Enhancing the Administration of Technology Transfer and Clinical Trials at Penn

July 30, 2014

Dear Colleagues:

On any given day, the range of activity at Penn Medicine is both extensive and extraordinary. Given the scale of our academic medical center, I am initiating a number of additional forums for communication to highlight key strategic initiatives and issues important to our Penn Medicine. These will include: more frequent updates to our websites, informal meetings with faculty, town hall style meetings, State of Penn Medicine addresses, and email messages. Today, I want to provide an update about two major initiatives that are critical to our mission: (1) tech transfer and commercialization and (2) clinical trials.

Penn Medicine has been a national leader in our effort to accelerate the translation of basic research into clinical applications. The creation of ITMAT, along with a number of other Centers and Institutes, has had the desired effect of catalyzing translational research, and this is reflected by remarkable growth in high impact publications. This exciting pace of discovery creates a predictable need to streamline and make as effective as possible the natural outlets of translational work in technology transfer and clinical trials.

During this past year we embarked on a reinvention of tech transfer at Penn.  Working together with the University, the Penn Center for Innovation (PCI) was launched. The PCI reflects a greatly expanded and reorganized structure of the former Center for Technology Transfer (CTT). Important in this effort is a new hub and spoke model that allows closer collaboration between technology licensing officers (TLO’s) and faculty. As part of this reorganization, we now have a satellite office embedded within the Perelman School of Medicine (2nd floor of the John Morgan Building) that is directed by Heather Steinman. The PCI also has a sharp focus on service excellence and supporting a culture that values innovation and commercialization as a means to have societal impact. Early results demonstrate considerable momentum and I encourage you to engage with this office and provide feedback as to how it can better support your partnerships with industry. More information about PCI can be found at http://www.pci.upenn.edu/.

We are now engaged in a similar process to review and transform the conduct of clinical trials at Penn. Success in the execution of clinical trials creates a virtuous cycle. It attracts top faculty and research sponsors. It improves patient care by providing access to the most advanced and potentially life-saving therapies. Instituting a more nimble clinical trials process is a means to an end. It is one of many ways in which we are working to extend the leadership in translational medicine for which Penn Medicine is already justly renowned.

Our overarching goal is to facilitate clinical research and support principal investigators, while ensuring regulatory compliance and subject safety. In late spring, I charged a group of senior faculty to identify operational challenges and administrative changes that would immediately accelerate the clinical trial initiation process. I am pleased with their recommendations, which include a number of actionable steps to minimize unnecessary delays. These include reducing the number of internal reviews, aligning the IRB and Abramson Cancer Center reviews, and enhancing patient recruitment, among other steps. Simultaneously, we engaged LEK, a consulting firm widely known for its expertise in this domain, to conduct a comprehensive review of each aspect of the clinical trials process at Penn and to develop a detailed set of recommendations that will facilitate true transformation.

We are now entering the implementation phase following their recent engagement. This will involve centralizing the authority and support structure for clinical research, eliminating inefficiencies and standardizing transparent review processes, developing performance metrics, and creating viable career paths for staff engaged in clinical research. Selected recommendations include:

Creating a new leadership position with authority and responsibility to work across offices to optimize clinical research at Penn Medicine.Centralizing clinical research support services.Adopting a service model for all functions that supports principal investigators.Investing in IT infrastructure to facilitate access to information and provide support tools that enable clinical research.

I look forward to communicating further in the coming months about this and the many other strategic initiatives we are undertaking to maximize the impact of the breakthrough work being conducted in labs and clinics across campus.

In the meantime, best wishes for a productive and enjoyable summer.


J. Larry Jameson, MD, PhD