Day One - Plenary Sessions | Tuesday, October 16, 2018
8:15AM
Registration Opens and Continental Breakfast
9:00AM
Opening Remarks
9:15AM
A Public Policy Perspective on Market-Shaping Considerations for Emerging Infectious Diseases
  • Compare the systems in place for expedited access to vaccines and available therapies during public health emergencies
  • Evaluate existing domestic and international policies that maximize market access in emerging markets for infectious disease products
  • Consider innovative business model proposals for emerging infectious diseases that leverage internal regulatory expertise and strategic funding options
John Billington, Director U.S. Public Policy Vaccines, GSK
10:00AM
Review of Advancements and Challenges in the Clinical Development of Therapies for Those With Unmet Medical Needs
  • Understand the impact that the current global regulatory environment has on the development of drugs for neglected diseases
  • Outline the market access forces driving regulatory innovations that impact clinical development
  • Understand how regulatory agencies have provided support to advance the control of some NTDs like malaria and TB
Leonard Sacks, M.D., Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA
10:45AM
Networking Break
11:15AM
Generic Drug Incentives That Can Drive More Treatments to Patients Faster
  • Grasp how recycling of CONSUMER-USED materials has been a part of life for centuries and how technology has changed it
  • Understand how new technology, economic incentives, and government requirements have repurposed therapy development
  • Describe the future of drug repurposing research and discover how to find new drug targets quickly and more efficiently
Bruce Bloom, CEO, CURES WITHIN REACH
12:15PM
Networking Lunch
Day One - Tracked Sessions | Tuesday, October 16, 2018
Priority Review Vouchers Track
Strategic Partnerships for Drug Repurposing Track
Neglected Tropical Diseases Track
Investment and Business Models for Drug Development Track
1:15PM
Opening Remarks
David Ridley, Ph.D., Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY
Opening Remarks
Bruce Bloom, CEO, CURES WITHIN REACH
Opening Remarks
Marco Biamonte, President, DRUGS & DIAGNOSTICS FOR TROPICAL DISEASES
Opening Remarks
William D. Paiva, Ph.D., Executive Director, Center for Health Systems Innovation (CHSI), OKLAHOMA STATE UNIVERSITY
1:30PM
Manage the Complexities of Clinical Trials for PRV-Eligible Products
  • Discover the lessons learned from conducting clinical trials for Ebola, Chikungunya and Zika during outbreaks
  • Understand how the challenges of these trials differ from conducting research in well-equipped, experienced sites
  • Review financial and logistical considerations associated with conducting research in developing countries
Ted FitzGerald, M.S., Director, Global Research Services, FHI 360
Strategic Partnerships for Open Clinical Innovation Successes
  • Address the value proposition for repositioning through Open Innovation means
  • Discuss what happens when you open the doors to collaboration
  • Touch on how we can get a new view of old compounds through informatics approaches
  • Understand the key to success in industrial-academic partnerships
Leslie Cousens, Director, Translational Medicine Emerging Innovations, ASTRAZENECA
Top Considerations to Reassess Global Health Strategies to Build Sustainable Infrastructures That Combat NTDs
  • Identify models of treatment access expansion through capacity building
  • Assess the long-term impact of donation programs on the allocation of resources to explore new licensing or pricing models for existing drugs
  • Strengthen global strategy programs that address the substantial NTD burden implement models that aim to utilize sustainable plans

Bill Lin, Ph.D., Global Program Leader, Neglected Tropical Diseases (retired), JOHNSON & JOHNSON
Capital Raising for a Pre- NDA PRV Candidate
  • Assess the development pathway of a product that addresses an unmet medical need
  • Gain an overview of the capital raising activities and timeframe
  • Review the global health impact obligations within the agreements
  • Understand the post-PRV plans to build a sustainable global health biotechnology company
Curt H. LaBelle, M.D., MBA, President, GLOBAL HEALTH INVESTMENT FUND
2:15PM
Overview of the Recent Pandemic and All- Hazards Preparedness and Advancing Innovation Act of 2018 (PAHPA Reauthorization) and Its Implications for MCM PRVs
  • Examine and discuss the current landscape for medical countermeasure development and procurement with the U.S. government
  • Understand the implications of the PAHPA Reauthorization on medical countermeasure PRVs
  • Discuss future opportunities to incentivize the development of medical countermeasures
Patrick Lucy, Chief Business Officer, PFENEX
Using AI and Drug Repositioning to Accelerate Solutions for Vulnerable Populations, Vulnerable Patient Populations Have Zero Luxury of Time
  • Address every new tool, approach, and novel operating frameworks to advance solutions timely and cost-effectively, given the huge quantity of healthcare data worldwide, AI is central to developing new solutions
  • Understand AI in combination with drug repositioning, which accelerates the development of new therapeutic entities faster than any other development process, we stand at the dawn of a new operating framework to develop solutions for vulnerable populations
  • Hear specific case studies of the use of the Project Prodigy AI
Aris Persidis, President and Co- Founder, BIOVISTA
Regulatory Considerations That Are Essential to Overcome Global Health Concerns in the Developing World
  • Address the challenges of providing LMIC access to innovative solutions
  • Review current and ongoing public sector engagement programs
  • Industry methods that support the building of an independent capacity to execute public health initiatives
  • Discuss the potential of the market value of NTD vaccines as the foundation for sustainable business model for future innovations in emerging markets
Jean-Antoine Zinsou, Head of Global Public Affairs, New Vaccines, SANOFI PASTEUR
Insights From a PRV-Centered Investment Deal Between Private and Non-Profit Entities
  • Gain an overview of the terms and structure of a PRV-based deal to fund development
  • Describe the nature, timeline, and challenges associated with arranging such a deal and the concerns about ongoing developments and uncertainties in this dynamic space
  • Discuss how this investment is enabling the development of a new, urgently needed drug and how it’s partners aim to have this new drug reach hundreds of millions of people living in low-income countries
Scott Requadt, J.D., MBA, Managing Director, CLARUS
3:00PM
Networking Break
3:30PM
Valuation Considerations for PRVs
  • Assess the current supply and demand for PRVs in the marketplace
  • Evaluate whether public perception of PRVs has shifted and if that will impact awarding habits and future legislation
  • Determine how geographic pricing (U.S./EU/ROW) corresponds with regional demand
  • Review tax consequences around PRV sale structuring
Prashant Raykar, Senior Manager, Corporate Development, EMERGENT BIOSOLUTIONS
Explore New Therapies to Put Autoimmune Diseases Into Long-Term Remission
  • Hear how we have developed a treatment to prevent and/ or reverse the cognitive impairment due to Multiple Sclerosis
  • Define a novel therapeutic strategy for the treatment of cognitive impairment in MS, inhibition of glutamate carboxypeptidase II (GCPII)
  • Study recent clinical data collected at the Johns Hopkins Hospital in MS patients and their performance on a battery of cognitive tasks
  • Examine a mood-tracking technology to help track your daily mood
Adam Kaplin, Assistant Professor of Psychiatry and Behavioral Sciences, JOHNS HOPKINS HOSPITAL
Global Health Partnerships Models That Encourage Sustainable Development
  • Implement alliance development strategies across the private sector, multilateral and NGOs
  • Consider policy frameworks for public and private sector engagements and understand current policy gaps that encourage sustainable program development
  • Develop programs that leverage resources to balance social equity with business goals
Phillip L. Gomez, Ph.D., CEO, SIGA TECHNOLOGIES, INC.
Impact Investing for Research Through the Leukemia & Lymphoma Society
  • Gain an overview of the history of the Leukemia & Lymphoma Society
  • Understand the mechanisms of how we fund
  • Gain insights into the diligence process, how to manage risk and what we look for in an investment opportunity
  • Discuss successful examples of collaboration
Kenneth LaMontagne, Ph.D., MBA, Vice President, Research, Therapy Acceleration Program, THE LEUKEMIA and LYMPHOMA SOCIETY
4:15PM
Panel The Value of Priority Review Vouchers in the Marketplace
  • Discuss historical transactions and trends in pricing
  • Explore changes in supply and demand effects
  • Share thoughts on voucher value from the buy and sell side
  • Forecast future prices for PRVs
Case Study Repurposing FDA-Approved Drugs for Neurodegenerative Diseases: From Mechanism to Medicine
  • Understand the common mechanisms of neurodegeneration and cancer in repurposing drugs
  • Elucidate drug action at the cellular and molecular levels
  • Discuss the impact of a repurposed drug on patients including rare and orphan diseases
Charbel Moussa, Director, Laboratory for Dementia and Parkinsonism, GEORGETOWN UNIVERSITY MEDICAL CENTER
Novartis Institute of Biomedical Research Case Study: Strides in Drug Development to Combat Cryptosporidiosis and Leishmaniasis
  • Review the Leishmaniasis program milestones and accomplishments in identifying ways modulate the activity of a conserved parasite target
  • Learn about the expanding drug discovery efforts being made to identify novel therapies to fight cryptosporidiosis
  • Hear about the challenges of navigating the IND pathways when working with non- ICH regulatory bodies to make these novel therapies accessible
Richard Colvin, M.D., Ph.D., Executive Director, Senior Translational Medicine Expert, NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH (NIBR)
Funding Flexibly and Collaboratively in a Healthcare System Focused on Coverage and Reimbursement
  • Review various models and structures that biopharmaceutical companies can utilize to secure program funding
  • Discuss how alternative funding can be an innovative approach to sharing the inherent risks of drug development while progressing programs to ultimately benefit patients
  • Explore some advantages to risk sharing approaches, potential funding models, how risk is viewed and assessed, and criteria used for determining asset funding decisions
Brian Axe, Principal, NOVAQUEST CAPITAL MANAGEMENT
5:00PM
Day One Sessions Conclude
5:30PM - 7:30PM

CureAccelerator Live!

This is a philanthropic pitch competition that gives attendees the chance to find and fund the next breakthrough treatment at a unique networking event for researchers, clinicians, patient groups, biomedical industry professionals, and funders. This opportunity to help harness the power of repurposing research and help bring groundbreaking treatments to patients in need.

The finalists will be announced pending review of submitted proposals.

Complimentary with conference registration, but sign-up is required to reserve your spot.

Day Two - Tracked Sessions | Wednesday, October 17, 2018
Priority Review Vouchers Track
Strategic Partnerships for Drug Repurposing Track
Neglected Tropical Diseases Track
Investment and Business Models for Drug Development Track
8:00AM
Continental Breakfast
9:00AM
Opening Remarks
David Ridley, Ph.D., Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY
Opening Remarks
Bruce Bloom, CEO, CURES WITHIN REACH
Opening Remarks
Marco Biamonte, President, DRUGS & DIAGNOSTICS FOR TROPICAL DISEASES
Opening Remarks
William D. Paiva, Ph.D., Executive Director, Center for Health Systems Innovation (CHSI), OKLAHOMA STATE UNIVERSITY
9:15AM
TPOXX®: A Case Study in Medical Countermeasure Development and Stockpiling
  • Review the development and supply of a novel antiviral drug for treatment of smallpox infections
  • Evaluate the opportunities and challenges of partnered development with the U.S. Government for a critical public health need
  • Provide an overview of the business opportunities and challenges for Biodefense products
Phillip L. Gomez, Ph.D., CEO, SIGA TECHNOLOGIES, INC.
Combining Chemogenomics and Phenotypic Screening With Machine Learning to Rapidly Identify Drug Targets and Anti-Targets
  • Explore studies have demonstrated that drug sensitivity information at the level of the proteome is not available at the level of the corresponding DNA or mRNA
  • Hear a discovery platform for Identification of Drug Targets and Anti-targets by Cellular and Molecular Crossreferencing (idTRAX)
  • Discuss a custom developed machine learning algorithm is then used to relate the resultant cellular phenotypes to the compounds’ kinase inhibition profiles
Hassan Al-Ali, Research Assistant Professor, Department Of Neurological Surgery, UNIVERSITY OF MIAMI
The CURE Platform: An FDA and NCATS Collaboration to Capture and Organize Drug Repurposing Option For NTDs
  • Hear and overview of repurposing’s promise for neglected infectious diseases
  • Review repurposing examples in the preclinical versus clinical space
  • Discuss CURE platform limitations and its potential to inspire formal drug development innovations for tropical infectious diseases
Heather Stone, Public Health Analyst, FDA
An Overview of Fifteen Years of Experience of a PDP, DNDi, to Address Disease Burdens on Developing Nations
  • Understand the role of DNDi and how it contributes to the research and development of treatments for neglected diseases
  • Review case examples of successful collaborations with industry partners
Serge Sagodira, Ph.D., Director of Business Development and Legal, DRUGS FOR NEGLECTED DISEASES INITIATIVE (DNDI)
10:00AM
Incentivizing Industry Investment in Medical Countermeasure Development
  • Provide background on the role of private sector in medical countermeasure development
  • Review why bioterrorism-type threats are increasing and different incentive options that have been generated to attract investment
  • Identify gaps in the literature to better understand the relative strengths of industry partners and highlight new recommendations for leveraging industry involvement
  • Explore how a more nuanced understanding of industry “players,” along with a portfolio of creative incentives, targeted at different kinds of companies, would be more effective than a “one-size-fits-all” approach
Rebecca Fish, Vice President, Marketing and Product Strategy, Biodefense Division, EMERGENT BIOSOLUTIONS
Panel Drug Development Partnerships With Stakeholders
  • Clarity the partnerships between life science companies government, nonprofits and patient advocacy groups
  • Identify some of the issues and challenges surrounding drug repositioning
  • Incentives from the FDA for drug repurposing for orphan and pediatric diseases
  • Understand a systematic approach to evaluate drug candidates
  • Piece together funding for smaller companies, partnerships
Panelists:

Bobbie Austin, Program Officer, Drug Development Partnership Programs, NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES, NIH
Zhichao Liu, Staff, Fellow, NCTR, FDA
Heather Stone, Public Health Analyst, FDA

Strategies to Mitigate the Financial Risk of Novel Therapeutic Development of for Neglected Patients by Bridging Funding Gaps
  • Outline the market access forces that drive pricing considerations and how drug developers can react appropriately
  • Cultivate strategic partnerships that lessen the risk of investing in development for both parties
What to Do When Raising Capital Locally for Life Science Companies Is a Challenge
  • Learn how national and local foundations can make seed investments in life science organizations using grant dollars through Program- Related Investments (PRIs)
  • Gain an overview of the Venture Philanthropy category and examine organizational and management best practices
  • Review local and national examples of success
William D. Paiva, Ph.D., Executive Director, Center for Health Systems Innovation (CHSI), OKLAHOMA STATE UNIVERSITY
10:45AM
Networking Break
11:15AM
New Models for Innovation of Access
  • Explore novel routes to guaranteeing access to PRV-eligible drugs
  • Discuss how imperative it is to consider the needs of patients in endemic regions when constructing a market access plan
  • Discover the different ways to accommodate fair pricing for populations that actually need these products
Forrest Cox, Co-Founder and SVP, Corporate and Business Development, AFFIGEN
Develop a Repositioning Strategy to Repurpose Drugs for New Indications
  • Learn about drug treatments for post-acute/chronic neurorehabilitation needs
  • Delve into some of the NeuroHealing clinical programs that are in the pipeline
  • Discuss innovative drug treatments for specialty indications based on neurologically active compounds
  • Review some trends and comparisons of development paths for CNC focus
Neal M. Farber, CEO, NEUROHEALING PHARMACEUTICALS, INC.
Commercialization of Cost-Effective Diagnostics for Targeted Mass Drug Intervention for River Blindness Patients
  • Establish a testing strategy to map the distribution of Loa loa infection in patients also infected with river blindness
  • Discuss the low-cost implications of designing a platform that can be adapted to multiple diseases to avoid adverse events
  • Construct a feasible trial plan that incorporates regional global health initiatives skill in market access strategies for underserved populations globally
Marco Biamonte, President, DRUGS & DIAGNOSTICS FOR TROPICAL DISEASES
Case Study Adapting Investment Strategy to Business Model
  • Examine the different types of investors and what they expect from traditional investments
  • Learn about the benefits of working with patient advocacy groups and how they can raise political awareness to help define guidance for drug development
  • Understand the challenges of raising awareness for a disease that lacks a definitive means of diagnosis
Amrit Shahzad, MBBS, MBA, Industry Alliance Officer, UC SAN DIEGO
12:00PM
Extensions of the Priority Review Voucher Program Concept
  • Understand how the PRV program creates value through faster regulatory review
  • Consider how the value of a PRV can be leveraged to encourage innovation for underserved populations
  • Explore how the same principle has been and can be applied in other settings, for example:
  • United States Patent and Trademark Office: Patents for Humanity
  • United States Environmental Protection Agency: Vector control
  • Europe: Regulation and reimbursement
David Ridley, Ph.D., Faculty Director, Health Sector Management, Fuqua School of Business, DUKE UNIVERSITY
Advance Precision Medicine Through an Understanding of Current and Future Strategies
  • Understand biomarker-based repositioning in precision medicine (personalized medicine)
  • Touch on systematic repurposing approach and how to integrate with precision medicine
  • Establish the importance of drug repurposing in the era of medicine • Finding economic incentives for repurposing and drug pricing
  • Explore bioinformatics for repurposing in rare diseases
Mark Hasleton, Senior Director, Global NTE Pipeline Manager, TEVA PHARMACEUTICALS
DNDi Drug Discovery Booster Program: An Innovative Product Development Partnerships Spanning the Biomedical Landscape
  • Understand the impact of strategic product development partnerships to accelerate innovation of novel NTD therapies
  • Discuss the role PDPs play in developing relationships with endemic regulatory authorities that facilitate clinical work with neglected populations
  • Develop partnerships with endemic country institutions to implement post registration commitments and facilitate policy adoption
Anita Staud, Senior Manager Business Development, DRUGS FOR NEGLECTED DISEASES INITIATIVE (DNDI)
Accelerate Life-Changing Breakthroughs to Cure, Prevent and Treat Type 1 Diabetes and Its Complications
  • Gain an overview of JDRF’s funding mechanism and discovery and development partnerships program
  • Discuss key considerations for selecting the right partners
  • Examine the evolving business model and the establishment of a scalable, missiondriven venture philanthropy platform exclusively focused on investment in early stage commercial opportunities
Michael Batten, M.D., MBA, Director, T1D Fund, JDRF
1:00PM
Networking Lunch
Day Two - Plenary Sessions | Wednesday, October 17, 2018
2:00PM
Closing Plenary Panel
Collaborative Partnerships That Enable Multi-Phase Development Therapies for the Greatest Public Health Concerns
  • Gain an overview of how companies of various structures like PDPs, nonprofits, and industry collaborate to accomplish a shared goal
  • Promote balanced and productive relationships with social enterprises
  • Build drug development programs that leverage private and public sector resources to balance social equity with business goals
Moderator:

Bruce Bloom, CEO, CURES WITHIN REACH

Panelists:

Richard Colvin, M.D., Ph.D., Executive Director, Senior Translational Medicine Expert, NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH (NIBR)
Leslie Cousens, Director, Translational Medicine Emerging Innovations, ASTRAZENECA
Adam Kaplin, Assistant Professor of Psychiatry and Behavioral Sciences, JOHNS HOPKINS HOSPITAL
Zhichao Liu, Staff, Fellow, NCTR, FDA
William D. Paiva, Ph.D., Executive Director, Center for Health Systems Innovation (CHSI), OKLAHOMA STATE UNIVERSITY

3:00PM
Conference Concludes