Membership Has Its Privileges

All is quiet at the Drug Information Association's new headquarters, a short ride from the hubbub of Philadelphia. But inside, the association buzzes with change as it harnesses the expertise and energy of its members to improve healthcare around the world. Now approaching its 40th year, DIA is expanding both its educational programs and its global reach.

DIA's executive team includes (l to r) Charles Depew, president, Bob Assenzo, executive director, and Irwin Martin, immediate past president and associate executive director.

An association member since 1967, Executive Director Bob Assenzo confesses that his history is wrapped up with DIA's. He shares both accounts in an easygoing style, combining industry expertise gained from his former jobs in the regulatory departments of Novo Nordisk and Upjohn with the idealism of a director of a nonprofit organization.

From a Small Seed

DIA barely resembles the association that was incorporated in 1964. "We started out with 30 members, and now we have almost 1,000 times as many," says Assenzo. "The whole focus was on medical communications and figuring out how to best deliver up-to-date information to patients about the use and potential problems of pharmaceuticals. We formed because there was an interest in finding out how executives in other companies did their jobs. What their barriers and concerns were and whether they were the same as ours. And by and large, we found out that they were the same." (See "Membership Growth," page 36.)

Today, DIA's 27,000 members come from every level of the pharma industry as well as from government and regulatory agencies, academic institutions, contract service organizations, and healthcare consultancies in 75 countries. DIA programs and services cover the gamut of drug development and marketing. But the association's purpose-the exchange of information to foster healthcare advances-remains the same.

DIA's lifeblood is its volunteers-plus a small paid staff-and it survives because of their efforts to accomplish its mission of advancing members' careers, professions, and organizations. Volunteers' dedication to that goal, their ability to step outside of insular corporate thinking, and their grass-roots approach to tackling industry issues are what set DIA apart from commercial training companies.

Members often find that, as their careers mature, they end up volunteering to speak at or chair the same types of events they attended during the early part of their career. That's because, despite busy schedules, they find that membership has its privileges.

"When people share scientifically with friends and colleagues, they get a passion for DIA," says Assenzo. "Some people, like myself, volunteer because it's pay-back time. DIA helped my career, and now I can help other people. Others volunteer because they have something to say and they need a place to say it. DIA gives them that opportunity. Other people want visibility or recognition, and we can give them that, too, by offering them a stage to speak on. And the companies benefit. When I was at Upjohn, they supported my involvement because they knew, when I spoke on stage, people would say, 'Wow! Upjohn has a lot of good scientists. That's a company I'd like to work for.'"

Companies may benefit, but DIA remains solidly committed to the individual. DIA's mantra of "meeting member needs" is especially notable, given an industry environment made faceless by megamergers in which long-standing employees have little job security. It gears its programs and services toward people within the healthcare industry, not just pharma. There are no corporate memberships or sponsorships, and individual dues are only $100, or 100 euros, annually. Those two factors create a neutral forum where all healthcare players-especially regulators-feel comfortable discussing healthcare issues and receiving training.

Assenzo says DIA's neutrality encourages the multidisciplinary approach necessary to make the organization work. "When we discuss controversial issues, we involve all parties. As such, DIA gives the industry the type of elasticity it won't find in pharma company board rooms-a forum where sides can challenge each other and they don't snap."

Growing Pains

Despite its age, DIA has yet to hit its stride. Various executives discuss the organization's current growing pains.

Irwin Martin, immediate past president and associate executive director, a newly created position, says, "DIA started as a "mom and pop" shop. There are still a lot of residuals of how we used to do things and a 'this is how we've always done it' attitude." (See "From Past to Present," page 44.)

That may change as DIA's structure becomes more complex. Specifically, it expects a proliferation of special interest area communities (SIACs), DIA's global grass-roots system responsible for identifying and prioritizing programming. (See "Special Interests," page 38.)

But for a group based on volunteerism, DIA is becoming too systemized, says Lou Morris, a former DIA president and past acting director and branch chief of FDA's Division of Drug Marketing, Advertising, and Communications, who now heads his own consultancy. "Volunteers today must be a member of a special interest group; there's an organization for those groups and a mission statement for each one. Overall, it is a much more complex method of creating workshops, and some of the oldtimers say it's getting to be too much like work and not as much fun."

DIA executives say members don't have to join a SIAC but that those groups are the major conduit for building an affiliation with the association.

Martin says new committees are needed because "there's much work to do." That's especially true in areas outside of clinical development, which involves more than 45 percent of DIA's membership.

"In the past, we were strictly focused on the pharma industry and drugs, but that has changed because healthcare has changed," says Eleanor Perfetto, president-elect of DIA and managing consultant for the Weinberg Group, a scientific and regulatory consulting firm. "Now DIA is trying to cover the gamut and it is inevitable that groups such as device manufacturers, because of drug-device combinations, come under the DIA umbrella."

Annual Meeting

DIA's annual meeting is known as the event for those in research and development. It's an all-inclusive week-long buffet of poster sessions, networking dinners and functions, tutorials, and more than 350 sessions on topics ranging from advertising to validation. The 39th Annual Meeting, scheduled for June 15-19 in San Antonio, Texas, will feature 1,000 speakers and is expected to draw 9,000 people. Murray M. Lumpkin, MD, MSc, principal associate commissioner for FDA, will chair the event.

"When people ask if you're going to DIA, they're referring to the annual meeting," says Martin. "Even in the 1980s, our meeting was very important, though we had only 900 attendees. But it was still the place to be to get up to date on virtually anything related to pharmaceutical R&D."

Carol Layer, administrative director and DIA's longest-term employee, says the meeting has become so popular that the organization must limit the number of exhibitors. Although that cuts into proceeds, she says, "keeping a reasonable balance between exhibits and attendees makes for a happier crowd."

The DIA office in Basel, Switzerland, holds an annual EuroMeeting with content similar to the US meeting, but regional experts present the sessions. Scheduled for March 5-7 in Rome, Italy, the meeting will have already occurred by the time this story goes to press.

Co-chairs for that event were Andrzej Czarnecki, worldwide pharmacovigilance and epidemiology expert for Eli Lilly, UK, and Jacques Mascaro of Johnson & Johnson pharmaceutical R&D, UK. Around 2,000 participants-double the number at last year's EuroMeeting in Barcelona, Spain-were scheduled to attend.

Career Track

Long before pharma companies instituted "customer-centric" approaches, DIA was keenly aware of how its efforts helped patients.

"I'm old enough now to say this: DIA is going to help society," says Assenzo. "Our goal is to help people develop professionally so they will do a good job for their employers. Then companies will produce better drugs for patients. They will look at the right questions and not cut corners."

The DIA center for career and professional development (CC&PD), launched in June 2002, is charged with centralizing professional programs aimed at developing the organization's-and the healthcare industry's-future. Susan McLaughlin, worldwide director of CC&PD (formerly with Johnson & Johnson), says, to help employees remain competitive in the event of a pink slip, DIA must offer the training programs pharma companies have cut in the last four to five years.

"Training and education are critical to meeting our members' needs," says McLaughlin. "The center focuses on individuals and helps them shape their career in whatever path that might be. Down the road, DIA plans to start a mentoring program, so a member can come to us and say, 'This is what I've been doing. I'd like to move over here. What do I need to be able to do that?'"

Layer believes that, because DIA is about career and professional development, people should join for the most selfish of reasons. She says, "I don't focus on the altruistic aspect of volunteering. People should join because they want to do a better job, get promoted, increase their pool of knowledge, and be able, when their company downsizes, to move into another job. They should be mentored, networked, trained. They should know as much as they can about everything that's going on. We have 27,000 members, but only 1,000 are volunteers. The 26,000 members are not here for the warm fuzzies; they are here for the nuts and bolts, the content that we give away and that they buy."

To jump-start college students' careers, CC&PD also maintains partnerships with several universities, including the Massachusetts College of Pharmacy and Health Sciences, the University of Southern California School of Pharmacy, and West Chester University in Pennsylvania.

"We've started working with students because they are our future," says McLaughlin. "Universities are where new people are coming from, and they need to understand everything that they possibly can about the pharmaceutical industry."

CC&PD also houses DIA's new e-learning programs, created to better accommodate its internationally dispersed membership as well as increased travel concerns.

"Everybody can grow, but we needed a spike of innovation to get us to the next tier," says Layer. "In the strangest way, September 11th was that spike, because so much of our information sharing-other than DIA journals-came through face-to-face meetings. What if we lost the opportunity to communicate to people in a live meeting? Would the association go away? No, but we would need to get content out in different ways."

In October 2002, the organization launched its first digital medical communications program, which is certified by the Accreditation Council for Continuing Medical Education and the American Council on Pharmaceutical Education. It was so successful, says McLaughlin, that DIA is developing more e-learning modules, including a first-of-its-kind clinical investigator certification program.

Like other associations, members maintain that much of the value of DIA meetings comes from networking. To transfer that interaction to web-based programs, the association is creating several "blended learning" initiatives, which consist of a face-to-face meeting and a follow-up or a continuation of that same subject online.

McLaughlin says those programs hold the most promise for now because they provide a middle ground for executives, regardless of how web-savvy they may be: "We conducted a one-day, face-to-face HIPAA workshop, which was followed by two weeks of online web board access in which attendees could ask the instructor or other students questions. Participation was much higher than expected-85 percent of students participated in the follow-up. We are now looking at adding a workbook, CD, or video withthe live instruction."

Going Global

Efforts such as the International Conference on Harmonization and the common technical document are ushering in a decade in which drug development is a truly global process.

"Constituencies from around the world that were on the periphery of drug development are now becoming more actively involved because their governments are regulating more and want to interact with FDA and because the business of conducting clinical trials has spread to formerly fringe areas like Eastern Europe, Asia, and the Pacific Rim," says Michael Umen, DIA member and president of Michael Umen & Associates, a consultancy that helps generate drug approval applications for FDA submission.

With international offices in Basel and Tokyo, DIA already has a foot firmly planted oversees. Its executives believe that more offices may be established during the next five years as regional chapters begin to grow and prosper. In particular, DIA President Charles Depew, vice-president, worldwide regulatory affairs for GlaxoSmithKline, thinks membership in Japan will grow rapidly. Adding two new meetings there each year doesn't even keep up with demand.

"Even though you may develop a drug in one country, that doesn't mean it will be marketed in only one country," says Depew. "I was in a pharmacovigilance meeting in Japan, but the Japanese audience was interested in pharmacovigilance regulations outside of Japan. Industry people can go to DIA meetings to learn about regulations within their own country, but they can also learn about regulations involved in preparing their drugs for market elsewhere."

Presidents' Projects

The executive committee, comprised of the current president, the president-elect, the immediate past-president, and the executive director, governs DIA's member-elected board of directors.

Executive committee volunteers-all unpaid except Assenzo-commit to a three-year term, while board members are elected to either a two- or a three-year term. Because the board only meets quarterly, allowing volunteers to meet the obligations of their day jobs, that time in office is necessary to affect change.

"Each president takes a platform, kind of like Miss America," says Martin. "Nobody tells the president that they have to pick a pet project, but every president does."

Eleanor Perfetto, who takes the reins at the annual meeting in June, agrees that the three-year term is necessary because it "helps develop ideas for what you want to contribute, allows time to implement them, and ensures you'll still be around to follow up on that implementation."

Perfetto is forming her plan now but says it will probably include staff education: "What will help maintain DIA's success is having a board of directors and staff who are well trained and prepared to handle the new roles, responsibilities, and budget that a large membership brings."

Depew's focus on Europe in 2002 greatly expanded the organization's ability to work globally. By instituting operating systems and practices between the United States and international offices and by implementing standard operating procedures, DIA aligned the responsibilities and protocol for volunteer leadership throughout all offices. Having laid that groundwork, DIA was able to increase programming in Europe.

Depew also revisited the strategic plan, opening it up for the first time to DIA staff below the senior management team level. The new plan, which includes an environmental statement that tracks trends in discovery, development, regulation, licensing, utilization, industry consolidation, evolving communications, and information management technologies, should help DIA keep its finger on the pulse of drug development and ensure that its programs are cutting edge.

Martin says his focus was building the new headquarters and formally establishing the DIA Foundation, which coordinates all the organization's charitable activities. The foundation's endowments support a wide range of training opportunities, from hosting meetings to arranging for regulatory agencies such as Australia's Therapeutic Goods Administration or the European Medicines Evaluation Agency to train other regulatory officials within their regions.

"In 1999, some unexpected expenses came along, and we paid for them by not giving as many research grants," says Martin. "The board was very embarrassed by that. We decided to separate those funds from expenses and to put up a fire wall to prevent that from happening again."

The foundation also supports the International Development Committee (IDC), DIA's major effort to help drug development outside North America, Europe, and Japan-DIA's three core areas. IDC will pinpoint meetings needed in "Type A" countries or regions, such as Korea, Taiwan, China, Hong Kong, Singapore, and Latin America, which have the potential to become full-blown DIA regions. For other areas, IDC will suggest organizations to give grants to so they can run meetings similar to those DIA would offer.

"We could have easily been successful being a North American meeting company," says Martin. "But North American members had colleagues around the world. They were learning things that their colleagues did not have the opportunity to learn. We knew that we needed to at least train the European research sites. So we went into Europe. From there, we realized there are people all over the world in the pharma and related industries that could use training. The IDC is one way of doing that."

Challenges and Opportunities

DIA is a contradiction of sorts. The organization is still in its infancy, yet it has the ability to gather all disciplines together to hold the most sophisticated healthcare debates.

Despite that ability, challenges abound. DIA must attract a steady stream of new volunteers, otherwise it will become an old boys' club-a past problem, according to Assenzo. But getting volunteers is harder than before. "The difference between then and now," says Assenzo, "is that people were more sharing then. Today's industry executives are insular. They think if they share something scientific that they're giving away a secret. But they're not. It's just science."

DIA's strategic plan instructs the organization to diversify its membership-more than 70 percent of members currently come from pharma, biotech, or medical device industries.

To represent a more holistic approach to healthcare and to access clinical trial subjects, DIA needs to increase membership for executives from HMOs, contract service organizations, and patient groups. But there is increased competition for participants. Publishers, meeting companies, pharma companies themselves, and other associations are recruiting the same audiences. For-profit organizations pose the greatest threat because they are willing to pay speakers and educators.

"We rely on the good nature, heart, and soul of the volunteer board members who give up their time and their weekends to help DIA," says Depew.

He believes that membership will increase because those working in healthcare naturally want to give back by sharing information, talking about their careers, and mentoring newcomers.

Assenzo is especially focused on small, start-up biotech companies, which he calls "shining lights." "That," he says, "is where the energy and high motivation are. They have no history and they can try new things. That's where we need to concentrate, to attract more of the small businesses, because we can really help them and they'd love to have the help."

Another challenge for the association is its lack of promotion. Because it is committed to remaining neutral on controversial issues, DIA has no media spokespeople. Therefore, it misses an opportunity to raise the industry's reputation by providing balanced information. Instead, the press goes after political organizations, such as company-funded PhRMA, whose information is not as balanced.

"Charles Depew could never interpret an issue or speak for DIA because he is with GlaxoSmithKline," says Kate Strauser, worldwide director of member services and communications and executive editor of DIA publications. "We have no business taking a position or advocating or lobbying on controversial issues. But if it's process or clinical trial oriented-trial designs or innovative ways of capturing clinical trial information-we can speak to that."

Meanwhile, industry turnover prom-ises to keep DIA busy. "If you look at industry trends, rarely do people stay

in the same company for 25 or 30 years," says Martin. "That used to be the norm. Now people stay three to five years and go on to another job. There is a big need for training that companies may no longer be willing to do in-house because of the rapid turnover."

DIA's biggest asset-commitment to patients without commitment to party lines-means there will always be a place for it as long as pharma companies need to work with other audiences to manage and improve patient health.