September 19th: Northern California BioPharmaceutical Project Management Breakfast Meeting

Antibacterial Drug Development and Commercialization:
Avoiding the pitfalls in pre-market AST device development for post-market success

Speaker: Kevin Krause, Associate Director - Clinical Microbiology, Cerexa, Inc

Time: 8:00-10:00 AM, presentation begins at 8:30 sharp

Place: Achaogen, 7000 Shoreline Ct, S San Francisco, CA 94080
RSVP: http://NCBPPMSeptember2014Breakfast.eventzilla.net (Admission is free, but registration is required by 11:45 pm 9/17)

Speaker Bio:

Kevin has spent more than 15 years in various R&D Infectious Diseases roles in the biopharmaceutical industry. For nearly 11.5 years, Kevin was on the team that led to the discovery of telavancin and brought this drug to both the US and EU markets as Vibativ™. In parallel, he worked on multiple additional programs that led to two other compounds now successfully in clinical development. For the last 4 years, Kevin has been working in the Clinical Microbiology group at Cerexa, Inc. (A subsidiary of Forest Laboratories, Inc., now Actavis) on the Advisory Committee, launch and product support of Teflaro™, the clinical development of ceftazidime-avibactam, ceftaroline-avibactam and Quinsair™ (Inhaled levofloxacin) and post-approval commitments for Colobreathe™(Inhaled colistin).

Abstract:

The infectious disease landscape has reached a pivot point in the history of antibacterial drug development. Healthcare providers are begging for new antibiotics and daily news reports remind us about a coming global pandemic of multi-drug resistant “Superbugs”. Government officials, the FDA and the Infectious Diseases Society of America have all made public statements about the need to promote the development of novel antibacterials to stave off a looming public health crisis. Despite these proclamations, very few new antimicrobials have made it to the marketplace in the last 20 years and even fewer have been commercially successful. Why is that? For many years, there were significant regulatory challenges in the US that prevented new drugs from reaching the market, but those times are changing. Recently, the FDA’s Center for Drug Evaluation and Research has begun to completely rethinking its approach to antibiotic development in ways that will help reduce costs and speed the delivery of new medicines to the marketplace.

Despite this improving regulatory landscape, there are other significant barriers to market that most companies and few regulators understand that will continue to stand in the way of wide spread adoption of new antibacterials. Among these barriers, a major contributor is the development of antimicrobial susceptibility testing (AST) devices.
AST devices are used by hospitals to make formulary decisions and to guide patient care. Without a robust set of FDA approved AST devices, hospitals can’t test a drug against their patient’s bugs to know if they are susceptible. For this reason, a new drug will never be used by a hospital without the widespread availability of AST devices. Unfortunately, many companies don’t realize this until it is too late and their initial sales do not meet expectations. 


While there are financial, scientific and regulatory challenges in proper AST device development, there are several critical steps that can be taken to mitigate the risk of leaving healthcare professionals with a new drug that they desperately need but that they can’t routinely use. During this presentation, Mr. Krause will share his strategic expertise and tactical knowledge on successful approaches in AST device development, particularly in collaborating with and overseeing AST device manufacturers to maximize the potential for new antibacterials across the entire product lifecycle.

*2 PDUs awarded for PMP re-certification

See slides from the presentation here.