Tim Shaw Email & Phone Number

London, United Kingdom

Global Medical Affairs lead for rheumatoid arthritis

Independent Pharmaceutical Consultant providing support to Clinical development and Medical Affairs. Currently assisting clients with lead indication identification and early clinical development scenarios in preparation for venture capital investment, as well as study design and protocol development. Areas in which I can offer support include:Strategic clinical development plansStudy design and protocol writing,Clinical study report and clinical regulatory documentationPublication planning and medical writingPhase IV and real-world data generationValue and reimbursement dossiersStrategic Medical Affairs Plans.

Within inflammation/immunology, responsible for all post approval data generation activities for apremilast (Otezla) in psoriatic arthritis and psoriasis, including Phase IV strategy and design, real-world data collection via registries, non-interventional, observational studies and investigator initiated research. European Medical Affairs team responsible for the strategic medical communication, maximising the value proposition. Medical lead for all activities with NICE, SMC and NCPE.

Responsible for all local Medical Affairs activities for inflammation/immunology within UK/IRE, Nordics and Netherlands. Key activities included establishing Celgene as a new partner within immune-inflammatory disease area, UK strategic and tactical plan, advisory boards, KOL relationship management, and local congress exhibition presence (including scientific symposia and abstracts). Primary Celgene contact for all UK clinical research with apremilast (PhIII in psoriatic arthritis and psoriasis).

Accountable for medical science team responsible for all clinical activities for rituximab (MabThera®) in rheumatoid arthritis, including clinical development plan (Phase II-IV), study protocols, medical data review, analysis plans, study reports and regulatory clinical documents (including briefing packages, integrated summaries, clinical overview, label language).Clinical Team Leader and Submission team leader (cross-functional teams).Other responsibilities included, clinical representative to full Life Cycle Team for rituximab in autoimmune diseases, advisory boards, interactions with Health Authorities, clinical lead for publication team and clinical consultation for early development teams.

From 1988 - 1994 held variety of positions within clinical development including Clinical Operations (Clinical Reseach Associate, Clinical Project Co-ordinator) and early clinical development (Clinical Pharmacologist responsible for Phase I studies including entry in to humans).