David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. He is the founder of ORPHA Strategy Consulting, based in Basle, Switzerland, and focused on the timely patient access to orphan and advanced therapy medicinal products.
This dedication to client consulting has enabled David to develop a capacity for rapid complex problem solving allowing him to provide creative and analytically rigorous advice on strategic challenges and to devise effective solutions to drive his clients' programs forward. David has longstanding scientific experience and expert contacts in rare diseases, has authored and co- authored peer-reviewed publications and is a speaker at international meetings. He is an accomplished trainer in rare diseases, orphan, gene and cell therapy medicinal products, and leads Masterclasses as well as customised in-house training workshops.
As Vice President with PAREXEL International in the US, David was responsible for registries, outcomes research, market access, and expanded access programs. Since returning to Europe, David has designed and implemented real-world studies including more than 200,000 patients.
From 2010, David's capabilities have expanded to rare diseases, including acute myelogenous leukaemia (AML), multiple myeloma (MM), neuroendocrine tumours, pulmonary arterial hypertension (PAH), Niemann Pick disease, acromegaly, graft versus host disease (GvHD), primary sclerosing cholangitis (PSC), Mucopolysaccharidosis (MPS), Myasthenia Gravis (MG), Graves Orbitopathy (GO), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Antibody- Mediated Organ Rejection (AMR), Narcolepsy, and Friedrich’s ataxia. David is currently working in rare autoantibody-mediated diseases, oncology/haematology, metabolic, CNS and GI indications.
David has developed a unique understanding of accelerating marketing authorization and market access in the hyper-dynamic European environment. Based on this, David supports clients in the attainment of “fast to market" objectives by integrating rare disease development, regulatory and market access strategies. This involves indication prioritisation, evidence generation planning (RCTs and RWE), patient engagement and PROs, orphan designation, compassionate use programs, product differentiation, and early value demonstration with fewer data. A crucial component of early access strategy is the application of innovative regulatory, health technology assessment, pricing and reimbursement pathways that leverage the use of real-world evidence (RWE).