ClinPharm Consulting Launches Population Pharmacokinetics Service

Giulia Ghibellini, Ph.D. hired to lead new Population PK modeling efforts. End Quote

Raleigh-Durham-Chapel Hill, NC (1888PressRelease) November 03, 2010 - ClinPharm Consulting, a specialized consulting firm offering a unique paradigm for empowering drug development pipelines, has added Giulia Ghibellini, Ph.D. to its team of credentialed industry veterans to implement a new population pharmacokinetics service.

Population PK modeling is an integral part of drug development and is typically conducted within or across large studies (e.g., Phase 2 and 3) to explain variability by identifying factors that may influence the pharmacokinetic behavior of an investigational drug. Along with ClinPharm's extensive experience in traditional PK analyses (i.e., those typically conducted in Phase 1 studies involving a small number of healthy volunteers), expansion into population PK allows ClinPharm to be a complete resource for clients throughout all clinical phases of drug development.

"Widening our services to include population PK is a logical expansion of our business," said Geoffrey Banks, Ph.D., ClinPharm Consulting President & CEO. He added "While traditional PK has been our focus to date, Dr. Ghibellini and our pharmacokinetics group have taken great strides to prepare the company for addressing the needs of our clients regarding population PK modeling."

According to Dr. Banks, ClinPharm Consulting's growth is a response to the needs of small biopharmaceutical companies with minimal R&D infrastructure who are seeking access to specialized expertise with both traditional and population PK capabilities at an affordable cost.

The hiring of Dr. Ghibellini increases the broad range of leadership experience at ClinPharm Consulting, from scientific and strategic planning to operational implementation of drug development programs dealing with both small molecules and biologics. Previously, Dr. Ghibellini led early phase clinical development of neuroscience assets with the Discovery Medicine department at GlaxoSmithKline, and currently serves as an adjunct faculty member in the UNC-Chapel Hill School of Pharmacy.

ClinPharm Consulting's focus on clinical pharmacology and pharmacokinetics is paying dividends for clients in the ability to draw upon a wealth of experience and address complex PK and pharmacodynamic studies. ClinPharm Consulting's population PK services include:

- Clinical protocol design to ensure collection of relevant information to use in population PK analyses
- Clinical operations support to ensure PK data and important clinical covariates are collected and handled properly by investigational sites
- Liaison services with bioanalytical facilities and clinical data management groups to ensure data is captured and reported properly for population PK analyses
- Comprehensive population PK analyses using industry leading software (NONMEM)
- Data management services for PK data to ensure compliance with current CDISC standards
- Superior writing capabilities to prepare complete population PK reports that highlight the most salient information obtained from the analyses

Dr. Banks and other members of the ClinPharm Consulting team will be sharing their knowledge and experience at the American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in New Orleans, Louisiana November 14-18. ClinPharm Consulting is exhibiting at the event to showcase its unique combination of horizontally integrated services across a drug development program incorporating the firm's PK/PD expertise, medical/scientific writing skills, and complete understanding of clinical pharmacology from a scientific, regulatory, and clinical conduct perspective which is unmatched in the industry.

ClinPharm Consulting has been steadily growing its client portfolio ranging from small emerging and virtual drug development firms to large pharmaceuticals companies. These companies are seeking assistance from the firm's team of credentialed industry veterans to position their drug development programs for success.

For more information on ClinPharm Consulting services, email discover ( @ ) clinpharmconsulting dot com or visit www dot clinpharmconsulting dot com dot

ABOUT CLINPHARM CONSULTING
ClinPharm Consulting is a specialized consulting firm offering a unique paradigm for empowering drug development pipelines. Our business model focuses on matching scientific and pharmacokinetic/pharmacodynamic expertise with superior writing capabilities to maximize the impact of individual studies on an overall clinical pharmacology program. We specialize in helping small biopharmaceutical companies with minimal R&D infrastructure find scalable solutions for emerging early phase drug development challenges, providing an unmatched combination of technical expertise and robust understanding of clinical pharmacology from a scientific, regulatory and clinical conduct perspective.

The breadth of our experience allows ClinPharm Consulting to be a complete resource for clients to set up their drug development programs for success. ClinPharm Consulting typically engages clients as early as the IND planning stage to develop robust clinical pharmacology strategies and then works as a horizontally integrated, in-house resource to assist with the execution and analysis of those strategies. Our efforts not only include the design, conduct, and analysis of clinical pharmacology studies but also helping clients transition from nonclinical research into early phase clinical trials as well as transitioning from healthy volunteers into patients with the target disease.

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