ORPHA Strategy Consulting, CEO
David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. Founder of ORPHA Strategy Consulting and former Vice President with PAREXEL International in the United States. David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access in the hyper-dynamic environment of rare conditions, orphan and advanced therapy medicinal products.
David’s extensive therapeutic area experience includes acute myelogenous leukemia (AML), multiple myeloma (MM), cutaneous t-cell lymphoma(CTCL), non-small-cell lung cancer (NSCLC), breast cancer, neuroendocrine tumors, 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), Leber’s congenital amaurosis (LCA), retinitis pigmentosa (RP), USHER Syndrome, Narcolepsy, and Friedrich’s ataxia. David is currently working in rare Inherited Retinal Dystrophies (IRD), oncology/hematology, metabolic, CNS, and dermatological indications. David has developed a unique understanding of accelerating marketing authorization and market access for orphan drugs. This involves indication prioritization, evidence generation planning, 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 pathways that leverage the use of real-world evidence (RWE).
David is the author and co-author of numerous peer-reviewed publications and speaker at international meetings (ISPOR, RAPS EU Congress, Orphan Drugs Development and Commercialisation, Expanded Access Summit). He is an accomplished trainer in rare diseases, orphan, gene and cell therapy medicinal products, and leads training courses as well as customized in-house training workshops.