Tracy Rockney J.D. Tracy Rockney is a respected regulatory leader with more than 20 years of experience in the pharmaceutical industry. She is the Co-founder and Managing Partner at OneSource Regulatory, a consulting firm specializing in Regulatory Advertising & Promotion, Medical Review, Labeling Development and Healthcare Compliance. Her senior regulatory management experience included her role as Vice President, Regulatory Affairs, Global Labeling, Advertising & Promotion, Regulatory Policy & Intelligence at AbbVie (formerly Abbott Pharmaceuticals), Senior Director, Global Regulatory Affairs at Shire Pharmaceuticals, Director, Regulatory Affairs at Wyeth, and Director, Global Regulatory Strategy at Pfizer. Tracy received her Juris Doctor from Washburn University School of Law, and her Bachelor of Arts from the University at Albany, State University of New York, Rockefeller College of Public Affairs & Policy. Tracy is a board advisor and Regulatory Officer in Residence for Doctor Evidence, a specialty software platform and services company that transforms clinical studies, drug labeling and epidemiological databases into reusable dynamic relational databases.
Donna Beccaria is the Executive Director of the Worldwide Medical Content team which is evolving the current global MI team into a core content capability, of process, people and technology to distribute and curate our scientific content.
Previously, Donna led the global R&D learning and collaboration team at Bristol-Myers Squibb, including building the SharePoint capability across Global Development & Medical Affairs, development for key talent groups, disease & product learning (including external physicians), drug development learning, multiple IT systems’ learning and compliance training. Since joining the company in 2006, Donna increased the 40+ global team’s productivity by 50% and decreased spending by 63%. The increased productivity resulted in multiple new learning deliverables which now drive global R&D knowledge distribution.
Before joining Bristol-Myers Squibb, Donna was principal in her own management consulting firm servicing fortune 500 companies, which specialized in executive coaching, talent & leadership development, team effectiveness and organizational operating models. She is recognized for building collaborative relationships at all levels, in order to lead and influence business strategies and outcomes.
Donna’s leadership experience includes Executive Board Member for Enable Inc, HR Executive working directly for CEO, CFO, and CTO; in addition to her current pharmaceutical role she has over 15 years of experience in financial services and technology industries.
Donna has a bachelor's degree in Psychology and a Master of Science, both from Rutgers University. Donna makes her home in the Montgomery NJ, with her husband, two children and two dogs.
Michael is the Director of Business Planning and Communication for Pfizer Medical Information in the Americas where he oversees regional projects and budgets collaborating with regional leads to define Medical Information’s global strategy.
Michael earned Bachelor of Science in Pharmacy and Doctor of Pharmacy degrees from St John’s University and began his career practicing community pharmacy in independent and chain pharmacies. In 1997, he joined Lyons Lavey Nickel Swift providing various medical information services such as scientific research, medical writing, project management, and web publishing for the pharmaceutical industry as well as internal teams. In this role, he was integral in deploying Pfizer’s first internal Medical Information website. In 2001, Michael joined Pfizer’s Global Medical Information Services group where he served in roles that led the department’s efforts in globalizing training, quality standards, and relationship management.
In 2009, he joined Pfizer’s External Medical Communications’ Business Operations team where he managed the current U.S. Medical Information platforms and served as a key member of the team that deployed Pfizer’s first global Medical Information platform enabling the department to more easily share information, resources, and work-load globally. In 2014, he served on the team that deployed a regional Medical Information contact center that supports most of Latin America. Michael has also served as an Adjunct Professor at Long Island University.
With more than 25 years of experience in the Life Sciences industry, David is a seasoned executive with extensive experience delivering solutions to clients, with a particular focus in the areas of content management and collaboration. David leads the technology practices of Navitas that develop and deliver business solutions across all areas of the R&D segment for pharmaceutical, medical device and biologics companies. Key solutions include IDMP solutions, TrackWise and Safety Database implementations, electronic Trial Master Files (eTMF), regulatory and controlled content management, and submission publishing.
David also leads the DIA EDM Submission Reference Model team, which has developed a document architecture for use when designing and building content management solutions. This architecture has been leveraged by numerous companies and vendors to provide submission management solutions that are compliant with global regulations.