Meet our Speakers
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 Professional Services
Shrishaila has done Masters in Biotechnology from Bangalore University & have more than 16 years of experience across Drug Development. He is currently working as Vice President at Navitas Data Sciences, heading the Statistical Programming department, India. He is also working as "CDISC Volunteer" & “PhUSE India Membership” officer. He is also supporting “R Package Validation Framework” and “Open Source Technologies for Regulatory Submissions” Projects in PhUSE working group “Data Visualisation and Open Source Technology in Clinical Research (DVOST)”. He has authored an International book “FDA Clinical Outcome assessments and CDISC QRS supplements” under “Clinical disciplines” category with LAMBERT Academic Publishing group. He has exposure to various Analytical tools like SAS (Base and Advance Certified), R, PYTHON and CDMS Tools like Inform (EDC), Medidata Rave(EDC), Clintrial and Oracle Clinical LSH. He is a passionate Speaker & active in most of the conferences in the industry. His hobbies are Reading, playing Table tennis etc.
Director, Real World Evidence and Market Access at Covance.
Madhur Garg is Director, Real World Evidence and Market Access at Covance. Madhur has worked across global and regional roles in the pharmaceutical industry. He is a market access and pricing strategist with health economics and outcomes research background. His career has spanned across Europe and Asia working for various life science companies (including J&J, Lundbeck & LEO Pharma). He possesses experience with all major payers and health technology assessment (HTA) bodies across Europe, North America, Middle East and Asia Pacific. Madhur holds a Master’s in Medical Sciences (specialization in global health, health economics) from Karolinska Institute, Stockholm and Master’s in Health Administration from Tata Institute of Social Sciences, Mumbai. He serves as a board of studies member at Manipal University and is an adjunct faculty for health economics. He is a speaker/ faculty for HEOR, MA & RWE at various forums and peer reviewer for journals. He continues to be an active learner esp. in data analytics/ HEOR/ RWE and completed an executive course in advanced Big Data Analytics from IIM- Ahmedabad in 2019
AVP – Biostatistics & Statistical Programming
Tushar Sakpal is working as AVP for the Biostatistics and Statistical Programming (B&SP) group within TCS Life Science. He is currently responsible for the North America B&SP delivery across various accounts. As a domain consultant, responsible for working closely with TCS Platform team to develop solutions based on metadata drive, AI/ML, CDISC 360 based concepts. Tushar has presented various topics automations and metadata driven solution, including concepts around graphical databases. He is a frequent speaker / chair / panelist at SCDM, PhUSE, DIA, IASCT, ConSPIC, ISCR and other conferences. He brings in 19+ years of Clinical Development expertise with prior experience in Pfizer, GE Capital, Reliance Life Sciences, Siro ClinPharm and PharmaNet (now Syneos). Prior to joining TCS, he worked with PharmaNet-I3 as Principal Biostatistician. He has earlier worked as Manager - Biostatistics & Statistical Programming at Siro ClinPharm, Lead Statistical Programmer at PharmaNet and prior to that has worked with RCRS, Pfizer and GE Capital. He has around 19+ yrs. of experience and has expertise in Biostatistics, Statistical Programming and Data Management. He has good understanding of CDISC guidelines, Policy 70 requirements, eSubmission package requirement, EudraCT / CT.Gov requirements, AI/ML based concepts. In TCS, Tushar is involved in following key strategic initiatives: Automation Projects: For US based customers, Tushar, is closely working with the TCS IT team to develop various automations using agile framework, MFDMTM ideology, ML/AI techniques and applying cognitive methods. Tushar holds IP for one of the TCS ADD platform solutions. Metadata Based Solutions: Provide domain inputs and work closely with the TCS ADD platform team to develop metadata repository based solution for clinical trails. Discuss AI/ML based concepts to automate SDTM package. CDISC Initiatives: Focus on CDISC 360 based concepts and its implementation at TCS. Drive core CDISC team involved in streamlining CDISC related processes within TCS. He holds a Master’s Degree in Statistics and has completed Six Sigma Green Belt Certification (GE Capital) and is a strong believer in systems and process and has a strong niche for process improvement. He loves watching & playing cricket, listening to music and being with his family in his spare time.
Director, Data Management, Covance
Tanusha Dutta is a versatile professional leader with proven industry experience of around 17 years. She brings to the team a blend of core domain expertise across therapeutic areas, along with diverse operational adeptness in handling large, global delivery teams. As a strategic leader, she is capable of wearing many hats, changing them on the fly and quickly picking up new hats along her professional journey. Her success mantra orbits around the human side of leadership….empowering, recognizing and championing talents while building an environment where all employees can thrive. In her current role, Tanusha manages a team of over 150 data management professionals, ensuring seamless delivery, high customer satisfaction index and develop strategies to stay competitive in the market. She has pioneered several process improvement initiatives and steered global implementation of these processes, which resulted in improved operational efficiency and profitability. She has been recognized for driving a number of people centric initiatives with a focus to retain top talents and strengthening the organization’s cultural beliefs. She is an active core committee member of the India WEN chapter. Prior to joining Covance, Tanusha has held numerous other leadership positions across the CRO, BPO and ITeS industries. She has been featured in company's’ websites for accelerated career growth stories and customer testimonials. When not at work Tanusha enjoys travelling and discovering new places, cherishing motherhood and being engaged with several social and charitable causes.