ORPHA Strategy Consulting, CEO
David Schwicker has biopharmaceutical consulting expertisespanning more than 25 years. Founder of ORPHA Strategy Consulting, and formerVice President with PAREXEL International in the United States, David is asought-after expert for accelerating marketing authorisation, time to launch,early patient and market access in the hyper-dynamic environment of rareconditions, orphan and advanced therapy medicinal products.
David’s extensive therapeutic area experience includes acutemyelogenous leukemia (AML), multiple myeloma (MM), cutaneous t-cell lymphoma(CTCL), non-small-cell lung cancer (NSCLC), breast cancer, neuroendocrinetumors, 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 hasdeveloped a unique understanding of accelerating marketing authorization andmarket access for orphan drugs. This involves indication prioritization,evidence generation planning, patient engagement and PROs, orphan designation,compassionate use programs, product differentiation and early valuedemonstration with fewer data. A crucial component of early access strategy isthe application of innovative pathways that leverage the use of real-worldevidence (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 isan accomplished trainer in rare diseases, orphan, gene and cell therapymedicinal products, and leads training courses as well as customized in-house training workshops.