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Monday, June 27 • 10:45am - 12:00pm
#133: Take Advantage of Global Expedited Pathways: Breakthrough, Sakigake, PRIME!

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Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-543-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Breakthrough Designation (US), PRIME (Europe), and Sakigake (Japan) aim to reduce overall drug development times for certain products. This session shows you how to take advantage of these and other global expedited development programs.

Learning Objectives

Compare and contrast global expedited development pathways; Discuss ways to adapt global development programs to take advantage of all expedited pathways.


Khyati Roberts, RPh


The New Japanese “Sakigake” Strategy for Accelerated Development and Approval: Status, Procedure, and Prospects for Industry
Alberto Grignolo, PhD

Strategies for Using the New European PRIME Pathway
Sharon N. Olmstead

avatar for Khyati Roberts

Khyati Roberts

Senior Director, Regulatory Policy and Intelligence, AbbVie Inc.
Khyati is currently Senior Director at AbbVie where she coordinates regulatory policy and intelligence activities for the US regulatory environment. She also oversees regulatory policy initiatives in Japan, Asia-Pacific, China, Australia, and Latin America. Khyati also worked at the FDA for 14 years developing and implementing regulatory policies and programs. She has over 24 years of regulatory experience. Khyati attended Rutgers, College of... Read More →

avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, PAREXEL International
Alberto Grignolo, PhD is Corporate VP, Global Strategy at PAREXEL Consulting, where he has worked for 24 years in various regulatory, drug development and management capacities. Most recently he relocated to PAREXEL's Tokyo Office for two years, establishing a new consulting unit there. He is currently engaged in initiatives that address clients' most significant opportunities and challenges in product development and commercialization. He is the... Read More →
avatar for Sharon Olmstead

Sharon Olmstead

Global Head, Development and Regulatory Policy, Novartis Pharmaceuticals Corporation
Sharon Olmstead is the Global Head of Development & Regulatory Policy at Novartis. She first joined Novartis in 1997, in their FDA Liaison Office. From 2002 until returning to Novartis in 2011, she held leadership positions at Merck, Schering-Plough, and Pharmacia. She built a foundation for her future roles working at the FDA for six years in science policy, consumer affairs, and consumer safety. Sharon holds a bachelor’s degree in biology... Read More →

Monday June 27, 2016 10:45am - 12:00pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA