John A. McLane Named Executive of the Year in Pharmacovigilance & Operations Management

HUDSON, MA, March 18, 2014 (Press-News.org) John A. McLane, Chief Operating Officer and Vice President of Clinical and Regulatory Affairs for Clinquest, Inc, has been named a Worldwide Branding Executive of the Year in Pharmacovigilance & Operations Management. While inclusion in Worldwide Branding is an honor, only a small selection of members in each discipline are chosen for this distinction. These special honorees are distinguished based on their professional accomplishments, academic achievements, leadership abilities, years of service, and the credentials they have provided in association with their Worldwide Branding membership.

An innovative leader, Dr. McLane is known for formulating and executing strategies that align mission, operations, products and goals for competitive advantage, improved returns on investment and generating quality results.

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 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. Currently, he is helping biotech and Pharma companies with INDs, clinical and pharmacovigilance projects and developing business plans

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.

Dr. McLane prides himself on being a doer, a thinker and a listener. Because of this, he can work around problems and strategically come up with great solutions. He loves working with teams and developing the capacity out of individuals and the unit as a whole.

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 approximately 20 years at Hoffmann-La Roche working with international teams 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.

About Worldwide Branding
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We presently have two offices, but we are headquartered on Long Island. Our team comprises more than 100 staff members and spans 10 key departments.

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Contact:
Ellen Campbell
Director, Media Relations
mediarelations@worldwidebranding.com