2018 Agenda                   

Washington, DC, 25 - 26 October 2018

Schedule

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Oct 2508:55
Conference pass

Keynote address: Leading the industry in novel class antibiotics and stewardship initiatives – coordinated efforts in stewardship, diagnostics and drug development to fight resistance

Keynotes
  • Moving past commercial stage to conduct AMR surveillance through post marketing susceptibility testing and real-world evidence use registries
  • Economics of stewardship – evaluating economic models to support the responsible and sustainable use of antibiotics
  • Ensuring appropriate antibiotic use through coordinated educational efforts with providers
  • What next? How CARB-X funding is impacting Melinta’s pipeline of novel class antibiotics to further combat resistance
Oct 2509:20
Conference pass

Keynote address – Sponsored Session

Keynotes
If you’re interested in sponsoring this session contact Fred Sansiveri at fred.sansiveri@terrapinn.com or +1 646 619 1838
Oct 2509:45
Conference pass

Keynote address: Coordinated Pull – engaging all stakeholders to make “pull” incentives a reality

Keynotes
  • How can industry, regulators and funders come together to implement effective pull incentives
  • Using evidence provided buy studies like the DRIVE AB report to influence policy makers
  • Looking at different funding models with continuous clinical evaluation
  • Picking the baton from push initiatives to achieve viable
  • Market entry rewards v.s. transferable vouchers
Moderator: Greg Frank, Director, Infectious Disease Policy, B.I.O.
Mark E. Jones, Head of Clinical Development and Preclinical Development, Basilea Pharmaceutica Ltd
Jeremy Knox, Policy and Advocacy Lead, Drug-Resistant Infections Programme, Wellcome Trust
Silas Holland, Merck & Co
Oct 2511:30
Conference pass

Gaps in diagnostics innovation and areas for further technological development

Diagnostics
  • What are the next steps for diagnostic developers to meet the demand for innovation based on the WHO’s Essentials Diagnostics list
  • Uncovering the barriers and opportunities in developing diagnostics for low resource settings
Rangarajan Sampath, Chief Scientific Officer, FIND
Oct 2511:30
Conference pass

LPAD – new pathways for antibacterial drug development

Diagnostics
  • Creating pathways for companies to reinvigorate antibacterial R&D with limited number of patients in clinical trails
  • Reestablishing a balance in FDA’s antibacterial risk-benefit decision making
  • Review - how is it working and what is the future of this clinical trial pathway
Dmitri Iarikov, Deputy Director in the Division of Anti-Infective Products, FDA
Oct 2511:30
Conference pass

Case study: CDC, State Departments of Health and Aetna collaborate to tackle antibiotic overuse

Stewardship
  • Reducing the frequency of unnecessary antibiotic prescriptions through education
  • Data driven approaches to encouraging physicians behavioral change
  • Reminding doctors of evidence-based treatment practices for acute infections
Oct 2511:30
Conference pass

VC Panel: Funding for innovative traditional drugs as well as non-traditional antibiotic development

Innovation Showcase
  • Investing in traditional innovation in the antibiotic space
  • Non-traditional products and pipeline a private funders perspective.
  • What is the future of additional VC funding for both traditional and non-traditional antibiotics and innovation
Henry Skinner, Senior Vice President, Tekla Capital Management
Steve Nagler, Executive Director, MedPro Investors LLC
Oct 2511:55
Conference pass

CARB-X Turns 2!

Antibiotic R&D
  • Is the X Model Working?
  • What have we learned about Accelerating Global Antibacterial Innovation
  • Our Vision of Expanding this Global Antibacterial Innovation Fund
  • What’s next for CARB-X and for BARDA
Oct 2511:55
Conference pass

New technologies: Full pipeline overview of new rapid and susceptibility testing technologies

Diagnostics
  • What are the technologies that are close to market for susceptibility testing and rapid DX and will they close the gap for industry?
  • How will regulation influence the potential and timeline of the diagnostic pipeline
  • What are the differing opinions of the effectiveness of these technologies
Oct 2511:55
Conference pass

Putting Vision into Practice: Innovative IT Strategies to Improve Antibiotic Prescribing

Stewardship
  • Developing and deploying a global, mobile-based software solution for antimicrobial stewardship and infection control in Latin America
  • Creating a regional surveillance platform for coordinated tracking, alerting and management of multi-drug resistant pathogens
  • Employing predictive analytics to personalize traditional antibiograms
Brandon Palermo, CMO at ILUM Health Solutions and Executive Director and CMO, Merck & Co
Oct 2512:15
Conference pass

Antibiotic Development – Successes, incentives and unintended consequences

Antibiotic R&D
  • Examining the impotence of push and pull incentives
  • What makes for success for recent approvals
  • What to expect in the next 5 years
Oct 2512:15
Conference pass

After push funding: innovation in rapid diagnostics, powered by CARB-X funding

Diagnostics
  • Sparking innovation in translational science and diagnostic development to shorten time to diagnosis for bacterial respiratory infections
  • Initiating conversations with funders in early stage diagnostic development
  • Milestones for diagnostic development in CARB-X nondilutive funding
  • Preparations for commercialization and additional rounds of VC funding pull funding or reimbursement

Oct 2512:15
Conference pass

The Melinta Antimicrobial Stewardship Program: A New Effort to Address a Public Health Priority

Stewardship
  • Implementing stewardship measures within Melinta’s R&D, manufacturing, soligenand commercial operations
  • Executing AMR surveillance including post-marketing susceptibility testing and real-world use registries
  • Supporting responsible and sustainable use of Melinta products through educating healthcare providers and evaluating economic models
Oct 2512:15
Conference pass

Stimulating R&D for new Antimicrobials to address global public needs in AMR

Innovation Showcase
  • Need for multi-actors interventions to refill the pipeline
  • Role and objectives of a PPP in the space along with other initiatives.
  • Global and regional impact of drug-resistant infections
Jean-Pierre Paccaud, Director, Business Development and Corporate Strategy, Global Antibiotic Research and Development Partnership (GARDP)
Oct 2512:35
Conference pass

Stealth targeted nanoparticles (STN): A platform to fast-track poorly bioavailable antibiotics into Oral dosage form

Antibiotic R&D
  • Conundrums of IV to Oral shift: Clinical implications
  • Our experiences from the STN Development Programme
  • Advancing IV breakthrough drugs to Oral therapy during drug development programs
  • Redefining the economics of antibiotic drug development
Oct 2512:35
Conference pass

Advancing biofilmograms to better detection and treatment of Diabetic Foot Ulcer (DFU)

Diagnostics
  • Characteristics of the Diabetic Foot Ulcer (DFU) as a recurring complication of diabetes and the requirement of long-term treatment
  • Societal burden and the high cost that DFU represents in healthcare systems of high-income countries (4 billion € yearly)
  • Importance of bacterial interactions on the skin surface in the pathophysiology of DFU and time to healing
  • Challenges of effectively diagnosing presence and role of biofilm in these infections and choosing the right treatment
Yannick Pletan, Acting Chief Medical Officer, Biofilm Pharma
Oct 2512:35
Conference pass

Update from CARB-X

Innovation Showcase
  • Main areas of focus – who and what CARB-X funds
  • Understanding CARB-X’s the global reach, application process and decision making process
  • Looking into what stage of development is funded
Conference pass

Roundtable 1: Fighting Infections – AntiMicrobial non-antibiotic strategies to address specific chronic infections

Keynotes
Yannick Pletan, Acting Chief Medical Officer, Biofilm Pharma
Conference pass

Roundtable 2: Hostcentricity - a discussion on the undeniable superorganisms of human and animal health, and their contribution to holistic and sustainable antimicrobial stewardship

Keynotes
Brian Michael Aldridge, Clinical Professor, Department of Veterinary Clinical Medicine, University of Illinois College of Veterinary Medicine
Conference pass

Roundtable 3: Hematology/Oncology ASP – a successful reduction of antimicrobial usage in high risk hematology/ BMT/ oncology patients

Keynotes
Sanjeet Dadwal, Associate Clinical Professor Head of Antimicrobial Stewardship Program, City of Hope
Conference pass

Roundtable 4: Industry & Agriculture – what strategies may both benefit the industry and also the consumer as well as preventing increased AMR as a result of unregulated use in agriculture

Keynotes
Conference pass

Roundtable 5: Supporting Development – BARDA’s role in stimulating innovation in preclinical antibacterial research and development, and addressing key issues of resistance

Keynotes
Conference pass

Roundtable 6: Restoration Therapy – Microbiata-based drug candidates promise to change drug resistance characteristics of the microbiome

Keynotes
Lee Jones, Founder, President and Chief Executive Officer, Rebiotix, Inc.
Oct 2515:30
Conference pass

NIH programs to combat AR

Antibiotic R&D
  • NIH basic science: enabling innovative product development to combat AR
  • NIH support for traditional and non-traditional therapeutics to combat AR
  • NIH funding opportunities to combat AR
Oct 2515:30
Conference pass

The implications of antimicrobial resistance at the clinic and the bedside

Stewardship
  • History of resistance with patient perspectives
  • What we have been able to accomplish through stewardship and increased support for drug development of new antimicrobials
  • What resources are needed to further decrease the development of resistance and spread of current MDROs
Oct 2515:50
Conference pass

The UK’s response to the development of new therapeutics to tackle critical drug resistant infections

Antibiotic R&D
  • Presenting an overview of the AMR therapeutics landscape in the UK from an industrial perspectiveParticularly describing the key role that small-to-medium enterprises (SMEs) are playing, and the AMR Centre’s role in accelerating programs into clinical trialsHighlighting the importance of international collaboration and funding for the successful development of new drugs against AMR
Oct 2515:50
Conference pass

Phases in Evaluations of Diagnostics & Implications for Clinical Stances

Diagnostics
  • What are the key steps and considerations in the assessment of diagnostics?
  • Present & discuss the assessment processes using standard parameters & guides
  • Proposals for understanding and overcoming the lack of support through robust evidence
Eugean Jiwanmall, Senior Research Analyst, Technology Evaluation & Medical Policy, Independence Blue Cross
Oct 2515:50
Conference pass

Employing Hospital Informatics for Antimicrobial Stewardship

Stewardship
  • Identifying opportunities through baseline data for implementing interventions
  • Benefits and barriers to integrating external third party software and CPOEs
  • Prospectively identifying patients for targeted interventions – prospective audit with feedback and using alerts to intervene in real time
Benjamin Hammer, Co-leader of the Antimicrobial Stewardship Program, Children's National Health System
Rana Hamdy, Director, Antimicrobial Stewardship Program, Children's National Health System
Oct 2515:50
Conference pass

Vaccines in the global fight against AMR: Targeting the virulence or infection?

Innovation Showcase
  • Vaccines that can harm highlight the importance of virulence factors; what do we learn from staphylococcus aureus vaccines
  • Vaccines targeting virulence factors
  • IBT-V02 the first MRSA vaccine exclusively targeting virulence and the first vaccine supported by CARB-X
Javad Aman, Chief Executive Officer, Integrated Biotherapeutics
Oct 2516:10
Conference pass

Sponsored Session

Antibiotic R&D
If you’re interested in sponsoring this session contact Fred Sansiveri at fred.sansiveri@terrapinn.com or +1 646 619 1838
Oct 2516:10
Conference pass

Diagnostic value and evaluating the translation of evidence into policy and ensuring appropriate placement and equitable access of new diagnostics.

Diagnostics
  • Modelling the value of diagnostics using different lenses
  • How good is good enough and how much evidence is needed to translate into policy?
  • Ensuring equitable access to diagnostics: what does it take?
Rosanna Peeling, Director, International Diagnostics Centre and Chair and Professor of Diagnostic Research, London School of Hygiene and Tropical Medicine
Oct 2516:10
Conference pass

Panel - Hospital Antibiotic Stewardship programs – Challenges in infrastructure, education and data collection

Stewardship
  • What is working in hospital ASPs today?
  • How do different funding structures impact stewardship efforts and what needs to change to continue to ASPs
  • Recommendations to advance both in-patient and out-patient stewardship programs
  • What technological advancements do hospitals need in order to monitor and reduce use of antibiotics in both in-patient and out-patient settings
Oct 2517:00
Conference pass

Keynote Address: Updates to Iclaprim clinical development program

Keynotes
  • Nearing commercialization: Updated data from two phase 3 clinical trials
  • New data from non-clinical trials including in-vitro testing, global surveillance, animal testing, different indications and pathogens
  • Navigating the regulatory approval process: filing NDA and NAH to the FDA and EMA respectively
  • What’s next? Looking to future studies to address high unmet medical needs
David Huang, Chief Medical Officer, Motif Bio
Oct 2517:20
Conference pass

Keynote CEO Panel: How to do business in a challenging environment - Current landscape for biotechs looking to commercialize or commercializing antimicrobials

Keynotes
  • How do you turn the current antibiotic development and commercialization model into one that is attractive to big pharma
  • Partnering and business development opportunities for smaller antibiotic biotechs – overcoming low stock prices
  • How can developing companies survive in this space and get continuous investments? Is the emergence of smaller companies the way to commercial viability and efficient distribution of resources
  • What is the investment landscape going to look like for up and coming companies
  • How to launch a product and demonstrate commercial success

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Oct 2609:00
Conference pass

Keynote address: A Crucial Time for Global Coordination – Harmonizing Action Against the Threats of Antimicrobial Resistance (AMR)

Keynotes
  • Working through the G7, G20, United Nations, and the Trans-Atlantic Task Force on Antimicrobial Resistance [TATFAR] to spur action to combat AMR
  • Partnerships for developing comparable stewardship programs to preserve the efficacy of the existing antimicrobial drugs
  • Strategies for improving the pipeline of new antimicrobial drugs, vaccines, and diagnostics through enhanced global collaboration

Oct 2609:45
Conference pass

Keynote Address: Can non-traditional be our next line of defense? Challenges in non-traditional development, stewardship and diagnostic approaches

Keynotes
  • What are the most promising non-traditional therapeutics in the pipeline and are these commercially viable
  • Outlining an action plan for further development, partnered diagnostic development, and stewardship implications
  • Understanding clinical trial regulation and approval pathways for non-traditional in the U.S, Europe and beyond
  • How to get regulators, industry and payers more involved in new and non-traditional therapeutics
Jeff Stein, President and Chief Executive Officer, Cidara Therapeutics
Steven Gilman, Chief Executive Officer, Contrafect Corporation
Oct 2611:10
Conference pass

Guidelines for successful clinical trials to tackle Hospital Acquired Pneumonia

Antibiotic R&D
  • Multi stakeholders working in industry, patients, public-private partnership collaboration
  • Risk prediction models for preventative hospital acquired pneumonia
  • Recommendations for biotechs looking to gain approvals for their drug through challenging clinical trials.
Pamela Tenaerts, Executive Director, Clinical Trials Transformation Initiative
Oct 2611:10
Conference pass

Update on FDA guidance for the coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices

Diagnostics
  • Importance of coordinated development for both drug and device manufacturers
  • What has happened in the past year after the guideline implementation for AST
  • How are providers taking advantage of new developments to decrease time to approval and market
Oct 2611:10
Conference pass

Putting a One Health Approach to AMR into Action at Merck

Stewardship
  • What does One Health mean and why is it important to AMR?
  • What are opportunities for One Health collaboration between human and animal health?
  • Are there any best practices for a One Health approach?
Oct 2611:10
Conference pass

Immunobiotics: Cloudbreak Antibody Drug Conjugates (ADC) as countermeasures against MDR bacterial infections

Innovation Showcase
  • ADCs tightly bind to conserved targets on the surface of Gram negative bacteria, demonstrating broader spectrum than monoclonal antibodies.
  • ADCs kill by direct bactericidal action and recruitment of specific innate immune system components, minimizing resistance potential.
  • ADCs possess extended half-lives to support once-weekly/bi-weekly dosing, making them suitable as both immunoprophylactic and immunoitherapeutic agents
Leslie Tari, Vice President, Discovery, Cidara Therapeutics
Oct 2611:30
Conference pass

Outer membrane protein targeting antibiotics (OMPTAs): A novel class with potent activity against Gram-negative organisms to combat resistance

Antibiotic R&D
  • Presenting an overview on the development of the OMPTA antibiotics
  • Particularly describing the development of murepavadin, a pathogen specific anti-pseudomonal antibiotic which has entered Phase 3
  • Describing the in vitro and in vivo activity of the new series of OMPTAs displaying potent coverage the gram-negative pathogens designated as critical by the WHO
Glenn Dale, Head of Early Development, Antimicrobials, Polyphor Ltd
Oct 2611:30
Conference pass

Ensuring availability of approved susceptibility tests

Diagnostics
  • Working with all stakeholders in susceptibility testing development, pharmaceutical companies, device manufacturer, clinical microbiology lab and physicians
  • Historical delays and potential solutions to streamline testing approvals and availability
  • Issues of research use only (RUO) testing devises
Oct 2611:30
Conference pass

Reforming payment to enhance stewardship and public health value

Stewardship
  • Understanding how payer reimbursement models impact stewardship
  • Designing incentive and payment models that support stewardship
  • Adapting a long term economic outlook - new mindset and economic model for biotech and industry
Oct 2611:30
Conference pass

Sponsored Session

Innovation Showcase
If you’re a biotech developing a non-traditional antibiotic and you’re looking for funding or partnership opportunities, contact Fred Sansiveri at fred.sansiveri@terrapinn.com or +1 646 619 1838
Oct 2611:50
Conference pass

Sponsored Session

Antibiotic R&D
If you’re a biotech developing a non-traditional antibiotic and you’re looking for funding or partnership opportunities, contact Fred Sansiveri at fred.sansiveri@terrapinn.com or +1 646 619 1838
Oct 2611:50
Conference pass

Sponsored Session

Diagnostics
If you’re interested in sponsoring this session contact Fred Sansiveri at fred.sansiveri@terrapinn.com or +1 646 619 1838
Oct 2611:50
Conference pass

Engaging industry on stewardship best practices based on the first Antimicrobial Resistance Benchmark

Stewardship
  • What are the antibiotic development opportunities for industry in low and middle income countries where the highest rates of resistance occur
  • Employing “access thinking” to product development and strategies for companies to monitor stewardship of their drugs on the market
  • Implementing best practices and identifying progress gaps based within the pharmaceutical industry
Marijn Verhoef, Engagement, Access To Medicine Foundation
Oct 2611:50
Conference pass

Sponsored Session

Innovation Showcase
If you’re a biotech developing a non-traditional antibiotic and you’re looking for funding or partnership opportunities, contact Fred Sansiveri at fred.sansiveri@terrapinn.com or +1 646 619 1838
Conference pass

Roundtable 1: Vaccines vs. AMR – Outlining the important role vaccines play in combatting AMR and exploring the potential synergies between vaccines and antimicrobial drugs/ monoclonal antibodies to p

Keynotes
Timothy Cooke, Chief Executive Officer, NovaDigm Therapeutics
Conference pass

Roundtable 2: Non-traditional Approaches – Understanding the preclinical and clinical challenges associated with the discovery and development of non-traditional therapies

Keynotes
Conference pass

Roundtable 3: Hostcentricity – a discussion on the undeniable superorganisms of human and animal health, and their contribution to holistic and sustainable antimicrobial stewardship

Keynotes
Brian Michael Aldridge, Clinical Professor, Department of Veterinary Clinical Medicine, University of Illinois College of Veterinary Medicine
Conference pass

Roundtable 4: Essential Diagnostics – Understanding the implications of WHO’s first ever Essentials Diagnostic List and why quality diagnostics are the linchpin to breaking the AMR Pandemic

Keynotes
Anthony Emeribe, Professor, University of Calibar, Nigeria and Member, WHO Strategic Advisory Group of Experts on In-Vitro Diagnostics (SAGE-IVD)
Conference pass

Roundtable 5: MASTERMIND Diagnostics – Bringing microbial diagnostics to the clinic through a new clinical-trial design that brings together multiple stakeholders and maximizes trial efficiency by usi

Keynotes
Sarah Doernberg, Associate Professor, University of Southern California
Conference pass

Roundtable 6: Drug Reimbursement - Discussing the factors for and against proposed models - incentive-driven, pricing, and other business-based initiatives. Reviewing the variety of problems and solut

Keynotes
Eugean Jiwanmall, Senior Research Analyst, Technology Evaluation & Medical Policy, Independence Blue Cross
Oct 2614:40
Conference pass

Forging innovation: leveraging credible funding and partnerships for novel class antibiotic pipeline expansion

Antibiotic R&D
  • Beyond grant funding: taking advantage of CARB-X due diligence and scientific approach to advance Forge’s metalloenzymes
  • How can strategic early stage partnerships for lead optimization and susceptibility testing gain the interest of investors?
  • Expanding pipeline to include multiple new novel class antibiotics
Oct 2614:40
Conference pass

Combining C-reactive protein (CRP) and myxovirus resistance protein A (MxA) detection to successfully identify clinically significant acute viral and bacterial respiratory infections

Diagnostics
  • Biomarkers lead to sensitive and specific identification of viral and bacterial infections
  • A 15-minute, single use disposable diagnostic test aimed to transform the way viral vs. bacterial infections are detected at the point-of-care
  • Supporting and guiding therapeutic decisions that could shift antibiotic stewardship to the outpatient setting
Oct 2614:40
Conference pass

Educating industry and policy makers: insights from global surveillance of resistance

Stewardship
  • How to educate regulators, and practitioners based on human behavior studies and global surveillance of resistance
  • The need to further develop surveillance practices and infrastructure to continue to inform all stakeholders and guide stewardship practices
  • Recommendations to incorporate epidemiology, practitioner behavior and stewardship into drug development and commercial design
Oct 2614:40
Conference pass

Sponsored Session

Innovation Showcase
If you’re a biotech developing a non-traditional antibiotic and you’re looking for funding or partnership opportunities, contact Fred Sansiveri at fred.sansiveri@terrapinn.com or +1 646 619 1838
Oct 2615:00
Conference pass

The Priority Antimicrobial Value and Entry (PAVE) Award proposal

Antibiotic R&D
  • Market entry reward with shift to value-based reimbursement for antimicrobials
  • Incentivizing the shift from volume to value
  • Leverages public and private funds to accomplish delinkage while supporting stewardship and availability
Gregory Daniel, Deputy Director, Duke University
Oct 2615:00
Conference pass

RADICAL: Rapid Diagnostics in Categorizing Acute Lung Infections

Diagnostics
  • The inability to discriminate bacterial, viral, and non-infectious illness continues to drive inappropriate antibiotic use
  • The host’s molecular response to disease is able to discriminate between bacterial, viral, and non-infectious illness
  • Host response signatures measured on technologically advanced platforms has created a new diagnostic paradigm
Ephraim Tsalik, Associate Professor of Medicine Division of Infectious Diseases, Duke University Medical Center
Oct 2615:00
Conference pass

A closer look: The United Arab Emirates’ National AMR Surveillance program and how the private sector is contributing to resistance data collection

Stewardship
  • Current ID landscape in Dubai & United Arab Emirates overall
  • Overcoming challenges in implementing critical ASPs in the private sector and how to replicate successes
  • Unpacking how the private sector in United Arab Emirates has contributed to national surveillance resistance
Dirar Abdullah, Head, Adult Critical Care Services, Chair, Antibiotic Committee and Antibiotic Stewardship Program, Prime Hospital- Dubai
last published: 08/Jun/18 16:25 GMT

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