DAVID SCHWICKER, MASTER OF ARTS (MA), ECONOMICS AND BUSINESS ADMINISTRATION
ORPHA Strategy Consulting, an independent consultancy based in Basle, Switzerland, is focussed on two specialties:
Early and accelerated marketing authorization and market access for orphan, specialty and advanced medicines. We provide insights and support to our clients for the development of early market access strategies, the feasibility and benefits of orphan designation,compassionate use programs, and evidence generation strategies for “fast to market” benefit/risk and value demonstration, including early global value dossiers (eGVD).
Real-World Patient-Centered Evidence is increasingly crucial in rare diseases, where the collection of data via traditional routes is difficult. We propose pre-planning real-world research as an integral component of an early access “fast to market” strategy in a life-cycle approach. We support our clients in the strategic evidence generation planning and design of real-world and patient-centric research from very early in development to post-authorisation, with a focus on innovative, adaptive development pathways that emphasise the use of real-world evidence.
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 serves as a Board Member on BioPharma Global and provides Technical Advice and Executive Oversight, and in addition she serves as a Key Regulatory Advisor on BioPharma Global client projects. 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.
CLINICAL NETWORK SERVICES
Clinical Network Services (CNS) is an integrated service group focused on product development headquartered in Australia with offices in New Zealand, the UK and the USA, who create value for small-medium sized biotechnology companies by progressing early stage products through phase 1 & 2 clinical trials or the marketplace sooner. CNS offers a unique service where it integrates BioDesk, an intelligent global product development and regulatory affairs consultancy, with our committed, highly experienced Australian/New Zealand clinical services and biometrics team. CNS’ regional clinical advantage is driven by the extremely pragmatic regulatory environment in Australia and New Zealand that makes it possible for clients to enter the clinic quickly, without prior regulatory approval.
CNS offers a uniquely differentiated, customer-orientated, suite of services to clients which enables CNS to guide products efficiently through critical post-discovery development and into initial human trials. Throughout, CNS takes a global development/ regulatory strategic approach to ensure that value is added at every stage of the product development life cycle.
Further information about CNS and its intelligent development services can be found at www.clinical.net.au.