Oncology One

Key Personnel

Michael J. O'Brien, President and CEO, has held various senior management positions in the healthcare industry, including experience with biopharmaceutical and medical device companies. Since 1993, he has held Vice President and CFO positions with Bionx Implants, a publicly held medical device company, Biosyn Inc., a biotechnology company, and Biocyte Corporation, a biotechnology company engaged in stem cell transplantation. From 1986 to 1993, he held senior finance and operations positions, domestically and abroad, with the Allerion Corporation, a high technology computer company. He began his career as an auditor with the accounting firm of Deloitte & Touche as a certified public accountant, and graduated from Villanova University in 1983.

Alison Martin, MD Alison Martin, MD, joined Beardsworth in 2010 as Scientific Advisor, Oncology, and is the U.S. lead for Medical Monitoring and Pharmacovigilance of OncologyOneSM , Beardsworth’s global oncology alliance. A medical oncologist, Alison has 25+ years of multisector experience in drug development and clinical trial methodology – at the National Cancer Institute (NCI), Food and Drug Administration (FDA) and Foundations. Her experience includes design and oversight of the conduct of phase 1-3 trials while a Senior Investigator in the Biologics Section of the Investigational Drug Branch of NCI; Head of Melanoma and Genitourinary Therapeutics in CTEP, NCI; NCI liaison to three Cooperative Groups and member of their DSMBs; and as a team leader in FDA’s Division of Oncology Drug Products. Alison has experience as an international reviewer of phase 3 protocols and program portfolios for UK’s Clinical Trials Advisory and Awards Committee, the NCRN’s Peer Review Committee and EORTC’s Protocol Review Committee. As an ASCO member, she has served on several of their committees – Public Relations and educational program committees. She currently is a member of the Scientific Advisory Board of the Melanoma Research Foundation (MRF) and is Chief Medical Officer of the MRF Breakthrough Consortium. She received her bachelor’s degree from New York University & her medical degree from the George Washington University Medical School. She completed her residency & chief residency at the University Health Center Hospitals of Pittsburgh and fellowship training at the Clinical Oncology Program of the NCI.

Robert W. Malone, MD Robert W. Malone, MD, MS, joined Beardsworth in 2010 as Medical Director for Vaccines. A Maryland-licensed physician Dr. Malone brings 20+ years of management and leadership experience in academia, pharmaceuticals & the biotechnology industry to this role. His biotechnology and pharmaceutical experience includes positions at the following companies: Vical, MentaGen, Intradigm, Solvay Biologicals, and Dynport Vaccine Company. His work in pre-clinical and clinical R&D experience in vaccines, gene therapy, cell therapy, biodefense, and immunology spans a wide variety of immunology service providers, contract manufacturers, cellular therapy and biological product developers including Aeras Global TB Vaccine Foundation, PATH, Iomai and VaxGen. His leadership experience with NGO, HHS, NIH & DoD contract and grant capture, proposal development and project management includes over $500 million in captured and managed funding. Dr. Malone is recognized internationally for his contributions as one of the original inventors of “DNA Vaccination” and many associated technologies, with fundamental domestic & foreign patents in the fields of gene delivery, delivery formulations, and vaccines. An author of 50+ publications, Dr. Malone has spoken at or chaired over 30 conferences and served as technical reviewer on numerous US Federal study sections. Dr. Malone received his bachelor’s degree in Biochemistry from the University of California, Davis, his Masters in Biology from the University of California, San Diego for work performed at the Salk Institute Molecular Biology and Virology Laboratories, his MD from Northwestern University, and completed both his medical internship and a research fellowship at the Sacramento Medical Center/UC Davis. He initially joined the faculty at UC Davis Medical School as an Assistant Professor (Pathology) with a research focus on gene transfer and vaccines. Subsequent academic faculty appointments have included the University of Maryland Medical Center (Pathology and Greenebaum Cancer Center), and Associate Professor appointments at the Uniformed Services University of the Health Sciences (Surgery, WRAIR Clinical Breast Cancer Program) and Kennesaw State University (Biotechnology). Dr. Malone currently serves as Editor-in-Chief of the open access, peer-reviewed Journal of Immune Based Therapies and Vaccines.

Art Gertel Art Gertel is the Vice President Strategic Regulatory Consulting, Medical Writing, and QA and heads the International Regulatory Team of OncologyOneSM, our global oncology alliance. With more than 30 years of experience in the pharmaceutical industry, Art has had a broad range of responsibility in virtually all phases of pharmaceutical drug research and development. He has been involved in developing and integrating global clinical study standards in collaboration with multinational professional organizations and regulatory authorities. Art’s prior experience includes heading the Medical Communications Department at Schering-Plough, with responsibility for preparing all new drug applications, worldwide; directing the Medical and Scientific Communications Department at Hoffmann-LaRoche; and serving as Senior Director, Clinical Operations, at iKnowMed, where he helped develop iKnowChart, an oncology-specific eDC tool, with an EHR-based platform. He served as President of the American Medical Writers Association (AMWA) and is the recipient of the organization’s 2009 Harold Swanberg Distinguished Service Award. Art is a frequent lecturer and teacher at Drug Information Association (DIA), European Medical Writers Association (EMWA), and AMWA meetings, and has been very active in the Clinical Data Interchange Standards Consortium (CDISC) efforts to standardize clinical data. Art is a Fellow of AMWA and EMWA. He received undergraduate education in Biology and Psychology at the University of Pennsylvania, and pursued graduate studies in Behavioral Medicine at New York Medical College, and Pharmaceutics at Temple University.

Dan Diaz Dan Diaz brings over 24 years of Pharma and CRO industry experience to his role as Vice President Business Development. Dan started his career with the former Merrell Dow Pharmaceutical Company where he specialized in respiratory medicine and hypercholesterolemia. With the merger of Marion Laboratories, he became a Medical Science Liaison focusing on late stage research before moving into the CRO and site management space with both specialty, global CROs and SMOs. His business expertise spans contracting with government entities, small & global Pharma, Biotech companies, niche CROs and SMOs in all phases of clinical research. Since joining Beardsworth in 2007, Dan has expanded Beardsworth’s diversity and vaccine initiatives to include corporate, government and vendor partnerships. He also leads the global development strategy of OncologyOneSM, Beardsworth’s global oncology alliance. Dan holds a degree in business administration and marketing from Central Missouri State University.

Evette RiegelAs Senior Director, Clinical Operations and Project Management, Evette Riegel, RN heads Beardsworth clinical research projects and leads the company’s integration of global services and oncology contract research operations. Her hands-on experience provides a practical and personal perspective on the realities of global outsourcing. With a career that spans 25 years in the health care arena, Evette brings a depth & breadth of experience to her current role. Enhancing her clinical study & project management experience with US and global trials is the valuable insight gained during her 15 years as a critical care nurse. Prior to joining Beardsworth in 2006, Evette was global project manager at Quintiles, a contract research organization. She had previously worked at Discovery Laboratories, ViroPharma and Wyeth where she was involved in adult, pediatric and neonatal infections disease, respiratory, cardiovascular and diabetes research. Evette earned her degrees in nursing from Bucks County Community College and Thomas Jefferson University, respectively.

Linda Diehl Martz, RN Linda Diehl Martz, RN is the Executive Director of Clinical Data Management and Project Director with responsibility for Beardsworth’s entire data management process including EDC integration. Linda brings to her role over 20 years of experience in both sponsor companies and CROs. Prior to joining Beardsworth in 2000, Linda was a manager at Johnson and Johnson in Raritan, NJ where she had 12 years combined experience in data management and clinical research. Enhancing Linda’s industry experience are her 18 years of nursing including service in critical care, the cardiac catheterization lab, and the transplant team. She also served as a clinical research coordinator and oversaw the Clinical Research Department at Overlook Hospital. Linda has experience in a wide variety of therapeutic areas with a particular emphasis on oncology, cardiovascular and hematology. She has managed multiple global and US only programs in complex therapeutic areas in Phase 1-4 and headed the largest CINV trial to date involving over 1400 subjects and 80 sites. She oversees the planning, management and delivery of clinical projects and functions as a senior-level consultant/contact to clients. Linda earned her RN at Somerset County College.

Sue Dabrowski, SPHR Sue Dabrowski, SPHR is Beardsworth’s Executive Director of Human Resources. With overall responsibility for establishing and driving HR strategies, her strong organization and leadership-development skills, solid project management skills, experience with the facilitation of cultural change and enhancement of the overall effectiveness of organizations are an asset to Beardsworth. Prior to joining Beardsworth, Sue was head of human resources for Fragomen, Del Rey, Bernsen & Loewy, LLP, a global immigration law firm. She held senior management positions in human resources with Keane, Inc. and AGS Information Services, Inc., business and information technology consulting firms. Sue is a Senior Professional in Human Resources (SPHR) and a Global Professional in Human Resources (GPHR) certified by the Society of Human Resource Management, and a Certified Benefit Specialist (CEBS) certified by the Wharton School and the International Foundation of Employee Benefit Plans. She holds a bachelor’s degree in business administration from the University of Georgia.

Jocelyn Colquhoun, PhD is Beardsworth's Director of Medical Writing since joining the company in 2002. Jocelyn brings over 20 years of experience in pharmaceutical clinical research and development, primarily in medical writing. Prior to joining Beardsworth, Jocelyn was Manager of Medical Writing at Schering-Plough Research Institute with responsibility for preparation of clinical study reports and integrated summaries for Phase 2 and 3 studies for eight new drug applications within the allergy and dermatology therapeutic areas. She was also a Director in Project Management at Quintiles, Inc. with responsibility for execution of full-service projects for Phase 2 to 4 studies, including several pediatric dermatology studies for two ‘exclusivity’ submissions to FDA. Jocelyn began her career in the pharmaceutical industry in 1987 at Roberts Pharmaceutical Corporation, where as Manager of Technical Documentation she served as project leader for the company’s first NDA, and held positions of increasing responsibility. She obtained a BA degree from Mount Holyoke College, a PhD in biochemistry from Baylor College of Medicine, and did post-graduate studies in biochemistry at the University of Wisconsin.

William Cooper, MS William Cooper, MS is a Senior Biostatistician at Beardsworth. Bill joined Beardsworth in 2008, bringing 27 years involvement in clinical drug development projects at Bristol-Myers Squibb and Revlon Health Care Group. His experience includes both the practical aspects of serving as an individual study statistician as well as strategic aspects of overseeing the statistical management of full clinical projects and regulatory submissions. He has managed groups of statisticians and programmers in this latter effort, and represented this function on multi-disciplinary development teams. He has had frequent interactions with regulatory authorities on past projects, including meetings for SPA, end of phase II and pre-NDA, as well as serving as a company representative at several FDA Advisory Committee meetings. He has designed and reviewed Analysis Plans and DMC Charters and had frequent interactions with Data Monitoring Committees. Bill’s therapeutic expertise includes oncology and supportive care, vaccines, cardiovascular, metabolic, pulmonary, anti-infective, and immunology. Bill attended Bucknell University for his undergraduate studies and received a master of science in biostatistics from the University of Wisconsin - Madison.


Vincent F. DiBianca Vincent F. DiBianca, a Beardsworth Principal, serves on the Executive Management Team and Advisory Board. Vince brings over 35 years of diverse international business experience. He was a partner at Touche Ross, now Deloitte & Touche, from 1969 to 1983, when he left to start a management consulting firm, The DiBianca Berkman Group. He has provided management consulting services to the leaders of many of the world’s largest organizations including, the CEOs of Warner-Lambert, Sears, Hughes Aircraft, Reebok, Allstate and a variety of smaller and start-up organizations. In the pharmaceutical industry, his focus was on implementing high-level strategy, developing senior teams and accelerating drug development projects. Beginning in 1983, Vince was responsible for building his own consulting firm up to 50 professionals until it was acquired by Computer Sciences Corporation (CSC) in 1993. He served on the Executive Team of CSC’s consulting group through 1999, when he left to focus on working with smaller companies and individual entrepreneurs. An author of numerous articles on leadership and change and featured in Newsweek, Fortune, Industry Week and The Wall Street Journal, Vince is currently co-authoring a book entitled, The Second Half of Life.

Richard Constantine Richard Constantine serves on the Executive Management Team and Advisory Board for Beardsworth. He has more than 35 years of experience in Public Accounting, encompassing the For-Profit and Non-Profit sectors and has 25 years of experience consulting in the healthcare industry. After graduating from Villanova University in 1967 he began his career, in Public Accounting, as an auditor with the accounting firm of Deloitte & Touche. In 1972 he started his own accounting practice and maintains that practice until the present.

 

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