, oral oncology, and neuropathic face pain. He is President of the Board of Directors of the International Pemphigus and Pemphigoid Foundation, an international healthcare non-profit dedicated to serving the needs of the community of people affected by these ultra-orphan autoimmune blistering disorders.

Bill Sullivan, MBA

Partner and Founder, Specialty Pharmacy Solutions

• Over twenty-five years of experience managing pharmacy risk and improving clinical outcomes — particularly for patients with chronic illness.
• As a nationally recognized leader in the specialty pharmacy marketplace Bill creates effective solutions for controlling high-cost injectables, infusibles and emerging biotech products.
• He has developed therapy-specific clinical management programs and built the national sales & contracting programs for  publicly traded and independently owned specialty pharmacies.
• Bill's pharmacy sales, product development and operations expertise helps organizations profitably expand their markets and optimize enterprise valuation
 
• His leadership has helped define the specialty pharmacy marketplace
• Member, Academy of Managed Care Pharmacy (AMCP)
• Member, Advisory Board, Specialty Pharmacy News
• MBA in Healthcare Administration, Boston University
• BA, Humanities and English Literature, Providence College

Dean P. Erhardt

Principal, D2 Pharma Consulting

Dean Erhardt is a principal of D2 Pharma Consulting. Mr. Erhardt offers nearly 20 years of strategic marketing and management experience across both the consumer product and pharmaceutical arenas. His areas of expertise include analysis and development of pharmaceutical support programs, pharmaceutical and consumer product distribution, and specialty pharmaceutical product management. Mr. Erhardt has provided marketing consultation services to biotech and pharmaceutical companies, where he has assisted 14 of the top 20 US pharmaceutical manufacturers in structuring and implementing various aspects of their specialty distribution and product support programs.

Mr. Erhardt has demonstrated expertise in sales and marketing leadership, business development and the negotiations and structuring of complex multi-million dollar contracts. His leadership has lead high performance teams to achieve outstanding growth experience in start-up, to Fortune 500 environments. Mr. Erhardt's sales and marketing leadership enabled a division of a fortune 150 company to grow from 6 employees to more than 500 and more than $1.5 billion in specialty program products dispensed annually. In a separate endeavor, Mr. Erhardt led the sales effort that increased revenues of a national specialty pharmacy by over 270% in less than one year.

Prior to his current role with D2 Pharma Consulting, Mr. Erhardt's experience spanned several Fortune 500 companies including Express Scripts, Inc., Cardinal Health and U.S. Healthcare. Mr. Erhardt has a BA in Marketing from the University of Oklahoma and an MBA from the Keller Graduate School of Management.

Jim Long

Over the past twenty years, Jim has held senior management positions in three health care industries including pharmaceutical, home health care, specialty pharmacy distribution and services, for companies ranging in size from start ups, to those in the Fortune 75.

He is currently Principal and Co – founder of BioSolutia®, Inc, a consulting firm dedicated to ultra-orphan specialty medications, providing commercialization and managed care services to all stakeholder companies involved in such niche therapies.

He served as Vice President, Specialty Pharmacy for Caremark, one of the nation's largest pharmacy benefit management and specialty pharmacy services companies; as Vice President, Specialty Pharmacy, for AdvancePCS, being involved in the start up and expansion of AdvancePCS SpecialtyRx; as President, American Medical Distributors (Bellco Health), a national specialty distribution and pharmacy services company; as Vice President, Specialty Pharmacy, for Chronimed (now MIM BioScrip); as Vice President, Sales, for Olsten Health Services (now Gentiva Health Services), the nation's largest home health care services company. Before being involved in home health services and specialty pharmacy, Mr. Long spent several years with a major pharmaceutical company in sales management positions of steadily increasing responsibility.

Accordingly, he is considered one of the few nationally recognized experts on specialty pharmaceutical channel development, distribution, specialty clinical services and managed care payer reimbursement strategies, particularly for narrow niche biotechnology and biological specialty medications.

Mr. Long earned his Bachelor of Science degree in Biology / Premedical Studies and graduated Cum Laude from Villanova University, in Villanova, Pennsylvania. He also attended medical school at the Faculty of Medicine and Surgery, of the University of Genoa, Italy.

Patrick Clinton

Patrick Clinton is the editor in chief of Pharmaceutical Executive magazine, a position he has held since 2003. He is a magazine editor, writer, and consultant of more than 30 years experience, having worked with publications as diverse as Building Design & Construction, the Chicago Reader, Chicago Magazine, Outside, Men’s Journal, University Business, and BioPharm International. From 1989 through 1987, Clinton was an assistant professor of journalism at the Medill School of Journalism at Northwestern University.

Douglas Paul, PharmD

MS - Partner

As a partner at MME, Doug has worked on a variety of initiatives for pharmaceutical and medical technology companies. Doug has led projects for clients with ultra-orphan products in the areas of marketing strategy, pricing strategy, pricing research, management/analysis of forecasts, market assessments, and value communication plans, both in the US and in international markets. Prior to joining MME, he served as Vice President of Marketing for a medical device firm. He received a PharmD and an MS in pharmaceutical marketing from the University of Mississippi and is currently completing a PhD in pharmaceutical marketing and management.

August 24-26, 2009
Ameristar Casino
St. Louis, MO

There is no charge for this event.
Seating is limited, so register early!