KEY PRESENTATIONS ANNOUNCED FOR LANDMARK FUTURE OF BIOSIMILARS EVENT - Conference to Incorporate Multi-Stakeholder Perspectives, including Focus on Patient Access by Arthritis Foundation
Boston, MA, April 28, 2011—PAREXEL International Corporation (NASDAQ: PRXL), a leading global biopharmaceutical services provider, which serves on the Program Committee for “The Future of Biosimilars in the U.S.” conference, today announced distinguishing features of this event, which the Drug Information Association (DIA) will host in cooperation with the Food and Drug Law Institute (FDLI). The landmark event, to be held May 4 - 5, 2011 in Bethesda, Maryland, will feature perspectives of the U.S. Food and Drug Administration (FDA), as well as industry, lawyers, academics, clinicians, payers and patients on the introduction of biosimilars to the U.S.
This first truly comprehensive conference on biosimilars since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010 will focus on the critical challenges and current ideas of stakeholders impacted by the development and availability of biological medicines in the U.S. Featured topics will include industry challenges in developing biosimilars and the need for biosimilars, as well as associated economic and legal considerations. The conference program will feature the following key presentations representing patient, regulatory, and industry viewpoints during the first day of the conference, on Wednesday, May 4:
- Patience Haydock White, M.D., MA, Chief Public Health Officer of the Arthritis Foundation, the nation’s largest national, nonprofit health agency working on behalf of 43 million Americans with doctor diagnosed arthritis and related diseases, will present “Patient Access to High Quality, Safe and Effective Biological Medicines” at 8:25 a.m.
- Steven Kozlowski, M.D., Director, Office of Biotechnology Products, CDER, FDA, will present “FDA: The Agency’s Approach to Biosimilars” at 10:00 a.m.
- Sandra J.P. Dennis, J.D., Deputy General Counsel of the Biotechnology Industry Organization (BIO), and John Coster, Ph.D., RPh, Senior Vice President for Government Affairs, Generic Pharmaceutical Association, will present “Industry Challenges in Developing Biosimilar Medicinal Products” at 11:15 a.m.
Susan C. Winckler, President and CEO of FDLI, and Paul Pomerantz, Worldwide Executive Director of DIA, will provide the welcome and opening remarks for the event. Program Co-Chair Philip L. Huang, MBA, M.D., Vice President, Vaccine Strategy & Innovation, Merck & Co., Inc., will present the first session of the conference entitled “Overview of Biosimilars: Patient Access, Challenges, Statutory Framework Enacted as Part of Affordable Care Act.”
According to Alberto Grignolo, Ph.D., Corporate Vice President, Global Strategy and Services, PAREXEL Consulting, and a member of the Program Committee, “Participants will learn about all the significant issues, opportunities and challenges associated with biosimilars development and commercialization in the U.S., including the perspective of the FDA. These learnings will provide the foundation for strategic decisions that companies will need to make, and will no doubt lead to further debates, initiatives, and events as this field continues to evolve.”
To access a podcast with a preview of the key issues that will be discussed at the event, including the viewpoints of Program Co-Chair Cecil J. Nick, B.Sc. (Hons), FTOPRA, Vice President, Technical, PAREXEL Consulting, visit: http://www.fdli.org/podcast/FDLI_Biosimilars_Podcast.mp3. More in-depth information about the conference can be found in the article “DIA Teams Up with FDLI for Groundbreaking Biosimilars Conference” published in the DIA Global Forum magazine. To register for “The Future of Biosimilars in the U.S.: Legal, Regulatory, Scientific, Clinical and Payer Issues,” visit: www.diahome.org.
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About PAREXEL International
PAREXEL International Corporation is a leading global bio/pharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to the worldwide pharmaceutical, biotechnology and medical device industries. Committed to providing solutions that expedite time-to-market and peak-market penetration, PAREXEL has developed significant expertise across the development and commercialization continuum, from drug development and regulatory consulting to clinical pharmacology, clinical trials management, medical education and reimbursement. Perceptive Informatics, Inc., a subsidiary of PAREXEL, provides advanced technology solutions, including medical imaging, to facilitate the clinical development process. Headquartered near Boston, Massachusetts, PAREXEL operates in 71 locations throughout 52 countries around the world, and has approximately 10,380 employees. For more information about PAREXEL International visit www.PAREXEL.com.
This release contains “forward-looking” statements regarding future results and events, including, without limitation, statements regarding expected financial results, future growth and customer demand. For this purpose, any statements contained herein that are not statements of historical fact may be deemed forward-looking statements. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “intends,” “appears,” “estimates,” “projects,” “will,” “would,” “could,” “targets,” and similar expressions are also intended to identify forward-looking statements. The forward-looking statements in this release involve a number of risks and uncertainties. The Company’s actual future results may differ significantly from the results discussed in the forward-looking statements contained in this release. Important factors that might cause such a difference include, but are not limited to, risks associated with: actual operating performance; actual expense savings and other operating improvements resulting from recent and anticipated restructurings, the loss, modification, or delay of contracts which would, among other things, adversely impact the Company’s recognition of revenue included in backlog; the Company’s dependence on certain industries and clients; the Company’s ability to win new business, manage growth and costs, and attract and retain employees; the Company’s ability to complete additional acquisitions and to integrate newly acquired businesses or enter into new lines of business; the impact on the Company’s business of government regulation of the drug, medical device and biotechnology industry; consolidation within the pharmaceutical industry and competition within the biopharmaceutical services industry; the potential for significant liability to clients and third parties; the potential adverse impact of health care reform; and the effects of exchange rate fluctuations and other international economic, political, and other risks. Such factors and others are discussed more fully in the section entitled “Risk Factors” of the Company’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2010 as filed with the SEC on February 9, 2011, which “Risk Factors” discussion is incorporated by reference in this press release. The Company specifically disclaims any obligation to update these forward-looking statements in the future. These forward-looking statements should not be relied upon as representing the Company’s estimates or views as of any date subsequent to the date of this press release.
PAREXEL is a registered trademark of PAREXEL International Corporation, and Perceptive Informatics is a trademark of Perceptive Informatics, Inc. All other names or marks may be registered trademarks or trademarks of PAREXEL International Corporation, Perceptive Informatics, Inc. or their respective owners and are hereby acknowledged.