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Sanjay Bhardwaj
Allergan | Global Head of Clinical Data Management

Catherine Celingant
Pfizer | Executive Director | Data Monitoring & Management, Oncology TA Lead

As the Oncology Therapeutic Area Lead in the Data Monitoring and Management (DMM) organization at Pfizer, Catherine Célingant leads a team of Clinical Data Scientists and Data Managers responsible for timely and high-quality data management deliverables supporting the Pfizer Oncology portfolio. Catherine has over 25 years of experience in Data Management, Clinical Informatics, and Medical Operations. Prior to joining Pfizer, Catherine worked at Millennium: The Takeda Oncology Company, where she successively led the Clinical Data Management and Clinical Systems, Medical Systems Innovative Technologies and Operations, and Medical Business Operations functions. Catherine also worked at Accenture, Wyeth, Genetics Institute, and MTRA (AAI). Over the years, Catherine has been involved in several PhRMA, eClinical Forum and Transcelerate-sponsored groups working with other bio-pharmaceutical sponsors, regulators and other stakeholders to facilitate the adoption of research-enabling technologies such as EDC, ePRO, and eSource. Catherine holds a M.A. in Linguistics from Cornell University and an undergraduate degree in Biology from the University of Bordeaux, France.

Ian Shafer
PwC | Partner

Ian Shafer is a Partner in PwC’s Pharmaceutical Advisory Practice and has been working in the BioPharmaceutical industry focused on Clinical Development for the past eighteen years. Ian joined PwC in 2019 and is focusing on global clinical development business transformation enabled by digital technologies. Previous to PwC, Ian led the Clinical Domain within Accenture’s R&D practice, was one of the initial Medidata employees, and held multiple roles within Amgen’s clinical development organization. Ian’s project experience includes business strategy/roadmap development, operating model design, business case development, global digital business transformation, technology selection and implementation, emerging technologies and advanced analytics, business process optimization, change management, and SDLC management. Ian’s functional focus spanned program/protocol design, study start-up, clinical trial operations, data management, analysis and reporting, and submissions and has led 50+ major transformational programs during his career. Ian received bachelor’s in molecular, Cellular, and Developmental Biology from the University of California, Santa Cruz in 1999.

Jonathan Andrus
Clinical Ink | Chief Business Officer

As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s solution management & compliance teams to help sponsors and CROs better leverage eSource, eCOA and ePRO data. With 20+ years of experience, Mr. Andrus brings extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution. At Clinical Ink, Mr. Andrus is responsible for P&L across Clinical Ink’s products and services and he is also focused on building relationships and forging strategic partnerships with sponsors, CROs, regulatory bodies and clinical research professionals. Mr. Andrus joined Clinical Ink from BioClinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services and IWRS. Prior to BioClinica, Mr. Andrus worked in pharmaceutical consulting and with CROs focused on quality, data management and validation. An active thought leader, blogger and presenter, Jonathan served as chair of the Society for Clinical Data Management (SCDM) in 2008 and 2013 and currently serves as the society’s Treasurer. He is also an active member of DIA (North American Advisory Council and Annual Conference Data/Data Standards Track Chair) and ASQ. He earned his bachelor’s and master’s degrees from Temple University’s College of Liberal Arts and Graduate School of Pharmacy and is a Certified Quality Auditor (CQA) and Certified Clinical Data Manager (CCDM®).

Michael Goedde
PRA Health Sciences | VP, Global Data Operations

Michael Goedde is a Certified Clinical Data Manager with 30 years of experience in the pharmaceutical and biotechnology industry. He started his career in 1990 at Hoechst, a predecessor company of Sanofi, in Frankfurt (Germany). After supporting numerous submissions and leading programs through all stages of clinical development, Michael then chose to join the Aventis Headquarters in Bridgewater, New Jersey (US) in 2001 as a Global Project Data Manager and Global Therapeutic Area Lead for Oncology and Neurology. After leaving Sanofi-Aventis in 2005 he joined Kos Pharmaceuticals in Florida for 2 years before accepting the position of Senior Director of Clinical Data Management at Human Genome Sciences (HGS) in Rockville, Maryland. After the GSK takeover of HGS in 2012, he joined MedImmune(Astra Zeneca) as Head of CDM, where he re-built the CDM department. In 2014 he decided to join PAREXEL International as VP, Global Data Operations, where he worked for 3+ years and led a global group of 850 CDMs, DB-Programmers and Statistical Programmers. Michael joined PRA Health Sciences in 2018 as Head of Global Data Operations. Michael holds a degree in Computer Sciences and Mathematics and is the current Chair of the Board of Trustees for the Society for Clinical Data Management (SCDM). He has presented and chaired sessions on numerous occasions at conferences including an invitation from the FDA in 2010 to present on “Industry Best CDM Practices” at the Center’s Bioresearch Monitoring course.