MARLENE HAFFNER, MD, MPH
Dr. Marlene Haffner was the Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA) for 20+ years. During her tenure in that program, it became the top orphan products program in the world. In addition to assisting in the development of more than 300 products in the US, she is credited with assisting in the development of programs in Japan, the European Union, Australia, and beyond. Her extensive speaking and writing brought the term “orphan products” to the mind of many in the pharmaceutical world.
Marlene is a problem solver and creative thinker. She founded Haffner Associates in 2009 in order to continue to apply her extensive experience in development of orphan products by working with small to large biotech/ pharmaceutical companies, patient advocacy groups, and government agencies. In addition to her work at Haffner Associates, Marlene serves as an expert advisor and board member to companies throughout the world. Trained as an internist and hematologist, Marlene graduated from the George Washington University School of Medicine and did further training at the Columbia University School of Medicine and the Albert Einstein College of Medicine, in New York City. She received her Masters of Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore. Following her tenure at FDA and prior to forming Haffner Associates, Marlene served as Executive Director, Global Regulatory Intelligence and Policy for two years at Amgen, the largest biotech company in the world.
Marlene has worked in the Washington, DC metropolitan area for more than 30 years. She has seen many changes in the regulatory scene during that period of time and is both sensitive and knowledgeable about politics and the political landscape. She knows “FDA think” and maintains close ties with her friends and colleagues in the agency.
Marlene serves as a Board Member on BioPharma Global and provides Technical Advice and Executive Oversight.
SANDRA HEIBEL, PHD
CSO, BioPharma Global
Dr. Sandra Heibel is an independent consultant and serves as the CSO for BioPharma Global. Sandi has worked with Haffner Associates and is the Principal at Heibel Consulting LLC. She has an extensive knowledge of drug development research for rare diseases, regulatory strategy, scientific writing, regulatory submissions, and project management. Sandi also serves as a Project Manager for Scientific Operations at BioPontis Alliance for Rare Diseases, a non-profit corporation dedicated to the development of new therapeutic agents to treat rare diseases. She has a Bachelor’s in Animal Bioscience from Penn State University and completed her Master’s and PhD at the University of Maryland where she studied the molecular biology of rare heritable diseases of metabolism. Through her doctoral experience and as part of a scientist-clinician team, she identified and characterized disease-causing mutations in patients with ultra-rare diseases, assisted with clinical studies, and learned about the need and value of developing drugs for rare diseases.
KATHARINE A. BURKE
CureSearch for Children`s Cancer
Katharine Burke is an experienced executive with a diverse background in training, operations, facilities, consulting and technical support at for profit and not for profit organizations. She is currently Vice President of Operations at CureSearch for Children’s Cancer where she is responsible for internal operations, Human Resources, Finance, Information Technology and facilities. Before joining CureSearch, Katharine was Vice President of Operations at Learning Tree International, a technical and management training company. At Learning Tree, she directed production, instructor relations, facilities and operational activities associated with delivering training classes. Prior to Learning Tree, Burke held progressive positions in operations and technical support at Sprint.
Katharine holds a bachelor’s degree from Drexel University and an MBA from University of Maryland. She has completed additional studies at University of Virginia, University of North Carolina at Chapel Hill and Northwestern University.
Katharine is a member of Women in Technology and the American Society for Training and Development. She currently serves as Treasurer for the Alpha Sigma Alpha Foundation and is a past Board member for NOVACO.
Clay has over 30 years of experience leading human resources teams and driving initiatives across HR functional areas in support of business objectives. Clay is currently a Vice President of Human Resources for DXC Technologies. DXC is one of the world’s leading technology companies providing innovative solutions for the new IT environment.
As VP of Human Resources, Clay serves as the senior HR executive for the US Public Sector supporting over 9,500 employees who tailor IT solutions and innovations for state governments, school districts, campuses, and federal agencies throughout the US and globally in support of the US government and various agencies. Clay is responsible for leading all people strategies, including organizational design, talent acquisition, workforce planning, performance management, total rewards, talent management, and executive development.
Prior to joining HP, Clay served in executive HR leadership roles in companies such as HP, Leidos, SAIC, L-3 Communications, Winstar Communications, MCI, and BioLab Inc. He currently serves on the board of the Washington Women’s Leadership Initiative as well as the HR Alliance DC organization. He has supported community and charitable organizations such as Habitat for Humanity and the Paralyzed Veterans of America’s National Veterans Wheelchair Games.
Clay received his bachelor’s degree in business administration from the University of Louisville and his master’s in business administration from the Robert H. Smith School of Business at the University of Maryland. His office is located in Herndon, VA.
Merito Group LLC
Carolyn is Board Chair for BioPharma Global. A graduate of Kansas State University, she is Founding Board Chair of the Washington Women’s Leadership Initiative (WWLI.org), a board member at The Girl Scout Council of the National Capital Area and My Sister’s Place in Washington, DC. As Principal of Merito Group, Carolyn leads a team of talent acquisition professionals providing client services to a wide range of industries including Big 4, Fortune 1000 companies and small business owners alike.
She is frequently called upon by national news organizations such as The Washington Post, The Wall Street Journal, NPR, CNN, MSNBC, and AOL Jobs among others to contribute content on a variety of topics. A creative entrepreneur and a credentialed career coach, she is regularly published on topics relating to employment, careers, job search, business strategy, social media, organizational and professional development and executive recruiting in various national magazines, trade journals, and on the Internet.
She is a frequent speaker on a national level and has received rave reviews as an engaging and enthusiastic presenter on a variety of topics as a member of the National Speakers Association. An alumnus of Kansas State University, Carolyn is the author of TEN EASY STEPS TO A PERFECT RESUME, TEN STEPS TO FINDING THE PERFECT JOB, and TEN SECRETS TO GETTING PROMOTED available on Amazon.com. Carolyn’s blog can be found at www.JobSearchJungle.com
With 27 years’ experience in the health care industry, Matt leads PwC’s Washington Metro Healthcare Practice based in McLean, Virginia, working with faith-based institutions, academic health systems, integrated delivery systems, and community hospitals.
When he promises to walk in his clients’ shoes, Matt speaks from experience. Matt possesses an MBA in Healthcare of Administration from LaSalle University and spent 10 years in the industry as a senior executive at a large integrated health system where he gained valuable experience with merger integration, performance improvement, clinical service line planning, and physician practice integration from both sides of the desk.
That background drives his passion to create real change in the industry at a strategic level with his current role as a National Deals Practice Partner for M&A Advisory services, helping his clients not just manage the disruptions caused by the increasing convergence of payers and providers but thrive through the upheavals.
Matt maintains his ties to the industry through membership of the American College of Healthcare Executives and the Healthcare Financial Management Association
As a highly-experienced partner in the firm, Matt is committed to building the next generation of leaders through coaching and teaching. Matt has served as a Champion for the firm’s Annual Review Committee for staff and is proud of having numerous opportunities to mentor staff for their professional development.
JAMES LAFLAMME, RPH, MS, FACHE
CEO, BioPharma Global
James LaFlamme has more than 30 years of health care operational experience and has held a variety of senior positions including CEO, Chief Operations Officer, Vice President of Clinical Services, and Administrative Director at several hospitals and health systems. In his current role as Chief Executive Officer he is responsible for leading global operations for BioPharma Global. This encompasses overseeing the development and delivery of all advisory opinions and client deliverables as well as a full complement of Client Development activities on a worldwide basis.
Prior to joining BPG, he was Executive Vice President at Coté Orphan where he oversaw all aspects of regulatory affairs and business development globally. Previously, he was Vice President for Accreditation and Recognition Operations at the National Committee for Quality Assurance (NCQA) where he was responsible for the delivery of NCQA’s nine accreditation and certification programs and three physician recognition programs. Earlier in his career he was the Director of the Healthcare Advisory Public Sector Practice at PricewaterhouseCoopers (PwC). At PwC, his primary focus was improving clinical and business operations for key healthcare clients.
James earned a BS degree in Pharmacy from the University of Connecticut School of Pharmacy and a MS degree in Management from Indiana Wesleyan University. He serves on the Deans Advisory Board at the UCONN School of Pharmacy and is a Fellow of the American College of Healthcare Executives.