ClinPharm Consulting Sharing Pharmacokinetics Knowledgebase at American Association of Pharmaceutical Scientists Annual Meeting and Exhibition
ClinPharm will be exhibiting at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting, following the firm’s recent participation in September’s Annual Meeting of the American College of Clinical Pharmacology (ACCP).
“Our message that pharmacokinetics is 'all about time' is resonating within the pharmaceutical industry,” said Geoff Banks, Ph.D., company CEO.
“Fundamentally, PK is analysis of a drug in a matrix over time, but proper incorporation of PK into a drug development program is about maximizing and saving time on an individual study, in addition to across the whole program,” he explained.
ClinPharm’s team of seasoned clinical pharmacology and PK consultants attending AAPS know about the pitfalls that beseech clinical pharmacology programs involving pharmacokinetics. This understanding has contributed to the firm developing a number of options to ensure rapid and efficient analysis of PK data and provide “horizontal” strategic planning across a drug development program.
More experience and better services means better interpretation of PK data and superior advice for clients, which translate into time savings in drug development, Dr. Banks explained.
“Time to market or time to an exit strategy for drugs in development is a clear focus for our clients,” he said, adding, “Everything we do at ClinPharm helps to reduce risk in drug development and increase efficiency for our clients, thereby allowing them to reach their goals faster.”
Examples of ClinPharm services focused on the “all about time” concept include:
• Rapid & Robust Pharmacokinetic Analysis
- Conducting the right type of PK analysis in a robust way that provides the greatest insight into a client’s drug and enables better downstream decision making.
- Traditional (rich sampling) and Population (sparse sampling) PK using methods that reduce time of analysis (e.g., a novel computational algorithm for selection of the most appropriate model for population PK analyses and parallel computing environments for high demand computations) all focused on saving time and enabling faster critical decision making.
• Unmatched Pharmacokinetic Interpretation
- Our industry leading consultants have 15-30 years of industry experience each. More experience means better interpretation of data and superior advice to clients that translate into time savings by avoiding missteps or pitfalls in drug development.
• Innovative Model Based Drug Development & Clinical Trial Simulations
- Prospective clinical trial simulations by experts that can provide insight into parameters (e.g., dose selection) for planned clinical trials to provide the greatest opportunity for success.
• Regulatory submissions written from industry experts in clinical pharmacology that know what the FDA will expect to see in these submissions (e.g., IND and NDA).
• Assistance with regulatory meetings from clinical pharmacology experts that have attended over 75 meetings with the FDA for clients.
• Horizontal strategic planning across all phases of drug development
• Intelligent design of clinical studies to set up PK studies for success by designing studies to allow for robust analysis and interpretation of PK data.
• PK help desk that allows rapid interaction with clinical pharmacology consultants and pharmacokineticists for emerging needs in a drug development program.
According to Dr. Banks, ClinPharm was involved in many active conversations about the proper applications of PK with national and international healthcare and drug development professionals at September’s ACCP meeting in San Diego, and looks forward to similar educational and networking opportunities with peers and prospects at AAPS.
Providing a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to health, AAPS offers timely scientific programs, ongoing education, opportunities for networking, and professional development. Founded in 1986, AAPS is an individual membership society of approximately 12,000 pharmaceutical scientists who have joined together to serve the public and their own common professional interests. AAPS is not a trade organization; it is a nonprofit organization that serves as an educational, scientific, and scholarly body.
Increasing interest in ClinPharm’s services has enabled the firm to expand its portfolio and, in turn, continue growing to becoming the go-to resource for PK in the pharmaceutical industry. In recent months the firm has added key staff and new services that will be announced in the coming weeks.
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.