NeuAge Institute (NAI)

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Faculty & Advisory Board

Faculty

NeuAge Program Advisory Board (PAB)

Program Advisory Board (PAB) provides an essential link between NAI and the Pharmaceutical Industry. PAB assists in evaluating the effectiveness of the NAI’s programs and in the identification of future trends and changes in the industry to ensure program relevancy. PAB members inform programming with respect to industry trends and thus any changes in skill and knowledge requirements, keeping the curriculum aligned with industry needs. They are the catalyst for growing and strengthening partnerships with the pharma industry. NAI’s advisory board is composed of relevant, accomplished experts offering advice and insight for guiding curricular, assessment, research, occupational, and marketing, initiatives.

Sase Boyo​

Clinical Research & Pharmacovigilance

Michael Balog

Quality Assurance and Regulatory

Ada George

Clinical Research & Pharmacovigilance

Dr. Shahin Fesharaki

Quality Assurance and Regulatory
Clinical Research & Pharmacovigilance

Ken Christie

Quality Assurance and Regulatory

David Vincent

Quality Assurance and Regulatory

Dr. Tigran Uzunyan

Clinical Research & Pharmacovigilance

Zsuzsanna Gesztesi

Clinical Research & Pharmacovigilance

Sase Boyo​​

Clinical Research & Pharmacovigilance

Sase Boyo has over 15 years’ experience in Clinical Research; this experience includes Clinical Trials’ Phases 1- 4 in Pharmaceutical and Biotech Clinical Development – with core work in Clinical Project Management and Clinical Operations. Ms. Boyo oversees all aspects of Clinical Trials – Protocol and Standard Operating Procedures (SOPs) Development, Risk Assessment and Management, Clinical Compliance and Monitoring, Clinical Research Regulations, Good Clinical Practice Adherence, Data Management and Reporting, and Pharmacovigilance.

Ms. Boyo has a Bachelor’s Degree in Biology from California State University, Northridge, a Master’s Degree in Clinical Research from Morehouse School of Medicine and a Master’s Degree in Public Administration from Kennesaw State University. Ms. Boyo is also a certified Project Management Professional (PMP) with the Project Management Institute (PMI).

Dr. Shahin Fesharaki

Quality Assurance and Regulatory
Clinical Research & Pharmacovigilance

Shahin Fesharaki holds the position of Chief Scientific Officer for Hikma Pharmaceuticals Plc.

He received a doctorate from the University of Mumbai and an undergraduate degree and a graduate degree from the University of Pune.

Prior to his role at Hikma, Dr. Fesharaki was Chief Operating Officer Global R&D at Actavis, where he led the global R&D operations. Prior to that, Dr. Fesharaki was the Director, Formulations Development, New Products at Apotex.

Dr. Fesharaki brings more than 25 years of extensive development experience in both generic and branded pharmaceuticals across a broad range of technologies and dosage forms. Dr. Fesharaki is a versatile pharmaceutical industry leader with diversified experience in both generic and branded research and development from conception to launch/commercialization.
Ken Christie

Quality Assurance and Regulatory

Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, supplier qualification, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Accomplishments include working on consent decree remediation issues for aseptically produced products, assisting clients in Japan, Dubai, Spain, China, and India by addressing audit observations and corrective actions dealing with sterilization. Performs PAI’s (pre-approval inspections) against current standards as found in the FDA’s ‘Pre-Approval Inspection Compliance Program #7346.832.

Mr. Christie is a speaker and trainer for several professional organizations and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
David Vincent

Quality Assurance and Regulatory

Dr. Vincent has over thirty-three (33) years of experience in the health care industry specializing in the Biotechnology and Pharmaceutical industries. He has over (26) twenty-six years dedicated to the field of validation (commissioning and qualification [C&Q]). Dr. Vincent has B.Sc. (industrial microbiology), Master Public Health (Specializing in Public Health Promotion), and Ph.D. (Doctorate Specializing Epidemiology).

He has hands-on experience in many areas of Regulatory Affairs, Quality Assurance, Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification, Cleaning/Process Validation, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation.

Dr, Vincent is especially strong in the areas of Upstream and Downstream Process Development and Validation and developing and implementing Cleaning Validation, Aseptic Process, and Environmental Monitoring Programs. Most of his career has been in the Biological Vaccine Industries, but he has also supported the Medical Device, Biopharmaceutical, and Biological industries.

Dr, Vincent has spent the last twenty-seven (27) years providing validation and quality consulting services to various national and international companies, including project management and project execution services.
Dr. Tigran Uzunyan

Clinical Research & Pharmacovigilance

Tigran Uzunyan is a medical doctor and research scientist with over 18 years of diversified experience in academia, pharmaceutical industry and clinical research. Tigran acquired a degree of medical doctor and then specialized in clinical pharmacology in Yerevan, Armenia. In 2008 he defended his PhD thesis in pharmacology.

Tigran Uzunyan has an extensive experience in drug development and regulation under various jurisdictions, designing and conducting early phase (bioequivalence, bioavailability, first in human, etc.) and late phase (II to IV) clinical and observational studies. He also managed medical cannabis development research projects in Canada.

Zsuzsanna Gesztesi

Clinical Research & Pharmacovigilance

An accomplished Pharmacovigilance Professional with profound knowledge and experience in Drug Safety, Medical Information, Risk Management and Phase I-IV clinical trials. Visionary leader and an influential team builder of the highest integrity with disciplined general business acumen with proven record of driving and accelerating corporate growth, implementing change, increasing productivity and efficiency. A role model for work ethic, dedication, and professionalism. I drive key business decisions in the areas of corporate growth, process, and productivity improvements across business units. Extensive experience designing, planning, directing and managing Risk Management programs and Phase I-IV clinical research trials combined with a strong working knowledge of relevant industry regulations. Global Director-level clinical research, pharmacovigilance, regulatory and medical affairs professional with extensive business development expertise and vendor/client management.
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