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DIA 2010

HigHligHts & Financial RepoRt

JanuaRy 1 DecembeR 31, 2010

We all have much to learn from each other. When the best minds work together in these diverse but independent DIA forums, innovation and collaboration happen and so do better health outcomes.
Dr. Richard O. Day
pResiDent, Dia boaRD oF DiRectoRs 2010 2011

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Strategic Update Association Governance and Support Volunteer Service & Community Awards Drug Information Journal Awards Member & Volunteer Services DIA In Canada DIA In China DIA In Europe 22nd Annual EuroMeeting European Educational Offerings DIA In India DIA In Japan

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DIA In Latin America DIA In North America 46th DIA Annual Meeting Interactive Regulatory Sessions Executive Policy Forum Multitrack & Megatrack Plenaries North American Educational Offerings DIA in Other Regions DIA Online Program Partners Philanthropy Report Financial Overview DIA Offices and Locations

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Dia 2010 annual Report

Market Development

Our new strategic plan implements a two-pronged approach to market development. Geographically, we look to reinforce our activities in our most mature regions of Europe, Japan, and North America; and to leverage our initial success in emerging regions such as China and India into other regions such as Latin America, where we already offer annual clinical and regulatory congresses; the Middle East, where we will soon return to once again present the regions most influential and respected regulatory conference; and Eastern as well as Southern Europe, where weve already begun to deliver training in EudraVigilance, the network for electronic safety reporting in the European Economic Area. We also look forward to constructing fresh inroads to new markets by developing content in three key areas. The first is to expand from DIAs traditional industry base in pharmaceutical and biopharmaceutical products into medical devices; although DIA has offered limited programming in the area of medical devices in the past, we look to develop robust content in the future. The second area is comparative effectiveness research and health technology assessment, the interface between science, outcomes research, and economics. As market access and pricing and reimbursement continue to be increasingly decisive factors in addition to the drug approval process, DIA will look to incorporate these important topics into future programming and training. Newer and stronger engagement of the patients voice in DIA is the third area. DIAs constituency has traditionally been industry, regulators, and academia. DIA now looks to more strongly join the voice of the patient with these constituents to enrich the dialogue facilitated by DIA.

DIA Strategic Update:

2011 & BEyOND

Updated extract from Strategic Update: 2011 & Beyond published in the December 2010 Global Forum Written by Yves Juillet, DIA President-Elect and Chair, Strategic Planning Committee; and Paul Pomerantz, DIA Worldwide Executive Director and Co-chair, Strategic Planning Committee.

As Chair and Co-Chair of the Board of Directors Strategic Planning Committee, we are both grateful for this opportunity to share this vision of DIAs future, based on strategic initiatives that were approved by the Board of Directors during our September meeting. Our refined strategic direction constructs three distinct building blocks from our DIA vision The global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide that will serve as the foundation for the future of DIA.

Digital Strategy

Our strategic digitalization initiative will impact just about every component of our organization and business. We envision the transformation of DIA from an association that relies heavily on print materials, in-person meetings, and a fairly basic website, into an association that thoroughly participates in our new digital age. This initiative will include a new enterprise content management system, an enhanced website searching functionality, new micro and regional websites, and the migration of existing content into a new DIA taxonomy that will allow you to customize your online DIA experience by grouping together the content and opportunities in which you are most interested. You have already seen the fruit of another aspect of our drive to digitalize DIA: The December 2010 launch of DIA ConneX, our exclusive online network that will allow members of DIA Special Interest Area Communities to virtually collaborate and network. Your always-needed feedback consistently indicates that professional education and networking are the top values you receive from joining our association. You can create, share, and edit documents, and share calendars and other event information, just like you could in person, through the new DIA ConneX social media platform on our website.
Dia 2010 annual Report

Quality Improvement

Our new strategic plan commits to continually soliciting feedback from our members, volunteers, and other constituents, so you can tell us how were doing. What are we doing well? What can we do better? Becoming a measures-driven organization will help us understand how our members and our marketplace perceive us, and in what areas and topics DIA can provide additional value to our members. We hope to create new transparency between you, our staff, and our Board, that will facilitate continuous evaluation, improvement, and innovation. On behalf of our entire Board of Directors, we thank you for your support and look forward to working with you, and for you, as we advance these new strategic objectives, and our association, into our bright future together. g

Todays changing landscape is forcing all of us to evolve in the way we bring safe and effective health products to market, underscoring the value of our association. But, for me, the dynamics of what we do also reinforces just how integral it is for all of us to work together from our volunteers, to our dedicated staff, to our board members, and most importantly, to all of you.
Dr. Jeff Sherman
pResiDent, Dia boaRD oF DiRectoRs 2009-2010
Dia 2010 annual Report

Management & Staff Support

Throughout 2010, DIAs management team expanded to meet our growing and changing needs: Jane Y. Cai, PhD

Jane works to develop DIAs presence in China, from program and market development through developing future leaders for DIA in China. Prior to DIA, Jane served the pharmaceutical industry for two decades, culminating in service as Senior Director of r&D Operations in the Johnson & Johnson (J&J) Group of Consumer Companies. Jane has received the Tribute to Women and Industry Award and many other industry and civic awards. Carlos Fulcher, MBA

Association Governance & Support

Members of the DIA Board of Directors, officers, and regional advisory council chairpersons are elected by association members and set the overall strategy for DIA activities, provide fiscal oversight for the association, and strengthen DIA programs and services. Election results were published in the August 2010 Global Forum. Please join us in congratulating these newly elected Board members: Yves Juillet, MD

2010-2011 ELECTIONS

Carlos brings to DIA years of experience working with nonprofit organizations, and with leading and changing the ways that organizations leverage technology and resources. he most recently served as Chief Information Officer/Chief Knowledge Officer for the American Society of Plastic Surgeons. Carlos is a member of the American Society of Association Executives and the Society for Information Management. Elizabeth Lincoln

Elizabeth served in management for some of the industrys largest and most prominent career consulting firms before joining DIA. She previously provided employee relations and training, performance management, and hr information system services to clients of the worlds largest consulting company. F. Andrew Pepito

Minnie Baylor-Henry, JD

Steve Caff, MD Per Spindler, DVM, E-MBA, MSc


Andrew brings to DIA decades of experience in corporate accounting and financial reporting, corporate development and restructuring, and business planning and analysis, for both fortune 500 and nonprofit corporations. he most recently served as Vice President for finance & Operation, and directed worldwide operations, for the uS Grains Council. Samy Ponnusamy

Truus Janse-de Hoog, MSc


Prior to joining DIA, Samy worked with association management/customer management software (AMS/ CMS) provider TMA resources for more than a decade, and brings to DIA strong technical experience in networks, databases, AMS, CMS, security, and performance. Ko Sekiguchi, MBA, MCP

Dia 2010 annual Report

Prior to joining DIA, Ko served for a decade as President of Janssen Pharmaceutical K.K., and also led the JapanBased Executive Committee (JBEC) of the Pharmaceutical research & Manufacturers of America (PhrMA) as Chairman. g

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fDA Commissioner Margaret hamburg with DIA Leadership President Jeff Sherman at Annual Meeting EuroMeeting Student Poster Winners Student Poster Winners at Annual Meeting Professor Stuart Walker moderates EuroMeeting Plenary Debate

Dia 2010 annual Report

Volunteer & Community Service Awards

DIAs service awards recognize significant individual or group accomplishments in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products, and/or recognize significant volunteer contribution in the advancement of the DIA mission, vision, and values. Please join us in congratulating our 2010 award winners. Distinguished Career Award

Community Service Award


In recognition of an Outstanding Community which fosters the professional growth of their constituents while advancing the mission of DIA. The Virtual Journal Club (VJC) is a forum that brings Drug Information Journal authors together with their readers, via teleconference, to discuss their specific article. VJC gives selected DIJ authors the opportunity to further describe their work in a virtual club setting.

The Distinguished Career Award recognizes and honors an individual with a distinguished career in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products. The recipient of this award has shown extraordinary service and dedication to the advancement of health care through career contributions to pharmaceutical and related industries that benefit industry, government and the patient. Prof. Per helboe is the senior director of the Licensing Division of the Danish Medicines Agency. Prof. helboe was a member of the DIA European Steering Committee from 1993 to 1998 and has actively served as chair and speaker for numerous DIA educational events. Dr. John C. Alexander retired from Daiichi Sanko Co., where he was President, Daiichi Sankyo Pharma Development and Global head of r&D. he continues to serve as a consultant and Chair of the Board of Daiichi Sankyo, Inc. Dr. Alexander first joined DIA as co-chair of the clinical track for the 1992 Annual Meeting, and served as chairperson for the 1999 Annual Meeting. Dr. Alexander was elected to the Board, and served as President, in 2000.

Excellence in Volunteer Leadership Award

Dr. FErguS SwEEnEY

The Excellence in Volunteer Leadership Award is given to recognize the individual who has demonstrated outstanding effective leadership during their dedicated and extensive voluntary service to DIA. For ten years or more, this individual has made consistent and significant contributions to the Association, not only as a volunteer, but as a volunteer-leader in various DIA roles. Some of these roles should include leadership positions in the following areas: meetings / workshops, communities, special committee positions, advisory council, editorial board, author, or DIA board membership. The breadth and depth of their service as a leader to DIA should have a lasting, positive effect in contributing to the fulfillment of the mission and vision of our association. Dr. fergus Sweeney is head of the Compliance & Inspection Sector at the European Medicines Agency. An active contributor to DIA activities for more than two decades, Dr. Sweeney has presented and chaired sessions on a wide range of GCP related topics and regulatory aspects of clinical trials, and serves as a faculty member and course director for our GCP Audit and Inspection training course.

Dia 2010 annual Report

Dr. John C. Alexander accepts the DIA Distinguished Career Award

Founders Service Award


Outstanding Service Award


The Founders Service Award is named after the group of 30 professionals who founded DIA in 1964 with a fundamental value that the Association is member driven and fueled by the pharmaceutical industrys need for a neutral forum. Having previously received the Outstanding Service Award, this next award level would be given with the highest recognition and appreciation for volunteerism in the DIA organization. It recognizes those individuals who have contributed to the advancement of the mission, vision and values of DIA and fostered its growth and development through their dedicated and sustained volunteerism. Dr. ron fitzmartin has authored over 20 articles for the Drug Information Journal, the Global Forum, and DIA Today, and served as session or program chair for more than 17 DIA meetings. Dr. fitzmartin chaired the Annual Clinical Data Management (CDM) Meeting for eight years and the CDM Special Interest Area Community (SIAC) for three years. he served on the Advisory Council of North America 19972004 and was elected to the Board of Directors. In 2005, he chaired the Annual Meeting; in 2006, Dr. fitzmartin was elected DIA President. he continues to serve on the Drug Information Journal and Global Forum editorial boards. Dr. Yves Juillet serves as Senior Advisor to LEEM (the Pharmaceutical Industry Association in france). Dr. Juillet was a member of the Annual Meeting Program Committee in 1994, 1998 and 1999, and of the EuroMeeting Program Committee in 2000 and 2003-2006. he also chaired the EuroMeeting Program Committee in 2004. In 1998, he received the DIA Outstanding Service Award. Dr. Juillet was a Member of the DIA Board of Directors from 2002 to 2008 and serves on the DIA Advisory Committee for Europe.

The DIA Outstanding Service Award is given to recognize those individuals who consistently, through their volunteer efforts, have made contributions to the DIA mission and vision over several years. These individuals have exceeded expectations in their volunteer activities with DIA. Craig h. Lipset is responsible for Pfizer initiatives in Molecular Medicine to advance personalized therapies, as well as in ehealth leveraging technologies to improve patient engagement in clinical research. Craig serves as Chair for the Clinical research SIAC and as a member of the Drug Information Journal editorial board. he has also served as track chair for the Annual Meeting program committee and vice-chair for the Portfolio review Committee. Craig has served as guest editor for a special issue of the Drug Information Journal, and on the Election Task force. Dr. Monika M. Pietrek is a medical doctor and epidemiologist. She has served as DIA volunteer for more than 15 years as a speaker, session chair, theme leader, and as a member of various program committees for annual conferences and workshops in North America and Europe, the Continuing Medical Education Committee, and the regional Advisory Council of Europe. Dr. Pietrek also serves as co-chair of the Professional Education, Training & Development SIAC, on the Drug Information Journal editorial board, and served on the 2010 Clinical forum in Europe program committee. g

Dia 2010 annual Report

Drug Information Journal Awards

The recipients of this years awards for articles published in the Drug Information Journal in 2009 were selected by members of the journals editorial board early in 2010. All published articles were evaluated by these volunteers, and the following articles were selected. These awards were presented during our 46th Annual Meeting. DIA thanks the members of the journals editorial board for their participation in the awards process, and congratulates the following award winners: The Donald E. Francke Award

Incomplete Data in Clinical Studies: Analysis, Sensitivity, and Sensitivity Analysis Volume 43, Number 4, Pages 409430, July 2009 Author: Geert Molenberghs, PhD, Professor of Biostatistics, universiteit hasselt and Katholieke universiteit Leuven, Belgium

The Thomas w. Teal Award


Good Practices for Adaptive Clinical Trials in Pharmaceutical Product Development Volume 43, Number 5, Pages 539556, September 2009 Authors: Brenda L. Gaydos, PhD, Senior research Advisor Eli Lilly and Company; Karen M. Anderson, Merck; Dr. Donald Berry, The university of Texas M.D. Anderson Cancer Center, Division of Quantitative Sciences; Nancy Burnham, GSK; Christy Chuang-Stein, PhD, Pfizer Inc; Jennifer Dudinak, Global head, Inflammation regulatory Affairs, roche; Parvin fardipour, Wyeth; Paul Gallo, Novartis; Samuel V. Givens, PhD, VP, Biostatistics, hoffmann-la roche, Inc; roger J. Lewis, MD, Pc g


Dia 2010 annual Report

Member & Volunteer Services

DIA Connex
The ability of our members and volunteers to share knowledge and collaborate in our global, multidisciplinary professional network entered a new era with the December 2010 launch of DIA ConneX. hosted on our DIA website, DIA ConneX is a members-only social networking platform that allows members of DIAs discipline-specific Special Interest Area Communities (SIACs) to network and collaborate online with professional colleagues all around the world. Every DIA SIAC has a community homepage through which members can share and collaborate on documents, post announcements of common interest, and communicate with other community members in a shared and secure environment.

Drug Information Journal

The May 2010 (Volume 44, Number 3) issue of our official publication, the Drug Information Journal, featured a special Clinical Trials section that addressed the fDAAA of 2007,, clinical trial registries, transparency, disclosure, and other critical topics. In late 2010, J. rick Turner agreed to serve as DIJ editor-in-chief, succeeding Michael r. hamrell, PhD, who admirably served in this position for six years.

Global Forum

Each 2010 issue of our Global Forum member newsmagazine featured a special section dedicated to a specific topic of essential interest to our members and volunteers around the globe: February: Risk evaluation, mitigation, and management strategies April: Comparative effectiveness research, health technology assessment, and evidence-based medicine June: Impact and implications of Food & Drug Administration Amendments Act August: Working in a multicultural environment October: Involving and informing patients, including an article by Nicola Bedlington, Executive Director of the European Patients forum December: Health care reform and policy perspectives The December Global forum also featured an interview with Thomas Lnngren, coinciding with the conclusion of his tenure as EMA Executive Director at years end. g

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DIA in Canada
In November, DIA returned to Ottawa, Ontario, where the international biopharmaceutical community convened for DIAs 8th Annual Canadian Meeting: Fostering Innovation & Access to Drugs. Designed by the program committee to focus on ways to improve clinical trial efficiency, and streamline provincial and federal approval processes to improve innovative drug development and access in Canada, this was the first DIA Annual Canadian Meeting to be presented in collaboration with the Clinical research Association of Canada. Two keynote addresses were delivered by Paul Karamanoukian (Partner and Canadian Leader, Life Sciences, Ernst & Young) and robert G. Peterson, MD, PhD, MPh (Executive Director, Drug Safety & Effectiveness Network, Canadian Institutes of health research). The meeting thereafter proceeded along clinical development, reimbursement, and regulatory parallel tracks, and culminated in an interactive Ask the regulators panel discussion featuring expert leadership from health Canadas health Products & food Branch. In another Canadian Annual Meeting first, the tutorial that provided An Overview of Signal Detection: See It, Analyze It & Deal With It was simultaneously webcast to interested individuals who could not attend in person. g


Dia 2010 annual Report

DIA in China
In february, DIA and the Chinese Pharmaceutical Association (CPA) signed a memorandum of understanding that outlined our respective intentions to collaborate on a newsletter and develop global and regional educational opportunities for professionals working in the development, discovery, and life cycle management of pharmaceuticals and related products. A national society of pharmaceutical professionals, with the mission to represent and serve pharmacy and pharmaceutical science development in China, the CPA was founded in 1907 and has more than 80,000 members all pharmaceutical professionals serving as scientists, pharmacists in pharmacies, hospitals/clinics and industry, and regulators in competent authorities throughout China. This signing ceremony was attended by, among others, Dr. Ling Su, Member of DIA Board of Directors and Chair of DIAs Advisory Council of China. DIA and the Chinese Pharmaceutical Association share the common goal of advancing pharmaceutical science in China, Dr. Su later explained. No doubt this collaboration will help to facilitate the development of safe and effective pharmaceutical products.
Dia 2010 annual Report


Our Joint Editorial Board, twelve high-level representatives from both DIA and CPA, published the first issue of the quarterly Chinese-language DIA/CPA Global Pharmaceutical Forum in November 2010. In October, DIA successfully held the first Joint DIA-ACT-CST Study Director workshop in Beijing, in collaboration with the American College of Toxicology (ACT) and the Chinese Society of Toxicology (CST), co-chaired by Dr. Li-jie fu, Vice President of the CST. There has been rapid growth in the contract research organization industry over the last several years in China, but training of international standard for professional and technical staffs in the conduct of toxicology and safety studies has been limited, said Dr. fu. first offered in 2009, Understanding the Statistical Thinking in Clinical Research for Drug Development was reprised in Beijing in 2010, chaired by Lingshi Tan, PhD (General Manager, Pfizer [China] research and Development Co., Ltd.; Vice President, Worldwide Development Operations, Pfizer Inc.), a member of the DIA Advisory Council of China. Co-sponsored by the China Center for Pharmaceutical International Exchange (CCPIE) under Chinas State and food Drug Administration (SfDA), DIAs 2nd China Annual Meeting: Priming China for Drug Development & Innovation: From Strategy to Execution was held in May. frank Jiang, MD, PhD (VicePresident, Global r&D and head Asia-Pacific r&D sanofi-aventis, and member of DIAs provisional Advisory Council of China [pACC]), served as co-chair with zhao Yajun, Director-General of the CCPIE, SfDA. Participants in three well-attended preconference workshops included over 30 Provincial delegates of the SfDA. Wu zhen, Deputy Commissioner of the SfDA, delivered the keynote address on Drug Supervision to Meet the Challenges of Drug Innovation. The morning plenary was chaired by Ding Jianhua, Deputy Director General of the Department of International Cooperation of the SfDA, and featured high level speakers from regulatory agencies, industry, and academia: Presenters included zhang Wei, Director General, Department of Drug registration of the SfDA; Song ruilin, Executive Director-General, Chinese Pharmaceutical Association research Center for Medicinal Policy; Executive President, China Pharmaceutical Industry research and Development Association; KE Yang, MD, Executive Vice President, Peking university; and Joseph Cho, Present & CEO, Astellas Pharma China, Vice Chairman, China Association of Enterprises with foreign Investment r&D-based Pharmaceutical Association Committee. g

first issue of joint DIA/CPA Global Pharmaceutical Forum


Dia 2010 annual Report

DIA in Europe
In June, DIAs 4th European Forum for Qualified Person for Pharmacovigilance (QPPV) was held in London. As the first reading about the amended pharmacovigilance directive 2001/83/EC was passed the day before, this was the first forum to discuss its significance, and it opened with two consecutive sessions about these updates to the Eu legislative framework. DIAs twenty-year history of presenting statistical research workshops in Europe culminated in our 1st Joint DIA/EMA workshop on Statistical Methodology in Clinical research & Development presented in Vienna in September. This workshop offered sessions on adaptive designs, quantitative benefit/risk analyses, biomarker selection, missing data, safety analyses, and other topics and also provided a networking reception that introduced the Statistics SIAC to workshop attendees. DIAs 4th Annual Clinical Forum: Lisbon 2010: navigating the Future was held in October. This forum offered attendees the ability to select their own sessions across multiple themes, in accordance with the forums Build your own conference hallmark. Its plenary session featured debate on the topic This house Believes that Increasing Bureaucracy is Killing the future of Clinical Trials, chaired by Detlef Nehrdich (Abbott Gmbh & Co KG, Germany). The panelists spirited discussion was reflected in the voting results: Before this debate, attendees voted 76% to 24% in favor of this motion; after their discussion, the vote changed to 65% to 35% in favor. It was exciting to have delegates from across the globe, South Africa, Asia, Australasia, and the Americas as well as Europe, to challenge todays givens and seek to better navigate clinical trials operationally through the future, said Clinical forum chairperson Julianne hull (Pfizer, uK). To facilitate information exchange on pharmacovigilance (PV) inspections between EMA PV inspectors and industry, ethics committees, and investigational sites/ academia, DIA and the European forum for Good Clinical Practice developed and presented the first DIA/EFgCP workshop on Pharmacovigilance Audits & Inspections: Opportunities for Patient Safety in October. This workshops interactive design provided opportunities for the PV pharmaceutical community, and PV auditors and inspectors, to discuss and exchange experiences since the inception of PV inspections in Europe.

DIA is THE international forum for regulatory business. Working for a regulatory agency, it is extremely important to reach out to a wide variety of industry and regulators and other stakeholders, and DIA offers a very good platform for that. Thomas Lnngren
executive DiRectoR euRopean meDicines agency
Dia 2010 annual Report


In November, we teamed to collaboratively present our 1st EnCePP Information Day, which provided updates on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance project led by the EMA; and our 2nd Joint DIA/EMA/CMD(h) Conference on Variations, both in London. Also in November, we presented our first conference on orphan drugs, Future Direction for Orphan Drugs in Europe, in Paris, reflections on experience gained through the first ten years of the European Orphan Medicinal Products regulation, and gathered from the EMAs tenyear celebratory Orphan Medical Products conference held at the Agencys London offices in May. This was immediately followed by our 2nd DIA Health Technology Assessment (HTA) Conference; participants were offered a special discount to register for both conferences and take advantage of valuable crossover sessions. November also featured our debut Conference on Combination Products: Finding the right regulatory Strategy, presented in zurich.

The DIA Advisory Council of Europe (ACE) also organized and presented two free workshops for delegates from countries in Central and Eastern Europe: Changing Eu requirements & Their national Impact in Warsaw, Poland, in May; and Eu Accession: Preparing for Day One, in zagreb, Croatia, in November. Throughout 2010, several instructor-led training courses debuted in Europe: Advanced GCP Study Monitoring, Clinical Project Management in Europe, eCTD Submissions in Switzerland, Good Management of Medical Devices, and Quality-by-Design: A Hands-on Short Training Course for Pharma, plus the first Identification of Medicinal Product (IDMP) Information Day and EMA Information Day: The New ICSR Standard & ICH E2B/M2. g


Dia 2010 annual Report

The 22nd EuroMeeting Plenary Session comprised a panel discussion formatted as a debate in which panelists spoke either in support of or against the motion: The house believes that the process for developing new medicines and bringing them to patients is neither efficient nor effective. Professor Stuart Walker (CMr International Institute for regulatory Science) moderated the debate, which featured Thomas Lnngren (Executive Director, European Medicines Agency), Eddie Gray (President, Pharmaceuticals Europe, GlaxoSmithKline), Eric Abadie (ChMP Chair; General Directorate, AfSSAPS), and richard Bergstrm (Director General, Swedish Association of the Pharmaceutical Industry) as panelists. I think everybody in this room would agree that the delivery of new medicines to patients, to be efficient and effective, requires an industry that consistently delivers innovation, and an efficient and effective regulatory mechanism to ensure their availability to patients, Eric Abadie said to close. DIA President Jeff Sherman and Brigitte franke-Bray presented the Student Poster Awards; Brigitte and DIA Worldwide Executive Director Paul Pomerantz presented the Professional Poster Awards. Accepted student poster abstracts were published in the March 2010 issue of the Drug Information Journal (Vol. 44, No. 2). The EuroMeeting presented numerous sessions of ongoing interest to the European pharmaceutical, regulatory, and patient communities, such as The Innovative Medicines Initiative (IMI), chaired by Michel Goldman, Executive Director, IMI, Eu. This session provided updates on the status of IMI development with a focus on projects related to pharmacovigilance, presented by expert representatives from france, the uK, Switzerland, and the EMA. It also featured a special focus on Small Agencies & Small Markets Agency Satellite Session, which highlighted the benefits enjoyed and challenges faced by smaller agencies in the European legislative and regulatory contexts, shared by agency representatives from Iceland, Lithuania, and Malta. DIAs EuroMeeting remained in the forefront of the green meetings trend, and used practical, innovative, and often simple measures to reduce its carbon footprint and practice the 3rs: reduce, recycle, and reuse. first presented in 2009, the DIA Greenest Exhibitor Award recognizes the exhibitor who does the most to green their booth by, for example, packing lightly when shipping and offering to email brochures rather than providing paper copies. Paul Pomerantz and Jeff Sherman presented the 2010 award to Crf health, which also won the award in 2009. Crf healths green efforts include offsetting their travel miles through, a paperless booth, and environmentally friendly giveaways. In addition to the annual DIA volunteer service awards, Thomas Lnngren, Executive Director, EMA, Eu, received a special award for his numerous contributions to DIA and to our patient, industry, and regulatory constituents, throughout Europe and around the world. g
Dia 2010 annual Report

2010 EuroMeeting
Brigitte franke-Bray, Director DIA Europe, opened the Plenary Session of the 22nd Annual DIA EuroMeeting in Monaco with special thanks to the European Pharmaceutical Students Association (EPSA) and the International federation of Medical Student Associations (IfMSA), for their participation. As in years past, this EuroMeeting offered a student networking reception and several sessions specifically designed for students, and continued to nurture the participation of students in our flagship European program. Brigitte franke-Bray also extended special gratitude to EurOrDIS, the voice of rare disease patients in Europe, with whom DIA has collaborated and in 2010 celebrated the fifth anniversary of our EuroMeeting Patient fellowship Program. EuroMeeting co-chairs Kerstin franzn (Pfizer, Sweden) and Professor Bruno flamion (Chair, ChMP, Scientific Advice Working Party, European Medicines Agency) focused their welcoming remarks on the program content.We have chosen to drift away from the share experience paradigm and go for more of a debate on current issues and hopefully also push these debates forward, said Kerstin franzn. If you are a patient yourself, you know how intensely hopeful one can be about new drugs, new approaches that will make your condition easier to stand, and your life happier to live, Bruno flamion explained. So my hope, when accepting to co-chair this meeting, was to help DIA build their annual platform where people can think together, get new ideas, and realize that we have to work more closely together to overcome the upcoming crisis in therapeutics around the world.


European Educational Offerings

1st Joint DIA/EMA Workshop on Statistical Methodology in Clinical r&D 2nd DIA/EMA Innovation forum: Is the Eu regulatory framework ready? 2nd health Technology Assessment (hTA) Conference 2nd Joint DIA/EMA/CMD(h) Conference on Variations 4th Annual European Clinical forum - Navigating the future: Incorporating 20th Annual European Clinical Data Management (CDM), 10th Annual European Validation, 6th Annual European eClinical, and 4th European Medical Information & Communications Conferences 4th DIA European Cardiac Safety Conference 4th European forum for Qualified Person for Pharmacovigilance (QPPV) 9th EudraVigilance Information Day 11th Conference & Exhibition on European Electronic Document Management: The New frontiers Advanced Good Clinical Practices (GCP) Study Monitoring Training Course (New for 2010) Building the eCTD: Practical Solutions to Compile Electronic Submissions Training Course Clinical Project Management in Europe Training Course (New for 2010) Clinical Statistics for Non-Statisticians Training Course Comprehensive Training on European regulatory Affairs Including Different registration Procedures & Variations: Expert Overview Conference on Drug & Device Combination Products: finding the right regulatory Strategy CTD Dossier requirements: focus on Eu Module 1 & Quality Module 3 Training Course DIA European regulatory Affairs forum 2010 eCTD Submissions in Switzerland Training Course (New for 2010) Essentials of Clinical Study Management Training Course EudraVigilance: Electronic reporting of ICSrs in the EEA Training Course EudraVigilance: Medicinal Product Dictionary Training Course European Medicines Agency Information Day: The New Individual Case Safety report (ICSr) International Standard & ICh E2B/M2 Training Course (New for 2010) European Network of Centres for Pharmacoepidemiology & Pharmacovigilance (ENCePP) Information Day European regulatory Affairs Training Course Excellence in Pharmacovigilance: Clinical Trials & Post-Marketing Training Course free Workshop: Changing Eu requirements & Their National Impact free Workshop: Eu Accession: Preparing for Day 1 future Direction for Orphan Drugs in Europe Good Management of Medical Devices Training Course (New for 2010) how to Prepare for Pharmacovigilance Audits & Inspections in Europe Training Course Identification of Medicinal Product (IDMP) Information Day (New for 2010) Introduction to Product Information Management (PIM) Training Course Introduction to Signal Detection & Data Mining in Pharmacovigilance Training Course Joint DIA/EfGCP Pharmacovigilance Audit & Inspection Workshop: Opportunities for Patient Safety Joint DIA/IfAPP Pharmaceutical Quality forum & 11th IfAPP Pharmaceutical Policy forum Joint EfGCP Children's Medicines Working Party 6th Annual Conference & DIA 4th Paediatric forum: Current & future Perspectives for Paediatric Medicines Medical Approach to Diagnosis & Management of Adverse Drug reactions (ADrs) Training Course Non-Clinical Safety Sciences & Their regulatory Aspects Training Course Practical Good Clinical Practices (GCP) Compliance Auditing of Trials & Systems Training Course Practical Guide for Pharmacovigilance: Clinical Trials & PostMarketing Training Course Quality-by-Design: A hands-On Short Training Course for Pharma (New for 2010) uS regulatory Affairs Training Course
Dia 2010 annual Report

India Offerings
3rd Annual regulatory Conference in India on Global regulatory Challenges: Quest for Optimization 5th Annual Conference on Drug Discovery & Clinical Development in India: Meeting the Challenges of Next Generation r&D: Enhancing Efficiency, Effectiveness & Innovation Clinical Trial Design, Analysis, reporting & review: uS regulatory Science Perspective: Bangalore Clinical Trial Design, Analysis, reporting & review: uS regulatory Science Perspective: hyderabad Clinical Trial Design, Analysis, reporting & review: uS regulatory Science Perspective: New Delhi CTD Dossier requirements: focus on Eu Module 1 & Quality Module 3: hyderabad CTD Dossier requirements: focus on Eu Module 1 & Quality Module 3: Mumbai Pharmaceutical Quality forum: CMC Compliance Pharmacovigilance & risk Management Quality of Active Pharmaceutical Ingredients

DIA in India
In January, with the assistance of the uS fDA, DIA India presented three offerings of our training workshop on Clinical Trials & Design Analysis: uS regulatory Science Perspective in Bangalore, hyderabad, and Delhi. More than 100 participants attended these workshops. In Chennai, DIA India presented our Pharmacovigilance & risk Management workshop in february, which was also attended by more than 100 participants. In March, DIA India presented two offerings of our training course on CTD Dossier requirements: Focus on Eu Module 1 & Quality Module 3, in Mumbai and hyderabad. DIAs 3rd Annual regulatory Conference on global regulatory Challenges: Quest for Optimization was presented in May in Mumbai. The conference focused on the regulatory challenges faced by Indian pharmaceutical manufacturers while supplying drugs to domestic and global markets; Keynote Speaker Dr. Sadhna Joglekar (GSK) addressed the challenges in the emerging biosimilar market that these manufacturers face. In September, working in collaboration with the World health Organization and the European Directorate for the Quality of Medicines & healthCare, DIA India presented our workshop on the Quality of Active Pharmaceutical Ingredients in Mumbai. This was followed by Octobers 5th Annual Conference on Drug Discover & Clinical Development: Meeting the Challenges of next generation r&D: Enhancing Efficiency, Effectiveness & Innovation, introduced with eight preconference tutorials, in Bangalore. under the guidance of Sultan Ghani, Director DIA India, and Nandkumar Chodankar, Chair of the DIA Advisory Council of India, a DIA Young Professionals Chapter opened in Gujarat, a hub of Indias pharmaceutical development and industry. At the opening ceremony for this chapter, Mr. hG Koshia (Commissioner of fDCA, Gujarat) delivered the Inaugural Address. In february, the DIA Student Chapter organized a seminar on the theme of Cosmeceuticals at Bombay College of Pharmacy. The Tamil Nadu chapter presented a meeting on Documents & Documentation in Clinical research: Fundamental & Basic Issues in October. g
Dia 2010 annual Report


In June, the ten-session 3rd DIA regulatory Affairs Training Course in Japan began at Keio university faculty of Pharmacy in Tokyo in June; it concluded in March 2011. DIAs 2010 calendar in Japan culminated in Octobers 7th DIA Japan Annual Meeting: Japans role & Contribution to global Drug Development. Previous DIA meetings were held to investigate the way to synchronize Japan with the global method and to explore the effective drug development process here in Japan in the new environment, co-chairperson Masura Iwasaki, MD, PhD (Vice President, Development & Medical Affairs Division, GlaxoSmithKline K.K., Japan) explained prior to this meeting. following these topics so far, and thinking about the recent clear trend of globalization, the DIA meeting this year will offer opportunities to clarify the role and the contributions of Japan to new drug development and to identify the value of Japan for the future. This meeting culminated in a roundtable panel discussion on Expectations for the Role of Asia and Japan in Global Development, chaired by Tatsuo Kurokawa, PhD (Professor, International Clinical Development & regulatory Sciences, Graduate School of Pharmaceutical Sciences, Chiba university, Japan). Tatsuya Kondo, MD, PhD (Chief Executive, PMDA, Japan), Thomas Lnngren, PharmD, MPharm, MSc (Executive Director, European Medicines Agency [EMA], Eu), and Murray M. Lumpkin, MD (Deputy Commissioner, International & Special Programs, Office of the Commissioner, uS fDA) were the featured panelists. In late December, Ko Sekiguchi, MBA, MCP, was appointed as our new Director, DIA Japan. he began service in January 2011 at our Tokyo office. g

Leadership for 13th Annual CDM Workshop in Japan

DIA in Japan
The DIA calendar in Japan opened in february with the 13th Annual workshop in Japan for Clinical Data Management: CDMAA: CDM Amendments Act The differences among I know, I understand, and I can make it. This workshop began with keynote speeches presented by Mr. Takeyuki Sato (Director, Office of Clinical Trial Promotion, research & Development Division, Ministry of health, Labour & Welfare [MhLW]) and Dr. Michio Kimura (Director and Professor, Department of Medical Informatics, hamamatsu university School of Medicine). This opening day also featured the perennially popular CCS (CDM Chatting Session), in which about 70 young clinical data managers divided into groups and freely discussed issues encountered in their daily work. In April, DIAs 4th Annual Conference in Japan for Asian new Drug Development was presented in Tokyo along three primary themes: Contributions for Asian Health Care and Patients; Asian Contributions for Global Studies; and Collaboration among Asian Countries. Opening keynote speeches were delivered by Dr. Satoshi Toyoshima (Executive Director, Director of Center for Product Evaluation, Pharmaceuticals & Medical Devices Agency [PMDA]) and Dr. Sun-hee Lee (Director General, Drug Evaluation Department, Korea food & Drug Administration [KfDA], Korea). DIAs 1st Cardiac Safety workshop in Japan featured presentations by sponsor representatives from uS and Eu, and by regulatory representatives from the Japan, Canada, the uS and Eu, to help professionals in Japan conduct clinical studies in support of the ICh E14 cardiac safety guideline. This workshop was presented in May in Tokyo.
Dia 2010 annual Report

Japan Offerings
1st DIA Cardiac Safety Workshop in Japan 3rd DIA regulatory Affairs Training Course in Japan 4th Annual Conference in Japan for Asian New Drug Development 7th DIA Japan Annual Meeting: Japans role & Contribution to Global Development 13th Annual Workshop in Japan for Clinical Data Management: CDMAA: CDM Amendments Act

DIA in Latin America

In 2004 and 2005, So Paulo (Brazil) hosted DIAs fourth and fifth Latin American Congresses of Clinical research. In 2010, DIA returned to So Paulo to present our 7th Latin American Congress of Clinical research: Harmonization & the Future of Drug Development in Latin America with the Brazilian Society of Pharmaceutical Medicine (the Sociedade Brasileira de Medicina farmacutica [SBMf]) serving as co-sponsor. This seventh Congress was chaired by Joo Massud filho (universidade federal de So Paulo; CEO/Executive Director, Newcotrials, Brazil) and co-chaired by Juan Carlos Groppa (SAMEfA Argentina Society of Pharmaceutical Medicine; Medical regulations Coordinator, Laboratorios Bgo S.A., Argentina). The Congresss Scientific Committee included Gustavo Luiz f. Kesselring, SBMf President from 200809. The first plenary session, Working for Harmonization on Regulations for Clinical Trials in Latin America, featured representatives from many of the regions regulatory and health agencies, including ANMAT (Argentina), ANVISA (Brazil), COfEPrIS (Mexico), INS (Peru), ISP (Chile), and the Pan American health Organization (PAhO). This session was chaired by Sergio Guerrero (OCA hospital/ Monterrey International research Center, Mexico), also a member of the DIA Board of Directors, and co-chaired by Daniel Mazzolenis (Kendle International, Inc., Argentina). The second plenary, Global Challenges with Bioethics in IRB Training, was chaired by Paulo fortes (Sociedade Brasiliera de Bioteca, Brazil) and cochaired by SBMf President Marcelo Vianna de Lima (GE healthcare, Brazil). At our Annual Meeting in June 2010, the Board of Directors officially established our new Steering Committee of Latin America. This committee originally comprised representatives of Argentina, Brazil, and Mexico, with plans to incorporate new members representing Chile and Central America to provide even better regional insight and representation. g

Dia 2010 annual Report


DIA in North America

Conferences, Meetings & workshops
DIAs 2010 North American conference and workshop calendar not only featured our long-standing clinical, regulatory, safety, and marketing annual educational programs, but also served to illustrate and advance our expanding strategic vision. Conferences such as Ensuring Quality & Balancing risks for Multiregional Clinical Trials: Clinical, regulatory & Ethical Factors, which was co-located with Tomorrows Project Manager: Evolving Competencies for Biopharmaceutical Professionals, for example, along with our global Approach to the risk Management of Medicines, and other programs, demonstrate DIAs commitment to communicating best practices and moving clinical research forward to benefit world health. Other DIA 2010 North American programming that addressed new and emerging content areas include our conference on Clinical Development of Stem Cell Therapies: Scientific, regulatory, and Ethical Considerations, co-sponsored with the American Society of Gene & Cell Therapy; Evidence-based Medicine & Health Technology Assessment: Moving from Separate Appraisals to Synergistic Communications; and our conference on Advancing Pediatric research in the uS, colocated so that attendees could cross over into our Maternal & Pediatric Drug Safety Symposium.

Designation workshop, where staff from the fDA Office of Orphan Products Development provided regulatory assistance to sponsors developing orphan drug designation applications. Throughout 2010, DIA presented our traditional, recurring annual programs of enduring importance to various constituents within our multidisciplinary association. In addition to the programs listed about, these included our: 5th workshop in Pharmacogenomics Series: generating & weighing Evidence in Drug Development & regulatory Decision Making; 9th Annual Conference on Contemporary Pharmacovigilance & risk Management Strategies; 9th Annual Electronic Submissions Conference: working Together Towards a global Strategy; 21st Annual workshop on Medical Communications: Defining the Future of Medical Communications, accompanied by the Medical Science Liaison forum 2010 and MedComm Core Curriculum, recognized as the essential industry introduction for professionals new to medical communications; 22nd Annual Conference on Marketing Pharmaceuticals: Integrated Marketing, Emerging Media Trends & new regulations; and our 23rd Annual Electronic Document Management Conference: global Content Management in an Electronic world.

To help professionals in the pharmaceutical, regulatory, and related business areas develop new or more effective training strategies and practices, the 1st DIA Training Forum convened at DIA worldwide headquarters in february. Leaders from the professional training community were invited to share Another emerging topic was addressed through our best practices and develop strategies and tactics to help one collaborative Adaptive Design for Clinical Trials: FDA anothers learning, development, and training programs succeed. Draft guidance Symposium presented with the fDA. 2010 A special keynote address was delivered during the luncheon educational programs collaboratively developed and presented break by Nancy Smith, PhD, former Director, Office of Training with the fDA, a hallmark of DIA North American programming, & Communication, CDEr, fDA, who served as chair for the 2009 included our: DIA/FDA CDEr/CBEr Computational Science Annual Meeting in San Diego. Annual Meeting; 3rd Annual DIA/FDA/Health Canada/AAPS/ OTS Oligonucleotide-based Therapeutics Conference, coClinical Safety & Pharmacovigilance Week presented a weeks sponsored by the American Association of Pharmaceutical worth of training courses, all located at DIA headquarters, Scientists, health Canada, and the Oligonucleotide devoted to the topic of clinical safety. Presented in May, this Therapeutics Society; 4th Annual FDA/DIA Statistics week included one of several new courses developed for 2010, Forum: Integrating Knowledge in Clinical Development: Risk Management & Communication to Optimize Product Safety, Meta-Analysis, non-Inferiority & related Topics; DIA/ instructed by Dr. Nancy Smith. Clinical Research Training Week in FDA/PVrI Debate on Clinical Trials for Pulmonary Arterial March, and two offerings of Project Management Training Week, Hypertension, in collaboration with the Pulmonary Vascular in April and October, were also presented at DIA headquarters in research Institute; and our interactive DIA/FDA Orphan Drug 2010. g
Dia 2010 annual Report

Instructor-led Training

46th DIA Annual Meeting

Plenary & Keynote
In Washington, DC, the plenary session for DIAs 46th Annual Meeting: Facilitating Innovation for Better Health Outcomes began with the Bel Canto String Quartets performance of Dvoraks New World Symphony, introducing a program devoted to a new vision of health and health care for the entire world. This 46th Annual Meeting is a step in our evolution, with a program that includes collaboration among industry, academia, regulators, and patient advocacy groups, to address major issues in health care, such as comparative effectiveness, health outcomes, evidence-based medicine, health technology assessments, and new therapeutic approaches, said Paul Pomerantz in his opening remarks. DIA President Dr. Jeffrey Sherman (horizon Pharma, Inc.) thanked his Board colleagues whose terms are ending before introducing the 2010-2011 DIA Board of Directors, ending with the Executive Committee, which consisted of Dr. Sherman as Immediate Past President; Dr. richard O. Day, President; Dr. Yves Juillet, President-Elect; Minnie Baylor-henry, Treasurer; and Paul Pomerantz. As I pass the DIA Presidency onto richard Day, we will witness a historic time in the 46-year history of DIA. It will mark for the first time an Executive Committee comprised of a DIA past president, current president, and incoming president, who represent three different areas of the world North America, the Asia-Pacific, and Europe. Clearly, this transition embodies our global perspective and purpose, Jeff said. This years Annual Meeting will focus on innovation and the factors that help to facilitate it. By innovation, we mean not only innovative products but innovative services to patients, to pave the way toward the future and better health outcomes, said Annual Meeting Chairperson Gaby Danan, MD, PhD (sanofi-aventis, france). This years theme speaks to innovation and how we must work together to facilitate innovation for better health outcomes.

Keynote Speaker fDA Commissioner Dr. Margaret hamburg discussed the collaborative nature of DIA, of the DIA-fDA relationship, and how collaboration can help both organizations meet our current challenges. I have been told that this is the event to attend for biotechnology pharmaceutical and regulatory professionals, so its certainly an honor for me to be part of this program, she offered. DIAs work is not only valuable, but its very much in sync with the priorities and concerns of the fDA. Your mission of fostering innovation and the exchange of information is important, really critical, to the future of the health and well-being of people worldwide. You provide an essential global forum, and we at the fDA appreciate what you do in this country and around the world. DIA represents a very important partner organization for our work at fDA. Both regulatory science and the challenges of globalization are ripe areas for collaboration between fDA and DIA. In fact, weve been engaged in activities together that support elements of these priorities, and we can identify many more areas for future work. I look forward to even greater partnership as we continue to define the scientific and public health agendas that will move us into the second decade of the 21st century, concluded Dr. hamburg.

Dia 2010 annual Report


Executive Policy Forum

Eric G. Campbell, PhD, (Associate Professor at the Institute for health Policy and Department of Medicine at Massachusetts General hospital and harvard Medical School) served on the uS Institute of Medicine Committee on Conflict of Interest in Medical research, Education, and Practice, to study industry financial support of medical education and training. In July 2009, Dr. Campbell appeared before the Special uS Senate Committee on Aging to discuss this Committees report.

It is always reassuring to have this kind of opportunity to exchange this kind of information with colleagues, because at the end of the day we are facing the same issues and we need to know how our colleagues have discovered their solutions to these issues. Having this network is really great for our day-today work. Gaby Danan, MD, PhD
46tH annual meeting cHaiR

Interactive regulatory Sessions

The European Medicines Agency (EMA) Town Hall, which debuted in 2009, returned in 2010 and was chaired by Anthony humphreys (head of regulatory, Procedural & Committee Support, EMA). The Pharmaceuticals & Medical Devices Agency (PMDA) Town Meeting also returned, chaired by Kyoichi Tadano (Director, Division of Planning & Coordination, PMDA) and featuring Tatsuya Kondo, MD, PhD, (Chief Executive, PMDA) as its first speaker. New for 2010, the Center for Biologics Evaluation (CBER) Town Meeting was chaired by robert A. Yetter, PhD (Associate Director for review Management, Office of the Director, CBEr). Also new for 2010, the interactive CDEr Compliance update, chaired by Deborah Autor, JD (Director, Office of Compliance, fDA), focused discussions on current, proposed, and newly implemented drug product enforcement strategies. CDrh Task force reports: 510(k) Devices Process Review & New Science in Regulatory Decision Making, which shared reports from two task forces launched in 2009, also debuted at our 2010 Annual Meeting. This session was chaired by Jonathan Sackner-Bernstein, MD (Associate Center Director, Post Marketing Operations, Office of the Center Director, CDrh). The two-part Center for Drug Evaluation & Research CDER Town Meeting, chaired by Nancy Smith, PhD (former Director, Office of Training & Communications, CDEr) and featuring the CDEr senior leadership team, provided another perennial meeting highlight.
Dia 2010 annual Report

In 2010, Dr. Campbell served as panelist on the first of our two-part Executive Policy Forum: The New Landscape for Industry-profession Relations: From Policy to Practice, our first Annual Meeting executive policy forum. This first part featured discussion of the current public policy landscape among thought leaders from government, media, ethics, and academia, and was chaired by Arthur L. Caplan, PhD, (Emmanuel & robert hart Director, Center for Bioethics and Professor of Bioethics, university of Pennsylvania). Part two examined strategies intended to restore and maintain public confidence in clinical research and medical education that are emerging from industry, medical societies, clinical researchers, and health care providers, and was chaired by Minnie Baylor-henry (regulatory & Capital Markets Consulting, Deloitte and Touche; Treasurer, DIA Board of Directors). Considering all the Sunshine Act issues and legislative issues in the states, plus new policies that are being enacted within the pharmaceutical and device industries and within medical centers, this topic is something that many, many of our members are interested in. We almost have an obligation to provide this forum, Minnie explained.

Multitrack & Megatrack Plenaries

Global experiences with comparative effectiveness research and health technology assessments were shared through a special Multitrack Plenary Session: Implications of Comparative Effectiveness Research for Health Care Innovation, a panel discussion chaired by Dr. Jeff Goldsmith (Associate Professor of Public health Sciences at the university of Virginia, and President, health futures, Inc.). Continuing medical education was also the subject of our joint Advertising, Marketing & Medical Communications Megatrack plenary session Is Industry Supported Education the Next Taboo?, chaired by John f. Kamp, JD, PhD (Coalition for healthcare Communication). The Information Technology (IT) Megatrack plenary session Will Electronic Health Records (EHR) Destroy Clinical Research or Transform It? was chaired by J. Michael fitzmaurice, PhD, fACMI (Agency for healthcare research & Quality [AhrQ]). The Clinical Research Megatrack plenary session Multiregional Clinical Trials: It Takes a Global Village of Expertise examined practical experiences in the design, implementation, summarization, and registration of information on multiregional clinical trials and, most importantly, the points at which theyre all interconnected. Bruce Binkowitz, PhD, MS, (Merck & Co., Inc.) served as chair. DIAs 46th Annual Meeting: Facilitating Innovation for Better Health Outcomes also featured a special Project Management / finance plenary session, Evolving Demands in a Changing Industry: Are You Prepared?, chaired by raymond G. Starrett, MS (Targacept, Inc.). g

North American Educational Offerings

3rd Annual DIA/fDA/health Canada/AAPS/OTS Oligonucleotide-Based Therapeutics Conference 4th Annual fDA/DIA Statistics forum: Integrating Knowledge in Clinical Development: Meta-Analysis, Non-Inferiority & related Topics 5th Workshop in Pharmacogenomics Series: Generating & Weighing Evidence in Drug Development & regulatory Decision Making 8th DIA Annual Canadian Meeting: fostering Innovation & Access to Drugs 9th Annual DIA Conference on Contemporary Pharmacovigilance & risk Management Strategies 9th Annual Electronic Submissions Conference: Working Together Towards a Global Strategy 21st Annual Workshop on Medical Communications: Defining the future of Medical Communications 22nd Annual Conference on Marketing Pharmaceuticals: Integrated Marketing, Emerging Media Trends & New regulations 23rd Annual Electronic Document Management Conference: Global Content Management in an Electronic World Adaptive Design for Clinical Trials: fDA Draft Guidance Symposium Advanced Clinical Statistics for Non-Statisticians Training Course Advancing Pediatric research in the uS Art of Writing a Clinical Overview Training Course (New for 2010) Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis & Bleeding Clinical Development of Stem Cell Therapies: Scientific, regulatory & Ethical Considerations Clinical Project Management Training Course Clinical research Certificate Program Clinical Safety & Pharmacovigilance Certificate Program Clinical Statistics for Non-Statisticians Training Course Computer Systems Validation for the Non-Computer Professional Training Course Development of a Clinical Study report Training Course Development of Type 2 Diabetes Mellitus Drugs: State of the Art Cardiovascular Assessments DIA/fDA CDEr/CBEr Computational Science Annual Meeting DIA/fDA Orphan Drug Designation Workshop DIA/fDA/PVrI Debate on Clinical Trials for Pulmonary Arterial hypertension Drug Safety Surveillance & Epidemiology Training Course Early Drug Development: Navigating the Treacherous rapids Ensuring Quality & Balancing risks for Multiregional Clinical Trials: Clinical, regulatory & Ethical factors Enterprise resource Planning Training Course Essentials of Project Management Training Course EudraVigilance & Electronic reporting of ICSrs in the EEA Training Course European regulatory Affairs Training Course
Dia 2010 annual Report

Evidence-Based Medicine & health Technology Assessment: Moving from Separate Appraisals to Synergistic Communications Executing & Controlling Projects Training Course fundamentals of Clinical research Monitoring Training Course Global Approach to the risk Management of Medicines high Performance Biopharm Teams Training Course how to Prepare for a Safety Inspection Training Course Introduction to Good Clinical Practices & Auditing Training Course Introduction to Portfolio Management & Performance Metrics Training Course Introduction to Signal Detection & Data Mining Training Course Leadership Experience Training Course Liability risks in Clinical Trials Maternal & Pediatric Drug Safety Symposium New Drug Product Development & Lifecycle Management Training Course Overview of Drug Development in Japan Training Course Overview of Drug Development Training Course Post-Marketing Drug Safety & Pharmacovigilance Training Course (New for 2010) Pre-Marketing Clinical Safety & Pharmacovigilance Training Course (New for 2010) Project Information, Communication & Knowledge Management Training Course Project Management certificate Program Project risk Management Training Course regulatory Affairs for Biologics Training Course (New for 2010) regulatory Affairs Part I: The IND Phase + Part II: The NDA Phase Training Course regulatory Affairs Part I: The IND Phase Training Course regulatory Affairs Part II: The NDA Phase Training Course risk Management & Communication to Optimize Medicinal Product Safety Training Course (New for 2010) Sustaining Clinical Trial Disclosure Tomorrows Project Manager: Evolving Competencies for Biopharmaceutical Professionals uS & International Prescription Drug Labeling: Comparisons & Important updates using risk Management Programs to Enhance the Safety of Medicines Training Course utilizing Chemistry, Manufacturing & Control (CMC) in Drug Development Training Course


DIA in Other Regions

2nd DIA African regulatory Conference
In March, the 2nd DIA African regulatory Conference was presented in Johannesburg, South Africa, organized by DIA and cosponsored by the South African Development Community (SADC). The conference program was developed by the Africa regulatory Network of the European federation of Pharmaceutical Industries and Associations, and a panel of advisors. In his introductory remarks, conference chair Professor Trevor Jones, CBE (Kings College London, uK) highlighted the importance of shortening the time-to-market availability of medicines as a critical part of enhancing access in Africa, and emphasized the need for data sharing to maximize use of limited regulatory resources. Conference co-chair Mr. Joseph Mthetwa (Senior Program Manager for health and Pharmaceuticals, SADC Secretariat, Botswana) called on participants to collaborate in order to secure reliable medicine supply systems, to improve regulatory mechanisms concerning registration as well as control of medicines, for the benefit of the African patient. In the keynote address, Ms. Mandisa hela (registrar, Medicines regulatory Agency, South Africa) urged exploration of new partnerships for collaboration and efficient use of resources through harmonization and information sharing.

DIA 2010 Korea Meeting

Networking is essential in our activity because medicines are global, the issues are global, and the solutions should be global. In order, then, to reach some solutions and to implement new approaches to our issues, we need to have a network all over the world. DIA provides this opportunity.
Gaby Danan, MD, PhD
46tH annual meeting cHaiR

In November, DIAs global and multidisciplinary network came together to present the DIA 2010 Korea Meeting: Excellence in global Clinical Development in Busan, Korea. A prime example of DIAs vision of collaboratively advancing health and well-being around the world, this meeting was endorsed by DIA in partnership with the Korean Society of Pharmaceutical Medicine and the Korea National Enterprise for Clinical Trials (KoNECT), who served as hosts. The meeting organizing committee was chaired by Sang Goo Shin (KoNECT, Seoul National university), who also delivered the plenary presentation on the Growing Role of Asia in Global Clinical Development. Yun hong Noh, Commissioner of Korean food & Drug Administration (KfDA) delivered the plenary session A Roadmap of Clinical Trials in Korea from the KfDA perspective. The meeting program committee was chaired by Yil Seob Lee (GlaxoSmithKline, Korea), who also co-chaired the simultaneous global development sessions with Dr. Ling Su, DIA Board of Directors and chair of the DIA Advisory Council of China, who delivered the Industry Perspective during these sessions. Deborah Chee, who chaired the site management sessions, served as vice-chair of the organizing committee. Min Young Kim (KoNECT) served as program coordinator. The meeting presented agency and industry perceptions from other Asian countries by featuring representatives from Australia, China, Japan (Pharmaceuticals & Medical Devices Agency, PMDA), Singapore, Taiwan (Center for Drug Evaluation, CDE), Thailand (ThaifDA), and the uS. g


Dia 2010 annual Report

DIA Online
webinars & Online Training Series
DIA delivered a robust 2010 calendar of online seminars (webinars) and training series that conveniently delivered essential content to participants home or office computers. Interested professionals who could not travel to Washington for an in-person Annual Meeting experience took advantage of our 46th Annual Meeting webinar Package captured in digital audio with synchronized slides (and which qualified for Continuing Education units). These webinar participants also had the opportunity to submit email questions to session panelists, and received six months unlimited access to all sessions available in our Live Learning Center. Other webinars reprised Annual Meeting sessions that filled to capacity, such as Pharmacovigilance from the Medical writers Perspective; still others reprised content from popular meetings and workshops, such as our Progression-Free Survival Oncology series. Many webinars were moderated by or featured presentations from fDA leadership. These addressed specific regulatory guidance for industry on submissions for the evaluation of propriety names; on drug-induced liver injury; on adaptive design clinical trials for drugs and biologics; and on developing drugs to treat acute bacterial skin and skin structure infections. Others addressed specific rules for major statements in direct-to-consumer advertisements, and for investigational new drug safety reporting. Many webinars offered participants the opportunity to submit advance email questions for this leadership to address in their presentations, such as: FDA Strategic Plan for risk Communication; Patient-reported Outcome Measures: Announcing the Final FDA PrO guidance; FDAs Draft non-Inferiority guidance; and CDEr and CBEr Town Meetings on Current eSubmission Hot Topics. DIAs reach through cyberspace extended into other regions of our international membership through webinars on Safety reporting requirements in Clinical Trials: Indian & European Perspectives, Conducting Clinical Trials in India: Current update on Opportunities & Challenges, and our combined series on regulatory Strategies in Latin America coupled with Expanding Clinical research Beyond Borders: The Importance of Latin America.

Online Training Series

DIA also repurposed several of our acclaimed instructor-led training courses for digital delivery as online training series. In 2010, these online training series included courses on writing a clinical overview, basics of the IND and NDA and interacting with the fDA during the IND/NDA phases, developing standard operating procedures, developing a clinical study report, GCP for clinical research professionals, an introduction to signal detection and data mining, the regulatory aspects of advertising and promotional labeling for prescription drugs and biologics, and our overview of drug development. Other offerings helped participants expand their professional horizons by providing training in clinical statistics for non-statisticians, in computer system validation for the non-computer professional, and in the fundamentals of project management for the non-project manager. g

Dia 2010 annual Report


Online Offerings and Webinar Plus Training

21 Cfr Part 11 Inspection Assignments An Inside Look Inside CDErs 21st Century NDA/BLA review Process Art of Writing a Clinical Overview: Online Training Series Basics of Interactions with fDA During IND/NDA Phases: Online Training Series Basics of the IND: Online Training Series Basics of the NDA: Online Training Series Case Processing & Signal Detection: Business Process Optimization in Pharmacovigilance CBEr Town Meeting: Current eSubmission hot Topics CDEr Town Meeting: Current eSubmission hot Topics Clinical Data Standards & Submission Compliant Deliverables Series: Data Standards for regulatory Submission Deliverables Clinical Data Standards & Submission Compliant Deliverables Series: history, Benefits & Implementation of Data Standards Clinical Statistics for Non-Statisticians: Online Training Series CMC Issues & 505(b)(2) Submissions Computer Systems Validation for the Non-Computer Professional: Online Training Series Conducting Clinical Trials in India: Current update on Opportunities & Challenges Contributing to high Performance Biopharm Teams: Online Training Series Critical Chain in the Pharmaceutical Industry Developing Standard Operating Procedures: Online Training Series Development of a Clinical Study report: Online Training Series DIA Trial Master file reference Model: Overview & Implementation Do Subvisible Particles Contribute to the Immunogenicity of Therapeutic Proteins? eCTD 101: Overview & Impact on the regulatory Submissions Process Ethical Considerations for Conducting Clinical Trials in the Emerging Markets fDA Discusses Guidance for Industry on Drug-Induced Liver Injury fDA Discusses Signaling using Data Mining results fDA Draft Guidance on Adaptive Design Clinical Trials for Drugs & Biologics fDA Draft Guidance: Developing Drugs to Treat Acute Bacterial Skin & Skin Structure Infections fDA Strategic Plan for risk Communication fDAAA & rEMS: Two Years Later fDA-CDEr Discusses Activities to reduce Preventable Medication harm: rEMS, Medication Errors & Safe use fDAs Draft Non-Inferiority Guidance fDAs Proposed rule on Major Statements in Direct-to-Consumer TV & radio Advertisements final fDA rule on Investigational New Drug Safety reporting five Key Strategies for Leveraging Comparative Effectiveness research fundamentals of Project Management for the Non-Project Manager: Online Training Series Going Paperless: A health Care Industry Initiative Good Clinical Practices for the Clinical research Professional: Online Training Series Guidance for Industry on the Contents of a Complete Submission for the Evaluation of Proprietary Names how the Center for Devices & radiological health (CDrh) is Advancing Public health Through Innovation how to Mitigate risk & Ensure regulatory Compliance of Specialized Samples Introduction to Signal Detection & Data Mining: Online Training Series Latin America Series: Expanding Clinical research Beyond Borders Latin America Series: regulatory Strategies in Latin America Navigating Medical Information Services Through Alliance Partnerships & Acquisitions Opioid Class rEMS: Whats It All About? Opioid Class rEMS: Whats Next? Outcomes Based Contracting: The Value-Based framework for Optimal Accountability Overview of Drug Development: from Discovery Through Marketing Application: Online Training Series Patient-reported Outcome Measures: Announcing the final fDA PrO Guidance Pharmacovigilance & Social Media Pharmacovigilance from the Medical Writers Perspective Prodrugs of Existing Drugs: 505(b)(1) or 505(b)(2) regulatory & Development Pathway? Progression-free Survival Oncology Series: Clinical Assessment & radiological Evaluation Progression-free Survival Oncology Series: Criteria for Determination of Progression & Statistical Evaluation Progression-free Survival Oncology Series: handling Missing/Censored Observations Progression-free Survival Oncology Series: regulatory Considerations regulatory Aspects of Prescription Drug/Biologics Advertising & Promotional Labeling: Online Training Course role of Medical Communications in Promotional review Safety reporting requirements in Clinical Trials: Indian & European Perspective Structured Product Labeling: update & Downstream use of SPL Data The Emergence of Digital Signatures in Clinical Operations understanding the Development & Label Allowances for 505(b)(2) AbuseDeterrent Products update on AMCP format Version 3.0: Industry Perspective update on the revised European Labeling Guideline: European Summary of Product Characteristics


Dia 2010 annual Report

Program Partners
American Association of Pharmaceutical Scientists (AAPS) American College of Toxicology (ACT) American Society of Gene & Cell Therapy (ASGCT) APEC harmonization Center (AhC) Biotechnology Industry Organization (BIO) Brazilian Society of Pharmaceutical Medicine (SBMf) Cardiac Safety research Consortium, Duke Clinical research Institute (CrSC, DCrI) China Center for Pharmaceutical International Exchange, State food & Drug Administration (CCPIE, SfDA) Chinese Pharmaceutical Association (CPA) Chinese Society of Toxicology (CST) Clinical research Association of Canada (CrAC) Co-ordination Group for Mutual recognition and Decentralised Procedures human (CMDh) European Directorate for the Quality of Medicines & health Care (EDQM) European federation of Pharmaceutical Industries & Associations (EfPIA) European forum for Good Clinical Practice (EfGCP) Childrens Medicines Working Party European Organization for rare Diseases (EurOrDIS) European Medicines Agency (EMA) fDA CDEr Office of Biostatistics health Canada heart rhythm Society Industry Pharmacovigilance Work Sharing Group (IPWG) Korea National Enterprise for Clinical Trials (KoNECT) International federation of Associations of Pharmaceutical Physicians (IfAPP) Korean Society of Pharmaceutical Medicine (KSPM) Oligonucleotide Therapeutics Society (OTS) Pharmaceutical researchers & Manufacturers of America (PhrMA) Pulmonary Vascular research Institute (PVrI) Southern African Development Community (SADC) Swiss Agency for Therapeutic Products (Swissmedic) uS fDA Center for Biologics Evaluation & research (CBEr) uS fDA Center for Devices & radiological health (CDrh) uS fDA Center for Drug Evaluation & research (CDEr) uS food & Drug Administration (uS fDA) World health Organization (WhO)

Dia 2010 annual Report


2010 Philanthropy Report

The Philanthropy Program is the means by which DIA supports charitable causes that benefit the public and help to fulfill the mission, vision, and social responsibility of the Association as a nonprofit Section 501(c)(3) tax-exempt, charitable, educational, and scientific corporation. The 2010 Philanthropy Program Committee was chaired by Dr. Tatsuo Kurokawa (Keio university faculty of Pharmacy, Japan). DIA is pleased to report the following 2010 research and event grant recipients:

American Cancer Society, Asian Initiatives

for a Cancer Support Group Workshop in be Conducted in Chinese for Chinese Cancer Patients

College of Pharmacy university of Minnesota

for their project factors related to the Success and failure of Designated Orphan Products

DrA, School of Pharmacy, Bonn, germany Duke university

for Drafting of a Table Guidance on Off Label use for the ICh

When were all discussing the same areas of concern, we can work so much better together.
Justina Molzon, MSPharm, JD, CAPT.
uspHs (cDeR, FDa)

for 4th Annual Clinical Trials Networks Best Practices (CTNBP) Study Coordinator Symposium

EurOrDIS (European Organisation for rare Diseases)

for the EurOrDIS Summer School in regulatory Affairs and health Technology Assessment (hTA) for Advanced Patient Advocates

university of Maryland

for health Literacy & health Information-Seeking Behaviors of Cancer Patients in Ambulatory health Care Settings g


Dia 2010 annual Report

Financial Overview
DIA is a not-for-profit and tax exempt Maryland Corporation organized under Section 501 (C) (3) of the IrS code. for fiscal year ended December 31, 2010, DIAs total revenue was $27.8 million. DIAs revenues were derived from various program offerings in North America, Europe, Japan, China, and India. Our operating revenue is primarily derived from meetings and workshops, training, membership dues, and advertising. The following two charts break down this revenue by revenue type and by region.


(USD in millions)
Membership $2.0 / 7% Advertising $1.1 / 4%


(USD in millions)
Japan, China and India $1.7 / 6%

Training $3.9 / 14% Meetings & workshops $20.8 / 75%

Europe $8.3 / 30% north America $17.8 / 64%

DIA maintains global operations through our headquarters in horsham, Pennsylvania (uSA) along with offices and operations located in Switzerland, Japan, India, and China. Total 2010 operating expenses were $18.6 million. Total direct cost of sales (revenues) was $13.9 million resulting in total contribution margin of $15.4 million or 55% of 2010 total revenue.


(USD in millions)

Cost of Sales (revenue) $13.9 / 25% Contribution Margin $13.9 / 25% Total revenue $27.8 / 50%

Net earnings from investments were $1.5 million, resulting in a net asset balance of $15.4 million at the end of fiscal year 2010. Notwithstanding the continuing weakness of the global economy throughout 2010, your DIA Board of Directors and management team remains committed to identifying and implementing careful, prudent, and strategic business practices that will ensure the financial security of DIA. g

Dia 2010 annual Report


wOrLDwIDE HEADQuArTErS Drug Information Association 800 Enterprise road, Suite 200 horsham, Pennsylvania 19044, uSA Tel. +1.215.442.6100, fax. +1.215.442.6199 EurOPE Elisabethenanlage 25 Postfach 4002 Basel, Switzerland Tel. +, fax. + JAPAn Nisso 22 Bldg. 7f 1-11-10, Azabudai, Minato-ku Tokyo 1010041 Tel. +81.3.5575.2130 InDIA A-303, Wellington Business Park I Andheri-Kurla road, Marol, Andheri (East) Mumbai 400 059, India Tel. +91.22.67653226, fax. +91.22.28594762 CHInA rm. 1155, Block A, Gateway Plaza No. 18 XiGuangLi, North road, East Third ring ChaoYang District, Beijing, 100027, China Tel. +86.10.5923.1109, fax. +86.10.5923.1090


Dia 2010 annual Report