Chief Executive Officer and Chief Medical Officer
Richard A. Lutes, MD
Dr. Lutes has over thirty years experience in hematology /oncology including direct patient care, clinical research business and marketing. Over the last ten years he has worked as a consultant in early phase clinical drug development consulting with both large pharmaceutical companies and a number of biotechnology companies often as the acting chief medical officer.
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Dr. Lutes spent seven years at Bayer Pharmaceuticals serving multiple functional areas in the Biological Products Division working in the areas of hematology, with clinical research in a number of areas including hemophilia, trauma, immunology, and pulmonary disease and in multiple areas on the Bayer oncology portfolio. During this time he originated a Phase IIB program initiating 30 strategic non-registration trials to test new hypothesis for marketed biological products. He also directed groups in scientific studies, drug information and medical communications and worked on medical oncology drug launch programs. He received an executive MBA degree from Notre Dame University.
Dr. Lutes started his clinical career in private practice, founding the Waterbury Hematology Oncology Associates and from the first year began working in clinical research conducting clinical trials as a member of ECOG, CALGB and at Univ. Conn. with the team led by Dr. Lee Hoyer and at Yale with Dr. Joe Bettino’s group. He held positions as an Adjunct Clinical Professor of Medicine at Yale University College of Medicine and the University of Connecticut College of Medicine.
Dr. Lutes received his undergraduate degree and MD degree from the University of Illinois. Following an internship at Cook County Hospital, he served a tour of duty in Viet Nam as a battalion surgeon for the First Air Cavalry Division. He then completed a residency in internal medicine at Thomas Jefferson University in Philadelphia and a fellowship in hematology/oncology at the Cardeza Foundation for Hematological Research in Philadelphia. He is board certified in internal medicine and hematology
Clinical Operations Officer
Charlene Sexton, BScN
Charlene Sexton has over twenty years experience starting with a strong nursing background starting in intensive care nursing and moving through various nursing positions of increasing responsibility and for the last fifteen years in clinical trial management and operations. She has worked in both device and pharmaceuticals and in the last five years worked exclusively in oncology. She has experience as a clinical research coordinator, and has Regional Clinical Research Associate with major US CRO. She is also fluent in French and English.
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Another innovative program was the International Prostate Cancer Symposium for the Patient---a patient meeting for prostate cancer survivors and family members with Mr. Bob Novak serving as National Chair. A further successful program was the International Breast Cancer Symposium for the Patient---developed and implemented national patient meeting for breast cancer survivors with Mrs. Betty Ford serving as National Chair.
John has served as President of AOI Communications, LLP---developed and launched company into the area of oncology-focused medical marketing. Reached $12MM in annual revenues within the first three years. Prior to that John was Deputy Director of the Center for Healthcare Education---and launched and led the organization through the formalized CME accreditation process, receiving Exemplary Compliance recognition from the Accreditation Council for Continuing Medical Education (ACCME), enabling the organization full right to accredit continuing medical education activities nationally. John founded and was the CEO of ForeCME, LLC and served as Executive VP of MEV Health and COO of Scientific News International
John has a prestigious List of Working Relationships---Clients included: Abbott, Amgen, AstraZeneca, Aventis, Bayer Oncology, Celgene, GlaxoSmithKlein, Millennium, Novartis, and Patient Support Groups such as; Cancer Care, Leukemia & Lymphoma Society, Multiple Myeloma Research Foundation, National Kidney Foundation, USToo International, Y-ME.
Clinical Communications
Gregory Carroll, Ph.D
J. Gregory Carroll, brings thirty years experience in clinical communications and was the founder and the driving force behind the world renowned Institute for Health Care Communications. Gregory has created programs for physician patient communication on end of life issue in cancer patients and most recently is working on communication on “why patients should enter into clinical trials”.
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Dr. Carroll is an educational psychologist with extensive experience in teaching interpersonal communication skills in the health professions. He served for six years as Project Director and then Director of Educational Services and Research at the University of Pennsylvania School of Medicine. From 1983 to 1989 he was Associate Professor and Associate Dean at Penn State’s College of Health and Human Development. From 1989 to 2009, he served as Director, Executive Director, and then Chief Executive Officer of the Institute for Healthcare Communication, a non-profit foundation in New Haven, Connecticut. During that time Institute staff members and consultants developed and tested communication workshops and faculty development courses on 15 related topics. A network of Institute-trained faculty members has conducted more than 10,000 communication workshops across North America since 1989 for approximately 120,000 clinicians and health care professionals.
Dr. Carroll teaches clinical communication workshops to senior medical residents as a Lecturer, Department of Medicine, at Yale University School of Medicine. His publications on clinician-patient communication include work on curriculum development, teaching methods, standardized patient techniques, and program evaluation. He is a Fellow of the American Academy on Communication in Healthcare and served on the editorial board for Patient Education and Counseling and CE Measure.
Clinical Research Management
Alice Heinig, B.B.A, CCRP (Certified Clinical Research Professional)
Alice Heinig has many years of extensive experience managing and monitoring clinical trials, databases and Contract Research Organizations (CROs). Strong commitment to innovation and organization in metrics visualization and project tracking as well as emphasis on team communication and success.
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She has experience in multiple fields of oncology such as Clinical Research Associate in Translational Medicine, Manager for Clinical Data Management, which included Management of all trial data including Oracle EDC databases in various phases. Responsible for database specifications, both EDC and paper-based and for database edit specifications.
As well she was a project manager for CRO’s, with a wide range of responsibilities including, the designed systems and tracking metrics generating improved cycle time and processes.
Clinical Research Development
Daniel F. Hoth, MD, Medical Oncologist
Dr. Dan Hoth is a medical oncologist with more than twenty five years experience in clinical development of investigational drugs in cancer and infectious disease. He has provided drug development and clinical trial consulting for numerous biotechnology and pharmaceutical companies and most recently he served as senior vice president, development, and chief medical officer of Axys Pharmaceuticals. Prior to that from 1993 to 1997 he held the position of Senior Vice President and Chief Medical Officer at Cell Genesys.
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Dr. Hoth served at the National Cancer Institute from 1980-1987 as Chief, Investigational Drug Branch, responsible for all clinical investigations of IND stage anticancer pharmaceuticals. Following that post he served from 1987-1993 as the Director, Division of AIDS at the National Institute of Allergy and Infectious Disease
He currently serves on several clinical/scientific advisory Boards, and the Board of Directors of three companies He has participated in four NDAs. He has experience developing small molecules, antibodies, cytokines, gene therapy, and vaccines. He has also served as a consultant to both the FDA and NIH in oncology drug development. Before the NIH, he was on the faculty of the Georgetown University School of Medicine. Dr. Hoth received his M.D. from Georgetown University School of Medicine and A.B. in Psychology from Franklin and Marshall College.
She has held senior level positions at Boyden Global Executive Search-Summit NJ, Addison Resources Group – Ridgewood NJ, Tschudin Inc., Riverdale NJ., and served as Vice President of The Stevenson Group - Englewood Cliffs NJ.
Elizabeth received a Business Administration Degree from The Cantonal College of Commerce in Trogen Switzerland. She subsequently received an English and Literature Degree from the West London College of Commerce. London England, a Marketing and Human Resources Management Degree from New York University, New York, N.Y. and studied at the Academia Suiza in Barcelona, Spain.
She is Bi-lingual in English and German and has a good command of French and conversational Spanish.
Clinical Information Technology
Jean-Marc Dubé, Computer Sciences Specialist
A senior IT specialist with the Distributed Engineering teams, Jean-Marc Dubé has over 20 years of experience and expertise in preparing and implementing advanced technical solutions and platform development operations.
Strategic Web Communications
Mario Bourgeois, Web Consultant & Developer
Since 2000, Mario Bourgeois has crafted extraordinary custom website designs and programming solutions for trusted clients worldwide. He is specialized in strategic web design and maintenance, search engine optimization, template integration and customization, advanced e-commerce & marketing and database development. |