Solving The Antibacterials Commercialization Equation - Day 1



2014 Solving The Antibacterials Commercialization Equation 

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Tuesday, October 28

 

MEETING THE CHALLENGES OF CLINICAL DEVELOPMENT AND REGULATORY COMPLIANCE  

1:20 pmChairperson’s Remarks

KarenShawKaren Joy Shaw, Ph.D., President, Hearts Consulting Group

 

1:30 Combined Plenary Keynote Presentation: Overcoming the Challenges of Developing Antibiotics for Resistant Bacteria with New Regulatory Support

BarryEisensteinBarry 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.

 

2:00 Session Break

 

2:10 Development of an Antibiotic with Broad Indications

PrabhavathiFernandesPrabhavathi 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

JorgeTavelJorge 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

 Novan Therapeutics3:40 Localized Delivery of Nitric Oxide for Challenging Infections 

Joyce NovanM. 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

LindaMillerLinda 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:
KarenShawKaren Joy Shaw, Ph.D., President Hearts Consulting Group
Panelists: Speakers of the session

 

Topics to be discussed:

  • Who will discover new antibacterial therapies?
  • What will new agents look like – broad vs narrow spectrum?
  • The role of rapid diagnostics in treating bacterial infections
  • The response of major regulatory agencies to the antibiotic crisis

5:15 Close of Day & Registration for Dinner Short Course

5:30-8:30 pm Dinner Short Course: Funding Opportunities for Antibacterial Research*

Instructors:
MellissaStundickMelissa Stundick, Ph.D., Acting Branch Chief, BARDA’s Broad Spectrum Antimicrobial Program





RosemarieAurigemmaRosemarie Aurigemma, Ph.D., Chief, Drug Development Section, DMID, NIAID

Additional Instructor to be Announced

 

The course will cover:

  • From basic research to the clinic – how do we support the discovery & development of new agents?
  • Grants, contracts and biodefense partnerships
  • Preclinical, nonclinical, and clinical product development services

*Separate Registration Required


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