What if the next big thing in biopharma wasn’t produced by one of the big pharma companies that line the Northeast corridor between Philadelphia and New York City, but by a whole bunch of them? Conshohocken-based TransCelerate BioPharma is attempting to accomplish this difficult feat by embracing cooperation instead of competition. It is a 501(c)3 non-profit consortium of 18 pharmaceutical companies (and growing) that works with the FDA and global regulators to advance the industry through collaboration with researchers, industry organizations, and federal oversight agencies.
Launched in 2012, their slogan of “accelerating the development of new medicines” was initially met with skepticism – prior attempts at industry bar-raising did not have a solid track record. After realizing pharma companies tend to be risk-averse, the team began by focusing inward – the initial group of ten members asked the simple question, “If we WERE to collaborate, what COULD we do differently?” The answers generally had similar sponsor-efficiency themes: Do more with less. Bring products to market faster. Reduce development cycle time.
TransCelerate began with five initial goals that have expanded to 16 different initiatives, divided into four areas: Patients, Sites, Sponsors, and Information Sharing & Harmonization. One important aspect of these initiatives is they are all voluntary; the “Member Companies” are not obliged to implement any or all of the proposed/active workstreams. As the group evolves, they are becoming more patient-centric – looking into creating better awareness of clinical research, and branching out to involve patient advocacy groups.
At the Drug Information Association (DIA) annual meeting this summer in Philadelphia, I spoke with TransCelerate CEO Dalvir Gill about the impact his organization is making on the industry. Dr. Gill highlighted some of TransCelerate’s accomplishment, including the Good Clinical Practices certification program, the Investigator Registry, and the Shared Investigator Platform that enhances communication between sponsors (the biotech companies) and sites where trials are held.
He also pointed to the Placebo and Standard of Care Data Sharing workstream (in a nutshell, sharing/reusing control arm data across studies) as a way one pharma company can provide another with information, allowing the second company to reduce patient enrollment requirements by half. Shrink the sample size necessary, and the burden to fill the study becomes lesser, while a greater percentage of patients get experimental therapies. Having one control arm for multiple treatment arms mean trials get completed quicker. Patients get better medicine. Everyone wins.
Another initiative Gill brought up was the Comparator Network – basically, providing competing pharmaceutical companies with standard of care drugs to use in trial. Currently, many “comparator” drugs used in trial are sourced via third party, introducing supply chain, counterfeit, and efficiency issues. Providing these comparator drugs to other Member Companies would significantly reduce inefficiencies in all areas of research – not just oncology, but also in HIV and Hepatitis C, among others. “If we did this,” Gill observed, “we would take away drugs as the bottleneck. It is one of several examples of an all-around opening of the funnel and granting access to information.”
Gill mentions the alignment across multiple stakeholders as being the biggest obstacle, but surprisingly, it isn’t the federal regulators that get in the way. It is the structure of the Member Companies and their self-imposed barriers that have provided to be the hardest hurdles to overcome. He noted, “We WANT people to hear that the drug development space is making an effort to be as efficient as possible in developing more treatments and do more with what we already have.” Having to jump through hoops just to get my first trial started, I can confirm that there are times when “litigious worries” and “risk minimization” can override innovation. That is why the enormity of what TransCelerate set out to accomplish – and is achieving – is quite remarkable.
Rehbar Tayyabkhan, Executive Director of Global Clinical Operations at Bristol-Myers Squibb and sponsor of TransCelerate’s Risk-Based Monitoring initiative (in short – developing a model for monitoring of trials to enhance patient safety and ensure quality of clinical data), presented at the DIA meeting and spoke about refining the initiative after interacting with the other Member Companies. “Areas that we focus on have shifted based on other projects,” Tayyabkhan explained. “External validation of approaches and peer validation buys down the natural risk aversion or skepticism.”
Being downstream of these landscape-altering collaborations (and, in the case of the TransCelerate-supported CLEAR initiative, being the inspiration behind one), it is impressive and hopeful to know the affect they will have on patients present and future. Very few people get the opportunity to impact the health, the lives, and the families of so many, as the leaders and team of each workstream do. Having met many of them, and hearing firsthand how dedicated they are to the TransCelerate mission, the future of clinical research looks promising for all stakeholders – most of all, the patients.
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