WHAT

THE THINK TANK

Future novel viruses are inevitable and there is no small likelihood that at least one such pathogen will be more contagious and/or lethal than COVID-19.

The Think Tank of the Ark Institute will assemble experts in the biological sciences, in public health and epidemiology, in infrastructure and supply chain management and in all other relevant disciplines to study, formulate and publish policy recommendations on what communities, governments and private institutional actors can do to be better prepared for the next pandemic.

With founding member institutions including leading medical research and teaching centers as well as public policy oriented organizations, the Think Tank will commission, support and ultimately distribute to all relevant audiences peer-reviewed papers including specific, substantive recommendations regarding future pandemic preparedness across all aspects of the necessary policy spectrum.

Keeping in mind that the ultimate object of the Think Tank’s academic work is to advance the development, manufacture and distribution of impactful therapies, vaccines and diagnostics, our team of fellows will comprise not only leading scientific researchers, but also industry professionals with successful track records in developing and commercializing the types of complex products needed to effectively combat any health pandemic. Working together, these experts from seemingly disparate walks of life will generate further research into both novel and well established therapeutic and preventative modalities, leveraging the existing insights gained from COVID-19. The Think Tank will also form strong collaborations with foundations so that it can access additional resources including funding and scientific insights when necessary.

THE DO TANK

Putting Word to Deed

The Ark Institute Do Tank will put into practice recommendations from the thought leadership generated by the Think Tank. Whether this involves investments in manufacturing capabilities, advanced purchases and storage of PPE, essential chemicals and other indispensable supplies, or public education and government relations advocacy on behalf of necessary public policies for proper preparation for the next pandemic, the Do Tank will engage in the practical operations centered at the nexus of applied research, logistics, and industry.

Applied Research

The Ark Institute’s Do Tank will support the work of its members and their networks to undertake in-depth and clinical research on new therapies not only for COVID-19, but for a wide range of immunological treatments. Already, one of The Ark Institute’s charter board members, renowned physician and researcher Dr. David Fajgenbaum, is spearheading two ambitious research initiatives, CORONA and STORM.

CORONA

Building upon its success identifying life-saving therapies for related disorders, the University of Pennsylvania’s Center for Cytokine Storm Treatment & Laboratory (CSTL) launched the CORONA (COvid19 Registry of Off-label & New Agents) project in March 2020 to identify and track all reported off-label and experimental drug use in COVID-19 in an open-source database. The CSTL has partnered with Google Health, the FDA, and Parker Institute for Cancer Immunotherapy to maximize the impact of this project. Through rigorous data mining and research, the team has identified over 300 treatments given to over 100,000 COVID-19 patients – and selected the most promising agents to push them forward in development. With limited infrastructure enabling cross-institutional data sharing, CORONA highlights the extent to which our ability to defeat COVID-19 depends on worldwide collaboration.

STORM

Given the major unmet need to track promising treatments for COVID-19, the US Department of Health & Human Services has encouraged the expansion of CORONA to include data on all COVID-19 treatments in every phase of research – from cell line studies to animal testing to human clinical trials – and leverage the data to synthesize recommendations. If funded, STORM’s (Systematic Tracker of Repurposed/New Medicines) integration of pre-clinical studies of promising drugs and not-yet-published clinical trials will help physicians and researchers around the world to effectively inform treatment selection and clinical trial design in real-time.

Looking beyond these two initiatives currently underway, The Ark Institute intends to support industry efforts to build a dedicated state-of-the art R&D facility, equipped with the latest equipment required to support any R&D program from conceptualization up to tech transfer to the manufacturing stage.

Logistics

The first days of the COVID-19 pandemic laid bare the vulnerabilities of the American industrial supply chain, as essential workers struggled to gain access to sufficient PPE, and consumers faced shortages of key household staples. While some improvements have been made on a national scale, they have been slow to emerge, unevenly distributed, and still largely unequal to the ongoing challenges we face.

In addition to developing strategies, software and other systems to enhance the distribution of critical products and materials during a disruptive public health event, The Ark Institute will be a powerful advocate for Good Manufacturing Practice (GMP) compliant facilities with the capacity to manufacture essential complex pharmaceutical products and medical devices The Ark Institute will support industry efforts to continue upkeep of these facilities and enable industry with the capabilities required to adhere to GMP requisites according to federal regulations, with advanced capabilities for both drug substance and drug product manufacturing (for either therapeutics, vaccines or diagnostics).

Manufacturing will not be dependent on just one modality, but encompass several including cell/gene therapy, viral or nonviral vectors, vaccines and recombinant proteins. The Ark Institute, through our consortium of embedded partners and our extended network of manufactures, will work towards ensuring these facilities can be scaled to meet any demand and address any crisis urgently.

Recognizing that in the realm of pharmaceuticals, logistics encompasses not only manufacturing, storage and distribution, but also a daunting and convoluted regulatory landscape, The Ark Institute’s Do Tank will provide guidance and support to life sciences companies seeking to bring new treatments to market. As firms began last to develop diagnostic and therapeutic tools to fight COVID-19, the U.S. Food and Drug Administration acted quickly to implement Emergency Use Authorization (EUA) protocols, to approve diagnostics, drugs and vaccines so that these supplies can reach patients rapidly. However, the FDA failed to prioritize US manufacturers versus foreign entities (including coming from China) in issuing EUAs. The Ark Institute will leverage our team’s regulatory expertise in life sciences to develop strong working relationship with FDA and CDC so that they can influence the reaction times and outcomes in case of another pandemic.

Industry

It is a well-worn cliché that crisis creates opportunity. This may be true, but those opportunities yield only to those actors with the vision and ingenuity to seize them. With our home base in Philadelphia, The Ark Institute is situated at the hub of burgeoning medical innovation. The Philadelphia region is home to some of the most renowned research hospitals, university labs and biotech firms. Life science companies in our region are eager to make their names as providing effective, accessible solutions to meet the needs of a world facing new and unpredictable global health emergencies. Leveraging our embedded experts from the financial, pharmaceutical, real estate and industrial sectors, The Ark Institute is positioned to provide integral support, to secure capital, and build the necessary infrastructure to shape the region as a global center of healthcare delivery, biotech development and novel drug discovery.