2015 Archived Content

Clinical Development and Commercialization of Antibacterials

The diminishing financial return and high commercialization risks have slowed down antibacterial drug development to the point where we are facing a public health crisis of antibiotic-resistant infections. In the face of the growing unmet needs, a number of government initiatives were designed to revive the field and to facilitate discovery and clinical development of new antibacterial agents. These initiatives expanded the funding opportunities and improved certain policies, leading to a heating effect with many companies returning to or initiating antibacterial research. However, the risks and uncertainty are still pretty high and we are at the very beginning of a long journey of turning antibiotic development into a successful therapeutic area. The Clinical Development and Commercialization of Antibacterials conference, part of Re-Entering Antibacterial Drug Development Summit, was designed to facilitate a broad discussion among all the stakeholders, and to search for solutions to make antibacterial drug development more sustainable and profitable.


Tuesday, November 17

12:45 Registration


Shared Session between Track 2 and Track 3

1:35 pm Chairperson’s Remarks

Barry Eisenstein, M.D., FACP, FIDSA, FAAM, Distinguished Physician, Antimicrobials, Merck & Co., Inc.

1:45 Overcoming the Challenges of Developing New Antibiotics for Resistant Bacteria with Regulatory Support and New Diagnostics

Barry EisensteinBarry Eisenstein, M.D., FACP, FIDSA, FAAM, Distinguished Physician, Antimicrobials, Merck & Co., Inc.

In this era of increasing antimicrobial resistance and widespread dissemination of virulent pathogens resistant to most, if not all, available antibiotics, society must come up with solutions, which includes both better paths to new agents active against such pathogens and to appropriate stewardship of existing agents. A means to help on both of these key aspects is improved rapid diagnostics. Together with streamlined regulatory pathways for approval of new agents, developing new, life-saving antibiotics would thus become more feasible.

2:15 Achieving Value and Improving Patient Safety Through Innovative Methods of Antimicrobial Utilization - Experience At the Front Line of Care

Ronald NahassRonald G. Nahass, M.D., MHCM, President, ID Care

Antimicrobial stewardship has become a priority because of concerns that overuse of antibiotics has contributed to greater prevalence of multi-drug resistant infections and epidemics of Clostridium difficile. The overuse and these complications add cost and risk which reduce value in our healthcare delivery system. This presentation will use real examples of to illustrate problems and provide a framework for a discussion on solutions. .

2:45 Diagnostics Update: Recent Advances in Pathogen and Antimicrobial Resistance Detection

Kimberly HansonKimberly E. Hanson, M.D., MHS, Section Chief, Clinical Microbiology, the University of Utah and ARUP Laboratories

Accurate and timely diagnosis can improve patient care and antibiotic stewardship. 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.

3:15 The Economics of Modern Anti-Infectives

Rene_RussoRene Russo, PharmD, Chief Development Officer, Arsanis, Inc.


3:45 Refreshment Break with Exhibit and Poster Viewing

4:15 Antibacterial Drug Development: The Role of Clinical Microbiology and the Need for Rapid Diagnostics

Grace ThorneGrace M. Thorne, Ph.D., Senior Director, Antibiotics and Rapid Diagnostics, Merck & Co., Inc.

Around the world, there is an increase in multidrug-resistant clinical pathogens, which is putting pressure on the development of new antibacterial agents. New clinical trial designs based on smaller data sets or focused on narrow spectrum agents require fast and accurate detection of the bacterial pathogen and resistance phenotypes so that enrollment of the target patient population can be met. This presentation will provide an overview of the changing landscape in antibacterial drug development and highlight current efforts to support the development of much needed rapid diagnostic tests.

4:45 The Contribution of Therapeutic Drug Monitoring to Clinical Trial Success and Effective Antibiotic Stewardship

Tilmann BrotzTilmann Brotz, Ph.D., Senior Director, Developmental Sciences, Achaogen

Therapeutic Drug Management (TDM) has been used in clinical practice for certain classes of antibiotics for many years, but its potential to impact clinical trial success and antibiotic stewardship has received little attention. Despite sophisticated pharmacokinetic and pharmacodynamic assessments and modeling, experimental antibiotics have failed in late stage clinical studies in part due to inadequate dosing, especially in patient populations with challenging pharmacokinetics, such as the critically ill with nosocomial, gram-negative infections. How TDM optimizes individual patient dosing in clinical trials with the potential to improve outcomes and safety will be discussed. The potential impact of TDM on health economic outcomes and prevention of the emergence of resistance in the context of antibiotic stewardship will also be highlighted.

5:15 Registration for Dinner Short Course

5:45 - 8:30 Dinner Short Course: Funding Opportunities for Antibacterial Research (Separate registration required, see page 6 for details.)


Wednesday, November 18

7:30 am Continental Breakfast 


8:15 Chairperson’s Remarks

Nicole Mahoney, Ph.D., Director, Global Regulatory Policy, Merck & Co.

8:20 V.C. Panel Discussion: What Are Actual Investors Looking For?


Ankit MahadeviaAnkit Mahadevia, M.D., Atlas Ventures


Vikas GoyalVikas Goyal, SR One


David SchubertDavid M. Schubert, COO, Accelerator Corporation


9:10 BARDA’s Public Private Partnerships

Melissa StundickMelissa Stundick, Ph.D., Chief, Anti-Infectives Program, BARDA

BARDA’s Anti-infectives program aims to help revitalize the antimicrobial pipeline by providing support for the advanced research and development of novel antibacterial and antiviral therapeutics. BARDA provides both funding and subject matter expertise to help our industry partners bring their therapeutic candidates from Phase I clinical development through and beyond approval. This presentation will highlight our ongoing public-private partnerships as well as the role that BARDA is playing in the execution of the National Action Plan for Combatting Antibiotic-Resistant Bacteria.

 9:40 Leveraging Government Support in Antibacterial Drug Development: Lessons Learned

Randall KincaidRandall L. Kincaid, Ph.D., Senior Scientific Officer, Concept Acceleration Program, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, NIH

The federal government reduces risk for product developers by providing a complementary array of support mechanisms for antimicrobial development. Many drugs on the market and in development have been touched by this support network. Leveraging our experience, this presentation will provide the “lessons learned” regarding factors that lead to success (or failure) of programs as developers take advantage of the grant, contract or product development services that are offered.

10:10 PROJECT ENABLE - Collaboration and Funding through Preclinical Development and Phase I Clinical Trial for Anti-Infective Gram-Negative Programs

Frederik DerooseFrederik Deroose, Ph.D., Member, Portfolio Management Committee, ENABLE

ENABLE has an €85 million budget over 6 years to fund a number of anti-infective Gram negative programmes from SMEs and research groups in Europe. The project brings an international development consortium, an ‘engine’ for gram negative development, and high potential programmes can be accelerated through the pipeline into clinical trials while remaining in full ownership of the originating partner.

10:40 Coffee Break with Exhibit and Poster Viewing



Shared Session between Track 2 and Track 3

11:20 We are the World: How Pharmaceutical Industry Can Contribute to Antimicrobial Stewardship

Elizabeth_HemsenElizabeth D. Hermsen, PharmD, Head, Global Antimicrobial Stewardship, Merck

We must come together. Collaboration between multi-sector stakeholders, including pharmaceutical industry, is needed in order to achieve the shared antimicrobial stewardship goals of minimizing and preventing inappropriate antimicrobial use, improving patient outcomes, and combating the development of resistance. This presentation will provide examples of how pharmaceutical industry can and should play a role in meeting these goals through antimicrobial stewardship education, implementation, research, and advocacy.

11:50 Panel Discussion: Mastering Antimicrobial Stewardship with the Help of Molecular Diagnostics

Moderator: Grace M. Thorne, Ph.D., Senior Director, Antibiotics and Rapid Diagnostics, Merck & Co., Inc.

Panelists: Elizabeth D. Hermsen, PharmD, Head, Global Antimicrobial Stewardship, Merck
Katherine K. Perez, Pharm.D., Clinical Pharmacy Specialist-Infectious Diseases, Houston Methodist Hospital and Houston Methodist
Melissa Miller, M.D., Professor, Pathology and Laboratory Medicine, Director, Clinical Molecular Microbiology Laboratory, Associate Director, Clinical Microbiology Laboratory, University of North Carolina, Chapel Hill School of Medicine
Karen C. Carroll, M.D., Director, Division of Microbiology, Department of Pathology, Professor of Pathology and Medicine, The John Hopkins School of Medicine
Edina Avdic, Pharm.D., MBA, Clinical Specialist, Infectious Diseases, Associate Director, Antimicrobial Stewardship Program, The John Hopkins Hospital

ID Genomics12:20 pm Luncheon Presentation: Rapid Clonal Diagnostics: Getting Personal with Pathogens at the Point of Care

Sokurenko_EvgeniEvgeni V. Sokurenko, M.D., Ph.D., Founder and Chairman, ID Genomics, Inc; Professor, Department of Microbiology, University of Washington, Seattle

The vast majority of human pathogens are clonal in nature, i.e. their species are comprised of a limited number of genetically related 'crime families', most with distinct antibiotic susceptibility profiles. ID Genomics develops high-resolution molecular tests that determine the infecting strain's sub-species clonal identity directly from patient urine or other specimens. When combined with a comprehensive database consisting of hundreds of clonal-level antibiograms, this diagnostic approach reduces drug-bug mismatches multi-fold at the point-of-care.

12:50 Session Break



1:10 Chairperson’s Remarks

Carl Foster, Executive Vice President, Business Development, Cempra Pharmaceuticals

1:15 Policies and Pathways to Address Antibiotic Resistance

Nicole MahoneyNicole Mahoney, Ph.D., Director, Global Regulatory Policy, Merck & Co.

As resistance diminishes the effectiveness of existing drugs and makes it difficult to treat some patients with serious bacterial infections, governments and health organizations across the globe are exploring steps to mitigate the looming public health threat, including ways to bring critically-needed new treatments to patients. This talk will provide an overview of proposed pathways and policies to facilitate antibiotic development.

1:45 CTTI Recommendations: Streamlining Hospital-Acquired and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) Clinical Trials
Sabrina Comic-Savic, M.D., Vice President, GCP Compliance, The Medicines Company
The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership that identifies and promotes practices to increase the quality and efficiency of clinical trials. A multi-stakeholder project team was convened to identify barriers and seek solutions for the successful conduct of HABP/VABP trials. Two sets of recommendations ensued
1) Streamlining protocol elements for HABP/VABP trials
2) Optimizing operational efficiency for data collection in HABP/VABP trials


2:15 Battling Superbugs with Statistical Thinking

Scott EvansScott Evans, Ph.D., MS, Senior Research Scientist, Department of Biostatistics, T.H. Chan School of Public Health, Harvard University

Clinical trials that compare antibiotic use strategies are of critical importance but are limited by competing risks that distort outcome interpretation, complexities of noninferiority trials, large sample sizes, and inadequate evaluation of benefits and harms at the patient level. Response adjusted for duration of antibiotic risk (RADAR) is a novel methodology utilizing a superiority design and construction/analysis of a desirability of outcome ranking (DOOR). DOOR/RADAR addresses neglected challenges in assessing outcomes in clinical trials that compare antibiotic use strategies.

2:45 Addressing The Need for Oral Antibiotic Development and Challenges Associated with Commercialization

Carl FosterCarl Foster, Executive Vice President, Business Development, Cempra Pharmaceuticals

Owing to the alarming rise of antibiotic resistance and the dwindling antibiotic pipeline, the number of effective outpatient oral antibacterial therapies are limited. The development of new oral antibiotics will result in fewer hospitalizations and significant cost savings to the healthcare system. Even though the government has recently initiated policies to bolster antibiotic development, most of them focus on intravenous antibiotics. This presentation will highlight the need for effective outpatient antibacterial agents, and the challenges associated with drug development, global pricing & reimbursement, and commercialization.


Shared Session between Track 2 and Track 3

3:20 Centers for Disease Control and Prevention (CDC) Data to Support Antibiotic Resistance (AR) Research, Development, and Innovation

Denise CardoDenise M. Cardo, M.D., Director, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, CDC

The emergence and spread of AR threatens the life-saving benefits antibiotics have provided over the past decades. AR Infections can affect people in all communities and healthcare settings. CDC surveillance data include resistance trends, populations at risk, and additional information that will help target clinical trials and support implementation of new diagnostic testing. CDC isolate bank will support research and development of new options for testing and treatment. Private-public partnership is critical to combat AR.

3:50 Battling Multidrug-Resistant Organisms in US Hospitals

Michael CalderwoodMichael S. Calderwood, M.D., Assistant Professor of Medicine, Harvard Medical School, Associate Director of Antimicrobial Stewardship Program, Brigham and Women’s Hospital

Dr. Calderwood will review hospital prevention and surveillance strategies for combating the selection and spread of multidrug-resistant organisms (MDROs), clinical cases where novel therapies are needed, and a discussion about hospital and provider approaches to novel antimicrobial drugs developed for the treatment of MDROs. The goal of this session will be to identify niches where drug development is needed and to better understand the clinical landscape in terms of MDROs in the hospital setting.

4:20 Close of Summit

Track 1 | Track 2 | Track 3

For more details on the conference, please contact:
Marina Filshtinsky, M.D.
Senior Director, Conferences
Cambridge Healthtech Institute
Phone: 781-972-5496
Email: mfilshtinsky@healthtech.com  

For exhibit & sponsorship information, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412, Fax: (781) 972-5470
email: cbenton@healthtech.com