By Kenneth L. Waggoner, Chief Executive Officer, President, General Counsel and Chairman of the Board, PharmaCyte Biotech
Scientific research is a cooperative enterprise. Researchers working today are standing on the shoulders of those who have gone before, and they are paving the way from the next generation of scientists. Today’s researchers attend conferences and exchange ideas in a collaborative effort to solve the puzzles of nature. Commercializing medical treatments and profiting from discoveries is much more competitive, sometimes inhibiting further research into a disease because of the need to monetize intellectual property.
Another hurdle to overcome in medical research is simply the vast amount of work being done around the world. Although there has been a revolution in communications in the last couple of decades, it doesn’t always follow that we communicate as well as we can or as well as we should. Today, researchers in Japan, Switzerland, and America who are working on complementary projects can, in theory, pick up a phone, send emails, text, tweet and video chat to pick each other’s’ brains, share insights, and report findings. But do they do this as effectively and efficiently as possible? Sadly, the answer is no. Often, researchers are unaware of studies others are undertaking that might benefit their own work.
To overcome the tension between research and commercialization and to manage the vast amounts of data being generated, those engaged in bio-technology often form a consortium to address a specific disease. The function of these consortia is to provide a more integrated approach to research and thereby speed treatments to patients.
For example, the Lupus Clinical Trials Consortium was established in 2002 “to support the process of getting promising new therapies for lupus tested and into the marketplace.” The Lupus Clinical Trials Consortium has over 20 academic institutions which receive infrastructure support grants to support readiness for testing new lupus therapies. The Lupus Clinical Trials Consortium is not a clinical trial sponsor, contract research organization, site management organization, or similar entity. The Lupus Clinical Trials Consortium does not participate in the conduct of clinical trials.” It is a charitable, tax exempt organization under Section 501(c)(3) of the Internal Revenue Code.
For prostate cancer, The Prostate Cancer Clinical Trials Consortium (PCCTC) is a 13-member clinical research group sponsored by the Prostate Cancer Foundation and the Department of Defense Prostate Cancer Research Program (PCRP), with its Coordinating Center headquartered at Memorial Sloan Kettering Cancer Center.” The “members of the PCCTC work together on a single mission: to design, implement, and complete hypothesis-driven Phase 1 and Phase 2 trials in prostate cancer, translating scientific discoveries to improved standards of care for patients.”
For private sector participants, the Biomarkers Consortium is a good example. A recent press release on developments in antibiotics that rely on biomarkers noted, “Scientific and financial contributions in support of this project have been provided by Actelion Pharmaceuticals, AstraZeneca, Basilea Pharmaceutica International, Cempra Pharmaceuticals, Cerexa, a wholly-owned subsidiary of Forest Laboratories, Cubist Pharmaceuticals, Merck, Nabriva Therapeutics and Trius Therapeutics. Clinical trial data were also contributed to the collaboration by Cerexa and Cubist, as well as by Durata Therapeutics and Pfizer.”
My company, PharmaCyte Biotech, is a clinical stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box. We were looking at our research schedule, and it seemed like we would be able to get our treatment for diabetes into clinic trials no sooner than 2020. That just wasn’t good enough. Although we aren’t Pfizer or AstraZeneca, I thought that a consortium approach to our research could improve that time-frame. So, we formed our International Diabetes Consortium. Now, thanks to this approach, our treatment may be in clinical trials by 2016.
Challenges And Opportunities
Recruitment: The toughest part of establishing a consortium is recruiting the right people. To succeed at this, three things must happen. First, you have to identify among the best researchers pursuing the most promising therapies. Second, you have to demonstrate that the consortium will improve their research capacity without undermining the originality of their work—help them break out of the silos. Third, leaders and coordinators of research have to have the support of the entire membership; internal bickering and fiefdom building has to be considered out of bounds.
Relations With Research Institutions: In most instances, you will have a relationship with the research institution for which your recruits work. This is preferred because all the legal, financial, and other complications have been settled already. In cases where you don’t, you will have to sign deals to handle these things. However, if you have an eager recruit, you also have an eager internal salesperson pushing for an agreement.
Mechanics For Sharing: In the bad old days before the Internet, clearinghouse functions probably worked against creating a consortium. Now, electronic exchange of data by e-mail, Dropbox, or other file sharing methods makes it vastly simpler. You just need one person, and usually it’s the researcher who volunteers to coordinate the exchange.
Costs: What is most amazing is that the cost of forming a consortium is negligible. Since the researchers are already being paid by their institutions, you don’t need a secretariat of any size (administration is usually a small chore as part of a person’s working day). Computerization and the Internet have also more or less eliminated costs.
Benefits: A consortium can do two things that need doing: First, it can reduce the amount of time research takes meaning that treatments get to patients faster. Second, it encourages the exchange of ideas that can lead to new concepts and approaches. The intellectual cross-pollination is difficult to measure, but it is clearly there every time a scientist says “Why didn’t I think of that before?” Those moments are frequent for the members of our International Diabetes Consortium.
Obviously, the expertise and scientific principles required remain the same. Ultimately, what we are proposing here is not so much a shift in the scientific research, but rather that there is a much better way of managing the information flow among researchers in pursuit of a common goal.
Kenneth L. Waggoner has almost four decades of experience in management, business, operations and law. Mr. Waggoner started his career as an attorney in private practice. Notably he was a senior partner with Brobeck, Phleger, and Harrison, named one of the top two law firms worldwide that provide services to biotechnology clients including Chiron, Amgen, Biogen Idec, Sangamo, Ligand, DepoTech, and many others. He was the Managing Partner of Brobeck’s Los Angeles office. Mr. Waggoner was also a member of the Executive Committee for almost ten years and on the Policy Committee for numerous years managing Brobeck’s worldwide operations with annual revenues in excess of $750,000,000. While at Brobeck, Mr. Waggoner was the Co-Chairman of Brobeck’s world-wide Environmental Law Group. Mr. Waggoner received his Juris Doctorate with honors in 1973 from Loyola University School of Law in Los Angeles.