JOHN A. MCLANE, PH.D. 25 Cromwell Avenue, Warwick, RI 02889mclane5@cox.net • 401-286-3652

COO / VP Clinical and Regulatory Affairs

An innovative leader, international experienced in start-ups, venture capital funded biotechs, large pharma, and clinical research (CRO) firms encompassing all Phases and types of products in the pharmaceutical, biological and medical device industries. Known for formulating and executing strategies that align mission, operations, products and goals for competitive advantage, improved ROI and generating quality results.

Skilled at leading full regulatory and clinical development projects resulting in successful INDs, IDEs, NDAs, MAAs and developing regulatory and clinical processes and strategies. Extensive experience leading global management teams by providing strategic assessment, management and program metrics to develop innovative drugs. Build regulatory and quality assurance functions within start-up companies; develop clinical, regulatory and quality strategies.

• P&L • Regulatory Compliance • Global Management• Start-ups • Negotiation • Vendor Relations• Strategic Planning • Risk Assessment • Conflict Resolution• Quality • Communications • Investor Relations

SELECT ACCOMPLISHMENTS

Submitted three NDAs in Parkinson’s, Alzheimer’s and Dermatology indications. Recruited, developed and led international clinical operational teams, programs, and strategies for clinical candidates in multiple therapeutic areas.

Achieved successful audits by creating comprehensive SOPs and Quality systems. Clinical group was dysfunctional with little standard procedures. Implemented substantial clinical and pharmacovigilance operation improvements increasing efficiency in “back-room” activities and quality management system (QMS) with over 50 new SOPs leading to successful audits.

Overcame vendor issues for Hoffmann-La Roche, Ariston and Clinquest. In multiple situations, identified and provided solutions to outsourced activities. Responsible for successfully integrating multiple clinical Phase II/III projects valued from $12M to $50M.

Won more than $20M in venture capital funding for start-up Ariston Pharmaceuticals. Crafted business development, strategic and financial plans for approximately 20 clinical-stage neurological-based compounds considered for in-licensing. Presented at venture capital meetings and scientific conferences for company.

Led $900M of product submissions sent to regulatory authorities on time and within 3-5% of budget. At Hoffmann-La Roche, led full development teams with submissions for new products with financial responsibility for $9M+ development budgets each.

Spearheaded new formulation of old drug, completing project 10% under budget at Hoffmann-La Roche . Budget was limited to $10M. Recruited global team, received FDA approval on plans and received approval with (505(b)(2)) NDA using one animal study and one clinical study. Completed 3 months ahead of schedule and under budget.

Successfully filed multiple Orphan Drug Designations applications in the US and EU for several companies including Roche. Met with various advocacy groups and KOLs to discuss best treatment schemes. For one drug in development, where benefits outweighed the risk for an orphan indication, was strategically able to move product to clinical trials.

Turned around stalled international project for Hoffmann-La Roche. Worked with Project Manager to resolve communication and metric issues with a European subgroup. Discovered flawed analysis, and established acceptable analytical solution. Reorganized staff and instituted policies allowing successful project completion.

CAREER HISTORYCLINQUEST, INC. 2009 to PresentSpecialty healthcare product development and drug development consulting organization (CRO)

COO & VP Clinical and Regulatory Affairs

John A. McLane, Ph.D. mclane5@cox.net 401-286-3652 Page 2

Manage strategy, operations, and budget while directing 25+ people and revenues in excess of $6M annually. • Direct clinical trials providing regulatory reporting requirements including IND and orphan drug submissions.• Manage development and execution of strategic plans, expanding the company’s revenue and profitability.• Coordinate Data and Clinical Operational management, improving profit ~5-10% for individual clinical products.• Lead strategic clinical and regulatory development planning, budget forecasting, timeline analysis, international

regulatory interactions (FDA and EMA) and global clinical trial expansions.• Serve as US regulatory agent for European and Canadian drug and device companies. Submitting

pharmacovigilance safety reports, annual reports, orphan applications, and representing foreign medical device manufacturing facilities.

ARISTON PHARMACEUTICALS, INC. 2004 to 2009Startup virtual specialty pharmaceutical company

VP, Pharmaceutical DevelopmentManaged $14M annual operational budget and drove contributions from VC funded activities for a virtual company with 3 other full and part time employees.• Directed Phase I and IIb clinical trials for CNS and migraine prevention drugs. • Provided scientific and regulatory input for raising money with VCs. • Interacted with FDA and European regulatory authorities to win approval for drug development. • Identified and managed external international vendors for regulatory guidance and global clinical operations and

leading to successful Phase I and II clinical studies in United States and Europe.• Won contract negotiations and directed over 15 different cross-functional manufacturing, regulatory, clinical, and

business management outsourced functions (vendors).• Authored and published four new patent applications.

MILKHAUS LABORATORY, INC. 2002 to 2004Startup clinical biotech company

VP, Clinical and Regulatory AffairsManaged 6 staff and 5 service providers for manufacture and clinical trial operations with a budget of $18M.• Supervised the development of research, clinical, and regulatory departments in a small biopharmaceutical

company with three (3) active INDs and Phase IIb clinical trials.• Organized and participated in outsourced activities with different CROs for GLP/GMP in CMC, toxicology, and

clinical components of programs.

HOFFMANN-LA ROCHE 1987 to 2002Top Five Global Pharmaceutical Leader, developing innovative diagnostic and therapeutic products and services

Director Early Strategic Planning; Global DevelopmentManaged cross-functional teams, providing regulatory strategic leadership of development projects and portfolios. • Liaison with international life cycle business and development teams to develop and present clinical, regulatory

and marketing strategies for multiple portfolio products in late stage development.• Implemented overall clinical operations and regulatory project plans, budgets and organization for projects from

Phase I to III reporting directly to Global Executive Committee in Switzerland.• Strategically managed new programs (Phase III & IV) for CNS and Dermatology products that resulted in increased

revenue projections of approximately $300M/year.• Developed value/risk assessments, operational and regulatory plans, and resource allocation budgets for

development areas in neurology, diabetes, and respiratory diseases.

PREVIOUSLY WITH HOFFMANN-LA ROCHERoche Representative to PhRMA Committee on Clinical Safety • Director of Medical Science and Safety Teams

Clinical Science Leader • Associate Research Investigator • Senior ScientistEDUCATION

Doctor of Philosophy in Cell Biology/Zoology, University of Rhode Island, Kingston, RIMaster of Science in Developmental Biology, University of Rhode Island, Kingston, RI

Bachelor of Science in Biology; Graduated cum laude, University of Bridgeport, Bridgeport, CT

PUBLICATIONS & PATENTS

John A. McLane, Ph.D. mclane5@cox.net 401-286-3652 Page 3

Over 29 peer-reviewed publications • 12 Patents/applicationsNumerous abstracts, presentations and white papers on pharmaceutical development and risk management