ABC Laboratories Announces Pharmaceutical Program Management

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Tue Apr 8, 2008 2:54pm EDT

Growing Contract Laboratory Targets Virtual and Other Small Pharma
Companies with Pharmaceutical Program Management Services
COLUMBIA, Mo.--(Business Wire)--
Analytical Bio-Chemistry Laboratories, Inc. announced today a
strategic organizational restructuring aimed at supporting the drug
development efforts of specialty, virtual and other small drug
development companies. The company's new Pharmaceutical Program
Management unit will assist sponsors with study design and regulatory
consulting services, and dedicates senior staff to provide oversight
of operational performance, facilitate collaboration and ensure timely
delivery of its products. The program is backed by rigorous
metrics-driven performance measurement.

   "The business of contracted pharmaceutical development has shifted
in recent years," said John Bucksath, Sr. Vice President and General
Manager of ABC Laboratories' pharmaceutical services division. "Small,
entrepreneurial companies are responsible for a larger share of
development, and most turn to contract laboratories like ABC for
analytical support services. We've found those same customers often
seek help understanding the types of studies and data required to
support IND and NDA applications, and place a high value on direct,
frequent communication. Our Program Management unit brings a new level
of personalized service to the table."

   Patrick Noland, an industry veteran with 30 years of
pharmaceutical development, research and manufacturing experience, has
been named Vice President of Program Management, and will lead the
unit. "ABC has long been a reliable technical resource for contract
laboratory services," said Noland. "This initiative takes outsourcing
relationships to the next level. It's about partnering with our
customers to develop drugs." Noland's experience includes direct
responsibility for pharmaceutical product development, extractables
and leachables, method validation, and technical support for product
and material investigations. He is a contributing author to the CMC
sections of four approved NDAs, two of which were inhalation products
approved in the first application round.

   Also supporting ABC's Program Management initiative is Noel
Premkumar, Ph.D., who was recently named the pharmaceutical division's
Chief Scientific Officer. Dr. Premkumar has more than twenty years of
industry experience conducting in-vivo and in-vitro xenobiotic
metabolism studies, and has extensive knowledge of FDA, ICH, EPA,
OECD, and JMAFF guidelines, as well as Phase 0 guidance for
radiolabeled micro-dosing studies. Dr. Premkumar has been with ABC
Laboratories since 1990, and was a key player in developing the
company's DMPK and bioanalytical programs.

   About Analytical Bio-Chemistry Laboratories, Inc.

   Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a GLP and
CGMP-compliant contract laboratory with expertise in analytical
services and radiolabeling synthesis. From its inception in 1968, ABC
Laboratories has been dedicated to solving scientific problems and
providing expert analytical chemistry services to businesses required
to meet government health and safety regulations. The company is
celebrating its 40th anniversary and will be expanding into a new
90,000-square-foot pharmaceutical facility at the University of
Missouri Discovery Ridge Research Park later this year.

   For additional information, visit http://www.abclabs.com or
contact Kristein King at (573) 441-3409.

   Release Summary:

   ABC Laboratories' new Pharmaceutical Program Management unit
assists sponsors with study design and regulatory consulting services,
and dedicates senior staff to provide oversight of operational
performance, facilitate collaboration and ensure timely delivery.

   Keyword Tags:

   pharmaceutical, program management, pharmaceutical development

Analytical Bio-Chemistry Laboratories, Inc.
Kristein King, 573-441-3409
http://www.abclabs.com

Copyright Business Wire 2008
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