Clinical Trials Series 2025
Clinical Trials Series 2025
25th September, 2025
Sterlings Mac Hotel, Bangalore, India
5 Reasons
to attend the event
Knowledge
Gain insights from experts, researchers, and professionals to stay updated on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminating travel hassles while accessing high-quality content at your own pace.
Cutting-Edge Insights
Discover the latest trends, innovations, and breakthroughs shaping the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with actionable strategies, real-world case studies, and learn best practices to implement in your work.
Knowledge
Gain insights from experts, researchers, and professionals on the latest pharma advancements.
Convenience
Attend sessions from anywhere, eliminate travel hassles & access quality content at your own pace.
Cutting-Edge Insights
Explore the latest trends, innovations, and breakthroughs driving the future of the pharmaceutical industry.
Networking
Connect with peers, industry leaders, and collaborators to exchange ideas and explore new opportunities.
Practical Takeaways
Walk away with practical strategies, case studies, and proven best practices to apply in real-time.
Event Speakers
KHALID A K
Food Safety and Drug Administration
MAYUR PARMAR
FDA
SUBHASH THULUVA
Biological E
KAMALA RAI
Novartis
ANIL KUKREJA
Emcure Pharmaceuticals
SHUBHADEEP S
Hetero
LATEEFUDDIN S
AstraZeneca
MILIND ANTANI
Nishith Desai Associates
KRISHNENDU S
AstraZeneca
MONISHA SHARMA
MSD
VIJAY PARTHASARATHY
Novo Nordisk
DEEPAK NEMA
Pfizer
FRANCIS MICHEAL
Viatris
RAJESH P
AstraZeneca
TAPANKUMAR SHAH
AstraZeneca
RAHUL RATHOD
Abbvie
KHALEEL AHMAD
Bristol Myers Squibb
ASHISH PAWAR
Eli Lilly and Company
PRITAM GUPTA
Bristol Myers Squibb
ANUP CHOUDHURY
Novartis
ANIL BHOJWANI
GSK
RAVI GAWARE
Novo Nordisk
PRIYA RAJAGOPAL
GSK
ANURADHA NAIR
Dr. Reddy’s Laboratories
SAJJAD PATIL
Biocon Biologics
DHARMAPAL S
Viatris
PIYUSH AGARWAL
Dr. Reddy’s Laboratories
UME ASMA
Pfizer
AVIK GHOSH
Sun Pharma
PRITI GUPTA
GSK
AAKASH DHRUVA
Viatris
Event Schedule
Meet to learn and network with your conference colleagues.
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
09:20 – Welcome Address
09.30 – “Smarter Trials, Safer Outcomes: Driving Success with Risk-Based Quality Management (RBQM)”
RBQM
• Understanding the core principles and components of RBQM in clinical trials.
• Identifying critical data and processes to focus quality efforts where they matter most.
• Shifting from reactive to proactive risk detection and mitigation strategies.
• Overcoming challenges in RBQM adoption, including culture, technology, and training gaps.
• Utilizing advanced analytics and AI for real-time risk assessment and decision-making.
• Collaborating effectively with CROs and sites to implement risk-based approaches.
• Measuring the impact of RBQM on trial timelines, cost-efficiency, and quality outcomes
Speaker
KRISHNENDU SENGUPTA
Director – Centralized Monitoring
AstraZeneca
10:00 – KEYNOTE PANEL DISCUSSION: Rise of Clinical Trials: Smarter, Decentralized & Patient- Centric
(DCTs)
• Learn how DCTs improve patient engagement, flexibility, and cost efficiency.
• Hybrid Trial Approaches – Explore how combining digital and traditional methods broadens reach and data collection.
• Identify essential factors for effective DCT implementation.
• Evaluate the long-term viability and environmental impact of DCTs.
• Platform Trials – Unpack benefits, challenges, and best practices for maximizing impact.
• Personalized Patient Care – Examine how these innovations push healthcare toward more tailored treatments.
• Future Outlook – Are DCTs truly more sustainable in future? Where are we heading?
Moderator
SUBHASH THULUVA
Sr. Vice President & Head – Clinical Development
Biological E
Panellists
KAMALA RAI
Vice President, Senior Global Program Head
Novartis
MONISHA SHARMA
Senior Director, APAC. Global Clinical Trial Operations
MSD
RAVI GAWARE
Head – Diabetes and Obesity, Clinical Research
Novo Nordisk
ANURADHA NAIR
Head Clinical Quality and Training
Dr. Reddy’s Laboratories
10:50 – Morning Coffee/Tea & Discussion
11:20 – DISCUSSION WITH EXPERTS: “SPONSOR – SITE – CRO – PATIENT: Building Stronger Clinical Trial Partnerships”
WORKING TOGETHER
• Evolving sponsor, site, CRO, and patient collaboration to meet rising clinical trial demands.
• Embedding real, measurable transparency across all stakeholder relationships.
• Implementing structural changes sponsors need to build stronger, more agile partnerships.
• Enabling CROs to drive performance through continuous improvement and benchmarking.
• Moving beyond intentions to make transparency a tangible, operational standard.
• Enhancing site preparedness and collaboration for more effective trial execution.
• Applying key learnings from past disruptions to strengthen future clinical trial success.
Moderator
SHUBHADEEP SINHA
Senior Vice-President & Medical Director
Hetero
Panellists
ANIL KUKREJA
Executive VP – Clinical Research & Medical Affairs
Emcure Pharmaceuticals
KRISHNENDU SENGUPTA
Director – Centralized Monitoring
AstraZeneca
FRANCIS MICHEAL
Director
Viatris
KHALEEL AHMAD
Associate Director, Line Manager, Global Trial Management,
Bristol Myers Squibb
AVIK GHOSH
GM & Head Clinical Operations
Sun Pharma
PRIYA RAJAGOPAL
Director Study Delivery, Vx GCD, GCO
GSK
12:10 – From Sponsor-Centric to Patient-Centric: Transforming Recruitment & Engagement
PATIENT CENTRICITY
• Leveraging innovative tools to boost patient recruitment and involvement.
• Addressing key barriers and challenges to patient participation.
• Enabling secure data sharing while safeguarding patient privacy.
• Navigating the evolving space with limited regulatory guidance and emerging models.
12:40 - Networking luncheon
13:30 – DISCUSSION WITH EXPERTS: Outsourcing in Clinical Trials: Crafting Partnerships for Success
REGULATORY
• Decentralized Trial Regulations – Adapting to evolving global and regional guidelines.
• AI & Compliance, Leveraging AI in regulatory submissions, safety, and inspections.
• Inspection Readiness – Best practices for FDA and global regulatory preparedness.
• GCP & Ethics – Upholding human rights, data integrity, and ethical standards in the digital era.
• Using real-world evidence to support regulatory outcomes.
• Managing Global Trials – Aligning protocols, GMP/ GDP, and documentation across sites.
• Ensuring uniform compliance in multi-country trials. Maintaining consistency across borders.
• India’s Regulatory Progress – Where are we heading and where should we be?
Moderator
Panellists
MILIND ANTANI
Leader, Pharma and Healthcare
Nishith Desai Associates
KHALID AHMED KHAN
Deputy Drugs Controller
Food Safety and Drug Administration
MAYUR PARMAR
Drugs Inspector (Deputy Collector, Gujarat Government),
FDA
ANUP CHOUDHURY
Medical Director, Global Clinical Development
Novartis
ANIL BHOJWANI
Associate Director, Medical Writing Asset Lead
GSK
SAJJAD PATIL
Therapeutic Area Head – Clinical Operations
Biocon Biologics
DHARMAPAL SHAROFF
General Manager & Head – Global Regulatory Medical Writing,
Viatris
UME ASMA
Global Medical Safety Scientist
Pfizer
14:20 - The Evolving Landscape of Clinical Research: Challenges to Opportunities
CLINICAL RESEARCH
• Balancing data privacy, global regulations, and the rise of decentralized trials.
• Tackling data complexity while advancing trial innovation and adaptive designs.
• Breaking down barriers to diversity, inclusion, and digital accessibility in participation.
• Navigating high costs, long timelines, and funding pressures impacting trial efficiency.
• Leveraging India’s growing potential as a clinical research hub.
• Strengthening vendor partnerships and optimizing patient engagement through tech-forward strategies.
14:50 – Afternoon Tea/Coffee
15:10 – DISCUSSION WITH EXPERTS: Challenges & Opportunities - Clinical Trials at the Crossroads: Tackling Today, Transforming Tomorrow
CHALLENGES & OPPORTUNITIES
• Managing trial delays, recruitment bottlenecks, and high dropout rates.
• Addressing diversity, equity, and inclusion gaps in trial participation.
• Innovative trial designs to save time and cost without compromising on the efficiency
• Ensuring patient-centricity through better engagement and personalized trial designs.
• Building agile, risk-resilient frameworks to future -proof trial operations.
• Navigating trial delays due to supply chain disruptions and geopolitical factors
• Building flexible, risk-based quality management systems
Speaker
VIJAY PARTHASARATHY
Senior Director, Clinical Operations
Novo Nordisk
TAPANKUMAR SHAH
Senior Director
AstraZeneca
RAHUL RATHOD
Director Medical Affairs
AbbVie
PIYUSH AGARWAL
Head Clinical Development
Dr. Reddy’s Laboratories
AAKASH DHRUVA
Global Clinical Strategy Lead
Viatris
15.50 - Master Clinical Trial Protocol
PROTOCOL DESIGN EXCELLENCE
Speaker
ANIL BHOJWANI
Associate Director, Medical Writing Asset Lead
GSK
16:20 – DISCUSSION WITH EXPERTS: Revolutionizing Clinical Trials Through Technology - Innovation, Efficiency & Access
IMPACT OF TECHNOLOGY
• Tech-Powered Trials: Enhancing Speed, Safety, and Patient Engagement
• The Smart Shift: How Technology is Reshaping Clinical Trials?
• Smarter Trials with AI – Discover how artificial intelligence is transforming trial design and control
• Blockchain in Data Management, Understand its role in secure, decentralized data handling
• For Smarter Trials, Smarter Tech – How digital innovation is redefining clinical research?
• Overcoming barriers to tech in trials by cracking digital adoption
• Understanding how (RWE) and (RWD) is transforming clinical trials.
• From Glitches to Gains: Navigating Tech in Trials
Moderator
LATEEFUDDIN SHARIFF
Senior Director – Global Lead CDMO
AstraZeneca
Panellists
DEEPAK NEMA
Director, Clinical Data Sciences
Pfizer
ASHISH PAWAR
Associate Director, Clinical Data Science
Eli Lilly and Company
PRITAM GUPTA
Associate Director, Biostatistics
Bristol Myers Squibb
RAJESH PICHAPILLAI
Associate Director, Clinical Programming
AstraZeneca
PRITI GUPTA
Centralized Monitoring Lead
GSK
17:00 – Closing Remarks & End of conference
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues
09:30 – Welcome Address
09:40 – Innovative methods for Clinical trial design
Clinical Trial Inspection
- 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
Speaker
Head Medical Affairs,
Alkem Laboratories
10:10 – DISCUSSION WITH EXPERTS: Working together to accelerate trials - SPONSOR – SITE – CRO – PATIENTS - REGULATORS - “Collaborate, Communicate, Accelerate.”
SPONSOR – SITE – CRO – PATIENTS – REGULATORS
- 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.
Moderator
Founder & Director,
Zantus Lifesciences
Panellists
Associate VP & Head,
Development Center of Excellence Specialty Medicine,
Sun Pharma
Head – Medical, Regulatory, Vigilance & Quality (South Asia),
Fresenius Kabi
MUKESH GORI,
Director ESP Engagement PV & PS,
Novartis
Head Medical Affairs,
GSK
Bharat Serums and Vaccines
11:00 – Morning Coffee/Tea & Discussion
11:30 – DISCUSSION WITH EXPERTS: “Patients First, Always.” - Prioritising patients in trials – Bringing it all together to enhance the patient safety
PATIENT CENTRICITY
- 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.
Moderator
Founder Director,
Pharmawisdom
Panellists
Country Medical Head,
Novartis
Head Medical Affairs,
Alkem Laboratories
MANISH MAHAJAN,
GM – Lead Medical Affairs BU Biologics,
Zydus Group
Senior GM – Medical Affairs,
Ipca Laboratories
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.
Speaker
Solution Consultant, Medidata,
a Dassault Systèmes company
12:50 –Networking luncheon
14:00 – Keynote Panel Discussion: Decentralisation - Sustaining DCT adoption in a challenging economic environment. Ensuring best blend of DCT & in-person elements
DECENTRALISATION
- 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.
Moderator
Founder Director,
Pharmawisdom
Panellists
VP, Medical Dept, Clinical Research & PV,
Bharat Serums and Vaccines
Director and Head,
Sanofi
JEROZE DALAL,
Head of Clinical Operations,
Medical Governance & Risk Management,GSK
AssociAte Director & Cluster Head Medical Affairs,
Cipla
Head – Study & Site Operations(SSO India),
Global,Clinical Operation(GCO), Novartis
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
15:20 – Afternoon Tea/Coffee
15:40 – Clinical Trials – Market Analysis: Opportunities & Challenges
CHALLENGES & OPPORTUNITIES
- 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
Moderator
Founder & CEO,
RENOVARE Healthcare
16:10 – DISCUSSION WITH EXPERTS: Outsourcing in Clinical Trials: Crafting Partnerships for Success
OUTSOURCING / PARTNERSHIPS
- 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.
Moderator
CEO, QBD International,
United Nations Adviser
Panellists
ASHISH GAWDE,
Country Medical Director,
Bayer
Medical Director,
Global Health Access, GSK
NISHITH VYAS,
Senior Global Management Consulting,
Novartis
Managing Director,
Proteomics International
Associate Director,
Strategic Engagements & Vendor Management,
Clinical & Medical Affairs, Organon
17:00 - End of conference Day 01
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Event Testimonials
A huge thanks to all our sponsors, attendees and partners!
Pricing Details
Exclusive Offer — 3 Delegates for the Price of 2!
SUPER EARLY BIRD PRICE — INR 10,000 + GST (18%) PER DELEGATE (Valid until 8th August 2025)
STANDARD PRICE — INR 15,000 + GST (18%) PER DELEGATE
You can simply email or call and book your conference delegate seats on:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
CONFERENCE SPONSOR & EXHIBITION STALL
Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to:
TEL: + 91 44 42108101 (or) Email — bookings@virtueinsight.com
Venue details
The venue is easily accessible, well-equipped with modern amenities, and offers a comfortable, professional setting for all attendees.
Venue
Sterling’s Mac Hotel
134, old, HAL Old Airport Rd,
opposite to Leela Palace Road, Kodihalli,
Karnataka 560017
+91 80 4249 4949
Venue
Sterling’s Mac Hotel Bengaluru
134, old, HAL Old Airport Rd,
opposite to Leela Palace Road, Kodihalli, Karnataka 560017
+91 80 4249 4949
