Jayne Douglas is an experienced executive leader in the medical device and pharmaceutical industries. As President of Cardinal Coaching and Consulting, she specializes in the areas of strategic alignment, process improvement, organizational change, pharmaceutical and medical device development, and leadership and team development. Ms. Douglas has a 23-year corporate background primarily at Pfizer Hospital Products Group and Pfizer Global Research and Development, with diverse experience in the design and testing of medical devices and pharmaceuticals in both large and small organizations, including preparation of 510(k)s, IDEs, PMAs, and INDs. Her key skills include strategic leadership in the clinical trial development space; growth, contraction and merger phases of the pharma/device industry; people management and leadership; and process improvements using risk assessment methodologies and Lean principles.
Ms. Douglas has a B.S. in Chemical Engineering from Washington University in St. Louis, MD from Duke University School of Medicine, Masters in Management from the Hartford Graduate Center and is a Certified Professional Coach from the Institute from Professional Excellence in Coaching.
Kathy Ford is a clinical operations executive with over 20 years' experience in the biopharmaceutical industry. She currently provides consulting services to biopharma clients. Throughout her career, Ms. Ford has been actively involved in clinical development and regulatory strategy and alliance management. She served as Vice President, Clinical Operations for Millennium Pharmaceuticals from 2002 to 2009, where she was responsible for leading global clinical operations for all clinical trial activities including trial management, database and clinical data management, medical writing, clinical business operations, quality, and outsourcing groups. Prior to Millennium, Ms. Ford led clinical operations for Alkermes from 1993 to 2002, where she was responsible for building the integrated clinical operations function from the ground up, including a UK-based group, which managed ex-US studies. She has participated in the filing of multiple INDs, NDAs and SNDAs. Prior to Alkermes, Kathy worked in the service sector providing trial management services for MTRA (now AAI).
Ms. Ford graduated from the Massachusetts General Hospital School of Nursing, after which she worked as a critical care nurse in multiple Boston hospitals. She completed her BSN (Summa Cum Laude) at Fitchburg State College and is currently in the doctoral program in health policy at Brandeis University.
Joseph Gentile is Vice President and General Manager of BD Biosciences Discovery Labware, with more than 25 years of experience in the high-technology medical device and life sciences industry. He is responsible for the strategic and operational restructuring of the company by re-focusing the business on the higher growth areas of drug discovery and proteomics while further developing, revitalizing and strengthening the core business of tissue culture and fluid handling. As a member of the BD Biosciences Leadership Team, he has joint responsibility for overall business performance and development including business alliances, acquisitions and portfolio management. Prior to joining BD (Becton, Dickinson and Company), of which BD Biosciences is one of four business segments, Mr. Gentile served as a member of Hewlett-Packard's core management team responsible for the determination of customer needs, product requirements and business structure for a major new business start up. During his tenure with Hewlett-Packard, he was responsible for the design and implementation of the Medical Group's Global Technology Strategy and management of a group-wide task force chartered with the design of a comprehensive resource allocation model for project, program and portfolio valuation. Mr. Gentile has a B.S. in Electrical Engineering and a minor in Biology from Northeastern University and an M.S. and M.B.A. (Summa Cum Laude) from Boston University.
Ed Tripp is the President of Edward S. Tripp and Associates Inc., a Management Consulting firm specializing in Regulatory Strategy, Document Management, e-Submissions, and HL7 standards. Mr. Tripp retired from Abbott Laboratories after 36 years of Pharmaceutical and Device industry experience. As Program Director for Electronic Submission for Abbott Laboratories, he implemented an enterprise-wide system for content management and submission publication for Abbott Laboratories. This is a global system with access and users from the US, Europe and Japan and other areas around the world. He integrated Structured Product Labeling solutions with the electronic submissions repository. His 36 years of experience spans Quality Assurance, Manufacturing, Engineering, Research and Development, and Regulatory Affairs. In 1991, he was selected as Outstanding Researcher at Abbott. Mr. Tripp is past Chairman of the PhRMA Electronic Regulatory Submissions Working Group, and Liaison to the PhRMA Information Management Policy and Coordinating Committee (IMPACC). Mr. Tripp is a member of HL7 and co-Chair of the Regulated Clinical Research Information Management (RCRIM) Work Group, co-Chair of the HL7 Domain Experts Steering Division and member of the HL7 Technical Steering Committee.