Targeting Key Antibacterial R&D Challenges
Solving The Antibacterials Commercialization Equation
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Tuesday, October 28
MEETING THE CHALLENGES OF CLINICAL DEVELOPMENT AND REGULATORY COMPLIANCE
12:55 Chairperson’s Remarks
Karen Joy Shaw, Ph.D., President, Hearts Consulting Group
1:00 Combined Plenary Keynote Presentation: Who Will Mourn the Passing of the Pharmaceutical Industry?
Steven J. Projan, Ph.D., Senior Vice President, R&D, Innovative Medicines, Head, Infectious Disease & Vaccines MedImmune
The second decade of the twenty-first century marks a perfect storm of patent expirations, contracting western economies, and increasing demands from “payers” that pharmaceuticals demonstrate cost effectiveness of their drugs. The result is the shrinking of “big pharma” right before our eyes and nowhere has the impact been felt more than in infectious disease research at large pharmaceutical companies. All the while bacterial resistance to antibiotics is increasing even as the number of new drugs being developed to treat bacterial infections is at its lowest point since the drawn of the antibiotic era. This surfeit of new agents implies that the “traditional” approaches to drug discovery and development have run their course and novel (entrepreneurial, opportunistic) approaches for the treatment and prevention of microbial infections (and forestalling the emergence of resistance) are required. Against that background we are have seen an increasingly convoluted regulatory regime with indications being parsed finer and finer yet with larger numbers of patients required to reach arbitrary (but often clinically meaningless) statistical endpoints. To date there has been some modest biologics drug discovery efforts to discover novel antibacterial agents for the prevention and/or treatment of Staphylococcal and Pseudomonal infections but these efforts now appear to be picking up speed and are progressing in the clinic. Is there hope?
1:40 Overcoming the Challenges of Developing Antibiotics for Resistant Bacteria with New Regulatory Support
Barry Eisenstein, M.D., Senior Vice President, Scientific Affairs, Cubist Pharmaceuticals Editor, Antimicrobial Agents and Chemotherapy
Increasing antibiotic resistance among the most important bacterial pathogens together with a thin pipeline of new agents, particularly for Gram-negative bacteria, is causing major therapeutic issues in the US and abroad. Recently, though, the US Congress together with the major regulatory agencies in the US (FDA) and Europe (EMA) have responded to this impending crisis with expedited pathways for approval of new key agents. This talk will review this progress.
2:10 Development of an Antibiotic with Broad Indications
Prabhavathi Fernandes, Ph.D., President and CEO, Cempra, Inc.
Antibiotics that have broad use potential, such as azithromycin and the fluoroquinolones have been used for multiple indications and in the community as well as the hospital. Solithromycin is a fourth generation macrolide, the first Fluorketolide, in Phase 3 clinical development for community acquired bacterial pneumonia (CABP). It is being developed in intravenous, oral and pediatric suspension formulations for use in adult and pediatric patients.
2:40 Refocusing Antibacterial Development on Pathogen-Specific Therapy
Jorge A. Tavel, M.D., Medical Director, Genentech Research and Early Development
Broad-spectrum antibiotics allow for empiric treatment of many infections without the need for specific pathogen identification, but these agents can lead to resistance among targeted and non-targeted organisms. While these broad-spectrum antimicrobials will continue to be used for the treatment of polymicrobial infections or fulminant disease, advances in our understanding of pathogen physiology and virulence, and efforts to enforce antibiotic stewardship are refocusing antibacterial development on pathogen-specific therapies.
3:10 Coffee Break with Exhibit and Poster Viewing
3:40 Localized Delivery of Nitric Oxide for Challenging Infections
M. Joyce Rico, M.D., CMO, Novan Therapeutics
Novan is developing its platform Nitricil™ technology for the localized delivery of nitric oxide to treat microbial-associated diseases. Macromolecular nitric oxide-releasing NCEs have demonstrated potent broad-spectrum antimicrobial efficacy against multidrug-resistant ESKAPE pathogens, offering a multi-target solution for polymicrobial wound infection while exhibiting a low propensity for drug resistance.
3:55 Sponsored Presentation (Opportunity Available)
4:10 The Changing Landscape of Antibacterial Drug Development and Therapy: The Role of Rapid Diagnostics
Linda A. Miller, Ph.D., Director, Diagnostics & Clinical Microbiology, Antibacterials R&D, Infectious Diseases Therapeutic Area Unit, GSK
Key to the success of both antibacterial R&D and appropriate use of antibacterials are accurate, rapid, simple, and inexpensive diagnostic tests capable of identifying bacterial pathogens and bacterial drug resistance directly from patient samples. New clinical trial designs based on limited patient populations and development of narrow spectrum agents could result in new drug labels that restrict use. These new drugs will likely require rapid diagnostics for use in conducting the clinical trials as well for use in the clinical setting to ensure rational prescribing. This talk will summarize the changing landscape of anti-bacterial R&D, identify some of the rapid diagnostics that are needed for appropriate prescribing of antibacterial agents and clinical trials, and highlight current efforts to catalyze and support the development of these critical tools.
4:40 Panel Discussion: Developing and Commercializing Broad Indications vs Pathogen Specific Antibiotics
Moderator:Karen Joy Shaw, Ph.D., President Hearts Consulting Group
Panelists: Speakers of the session
Topics to be discussed:
5:15 Close of Day & Registration for Dinner Short Course
5:30-8:30 pm Dinner Short Course: Funding Opportunities for Antibacterial Research*
Instructors:Melissa Stundick, Ph.D., Acting Branch Chief, BARDA’s Broad Spectrum Antimicrobial Program
Rosemarie Aurigemma, Ph.D., Chief, Drug Development Section, DMID, NIAID
Additional Instructor to be Announced
The course will cover:
*Separate Registration Required
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