Key Note Speaker
Senior Vice President,
Data Science, Safety and Regulatory Research,IQVIA
As senior vice president of Data Sciences, Safety and Regulatory at IQVIA, Gregg Dearhammer leads the data management, lifecycle safety, connected devices, biostatistics, medical writing and regulatory affairs teams for the Research & Development Solutions organization.
A biopharmaceutical industry veteran with more than 20 years of experience, Gregg recently joined IQVIA in November of 2017. Prior to joining IQVIA, he served as Chief Operating Officer at inVentive Health Clinical where he was
responsible for all aspects of clinical operations. A strong operational leader, Gregg grew one of the largest DSSR FSP operations in the CRO industry and has leveraged his strong client relationships and customer service focus to
drive business success throughout his career. In addition to his operational accomplishments in senior positions at multiple CROs, he is a long-time board member of the Society for Clinical Data Management.
Global Head Data Operations,
With broad industry experience over the past 20 years, Dermot now leads Novartis’ global Data Operations group, overseeing the data management and programming teams who have end to end responsibility for Novartis clinical data from the point of design through to the point of analysis. He is based in Dublin, Ireland and has been with Novartis for the past two years. Prior to Novartis, he was a global leader with ICON Clinical Research and held various positions across the clinical development landscape, with a broad history of systems implementation and organizational transformation.
Dr Krishna Asvalayan
Sr. Director, Head of Functional Services,
Ancla Consultancy Servicess
Dr. Asvalayan brings his 14 years of Pharmacovigilance experience in the pharmaceutical sector including five years of Clinical experience to help in technological advances that helps in solving issues related to patient safety. Passionate to bring technological solutions into the real world to address the challenges in field of life science, healthcare and biotechnology.
SCDM India Steering Committee Chairperson
Mr. Mayank Anand
Head of Global Data Management Service Delivery
Mayank Anand is presently working for Bristol-Myers Squibbs as “Head of Global Data Management Service Delivery”.
He brings 12 plus years of experience in the clinical industry across all phases of clinical trials managing Biometrics (Data Management, Clinical Programming and Biostatistics). Mayank has played some very important roles in vendor organizations for three out of the top five pharma / biotech companies of the world. Managed Larger Biometrics accounts globally to provide effective and efficient clinical services. He have been part of reputed companies like TCS, Cognizant and Accenture in the past. He was also associated with Bangalore University as faculty for Human Genetics and Biotechnology discipline, apart from being visiting faculty for several clinical research colleges.
He has successfully managed Session Chair’s for SCDM India 2015, SCDM Global 2016 Conference and Session Chair SCDM India 2016 Conference. Invitee for European Leadership meets for SCDM 2015. Mayank Anand was Conference Chairperson for SCDM India 2016 conference. Steering committee Lead for SCDM India. He has presented in PhUSE single day event in Delhi, Bangalore. His paper abstract on big data was selected for Annual PhUSE conference 2017 in Scotland and received the best presenter award for the conference. He was invited as Speaker for Singapore first SDE for PhUSE. Mayank was Speaker in the DIA Bangalore conference in 2017 and Panelist for multiple forums in SCDM and DIA. He is also Steering council member of ISCR in India for Biometrics.
SCDM India Conference Co-Chairs
Head, Data Science,
Praveen Dass currently serves as the Head of Data Sciences for the Scientific Services Practice at Novartis. In his role, Praveen is responsible for delivery of Data Management, Stats and Programming and Medical Writing services.
Praveen has extensive leadership experience having managed large teams at global CROs and KPOs. In his previous role as Country Head and VP of Data Management, Praveen was responsible for managing operations for India across functions and was the Global Head of Data Management. Praveen started his career in Clinical Research as a Manager in Accenture’s Clinical Data Management operations and has since been responsible for building and managing service delivery teams across varied functional domains such as DM, Pharmacovigilance and Programming.
Praveen also has the privilege of serving on the SCDM Steering Committee in India.
Dr. A. V. Prabhakar
Group Head, Clinical Database Delivery Reporting & Analytics,
Dr.A.V.Prabhakar is a Statistician by qualification having more than 21 years of working experience across Pharma & CRO industry. He started his career as a Statistician with Torrent Pharmaceuticals post which he worked as Head Biostatistics & Data Management division at Lambda Therapeutic Research. His last assignment was with Quintiles as Director of Clinical Data Management before moving to Novartis where he is currently working as Group Head of Clinical Database Delivery.
Till date he has published 15 articles & has also been speaker, session chair at various National & International Conferences.
He underwent middle management development training at IIM Ahmedabad & leadership workshop at IIM Bangalore.
In addition he currently is an active member of SCDM (Society of Clinical Data Management) India Steering Committee & SCDM Education Committee.
Vice President (FSPx – Biostats, CDM & Clinical Analytics) and Member (Board),
With more than two decades of experience largely devoted to the CRO/IT/KPO functional carve-outs within the Life Sciences segment, Shankar brings in rich expertise developing solutions around the Clinical Ecosystem involving domains like EDC, CTMS, IVRS and Safety. Until recently, Shankar was heading the FSPx unit of Covance which specialized in providing Clinical Data Management and Biostats Programming services for large MNC Pharma clients. Before joining the Life Sciences Industry, he worked as a consultant in the US for some of the prestigious names like Microsoft (Seattle) and Apple (Cupertino).
A Technology Evangelist, Shankar specializes in designing solutions within the Clinical Research space around the frameworks of “SMAC” (Social Media, Mobility, Analytics and Cloud) and is an active proponent of “Go Digital” models. He was also leading Covance’s Innovation Initiative on the areas of Artificial Intelligence and Robotic Process Automation as they relate to the field of Clinical Development.
Shankar is an active participant in external forums like Cypher Analytics Summit, India Analytics Summit, SCDM, DIA etc where he has presented keynote speeches on topics related to Machine Learning, RPA and IOT. A strong believer in people power, Shankar is focused on mentoring and coaching his teams to maximize their full potential.
Leadership Forum Speakers
Dr. Arshad Mohammed
Clinical Data Management, IQVIA
Dr. Arshad Mohammed 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, and Medico-marketing and in development of India’s First Web Based Clinical Trials System in year 2000, followed by Life Sciences Consulting, Software Product Management and finally Clinical Data Management.
Arshad joined IQVIA (earlier known as Quintiles) Clinical Data Management in January 2008 and has managed CDM teams for early development, late phase and observational studies.
Arshad has been a speaker or a session chair at SCDM conferences since 2013 and is currently on the Board of Trustees of SCDM.
Life Sciences, Accenture
Sowmya is an accomplished Life Sciences Executive with over 20 years of business experience and extensive leadership in driving new solutions and competencies, product management and business development for both large and start up organizations in the Life Sciences industry. In his current role at Accenture he is the Life Sciences Industry Lead.
In his last role at Cognizant, as a Leader of the R&D Centers of Excellence he held responsibility for solutions for non linear growth and thought leadership. He also drove transformation initiatives around digital solutions impacting R&D. He is associated with industry forums like Pistoia Alliance and tranSMART Foundation.
Prior to Cognizant, Sowmya was a part of the management team of a bioinformatics start up, Strand Life Sciences, a product development company.
Ms. Chandrika Arora
Founder & CEO,
QMATRA Services LLP
QMATRA Services is an Independent GXP Quality Assurance consulting firm.
She is an experienced Quality Assurance professional with over 25 years of Industry experience in Clinical Research and Pharmaceuticals. Well versed with international and national regulatory requirements for Global Clinical Trials as well as requirements for computer system compliance. Has extensive experience in the conduct of audits in GXP (GCP, GLP, GPhV, CSV, Data Management). Audit experience covers geographies including India, US, Europe, South Africa, New Zealand, Russia, Ukraine, China and South East Asia.
Director, Data Management,
GCE Solutions Inc.
Andrew is an experienced Biometrics and Clinical Operations leader in the pharmaceutical industry, with over 25 years of experience. He has specialized in building effective organisations, from small teams to large cross-functional departments. Andrew has extensive global experience, having worked in Europe, Australia, China and the USA for large pharmaceutical companies and a large, global CRO. Recently, he led a global pharma Risk-Based Monitoring initiative from inception through to successful implementation. Andrew joined GCE Solutions in July 2017 to further enhance their data management capabilities.
Vice President, Clinical Analytics,
Casey Higgins is currently Vice President of Clinical Analytics at Covance’s FSPx Business Unit, with over 20 years of industry experience. He provides management for Strategic Partnerships and Technology Alliances focused on functional outsourcing, along with providing global accountability for Data Management Operations and Reporting & Analytics. Mr. Higgins has been an active participant and speaker in several industry organizations, such as SCDM, CDISC, and PhUSE.
COO and Data Officer,
As Chief Operating Officer, Jonathan Andrus leads Clinical Ink’s global data management and quality & compliance teams to help drug sponsors better leverage eSource 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.
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. While at BioClinica, Mr. Andrus built relationships and forged strategic partnerships with sponsors, CROs, regulatory bodies, technology developers and clinical research professionals. 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 2014 and currently serves as the society’s Treasurer. He is also an active member of DIA, ASQ, ACRO and CDISC. 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®).
Sr. Director, Quality Assurance (Asia Pacific)
Sachin Satija has over 20 years of experience, in the clinical research industry, five of which have been in the pharmaceutical industry and 15 years in the CRO industry including Phase I, Phase II to III and BA/BE centers. Most of her time has been spent in establishing and managing global quality assurance teams to ensure quality and excellence. She has been central to the planning and execution of global audit programs in the organizations.
She has extensive experience in hosting inspections of various Regulatory Agencies like FDA, EMEA, DCGI, ANVISA and PMDA (Japan Regulatory Authority). She has been involved in leading harmonization activities subsequent to integration of companies in her current and prior organization. She also has international training related experience and has been significant contributor to the process improvement initiatives within her organizations.
Global Head, Business Technology Services
Mr. Maniar areas of responsibilities includes technology optimization, digitization, enable adoption of new technologies & provide value added services for efficient clinical trial execution. He supports initiatives & solution to scale in Digitization space such as eSource, eCOA, Novel Settings. He is currently a Global Head, Business Technology Services at Novartis, USA. Previously, He was the Global Head of Clinical Database Delivery in the Clinical Data Management at Novartis responsible for databases, data transformations and standards implementation. He is a SCDM eSource Implementation Consortium Co-Chair and TransCelerate Biopharmaceuticals eSource Work stream Co-Lead. He has been in the industry for 23 years and holds MS in Biomedical Engineering from USA.
Life Sciences R&D Operations & Clinical Data Services Capability Lead, Accenture
Shobhit Shrotriya is an experienced professional in Accenture’s Life Sciences R&D practice based out of Bangalore.
He is an Engineer by training with a Masters in Industrial Management from Indian Institute of Technology (IIT) Kanpur. He is a Certified Six Sigma Black Belt and Project Management Professional (PMP).
With 17+ years of work-experience Shobhit has extensive experience in Operations Management, Project & Program Management, Process Excellence and Innovation. Shobhit is a Subject Matter Expert who contributes to the solution development, process re-engineering, and implementation of clinical outsourcing service delivery. With extensive experience in clinical data management and clinical operations, he has managed end to end global projects and large customer accounts with an excellent track record of delivering mega-scale projects on time, under budget and with high standards of quality.
Shobhit has been associated with leading industry forums such as Project Management Institute, DIA and SCDM over the years where he has contributed both as a presenter and a session chair.
In his current role as Accenture Life Sciences Clinical Data Services Capability lead, Shobhit is responsible for providing comprehensive data management expertise and driving standardization of processes and best practices across client teams.
Sarvesh Singh is Vice President for Data Management group in ICON Clinical Research. In his current role he has oversight of 600 member team spread across India, China, Japan. He is also on PhUSE Board of Directors representing APAC. As APAC Regional Director of PhUSE, his primary responsibility is to deliver high quality events to advance PhUSE’s learning and network opportunities for APAC Data Scientists. He organizes 8 PhUSE events in APAC every year (4 in India, 2 in China, 2 in Japan).
He was chair of PhUSE SDE held in India in July’2014. He has also been on the scientific committee and judging panel of CONSPIC organized by IASCT (Indian Association of Statistics in Clinical Trials) for two years in 2015,2016. He is renowned speaker and was invited by Dutch Parliament to express his views on the topic “How Netherlands can achieve its target of Energy Efficiency by 2020”. In 2013; he visited European Commission in Brussels and heard from Director General on how EU is organized and how to do business in Europe. He was also invited by The Hague Institute for Global Justice to attend a seminar on “Dutch Foreign Policy”.
He attended ISHA INSIGHT program in Nov’2014 and got privilege to meet renowned people like Ratan Tata, Kiran Bedi, Ramcharan etc and heard their views on how to scale up businesses. He is also very actively involved with many NGOs and is a regular contributor to many of their teaching initiatives. He was invited in May’2015 for a guest lecture to address the Faculty Development Workshop in Anna University. In Oct’2015; he was invited to House of Lords, UK Parliament to attend London Global Convention.
Apart from working in India he has also lived and worked in USA and Netherlands for close to 5 years. He completed his MBA from Rotterdam School of Management (Netherlands) and M.Sc. in Statistics from University of Delhi. He has decades of experience in the clinical industry across all phases of clinical trials managing Biometrics (Data Management, Clinical Programming and Biostatistics).
DGM, Cognizant Technologies
Suraj Ravindran is a clinical research professional with a CDM background and brings with him over 14 years of experience handling operations in various phases and therapeutic area. He has handled multiple key accounts of top pharmaceutical companies and served in the top tier vendor companies like Quintiles (IQVIA), TCS and Cognizant. Suraj has been instrumental in handling varying functions right from Transitions to business development to sales.
As an added challenge, he now handles pharmacovigilance operations with teams spanned across APAC and Europe. Suraj is a thorough promotor of SCDM initiatives and supported multiple conferences to bring forth key speakers to discuss industry best practices and future growth.
Clinical Data Management, Chiltern Clinical Research
I have over 16+ years of industry experience including 11+ years in CDM. Currently working as Associate Director, Clinical Data Management at Chiltern Clinical Research with deep expertise in a broad range of therapeutic areas and in all phases of trials. I am a SCDM member and have been speaker in the SCDM Asia conference 2013,2015, 2016 and 2017 DIA conference and most recently at SCDM Second Single Day Event at Bangalore – June 2018.
My current responsibility includes establishing new standards and driving operational efficiency through continuous process improvement initiatives along with the below tasks
- Provide overall technical, financial, administrative and functional oversight for the data management functions of the organization. oversee efficient, accurate, and timely execution of all assigned data management projects within the division
- Monitor and audit clinical data analyst operations for throughput, quality and customer satisfaction performance standards specifically on data review function
- Provide support in the development/revision of global clinical data management sops, working practice guidelines and training guidelines
Mr. Deven Kishor Babre
Associate Vice President,
Tata Consultancy Services
After securing a postgraduate degree in life sciences from Mumbai University, Deven started his career as research investigator at Tata Institute of social sciences (TISS). After TISS, Deven was managing medical information division at Wockhardt Pharmaceutical. Thereafter, he joined Data Management unit of Quintiles & PharmaNet. There after he worked as in Pharmacovigilance Operation at Sciformix.
Deven presently is working with TCS since November 2014. He has overall twenty two years of experience in Pharma, clinical data management and Pharmacovigilance. He was a Certified Clinical Data Manager (CCDM) from Society of Clinical Data Management (SCDM).
Deven has several publications on his name and is on the editorial board of PICR Journal Deven is associated with various charitable institutes and is actively involved in providing support to such organisations. His association for 9 years with the diabetic detection centre located in Tarapur in Maharashtra is worth mentioning.
PhD, Biostatistics Site Head,
Arghya Chattopadhyay is the Biostatistics Site Head, responsible for the growth and development of the Biostatistics team within Clinical Development and Analytics in India. He is also a part of the GDD India leadership team as well as the GDD Biostatistics and Pharmacometrics leadership team.
Arghya has over twenty years of experience in Clinical Development. Prior to Novartis, Arghya has worked in several pharmaceutical companies like Sanofi, Merck Research Laboratories, and Johnson & Johnson PRD as a statistician. Arghya was with Novartis from 2008 to 2013, where he led a team of Biostatisticians in Hyderabad, and contributed to multiple submissions in Neuroscience and Respiratory Therapeutic Areas.
Arghya has a Master’s degree in Statistics from the Indian Statistical Institute, Kolkata, and a PhD in Statistics from the University of Maryland Baltimore County.
Dr. Anitha Kumari
Associate Vice President (Operations),
Dr. Anitha K. is a Maxillo facial Surgeon by profession she has over 24 years of experience in in handling large operations in Clinical Data Management, Medical Writing, Biostats and Programming team, Medical Affairs, Labelling and Regulatory Solutions team.
She is an inspirational leader who drives a culture of excellence organization-wide through motivation, empowerment, and personal example.
Innovative, versatile and solutions-driven professional with great leadership skills, focused towards strategic planning having strong inclination towards Project Management, Process Excellence and Innovation.
As a Head of delivery & Centre of Excellence, experience of managing a large end to end Pharma Program customer account with an excellent track record of delivering mega-scale projects on time, within budget and high standards of quality, consistently. Extensive experience leading a variety of areas within clinical research organizations in a matrixed, geographically dispersed environment and global on-site teams from Europe, India, Asia and the United States. An Efficient Fiscal Manager with proven history of slashing the cost by effective allocation and utilization of Human and Material resources.
Overall experience in managing large ‘Operations’, sophisticated and savvy in Project & Program Management, Quality Management, Process Excellence through Six Sigma and Lean Sigma, Clinical Operations and Clinical Data Management. Have experience of working in diversified method like CROs and BPO way of Clinical data management.
Key skills: Program Management: Quality Management: Innovation: Process excellence and Six Sigma Analytics and Product development.
She is a certified Black Belt in Six sigma, PMP certified and MBA in International Business management.
Chief Operating Officer,
Cytespace Research Private Limited
Bhavesh Acharya is Chief Operating Officer at Cytespace Research Private Limited. Cytespace is a Research Organization providing services in the area of Biometrics and Site Solutions Organization. The Cytespace team of Data Management and Biostistics is based in Bangalore, whereas Site Solutions team is spread across in 20+ cities in India.
A total of 20+ years of Clinical Research experience across Clinical Operations, Clinical Data Management, Statistics and Clinical Trials Site Solutions in India and China.
Bachelor in Pharmacy, Bhavesh Acharya is trained in the various programs at IIM, Ahmedabad and Forum Corporation (USA) on building Strategies, Leadership and Coaching. Have participated in various clinical research conferences in India and abroad.