by Chris M. Slawecki, Senior Copywriter, DIA
DIA, the global connector in the life sciences product development life cycle, will celebrate the 50th anniversary of its 1964 founding with several special events at its DIA 2014 50th Annual Meeting: Celebrate the Past, Invent the Future, June 15-19, 2014, in San Diego (CA).
DIA is a global volunteer and member community representing thousands of stakeholders working together to bring innovative, safe and effective products to patients. An association of more than 30,000 key stakeholders, DIA (formerly the Drug Information Association) builds productive relationships by bringing together regulators, life sciences professionals, academics and researchers, patient advocates and other influencers to exchange knowledge and collaborate in a neutral setting.
DIA’s founding in 1964 was closely tied to the 1962 passage of the Kefauver-Harris Drug Amendments implemented in the US after the use of thalidomide to treat morning sickness in expectant mothers was found to cause birth defects in thousands of babies born in Europe. These Amendments established a framework that required drug manufacturers to prove scientifically that a medication was not only safe, but effective. DIA was founded by a group of 30 individuals whose primary objective was the facilitation, standardization and sharing of information with professionals in medical and drug information related industries, to help all interested parties work within this new scientific and regulatory framework. In these early days, DIA mainly focused on medical communications and how to deliver the best information to patients about uses and problems of pharmaceutical products; these topics quickly expanded to incorporate discussion of related clinical data, data management and records management systems. Meeting proceedings and other pertinent information were shared through the Drug Information Bulletin, soon to become the peer-reviewed official DIA publication, the Drug Information Journal. In 1979, retired US Navy Commander Thomas W. Teal, Director of Statistics and Scientific Data Management at McNeil Pharmaceutical, became DIA’s first Executive Director and Drug Information Journal Editor in Chief.
In 1990, representatives of the regulatory agencies and industry associations of Europe, Japan and the US met in Brussels to originate the International Conference on Harmonization (ICH) for the purpose of rationalizing and harmonizing medical product registration controls in their respective jurisdictions. This need to globally harmonize ways for industry and regulatory reviewers to meet emerging scientific and regulatory requirements, combined with patient demand for safe and effective products, also heralded a new era of strategic geographic and operational expansion for DIA, first through the primary ICH regions of Europe, Japan and the US, and ultimately into China, Latin America, India, the Middle East and Africa.
Advancing its mission around the world, DIA presented the first Middle East Regulatory Conference in the United Arab Emirates in 1996. This same year, DIA opened its www.diahome.org website, to deliver information and networking and educational opportunities for interested digital participants regardless of location.
DIA’s strategic expansion continued through the first decade of the new millennium. In partnership with the European Federation of Pharmaceutical Industries and Associations, and with the South African Development Council, DIA presented its first Africa Regulatory Conference, featuring speakers from industry, government, and the World Health Organization, in 2008. In 2009, leadership from the FDA, WHO, Bill & Melinda Gates Foundation, International Vaccine Initiative, Developing Countries Regulatory Network, and BIO Ventures for Global Health, convened at DIA’s first Global Vaccine Development for World Health Symposium in Bethesda, MD. DIA’s first training workshop in China, and first DIA China Annual Meeting, presented in collaboration with the China Center for Pharmaceutical Information Exchange of the State Food & Drug Administration, were also presented in 2009.
In 2011, DIA presented the first in a series of US Conferences on Rare Diseases and Orphan Products in co-sponsorship with the National Organization for Rare Disorders and in collaboration with the FDA, (US) National Institutes of Health, European Organization for Rare Diseases, and the Department of Pediatrics of the Duke University School of Medicine. DIA also served in 2011 as co-sponsor of the Asia-Pacific region’s first Asia Regulatory Conference presented in Seoul, Republic of Korea, with the APEC Harmonization Center and the International Federation of Pharmaceutical Manufacturers & Associations.
The DIA 2013 49th Annual Meeting in Boston convened a historic regulatory forum in which representatives from the Centers of Drug Evaluation (CDE) from Mainland China and from Taiwan shared their respective regulatory review experiences. Forum moderator Dr. Ling Su, DIA’s first Board President to be elected from China, noted the historic importance of this forum: “This is the first time ever to have both sides of the strait sitting in the same room to discuss the same topic.”
In 2013, DIA retired the Drug Information Journal and launched the new journal Therapeutic Innovation & Regulatory Science to reflect the organization’s expanded topical reach – in addition to drugs, products such as devices, diagnostics, and drug-device combination products, plus emerging disciplines such as comparative effectiveness research and new models for collaboration between product developers, patients and payers – as well as the growing synergy between therapeutic innovation and innovative regulatory science that keeps pace.
To illustrate DIA’s unique ability to bring industry and regulatory leadership together to advance therapeutic innovation and regulatory science, DIA 2014 50th Annual Meeting: Celebrate the Past – Invent the Future is DIA’s first Annual Meeting to be co-chaired, and will be jointly led by Freda C. Lewis-Hall, MD, Chief Medical Officer and Executive Vice President of Pfizer, Inc.; and Rear Admiral (retired) Sandra L. Kweder, MD, Deputy Director, Office of New Drugs, CDER, FDA.
Dr. Murray M. “Mac” Lumpkin has been participating in DIA since the late 1980s, served for six years on the DIA Board of Directors and in 2009 received the DIA Distinguished Career Award. He served at the FDA for more than two decades before retiring in late 2013 to join The Gates Foundation, where he leads strategic initiatives around global regulatory systems. “DIA brings together regulators, industry, academics, patients, NGOs (non-governmental organizations) and others, and gives us a chance to really talk about issues that are important to us in an appropriate neutral, transparent forum,” Mac explains. “How DIA started, what DIA has and is trying to accomplish, and how it has changed and evolved over the past five decades, is just remarkable.”
“When I think about some of the important elements that enable getting the appropriate therapies, devices and diagnostics to people globally, DIA is right in the middle of that conversation and has the opportunity to accelerate, tailor and make valuable medical products economically viable for those facing health challenges around the world,” explains DIA Global Chief Executive Lopez Kunz. “We are determined to see DIA continue as the destination, in person or virtual, for our stakeholders, members, staff and volunteers to converge and convene. We want to maintain the strong foundation that has made DIA successful for the past fifty years, but also add those elements that will take DIA to the next level as a forum where constituents come together to advance this cause.”
DIA is an independent, nonprofit organization with its global center located in Washington, D.C., USA; and with regional offices covering North and South America (Horsham, Pennsylvania, USA); China (Beijing); Europe, Middle East & Africa (Basel, Switzerland); India (Mumbai); and Japan (Tokyo). For more information, visit www.diahome.org.