Archives: Speakers

Colleen is a pharmaceutical industry leader experienced in building, changing, and growing teams into highly successful organizations

Kristina has excellent interpersonal, verbal and written communication skills; A flexible attitude with respect to work assignments and new learning; Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; Ability to identify and address issues proactively in a timely manner and willingness to work in a matrix environment and to value the importance of teamwork. She also possesses team leadership skills and excellent organizational ability.

Sudip is a performance driven executive with 25+ years of global experience in delivering business value through R&D Digital Technology management. His roles have had progressive scope, complexity and authority for planning and execution of strategic business and technical delivery. He is a proven leader with multi-sector international experience in building organizations, establishing business relationships, developing high performance teams, and innovative clinical digital solutions & services to enable science in accelerating delivery of the drug pipeline.

Sudip’s specialties include: Significant experience in the global Pharmaceutical and Information Technology industry in a variety of strategic senior management roles. He has a proven ability to lead major change initiatives and transform R&D technology and Clinical Digital Solutions organizations. He has also effectively developed relationships with key business partners and managed diverse stakeholder interests.

Karrie Hilsinger is  Director, Clinical Operations at Immunomedics. She has been in the pharma industry for 20+ years, spanning numerous therapeutic areas, phases and roles supporting clinical trial conduct at several large pharmaceutical companies, CROs and Medical Device organizations. Her recent roles have focused on cross functional operational oversight of global programs. Karrie has been crucial to leading organization through SOP development, Inspection readiness and successful agency inspections.

Judith Koehnen is Director Project Management of Covance’ Device and Diagnostic Solutions Business Unit. She has 24 years industry experiences with over 21 years in the CRO environment and over 16 years in the Medical Device arena.

Judith has been in leadership roles in Project Management and the Medical Device Business unit. She has been responsible for Global Medical Device Training initiatives across all functions at Theorem and Chiltern now Covance and SOP revision in order to comply with Medical Device requirements and terminology across the globe. Currently she is leading the trainings initiative for the upcoming Medical Device and In-vitro Diagnostic Regulation.

From 2012 – 2015 Ms. Köhnen was co-chair and from 2015 – 2016 chair of the European CRO Federation Medical Device Working Group.

Rodney Villanueva, M.D., received his medical degree from the Uniformed Services University of the Health Sciences in Bethesda, Maryland.  He completed a residency in psychiatry at Tripler Army Medical Center in Honolulu, Hawaii and a fellowship in forensic psychiatry at Walter Reed Army Medical Center in Washington, DC. He also holds a certification in LGBTQ Health from Drexel University.  He had an extensive career as a US Army psychiatrist, spending 16 years in the Army, which included a year-long deployment to Iraq.

He is currently a psychiatrist with Atrium Health in Charlotte, NC where, he serves as the Psychiatry Clerkship Director, the Associate Program Director for the Psychiatry Residency Program, and the Co-Medical Director of the Behavioral Health Advanced Practice Provider Fellowship Program.  He is an advocate for diversity and inclusion in healthcare, with particular interest in LGBTQ mental health. He has spearheaded efforts to raise awareness in LGBTQ health such as establishing an annual LGBT healthcare symposium with the Charlotte Area Health Education Center. He has spoken nationally and internationally on LGBTQ mental health as well as on the topic of minorities in clinical trials.

Dr. Villanueva is an Assistant Professor of Psychiatric at Carolinas Medical Center and an Adjunct Associate Professor of Psychiatry at the University of North Carolina School of Medicine.

Kathy Leach is Senior Director, Clinical Study Team Lead at Pfizer. She has been in the pharma industry for 25 years, spanning numerous therapeutic areas, phases and roles supporting clinical trial conduct at several large pharmaceutical companies. Her recent roles have focused on cross functional operational oversight of global programs. Kathy is a certified Project Management Professional, received her bachelor degree from Villanova University and Masters in Organization Leadership from Immaculata.

Tim Koch has spent the last 18 years working in Big Pharma including time at Johnson & Johnson, GlaxoSmithKline, and currently Novartis, along with prior experience in the Financial Services Industry and the Hospital Setting. He is a Lean Six Sigma Black Belt who’s deepest passion is Metrics and Analytics but has a broad range of experience from Finance to IT to Quality Assurance to Resource & Risk Management. He is known as a domain expert in Clinical Trial Optimization via Data and Technology, supporting the operational delivery of thousands of Trials from feasibility/site selection to recruitment planning/tracking to instream monitoring, resource maximization and risk detection to leading health authority inspections. Tim has been an innovative pioneer, infusing an evidence-based analytical culture in countless areas of the business, building multiple Analytics units from the ground up and launching >50 industry-first analytics platforms to >20,000 users in Drug Development. In his current role as  Global Head of Key Account Mgmt, he partners closely with the Trial Mgmt Leadership team providing consultation, solutions and know-how anchored around  the use of data, analytics, processes and technology during Trial Delivery.