Program Overview


Co-Chairs for the Annual Conference
Dr. Anitha K
Global Head of Operations, Novartis
Deven Babre
Director Biometrics Life Sciences Digital Operations, Cognizant
Dr. Deepak Kallubundi
SCDM Board member and Director, FSPx- Covance
Evolution of Clinical Data Science - Data | Technology | Analytics
With developments happening in clinical research area there is an uptick in the data which is complex, huge and there is variety of data. Industry is adopting variety of technologies and are using data analytics for making informed decisions for this to happen these are three enablers for this evolution within Clinical Data Science
Leadership Forum – 3rd Dec 2020
  LEADERSHIP FORUM (By Invitations Only) Identification and Engaging Outsourcing of Services in Life Science
17:30 - 18:15 Keynote Speaker:
Uma Shankar R
VP & Head - Connected Lifestyle Division, Harman International 
Leadership Talk 1
Is Acceleration in Digital Transformation within Healthcare Industry a New Normal – Case Studies & Adoption Strategies
18:15 - 19:00 Keynote Speaker:
Bola Oyegunwa
VP & Head of DCT, Covance
Leadership Talk 2
Future of Decentralized Clinical Trials in New normal
19:00 - 20:00 Panelists:
Robert Lindblad - Executive Vice President, The Emmes Company, LLC
Jeanne Wu - Head of Clinical Trial Risk Management for Data Generation and Analysis, Bristol Myers Squibb
Jonathan Andrus - Chief Business Officer, Clinical Ink
Suresh Ramu - Co-founder and CEO, CyteCare Hospitals
Sanjay Vyas - Senior Vice President, India Country Head & Managing Director & SBU Head - Clinical Trial Supplies & Logistics, Parexel International

Session Chair:
Debu Moni Baruah - Manager, Software Development, IQVIA
Panel Discussion:
Understanding Data Democratization in Clinical Research Landscape - Advantages, Challenges & Way Forward
Day 1 – 4th Dec 2020
10:00 - 10:30 Inauguration & Welcome Session

10:30 - 11:15
Keynote Talk - 1
Digital Disruption / Transformation in Life Sciences

Avi Kulkarni - Managing Director, Applied Life Sciences Solutions, Accenture
11:15 - 11:30 Break

11:30 - 13:30
Industry Workshop:
Leap from traditional Data Management to Data Science
Understanding guiding principles related to Data Science. Tips and Tricks to implement concepts such as Metadata consolidation (PRM to eCTD), Visualization considering ICH E6 R2 framework a practical insight

Presenter:
Senthil Kumar - Program Manager, Cognizant
Godfrey Machado - TCS

Session Chair:
Raghavendra Kalmadi - Senior Director, CDM, IQVIA
Tushar Sakpal - AVP Biostatistics & Statistical Programming, TCS
M Srinivasan - Director – Global Clinical Development Delivery Operations, Cognizant
13:30 - 14:00 Lunch Break - Accenture Product DEMO 
  Parallel Tracks - Session 1
14:00 - 15:30 Track 1 – Metrics / KPIs used in CDM to Track & Monitor Progress of Study / Program

Speakers:
Mallikarjun Koripadu - Associate Director, Covance
Kartik Ahuja - Senior Clinical Data Analyst, Parexel International
Ganesh Kini Chandrakanth - General Manager, Accenture

Session Chairs:
Susan Korah - AVP and Delivery Head, TCS Life Sciences
Nagendra Kumar - Director, DM, ICON PLC 
Track 2 – Evolution of Monitoring Approach (2.0)

Panelists:
Naveen KK - Executive Director & Head Centralized Medical Data Review & Analytics and Safety Solutions, Covance
Mahesh Kumar - Senior Manager, IQVIA
Raghu Punnamraju - TrierHealth
Asha Nair- Associate Director, Cytespace Research

Session Chair:
Abby Abraham - Global Head Data Science
Country Head, India, George Clinical 
Track 3 – SDTM & CDASH- Do we need both data standards?

Panelists:
Bhaskar Subramanian - Senior Director, Clinical Programming & Data Management, Covance Lakshmikanthan Santhanakumar - Director, Statistical Programming, Parexel
Balaji Rajanna - Senior Project Manager, CDM, Quanticate
Akshaya Kamath – General Manager, Accenture

Session Chair:
Shrishaila Patil - Vice President, Navitas life sciences
  Parallel Tracks - Session 2
15:30 - 17:00 Track 1 – Technology & Big Data Impacting Clinical Development during New normal

Speakers:
Payal Ghosh - Manager, CDM, PPD
Mayur Challawar - Lead Business Application Project Manager, Bayer
Narasimha Rayaprolu - Principal Clinical Programmer, Novartis
Dharmaraj Ramji - Director, Data Operations Technical Service, Syneoshealth

Session Chair:
Raghuram Thata - Global Programming Shared Services Head, IQVIA
Track 2 – Embracing Risk-Based Monitoring during New Normal

Panelists:
Debjit Chakrabarti - Director - Head of MDR & CM FSP Operations, IQVIA
Deepu Joseph - VP and Global Head of DM, Quanticate
Adriaan Kruger - Co-Founder & CEO, NuvoteQ
Ahmed Shujauddin - Head of India Clinical Operations group, Icon Clinical Research
Jagadeesh Rudraswamymath - Global Head - Clinical Data Management, Novartis

Session Chair:
Bhavesh Acharya  - Chief Operating Officer, Cytespace Research 
Track 3 –  “Humans” + “Machines” = Intelligence with Speed:  DM Case Studies "

Speakers:
Amol Dhawale - Senior Consultant, Infosys
Vijayroshan Maricherla - Principal Clinical Database Developer, Novartis
Damon Fahimi - Product & Outreach Manager, Uppsala Monitoring Centre

Session Chairs:
Suresh Sharma - General Manager & Domain Delivery Head, Life Sciences, TCS
Jeba kumar - Statistical Programming & Analysis Programming Standards Lead - India, Pfizer
17:00 - 17:15 BREAK
17:15 - 18:00 Panel Discussion:
Clinical Data Management in 2030 - What does it look like & how different the role of Data Manager would be?

Moderator:
Deven Babre - Director Biometrics Life Sciences Digital Operations, Cognizant
Panelist:
Mayank Anand - Head Global Data Management Service Delivery, Bristol Myers Squibb
Shobhit  Shrotriya - VP & India Lead – Life Sciences R&D Operations, Accenture
Jayathirtha Gopalakrishnan - Associate Vice President, TCS

18:00 - 18:45
Keynote Talk -2
Technology Adoption in New Normal for Conducting Clinical Trials 

Keynote Speaker:
Eugene Hayden - Head of Global Data Management & Centralized Monitoring, Bristol Myers Squibb 
Day 2 – 5th Dec 2020
10:00 - 11:00
Academic Session
Understanding Analysis of RWD

Panelists:
Nincy Philip, Pursuing Doctorate in Pharmacy ( Pharm D), Chitkara University
Ashi Siddiqui, MBA (Pharm), NIPER Mohali
Chetna Demla, Masters in Health Economics (MSc), Manipal Academy of Higher Education
Vineeta Gowrisetty, Masters in Clinical Research (MSc), UPES, Dehra Dun

Session Chair:
Roopa Basrur - Senior Director, Data Management, Parexel International
  Parallel Tracks - Session 3
11:00 – 12:30
Track 1 - Balance in Technology vs Human, Are we there? – Data Science

Speakers:
Ali A Hoque - Engagement Delivery Lead, Cognizant
Shunmuga Priya Sj - Clinical Data Management Associate, Accenture
Sandhya Y - Principal Statistical Programmer, Icon Docs
Praveen Arockiaraj - Associate Director, Covance

Session Chairs:
Tanusha Dutta - Director, Data Management, Covance
Priyadharshini Lobow - Director – Data & Analytics, Eli Lilly
Track 2 – eSource- Current State vs Future State.

Panelists:
Poulamee Pande - Manager  Biometrics, PRA Health Science
Abhijit Parab - Senior Director, Bristol Myers Squibb
Rakesh Maniar - Head of eClinical Technologies, Global Data Management and Standards, Clinical Trial Operations, Merck

Session Chairs:
Arshad Mohammad - Global Head-CDM Functional Service Provider (FSP), Covance
Sujit Nair - Director Operations, Cenduit
Track 3 – RWE/RWD Is It Beginning To Pay Off

Speakers:
Kalyani Sonawane - University of Texas Health Science Center, Houston
Abheenava Kumar - Senior Principal RWE Data Scientist, Novartis
Saipoojitha Gudiboina - RWE Scientific Data Analyst, Novartis
Kothuri Sneha - Medical Services Specialist, Accenture

Session Chair:
Madhur Garg - Director, RWE and Market Access, Covance
12:30 - 13:00 Lunch BREAK Accenture Product DEMO
13:00 - 13:45
Keynote Talk - 3
Defining patient centricity going forward.

Keynote Speaker:
Arno Tellmann - Head Global Drug Development, Novartis
  Parallel Tracks - Session 4

13:45 - 15:15
Track 1 –  Complex Endpoints for Decentralized Trials - Data Science

Speakers:
Shariff Lateefuddin, Group Head, Data Management,Novartis.
Ritu Karwal, Associate Manager, Accenture.
Rasmus Hogreffe, Vice President DCT Innovation, Medable.

Session Chair:
Mahesh Iyer - Head - Stats and Programming group, Parexel
Track 2 – Are We Adequately Addressing Risks and Quality Compliance?

Speakers:
Usha Rani Amarnath - Lead Data Manager, Cytespace
Shobha Muniyappa - Senior Manager, Covance
Sheeba Manoj Nair - Manager, Accenture

Session Chair:
Sanjay Jankar - Head Biometrics and Medical Writing at Glenmark Pharmaceuticals Ltd
Track 3 – ML/AI- Challenges and opportunities in  implementing analytics in Clinical Trials

Speakers:
Mr. Chiranjib Sarma - Software Development Analyst, Iqvia
Mr. Vinod Kumar - Associate Manager, Accenture
Amit Patil - Accenture

Session Chair:
Christina Gunther - European Clinical Domain Lead, Accenture
15:15 - 15:30 BREAK

15:30 - 16:30
Regulatory Talk
Driving Regulatory Strategy to meet the needs of Patients and Health Authorities

Speaker:
Vijay Reddi - Regulatory Transformation Lead, F. Hoffmann-La Roche Ltd – UK
16:30 - 17:15 Keynote Talk - 4
Evolution of Data Science in New Normal

Keynote Speaker:
Michael Goedde - Vice President, PRA Health Sciences, Chair, SCDM board
17:15 - 18:15 Special Session by
Dr. Ashwini Mathur - Head DSAI Ireland Hub - Solution Lead
Innovation Execution, Data Science and AI, CDO Session
Topic: Leadership in the data and digital age
18:15 - 18:30 Vote of thanks



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