2020 Conference Agenda

All Times Central Time Zone (Chicago)

September 21, 2020

9:00 am Technologies and Techniques to Repurpose Drugs as Antivirals
S.A.F.AN. BIOINFORMATICS offers one of the most innovative and effective computational profiling technologies supporting initial drug discovery and repositioning projects. We used our technology for massive screening of compounds to hit potential COVID19 targets. In the first part of the talk, we describe the technology, the results of the screening, and their in-vitro validation. As a transmembrane protein, ACE2 serves as the main entry point into cells for COVID19, by interacting with the virus' SPIKE protein. Thus, inhibiting this interaction would help prevent infections. The second part of the presentation describes S.A.F.AN. BIOINFORMATICS approach and results to find potential new molecules inhibiting the formation of ACE2:SPIKE complex.
Luisa Pugliese, Ph.D., Chief Executive Officer, SAFAN Bioinformatics

9:30 am Harnessing the Power of Drug Repurposing and Drug Rescuing Through in Vivo Phenotypic Screening Using Worms and Fish
Drug Repurposing and rescuing represent strategic paths to accelerate drug discovery and development. However, the power of these approaches can be catalyzed by combining them with phenotypic screening strategies. At this juncture, simple animal models like worms and fish represent models of choice to expedite the identification of small molecules for further preclinical and clinical development.
Eric Samarut, Ph.D., MBA, Co-Founder and Chief Scientific Officer, Modelis

10:00 am Morning Networking Break

10:20 am Commercializing Academic Repurposing Discoveries: the Tech Transfer and Company Perspectives
In this presentation Dr. Bloom and Dr. Krishnan will delve into a range of topics that are key considerations for academic institutions and companies engaged in tech transfer negotiations. Our presenters will address the following:
- Working with the Inventor/PI
- Patenting and other exclusivity issues
- Collaboration and negotiations
- Due diligence issues
- Contracting, goals and reporting
- Relationship management
- Confidentiality and other disclosure issues
Raja Krishnan, Manager - Life Sciences, Commercialization & Licensing, Office of Technology Commercialization, University of Kentucky
Dr. Bruce Bloom, Founder, Cures Within Reach, Chief Collaboration Officer, Healx

11:05 am Pharmaceutical Patent Strategy and Drug Repositioning with Solid Forms
The composition of matter patent is usually the most valuable IP asset in any drug development project or deal. Too often, however, this IP is long in the tooth and hampers the estate value. In some circumstances, it is possible to reinvigorate composition of matter status with new patents using solid forms such as salts and cocrystals. This talk will introduce that topic and explore some of the IP and regulatory aspects of such a strategy.
Eyal Barash, JD, Founder, Barash Law

11:35 am Good Versus Bad Repositioning: the Era of AI
Aris Persidis, Ph.D., President, Biovista

12:05 Lunch Break

12:45 pm Drug Repurposing Before and During The Pandemic
As a small company Collaborations Pharma has actively used drug repurposing for the past 5 years to work on well known diseases that lacked treatments. They started with their work on using machine learning to identify drugs for Ebola and Chagas disease. This led to in vivo studies in animal models to test efficacy. Repurposing was definitely seen as a niche area. The SARS-CoV-2 pandemic has changed all that such that they and many others have had to repurpose drugs for a brand-new disease in real time. In the space of a few months they have been involved with numerous national and international collaborations working on SARS-CoV-2. Some of these projects will be highlighted to show how they can put machine learning models to good use for SARS-CoV-2 drug discovery. Dr. Ekins will also describe their efforts on repurposing for Alzheimer’s disease and rare disease projects. Their experience during this pandemic has taught them that a small company can have an outsize impact by leveraging and integrating computational and experimental approaches alongside those of a range of collaborators.
Sean Ekins, Ph.D., DSc., CEO & Founder, Collaborations Pharma

1:15 pm Key Business and IP Considerations for Furthering Drug Repurposing Programs
In this presentation our speakers will cover the following:
- Increasing the value of your 505(b)(2)
- Dealing with CMS actions that increase the value of independent 505(b)(2)s
- Monitoring FDA and Congress for the impact of user fees on 505(b)(2)s
- Assessing the impact of Executive Orders on 505(b)2()s
Edward John Allera, JD
, Shareholder, Buchanan Ingersoll & Rooney
Matthew Fedowitz, JD, Shareholder, Buchanan Ingersoll & Rooney

1:55 pm Drug Combination Therapy for Repurposing Approved Drugs to Treat Emerging Infectious Diseases
A common issue for drug repurposing to treat new indications is that the human plasma drug concentration is not high enough to achieve the therapeutic effect (i.e. drug plasma concentration is lower than the IC50 or EC50 of approved drug). This issue prevents clinical applications of many drugs identified from drug repurposing screens due to low efficacy as well as potential drug toxicity. We have studied the synergistic drug combination that uses 2 to 3 drugs with different mechanisms of action for drug repurposing studies in emerging infectious diseases including Ebola virus infection and severe infections with multidrug resistant bacteria/fungi as we as SARS-CoV-2 infection. The results of drug recombination therapy for drug repurposing will be presented and discussed.
Wei Zheng, Ph.D., Leader (Biology), Division of Preclinical Innovation, Therapeutics for Rare & Neglected Diseases, National Center for Advacing Translational Sciences (NCATS), National Institutes of Health

2:25 pm Identification of a Novel Therapeutic for Idiopathic Pulmonary Fibrosis
In this presentation, Dr. Becker will discuss research recently conducted which has led to the identification of a novel therapeutic for idiopathic pulmonary fibrosis. This work was carried out in collaboration with the Emerging Innovations Unit at Astra Zeneca and her team used computational drug repurposing to identify novel indications for compounds.
Christine Becker, Ph.D., Assistant Professor, Icahn School of Medicine at Mount Sinai

2:55 pm End of Day's Sessions

September 22, 2020

9:00 am A Novel Methodology with Deep Learning for Drug Repurposing: a Treatment for COVID-19
Graph convolutional networks (GCNs) had been developed in the last several years and were expected to be able to predict the physical/chemical properties of molecules much faster than quantum simulations. In the recent studies of prediction using deep learning, structural formulas were widely used as input of the GCNs. In the current study, we would like to develop 3-dimensional convolutional networks in the real world coordinates which could receive scale free input inspired by GCNs. We would also like compare accuracies in predictions of physical/chemical properties especially for reaction to proteins in the both models; one developed in the current study whose input is electrostatic potential in the real world coordinates and one of GCNs. Finally using the champion model, we would perform drug screening on the point of views for effectiveness and safety as a silver bullet on COVID-19.
Yusuke Nakamura, Managing Partner, Plusman LLC

9:30 am TAILoR Clinical Trial - An Academic Translational Approach to Drug Repositioning
Insulin resistance is central to the development of cardiovascular and metabolic adverse effects resulting from the chronic use of anti-HIV drugs. Telmisartan, an ARB, is used as an anti-hypertensive agent; it has off-target effect on other receptors leading to beneficial effects in cardiometabolic disease. TAILoR is a UK NIHR-funded academic phase IIb clinical trial which investigated repurposing of telmisartan in reducing insulin resistance in HIV-positive patients. It used a novel adaptive trial design to evaluate the dose response and see how telmisartan affected protein and imaging biomarkers. In this presentation, Dr. Pushpakom will discuss this research at length.
Sudeep Pushpakom, Ph.D., Lecturer in Pharmacology, The Wolfson Centre for Personalised Medicine, Dept. of Molecular & Clinical Pharmacology, University of Liverpool

10:00 am Morning Networking Break

10:20 am Bridging Patient Needs and Data scientists’ Methods: A Drug Repurposing Datathon for Chronic Pancreatitis
The nonprofit patient advocacy organization Mission:Cure and the Pistoia Alliance were recently awarded an Innovative Practice Award for the drug repurposing datathon they conducted with Elsevier in 2019. This datathon brought together data scientists from across the US and Europe to identify drug repurposing candidates for chronic pancreatitis, a devastating disease with no effective treatment. In this session, Ms. Golden will discuss the nonprofit's collaboration with data scientists in its pursuit of effective therapies for pancreatitis. A chronic pancreatitis patient will share their experience and perspectives on drug repurposing. Dr. Wilson will present the datathon methodology and results. We will then have a discussion about next steps and challenges in bringing repurposed treatments to patients.
Megan Golden, JD, Co-Director, Mission: Cure
Jabe Wilson, Ph.D., Consulting Director of Text and Data Analytics, Elsevier

11:00 am Achieving Commercial Success for Repurposed Drugs: Marketing Considerations for Every Step of Development
In the competitive landscape of repurposed drugs, each phase of development can impact the marketing success of a product, and each milestone brings new questions to consider:
- What is the current market opportunity?
- What drivers and barriers could affect physician, patient, and payer behaviors in the market for your product? Will those drivers and barriers change before your product launch? How can you address them?
- How can your product be positioned to maximize commercial success?
- What are the ideal labeling claims? How can you achieve them?
This presentation will analyze these and other questions sponsors must consider and the points in a development timeline where each should be answered.

Ken Phelps, President & Founder, Camargo Pharmaceutical Services

11:30 am Repurposing Generic Drugs for COVID-19 and Cancer Using AI-Powered Technology
Dr. Kleiman's nonprofit startup is developing new and affordable cancer treatments more quickly than traditional approaches. Their technology uses AI and machine learning to aggregate massive amounts of data on repurposed generic drugs and reduce the time to identify the most promising treatments from years to weeks. In this presentation, She will describe how they are leveraging their evidence synthesis technology to help cancer patients who contract COVID-19 quickly assess how a particular treatment choice might affect both their COVID-19 and cancer.
Laura Kleiman, Ph.D., Founder & CEO, Reboot Rx

12:00 pm Lunch Break

12:45 pm Repurposing AvoB for Glucose Regulation
AvoB, a novel avocado-derived molecule, was recently shown to posses anti-cancer activity via inhibition of fatty acid oxidation. Leveraging this data, extensive pre-clinical work then demonstrated that AvoB inhibits long chain fatty acid oxidation in cell and animal models of lipotoxicity and obesity which improves insulin sensitivity in skeletal muscle and insulin release in pancreatic tissue, respectively. Subsequent to these preclinical findings, a Phase I trial demonstrated the safety and bioavailability of consuming a product containing AvoB. This product has since been reformulated and has resulted in the creation of a commercially available and Health Canada approved product with health claims associated with healthy blood glucose management.
Paul Spagnuolo, Ph.D., Associate Professor & Research Program Director, Ontario Agri-Food Innovation Alliance, University of Guelph, Department of Food Science

1:15 pm Harnessing Network Medicine for Drug Repurposing in COVID-19
As SARS-CoV-2 requires host cellular factors for successful infection and lifecycle, systematic identification of virus-host protein-protein interactome (PPI) and host-targeting interactome-inhibitory therapies offers an innovative strategy for the development of effective COVID-19 treatment. In this talk, Dr. Cheng will introduce an integrative, network medicine infrastructure that quantifies the interplay between the SARS-CoV-2 virus-host interactome, transcriptome and proteome derived from SARS-CoV-2 infected human cells or positive patients, and drug targets in the human PPI network, for systematic identification of clinically relevant host-targeting therapies (i.e., repurposed drugs [melatonin] and combination therapies [melatonin and toremifene]) for effective treatment of COVID-19. He will highlight how they validate drug efficiency from the large-scale Cleveland Clinic COVID-19 patient registry using the state-of-the-art pharmacoepidemiologic analysis and Artificial intelligence (AI) approaches.
Feixiong Cheng, Ph.D., Assistant Professor Molecular Medicine, Cleveland Clinic Lerner College of Medicine

1:45 pm The Role of Repurposing to Treat COVID-19 and Other Infectious Diseases
In this presentation, Dr. Thibodeaux will provide an update of the many fast-tracked clinical trials using repurposed drugs to treat COVID-19 patients and other efforts to get repurposed treatments to patients in need. She’ll highlight the published results of some of the more well-publicized trials and review the “good, bad and the ugly” of how the media and the public viewed these not-yet-proven treatment options. Clare will also highlight the work of Cures Within Reach to find treatments for infectious diseases and other unmet medical needs in the US and globally.
Clare Thibodeaux, Ph.D., Director of Scientific Affairs, Cures Within Reach

2:15 pm How to Protect Your Product and Overcome Generic Substitution - Combination/Formulation/Innovation
Both Pharma and Venture Capital Firms are often hesitant to make investments in 505(b)(2) products because of concerns over generic substitution. However, there are multiple strategies to pursue that can prevent substitution and provide a significant amount of time for market exclusivity to ensure a proper return on investment. This presentation will provide an overview of different approaches to protect your product that will help secure financing and advance your product to the market.
John Seman, Chief Executive Officer, REVITALE Pharma

2:45 pm Computer-Aided Drug Repositioning for COVID-19: Workflow and Results
Tudor Oprea, MD, Ph.D., Chief, Division of Translational Informatics, Department of Internal Medicine, University of New Mexico

3:15 pm End of Conference