Approaches to Developing an AI-based Pharmacovigilance System – Automation is Changing the Way Pharma Manages Pharmacovigilance

Dinesh Kasthuril, Head, Global Client Relations & Project Management, Labcorp Patient Safety Solutions

Dinesh is a seasoned leader with more than 20 years of experience in pharmacovigilance across the Americas, EU and APAC. He is currently Global Head, Client Relations and Project Management, Patient Safety at Labcorp Drug Development. In his current role he leads a team of project managers that provide oversight to end to end safety services across 150+ pharmaceutical and biotech companies across clinical development and post-approval.

Shalin Patel, Sr. Director, Safety Evaluation and Reporting, Johnson & Johnson

Shalin has more than 20 years of experience in pharmacovigilance (PV) and is currently the Senior Director, Global Head of Safety Evaluation and Reporting at Johnson and Johnson Consumer Health based in the UK where he is responsible for providing strategic management and defining the PV operational framework for case management, aggregate reporting and PV reporting from commercial programs. Shalin has held various other roles within PV both in Janssen and the J&J Consumer companies including two international assignments in China and India leading the local safety office and providing vendor oversight respectively.

Marina Suvakov, Global Head, Product Safety Surveillance, Philip Morris International

Marina Suvakov is a pharmacovigilance and safety professional with over 15 years of experience in the pharmaceutical industry. Marina joined Philip Morris in May 2021 as the Global Head, Product Safety Surveillance for their smoke-free products as the company builds its smoke-free future. She holds a bachelor’s in medical biochemistry and a masters in pharmaceutical sciences from Greenwich University.

Marina is experienced in safety risk management and mitigation; she has extensive experience in setting up safety/PV systems and managing MAHs/NDAs globally. She has worked in safety compliance, regulatory intelligence and signal detection, and has experience setting up data platforms for analysis. During her time with PMI, Marina has implemented an automated safety database with artificial intelligence and machine learning capabilities, one of the first companies in the world to go live with a fully automated database.

Michael Murphy, Executive Director, Head of Pharmacovigilance Operations, Amgen

Michael Murphy leads the PV Operations team within Global Patient Safety at Amgen, a position he has held since April 2019.  Responsibilities include overseeing and managing teams accountable for adverse event case processing and medical review, periodic reporting, safety reporting obligations for clinical, commercial/marketing programs and oversight of the safety technologies. Michael has over 22 years of experience within the pharmaceutical industry, focused within pharmacovigilance, with expertise in change management, process excellence and safety systems.