John Mclane is known for regulatory submissions for new drug applications
HUDSON, MA, January 27, 2014 /24-7PressRelease/
-- John A. McLane, Chief Operating Officer, Vice President of Clinical and Regulatory Affairs for Clinquest, Inc, has been recognized for showing dedication, leadership and excellence in pharmaceuticals.
John Mclane is known for regulatory submissions for new drug applications. He holds 10 pharmaceutical patents for new drugs and process, and he currently is working in pharmacovigilance and clinical research for new biological drugs.
In Dr. McLane's career, he has led the clinical and regulatory teams for submissions of three NDA's in Parkinson's, Alzheimer's and Dermatology indications. Dr. McLane has recruited, developed and led international clinical operational teams, programs, and strategies for clinical candidates in multiple therapeutic areas. He currently is responsible for integrating successful multiple clinical Phase II/III projects by identifying and managing vendors with project costs exceeding $12 -50 million at large Pharma.
Dr. McLane has successfully filed multiple orphan (rare disease) drug designations applications in the US and EU and led the clinical program for these projects and hopes to focus on the development of an innovative drug for orphan indications. He established and strengthened long-term and international regulatory and operational strategies and rationale for large and small pharmaceuticals/biotechs.
In the past as an entrepreneur, he co-founded one company, Catalyst Oncology, and he has been the key first employee in two other biotech start-ups, successfully helping to raise more than $35 million. He has implemented substantial clinical operations improvements increasing efficiency in 'back-room' activities and quality management system (QMS) with over 50 new SOPs leading to successful audits. He spent 20 years at Hoffman-La Roche working with international team in clinical and regulatory areas.
Dr. McLane completed a research fellowship in dermatology and cell biology, and he completed postdoctoral research at Yale School of Medicine. He has earned a Ph.D. in biology and a master's degree in biology, both from the University of Rhode Island. He was recently inducted into Worldwide Branding and also maintains affiliation with the Drug Information Association and the Regulatory Affairs Professionals Society. In years to come, Dr. McLane plans to develop an innovative drug for a rare disease.
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Director, Media Relations