Diana Anderson — Recruiting an Authority Bringing together her knowledge in rheumatology and her expertise in patient recruitment, Diana L. Anderson, Ph.D., has helped turn RRI into a leader in rheumatology services and is positioning its sister company, D. Anderson and Company, as a leader in helping pharmaceutical and biotechnology companies recruit patients into clinical trials. diana anderson Although I’m a busy person with many irons in many fires, I feel most comfortable operating with an open-door policy. October 2003 3 companies, a plethora of papers, speaking engagements and lectures, two books with a third on the way, as well as a busy life outside the workplace — juggling so many tasks would be enough to make many people stumble. For Diana L. Anderson, Ph.D., president and CEO of D. Anderson International, managing so many projects is not just a result of good time-management, but a way of life. From early in her career, Dr. Anderson has found she is most challenged when she has multiple projects in the works at the same time. Throughout her career she has been involved in more than one business at the same time. Multitasking is, she believes, a smart way to do business, particularly for smaller companies, since a company that has a range of projects is less likely to be hurt by weak market trends. “A company will be more stable if it has more than one product line to rely on,” she says. “One component of the business may be on an upward trend, while another component may be on a downward trend.” Diversification is exactly what Dr. Anderson has helped create at the company now known as D. L. Anderson International Inc., a recently formed holding company with two subsidiaries — RRI and D. Anderson and Company. RRI, which has been in business for 11 years, provides rheumatology services as well as site management and CRO services. D. Anderson and Company, which was born out of RRI and which has been in operation for more than a year, is a multitherapeutic patient-recruitment organization. Dr. Anderson and her colleagues also formed a third subsidiary, called Best Recruitment Practices, which will include the company’s newly developed patient-recruitment training program. Playing an active role in all the subsidiaries can be quite a balancing act, Dr. Anderson acknowledges, but in many ways the close relationship between the companies means her different roles interweave. “Although the staff at RRI and D. Anderson are clearly differentiated, there often is a strong cross over between the two companies,” she says. “That’s important for us. We want the staff to have a clear understanding that we’re working for one company with a common goal, and that goal is the success of all the subsidiaries.” A Natural Progression Dr. Anderson’s position today as head of a group of healthcare companies is somewhat unusual because she began not in finance or sales and marketing or as a physician investigator, as many of her peers have done, but in nursing. “When people learn that I have a background in nursing, they are quite surprised,” she notes. Dr. Anderson decided to study nursing close to home, at the University of Nebraska, before heading to the University of Texas Health Center, near San Antonio, for her master’s degree. That move was at the recommendation of a woman she credits as one of her mentors. “The dean of the college of nursing, Nancy Langston, Ph.D., encouraged me to go to the University of Texas Health Science Center at San Antonio because she believed it was an innovative school and program,” Dr. Anderson says. While an undergraduate, Dr. Anderson was given a rare opportunity to work as a faculty member, an experience that awakened her love of teaching and has provided benefits throughout her career. “I taught for about three and a half years and enjoyed the experience immensely, but I wanted a different career path,” she says. “I eventually landed at the St. Paul Medical Center and, through my work, earned my Ph.D. at Texas Women’s University in Denton.” A series of events helped to lay the foundation for Dr. Anderson’s career. Firstly, through her nursing experience, she developed a keen interest in the area of pain. Then, while at San Antonio, she met her husband, who had arthritis as a result of an old injury. Thirdly, an opportunity to work in the field of arthritis presented itself with the job opening at St. Paul. As director of the St. Paul Arthritis Center, Dr. Anderson’s task was to develop an arthritis program that would be community-service oriented as well as profitable. Her later move into clinical research was, she says, a matter of fate. Through her job at St. Paul’s she worked with a group of physicians who were in private practice and also conducted clinical research. “I began by helping to market Metroplex Clinical Research Center,” she says. “The center’s executives were interested in growing from a mom-and-pop organization to a moderate-size business. I helped them develop marketing collateral materials and concepts to increase the center’s visibility.” The experience at Metroplex, where she worked for some years as chief operating officer while also continuing her work at St. Paul’s, fueled Dr. Anderson’s fascination with the field of clinical research. Building a Network The physicians behind Metroplex — Dr. Stanley Cohen, Dr. Roy Fleischmann, Dr. Tom Schnitzer, and Dr. Marshall Sack, all rheumatologists — had the idea to form a cohesive network that would bring research sites together. In 1992, they formed what Dr. Anderson describes as one of the first site-management organizations (SMOs), Rheumatology Research International, later RRI. Dr. Anderson was brought in within a few months and once again found herself straddling two worlds. For about a year and a half, she continued her work at Metroplex, while helping to establish the SMO. RRI provides comprehensive rheumatology services, including consultation and advertising, site management, worldwide affiliates, patient-recruitment and call-center management, market research, and communications and custom publishing. The company has performed more than 60 clinical-research projects since 1994, managed more than 20 national patient-recruitment campaigns, and acts as an advisor to 18 major pharmaceutical companies. RRI’s staff members are experts in the field of rheumatology. Because of its focus, RRI has been involved in many key clinical-research projects in rheumatoid arthritis (RA) and other rheumatological conditions, beginning with work on the drug Arava (leflunomide), a disease modifying anti-rheumatic drug from Aventis for the treatment of RA. Dr. Anderson says in the past five years in particular, huge progress has been made in the development of treatments for RA. “I’ve had the good fortune to be involved in many clinical trials for the new compounds for the treatment of RA,” she says. “Now, those medications can not only treat the symptoms, but even halt the progression of the disease in many instances. That’s revolutionized the quality of life for people with RA.” Research and discovery for new, improved medications means clinical trials are critical to releasing successful drugs. But a huge obstacle to clinical trials is patient recruitment. It is an area that has fascinated Dr. Anderson for the past 12 years and an issue that has been central to her work at RRI. In June of last year, Dr. Anderson and her colleagues created a private company to focus on patient recruitment. The new company was launched under Dr. Anderson’s name. “Within the first 30 days of business we had $1 million in new business, almost exclusively from repeat clients from RRI,” she says. Among the services D. Anderson provides to clients are: consulting and patient-recruitment management, market research and feasibility assessments, regulatory management, clinical-trial branding, community outreach and public relations, site-specific recruitment services, direct-to-consumer strategies, call-center support, and retention services. Dr. Anderson says many of the problems in clinical-trial recruitment stem from high-investigator turnover, with about 50% of the 30,000 investigators nationwide only likely to complete one clinical trial. “We’re constantly engaging and seeing new investigators entering the system,” she says. “There are many variables that impact the challenges in patient recruitment. Another key issue is that less than 10% of the population has ever participated in a clinical trial.” Through the establishment of D. Anderson, as well as articles, books, speaking engagements, and discussions, Dr. Anderson has been working to bring together experts in the field to share their knowledge so the healthcare community might better understand what works and what doesn’t in recruiting for clinical trials. As for D. Anderson, Dr. Anderson says because it started out as a SMO, the staff has a broad understanding of site-related issues. The company has brought in marketing and communications staff to supplement its clinical knowledge base. “We put together a menu of services for our clients,” she says. “The focus is on working with study coordinators and helping them to understand the recruitment process, working with the sites to help them understand trial requirements, as well as doing community outreach. “We also focus on understanding the subject population and finding out what motivates people to want to participate in a trial,” she continues. “Consumer awareness is critical. If the industry is going to continue to have more studies, it needs more subjects to participate. To do that, as an industry we are going to have to find a way to work together to heighten people’s awareness of what a clinical trial is.” Dr. Anderson and her colleagues have established a patient-recruitment training program that will be part of Best Recruitment Practices. “Right now the program is geared toward educating CRAs, IRB personnel, investigator sites, and project managers,” she says. “If this concept catches on, I hope we can help increase the number of people who understand and can help provide patient-recruitment services.” A Juggling Act Dr. Anderson is involved in a number of other areas, including providing consultation to the pharma industry, conducting lectures on the work of SMOs and patient-recruitment organizations, serving on a number of boards, particularly in the areas of clinical research and rheumatology, as well as writing books and articles. “I learn so much by networking with my peers in the field, as well as coming up to speed with things that are going on in the industry,” she notes. Dr. Anderson is the author of two books — “A Guide to Patient Recruitment: Best Practices and Proven Strategies” and “50 Ways to Cope with Arthritis.” The patient-recruitment book has been used as a textbook in clinical-trial classes at several colleges, including Georgetown University. “It’s been rewarding to have the opportunity to generate interest and bring in other experts in the field to participate and share their knowledge,” she says, referring to her work for the patient-recruitment book. The arthritis book is in its second printing and will be available in paperback. She says a number of clients have distributed the book worldwide, and one pharmaceutical company plans to translate it into several languages. The book on arthritis, she says, was a labor of love. She had seen her husband deal with osteoarthritis and that experience led her to write the book. Above all, Dr. Anderson says balance with family is critically important for her. Both her children live near her, she has two young grandchildren, and she and her husband are often busy with their favorite hobby, interior decorating and home renovation. That open, energetic lifestyle has found its way into the workplace, especially in how Dr. Anderson works with her staff and in her efforts to bring balance into the office environment. “Although I have many irons in many fires, I feel most comfortable operating with an open-door policy,” she says. “I’m still quite hands-on in terms of grooming younger staff and working closely with experienced staff to a certain point. But I allow people to function autonomously and independently once they are comfortable. I believe it is paramount to be fair and ethical in how I carry myself and in terms of influencing others.” PharmaVoice welcomes comments about this article. E-mail us at [email protected]. A clinical path 2003 — Present. President and CEO, D. Anderson International, Dallas, holding company for RRI, D. Anderson and Company, and Best Recruitment Practices 2002 — Present. President and CEO, D. Anderson and Company, Dallas 2000 — Present. President and CEO, RRI, Dallas 1997 — 2003. Manager, The Osteoporosis Center, St. Paul Medical Center, Dallas 1997 — 2000. President and chief operating officer, Rheumatology Research International (RRI), Dallas 1997 — 1999. Consultant, marketing/patient recruitment, Metroplex Clinical Research Center, Dallas 1995 — 1997. VP, operations, Rheumatology Research International, Dallas 1993 — 1996. Chief operating officer, Metroplex Clinical Research Center, Dallas 1992 — 1996. Director, Outpatient Bone and Joint Services, St. Paul Medical Center, Dallas 1989 — 1992. Director, The St. Paul Arthritis Center, St. Paul Medical Center, Dallas. Education 1997. Ph.D., Texas Woman’s University, Denton, Texas 1981. M.S.N., University of Texas Health Science Center, San Antonio 1978. B.D.N., University of Nebraska, Lincoln, Neb. Professional Affiliations 2003. Chair, Association of Clinical Research Professionals (ACRP), Alexandria, Va. 2002. Vice chairman, ACRP 2000 and 2001. Chairman, Communications Committee, ACRP 1999 — 2001. Chairman, Communications and Public Relations Committee, ACRP 1998 — 2001. Board of Trustees, North American Council, ACRP 1996 — 2001. Board of Directors, North Texas Chapter Arthritis Foundation 1997. Chair, North Texas Chapter Arthritis Foundation, Public Education Committee 1996 — 1997. Board of Trustees, House Delegates, National Arthritis Foundation 1996. President. Association of Rheumatology Health Professionals (ARHP) 1995. First VP, ARHP 1994 — 1995. Board of Directors, American College of Rheumatology 1993. Chairman, Operations Committee, ARHP 1989 — 1993. Government Affairs Committee Chairman, North Texas Chapter of the Arthritis Foundation 1988 — 1993. Board of Directors, North Texas Chapter of the Arthritis Foundation 1990 — 1991. Publications Committee, National Arthritis Health Professions 1988 — 1989. Chairman, Public Education and Information Committee, Arthritis Foundation North Texas Chapter 1988 — 1989. President, Western U.S.A. Pain Society 1988. President, Arthritis Health Professions, North Texas Chapter 1986. Secretary, Western U.S.A. Pain Society diana L. anderson – resume Finding a Caring Focus In an exclusive interview with PharmaVOICE, Diana L. Anderson, Ph.D., president and CEO of D. L. Anderson International, talks about what motivates her, the people who have influenced her, and how she hopes to influence others. What is it about the clinical-trial process that attracted you, and in what way does it motivate you? I wanted to be a nurse since I was a little girl and although I didn’t choose to stay in that field, I’ve always been involved in the health professions. I’ve managed to grow in my career path and in my development professionally as well as personally, keeping that focus of being in a caring profession as a backdrop. Clinical research is just a different way of remaining in the caring profession, since ultimately it’s about the development of new medications an new devices that will help improve the quality of life, and in some instances, prolong life. Where do you believe you personally have had the greatest influence in the research field, and what would you hope your legacy would be? A significant moment for me was when I submitted an abstract at a conference and was asked to speak about patient recruitment many years ago. Someone I respected quite a bit, Bob White from Amgen, said to me, “Well young lady, I think you’ve really made a mark here with your innovative concepts with respect to this area”. I’m certainly not alone in this — there have been many significant contributors to the area of patient recruitment — but I’d like to think that I’ve been able to have some influence in developing this concept. Also, the opportunities I have had to mentor my women colleagues would be important to me as part of my legacy. We hold the status of a woman-owned (minority) business and I am proud of this accomplishment. Have there been people who have had a significant influence on the choices you have made? My father was a significant influence on my life and career. He was a kind, ethical man, more patient than myself. He always told me, “the harder you work, the luckier you get” and “that if you work hard you can be successful.” I don’t believe the sky is the limit; a lot of other variables are involved in how we progress in our success, but hard work is important. Yet to be successful it’s important not to lose focus and keep a balance in one’s life. My husband has always been a strong adviser for me. He retired a few years ago when he was 50 after we made a decision about quality of life and how we wanted to work together to support our life and family. We both feel challenged and happy with what we’re doing. Early on in my career I had the opportunity to work with a very strong individual, Judy Nemeyer, who was a supervisor of nurses. She taught me a lot about compassion and thinking about how people feel and respond, and how important it is, no matter how busy or stressed we become, to put people first. Then Dr. Roy Fleischmann, who has been a friend for 18 years, has been a significant leadership mentor. Also, our chairman of the board, Dr. Tom Schnitzer, has been a valued advisor and mentor who has “given me wings,” so to speak. Dr. Schnitzer is free with praise and support, which I find unique in business. What is your most pressing professional concern? I truly believe that with regard to consumer awareness, the work that we do as a profession in finding ways to interest people in becoming participants in clinical trials is a pressing issue. It reminds me of the days when we didn’t have DTC for medications. If there were heightened consumer-awareness programs where we referred people to, for example, clinicaltrials.gov, that would benefit everyone. The problem is, because everyone is in competition, it is difficult to mobilize an industry effort to develop messages and programs that will change this. What is your philosophy with regard to finding and hiring quality staff? I surround myself with quality staff; I try to bring in people who have crossed my path both professionally and personally. There are a couple of people from my family who work in the business, which reinforces my overall philosophy that in looking for the best people, it’s important to recognize that they can come from many different aspects of life. Another example of my recruitment approach is our chief financial officer, Steve Gallob. His sister was my personal assistant for nine years and he came in to do some consulting, and we ended up hiring him. Then our director of marketing, Margo Whitley, who has been a personal friend for 15 years. She is a multitalented individual and I hired her to develop patient-recruitment programs for the research site. She’s since come to work with RRI and DAC. Margo was someone who I just recognized had incredible creative talents, and she has been able to translate those talents to develop the expertise of the clinical-trials business. Dr. Diana Anderson Leadership through volunteerism Throughout her career, Diana L. Anderson, Ph.D., has been involved in serving on the boards of various industry associations and organizations. to be in a position to give back to an industry that has done so well by me has been very rewarding. “By serving on boards, I’ve always taken away a lot more than I’ve given,” she says. “I’ve learned so much about the dynamics between people, working together as a team, compromise, managing politics, and leadership.” This past year, Dr. Anderson has taken on the role of chair of the Association of Clinical Research Professionals (ACRP). ACRP is the primary resource for clinical-research professionals in the pharmaceutical, biotechnology, and medical-device industries, as well as those in hospital, academic medical centers, and physician-office settings. The mission of the association is to provide global leadership for the clinical-research profession by promoting and advancing the highest ethical standards and practices. “My goal this year has been to offer my clinical and business experience, along with the experience of other board members and the CEO to look at the infrastructure of the organization, investigate where we need change, and help the organization become more nimble and flexible, while at the same time focusing on ACRP’s primary goal, which is member services,” Dr. Anderson says. “I have been a member of ACRP for years, and I strongly believe in the goals and missions of the organization.” Dr. Anderson was delighted to step into the role as chair of ACRP. “To be in a position to be able to give back to an industry that has done so well by me has been very rewarding,” she says. “I had served on the board and my peers encouraged me to accept the chair. It was important to me that my colleagues on the board thought I could bring value and experience. The organization is critically important and I believe ACRP will become even more important in the future.” ACRP was founded in 1976 to address the distinct educational and networking needs of research nurses and others who supported the work of clinical investigations. With its own professional society came the recognition of a new distinctive profession — that of the clinical researcher. More than 25 years later, ACRP is an international association comprised of more than 18,000 individuals dedicated to clinical research and development. Dr. Anderson notes that the rapid growth of the organization has led to some significant challenges. “The organization, which started with about 5,000 or 6,000 members has had rapid membership growth in the last three years,” she says. “ACRP has gone from a mom-and-pop-type organization to a very large, international organization. Interest from our members to serve on the board also has grown. Last year, 25 individuals ran for five board seats. We’ve also seen greater diversity of members. “ACRP has added a physician component to the organization where it provides training and certification, which has been a challenge as well as an opportunity,” Dr. Anderson continues. “This component almost takes ACRP into a different market.” ACRP members can enhance their knowledge of clinical research with skills and expertise gained by attending ACRP seminars, educational sessions, audio conferences, certification programs, and forum activities. These professional development opportunities provide study coordinators, study monitors, project managers, QA/QC auditors, site managers, regulatory-affairs professionals, data managers, and others with information and tools to perform their job functions. ACRP also includes the investigator in the training process and offers continuing medical education (CME) credit hours covering a broad range of good clinical practice (GCP) topics and human subject protection issues. Clinical research has brought significant improvements in the human condition and quality of life. ACRP helps industry professionals stay abreast of current and upcoming research, industry news and information, and educational and professional-development opportunities. “ACRP also keeps members abreast of government-related issues, ” Dr. Anderson says. “The organization is further developing its government affairs component and will soon have a government affairs committee.” As ACRP goes forward, Dr. Anderson says some goals are to approve new educational efforts, including e-learning initiatives, and to improve its global structure. Becoming global has been a challenge since each country has different regulatory nuances, different cultures, and different language issues. “Providing education and learning opportunities are key components to the value the organization brings to help professionals worldwide,” Dr. Anderson says. “The organization also brings opportunities to members through its many publications and Web-based activities.”

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