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About the Summit - GIIEventKeeve nachman, Ph.D., mHs, Program Director, Food Production & Public Health Program, JOHNS HOPKINS UNIVERSITY Additional Panelists to be Announced Panel

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Though the frenzy from Ebola has died down, it has brought up a heightened importance to prepare for public health issues. Government funding to fight bioterrorism has dried up and the high cost of R&D to develop drugs to combat these issues means new drugs are not appearing as quickly as needed. A recent report by the Blue Ribbon Study Panel on Biodefense stated:

‘There is no comprehensive national strategic plan for biodefense. There is no all-inclusive dedicated budget

for biodefense.’

Biodefense, along with the very real threats of antimicrobial resistance and emerging and engineered infectious diseases needs solutions; and fast.

How can we stimulate the development of new drugs and alternative therapies? What incentives are in place to promote innovation and develop new vaccines? What are the next emerging threats we need to prepare for?

The 14th Annual Vaccines & Therapeutics 2016, scheduled for May 17-19, 2016 in Washington, D.C. will bring together government, private company and other stakeholders from the U.S. and the rest of the world will discuss the future in the war against bioterrorism, infectious disease threats and antimicrobial resistance and the importance of innovation in fighting back.

The conference will be preceded by the Symposium: Rapid Diagnostic Innovation and Preparedness for Public Health Threats on May 17, 2016, which will cover the latest ground-breaking research being conducted on infectious diseases, AMR and pathways to regulatory approval.

About the Summit

SET UP MEETINGS WITH OTHER PARTICIPANTS BEFORE THE EVENT.

As a confirmed attendee, one week prior to the event you will receive an email with a password granting you exclusive access to all other attendees so you can set up face-to-face meetings before the event.

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Summit Agenda

Presentation: Prioritization and Alignment of Investments in Medical Countermeasures Prioritizing and budgeting for the right countermeasures will be key for the country’s Biodefense plan to succeed. Will dual use drugs be the key to seeing an increase in the government’s portfolio? In this session, hear what factors need to be taken into consideration when prioritizing and budgeting correctly.

Presenter: rosemarieAurigemma,Ph.D., Chief, Drug Development

Section, Office of Biodefense, Research Resources, and Translational Research, DMID, NIAID, NIH

Case Study: Development of a New Treatment for Anthrax in Partnership with DoD and HHSPresenter: elizabethg.Posillico,Ph.D.,President & CEO,

ELUSYS THERAPEUTICS, INC.

Panel Discussion: Government Perspective—Funding Success and Opportunities What different platform technologies have been developed through partnerships between industry and government? What are future government funding plans?

Panelists:Paulabryant,Ph.D., Senior Scientific Officer, Concept

Accelerator Program, OBRRTR, DMID, NIAID, NIH*erinreichert,Ph.D.,Chief, Translational Medical S&T Division

(J9-CBM) Joint Science and Technology Office, DEFENSE THREAT REDUCTION AGENCY (DTRA)

ltcVictorsuarez, Joint Product Manager, JOINT VACCINE ACQUISITION PROGRAM (JVAP)

Panel Discussion: Industry Perspective—Funding Success StoriesPanelists:D.grayHeppner,mD,Chief Medical Officer, BIOPROTECTION

SYSTEMS/NEWLINK GENETICS CORPORATIONgaryHorwith,mD,EVP Regulatory, Quality, Pharmacovigilance,

CEMPRA, INC.JeremyD.middleton,VP, Corporate Development,

ELUSYS THERAPEUTICS, INC.seniorrepresentative, EMERGENT BIOSOLUTIONS

Biodefense

Presentation: Current U.S. Government Views on Biodefense What is the government’s current approach towards biodefense? What are future biodefense plans?

Presenter: michaelg.Kurilla,mD-Ph.D., Director, Office of BioDefense,

Research Resources, and Translational Research, Associate Director for BioDefense Product Development, DMID, NIAID, NIH

Presentation: Overview of the Blue Ribbon Panel Report on BiodefenseAccording to a recent report by the bipartisan Blue Ribbon Study Panel on Biodefense, the United States is not prepared to deal with a biological event with catastrophic consequences. Success in preventing and responding to such events—whether due to a bioweapon, naturally-occurring disease, or accidental release—will depend on a renewed prioritization of biodefense leadership at the highest level of government. The Panel’s comprehensive report, A National Blueprint for Biodefense: Leadership and Major Reform Needed to Optimize Efforts, calls for a dramatic shift in the government’s approach to biodefense leadership, one that would enable greater successes in innovation, coordination, and collaboration among all elements of the biodefense enterprise. This includes a renewed focus on innovation in the development of medical countermeasures, from funding cutting edge platform technologies to rethinking how the government prioritizes emerging infections to developing transformative approaches to public-private partnerships. In this session, hear an overview of key recommendations and a status update on their implementation from one of the Study Panel’s directors.

Presenter: ellenP.carlin,DVm,Panel Co-Director,

BLUE RIBBON STUDY PANEL ON BIODEFENSE

Presentation: The Challenges of Developing Medical Countermeasures against Weapons of Mass DestructionPresenter: russelle.coleman,Ph.D.col,ms,Joint Project Manager,

Medical Countermeasure Systems Assistant Corps Chief (Medical Service Corps) for Preventive Medicine Entomology Consultant to The Surgeon General, JPM-MCS

Wednesday May 18, 2016

Networking Break

To Register Visit: www.infocastinc.com/vaccines

Call: (818) 888-4444

Email: [email protected]

Fax: (818) 888-4440

*Invited

Group Luncheon

Summit Agenda (continued)

Wednesday May 18, 2016 (cont.)

Antimicrobial Resistance

Panel Discussion: The Relationship Between Food Animals and AntimicrobialsDeadly diseases such as Ebola and avian flu can jump between animals and humans. Prevention of the spread from animals to humans in the first place is key. Food animals serve as a reservoir of resistant pathogens and resistance mechanisms that can directly or indirectly result in antibiotic resistant infections in humans. Improving surveillance of and planning for animal and zoonotic outbreaks will be an important factor in preventing epidemics. This panel will discuss the changes that need to be made over the next five years to slow the emergence of resistant bacteria and prevent the spread of resistant infections.

Panelists: guyH.loneragan,Professor of Food Safety and Public Health,

TEXAS TECH UNIVERSITYKeevenachman,Ph.D.,mHs,Program Director, Food Production

& Public Health Program, JOHNS HOPKINS UNIVERSITY Additional Panelists to be Announced

Panel Discussion: Stimulating Investment in Diagnostics, Drugs and Alternative TreatmentsNew diagnostic tools are needed to know how and when to use new antibiotics. Due to a weakening business case for pharma to invest, this has been difficult. How can we stimulate the development of new AMR drugs and alternative therapies?

Panelists:Davidcook,Executive Vice President of Research & Development

and Chief Scientific Officer, SERES THERAPEUTICSerinm.Duffy,Ph.D., Chief Scientific Officer,

MELINTA THERAPEUTICS, INC. rogerechols,mD, Principal Member, INFECTIOUS DISEASE

DRUG DEVELOPMENT CONSULTING, LLCAmandaJezek, Vice President, Public Policy and Government

Relations, INFECTIOUS DISEASES SOCIETY OF AMERICAJosephlarsen,Acting Deputy Director, BARDAltcericmidboe, Joint Product Manager (JPdM),

BioDefense Therapeutics (BDTX) Product Management Office (BDTX JPdMO), MCS JPM

JayanandVasudevanPh.D.,Senior Scientist, JPM MCS-BIODEFENSE THERAPEUTICS

Presentation: NIH, BARDA and the CARB InitiativeThe U.S. Department of Health and Human Services (HHS) is holding a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care (POC) diagnostics. The goal of the program is advanced development of innovative diagnostic tests for identification and characterization of resistant bacteria for use by health care providers. In this session, hear an update on the initiative.

Presenter: rosemaryHumes,Interdisciplinary Scientist, BARDA

Presentation: Evolving Ecosystem for AMR Antibiotics Development: Licensing-In Vs. In-House Research?How can biotech and big pharma work together to bring innovation from academia to market? Is the current system conducive to producing a sustainable pipeline of antibiotics? What should the future ecosystem for antibacterial R&D look like, and what can we do to prepare for it? Will dual use drugs be the best way to fight AMR?

Presenter: christopherHouchens,Health Scientist, BARDA

Presentation: Is MCR-1 the next ‘Superbug Gene’?Chinese researchers have discovered a new superbug gene called MCR-1 that enables bacteria to be highly resistant to polymyxins, the last line of antibiotic. This presentation will discuss the importance of global awareness to prevent this spread.

Presenter: lancePrice, Professor, GEORGE WASHINGTON UNIVERSITY

Presentation: Measures and Metrics for Evaluating Progress in Preventing and Controlling AMRThis talk proposes that an historical lack of progress in combating AMR is a result of the absence of good metrics and that we need to work hard to avoid repeating that mistake with our current efforts, and offers some ideas for achievable metrics for prescribing and infection control in human health and what some comparable approaches might be in animal health and agriculture.

Presenter: stevensolomon,mD,Principal,

GLOBAL PUBLIC HEALTH CONSULTING Networking Break

Cocktail Reception

Panel Discussion: Zika Virus, MERS, Q-Fever, Flu, NDM-1, TBA convergence of factors, including global increases in livestock farming and more frequent interfacing among humans, livestock and wildlife, is allowing pathogens like influenza to emerge with greater frequency and virulence. As we’ve seen recently with the Zika virus. Disease can spread rapidly from country to country. To effectively prepare for emerging infectious disease and bioterror threats, we must take animal populations into more serious consideration and address the animal-human interface. This is difficult to do when funding for animal health research is not supported in the same way as it is for humans.

Panelists: Davids.cho,Ph.D.,m.P.H., Senior Scientist for Emerging

and Pandemic Threat Preparedness, Senior Scientist for Global Inspectional Collaborations, Immediate Office of the Director, Center for Biologics Evaluation and Research, U.S. FOOD AND DRUG ADMINISTRATION

Kayvonmodjarrad,m.D.,Ph.D., Associate Director, Emerging Infectious Disease Threats, MILITARY HIV RESEARCH PROGRAM/WALTER REED ARMY INSTITUTE OF RESEARCH

s.s.Vasan,Ph.D.,Senior Business Development Manager, PUBLIC HEALTH ENGLAND

Emerging & Engineered Unknown Threats

Presentation: Current State of Emerging and Engineered ThreatsWhat threats are causing researchers concern? How will we prepare? What have we learned from the Ebola crisis in Africa? How can this help prevent the spread of Zika virus?

Presenter:stephenJ.thomas,mD, Deputy Commander for Operations,

Walter Reed Army Institute of Research Infectious Diseases Consultant to the US Army Surgeon General, USAMRMC EBOLA RESPONSE MANAGEMENT TEAM LEAD

Presentation: Global Impacts of the Zika VirusPresenter to be Announced

Presentation: BARDA’s Investments in Universal Flu VaccinesPresenter: mariobarro, Interdisciplinary Scientist, BARDA

Panel Discussion: C’est difficile and Other Enteric-colonizing Multidrug Resistant OrganismsClostridium difficile poses a difficult problem. It can cause serious illness with 10% mortality rate in hospital patients whose gut flora have been disrupted by antibiotics. This session will explore the global burden of this bacteria and other enteric-colonizing drug resistant organisms, key challenges and leading countermeasures including vaccines, polyclonal antibodies, microbiome therapies and antibiotics.

Panelists: christianfelter,mD,Associate VP, Global Medical Expert,

SANOFI PASTEUR l.cliffordmcDonald,mD,Senior Adviser for Science and

Integrity, Division of Healthcare Quality Promotion, CENTERS FOR DISEASE CONTROL AND PREVENTION

s.s.Vasan,Ph.D., Senior Business Development Manager, PUBLIC HEALTH ENGLAND

Thursday May 19, 2016

Summit Agenda (continued)

Networking Break

EARLY BIRD

ENDSAPR. 1, 2016

To Register Visit: www.infocastinc.com/vaccines

Call: (818) 888-4444

Email: [email protected]

Fax: (818) 888-4440

Symposium: Rapid Diagnostic Innovation and preparedness for public Health Threats

Tuesday May 17, 2016

Presentation: Innovation and Best Practices for Infection Control, Use of Medicines and Technology Development Presenter: JohnJ.Woloszyn, President & CEO, INTRALYTIX, INC.

Presentation: BARDA Innovation Opportunities in AMR DiagnosticsPresenter: Johnlee, Health Scientist, BARDA

Presentation: NIH’s HIV/AIDS Research PrioritiesPresenter: robertW.eisinger, Acting Director, Office of AIDS Research and

Acting NIH Associate Director for AIDS Research, NIH

Panel Discussion: Building Clinical Research Capacities in Geographic “Hot Spots” for Emerging DiseasesPanelists: Jeannem.fair,Ph.D.,Defense Threat Reduction Agency,

Cooperative Biological Engagement Program, Science Lead Middle East & South Asia, DTRA

lauragibson, Program Assistant, BARDAltcericmidboe, Joint Product Manager (JPdM),

BioDefense Therapeutics (BDTX) Product Management Office (BDTX JPdMO), MCS JPM

JayanandVasudevanPh.D.,Senior Scientist,JPM MCS-BIODEFENSE THERAPEUTICS

Presentation: Lessons from the Early Days of HIV/AIDSPresenter: georgeW.christopher,mD,Chief Medical Officer,

JPM-MCS

Presentation: Acceleration of Candidates During A Crisis: Experiences, Lessons ObservedPresenter:ericepseland, Chief, Vaccine Countermeasures, Division of CBRN

Countermeasures, BARDA

Panel Discussion: Randomized Controlled and Adaptive Trial Designs: Pro, Con, or Complementary?Panelists: lucianaborio,m.D., Acting Chief Scientist,

FOOD AND DRUG ADMINISTRATIONKayvonmodjarrad,m.D.,Ph.D., Associate Director, Emerging

Infectious Disease Threats, MILITARY HIV RESEARCH PROGRAM/WALTER REED ARMY INSTITUTE OF RESEARCH

Additional Panelists to be Announced

Presentation: A Business Model for Global Health SecurityPresenter: rebeccafish,Vice President, Biodefense Division,

EMERGENT BIOSOLUTIONS

Presentation: Efforts to Survey the Landscape of MERSPresenter: Karlerlandson,Prat Fellow, BARDA

Networking Break

Group Luncheon

Networking Break

To Register Visit: www.infocastinc.com/vaccines

Call: (818) 888-4444

Email: [email protected]

Fax: (818) 888-4440

May 17-19, 2016Almas Temple ClubWashington, D.C.

An Infocast Deal Working EventPRESORTEDSTANDARD

U.S. POSTAGE pAIDPBPS

Infocast20931 Burbank Blvd. Suite BWoodland Hills, CA 91367

EARLY BIRD

ENDSAPR. 1, 2016

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“Attending this meeting has been especially enlightening. As a person trying to build statewide momentum in building a biodefense sector, I found the full breadth of issues covered with very experienced and highly relevant speakers.”

– Mary Beth Thomas, North Carolina Biotechnology Center

“Great topics and informed panel participants.”– Stuart Knight, Quintiles

What previous participants said about our Annual Vaccines + Therapeutics Summit: