Vice President, PRA Health Sciences, Chair, SCDM board
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.
Vice President, Global Data Management & Centralized Monitoring, Bristol Myers Squibb (BMS)
Eugene Hayden is Vice President, Global Data Management & Centralized Monitoring at Bristol Myers Squibb (BMS). Since joining BMS in Feb 2018, Eugene has provided leadership to a global team focused on a diverse portfolio of disease areas and committed to leveraging innovative technologies and optimized processes to consistently deliver high quality clinical trial data. Eugene has more than 27 years industry and data management experience having worked for Allergan and Pfizer prior to BMS. Originally from Wales, Eugene holds a bachelor’s degree in Statistics with Management Science Techniques from Cardiff University, Wales, moved to the United States in 2003, and currently works for BMS in California.
Avi Kulkarni. Ph.D
Managing Director, Accenture - Applied Life Science Solutions
Dr. Kulkarni’s focus is on capabilities-led transformation of life sciences companies. He has extensive experience in drug and diagnostics product development, mergers and acquisitions, and clinical operations processes. He has helped the world’s leading biotechnology companies develop cell and gene therapies, build precision medicine capabilities, and diversify into new businesses and markets. His thirty-year career includes management consulting at IQVIA and Booz & Co.
Avi is currently spearheading Accenture’s expansion into Near To Patient Trials and into Data Driven Solutions for improving the clinical development process and enabling Clinical Commercial Convergence.
Avi obtained his MBA degree from Stanford University, Ph.D. and MS degrees in Pharmaceutics from Temple University, and BS degree in Pharmacy from the University of Bombay.
Uma Shankar R
VP & GM, Connected Lifestyle, Harman International
Uma Shankar is the VP & GM of Connected Lifestyle division within Harman. He has close to 3 decades of industry experience and has performed various kinds of roles for various organizations across the globe. Over the three decades of IT industry experience, he has had to opportunity of working with several 500 customers across various technologies with team spread across various countries. Prior to joining Harman, he spent 12 years in Cognizant, where he was serving as VP and Strategic Business Unit Head in Healthcare vertical. While in Cognizant, he was leading a large portfolio of healthcare customers. He was instrumental in driving innovation and also for training efforts for associates within the vertical.
Before Cognizant, he was with Tata Consultancy Services (TCS) for 14 years. While in TCS, he was a part of the Telecom group and was instrumental in making green field technology implementations for some of the large telecom customers both in India and in the US.
Uma Shankar graduated as Computer Science Engineer and then did his MBA from University of Liverpool, UK. He is currently pursuing his PhD in strategy from IIM.
Head Global Drug Development (GDD) India & Global Data Operations (GDO), Novartis
Arno Tellmann is the Head of Global Drug Development (GDD) India & Global Data Operations (GDO) for Novartis. In this role, Arno’s focus is on the strategic growth of the Novartis global drug development organization in Hyderabad, ensuring timely and high quality support for development of the Novartis global development portfolio. He champions the strategy for GDD India and heads the GDD India leadership team. He is also a member of the Country Executive Committee of Novartis in India.
Arno previously led the Novartis Global Pharmacovigilance, Strategy and Operations function. He has been with Novartis for 14 years, serving various roles of increasing responsibility in the Chief Medical Office and Patient Safety functions. He has an overall 17 years of experience in the pharmaceutical industry.
Arno is a registered nurse and holds an executive MBA degree from the University of Strathclyde, UK.
Regulatory Transformation Lead, F. Hoffmann-La Roche Ltd – UK
Transforming our industry has become Vijay’s passion during his pharmaceutical career and is eager to drive generational changes to reduce the mechanical part of our clinical trial process to the point it becomes real time. Vijay imagines a future where we can spend our time discussing high value scientific topics about our medicines in order to do what is best for patients rather than spending time on manual transactional activities. In which each of us are contributing, accessing and analyzing information in real time. Vijay Reddi is currently a Regulatory Transformational Leader at Roche Product Ltd working across Pharma Development Regulatory, Pharma Technical Regulatory and Drug Regulatory Affiliates. He leads a team which is transforming the Regulatory landscape to drive towards this future state. He has over 20 years’ experience in the pharmaceutical industry with 13 years at Roche. Vijay started his career as a statistician and holds MSc in Statistics. At Roche, Vijay has led teams in inflammation and oncology. Over the years Vijay has also led a number of transformative initiatives ranging from Real World Data, CDISC and integration of analytics.
PhD, Vice President and Global Head of Decentralized Clinical Trials, Covance
Industry thought leader in developing and implementing decentralized clinical trial solutions.
Champion for reducing patient burden in clinical trials.
Led the implementation of innovative technology-enabled hybrid and virtual trials solutions for leading Biotech and pharmaceutical companies.
Ex-strategy consultant with leadership roles in Corporate Strategy, Product Development and Innovation at leading CROs.
Regularly engages with regulatory authorities to remove regulatory barriers to the adoption of decentralized clinical trials.