Learn why collaboration is key at three ATS 2011 sessions.
Sometimes the hard way is the best way. This is what Lenny Sicilian, MD, believes when he thinks about managing relationships between researchers at academic and commercial institutions.
“The easiest thing would be to divorce the two—and there are those who advocate just that—but our patients would suffer,” explained Dr. Sicilian, who is vice-chair of the ATS’s Ethics and Conflict of Interest Committee. “It’s harder to manage the relationship, but that’s what must be done if we are going to develop new therapeutics.”
The importance of managing conflicts, not just financial, among scientists, wherever they work, will be among the topics explored during D90 “Scientific Relationships Including Industry: Collaborative Success Factors,” which will take place from 2 to 4:30 p.m. on Wednesday, May 18, at the 2011 International Conference.
Although the symposium will take a broad look at conflicts, much of the session will focus on the relationship between industry and academe—a relationship that is as much in flux as it is in the news recently.
Dr. Sicilian, clinical director of Massachusetts General’s adult cystic fibrosis program, Boston, is co-chair of the session with Molly Osborne, MD, PhD; Ted Reiss, MD; and Jeff Gold, MD. The co-chairs hope that the session will help clarify the issues—and highlight the strengths each group brings to the table.
“There is an art and a science to taking a discovery and making it something that benefits patients,” said Dr. Reiss, who is in charge of global drug development at Covance and past chair of the ATS’s Drug/Device Discovery and Development Committee.
“This translational expertise is the core strength of pharma,” said Dr. Reiss, who was involved in respiratory drug development at Merck for 18 years. “Pharma’s job is to turn a discovery into something that benefits patients in the most effective, complete way possible.”
But where does that leave the academic researcher?
“The groundbreaking ideas tend to come from the academic side, because these scientists often take more risks,” said Dr. Gold, a pulmonologist and intensivist at Oregon Health and Science University in Portland. “But industry has the resources and the know-how to conduct well-designed trials, so that a promising discovery may one day end up being a useful therapeutic.”
Drs. Sicilian and Gold point to the CF Foundation’s Therapeutic Development Network as a potential model for how industry and academic researchers can collaborate successfully. Through the network, industry sponsors clinical trials at medical centers around the country.
“This is a disease where the median life expectancy has grown by more than 10 years since the network was established in 1998,” said Dr. Gold, who also noted that the National Institutes of Health (NIH) has an entire granting mechanism, the Small Business Innovation Research (SBIR), for companies.
Joel Moss, MD, PhD, deputy chief of the Cardiovascular and Pulmonary Branch of the National Heart, Lung, and Blood Institute, will discuss the mechanisms that the NIH uses to foster effective collaborations between government and industry, government and academia and, sometimes, between all three parties.
Dr. Moss is a member of the NIH’s Cooperative Research and Development Agreements, or CRADA, subcommittee. CRADAs were created at the NIH in response to help ensure that the American people benefit from government inventions. The agreements today take several forms, including licensing of technology and long-term collaborations between NIH scientists and scientists outside government.
One of the most important benefits of these agreements, according to Dr. Moss, is that they formalize a relationship in a way that addresses potential conflicts of interest and intellectual property considerations. “CRADAs provide a ‘blueprint’ for working together that makes collaboration and its scientific objectives transparent,” he said.
Dr. Moss will also discuss today’s higher standards for disclosing potential conflicts of interest to patients participating in clinical studies. “Consent documents for NIH-sponsored trials are increasingly noting,” he explained, “that academic physicians, just like pharmaceutical colleagues involved in studies, have competing interests that may be perceived as a conflicts of interest.”
Among the other speakers will be Lewis Rubin, MD, and James Donohue, MD.
Collaborative Opportunities
Attendees will learn of consortia accelerating discoveries and clinical sciences into new therapeutic agents for COPD and asthma during B82 “Challenges and Collaborative Opportunities in the Development of Novel Drugs for Obstructive Lung Diseases,” which will take place from 2 to 4:30 p.m. on Monday, May 16.
The session will provide an overview of recently described COPD pathomechanisms serving as a reservoir of potential new therapeutic agents, as well as the challenges to clearing the final health authority approval. Attendees will learn that consortia of academic and industry labs, plus government agencies, offer exciting opportunities to speed development of new therapies through presentations of the COPD Biomarker Qualification Consortium, the NHLBI SPIROMICS (Subpopulations and Surrogate Markers Study) and the MRC COPD Consortium.
Robert B. Fick Jr., MD, senior director, Merck Research Labs, and Frank Sciurba, MD, associate professor of medicine, director of the Emphysema Research Center and director of the Pulmonary Function Exercise Physiology Laboratory at the University of Pittsburgh Medical Center, are the co-chairs.
Creating Partnerships
Another session, D88 “The Importance of Communication in Creating Partnerships for Patient-Centered Care,” will review recent advances that can enhance communication between clinicians, patients and family members, and improve quality of care and patient and family outcomes. The session will take place from 2 to 4:30 p.m. on Wednesday, May 18.
Teresa Barnes, chair of the ATS Public Advisory Roundtable and vice president for patient outreach and advocacy at the Coalition for Pulmonary Fibrosis, will co-chair the symposium with ATS Immediate-Past President J. Randall Curtis, MD, MPH. Dr. Curtis is a professor of medicine in the Division of Pulmonary and Critical Care at the University of Washington and head of the Section on Pulmonary and Critical Care at Harborview Medical Center in Seattle.
Ms. Barnes will give a patient perspective, and other talks will focus on communication with patients about self-management and adherence to treatment; the burdens of family care-giving during chronic illness; prognosis; advance care planning; and surrogate decision-making in the ICU. The speakers will also discuss future research needs to further enhance communication.