Webinar: Investigator Perspectives on Alzheimer’s Disease Trials

Presented by

Rolando Gutierrez-Esteinou, MD,

Vice President, Therapeutic Area Head Neuroscience Medical and Scientific Services, Covance Inc

Dr. Gutierrez currently serves as the head of Covance’s Neuroscience therapeutic area. In this role, he has oversight for all studies in Neuroscience conducted by Covance across the globe. Dr. Gutierrez previously held positions in the Neuroscience franchises at J&J, Novartis and BMS where he had worldwide responsibility for the development of compounds in both psychiatric and neurologic indications. He has more than 18 years of pharmaceutical development experience in Clinical Development, Project Management and Medical Affairs. He has led or supervised the development of compounds in a range of indications including schizophrenia, depression, bipolar disorder, anxiety, migraine, Parkinson’s disease, epilepsy, and chronic pain.

In Alzheimer’s Disease, Dr. Gutierrez’s experience while at J&J includes one of the first developments of a disease-modifying agent, Sabuluzole, which completed a 2-yr randomized pivotal trial. This drug was eventually terminated for lack of efficacy. He also participated in the phases II and III development of galantamine, a symptomatic treatment for Alzheimer’s disease, which resulted in approval and commercialization in moderate to severe stages of the disease. While at Novartis, Dr. Gutierrez participated in the development of rivastigmine, also for symptomatic treatment. The clinical work ongoing at that time were related to programs in Minimal Cognitive Impairment, and in a transdermal delivery of rivastigmine for moderate to severe Alzheimer’s disease, and in dementia associated with Parkinson’s disease. Currently, Covance is conducting a large, multinational trial in Alzheimer’s disease, testing the effects of a drug and validating a biomarker simultaneously.

Dr. Gutierrez received an MD from the National Autonomous University of Mexico Medical School, in Mexico City and completed his psychiatric residency at Harvard Medical School in Boston, Massachusetts. He then completed a research fellowship in Neurochemistry at the Laboratories for Psychiatric Research, Mailman Research Center at Harvard Medical School in Belmont, Massachusetts; and a clinical fellowship at the National Institutes of Health, Experimental Therapeutics Branch in Bethesda, Maryland. He is accredited by the Educational Commission for Foreign Medical Graduates and is a Diplomate of the ABPN.

Mary Mande,

Senior Director, Operational Strategy & Planning, Covance Inc.

Mary Mande provides senior leadership in the development and implementation of the operational platform for Clinical Development Services at Covance. She provides training and coaching to project teams on aspects pertaining to project strategy, including feasibility and scenario planning. In her current position, she is tasked with using evidence-based approaches to support the design of innovative strategies in conjunction with subject matter experts and assigned team members for the successful implementation and conduct of clinical trials for clients. She engages with project teams at key time points in the project lifecycle to ensure actual performance is in line with strategic plans and provides advanced interventional guidance when required.

Ms. Mande has 18 years of clinical experience, and has held various leadership positions in the CRO and pharmaceutical industries. She has extensive project management experience leading global teams and managing worldwide clinical programs, ensuring clinical operational excellence by facilitating the development of specific operational process improvements, best practices, metrics reporting, and performance measurement. Ms. Mande's most recent leadership role prior to joining Covance was as director of Global Clinical Trials Operations at a pharmaceutical company, where she provided leadership to clinical trial management operations; analyzed business performance; and served as an advocate, mentor and role model for integrating best practices into the organization.