(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”. (more…)

(Research Triangle Park, N.C.) Fast becoming the pharmaceutical industry’s go-to resource for pharmacokinetics (PK), ClinPharm Consulting, LLC is pleased to announce the addition of David Y. Mitchell, Ph.D. to its experienced team of drug development professionals. Currently serving as President of the American Association of Pharmaceutical Scientists (AAPS), Dr. Mitchell strengthens ClinPharm’s core competencies in PK and clinical pharmacology, with regulatory affairs, medical writing, protocol development, and strategic planning services to help navigate client companies down the complex path to marketing approval. “Dr. Mitchell is an accomplished pharmacokinetic and drug development consultant and we are very pleased to have him bring his professional and scientific talents to ClinPharm,” said Geoffrey Banks, Ph.D., ClinPharm President and CEO. Over the past 20 years Dr. Mitchell has guided projects at Array BioPharma, OSI Pharmaceuticals, and Pfizer, and has directed clinical pharmacology programs at Pfizer and Procter & Gamble Pharmaceuticals in the areas of oncology, neuroscience, and bone disease. He has published over 60 manuscripts, chapters, and abstracts in the areas of pharmacokinetics, metabolism, toxicology, and epidemiology. (more…)

(Research Triangle Park, N.C.) ClinPharm Consulting, a specialized consulting firm offering a unique paradigm for empowering drug development pipelines, announced two major staffing changes to further integrate its scientifically sound PK-PD services with new approaches to reduce risk to drug development programs and maximize return on R&D investment. Chief Scientific Officer M. Alexander Shaw, Ph.D., has been promoted to Chief Operating Officer, while Bill Wargin, Ph.D., has taken over as the firm’s new Chief Scientific Officer. (more…)

(Research Triangle Park, N.C.) NCTechNews, North Carolina’s technology news source, will be blogging live from the BIO International Convention in Washington, D.C. June 27-30 to cover major trends affecting the life sciences community. The BIO International Convention is the largest global event of its kind, attracting the biggest names in biotech and featuring keynotes and sessions from key policymakers, scientists, CEOs, and celebrities, and the world’s largest biotechnology exhibition - the BIO Exhibition. (more…)

(Raleigh, N.C.) d-Wise, provider of powerful business solutions for the unique challenges of the Life Sciences & Healthcare industries, has introduced Reveal™, an innovative, web-based search platform that quickly returns results across multiple clinical data systems. Working in partnership with Daiichi Sankyo, Inc., a global pharmaceutical company with a development and commercial headquarters located in New Jersey, d-Wise designed and developed a new software solution to enable the company’s researchers, administrators, managers and informatics directors to perform comprehensive exploration of its clinical data systems. (more…)

(Research Triangle Park, N.C.) NCTechNews, North Carolina’s technology news source, is accepting nominations from businesses and organizations for its “Biotech Story of the Year” top ten list for 2009. The list of stories will provide NCTechNews readers with detailed information about each top ten nominee and their newsworthy milestones contributing to the life sciences community in North Carolina. Every qualifying organization or business submitting a nomination will appear on the final list compilation to be published on NCTechNews, along with a hot link to their individual websites, with the top ten headlining a feature article and press release announcing the final list. (more…)

(Raleigh, N.C.) Clinsys Clinical Research, Inc.®, a therapeutically focused clinical research organization, today announced that Karen Lewis has joined the company as Vice President of Global Clinical Operations. Ms. Lewis brings more than 20 years of clinical research experience in multiple therapeutic areas including infectious disease, gastrointestinal diseases, cardiovascular, central nervous system, ophthalmology, dermatology and women’s health. (more…)

(Research Triangle Park, N.C.) Early phase drug development consulting firm ClinPharm Consulting and 23-year pharmaceutical industry veteran Bill Wargin, Ph.D. have announced a strategic partnership to further enhance ClinPharm Consulting’s clinical pharmacology expertise. Formerly with Burroughs-Wellcome and then GlaxoWellcome, Dr. Wargin has spent the last eight years consulting with numerous clients in all aspects of pre-clinical and clinical pharmacokinetics including study design, data analysis, and strategic planning. (more…)