12th Annual Clinical Trials Summit 2021

09:20 - Welcome Address & Virtual Conference Platform Instructions

MARKET OVERVIEW & ANALYSIS

09:30 – Impact of Covid-19 pandemic on conducting global clinical trials - Focus on safety aspects
• Protecting patients while keeping data integrity
• Some aspects of Regulatory guidance worldwide
• Adapting risk mitigation strategies
• Medical evaluation of adverse events
• Impact of vaccines

MIRCEA CIUCA, Global Therapeutic Area Head - Global Clinical Safety and, Pharmacovigilance, CSL Behring (Switzerland)

10:00 – Diagnostic testing in the times of SARS-CoV-2 variants and COVID-19 vaccines
MOHAN RAVURU, Director, Medical and Scientific Affairs, APAC, Abbott Rapid Diagnostics

10:30 – Morning Coffee / Tea & Discussion

CHALLENGES & OPPORTUNITIES

10:50 – DISCUSSION WITH EXPERTS: Concerns, complexities & the way forward in performing clinical trials
• Addressing COVID-19’s global effect on clinical trials and the way ahead
• How to enhance clinical research capabilities
• Challenges and opportunities for sponsors while conducting clinical trials during pandemic
• Will COVID-19 hold us back?
• With the declaration of COVID-19 as a global pandemic, how the Indian healthcare industry can deliver optimally with limited resources and many challenges
• How sponsors, researchers and clinical trial professionals respond to this situation and recognise and minimise possible threats and obstacles in order to execute clinical trials
• Real world evidence / Non interventional studies and its implications for healthcare improvement

Moderator:
DILIP PAWAR, Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories

Panellists:
AMGAD SHEBL, Director, Global Clinical Safety & Pharmacovigilance /, Clinical R & D, CSL Behring (Germany)
ARANI CHATTERJEE, Senior Vice President, Clinical Research, Aurobindo Pharma
TAUSIF AHMED, Director - Global Clinical Management, Dr. Reddy’s Laboratories
PANKAJ GUPTA, Chief Scientific Officer, Novartis
RAJENDRA JANI, Senior Subject Expert & Advisor Clinical Research, Consultant
VAIBHAV SALVI, Head – Medical Information, Asia, Sanofi

IMPACT OF TECHNOLOGY

11:40 – COVID-19 & Technological Transformation of Clinical Research - Why, What & How?
• Impact of COVID-19 on Clinical Research
• COVID-19 as a Catalyst for Digital Transformation
• Why and how digital transformation happened?
• Some examples of transformational technologies put to use
• How will CR look like in the future?

AMMAR RAZA, Regional Medical Director - Middle East & Africa (MEA), Allergan Aesthetics, Abbvie (UAE)

12:10 - Networking luncheon

13:20 – DISCUSSION WITH EXPERTS: Improving patient - centricity by protecting patients, especially in pandemic
• What are the challenges faced while recruiting patients?
• Adopting the correct methodologies to help and drive patient-centered trials
• What are the risks of compromised data integrity and how to resolve this issue
• Key conditions for ensuring success in direct-to-patient trials
• Addressing patient-centric research in the time of COVID-19
• Addressing wearable technology that may help to reduce patient burden in several ways

Moderator:
PRASHANT BODHE, Head Clinical Operations, Rubicon Research

Panellists:
KAMAL K HALDER, ADCI, CDSCO (East Zone Kolkata)
ARUN BHATT, Consultant – Clinical Research & Development
SEEMA PAI, Director - India Cluster, GSSO, Clinical Development &, Operations, Global Product Development, Pfizer
KRANTHI KIRAN PEBBILI, Director and Cluster Head - Medical Affairs, Dr. Reddy’s Laboratories
RENUKA NEOGI, CPL Manager, Sanofi

REGULATORY

14:20 – DISCUSSION WITH EXPERTS: Current framework of clinical trial regulations in India
• Update on the new Clinical Trial Regulation, timescale for applications, implementing acts
• What key changes can be introduced?
• Roles and responsibilities: sponsor and investigators
• Settling in after the pandemic

Moderator:
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates

Panellists:
K BANGARURAJAN, Adviser, CDSCO (New Delhi)
OMPRAKASH S. SADHWANI, Former Joint Commissioner and Controlling Authority, Food and Drug Administration (Maharashtra state)
RAJEEV SHRIVASTAVA, Associate Director - Regulatory Affairs and, Pharmacovigilance, Eli Lilly
KRUNAL KAVATHIYA, Medical Affairs, Torrent Pharmaceuticals
SNEHA GUPTA, Manager Regulatory Affairs, Sanofi
KAVYA KADAM, Consultant Global Clinical Trials

15:10 – Afternoon Tea / Coffee

15:30 – DISCUSSION WITH EXPERTS: Strategic partnership and outsourcing approaches
• Different approaches to choosing the best CRO to ensure the fulfilment of your needs
• Establishing a team atmosphere for creative problem solving
• Constructing an effective model early on for a successful partnership with CROs
• Ensuring effective management and governance - appointing consistent sponsor and CRO responsibilities and obligations to avoid duplicative attempts and to set practical standards
• Addressing what the stakeholders need in order to continue delivering standards for a strategic partnership?
• Discussing what advantages would biopharmaceutical businesses gain from a strategic partnership?
• Clinical services and outsourcing

Moderator:
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellists:
RAVI SEKHAR KASIBHATTA, Senior Vice President, Lupin
ANIRBAN ROY CHOWDHURY, Vice President - Clinical Research & Pharmacovigilance, Bharat Serums and Vaccines
GANESH DIVEKAR, Vice President - Clinical Operations and Biometrics, SIRO Clinpharm
ASHOK SRIVASTAVA, CEO & CMO, Trans Atlantic Therapeutics (USA), COVI-19, Vaccine and Drug Development
RISHI JAIN, Medical Director, AbbVie
AMIT KUMAR, Head – Clinical Trials, Publications and Medical Excellence, AstraZeneca
MANISH MISHRA, Chief Executive Officer, Labaid Hospitals and Diagnostics

16:20 – Orchestrating a Human-Centric Digital Experience to Accelerate Clinical Trial Operations from Anywhere
• Key findings from clinical trials stakeholder interviews before and during the pandemic
• Top priorities of clinical operations leaders
• Making sense of the perspectives of different stakeholders
• Striking the right Balance between technology innovation and human factors

HARSHA K RAJASIMHA, Founder and CEO, Jeeva Informatics Solutions

16:50 - Chairperson’s closing remarks and end of conference