Abhay Phansalkar, Head Clinical Trials, Cipla,

Abhay Phansalkar

Head Clinical Trials

Cipla

Cipla House, Peninsula Business Park, Ganpatrao Kadam Marg, Lower Parel, Mumbai-400013

http://www.cipla.com/en/

Medical Physician with approx. 10 years of drug development experience in biopharmaceutical industry in Clinical Development, Medical Affairs, Pharmacovigilance and Medical Writing functions.

Worked across therapeutic areas including Respiratory Medicine, HIV, Cardio-metabolic, Gastroenterology, Nephrology, Oncology, Immunology, Transplantation and Infectious diseases, Vaccines, Hematology, Critical Care, Orthopedics and Pain Management, and Gynaecology.

Role in Clinical Development & Pharmacovigilance

· Currently, responsible for the design, conduct and publication of clinical trials in India and Emerging Markets.

· Clinical strategy for Portfolio planning and development.

· Protocol and clinical trial documents (safety narratives, CRF, IB, Safety Management Plan) development of Biosimilars in collaboration with various stakeholders.

· Medical review of Statistical Analysis Plan & Trial Data Analysis and development of Clinical Study Report.

· Medical Safety Monitoring of the clinical trials including regulatory safety reporting, medical coding using MeDRA & liaison with Data Safety Monitoring Board (DSMBs) for medical safety reviews

· Medical Writing and review of Development Safety Update Reports (DSUR), Risk Management Plans (RMPs), and Clinical trial report database (CTRDs), and Annual Safety Update Reports (ASRs).

· Presentation of Study results to Regulatory (DCGI) expert committees for marketing authorization approvals and in medical conferences.

· Vendor Management & Budget Management of Phase 3 & 4 Studies

Role in Medical Affairs

· Product Portfolio Development: Collaboration with various stakeholders for product identification, review & finalization.

· Development of Medical Strategy for the brand life cycle management

· Identification & Engagement of Key Opinion Leaders & Medical Associations in India

· Regional Medical Affairs Team management