Barry Eisenstein, SVP at Cubist Pharmaceuticals to Give Keynote Presentation at GTCbio’s Bugs & Drugs Conference on September 22-23, 2008 in San Diego, CA
Monrovia, CA, August 21, 2008 --(PR.com)-- Dr. Barry Eisenstein, Senior Vice President of Scientific Affairs at Cubist Pharmaceuticals in Lexington, MA and Clinical Professor of Medicine, Harvard Medical School in Cambridge, MA gives the keynote address on getting congress to understand the need for antibiotic development.
In contrast to the discovery and development of other therapeutic areas, antimicrobials, and specifically anti-bacterial agents, have unique biological, regulatory, and economic challenges, which have produced a dry pipeline. As they are used almost exclusively for acute conditions, sales and marketing requires many more new patient interactions for the same return on investment. As infectious agents are unique in both mutating to resistance, a property shared with cancer cells, and also transferring horizontally to new patients (not seen with cancer cells), antimicrobials have a limited life and are depreciating assets. As a consequence, physicians tend to reserve the newest (and sometimes the best) antimicrobial agents for the sickest patients and sometimes only as rescue agents when other drugs have failed. This approach, along with others like rapidly narrowing the anti-bacterial spectrum once susceptibilities are determined, is known as “antibiotic stewardship”, and is actively taught and modeled in teaching institutions. Although aiding the “demand side” on antibiotic resistance, this approach further suppresses economic incentives to discover and develop new agents, leading to a problem on the “supply side”. An additional challenge is the regulatory uncertainly brought about by the need to demonstrate efficacy and safety compared with placebo under conditions where placebo controlled trials are unethical. The alternative approach of using “non-inferiority” studies for registration is fraught with regulatory concerns about how potent and efficacious the “old” comparator agent ever was or now remains. Paradoxically, these old agents, though held in questionable repute by regulatory agencies, are held up as “standard of care” by practitioners, who are often using old labeling standards for determination of antibiotic resistance (i.e., “breakpoint”) and for spectrum of indications. The example of vancomycin, which was approved before the modern criteria for efficacy were established, will be discussed. Taken together, these challenges require new statutory approaches. Recent testimony before the HELP committee of the Senate will be discussed, which focuses on some of the potential economic incentives that can be applied to reignite the vigor of antibiotic discovery and development that used to exist and that led to the medical miracle of the last century.
GTCbio’s Bugs & Drugs conference brings together top industry leaders including directors, vice presidents, heads, managers, supervisors, from all over the world to collaborate and discuss novel approaches to problematic pathogens for community-acquired Infections and hospital-acquired infections, contingency plans for biological weapons and disease outbreaks, the changing landscape of antibacterial development - politics vs. commerce, and the future of infectious disease therapeutics. For more information including a detailed agenda, exhibitor opportunities and registration information visit http://gtcbio.com/conferenceDetails.aspx?id=129.
About GTCbio
GTCbio organizes conferences specifically for the biomedical and biopharmaceutical industries. Our goal is to facilitate the exchange of biopharmaceutical and biomedical intelligence between industry leaders, academic and government organizations, and the financial community.
GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company founded in 2002.
Contact: GTCbio 434 W. Foothill Blvd. Monrovia, CA 91016 Tel: (626) 256-6405 fax: (626) 256-6460 email: nina.tran@gtcbio.com
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In contrast to the discovery and development of other therapeutic areas, antimicrobials, and specifically anti-bacterial agents, have unique biological, regulatory, and economic challenges, which have produced a dry pipeline. As they are used almost exclusively for acute conditions, sales and marketing requires many more new patient interactions for the same return on investment. As infectious agents are unique in both mutating to resistance, a property shared with cancer cells, and also transferring horizontally to new patients (not seen with cancer cells), antimicrobials have a limited life and are depreciating assets. As a consequence, physicians tend to reserve the newest (and sometimes the best) antimicrobial agents for the sickest patients and sometimes only as rescue agents when other drugs have failed. This approach, along with others like rapidly narrowing the anti-bacterial spectrum once susceptibilities are determined, is known as “antibiotic stewardship”, and is actively taught and modeled in teaching institutions. Although aiding the “demand side” on antibiotic resistance, this approach further suppresses economic incentives to discover and develop new agents, leading to a problem on the “supply side”. An additional challenge is the regulatory uncertainly brought about by the need to demonstrate efficacy and safety compared with placebo under conditions where placebo controlled trials are unethical. The alternative approach of using “non-inferiority” studies for registration is fraught with regulatory concerns about how potent and efficacious the “old” comparator agent ever was or now remains. Paradoxically, these old agents, though held in questionable repute by regulatory agencies, are held up as “standard of care” by practitioners, who are often using old labeling standards for determination of antibiotic resistance (i.e., “breakpoint”) and for spectrum of indications. The example of vancomycin, which was approved before the modern criteria for efficacy were established, will be discussed. Taken together, these challenges require new statutory approaches. Recent testimony before the HELP committee of the Senate will be discussed, which focuses on some of the potential economic incentives that can be applied to reignite the vigor of antibiotic discovery and development that used to exist and that led to the medical miracle of the last century.
GTCbio’s Bugs & Drugs conference brings together top industry leaders including directors, vice presidents, heads, managers, supervisors, from all over the world to collaborate and discuss novel approaches to problematic pathogens for community-acquired Infections and hospital-acquired infections, contingency plans for biological weapons and disease outbreaks, the changing landscape of antibacterial development - politics vs. commerce, and the future of infectious disease therapeutics. For more information including a detailed agenda, exhibitor opportunities and registration information visit http://gtcbio.com/conferenceDetails.aspx?id=129.
About GTCbio
GTCbio organizes conferences specifically for the biomedical and biopharmaceutical industries. Our goal is to facilitate the exchange of biopharmaceutical and biomedical intelligence between industry leaders, academic and government organizations, and the financial community.
GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company founded in 2002.
Contact: GTCbio 434 W. Foothill Blvd. Monrovia, CA 91016 Tel: (626) 256-6405 fax: (626) 256-6460 email: nina.tran@gtcbio.com
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GTCbio
Rania Hafez
626-256-6405
http://www.gtcbio.com
Rania Hafez
626-256-6405
http://www.gtcbio.com
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