Mumbai: Leading experts delve deeper into the complexities of contemporary clinical researchAddressing challenges and highlighting important progress etpharmaClinical Research Excellence Conference 2024, theme ‘From Insights to Impact’. The conference stood as a gateway for participants, providing a unique opportunity to open transformative pathways to success in clinical research. Discussions revolved around challenges, support Ethical standards As inevitable, and demands openness, respect for participants’ choices and strict confidentiality protections. The participants reiterated that to be successful in this environment, researchers must have an innovative and visionary approach, which will help them overcome obstacles and produce good results that will ultimately improve Patient Care And medical knowledgeThe conference started with the welcome address by Pratibha Raju, Assistant Editor, ETpharma, followed by the keynote address by Dr. Neelima Kshirsagar, National President, Clinical Pharmacology. ICMR,

The keynote address was followed by a presentation by Chairman Dr. Anil Pareek on the topic ‘Clinical Research and Innovation: Clinical Insight is the Gateway’. medical Affairs & Clinical Research, IPCA Laboratories Ltd. He emphasized that the ability of clinical insights to inspire concrete change and improve health care decision making is what gives them their revolutionary potential. Using data and observations from the clinical environment, scientists can find trends, pinpoint areas that need improvement, and design focused treatments that have a direct impact on patient outcomes.

The session ‘Clinical Research and Innovation: Clinical Insight is the Gateway’ was followed by a presentation on ‘Powering 21st Century Clinical Research with Humans and AI’ by Dr. Archana Sarda, Managing Director, EMMES India.

Dr. Sarda’s presentation was followed by a panel discussion on ‘Strategic coordination in multinational trials: meeting the challenges and seizing the opportunities’. The panelists for the discussion were Dr. Chirag Desai, MD, Hemato-Oncology Clinic, Vedanta; Dr. Akhilesh Sharma, President and Chief Medical Officer, Alkem Laboratories Ltd; Dr. Anil Kukreja, Vice President, Medical Affairs and Regulatory, AstraZeneca India; and Dr. Rajendra Jani, Independent Subject Expert, Clinical Research and Development. The panel discussion was moderated by Dr. Rajendra Jani, Independent Subject Expert, Clinical Research & Development. Dr. Sharma focused on the development of coherence towards progress in bringing regulatory standards into compliance with global norms. Dr. Kukreja considered the need to improve clinical trial conduct skills and suggested that this is an area that can still be improved. Changing its ICH membership from observer to participant could give India greater influence over international regulatory norms. Potential gaps in participation in the early stages of research were highlighted by Dr. Desai. He also observed that India mainly participates in late-stage clinical trials. There may be scope for development in this area to make a major contribution to drug development. Ultimately, India’s dedication to maintaining ethical standards in medical research was positively reflected in Dr. Desai’s praise for the ICMR ethical guidelines.

‘Decentralized clinical trials and AI in clinical trials?’ The panel discussion was led by Dr. Arani Chatterjee, Joint Chairman, Cadila Pharmaceuticals Ltd., Dr. Subhash Thuluwa, Senior VP and Head, Clinical Development and Pharmacovigilance, Biological E Ltd. and Director, Clinical Study Unit, India and South East Asia, R&D and It was presided over by Dr. Vaibhav Salvi. -Clinical Sciences and Operations, Sanofi. The session was moderated by Dr. Shubhadeep Debabrata Sinha, Senior Vice President and Head (Global), Clinical Development and Medical Affairs. Hetero Labs Ltd, Dr. Sinha emphasized that decentralized clinical trials are a paradigm shift in research methodology from a site-centric to a patient-centric model. Decentralized testing improves convenience, accessibility, and inclusivity by bringing testing directly to patients, whether in their homes or through neighborhood medical professionals. Dr Chatterjee highlighted the trend towards consumer-centric practices in many industries including healthcare where patients are viewed as consumers with rights under consumer laws. By comparing online banking and food delivery services, they highlighted the shift in providing services to customers rather than making them seek them out.

Dr. Thuluwa emphasized the important role of decentralized clinical trials in improving patient outcomes and accelerating the therapeutic development process. Trials that prioritize innovative strategies facilitate participant participation by overcoming specific hurdles, such as convincing healthy volunteers to participate in a vaccine study. Dr. Salvi said that it will take 10 years to achieve decentralization. Most trials are still hybrid models, and only a few trials, such as that conducted by Sanofi, have achieved full decentralization. Patient-centricity is the main force behind the shift towards decentralization, which aims to accelerate trial participation without interfering in patients’ lives.

‘Decentralized clinical trials and AI in clinical trials?’ The panel discussion was followed by a presentation on ‘Transforming Pharma: Streamlined Solutions with Adobe Document Cloud’ by Mohammad Yaman, Product and Solutions Specialist, Adobe.

Mohammed Yaman’s presentation was followed by a presentation on ‘Data-driven acceleration and predictive paradigms in clinical research and development’ by Anuj Saini, Vice President and Head-Biopharmaceutics and Clinical Development, Zydus Lifesciences Limited.

Saini’s presentation was followed by a panel discussion on ‘A multi-stakeholder perspective on integrating clinical research across the continuum of care’. Panelists at the session included Dr. Shubhadeep Debabrata Sinha, Senior Vice President and Head (Global), Clinical Development and Medical Affairs, Hetero Labs Limited; Dr. Avinash R Kakade, Senior Vice President, Global Head, Pharmacovigilance, Dr. Reddy’s Laboratories and Sunila Thatte, Head, R&D India, Merck Group. The session was moderated by Dr. Jaideep Gogate, Global Chief Medical Officer, Cipla Limited. Thatte said clinical research has a significant social impact, suggesting that the results impact not only individual patients but also the larger community. This emphasizes how important it is for medical research to take into account the impacts of society. Dr. Kakade highlighted the important changes that occur after drug release, suggesting that real-life application often differs from experimental settings. This emphasizes how important it is to conduct pharmacovigilance and post-market surveillance to monitor the efficacy and safety of medicines. Dr. Sinha stressed the importance of bridging the gap between research and healthcare delivery, viewing clinical trials and product development as a journey from the sponsor’s laboratory to the patient. This emphasizes how important it is to take a patient-centered approach to drug development and regulatory processes.

‘Next Generation Leadership and Clinical Development’ by Dr. Kamala Rai, Vice President, Senior Global Program Head, Novartis following the session ‘A Multi-Stakeholder Perspective on Integrating Clinical Research across the Continuum of Care’ session A presentation was given on ‘Future’. Where he explained the paradigm shift in drug development toward precision medicine and creative trial designs. The focus will be on using cutting-edge technology such as big data analytics and artificial intelligence to accelerate patient recruitment and engagement, tailor therapy and testing processes. Predictive modeling and biomarker identification will help in early disease detection and intervention, making prediction and prevention essential elements.

Dr. Rai’s presentation was followed by a presentation on ‘Integrated Evidence Generation: Using Real-World Evidence (RWE) in Product Development’ by Dr. Santosh Torah, Director of Medical Affairs, Vaccines, Rare Diseases and Digital, Pfizer India .

The conference concluded with a valedictory address on ‘Patient Recruitment and Retention Strategies in the Era of Decentralized Trials’ by Dr. Sudipto Roy, Scientist ‘E’ Clinical Studies and Trials Unit (CSTU), Development Research, Indian Council of Medical Research.