(Research Triangle Park, N.C.) Geoffrey Banks, Ph.D., CEO of the pharmaceutical industry’s go-to resource for pharmacokinetics (PK), ClinPharm Consulting, will be presenting on biosimilars at the inaugural Triangle Research Symposium August 21st 2012.
Dr. Banks will be delivering “What’s Up with the Term ‘Similar’ in Biosimilar? The Evolution of Biosimilars Science and Regulatory Policy” during the event at the NC Biotech Center in RTP.
“While biosimilar policy and science is still in its infancy, interesting trends have emerged in the evolution of this field in the pharmaceutical industry” Dr. Banks explained.
The presentation will also review the use of “similar” to describe generic copies of biologics, how the term has penetrated the pharmaceutical industry lexicon, and ask why can’t there be a “biogeneric”.
In crafting his presentation, Dr. Banks utilized his knowledge of biologics gained through doctorate and post-doctoral research in protein biochemistry and molecular biology in addition to pharmacokinetic drug development conducted on biologics as CEO of ClinPharm. ClinPharm helps clients navigate through the complex drug development process to marketing approval by taking a common sense approach based on scientific principles to provide excellence in PK and clinical pharmacology.
Focusing on the action and use of drugs in human clinical studies supporting overall marketing applications to regulatory authorities, ClinPharm looks at drug-drug interactions, cardiac conduction (thorough QT), first time in human safety and PK, single and multiple dose effects, hepatic and renal impairment on drug action, among other clinical pharmacology and PK issues. Services ClinPharm provides include pharmacokinetic analysis, pharmacodynamic analysis, and PK/PD analysis; strategic planning (program strategy, regulatory strategy, etc.); authoring integrated clinical/PK/PD study reports; and standalone PK/PD reports.
“Our common sense, ‘less is more’ philosophy provides companies with useable clinical pharmacology and PK advice from leading scientists and pharmacokineticists,” Chief Operating Officer M. Alexander Shaw, Ph.D., said.
Dr. Shaw points to organic growth at ClinPharm, such as the recent addition of accomplished pharmacokinetic and drug development consultant David Y. Mitchell, Ph.D., (Current President of the American Association of Pharmaceutical Scientists [AAPS]) as an example of the company’s commitment to meeting client needs with a team of seasoned consultants to provide a greater level of service and support.
Dr. Banks will be available at the August 21st Research Symposium to answer questions about the company and its services. The Symposium will focus on the theme of "Biotech Innovation in the Triangle” with over a dozen invited companies providing energetic and informative discussions centering around research, development, diagnostics and other topics.
For more information on ClinPharm’s integrated, flexible PK and clinical pharmacology outsourcing options visit www.clinpharmconsulting.com.
About ClinPharm Consulting
ClinPharm Consulting, LLC is a clinical pharmacology consulting firm specializing in pharmacokinetics (PK). Fast becoming the pharmaceutical industry’s go-to resource for PK, ClinPharm gives pharmaceutical companies and CROs rare access to a hands-on team of leading clinical pharmacology and PK professionals experienced in a multitude of therapeutic areas. We embrace the notion that simplicity and clarity lead to good decisions by taking complex PK principals and making them understandable and usable for common sense drug development. ClinPharm’s flexible business structure enables us to integrate with our clients and help them maximize the potential of clinical pharmacology studies and PK analyses to pave the way toward marketing approval. For more information visit www.clinpharmconsulting.com