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Wednesday, June 22 • 4:15pm - 5:15pm
#375: The Global Impact of ORBIS: Case Studies and Perspectives

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-22-643-L04-P ; CME 1.00; RN 1.00

The session will discuss the experiences from the ORBIS partners along with the FDA and Industry. Case studies will illustrate the practical experience.

Learning Objectives

Evaluate the increasing international collaboration between regulators to register new oncology indications as fast as possible to enable international patient access; Identify factors and apply lessons learned that contribute to the successful use of ORBIS for the international regulatory strategy.


Angelika Joos, MPharm


FDA Update on ORBIS Program
R. Angelo De Claro, MD

Swissmedic Experience from ORBIS Participation
Claus Bolte, DrMed, MBA

Project Orbis Case Study: A Global Collaborative Review of First Therapy for KRAS G12C-mutated Non-Small Cell Lung Cancer
Monica Batra

International Impact of ORBIS
Sabrina Girty, JD

MHRA Update on ORBIS
Krishna Prasad, DrMed, MD, MRCP, FRCP

avatar for Monica Batra

Monica Batra

Executive Director, Global Regulatory Affairs - Oncology, Amgen, United States
Monica Batra is Executive Director, Global Regulatory Therapeutic Area Head - Oncology at Amgen Inc and manages a team of global regulatory strategy professionals across solid tumor and hematology programs. She provides oversight of global regulatory decisions and advises in the development... Read More →
avatar for Claus Bolte

Claus Bolte

Head of Authorisation, Swissmedic, Switzerland
Claus Bolte currently serves as the Sector Head for “Marketing Authorization” and Management Board member at Swissmedic, the independent Swiss life sciences regulator. Claus joined Swissmedic 2012 to initially head their Clinical Review division. Prior to that, Claus had roles... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director, Global Clinical Sciences, OCE; Div Dir, DHM, OOD, CDER, FDA, United States
Dr. de Claro is currently the Associate Director (Acting) for Global Clinical Sciences with US FDA Oncology Center of Excellence (OCE). In this role, he leads OCE efforts to advance cancer drug development and regulatory science across the globe, including direction of Project Orbis... Read More →
avatar for Sabrina Girty

Sabrina Girty

Executive Director, Global Regulatory Affairs, Oncology, Merck & Co., Inc., United States
Sabrina Girty is an Executive Director in Global Regulatory Affairs, Oncology at Merck & Co. Inc and leads a team of global regulatory strategy professionals across the esophageal, gastric, colorectal and head & neck cancer programs. At Merck, she secured global marketing authorizations... Read More →
avatar for Krishna Prasad

Krishna Prasad

Deputy Director, Innovative Medicines, HQA/Licensing, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Krishna Prasad is the Deputy Director of Innovative Medicines, HQA at UK Regulatory Agency with management responsibility across multiple therapy areas Dr Prasad’s additional roles include Cardiology consultancy at St. Thomas’ hospital, London. Dr Prasad qualified in 1987 obtaining... Read More →

Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 187 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session