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.
Anthony is a Director in PricewaterhouseCoopers' Pharmaceutical & Life Sciences R&D Advisory Services practice with over 19 years of experience consulting to the biopharmaceutical industry.
Anthony is a subject matter expert in the areas of business planning & operations and regulated content management where he specializes in supporting his clients through the capability development lifecycle from strategy identification through capability implementation and support. Throughout his years in consulting, Anthony has worked with both large- and medium-sized organizations helping them achieve their strategic and tactical goals by improving their business processes, raising their employee's capability acumen and enabling technology solutions to support both people and processes.
Ray joined Author-it in 2010, bringing a strong customer perspective as a content author forced to use a variety of complicated tools. He has a breadth of experience with IT, software development, and technology with the military, fortune 500 companies, and startups. Ray understands business and technical issues and uses his hands on approach with the product to focus on how the Author-it platform can best help each customer solve critical business problems.
Ray holds a Bachelor of Educational Studies from the University of Missouri-Columbia.
Bruce Lotier is intensely interested in the interplay between people, process, and technology, and what makes organizations work—or not work. His 30-year résumé is a testament to this, encompassing an expertise in organizational modeling, the integration of shared service organizations, and the structuring and management of IT investment and project portfolios.
Among many, but not all career initiatives and responsibilities, Bruce has
- Developed and put in place operational governance processes for master data management, records management, portfolio investment management, and sourcing.
- Led a team that built the first laptop-based sales force automation and head office system in Pharma, and developed and implemented the first end-to-end clinical and regulatory capture-to-submission system in Pharma.
- Piloted the creation of an Information Management Services application that captured data concerning everything from policies, ownership, retention schedules and MDM though archiving.
- Led the Commercial Innovation team that built the first iPhone Healthcare Application offered on the iTunes App Store for personal care management.
- Worked with a coalition of companies, healthcare advocates, and insurers to build Microsoft Healthvault, a web-based platform that is still in use today.
Since 2009, Bruce and his TransAccel Group team of professionals have successfully helped clients to redefine how they work to work better and meet their business objectives.
Patrick is the Vice-President of Medical Contact, Content & Insights at Bristol-Myers Squibb Co. He has over 25 years of experience within the pharmaceutical industry, primarily at BMS. During his career at BMS, Patrick has held various leadership roles within the R&D organization, in both Development as head of the US Regional Monitoring group as well as Medical Affairs, where he led several US field medical teams and helped implement a global field medical capability in support of all products within the BMS portfolio.
Patrick is a member of the Global Medical leadership team and provides executive sponsorship for several key initiatives and programs including: developing new leaders through the BMS-Rutgers PharmD program; implementing new global systems and capabilities in support of a multichannel, customer centric strategy; and transforming the organization to a specialty care biopharma model. Patrick is a Physician Assistant by training and also holds a Master of Science degree in business administration and human resources management.
Susie specializes in solving localization problems and improving processes. As a localization strategist and consultant, she leverages her expertise in the translation industry to guide Author-it’s clients to success in today’s global market.
Prior to joining Author-it, she was a member of Xerox’ Content Development and Language Services division, where she was pivotal in using Author-it to drive over 50% reduction in localization costs for a multi-billion dollar business. She has over 10 years’ experience working for various language service providers, overseeing operations and technical engineering groups for multi-channel delivery into 100+ languages.
Experienced IT professional with 20+ years experience across several industries – Life Sciences, Automotive, and Financial. Currently engaged in several initiatives focused on developing technology solutions to address specific unmet needs in the Life Sciences domain specifically in the R&D and Regulatory areas.
The bulk of my direct consulting experience comes from my work in the Life Science domain delivering IT strategies and solutions. I have also built and managed IT Strategy and Implementation focused business units within several companies handling sales, marketing, resource management, and delivery.
Ellen Kelso is Head, Global Trends and Futuring at Knowledge Sharing and Engagement, LLC. She is a results-oriented business executive and advisor in developing strategic and operational frameworks for knowledge management. Ms. Kelso has more than 35 years of experience in the pharmaceutical industry serving clinical operations, domestic and international regulatory affairs, and human subject protections. Her experience includes managing worldwide regulatory strategies, and establishing electronic performance, quality, and knowledge management systems.
She excels in identifying creative solutions to complex problems in all aspects of regulated documentation and in facilitating change. Ms. Kelso began her career at Eli Lilly and Company facilitating worldwide product registration strategies and global labeling development. She also has significant experience in orchestrating diverse teams of expertise in collaborative effort to create best practices and in leveraging technology to enhance knowledge sharing and reduce cycle times.
Deb McNaughton currently holds the position of Sr. Director, Global Labeling Management at Pfizer. Deb has been with Pfizer, holding various positions within the Clinical, Regulatory and Safety areas, for the last 28 years. She earned degrees in Biology & Chemistry in Michigan and has a Masters Certificate in Project Management from George Washington University.
Currently, Deb leads a global team who manage strategic labeling and operational excellence in the creation and maintenance for the delivery of company CDS, USPI and EU SmPC documents. This global team also drives corporate labeling policies and cross portfolio content and processes, manages executive committees and liaises with other functions to drive accurate and consistent labeling worldwide. Deb and her team are also engaged with development and oversight for core Regulatory Strategy processes.
Deb has spent much of her career managing global teams in executing various regulatory and safety deliverables such as labeling documents, aggregate safety reports, and annual regulatory documents. In addition, she has led several large scale programs in the area of continuous improvement and change management. She has experience with labeling, regulatory operations, worldwide business management, strategic planning, process development and operational excellence.
Deb is currently based in the Raleigh/Durham, NC area with her husband and three children.
Ashwani Srivastava, M.D. is Doctor Evidence’s resident DOC Label expert. Ash has extensive experience helping clients leverage the DOC Label solution to meet their business needs. His background in medicine and expertise in technology enables him to design innovative solutions to transform industry’s issues of today to tomorrow’s answers.
Before joining Doctor Evidence, Ash worked at a clinical research site, outpatient clinic, and taught professionals for Apple, Inc. Ash graduated from Medical University of Lublin in 2013 with a Medical Degree.
Ben DeBlasi is a Medical Content Standards Manager at Bristol-Myers Squibb (BMS). He closely collaborates with various key stakeholders to optimise the use of technologies for creating, managing and delivering medical content to healthcare professionals and patients alike.
Ben obtained a Bachelor of Arts in Media & Communication at the University of Greenwich in 2006. He then spent several years working for Linguistic Services Providers as a Life Sciences Project Manager, where he focussed on delivering accurate and high-quality translations to leading Pharmaceutical Companies and Contract Research Organisations.
In 2010, he began translating on a freelance basis from Italian into English, with a focus on medical and clinical documentation. A year later, Ben undertook a Master’s of Science in Clinical Research at the University of Liverpool, and graduated in 2014. He joined BMS in 2014 as a Medical Writer and also worked on the global implementation of Author-it.
Eric Silverman is a Global Associate Director in Medical IT at Bristol-Myers Squibb (BMS). Eric obtained a Bachelor’s degree from the University of Delaware and a Masters in Information Science at Stevens Institute of Technology.
Eric has 20 years of experience in both the Pharmaceutical and Information Technology space. Eric began his pharmaceutical career with Pfizer pharmaceuticals in Manhattan & Brooklyn New York where he both built and managed large scale global data centers and served as a senior IT leader in Manufacturing, while leading IT initiatives across Corporate IT, Finance, and the Capsugel division in Pfizer Pharmaceuticals. Eric’s work at Pfizer became a standard for the Eastern region within the Pfizer Manufacturing space.
In 2007, Eric joined Bristol-Myers Squibb as a Business Lead / Business Capability Manager in R&D Informatics where he directed and led large scale business capability projects and operational governance across multiple R&D IT Business process areas. Eric was charged with ensuring value driven business process was delivered in the systems that R&D used for the collection and access to data across clinical trials, submissions to the FDA, the clinical trial package, and eventually worked with business organizations as a business lead in the global medical space. Eric served as an advocate for optimized business process and value driven capabilities across medical where he provided overall business analysis, business process modeling, and project / program management of strategic projects.
In 2012, Eric joined the Life Cycle Management and Operations group at Bristol Myers- Squib where he is currently directing and leading the IT operations of multiple R&D IT Business process governance groups, servers as the IT owner of R&D IT Medical capabilities, accountable for all life cycle operational projects, oversight of operations, which includes serving as an IT head for all inspections and audits, working collaboratively with R&D business stakeholders, Enterprise Services colleagues, and vendor partners. Eric has extensive leadership experience partnering with key vendor partners to help medical achieve its goals and aspirations in the medical IT space.
Brian is a Manager in the Pharmaceutical and Life Sciences R&D practice at PwC based out of the New York office. Brian has 8+ years experience in the R&D function of the pharmaceutical industry, which prior to PwC involved managing operations of Phase II-IV clinical studies for sponsor and CRO organizations.
Brian is a subject matter specialist in the areas of R&D organizational design, R&D analytics, and sourcing strategies where he has helped Pharma & Biotech clients develop and execute new strategic approaches to drug development. Brian has worked with small, mid, and large Pharma/Biotechs and CROs to drive strategic objectives through operating excellence and data-driven decision making.
As both a Life Sciences Informatics leader and consultant, Jim has delivered high impact technologies across R&D for more than 25 years. He has a track record of success in establishing the case for change, alignment of goals, clarification of objectives and delivery from concept to implementation. Jim specializes in content generation and management systems including automated content analysis, document classification & entity extraction, and structured content analysis and authoring.
- Automated Content Analysis & Structured Content
- Information Architecture and Data Standards
- Data Integration
- Program & Project Management
- Risk Management
- Process Optimization/Lean Sigma