ABC Laboratories Announces Pharmaceutical Program Management
Growing Contract Laboratory Targets Virtual and Other Small Pharma
Companies with Pharmaceutical Program Management Services
COLUMBIA, Mo. (Business Wire EON/PRWEB ) April 8, 2008 --
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
MULTIMEDIA GALLERY http://www.businesswire.com/cgi-bin/mmg.cgi?eid=5653049
See the original story at: http://eon.businesswire.com/releases/program/pharmaceutical/prweb842634.htm
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