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.
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.
Director – Data & Analytics, Eli Lilly India
Priyadharshini Lobow, Director – Data & Analytics, Eli Lilly India is a seasoned CDM leader with experience in managing global teams across clinical data programming and clinical data management. An engineer by training and a PMP certified professional, currently pursuing Masters in Business at IIM-K, Priya has diverse experience across Therapeutic Areas and device studies, technology platforms, transition and transformation management. In her current role, Priya leads the CDM capacity and capability building efforts at Eli Lilly India.
Debu Moni Baruah
Manager, Software Development IQVIA
Debu Moni Baruah's background spans the fields of clinical data management, research, marketing, and data analytics. He is lean six sigma black-belt and MMC metrics visualization certified. Debu has led key innovation projects with a major focus on the areas of people, process, and technology in CROs and technology companies. Debu has authored CDM SOPs, WIs, and over 40 articles, including peer-reviewed research papers, and presented his findings in several international and national conferences. Debu is a co-editor and an editorial board member of the Journal of SCDM and also a member of the SCDM academic committee. Debu has chaired sessions in the global SCDM annual conferences, acted as a speaker and led industry workshops in multiple SCDM India conferences, and invited as an expert faculty to the DIA annual conference. In recent activities, with an objective of bringing the academia closer to the industry, Debu has led multiple webinars and full day conferences. He was invited by 6 academic institutes where he could collaborate with more than 56 industry speakers and could virtually connect with over 1500 students, industry representatives and academicians from 15 countries during the COVID 19 situation. Debu is a wannabe artist and in his free time, he loves sketching and painting.
Currently, Debu is serving as a manager, software development at IQVIA.
Senior Vice President, India Country Head & Managing Director & SBU Head - Clinical Trial Supplies & Logistics Parexel International
Having recently moved from USA as the India Country Head & Board of Director, he is responsible to develop strategic direction & provide the leadership and vision necessary to grow the 5,400 plus India organization. He also heads Parexel’s Global Clinical supplies & Logistics business which also includes the global distributions centers & infrastructure.
Lived & worked in 8 countries & 4 continents, Sanjay brings over +23 years of experience in Global P&L management, Logistics & Supply chain management, Sales & Marketing, M&A's, Operations & People management.
Previously at DHL as the VP for Life Sciences and Healthcare APAC, based in Singapore he was responsible to manage the Global Logistics & Supply Chain business for the top Life Science & Healthcare Customers across all DHL BU’s within APAC. He was a member of the DHL Life Sciences and Healthcare Board.
Sanjay holds a Master’s Degree in Marketing Management & a Bachelor’s Degree in Commerce & Economics. He also has a Professional Diploma in Software Technology and Systems Management.
Senior Director, Data Management, Parexel International
Dr Roopa Basrur is a member of the SCDM India Steering Committee.
After nearly two decades in medical writing, Roopa decided to do something different in the clinical research arena. She now heads the clinical data management teams for India and is responsible for operations and delivery. Her experience is in medical communications, regulatory and safety writing, and, leading and developing teams in both a Pharma and CRO set up. She is one of the founders of the All India Medical Writers Association (AIMWA).
Roopa has previously held an administrative lead position for the Parexel Bengaluru offices and is actively involved in the company’s global gender partnership and LGBTQ+ programs. She co-leads the Parexel India D&I Committee.
She has an educational background in medicine, medical law and ethics and a professional development certificate from the European Medical Writers Association (EMWA).
Roopa is based in Bengaluru, India.
Director – Global Clinical Development Delivery Operations
Results oriented leader with 25+ years of experience in managing global delivery operations with team size of 500+ resources. A proven consistent performer, passion to innovate, build strategy and execute innovative solutions to achieve consistent business result. Proven expertise in technology enabled business transformation and high performing team supporting global pharma, device and Biological customers.
Accomplished and performance-driven individual with 25+ years of experience in clinical operations, project and information management, and product quality within the pharmaceutical industry. Proven record of success in creating/implementing concepts for clinical development, devising and executing strategic growth strategies and streamlining business processes. Skilled at leading global projects from inception to completion, preparing/employing consistent and realistic business plans and control structures for projects and ensuring completion within time and under budget. Excellent team player with deep experiences in cross-functional teams with strong communication skills. Broad expertise in managing global strategic programs, delivering high-quality systems, implementing and deploying technology, managing multiple work streams, and achieving results within multi-cultural and geographically diverse teams. Excellent written and verbal communication skills, strong attention to detail, highly motivated, flexible with a problem-solver mindset.
Managing large Global Delivery Team catering to multiple Phama companies. Team consist of varied Clinical System experience not limiting to EDC, ECOA, IRT, CTMS, Reporting and Analytics, Business Consulting, implementation and validation, ITIL support, Study Setup and Post production management, Business Process Transformation etc.
Director Operations, Cenduit India Services Pvt. Ltd
He has over 17 years of experience in global delivery, eClinical operations and operational excellence.
Sujit has worked for world-class services organizations including Pfizer, Johnson and Johnson, Cognizant and Tata Consultancy Services (TCS) in both Clinical Operations and eClinical. Prior to joining Cenduit, Sujit was Associate Vice President, Operations at Tata Consultancy Services (TCS), leading a very large Clinical Data Management operations unit for a top 5 global pharmaceutical company. Before TCS, Sujit was with Cognizant where he was part of the Life Sciences Clinical Data Management operations where he played multiple roles including transition management, business transformation and operational excellence.
Sujit holds a bachelors’ degree in Pharmacy from the Bombay College of Pharmacy and an MBA (systems and technology) from Narsee Monjee Institute of Management Studies. Sujit is also a visiting faculty with multiple prominent colleges in Mumbai including the academy of clinical excellence with Bombay College of pharmacy and St. Xavier’s College.
Head - Stats and Programming group, Parexel India
Mahesh currently heads the Stats and Programming group for Parexel India. In this role, he is responsible for also driving innovation in the clinical trials space for Parexel. Prior to this role, Mahesh was a co-founder of Sineflex Solutions LLP, a consulting firm focused on enabling and accelerating innovation in the healthcare space. He was also the head of the BIRAC funded med-tech accelerator located at the Centre for Innovation and Entrepreneurship, IIIT Hyderabad. In this role, Mahesh was responsible for mentoring startups in the medtech space, and helping them scale their products and solutions. Mahesh Iyer has over 20 years of experience in research and development in healthcare. He has been responsible for guiding many products through the development life-cycle. Before co-founding Sineflex Solutions, Mahesh was at Novartis in various roles, including Site Head, Biostatistics at Hyderabad, and Global head for Exploratory Safety and Statistical Analytics. Prior to Novartis, Mahesh worked with Bristol Myers Squibb and Boehringer Ingelheim.
Mahesh brings a strong analytical mind-set, deep insights into healthcare development and a proven record of implementing innovative solutions in the healthcare domain. Mahesh is passionate about enhancing industry academia collaboration; he set up one of the first part-time Ph.D. program in Statistics for Novartis associates, teaches at a number of Indian universities and has chaired multiple conferences over the years. He is currently Secretary of the Indian Association for Statistics in Clinical Trials and President of the International Indian Statistical Association, India Chapter.
Apart from his functional activities, Mahesh has led various organizational developmental activities and trainings. He is a certified coach in the areas of emotional intelligence, assessment centers, and psychometric evaluations. Mahesh has completed his Ph.D. in Statistics from Temple University, Philadelphia.
Global Head of Data Science, George Clinical
Abby Abraham currently serves as the Global Head of Data Science at George Clinical and also co-leads the global Centre for Innovation in the organization. Abby has 20 plus years of experience in pre-clinical and clinical research. Abby has worked in multiple areas such as Clinical and data-driven Monitoring, Project Management, Operations management, and technology adoption. In the past, Abby has held various leadership roles in global CROs. Before joining George Clinical, Abby was the Vice President of Data Analytics & RBM at OmniComm Inc, the USA after a successful stint in entrepreneurship at Algorics.
European Clinical Domain Lead, Accenture
Christina is passionate about changing the clinical trial process to make clinical trials and research truly human centric, utilizing all aspects available from experience design to cutting edge technology. She believes in extensive collaboration across all stakeholders on a global scale to foster research and patient outcomes.
As the European Clinical Domain Lead for Accenture’s Life Sciences practice, she is well positioned to make a difference.
She is working on a global level with Accenture’s Life Sciences clients on optimizing the end to end Clinical Trial process. Her work encompasses collaborating with a wide range of team members across the globe to change the way clinical trials are conducted – now and in the future.
Her work ranges from digital clinical trial set up and the implications of these changes for all clinical trial participants, over integrations of RWE and devices into the system infrastructure and the roll out on an enterprise level, to Clinical Trial Management System and Data Flow processes.
Whether it comes to assessing data flow processes, enhance the current clinical trial processes with automation and machine learning, and bring innovative solutions to Accenture’s portfolio – she believes that an open mind and the willingness to push boundaries and question the status quo will make a true difference to Research and Development – and ultimately enable us to treat patients better.
Global Head-CDM Functional Service Provider (FSP), Covance
Arshad is a Physician with over 20 years’ experience in the health sciences industry. His career path has been in Acute Patient Care at a Tertiary Care Center, Medical Affairs, Medico-marketing, followed by Life Sciences Consulting, Software Product Management, eCOA and Clinical Data Management. He has managed CDM teams for all phases including early development, late phase and observational studies. Currently, Arshad is the global head of CDM Functional Service Provider (FSP) organization at Covance.
Director, DM, ICON PLC
I have around 18 years of Industry experience which includes 16 years of Data Management along with 14 years of people and project management experience. Currently working as a Director, DM at ICON PLC and have worked with Accenture and IQVIA in the past.
Have extensively worked on Operations planning and management along with building resilient business operations with Intelligence, Innovation, Insights and Expertise with focus on building best leaders for now and future through effective Training, Coaching and Empowerment of people.
Chief Operating Officer, Cytespace Research Private Limited
A total of 22+ years of Clinical Research experience across Clinical Operations, Clinical Data Management / Biostatistics and Clinical Trial Sites in India and China.
Bhavesh is leading a multi disciplinary team of Clinical Development professionals in Bangalore and Clinical Trial Sites in 20+ cities across India.
Trained in the various programs at IIM Ahmedabad (India) and Forum Corporation (USA) on building Strategies, Leadership and on Coaching. Have participated in various clinical research conferences in India and abroad.
General Manager & Domain Delivery Head, Life Sciences, TCS Limited
22+ years of Clinical R&D services industry experience (Clinical Data Management, Statistics & Programming, Medical Writing, Regu la tory Affairs and Pharmacovigilance).
12+ years in TATA Consultancy Services (2008 till date) date): Roles handled includes Delivery/Operations, Pre sales and Solutions, Domain Consulting, Sales and Client Relationship Management in US.
~4 years in Quintiles Transnational (IQVIA), Bangalore (2004 2008): Managed CDM delivery across therapeutic areas and geographies for global top 20 pharmaceutical companies . Supported Business Planning & Market Research for Global Data Management.
~6 years in GlaxoSmithKline Pharmaceuticals in Bangalore (1998 2004): Project Managed large Phase 3 global programs in Vaccines Clinical Data Management captive center.
Worked as Research Assistant in the Department of Biochemistry, Indian Institute of Science, Bangalore (1996 1998).
Statistical Programming & Analysis Programming Standards Lead – India, Pfizer
Jeba Kumar has over fourteen years of experience in Pharmaceutical and Clinical Research Organization. Jeba has played multiple roles in his span of 14 years that includes, leading large teams, project management, coaching and mentoring, innovating & developing new applications to support Clinical Data Management and Statistical Programming. In the current role as Programming Standards Lead, he is responsible for leading and managing the implementation, delivery, and maintenance of programming standards, including the training and support of programming team utilizing Pfizer standard reporting software within the Clinical Data Analysis & Reporting System (CDARS).
AVP and Delivery Head, TCS Life Sciences
Susan Korah, is AVP and Delivery Head with TCS Life Sciences unit. She has over 25 years of experience in various fields of Patient care viz. Pharmaceuticals, Healthcare and Medical Devices. She has experience in managing large and strategic accounts/projects with high financial values. She has also managed Integrated accounts with multi domains (CDM, Biostatistics and Programming, Drug Safety, Medical Devices and Medico - Regulatory affairs).
Prior to TCS, Susan was with Cognizant Technology Solutions (CTS) in their Life Sciences and Healthcare Divisions. Before CTS, Susan was with Novartis Healthcare Ltd., Hyderabad. She was one of the founder members in establishing their CDM business in India. Susan has also worked with other Pharmaceutical majors like Dr. Reddy’s Laboratories Ltd. and Merck India. She was into Clinical research and Medico- Regulatory functions in these companies.
Susan is a Post Graduate in Pharmacy with specialization in Pharmacology and Bio- pharmaceutics. She is a certified Six Sigma Black belt and LEAN Coach. She has her PG Diplomas in Clinical Research, Marketing Management and Business Analytics. She is also a practitioner of AGILE Framework. Susan had undertaken several Business transformation activities to drive and implement Cost optimization and Process Automations for the Biopharmaceutical Companies.