16th Annual Clinical Trials Summit 2025

UTTAM C

08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues

UTTAM C

09:30 – Welcome Address

CLINICAL TRIAL DESIGN

UTTAM C

09:40 – Innovative methods for Clinical trial design

•   Contemporary strategies to improve clinical trial design
•   Setting up the best position to sustain an agile procedure for your study design
•   The flexibility to redesign clinical trials at an intermediate stage
•   How does AI transform key steps of clinical trial design from study preparation to execution to wards improving trial success rates?
•   Effective trial design and improved compliance

ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories

SPONSOR – SITE – CRO – PATIENTS - REGULATORS

UTTAM C

10:10 – DISCUSSION WITH EXPERTS: Working together to accelerate trials - SPONSOR – SITE – CRO – PATIENTS - REGULATORS - “Collaborate, Communicate, Accelerate.”

•   Sponsors and CROs: Building strong partnerships to align goals, share data, and streamline trial processes.
•   Sites and Sponsors: Enhancing collaboration to address operational challenges and drive trial efficiency.
•   Patients at the Core: Ensuring patient input and experience guide trial designs for better recruitment and retention.
•   Regulators and Transparency: Promoting open communication to expedite approvals and maintain compliance.
•   Cross-Stakeholder Synergy: Bridging gaps between all players to foster shared accountability and results.
•   Leveraging Technology: Enabling real-time data sharing and collaboration across teams and geographies.
•   Continuous Improvement: Using feedback and shared insights to refine processes and accelerate trial timelines.

Moderator
GANESH KADHE, Founder & Director, Zantus Lifesciences

Panelists
AVIK GHOSH, General Manager and Head Regional Clinical Operations, Sun Pharma
SADANAND KULKARNI, Head - Medical, Regulatory, Vigilance & Quality (South Asia), Fresenius Kabi
MUKESH GORI, Director Global Patient Safety, Amgen
KRUNAL DALAL, Head Medical Affairs, GSK
PRASHANT MEHROTRA, Senior GM - Clinical Research, Bharat Serums and Vaccines

UTTAM C

11:00 – Morning Coffee/Tea & Discussion

PATIENT CENTRICITY

UTTAM C

11:30 – DISCUSSION WITH EXPERTS: “Patients First, Always.” - Prioritising patients in trials – Bringing it all together to enhance the patient safety

•   Embedding Patient-Centric Practices: Strategies for integrating patient needs into every stage of clinical trials.
•   Enhancing Patient Safety: Key measures to safeguard participants throughout the trial lifecycle.
•   Improving Communication: Transparent, empathetic engagement to build trust and ensure informed participation.
•   Customising Trial Designs: Adapting protocols to accommodate diverse patient populations and preferences.
•   Leveraging Technology: Using digital tools to monitor, support, and ensure patient safety effectively.
•   Evaluating Success: Metrics and feedback loops to assess and continuously improve patient-first initiatives in trials.

Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panelists
RISHI JAIN, Country Medical Head, Novartis
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
MANISH MAHAJAN, GM - Lead Medical Affairs BU Biologics, Zydus Group
INDRANIL PURKAIT, Senior GM - Medical Affairs, Ipca Laboratories
HARSHAD MALVE, Medical Head - Self-Care & Operations, Kenvue
PANKAJ THAKUR, GM, Clinical Project Management - Drug Discovery, Biologics, Hetero Labs

UTTAM C

12:20 – From Discovery to Delivery: Harnessing AI, Data Management & Digital Transformation to Optimize Drug Development

In the fast-changing life sciences landscape, Dassault Systèmes is transforming drug development by fusing cutting-edge technology with extensive scientific knowledge, data power, and artificial intelligence. With tools like Clinical Data Studio for smooth data integration and compliance and Simulant for AI-powered trial optimization, Medidata propels clinical innovation. BIOVIA ensures manufacturing quality control while improving lab informatics, drug discovery, and predictive modeling. By enabling AI-driven simulations to enhance research design, enhance patient safety, and optimize operational efficiency, virtual twin experiences help to further create the future. When combined, these developments improve medical research, speed up discoveries, and enhance decision-making.

SAILESH BAJPAI, Solution Consultant, Medidata, a Dassault Systèmes company

UTTAM C

12:50 –Networking luncheon

DECENTRALISATION

UTTAM C

14:00 – Keynote Panel Discussion: Decentralisation - Sustaining DCT adoption in a challenging economic environment. Ensuring best blend of DCT & in-person elements

•   Understanding the Economic Impact on Decentralised Clinical Trials (DCTs): Adapting to cost constraints while maintaining trial efficiency.
•   Optimising the Hybrid Model: Balancing decentralised and in-person trial elements for patient-centric and cost-effective solutions.
•   Enhancing Patient Accessibility: Leveraging decentralisation to improve participation while minimising economic barriers.
•   Technology Integration and Cost Management: Ensuring scalable, cost-efficient platforms to support DCT adoption.
•   Regulatory and Operational Challenges: Navigating compliance and logistics in mixed trial models during economic uncertainty.
•   Measuring Success: Evaluating outcomes, cost savings, and patient engagement to sustain DCT adoption long-term.

Moderator
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panelists
RAMESH JAGANNATHAN, VP, Medical Dept, Clinical Research & PV, Bharat Serums and Vaccines
VAIBHAV SALVI, Director & Head – Clinical Study Unit, India & South East Asia, Sanofi
JEROZE DALAL, Head of Clinical Operations, Medical Governance & Risk Management, GSK
AMARNATH SUGUMARAN, Associate Director & Cluster Head Medical Affairs, Cipla
K. MURUGANANTHAN, Head - Study & Site Operations(SSO India), Global, Clinical Operation(GCO), Novartis

UTTAM C

14:50 - Clinical Trial Supply - What’s the new way forward?

•   Current scenario & communication transparency
•   Benchmarking success in avoiding common pitfalls & nightmares in clinical trial supply
•   Quantifying and mitigating the risk of drug shortages
•   Implementing true end-to-end visibility across the supply chain
•   Enabling full traceability of clinical trial supplies
•   Risk analysis

UTTAM C

15:20 – Afternoon Tea/Coffee

CHALLENGES & OPPORTUNITIES

UTTAM C

15:40 – Clinical Trials – Market Analysis: Opportunities & Challenges

•   The India advantage
•   Overview of global clinical trial challenges and myths and current reality of conducting trials in India
•   Review the challenges the industry is facing and the impact of clinical trial progression
•   Addressing challenges in recruiting diverse patient populations and ensuring long-term retention.
•   Balancing trial budgets while maintaining quality, data integrity, and timelines.
•   Learn lessons from experience / case studies

SAKHARAM GARALE, Founder & CEO, RENOVARE Healthcare

OUTSOURCING / PARTNERSHIPS

UTTAM C

16:10 – DISCUSSION WITH EXPERTS: Outsourcing in Clinical Trials: Crafting Partnerships for Success

•   Defining Clear Objectives: Establishing shared goals and expectations to align all stakeholders.
•   Selecting the Right Partners: Key criteria for evaluating and choosing CROs and other service providers.
•   Building Trust and Transparency: Strategies for fostering open communication and mutual confidence.
•   Setting Metrics for Success: Establishing performance benchmarks to monitor progress and outcomes.
•   Navigating Challenges: Proactive approaches to mitigate risks and resolve conflicts in partnerships.
•   Sustaining Long-Term Partnerships: Best practices for evolving and maintaining successful outsourcing relationships.

Moderator
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)

Panelists
ASHISH GAWDE, Country Medical Director, Bayer
ANUP PINGLE, Medical Director - Global Health Access, GSK
NISHITH VYAS, Senior Global Management Consulting, Novartis
RICHARD LIPSCOMBE, Managing Director, Proteomics International
VIVEK GUPTA, Associate Director - Strategic Engagements & Vendor Management - Clinical & Medical Affairs, Organon

UTTAM C

17:00 - End of conference Day 01