Research scientific breakthrough, innovation and efficient translation to new therapies was at the heart of the creation of Parker Institute for Cancer Immunotherapy (PICI). Sean Parker, one of the founders of the disruptive P2P music sharing system Napster, infused $250 million back in 2016 to capitalize on immunotherapy breakthroughs. The big picture goal—get away from the fragmented, bureaucratic “realpolitik” of research and infuse entrepreneurial culture into a focused and driven mission. The initial goal: establish a network of research centers located in UCSF, Memorial Sloan Kettering Cancer Center, University of Pennsylvania, Stanford University, MD Anderson Cancer Center and Dana-Farber Cancer Institute. While he was at it he thought why not turn the research apparatus on its head—or remind institutions about the basics—starting with the science and not the politics or administrative intrigue. How is PICI doing as it completes its third year?
PICI, a San Francisco-based 501(c)(3) non-profit organization (fund raising and/or Fund Distribution) had reported revenues of $73.5m in 2015, $39.9m in 2016 and $65.9m in 2017, according to ProPublica. Undoubtedly this represents at least some of the committed capital by Mr. Parker. Operating in seven centers (located in major academic center partners) PICI appears to employ about 90 professionals. Interestingly many of those who self-identify in professional network LinkedIn carry titles seen in a biotech or research venture hence it becomes clear that PICI isn’t just a fund raising and distribution entity but actually a working R&D institute. Employee overhead in 2017 was about $10 million. We suspect that could have creeped upward as they have more employees now.
Plug-in-&-Play & Disrupt
Generally PICI operators are sought a pragmatic and bold model as they embrace and work with the eventual dichotomy and conflicting forces rife in incredibly important endeavors such as major cancer research. While strategically entering the drug development scene on the one hand—carefully “Plugging in and playing” with established academic medical centers and essentially creating a sort of alternative R&D reality within established institutions; on the other hand they continue to work diligently to establish a different sort of culture within the PICI domains within the institutions. Once “superior” ideas from a scientific perspective were culled and vetted, scientists and researchers receive a steady steam of capital to keep the work going—in theory, reducing “the political and bureaucratic noise” they must deal with and hence, the hope of at least reducing the “realpolitik” of academic clinical research, for example.
PICI negotiated what we believe is a great deal in that the academic centers agreed, in exchange for steady investigator funding, that they are to share results from all of their immunotherapy work (even those funded by other sources) with PICI headquarters in San Francisco.
Leverage Powerful Immunotherapy Breakthroughs
The focus of PICI is immunotherapy—treatments that harness the body’s own immune system to combat cancer. Already breakthroughs such as engineered immune cells (T cells) and checkpoint inhibitors have helped many patients fight off tumors. However, this approach has been select—only for some cancers and in some patients. Parker sought to infuse entrepreneurial energy into this research field by changing-up the model; establishing different cultural and business drivers; hand selecting the right talent and unleashing R&D and market forces while reducing the previously mentioned realpolitik noise.
Focus is more than just a core emphasis—it is a mantra. PICI, like any entrepreneur with a start-up—seeks to keep focused on the mission. A core philosophy guides the disruptive process premised on science first over the political and bureaucratic intrigue common in major academic medical centers. Other core principles bolstering the underlying philosophy include collaboration, bold ideas, relentless commitment and patient centric. Who could argue against these?
PICI believes strongly that the research paradigm is broken and that much needed to be turned upside down. Importantly, scientists needed a steady stream of funding—the present environment of small increments amounted to surviving on crumbs—sometimes.
The Challenge—R&D System essentially broken
PICI positioned that the system is broken and that the best ideas in such as system don’t always turn out well. Moreover, Mr. Parker saw a broken, fragmented system that needed disruptive rationalization for improved results. Consequences in such a disjointed ecosystem that is the current research include 1) no coordinated strategy among individual research proposals 2) limited, small grants drive incremental advances and 3) limited organized cooperation among research groups to build upon findings as well as 4) limited organized cooperation among research groups to build upon findings.
PICI takes a sort of P2P and free market principal approach to R&D thinking assuming that superior scientific ideas should and will make their way to the top—much like in underlying economics, some core principles, if left alone and not tampered with by politicians and bureaucrats and those that don’t produce, will result in fabulous wealth generation drivers.
Hence, “let science lead the way” and fantastic solutions are obtainable, PICI’s website touts. Key underlying rules of the PICI mission: let investigators drive scientific strategy and not bureaucrats and middle management for example; fund collaborative teams so incentivization aligns with the human capital requirements for invention and innovation; introduce more flexibility and risk-taking in the funding process—which according to the premise, improves the odds of breakthrough occurrences.
PICI positioned itself not as a grant maker, or a broker, or an investor for that matter but rather took ownership as an actual research institute. Hence, much like Mr. Parker helped harness P2P technology to start the music industry rationalization (which of course is still unfolding), he sought to do something similar in one of the most critical endeavors of humankind—fighting killer disease and finding cures. How do they do that?
First, they establish a dynamic partner ecosystem that essentially becomes an idea factory for their participating investigators to vet—they in effect claim to have built a “bespoke infrastructure” to tap into and “mobilize discoveries” and “fortify” the R&D process from initial idea to actual outcome. Their declaration: that whatever the activity—from buying a compound and running clinical trials to developing novel new intellectual property—that their process and system will “yield optimum results.” Confidence is so high in this enabling infrastructure that they compare it with “gears and gas in a race care” in that “PICI’s infrastructure drives the concept forward with maximum efficiency and speed” till the finish line and victory.
With confidence high, capital allocated and talent recruited, how are they doing?
Discussion or Organization and Some Results
How can PICI accomplish all of the above? Surely, the money and talent helps but underlying organizational structure and driving principles is critical to success, mobilized in relentless execution that may make the difference. With an emphasis on data-driven results, they have set up an infrastructure and process to include the following:
- Strategic Partnerships
- Research Projects
- Clinical Development
- PICI BioTrust
Published Results to Date
PICI has been in business since April 2016, so exactly 2.5 years. What have they accomplished? Based on a review of their website, they have been incredibly busy. With “inventions” they have accomplished, 122 reviews of invention disclosures and to date are supporting 54 inventions ongoing. The touted underlying systems infrastructure has enabled them to support 35+ research collaborations over 7 sites while analyzing 17 molecular data types since inception. Strategic partnerships have been active—with 40+ and 6 “strategic inventions.” For partnerships they have gone beyond academia and into industry and non-profits to find the right synergies resulting in contribution directly or indirectly to new immunotherapy ventures not to mention ongoing clinical trials. Research Projects have been numerable—over 76 since inception and 146 PICI-supported projects; In 2.5 years, they have managed to launch 11 clinical trials treating 200 patients; the PICI BioTrust involves the centralization of samples, assay data and clinical outcomes from the network’s projects. As a result, PICI has accumulated 43K biospecimens and 15 transitional suite assays.
Of course, the details are of paramount concern here but from a cursory review the results in just 2.5 years is incredibly impressive.
As the focus of TrialSite News and the TrialSite Network is clinical trials, we offer more information about their current trials presently published on their website. Listed trials include the PORTER Trial with a focus on novel combination therapies to target metastatic prostate cancer; the MAHLER trial organized to study patient responses to checkpoint inhibitors; the PRINCE trial exploring if a combination of immunotherapy and chemotherapy can defeat pancreatic cancer; the SINATRA trial where cancer fighting T cells are engineered using CRISPR; the McGRAW trial where teams are exploring if gut bacteria can destroy cancer and the AMADEUS trial where PICI researchers are evaluating biomarkers for in checkpoint response in “hot” vs. “cold” tumors.
The devil is always in the details and this editorial is meant as a preliminary introduction to a very interesting organization called Parker Institute for Cancer Immunotherapy. We do cover clinical research with a critical eye—at times drug development and commercialization turns into too much of a Machiavellian, zero-sum game with such big economic stakes at play. We aren’t sure PICI can address that dynamic nor is it there intention to do so. For that matter, their disruption probably won’t create enough efficiencies in the system to deal with underlying health access equity factors in various health systems around the world. Patient access becomes a growing challenge with high-powered and high-priced cancer killers. Will we become a society in which those with means live longer because they can afford to? But, we also understand that those very high stakes (and associated behaviors that naturally follow) represent powerful incentives to spur innovation along with an equally powerful motivation based on altruistic impulses. PICI represents a truly exceptional experiment for which we are grateful for their presence as they attempt to create a dynamic, networked haven in research centers; safe, to some extent, from some of the disruptions inevitable in research hubs. Or at least that is our impression as naïve outsiders. Our hats off to Parker and his PICI crew in San Francisco and beyond. They are putting precious capital, talent and infrastructure to work to harness the power of science, entrepreneurialism and altruistic passion for the quest of medical progress—in a noble and what we believe is an exciting quest to develop what we hope will be cures to some deadly cancers. We only can hope that such an endeavor is ultimately successful, as measured by life-saving new treatments that are approved by the FDA, EMA and others, and that it influences other powerful and influential people with means to enter into and disrupt healthcare for the good. Their model should be studied by others interested in improving drug development.