2016 Archived Content
The challenge we face today is to reinvigorate the antibiotic drug pipeline and bring new drugs to market, while also diminishing commercialization risks such as low financial return. As government bodies design new initiatives to facilitate research,
discovery, and development, commercial entities are provided the opportunity to take advantage of funding and develop new products. The third annual Antibacterial Development and Market Access conference aims to examine
the pharmacoeconomic, regulatory, and investment challenges that pharmaceutical companies face.
Final Agenda
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Thursday, December 8
12:00 pm Registration
12:55 Chairperson’s Opening Remarks
Barry Eisenstein, M.D., FACP, FIDSA, FAAM, Distinguished Physician, Antimicrobials, Merck & Co., Inc.
1:00 New and Emerging Diagnostics for Antibiotic Stewardship and Clinical Trials
Kimberly E. Hanson, M.D., MHS, Associate Professor of Medicine and Pathology,
University of Utah
Accurate and timely diagnosis can improve patient care and antibiotic stewardship initiatives as well as potentially facilitate enrollment in clinical trials of new antimicrobials. This session provides an overview of new and emerging diagnostic technologies
for infectious diseases, with a focus on bacterial detection and drug resistance testing. The ways in which current assays may be optimally utilized along with potential barriers to the implementation of advanced technologies will be discussed.
1:30 It Takes Two: The Role of Rapid Diagnostics in the Success of Antimicrobial Stewardship
Kevin Alby, Ph.D., D(ABMM), Assistant Director Clinical Microbiology Lab, Hospital of the
University of Pennsylvania; Assistant Professor, Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania
The talk will focus on the currently available rapid diagnostics for bloodstream infection, and how partnering with antimicrobial stewardship teams leads to improved outcomes.
2:00 Global Bacterial Surveillance via Whole Genome Sequencing to Assess Genetic Diversity with Respect to Antimicrobial Drug Development and Resistance
David Tabor, Ph. D., Senior Scientist, Applied Immunology and Immunology, MedImmune, LLC
The presentation will discuss two global bacterial surveillance studies that employed whole genome sequencing in an effort to understand the genetic diversity within specific bacterial species. This was performed in an effort to guide antimicrobial
target selection and to assess the potential for drug resistance. The use of next-generation sequencing to replace traditional methods will be highlighted.
2:30 Panel Discussion: Considerations for Rapid Diagnostics in Antimicrobial Development
Moderator: Barry Eisenstein, M.D., FACP, FIDSA, FAAM, Distinguished Physician, Antimicrobials, Merck & Co., Inc
Panelists: Kimberly E. Hanson, M.D., MHS, Associate Professor of Medicine and Pathology, University of Utah
Kevin Alby, Ph.D., D(ABMM), Assistant Director Clinical Microbiology Lab, Hospital of the University of Pennsylvania; Assistant Professor, Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania
David Tabor, Ph. D., Senior Scientist, Applied Immunology and Immunology, MedImmune, LLC
- What role does diagnostics play in developing antimicrobials, and what are the possibilities for the future in terms of technology and scope?
- What are diagnostics unable to do, and what are the next steps in incorporating current needs into future developments?
- How can various stakeholders in diagnostics, antimicrobial stewardship, drug discovery, and clinical development work together to enhance the role of diagnostics in development?
3:00 Refreshment Break In the Exhibit Hall with Poster Viewing
3:30 Regulatory Update: An Overview of New Pathways and Updated Guidance
Nicole Mahoney, Director, Global Policy, Merck
Regulators have recently introduced several new pathways to encourage innovation and expedite the development of drugs for serious or life-threatening conditions. While the Breakthrough Designation in the U.S., the SAKIGAKE Designation
System in Japan and the new PRIority MEdicines (PRIME) program in the EU are all designed to speed patient access to promising new therapies, sponsors must understand the unique requirements and features of each in order to optimize
their global development strategy. This talk will explore available pathways and other recent regulatory developments with a specific focus on their relevance to the development of new anti-infective drugs.
4:00 Challenges with Antibiotic Drug Clinical Development: A U.S. Biotech Company Perspective
Patrick Horn, M.D., Ph.D., CMO, Tetraphase Pharmaceuticals
This presentation will discuss the many considerations and complexities involved when following traditional indication-specific pathways for the development of novel antibiotics that can play an important role in treatment of multidrug-resistant
pathogens, as well as the challenges that influence the conduct of global clinical trials due to the rise of antibiotic resistance.
4:30 Challenges in the Development of Biologics for Bacterial Diseases
David S. Mantus, Ph.D., Chief Development Officer, Arsanis, Inc.
Despite more than 120 years of clinical use, biologics other than traditional vaccines have seen limited recent development for the prevention and treatment of bacterial diseases. The clinical, regulatory, technical and policy challenges
of biologics development in this therapeutic space will be discussed.
5:00 Development, Regulatory, and Market Access Environments for Anti-Infectives in Animal Health
Raksha Tiwari, Ph.D., Research Director, Anti-Infectives Research, Zoetis
This presentation will focus on the challenges during both clinical trials and commercialization of antibacterials in animal health.
6:00 Dinner Short Course: SC2: Funding Opportunities for Antibacterial Research*
*Separate Registration Required
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Friday, December 9
8:00 Interactive Breakout Discussion Groups with Continental Breakfast
This session features various discussion groups that are led by a moderator/s who ensures focused conversations around the key issues listed. Attendees choose to join a specific group and the small, informal setting facilitates sharing
of ideas and active networking. Continental breakfast is available for all participants. Details on the topics and moderators are available on the conference website.
Driving Innovation by Delinking Investment in Antibiotic R&D from Sales Revenues
Tyler Merkeley, (Acting) Chief of Staff, Head, Special Projects & Portfolio Management, Biomedical Advanced Research and Development Authority (BARDA)
- Delinkage: how do we design this new incentive mechanism that will support innovation?
- Global access: how can we secure access to new products when resistance renders treatments ineffective?
- New business models: how can we drive antibiotic development in an era of antibiotic resistance?
Challenges in Policy Making
Barrett Thornhill, Executive Director, Antibacterial Innovation Alliance
- Political will: appreciation of the crisis in AMR and crisis in product development
- Funding: nothing comes cheap. How to afford a new series of R&D incentives
- New marketplaces: precedence and potential
8:45 Chairperson’s Remarks
Barrett Thornhill, Executive Director, Antibacterial Innovation Alliance
8:50 Industry Perspective on Finding, Getting, and Managing Non-Dilutive Funding
Andrew McCandlish, Ph.D., Director, Corporate Development,
Achaogen
Non-dilutive funding from government grants and contracts can be a powerful “push” mechanism to advance the discovery and development of novel antibacterials. From the company perspective, this funding offsets R&D costs
and supplements funding raised from private and public investors. However, factors such as long application review timelines and rigid contracting regulations represent challenges to companies in the dynamic biopharma industry,
and maintaining compliance with reporting and other deliverables requires significant resources. This talk will review such challenges from the industry perspective, and offer mitigation strategies that companies can incorporate
into their non-dilutive funding plans.
9:10 Panel Discussion: Venture Capitalists: What Are Investors Looking for?
Panelists: Vikas Goyal, Associate, SR One
Joshua Resnick, M.D., Partner, SV Life Sciences
Join two venture capitalists who will reveal the methods and metrics they use when investing in antibacterial companies. Understand the questions they ask of potential investments, and ask them your most pressing questions in turn.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:30 NIH and the CARB Challenge
Rosemarie Aurigemma, Ph.D., Chief, Drug
Development Section, Office of Biodefense, Research Resources, and Translational Research, DMID, NIAID, NIH
NIAID-supported research on antimicrobial drug resistance has helped facilitate translation of basic research discoveries from “bench to bedside”. Since the start of the National Strategy for Combating Antibiotic Resistant
Bacteria, all facets of this support have been boosted in order to drive greater interest and encourage investment and innovation in antimicrobial development. With the goal of breaking new ground and boosting momentum in the
field, NIAID hopes that the investment made will result in an upwelling of novel products into the pipeline and lead to new licensed products to stem the surge of resistant infections. This presentation will describe NIAID
programs that support antimicrobial product development, the results of the first year of the CARB initiative and the opportunities that lay ahead.
11:00 CARB-X: A Novel Partnership to Promote Innovation and Foster a Robust Antimicrobials Pipeline
Tyler Merkeley, (Acting) Chief of Staff, Head, Special Projects
& Portfolio Management, Biomedical Advanced Research and Development Authority (BARDA)
How will BARDA, NIAID and industry accelerate a portfolio of innovative early antimicrobial products to counter the threat of antimicrobial resistance (AMR)? Via the Combating Antibiotic Resistant Bacteria (CARB)-X! A novel public
private partnership approach launched in 2016 to identify, assemble, and accelerate a portfolio of innovative early antimicrobial products to counter the threat of AMR.
11:30 Driving Re-Investment in Antibiotics: Update from Europe’s DRIVE-AB
Kevin Outterson, J.D., Executive Director, CARB-X;
Visiting Fellow, Chatham House, Professor, Law, Health Law, Bioethics and Human Rights, Boston University School of Law
DRIVE-AB is a public-private partnership funded by EFPIA and the European Union. The goal is to make recommendations so that antibiotics become a more promising drug class for drug developers, without stimulating inappropriate
use and resistance. We will discuss the preliminary results reported in Amsterdam in June, together with the latest updates.
12:00 pm Enjoy Lunch on Your Own
1:30 Chairperson’s Remarks
Andrew McCandlish, Ph. D., Director, Corporate Development, Achaogen
1:35 Antimicrobial Market Incentives: State of Play in Washington DC
Barrett Thornhill, Executive Director, Antibacterial
Innovation Alliance
In order to direct commercial attention to the areas where the threat of antimicrobial resistance is the highest, federal interventions must be multifaceted, substantial and sustained. Improving antimicrobial stewardship, considering
the impact of antibiotic use in agriculture, and working more closely with global stakeholders and other countries is helpful, but to significantly counter drug resistant infections, establishing a strong and continuous R&D
enterprise is paramount.
2:10 Antibiotic Commercial Market Dynamics and Evolving Antibiotic Pricing Model
Cristina Larkin, Chief Commercial Officer, Spero Therapeutics
The commercial model for antibiotics is evolving. Stewardship and going resistance has forced industry to reconsider the old model and reshape the thinking in product position and pricing.
2:45 FEATURED PRESENTATION: Triple Threat – Doing Our Part to Address Antimicrobial Resistance
Elizabeth D. Hermsen, Pharm.D., M.B.A., BCPS-ID,
Head, Global Antimicrobial Stewardship, Merck & Co., Inc.
According to the World Health Organization, the health and economic consequences of antimicrobial resistance are considerable and costly, making it a serious threat to societal health. In January 2016, Merck joined over 80
pharmaceutical, diagnostic, and biotechnology companies, as well as key industry bodies, to issue a declaration at the World Economic Forum, which called on governments and industry to work together to take action against
antimicrobial resistance. As a next step, Merck has developed a Global Action Plan outlining the company’s efforts to address antimicrobial resistance in three key areas: driving innovation to develop new antibiotics;
promoting antimicrobial stewardship to ensure the responsible and appropriate use of antibiotics; and increasing access to antimicrobial medicines.
3:20 Close of Conference
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