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Virtual Event

Oct 05, 2020 12:00 PM - Oct 05, 2020 3:30 PM

(US Eastern Standard Time)

Horsham, PA 19044

Short Course: Current Biosimilar Policies: An Interactive Boot Camp for US Market Success

Instructors

Mary Jo  Carden, JD, RPh

Mary Jo Carden, JD, RPh

Head, Policy, Sandoz, Inc., United States

Mary Jo Carden serves as Head of Policy at Sandoz, Inc. She previously served as Vice President of Government and Pharmacy Affairs at AMCP. She has also served as Director of Regulatory Affairs at Medco Health Solutions, in various government affairs capacities at the American Society of Consultant Pharmacists., and practiced as a retail pharmacist. For more than 20 years she has provided expertise and contributed to policy issues in the areas of Medicare Part D and B, Medicaid, the Affordable Care Act, Food and Drug Administration issues, and state policy issues.

Anna  Welch, MA

Anna Welch, MA

Chief Editor, Biosimilar Development, Life Science Connect, United States

Anna Rose Welch is the Chief Editor of Biosimilar Development, an online publication featuring executive interviews and thought leadership columns about global biosimilar industry trends and regulatory and commercialization challenges. In addition to speaking at several U.S. biosimilar conferences, she was also invited to Brazil in 2018 to address members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilars manufacturers about how to establish a national biosimilar policy. Her writing was included in the book, Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development, published in 2018 by Springer.

John Michael O'Brien, PharmD, MPH

John Michael O'Brien, PharmD, MPH

Senior Fellow, Usc-Schaeffer Center For Health Policy & Economics, United States

John Michael O’Brien is a pharmacist who served as Senior Advisor for drug pricing to HHS Secretary Alex Azar. He also served as Deputy Assistant Secretary for Health Policy, and a key advisor to the Secretary for health policy research, development, and analysis. Dr. O’Brien is a certified health insurance executive, has held senior policy positions in the life sciences and managed care industries, was a career official at CMS during the Obama Administration, and served as a health policy fellow in the U.S. Senate. He holds a number of academic appointments, an MPH from the Johns Hopkins Bloomberg School of Public Health, a PharmD from Nova Southeastern, and studied pharmacy and public policy at the University of Florida.

William  Kramer

William Kramer

Executive Director, Health Care Policy, Pacific Business Group on Health , United States

Pam  Traxel

Pam Traxel

Senior Vice President, American Cancer Society Cancer Action Network, United States

Pam Traxel serves as the Senior Vice President for ACS CAN, the advocacy affiliate of the America Cancer Society. Pam is responsible for helping ACS CAN develop relationships with companies and individuals to help further the fight against cancer through dynamic partnerships, events, and forums. Pam began her career with ACS CAN in 2007. She has been integrally involved in helping to establish ACS CAN as a nationwide advocacy organization that influences and shapes public policy at all levels of government to impact our mission and to represent the voices of all cancer patients and their families.

Lisa  LeGette, MBA, RPh

Lisa LeGette, MBA, RPh

Government Affairs Principal, Cigna, United States

Lisa Le Gette, RPh, MBA, is a Government Affairs Principal for Cigna. In this role, she supports both Federal and State Regulatory policy, advocacy, and legislative matters. Lisa has more than 28 yrs. of professional pharmacist experience. After graduating from the University of Maryland, School of Pharmacy, Lisa spent her initial years in traditional practice settings. However, the last 17 yrs. have been in managed care at Express Scripts, a PBM acquired by Cigna. Prior to moving to Government Affairs in 2017, Lisa was Clinical Director for Express Scripts’ TRICARE Pharmacy Services contract, overseeing clinical programs and solutions for the Department of Defense (DoD). Lisa is an active member of the Academy of Managed Care Pharmacy.

Gillian  Woollett, PhD, MA

Gillian Woollett, PhD, MA

Vice President, Head Regulatory Strategy and Policy, Samsung Bioepis, United States

Gillian Woollett, MA, DPhil leads the Avalere FDA Practice. She provides the "prequel" of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate Centers for Medicare & Medicaid Services and healthcare policy/business world. Prior to joining Avalere, Gillian was chief scientist at Engel & Novitt, LLP, and was VP, Science and Regulatory Affairs at the Biotechnology Industry Organization. She joined BIO after being associate vice president at the Pharmaceutical Research and Manufacturers of America.

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