David Silverman Email & Phone Number

London, Gb

London, Gb

Welwyn Garden City

• Current Global Development Lead for new molecular entity for treatment of retinal disease.• Late stage clinical development expertise in retinal diseases. • Responsibilities include clinical development strategy, design of clinical development plan, clinical protocol authoring, and ensuring effective and efficient execution of late stage clinical trials. • Previous (2019-2022) Clinical Science Team Lead for Vabysmo, with responsibility for design, execution, analysis of clinical… Show more • Current Global Development Lead for new molecular entity for treatment of retinal disease.• Late stage clinical development expertise in retinal diseases. • Responsibilities include clinical development strategy, design of clinical development plan, clinical protocol authoring, and ensuring effective and efficient execution of late stage clinical trials. • Previous (2019-2022) Clinical Science Team Lead for Vabysmo, with responsibility for design, execution, analysis of clinical trials, and US, EU and global filings and label negotiations.• Health Authority interaction strategy planning, and leading Health Authority interactions (FDA, CHMP, etc).• Participation in global development teams, with provision of clinical science support to other relevant sub-teams, in particular for patient-centred outcome, regulatory, medical affairs, and international payer strategies.• Medical monitor for global Phase 3 trials. • Planning and execution of international KOL advisory boards and investigator meetings. • Contribution to strategic planning and implementation of global pricing and market access plans, including payer evidence generation, and validation of assumptions through scientific advice with payers.• Line manager for UK/Switzerland late stage ophthalmology clinical development team, with previous responsibility for China team also. Experience in recruiting and retaining physicians and scientists globally. Show less

Welwyn Garden City, Uk

Welwyn Garden City, Uk

• Experienced clinical assessor in the licensing division at the MHRA, with proficiency in assessment of Marketing Authorisation Applications of biologic and small molecule products across multiple therapeutic areas, in particular ophthalmology, gastroenterology, haematology and inflammatory disease. • Involvement in centralised, decentralised and National licensing applications. • Responsibilities also included provision of scientific and regulatory advice to companies on clinical… Show more • Experienced clinical assessor in the licensing division at the MHRA, with proficiency in assessment of Marketing Authorisation Applications of biologic and small molecule products across multiple therapeutic areas, in particular ophthalmology, gastroenterology, haematology and inflammatory disease. • Involvement in centralised, decentralised and National licensing applications. • Responsibilities also included provision of scientific and regulatory advice to companies on clinical development strategy reflecting contemporary regulatory guidance and relevant regulatory decisions. • UK member of the Scientific Advice Working Party (SAWP) at the European Medicines Agency (provision of scientific advice and protocol assistance for medicinal products on behalf of the Committee for Medicinal Products for Human Use (CHMP)). Show less

• Co-investigator for phase I/II studies with a global contract research organisation across a range of therapeutic areas. • Responsibilities included protocol design, writing informed consent documentation, dosing, safety assessments, review of clinical report files, and client meetings (study initiation meetings, dose escalation decisions, safety discussions).

Mrcophth

Msc In Economic Evaluation For Health Technology Assessment, Health Economics

Medicine (Mbchb)

Diploma In Pharmaceutical Medicine & Fellowship Of The Faculty Of Pharmaceutical Medicine

Pharmacology (Bsc)

Certificate In Leadership Principles

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