GLOBAL ggff forumAPRIL 2013 VOL 5 • ISSUE 2 INFORM ADVISE REACH EDUCATE IN THIS ISSUE DIA 2013 49TH ANNUAL MEETING PREVIEW: “ADVANCING ALZHEIMER’S INNOVATION: A CALL TO ACTION” Chaired by Meryl Comer President, Geoffrey Beene Foundation Alzheimer’s Initiative AIDS at 30: Patient Advocacy Makes an Impact Your FDA submission documents are serious. So are their translations. When translating documents for FDA submission such as dossiers, CRFs, labeling, adverse event reports, and product information, Corporate Translations understands the critical need for accuracy Our rigorous translation process includes multiple quality inspections, guaranteeing the most accurate translations quickly and cost-effectively. We stand by the quality of our translations by providing a certification of accuracy with each document. Partnering with Corporate Translations allows you to prepare your submissions with confidence. 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LOVE INFORM ADVISE REACH EDUCATE When translating documents for FDA submission such as dossiers, CRFs, 10 54 64 108 labeling, adverse event reports, and product information, Corporate Peter Staley UNLEASHING THE POWER OF P HOTO: © Acts Up HOW TO SURVIVE A PLAGUE W illiam Lucas W Translations understands the critical need for accuracy Our rigorous alker translation process includes multiple quality inspections, guaranteeing Open Forum 6 AIDS Advocacy 46 the most accurate translations quickly and cost-effectively. We stand by Andrzej Czarnecki Richard M. Klein the quality of our translations by providing a certification of accuracy President’s Message 8 with each document. Partnering with Corporate Translations allows you Ling Su Inaugural President’s Award Presented to Center for AIDS to prepare your submissions with confidence. That’s why Corporate INFORM 10 Program of Research in South Translations is the preferred supplier of ISO 9001 translation and Africa (CAPRISA) 50 Of DNA, HIV, Advocacy, Humanity, linguistic validation solutions to the world’s leading life science companies. Therapeutic Innovation and Regulatory Science 11 PROFILE Nikos Dedes 52 Stephen P. Spielberg ADVISE 54 3 www.corptransinc.com Exploring Impact of ‘US v. Caronia’ 55 1-855-727-6003 ACT UP Crashes the Gates 13 Jim Eigo Imaging Biomarkers: A Potential Tool for Cost Savings in Drug How Civil Society Helped Shape Development 57 the Response To HIV/AIDS: The Sheela Agarwal French Experience 22 Jean-François Delfraissy and Anna Laura Ross What Lies Ahead for 2013? 60 REACH 64 Interaction Between the European Medicines Agency and HIV Advocates/ CHINA 65 Patients Over the Years 25 5th DIA China Annual Meeting 65 Isabelle Moulon Understanding and Implementing Best Ethics Practices in Clinical Partnering with Community - Research 67 Translation | Back Translation | Desktop Publishing| Independent Review | Editing | Proofreading Could the Past Hold More Promise than the Future? 31 EUROPE 69 Lew Sibert Report on 25th Annual EuroMeeting, 4-6 March 2013, Amsterdam 69 How Cambodian Sex Workers Helped Change the Rules for Community 2013 EuroMeeting Student Engagement 41 Poster Winners 73 Meg Egan Auderset CORPORATE TRANSLATIONS Driven by Definition ® Process Cyan PMS 2935 PMS 296 gf GLOBAL FORUM The Global Forum (ISSN: 1944-1991) is a publication of the Drug Information Association. Editorial Office: Drug Information Association (DIA), 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA; phone - 215.442.6100; PUBLISHING fax: 215.442.6199. INFORMATION Copyright © 2012, Drug Information Association. The Global Forum (ISSN: 1944-1991) is published six times a year, in February, April, June, August, October, and December. Andrzej Czarnecki, MD, PhD, DSc, Periodical postage paid at Horsham, Editor-in-Chief Pennsylvania, and additional mailing offices. Global Forum Staff Thirteen dollars of each member’s annual Judy Connors, Associate Director, membership fee is for a year’s subscription. Editorial Services Prices include postage and are subject to Chris Slawecki, Senior Copywriter change without notice. Notify DIA eight weeks Jenny Kimbel, Senior Editorial Assistant in advance of address change with a copy Joe Krasowski, Sr. Digital Content Strategist of the mailing label. Back issues of most previously published issues are available from DIA. Mission The Global Forum provides a multidisciplinary, PUBLICATIONS MAIL neutral forum for communicating information AGREEMENT NO. 41103506 related to drug development and lifecycle 4 RETURN UNDELIVERABLE CANADIAN management on a global basis. The Global ADDRESSES TO CIRCULATION DEPARTMENT, Forum disseminates content that is relevant to PO BOX 1051, FORT ERIE, ONTARIO L2A 6C7 members’ professional experiences, including Postmaster: Send changes of address to international industry and regulatory updates Global Forum, 800 Enterprise Road, Suite 200, VOL 5 ISSUE 2 and news of the association and its programs. Horsham, PA 19044-3595, USA. The magazine is circulated six times a year as a benefit of DIA membership. Design: Imagevolution - 610.867.4460 Publishing and Subscription: DIA is a neutral organization that does not Drug Information Association (DIA), advocate for or against any issue. The views 800 Enterprise Road expressed by the individual authors or Suite 200, Horsham, PA 19044-3595, USA. interviewees in the Global Forum are theirs and do not necessarily represent the views of the Contact Information Drug Information Association. for Advertising: Mike Boucher Influence Media Director, Client Publishing Services The DIA Global Forum 267-419-8735 CONTENTS INDIA 76 Gujarat FDCA Signs MOU with DIA 76 Kaushik Desai The Core Competencies of a Medical Writer: Should a Medical Writer be Medically Qualified? 76 Dr. David Clemow Helle Gawrylewski Dr. Nimita Limaye LATIN AMERICA 81 Questions and Answers with Dr. Gustavo Kesselring 81 JAPAN 83 Clinical Data Management Workshop in Japan 83 Kenji Nagaya 7th Annual Asian New Drug Development Conference 85 Tetsuomi Takano EDUCATE 108 NORTH AMERICA 87 EPSA Intern Reflects on DIA 2013 EuroMeeting 109 5 DIA 2013: Alzheimer’s Call to Action 87 Milos Stojkovic Meryl Comer Regulators Meeting the Regulated Engaging the Patient: Birth of the at DIA 2013 92 DIA Patient Engagement Community 111 Marketing Pharmaceuticals 2013 Philanthropy Grant Workshop 95 Recipients Report 114 FDASIA, PDUFA & DIA 96 DIA Celebrates National Volunteer Appreciation Week 116 Exploring Social Me-DIA 98 Association NEWS Courtney Ingram GOVERNANCE CORNER 118 Board Approves Bylaws Amendments at March Meeting 118 Structured Approach to Benefit-Risk 101 ASIA PACIFIC 105 DIA, IFPMA & HSA Singapore Present Asia Regulatory Conference 2013 105 gf GLOBAL FORUM OPEN FORUM Recognizing Patients’ Role and Needs and Financing of Innovation It has been a year since we patients in all activities related published a first interview with a to drug development and patient representative Mary Baker, advice on new pharmaceuticals. the President of the European Regulatory bodies have over time Brain Council (Global Forum 2012, involved representatives from 4, 2, 104). She drew the attention several patients’ organisations in of everyone in the industry, discussions and their decision- 6 regulatory bodies and academia making process, which is to the importance of patients, presented in the Special Section their thinking, involvement and in more detail. Broader patient different perceptions that are not involvement has expanded our frequently, if at all thought about. knowledge and understanding VOL 5 ISSUE 2 of the differences in patients’ Following on the need to improve perceptions of acceptable understanding of patients, in this treatments, risk and benefits. It ANDRZEJ issue the Special Topic section has also provided with different has been edited by Nikos Dedes, directions in drug development CZARNECKI HIV advocate and a member and has enriched it with many of EATG and the Management views of patients, which frequently Board of EMA. Several articles in the past came as a surprise. cover a range of topics on HIV issues presented by patients Having gained different and by regulators on patients’ experiences from patients with involvement in improving research respect to drug development, and regulatory processes. I their needs and thoughts about would like to thank Nikos for this treatment (acceptable risks, important contribution to this convenience of drug use), it has publication. become even clearer that we need to strive to provide innovation for Ten years ago during the them overcoming all difficulties EuroMeeting that I was chairing in research and its financing, but we included a ‘patients’ theme”, also make them available through organised by Yann Le Cam, approval by the HTA assessment a recipient of this year’s ‘DIA in many parts of the world. President’s Award for Outstanding Achievements in World Health’. The cost of innovation limits Ever since, the DIA has had a their number, and the number of much broader involvement of enterprises that can financially support