Steve Gens (MSOD) is the Managing Partner of Gens & Associates Inc., a global Life Science benchmarking and advisory firm specializing in performance improvement, strategy, industry analysis, benchmarking and organizational transition. His early career was spent at Johnson & Johnson in a variety of management positions and then transitioned to consulting where he lead global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton. His organization is well known for their insightful industry benchmarks and World Class RIM thought leadership. Steve has a Bachelor’s of Science in Business Computer Science and a Master in Organizational Development and Performance.

Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market strategies and data harmonization. She was named PharmaVoice’s top 100 most inspiring individuals for Mentorship and Team Development and received the esteemed Excellence in Service award from DIA. Brooke has an integral role in shaping the discourse surrounding data and technology in regulatory affairs through her work with DIA as programming chair for the Data & Technology Track and as the co-chair of the DIA RA Community.

Pramod Sachdeva is the Founder and Managing Director at Princeton Blue and has been an evangelist for business transformation thru BPM and Business Rules since the late 90’s. Princeton Blue focuses on enhancing the user experience and improving operational efficiency through innovative technologies like BPM, Rules and Mobile. Princeton Blue has delivered many such projects for pharmaceutical clients in the area of clinical, safety and regulatory compliance.

Mike James is a Principal Consultant at Princeton Blue. For the past 8 years he has been designing custom applications for the healthcare and pharmaceutical industries. Before joining Princeton Blue he gained experience at Walgreens, Appian Corporation, and the contract research organization, PPD. Mike is a certified Appian Lead Designer and Platinum Practitioner, and in his current role at Princeton Blue, he provides leadership and guidance to solution delivery teams, ensuring that each of their clients is able to reach their business transformation goals.