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CNS Leadership
Michael Gibertini, PhD
Executive Vice President, CNS
Michael Gibertini earned his PhD in Clinical Psychology from the University of Houston (1984). He has broad experience in psychoimmunology, behavioral toxicology, and CNS drug development in addition to many years of clinical practice in psychology and neuropsychology. Dr. Gibertini has conducted numerous clinical trials on candidate antidepressants, including scientific lead responsibility for trials in MDD, atypical depression, geriatric depression, and pediatric depression. As a global development team leader in CNS, he has planned and implemented clinical development plans spanning phase I through Phase IV, as well as the clinical sections of NDA submissions, making several presentations before the FDA on aspects of antidepressant programs. He is an expert in trial methodology in CNS and in psychometrics. In addition, he has established a large network of clinical investigators who provide high-quality operations and access to appropriate patient populations important for clear answers in depression trials.

Thomas Schlagheck, PhD
Senior Vice President, Clinical Development, Global Analgesia
Dr. Schlagheck's clinical career spans more than 25 years with Procter & Gamble, Endo Pharmaceuticals, and Eastman Kodak Company during which he has been responsible for the development and submission of several INDs & NDAs. He has expertise in global drug development across several therapeutic areas including analgesia, gastrointestinal, respiratory, cardiac, nutrition, and pediatric research. His career responsibilities have included basic clinical research, clinical research management, strategy development, and senior management positions including vice president of clinical operations. Dr. Schlagheck earned a PhD in Physiology from the University of Arizona and completed a Postdoctoral Fellowship at Virginia Tech University. He is the author of numerous scientific articles and Phase I - IV clinical reports and regulatory submissions for the U.S. Food and Drug Administration, and is a frequent lecturer on clinical topics.

Tom Zoda, PhD
Senior Vice President, Clinical Development, Neurology & Psychiatry

Tom Zoda completed his doctoral degree in microbiology, specializing in immunology, at the University of Texas Health Science Center at San Antonio, followed by postdoctoral work at Dartmouth Medical College. Prior to joining INC Research, Dr. Zoda worked for a large, global CRO as Executive Director for Global Strategic Development for CNS studies. He has extensive experience in the design and management of multiple Phase II and III studies focused in various neurological and psychiatric indications. His extensive experience includes oversight of US based and global CNS studies in neurological and psychiatric disorders as well as pain management. Prior to his CRO career, Dr. Zoda worked for Tanox Biosystems, Inc., overseeing the development of therapeutic antibodies and vaccines for the treatment of allergy.

Biljana Andjelkovic, MD
Vice President, Clinical Operations, Global Analgesia
Dr. Andjelkovic has over 15 years of experience in product development within both the contract research and pharmaceutical industries. She began her career as global project leader for a specialty pharmaceutical company. Dr. Andjelkovic then joined Vujaklija, the first CRO to be founded in Eastern Europe, where she served as Director of Clinical Operations. She joined INC Research when Vujaklija was acquired in 2001. Dr. Andjelkovic moved into the role of Director, Project Management and Clinical Operations Europe at INC Research, and progressed to increasingly senior level responsibilities within the company. Dr. Andjelkovic has experience managing global Ph II-IV drug development programs and has considerable experience providing supervision, scientific guidance, and oversight for numerous pain trials in acute and chronic pain programs.

Additionally, Dr. Andjelkovic has served as Medical Advisor to several pharmaceutical companies. In addition to pain and CNS, areas of experience include oncology, cardiovascular, and various indications in pediatrics. Dr. Andjelkovic earned her MD from the University of Belgrade School of Medicine.

Warren Prosser, MBA
Vice President, Clinical Operations, Global Analgesia
Dr. Prosser has over 20 years of clinical research experience in academic, biopharma, and CRO settings. Prior to joining INC Research, he was the head of clinical operations at a mid-sized biopharmaceutical company where he led the operations for several full clinical development programs. Mr. Prosser has a wide range of experience in pain and analgesia including experimental pain models, post-surgical pain models, diabetic neuropathy, peripheral neuropathy, low back pain, osteoarthritis, migraine, and more. In addition, Mr. Prosser has an extensive background in Phase I-III studies, including specialty studies for proof of concept and clinical pharmacology models, cardiovascular risk assessment, clinical and preclinical PET studies to assess CNS penetration, distribution, and receptor binding profiles, studies using surrogate markers for CNS activity, and numerous Phase I “labeling studies”. Additional expertise includes deep knowledge of patient reported and care-giver reported outcomes necessary to assess subjective endpoints in a number of indications.

Andrew Silverman, PhD
Vice President, Neurology
Dr. Silverman has more than 16 years of combined clinical and research experience, with over 10 years experience managing drug development programs in the contract research industry. Dr. Silverman co-founded and served as Chief Operating Officer for Tanistry, a CNS focused CRO. Dr. Silverman joined INC Research after it acquired Tanistry. Dr. Silverman is responsible for overall strategy and direction for the neurology team and projects within the CNS division of INC Research. He possesses a comprehensive knowledge of the procedures and regulatory issues shaping the data management and clinical operations functions in contract clinical research today. Dr. Silverman earned his BGS in Psychology, Biology and Anthropology from the University of Michigan, and both his MA in Clinical Psychology and his PhD in Clinical Psychology and Neuropsychology from The University of Texas in Austin.

 

Case Studies

Pain: Chronic, Non-Malignant Pain
Pain: Chronic Painful Diabetic Neuropathy
Neurology: Stroke
Psychiatry: Panic Attacks
Psychiatry: Major Depressive Disorder

Leadership

Michael Gibertini, PhD
Executive Vice President, CNS

Thomas Schlagheck, PhD
Vice President, Clinical Development, Global Analgesia

Thomas Zoda, PhD
Senior Vice President, Clinical Development, Neurology and Psychiatry

Biljana Andjelkovic, MD
Vice President, Clinical Operations, Global Analgesia

Warren Prosser, MBA
Vice President, Clinical Operations Global Analgesia

Andrew Silverman, PhD
Vice President, Neurology