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As my term as ACRO Chairman comes to a close, I want to thank the ACRO Board, ACRO member companies, and ACRO staff for the opportunity to serve the organization and our membership in this capacity. I also want to thank our Committees and the respective chairpersons for all of their efforts and commitment this past year. A special word of thanks to my executive committee members, Chair Elect Bill Sharbaugh of PPD and Past Chair David Spaight of MDS. The state of the association is strong and I look forward to Bill’s leadership in 2010. I am also delighted that Joe Herring, Chairman and CEO of Covance, has agreed to serve as Chair Elect for 2010.
It has been a very challenging time for health care and for clinical research organizations. At this momentous time in the healthcare industry, ACRO has an important role in helping shape the healthcare landscape and I am honored to have been involved in and contributed to a very promising future for our industry.
As the pharmaceutical industry landscape has changed, so has the role of clinical research organizations. At the beginning of this year, the leadership of ACRO and the board took a critical look at the industry landscape and the mission of the organization. We engaged the services of an outside consulting group to help set our strategic course. As a result of these deliberations and building on the existing platform of high ethical and quality standards in the provision of day-to-day services across the world, we agreed on a strategic focus:
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To educate key stakeholders about our business model, such as regulators, policy makers, media and most importantly the patients who benefit from the therapies we help bring to them.
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To advance the value proposition of outsourcing and provide evidence to demonstrate our ability to be a credible partner in developing drugs.
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To be a strong advocate for the CRO industry rather than wait for others to do so and make sure we have a seat at the table when new health policies are being discussed.
These three priorities will remain ACRO’s focus for the foreseeable future. In addition, we will proactively reach out to other similar associations across the globe ensuring global standards and helping shape policy in these regions.
As many of you know, the CRO industry growth is highly dependent upon greater outsourcing. At the same time there are numerous threats and opportunities for the CRO industry in the United States and around the world, these include:
- Comparative Effectiveness Research (CER)
- Health Information Technology (HIT) and Data Privacy
- CROs and The Conduct of Research
- Globalization of the Research Enterprise
- Evolving Regulation of CROs
One of the greatest opportunities, but one that brings with it tremendous challenges and potential for negative perceptions is the globalization of research. We know that global trials speed drug development by reducing development time by half, lowering costs and maintaining quality and safety. This is a public health benefit. In demonstrating our initiative on these matters, it was important that ACRO make our stakeholders aware that our member companies apply the same research quality and ethical standards worldwide. A whitepaper ACRO released earlier this year on the subject of globalization has proven tremendously valuable in advancing our perspective and to date has been downloaded more than 700 times from the ACRO website.
A further challenge we face is increasing our membership and achieving a critical mass which would enable us to be an even more effective advocate for the industry. Our current membership reflects the leading global companies but the value of ACRO membership is being recognized by more and more CROs of all sizes that wish to have a voice in setting the future direction of our industry and participating in the industry’s growth. I am very pleased that ICON has now become a full member and that John Hubbard, Ph.D., FCP, Global President of ICON Clinical Research, will be taking a seat on the ACRO Board. We expect to announce the addition of other new members in early 2010.
While our numbers may be small, our footprint is sizeable; ACRO member companies employ over 66,000 people engaged in research activities around the world and last year conducted more than 9,000 clinical trials involving nearly 2 million participants in 115 countries. That said we need to expand our association to enable us to play a leading role in the transforming healthcare landscape.
We closed the year with a very successful dinner and Annual Meeting that included presentations from, amongst others, FDA Commissioner Dr. Margaret Hamburg and representatives of the Gates Foundation and the Association of Clinical Researchers and Educators. We are eager to work these organizations in areas of mutual interest in 2010 and beyond.
Thank you all again for allowing me to serve as ACRO Chairman this year. I look forward to continued participation in the association next year and beyond as ACRO heightens its level of engagement on a global scale.
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