15th Annual Clinical Trials Summit 2024
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WHY SHOULD YOU ATTEND?
Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.
Speakers
SUYOG MEHTA
Sun Pharma
SUYOG MEHTA
Sun Pharma
SUYOG MEHTA, Sr.VP & Head - Medical Affairs & Clinical Research, India & Emerging Markets, Sun Pharma
Have been associated with the Pharmaceutical Industry for 20+ years and have worked in positions of increasing responsibility over a period of time. Have been associated with various functions in Medical & Regulatory department including Medical Affairs, Clinical Research, Pharmacovigilance & Regulatory Affairs. Have been incharge of safety operations as a Local Safety Officer for 5 years. Have been incharge of Regional Medical Affairs function for Asia, Oceania and Middle East countries for 5 years. Have been trained in Effective Personal Productivity from Leadership Management International & Problem Solving and Decision Making by Kepner-Trojoe, Singapore. With a focused approach on talent identification and management, I have effectively developed and managed of team of professionals in Medical Affairs, Clinical Research, Pharmacovigilance & Regulatory Affairs.
Have successfully setup the function of Field based Medical Affairs and have been involved in successful identification and implementation of individual development plans for team members and have been able to make team members ready for next level of responsibility. Have driven successful development of resilient medical strategies resulting in innovative medical projects, award winning medical education programs and meaningful evidence generation leading to launch excellence and effective life cycle management. Have been associated with successful launches across specialties of neurology, neurosurgery, psychiatry, orthopedics, pediatrics, oncology, dermatology, pain management, cardiology, infectious diseases and immunology.
SANDESH S
Cipla
SANDESH S
Cipla
SANDESH SAWANT, VP Medical Affairs & Head - Clinical Trials, Cipla
Qualified Physician with extensive experience in patient management, Clinical Development, Medical Affairs, Pharmacovigilance, Clinical Research, and Training, with business acumen with a total experience of 25 years and exposure to various therapeutic areas like Respiratory, Diabetes, Oncology, Neurology, Vaccines, Nephrology and Pain
SHALINI MENON
Sanofi
SHALINI MENON
Sanofi
SHALINI MENON, Country Medical Director, South Asia, Sanofi
Shalini Menon has more than 18 years of industry experience in the field of medical affairs & clinical development. Her experience includes leading medical education and clinical development programs at Pfizer, and pipeline launches at Boehringer Ingelheim across cardio-metabolic, specialty care, and critical care portfolios. Currently she is working as the Country Medical Lead and Head of General Medicine at Sanofi, India. She has published in national as well as international journals and presented her research insights at various scientific symposia. She recently authored a publication on a LongitudinAl Nationwide stuDy on Management And Real-world outComes of diabetes in India over 3 years (LANDMARC trial). She is a Post-Graduate in Pharmacology (MD, DNB) from KEM Hospital, Mumbai and she also completed MSc in Pharmaceutical Medicine, from University of Hibernia, Dublin.
VAIBHAV SALVI
Sanofi
VAIBHAV SALVI
SanofiVAIBHAV SALVI, Director & Head – Clinical Study Unit, India & South East Asia, Sanofi • Dr. Vaibhav Salvi is a physician by training with specialization in Cardio-vascular science. • He has more than two decades’ experience in Clinical Research and Medical Affairs. • His research work has been presented at various national conferences (Cardiological society of India, Indian Society of Medical Statistics) and international conferences (Drug Information Association, Statisticians in Pharmaceutical Industry, International Congress on Electrocardiology). • He has more than two dozen publications to his credit published in journals like British Journal of Pharmacology, Journal of Pharmacology, Diabetes Medicine, Journal of Electrocardiology and Diabetes Care to name a few. • He is life member of Indian Society of Clinical Research and TransCelerate Inc.
RASHMI HEGDE
GSK
RASHMI HEGDE
GSK
RASHMI HEGDE, VP Medical Affairs, GSK
• Dr Rashmi Hegde is currently Executive Vice President Medical Affairs GSK. Dr Hegde is a Paediatrician by training and has vast experience with the International Pharmaceutical companies.
• She has been associated for over 2 decades with several global Pharmaceutical companies such as Abbott, Solvay, Wockhardt, Piramal, Novartis. Dr Hegde has led Medical Affairs, Medico-Marketing, Medical Strategy, Clinical Operations, Regulatory, Pharmacovigilance and Medical Scientific Liaison for both Pharmaceutical and Biotechnology companies.
• Dr Hegde takes a keen interest in Pharmaceutical laws, and Safety Regulations (EU, US FDA & Asia Pacific), and Health Technology, Precision Medicine, Big Data and Real World Evidence/ Data from the TechnoCommercial and Regulatory compliance perspective and its applications to Clinical Studies and New Product Development. Dr Hegde has been a prolific speaker and writer at several international scientific forums and has published several scientific papers.
VIPIN SETHI
Cadila
VIPIN SETHI
Cadila
VIPIN SETHI, Vice President, Cadila
• 13+ years’ chronicle of success in leading the Medico marketing / Business Development / Marketing of life saving drugs & Bioformulations as well as the provision of chronic care.
• Playing an important role in strategic planning of company
• Expertise in comprehending medical terminology due to medical degree.
• Analytical abilities and creativity to build-up competitive advantage and contribute to the growth of the business.
• Good relationship building skills developed over years in maintaining contacts with senior doctors and rich experience of working in the reputed Institutions of Delhi.
• Proven success in penetrating new markets and establishing rapport with medical professionals and druggists.
• Excellent resource balancing and leadership skills with an ability to drive initiatives through efficient team work.
• Motivated & ambitious with excellent interpersonal, relationship management, and presentation skills.
• Excellent temperament to multi-task and coordinate various activities under high pressure and time constraints
CHIRAG TRIVEDI
Sanofi
CHIRAG TRIVEDI
Sanofi
CHIRAG TRIVEDI, Global Head, Clinical Study Units (CSU) Early Operational Strategy, Sanofi
LOYA HIROM
Oncquest Laboratories
LOYA HIROM
Oncquest Laboratories
GOPAL NANDAN, GM, Head - Clinical Trial, Public Health, Outsourcing & Accessioning, Oncquest Laboratories
Gopal Nandan is Heading Clinical Trials & Patient Support Programs at Oncquest Laboratories Ltd. Into the industry from last 15 years out of that 10 years into central Laboratory adding value addition to the ongoing Clinical Research and Patient Support Programs for all Local & Global studies.
In past worked for the Global Leaders in Central Laboratory like Quest Diagnostics and Q2 Lab Solutions looking upon across the globe with his valuable experience and rare expertise in this particular field which is less talked and discussed. He has an ambition to make his organization Number “One” in India for Clinical Trial Central Laboratory.
ANUP PINGLE
GSK
ANUP PINGLE
GSK
ANUP PINGLE, Medical Director - Global Health Access, GSK
Dr. Anup Pingle is a medical postgraduate and a senior leader with around 20 years of experience in pharmaceutical industry in both country and above country global roles with expertise in Medical Affairs, Clinical Development, Regulatory Affairs, Safety and Pharmacovigilance, Medical Writing, Governance and Compliance. He has a rich experience working across multiple therapeutic areas and has held various strategic medical leadership roles in both country- based as well as global teams.
In his current role as Executive Vice President andGlobal Medical Directorwithin the Global Health Access team, he is committed to drive equitable access to GSK assets that can change the trajectory of high burden diseases in lower-income countries, with a focus on infectious diseases. He is involved in planning and execution of medical affairs strategiesto ensure early access to medicines and vaccines in low-income countries. This includes driving access strategies in the Public Health Markets by working closely with GSK country and regional teams, Healthcare Professionals, Government Officials, and Supranational partners.One of the key aspects of his role is tocollaborate withR&D colleagues andco-development partners to support the clinical development of Global Health pipeline assets, by providing medical expertise and gathering insights from external scientific community.
MUKESH GORI
Novartis
MUKESH GORI
Novartis
MUKESH GORI, Director ESP Engagement PV & PS, Novartis
15 years of experience | Patient Safety/Pharmacovigilance | Audits & Inspection | Out-sourcing/Vendor Management | Delivery | Strategy & Operations
Core expertise -
• Pharmacovigilance/Patient Safety, Audits/Inspections
• Project Management, Team Leadership
• Contract creation, Resources Planning & Recruitment, Outsourcing
• Metric & Compliance management
• Commerce - Financial budgeting and forecasting
ANIKET RAJE
Sanofi
OMPRAKASH S
FDA (Maharashtra State)
OMPRAKASH S
FDA (Maharashtra State)
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)
DIVAKAR KOLLI
Cipla
DIVAKAR KOLLI
Cipla
DIVAKAR KOLLI, Director - Development Quality Assurance, Cipla
• Total 20 years of experience in clinical quality assurance and currently Heading QA function for Clinical, Non-clinical, Formulation Development and Medical affairs at Cipla Limited.
• Instrumental in setting-up clinical QA function in Cipla. Implemented various risk based approached for vendor oversight in clinical research.
• Handled multiple regulatory inspections including USFDA, WHO, EMA, ANVISA and DCGI. Handled more than 25 USFDA inspections for clinical trials, BA/BE and In-vitro BE.
• Experienced in wide variety of audits including Investigator sites, BA/BE CROs, clinical trial CROs, Bioanalytical laboratories, Data Management, Drug Supply Management and IVRS/IWRS service providers, IT and 21 CFR part 11 compliance audits in clinical research.
• Experienced in conducting audits at both domestic and international CROs and investigator sites. Conducted audits in more than 10 countries.
VIVEK GUPTA
Organon
VIVEK GUPTA
Organon
VIVEK GUPTA, Associate Director - Strategic Engagements & Vendor Management - Clinical & Medical Affairs, Organon
DILIP PAWAR
MediLearn India
DILIP PAWAR
MediLearn India
DILIP PAWAR, Executive Director, MediLearn India
Heading Medical Affairs, PV and Global Clinical Development. I am oncologist and also Covid Expert
NEELAKANT K
Dr. Reddy’s Laboratories
NEELAKANT K
Dr. Reddy’s Laboratories
NEELAKANT KRISHNAN, Sr. Director - Clinical & Medical Operations (CMO), Dr. Reddy’s Laboratories
• Passionate clinical research professional with close to 2 decades of experience in Pharmaceutical Industry with proven ability to lead and manage teams across geographies.
• Dentist by training and currently associated with Dr. Reddy’s Laboratories as Senior Director- Lead CMO and responsible for delivery of Dr. Reddy’s portfolio of clinical trials across specialty, differentiated products for developed and emerging markets including India and China.
• Worked in increasingly responsible positions across organizations such as Sanofi, AstraZeneca, GSK and Lupin.
• Significant experience in managing and delivering complex clinical programmes (Phases I to III) across geographies including India, US, EU/UK and Latin America.
KAMLESH PATEL
Lupin
KAMLESH PATEL
Lupin
KAMLESH PATEL, Head - Medical Regulatory Clinical Research & Health Tech, Lupin
• Dr. Kamlesh Patel is Postgraduate Doctor and currently heading Medical Affairs, Clinical Research , Regulatory and Health Tech in Lupin Pharma.
• He is Doctorpreneur , having rich 20 + experience in Academic, Pharma, NIDHI Techno Business Incubation and Health Tech entrepreneur.
• His passion is towards building functional and operational excellence in MedTech segment by creating state of art services and facilities to improve overall clinical outcomes and quality of life.
• Before joining Lupin Pharma he worked as CEO at IIPH Gandhinagar to establish fully functional NIDHI TBI. Apart from that he headed Medical , Regulatory, Clinical research and Pharmacovigilance in Major MNC and Indian Pharma
ROSHAN PAWAR
Alkem Laboratories
ROSHAN PAWAR
Alkem Laboratories
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories
• Dr Roshan Pawar, MBBS, MD Pharmacology
• Currently working as Associate General Manager in Alkem Laboratories. Have more than 6 years of experience in pharmaceutical industry particularly in oncology therapy area and biosimilars. Handled clinical development as well as scientific marketing of Biosimilars (particularly MABs) and well versed with biosimilars regulations in India.
• Before pharma industry, worked as Assistant Professor in Dept of Pharmacology, Seth GS Medical College and KEM Hospital Mumbai.
KEDAR NAYAK
GSK
KEDAR NAYAK
GSK
KEDAR NAYAK, Head - Clinical Development, GSK
• Head of Clinical Matrix team comprising of subject matter experts and accountable for end to end study delivery of local interventional studies (phase IV, BA/BE studies) across Emerging markets.
• Over 16 years of experience in clinical research ( Phase II-IV, BA/BE) operations, and people management.
• Recognized with President’s award by Indian Society for Clinical Research for contribution as the Chair for the ISCR West Chapter in 2018 & 2019.
• Area of expertise - ICH GCP, Clinical Trials Management, Project Management, Clinical Development, Clinical Quality, BA/BE studies, People management. MBA
SADANAND K
Fresenius Kabi
SADANAND K
Fresenius Kabi
SADANAND KULKARNI, Head - Medical, Regulatory, Vigilance & Quality, Fresenius Kabi
Current Position
• Head, Medical, Regulatory, Vigilance, Quality, Fresenius Kabi India Pvt. Ltd., since Jan 2019
Professional experience:
• Vice President, Medical Affairs and Clinical Research, Fresenius Kabi India Pvt. Ltd., Pune/Gurgaon: July 2011 to 2018 (with Fresenius Kabi, since 2003)
• Assistant Medical Director, Serum Institute of India, Pune., Sept 2000-May 2003
• Teaching profession: February 1996 - August 2000
• M.D. (Clinical Microbiology): 1995: BJ Medical College, Pune
• DIB (Diploma in International Business) 2003: Symbiosis Institute of International Business
• Trained in clinical nutrition and volume therapy, Fresenius Kabi Advanced Nutrition course and Fresenius Kabi Advanced course in transfusion alternatives
Clinical/research interests:
• Co author of papers presented in ESPEN 2004, 2005, PENSA 2003, NATA, 2006 in the field of Clinical Nutrition and Volume Therapy
• 4 publications in the field of Clinical Microbiology and Vaccinology
Special areas of interest:
• Clinical Nutrition and immunonutrition
• Hospital acquired infections
• Clinical trials under GCP
PANKAJ THAKUR
Sanofi
GANESH KADHE
Abbott
DEVEN BABRE
GSK
DEVEN BABRE
GSK
DEVEN BABRE, Former Director Analytics & Benchmarking, GSK
Leadership in areas of clinical research, primary in Biometrics and Pharmacovigilance. I am a post graduate in Life Science. Twenty-four plus years of experience in Biometrics, Pharmacovigilance and Pharmaceutical Industry. Have supported product development of tools across life science. Active in Automation & Technology + Clinical Trials System Landscape changes. Rich experience in consulting, project management, managing delivery and training. Proficiency in technologies, information dissemination and numerous databases in Biometrics and Safety data management Systems such as Oracle Clinical (Certified from CSS), Inform (Certified from Phase Forward), Medidata Rave, ARGUS, WebSys, SAS and Client Developed Systems. Strong communication skills when working with project managers, subject matter experts and customers. Skilled instructor and project leader. Currently working as Director, Life Science Digital Operation @ Cognizant.
Prior to this Cognizant I was working as Associate Vice President at TCS. Prior to TCS I worked as Director, Pharmacovigilance Operations @ Sciformix. Where I was managing PV operation involved in oversight of Delivery Managers, across Manila and India. Prior to that I worked with PharmaNet managing CDM as a Director. I served as board of directors for PharmaNet as a representation for India unit. Prior to PharmaNet I worked with Quintiles in capacity of Assistant Training Manager / Clinical Data Coordinator. Prior to Quintiles I worked in Wockhardt as Executive for Medical Information. I had started my career with TISS as Research Investigator. Has travelled to several destinations on globe for training or representing organization for Investigator or Management or Business Development meeting and attending conferences.
RENUKA NEOGI
Sun Pharma
RENUKA NEOGI
Sun Pharma
RENUKA NEOGI, Head & Deputy General Manager – Global Clinical Quality Management, Sun Pharma
VISHVAJIT M K
Fresenius Kabi
VISHVAJIT M K
Fresenius Kabi
VISHVAJIT M. KARANDIKAR, Business Unit (BU) Head -Parenteral Nutrition, Fresenius Kabi
Educational Qualification:
• Science Graduate from Fergusson College -Pune ( with distinction)
• Completed Management studiesfrom Pune University -Pune ( with distinction)
• Completed Management Executive Education Program from Mt Eliza- Melbourne, Australia
Extracurricular activities:
• Cricket, college team captain
• Soft ball, West Zone
1) E Merck India Ltd (Pharmaceutical Sales)
2) Worked as Business Manager in Congo – Central Africa
3) Fresenius Kabi India Pvt Ltd (Speciality Division)
> Successfully launched Parenteral Nutrition in 1995 .
> Achieved leadership position in hospital segment
> Created Nutrition Advisory Board and organized expert meeting with top Nutritionists in the Zone
> Exhibited strong leadership in EnteralNutrition business
> Established Diabetes specific nutrition, High Protein formula as a new segment in supportive care;
> Actively participated "UCNtrial ( United for Clinical Nutrition)" this is a multicentric ,multinational trial
> Attended ESPEN LLL course (European Society for Parenteral and Enteral Nutrition,Life Long Learning course)
> Member of FRANC Asia Program (Fresenius Advanced Nutrition Course) with top international speakers
> Attended PENSA conference, Parenteral and Enteral Nutrition Society of Asia conference
> Conducted webinars and seminars with ISCCM – Indian Society for Critical Care Medicine
> Conducted numerous symposia with Indian Surgical Society, IASG, Indian Association of Surgical Gastroenterologists) , Oncologists etc
> Participated in meetings with national IDA (Indian Dietetics Association)
> Currently working as Business Unit Head ,Parenteral Nutrition Division at Fresenius Kabi
NISHITH VYAS
Organon
NISHITH VYAS
Organon
NISHITH VYAS, Associate Director, R&D Strategic Sourcing and Vendor Management, Organon
GOPINATH M
Pfizer
GOPINATH M
Pfizer
GOPINATH MADHU, Senior Client Partner, Digital & Technology, Pfizer
A highly motivated and result driven business technology leader offering a proven history of success supervising planning and managing one or more multifaceted digital project with multiple deliverables, complex dependencies and budgetary restrictions. Digital Solutions Director with extensive experience and ability to drive strategic initiatives in the areas of business growth, leadership and organization effectiveness. Experience professional who directs and oversees the evaluation, development, release and enhancement of digital solutions to achieve business objectives.
A real perfectionist with 19 years of experience in strategic management with the distinction of driving new IT initiatives, designing corporate infrastructures & contributing in achievement of organizational objectives. Demonstrated excellent expertise in technology management activities including project scoping, estimation, planning, risk management, finalization of technical / functional specifications, resource administration and quality of the product
SUCHETA R P
Sun Pharma
SUCHETA R P
Sun Pharma
SUCHETA ROY PANDIT, Head - Clinical Operations, Sun Pharma
Currently working as Head – Clinical Trial Operations for India Clinical Research in Sun Pharma Laboratories Ltd. Have been associated with Clinical Research Industry for 15years and have worked in both Pharmas as well as CROs such as Sun Pharma Advanced Research Company Ltd., Wockhardt Ltd., Q2 Solutions, Klinera Global Cooperation, Dr. Reddy’s Ltd., Medclin Research Pvt. Ltd., in positions of increasing responsibility.
Have contributed in development of clinical research teams in two pharma companies; trained CRA teams in EMEA Countries for Phase IV studies; handled the India Operations in Multinational Clinical Trials for USA clientsas a CRO partner. Author in multiple publications for real world evidence generations studies and EMR studies in Indian and International Peer-reviewed journals. Undergoing Effective Personal Productivity from Leadership Management International.
SANKET NEWALE
Wockhardt
SANKET NEWALE
Wockhardt
SANKET NEWALE, Head Medical Affairs & Business Compliance, Wockhardt
Sanket has 12+ years of Medical Affairs experience including clinical experience across diversified sectors in Pharma Industry, health care and devices. In his previous roles, Sanket was with Emcure Pharmaceuticals wherein he was Head-Medical Affairs. Prior to Emcure he has worked with Abbott, MSD and Lupin in Medical Affairs. He has a hands on experience in managing large teams and handled therapy areas including Critical Care, Orthopedics, Obs-gyne, Neurology, Psychiatry, Nephrology, Cardiology, Endocrinology and Diabetes.
In his career of over 12+ years in pharma industry, Sanket was responsible for developing & executing Medical strategy, including flagship medical education programs, digital initiatives, consensus statements, global advisory board meetings and global evidence generation projects with a focus on treatment paradigms, and strategies for overcoming barriers to access and optimization of patient outcomes.
Sanket has been significantly involved in building thought leader (TL) advocacy across organizations in India and Global regions and also in developing processes for facilitating the same. He has been involved in launch excellence with numerous successful launches to his credit in Cardiovascular and Diabetes space- Sacubitril Valsartan, Dulaglutide, Empagliflozin, etc. He is also credited with successfully establishing & driving the Field Based Medical Affairs (MSL) Excellence in the organizations he worked with.
As a part of his responsibility, he has also heads the Compliance Department and has steered the organization to have maximum adherence to regulatory standards providing innovative ways of KOL engagement and evidence generation.
Sanket has over 10+ publications to his credit in various National & International Journals of repute. He has also authored multiple book Chapters.
MAYUR M
Alkem Laboratories
MAYUR M
Alkem Laboratories
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
• Pharmaceutical physician, with >10 years of experience and expertise in key levers of medico-marketing
• Worked across medical and regional medical affairs, handled key super-specialty therapy areas and big brand’s in the industry viz. Cremaffin, Duphalac, Dupahston, Vertin, Influvac to name a few
• Spearheaded key project in medico-marketing, KOL profiling, Young doctor program in India
• Integral part of clinical research team across Abbott/Alkem and supported Phase III/Phase IV and RWE studies
• Aspired to lead passionate, scientifically sound, ethical and innovative medical team to impact patient’s lives at large
Professional Journey :
• MBBS: Dr. VM Govt Medical College Solapur (2002-2008)
• MD Pharmacology: Indira Gandhi Govt Medical College Nagpur (2009-2012)
• Lecturer Pharmacology: Govt Medical College Nagpur (2012-2013)
• Medical Advisor: Jubilant Life Sciences (2013-2014)
• Medical Advisor: Abbott India Ltd (2014-2016)
• Sr Medical Advisor: Abbott India Ltd. (2016-2019)
• Sr. Manager: Abbott India Ltd (2019-2022)
• Head Medical Affairs: Alkem Labs Ltd (2022 – Till date)
GODHULI C
Sanofi
GODHULI C
Sanofi
GODHULI CHATTERJEE, Senior Medical Advisor, India-South East Asia, Sanofi
• As a Senior Medical Advisor at Sanofi, I leverage my 18 years of experience and my MD in Pediatrics to provide medical leadership and strategic direction for the India-South East Asia Cluster.
• My mission is to improve patient outcomes and access to innovative therapies in the areas of diabetes, rare diseases, and immunology, which are my fields of expertise and passion.
• I have worked in the area of SWITCH for global consumer healthcare products.
• Another area of exposure and contribution has been in the discipline of gene therapy for rare blood disorders and rare diseases.
• In my digital journey, I have worked in e-consent, decentralized clinical trials, patient technology and design thinking.
• I have also participated in cross-industry collaborations and publications, such as the novel measurement of sleep in rheumatoid arthritis, which was featured in the Digital Biomarkers journal, as a TransCelerate Biopharma Inc. workstream co-authored article.
• Furthermore, I have contributed to clinical research safety and have ensured the highest standards of pharmacovigilance for clinical trials and post-marketing surveillance.
• During my tenure as the Asia Pacific regional point of contact for fellow safety leads in clinical research, I have worked across varied geographies and work culture, creating a sense of camaraderie and bonhomie among colleagues, embracing diversity and inclusion in daily work.
• Additionally, I deliver high-quality medical education and training to internal and external stakeholders, using the latest digital platforms and tools.
• I am comfortable with a matrix structure and can accommodate time zone differences in my regular work.
MARTINA GOMES
Bayer
MARTINA GOMES
Bayer
MARTINA GOMES, Head, Reg Affairs – CH, Bayer
Martina Gomes is the Regulatory Head for Bayer’s Consumer Health Division in India. She has over 16 years of Pharma and Consumer Health industry experience working in organizations like Pfizer & Sanofi across diverse portfolio of Biologicals, Specialty, Animal Health, OTC, Nutritionals and Ayush for South Asian countries. In her various roles, she has had opportunities to work closely on Health Authority interactions, Registration strategies, Internationa lproduct launches, Product life cycle expansions, business growth strategies and various other organizational projects. Martina has been involved with various Trade associations for the last 10 years and has worked on many initiatives to shape the external regulatory environment.
Martina strongly believes in building a regulatory framework and sustainable healthcare solutions to enable our Indian consumers to be in charge of their health and foster Self-care in our country.
Martina post-graduated from Sophia College, Mumbai with a Mastersin Microbiology and further a degree in Clinical Research from the Bombay College of Pharmacy, Kalina. She’s an active member on the Board of Studies of Sophia College since 2021. She joined Bayer India in July 2020. In her earlier stint, she was the Head of Regulatory Affairs CH for South Asia at Sanofi.
INDRANIL P
Ipca Laboratories
INDRANIL P
Ipca Laboratories
INDRANIL PURKAIT, Senior GM - Medical Affairs, Ipca Laboratories
Currently, heading the medical affairs function of domestic business of Ipca Laboratories comprising of 20 divisions. Leading and mentoring a team of 15 Medical Professionals. Key therapy areas- Cardiology, Diabetes, Rheumatology, Antimalarials and Pain management.
Indranil is a physician, specializing in Internal Medicine with special interest in cardio metabolic disorders. After completing his medical education from Calcutta Medical College Indranil practiced clinical medicine in National Health Service, United Kingdom for 4 years.
Subsequently, he has been working as a pharmaceutical physician in India for more than 11 years and has gained rich experience in global organizations like MSD & Abbott. In this capacity Indranil has led a wide range of research, advocacy, education,capacity building and patient support programs, all directed towards ensuring optimal access to innovative medicines for patients and enhancing scientific reputation of the organizations he has worked for. Indranil is also credited for team building, mentoring and performance optimization of medical affairs teams during all his assignments.
He is closely associated with the top functionaries of key societies like CSI, RSSDI, ESI & API in different projects.He has received various excellence awards in MSD (2) and Abbott (3) including 2 Vice President’s Awards for Best Brand Performance.
Indranil has authored nearly 10 publications in cardio-diabetes in peer reviewed journals like JACC, BMJ, JCI, Hypertension etc . He has spearheaded release of quarterly journals like What’s New in Dermatology and also contributed to the formation of consensus document and position statement.
His researchgate profile is https://www.researchgate.net/profile/Indranil_Purkait
KAVITA LAMROR
Maxis Clinical
KAVITA LAMROR
Maxis Clinical
KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical
Dr.Kavita Lamror has completed her MPH from Johns Hopkins [Baltimore, US] and MBBS from Maharashtra Institute of Health Sciences [Mumbai, India]. With extensive experience in the healthcare industry, she has worked across academia, pharma/medical devices, and services sector, to analyze and communicate evidence for improving health outcomes. She is adept at identifying, eliciting, and communicating the incremental value of a health intervention from an individual, societal, and payer perspective.
Prior to leading the RWE efforts at Maxis Clinical, Dr. Lamror was the Real-World Evidence Investigator Expert and Product Owner at Sanofi, leading RWE studies globally and was also responsible for developing 2 key custom RWE products for Sanofi users. She has held significant roles at organizations like Excelra, Cactus, Indegene, and Novartis where she helped establish Value Evidence functions as de novo revenue-driven verticals. Dr. Kavita merged and acquired 2 companies (digital RWE product-based US companies) as part of the inorganic growth strategy in her previous roles. She has been a part of multiple executive leadership teams and regularly contributes to driving the strategy, vision, and goals of the organizations, through organic and inorganic growth.
Dr. Lamror is invested in identifying the right talent for these highly skilled teams across the industry, and is proficient at nurturing bright minds inspired to take on challenges. Currently, she is responsible for generating real world evidence from established and novel patient-level as well as summary level data sets, across the globe. She ensures that the team maintains a high focus on creating value from traditional as well as heterogeneous unstructured data sources, while optimizing the use of technology, in the evolving healthcare environment.
SHRADDHA B
Sandoz
SHRADDHA B
Sandoz
SHRADDHA BHANGE, Senior Medical Safety Lead, Sandoz
“Dr. Shraddha Bhange is Senior Medical Safety Lead in Sandoz. In her current role, she is involved safety of products such as signal detection, literature review, development of core data sheets, responses to inquiries from regulatory authorities or health care professionals on safety issues, Risk management plan (RMP). Prior to this new role, Shraddha was Medical Director at EVERSANA for 5 years; there she was responsible for leading, delivering and implementing end to end Pharmacovigilance services, especially signal detection, and risk management for small to mid-sized pharma companies in different therapeutic areas in US and EU.
She was also leading business development and training academy. Overall, Shraddha has 14 years of PV experience in Pharma and CROs. She has worked in Paris for AB Science, a French BioPharma as deputy QPPV. She has worked in Wockhardt Pharma as Pharmacovigilance manager, prior to that as Pharmacovigilance expert with Novartis Healthcare Pvt Ltd, India and as Senior medical reviewer with Cognizant Technology solutions. A leader with strong management, strategic development and business development experience underpinned by extensive domain expertise.
Shraddha obtained her master’s in biomedical technology at Coventry University, United Kingdom and MBBS (Bachelor of Medicine and Bachelor of Surgery) in medicine at MUHS University, Nasik, India. She also has done certifications and diploma in genetics, six sigma and leadership topics.”
MANISH M
Zydus Lifesciences
MANISH M
Zydus Lifesciences
MANISH MAHAJAN, GM - Lead Medical Affairs BU Biologics, Zydus Lifesciences
• Qualified MD from the premier institute AIIMS (Delhi), PGD-Pharma Marketing and certified in Business Analytics, Health Economics, Clinical Research offering more than 15 years of experience in Medical Affairs acros top multi-national and Indian Companies like Abbott, Lupin, Danone and Zydus.
• Championing the purpose of “Patient Centricity” and experience of more than a decade of building high performing Medical Affairs teams.
• Currently Heading Medical Affairs at Zydus Lifesciences Biologics business with porftfolio size of INR 1100 crores, encompassing therapeutic areas of Oncology, Nephrology, Vaccines, Gastroenterology/ Hepatology, Rheumatology and Ophthalmology through team of Medical Advisors and Medical Science Liaison.
• Organization lead for Digital Therapeutics in areas of NASH and Oncology.
• Profound experience in New Product Development and Portfolio management
• Fertile mental faculties credited with guiding several research projects and publications.
• Skilled in ensuring promotional compliance for Food (FSSAI), Drug (DCGI) and UCPMP.
• Exceptional administrative and organizing capabilities with strong analytical and reasoning skills and a capability to collaborate with interdisciplinary team of Marketing, Regulatory, R&D and Sales.
• Areas of interests: Digital Therapeutics, Market Access, Biosimilars, Translational Medicine and Nutrition.
SAKHARAM G
RENOVARE Healthcare
SAKHARAM G
RENOVARE Healthcare
SAKHARAM GARALE, Founder & CEO, RENOVARE Healthcare Solutions
• Dr. Sakharam Garale, is Physician with E-MBA from IIM-Indore, BCMAS(USA), perusing a PhD in management with over 20 years of rich experience; in Global Medical Affairs, Medico-marketing, Clinical Research & Development, Public Health, Regulatory Affairs, Pharmacovigilance, Project Management, Vendor Management, Compliance, People Management in the Pharmaceutical & Healthcare industry.
• He has had exposure to domestics and international markets with MNCs like Mylan Laboratories Ltd, Abbott Ltd, Quintiles Translational Ltd, Sandoz India Ltd and Glenmark Pharmaceuticals Limited.
• He brings extensive experience of working in international markets i.e. Emerging Markets (LATAM, ASIA, Africa and JANZ) along with India for Global Medical Affairs, Medico-Marketing, Public Health, Commercial leadership, Operations and Strategy.
• He also has upper hand in setting up the units and managing Bioavailability & Bioequivalence studies with leading CROs, local and MNC Pharma organization in the industry at different levels.
• He is a well known KOL, Speaker and Trainer in Healthcare industry seen at various events and conferences in India and APAC.
• Associated with small and medium size healthcare/pharmaceutical startups as consultant for operations and strategy. With his vast international experience and exposure, he brings a detailed insights from international healthcare markets for commercial exchange.
• Founded Renovare Healthcare Solutions in 2018 with its office in Navi Mumbai to cater to KOLs, Hospitals and Pharmaceutical Industry serving global clientele.
• As part of CSR, Renovare has trained 7000+ people from different sections of society on covid-19 awareness during 1st wave and treated 5000+ covid-19 patients with a home care model during both covid-19 waves.
SUJAY PATIL
Abbott
SUJAY PATIL
Abbott
SUJAY PATIL, Clinical Project Lead, Clinical & Medical Affairs, Abbott
• Dr. Sujay Shivaji Patil is currently working as a Clinical Project Lead at Abbott in Mumbai
• By education, he is an MD Pharmacologist from Mumbai and a Data Science Professional from University of Texas.
• Professionally, has worked into various organizations in domains of medical affairs, clinical strategy, and clinical operations.
• Have exposure of working on different phases of clinical studies – right from First in Human to Phase 4 on biologics and small molecules.
• Has published peer reviewed articles in National Journals
• Passionate for working on Biosimilars and Medical Devices
• Committed to improving Quality of Life
KUSHAL SARDA
Shalina Healthcare
KUSHAL SARDA
Shalina Healthcare
KUSHAL SARDA, GM & Head, Medical Affairs, Clinical Research & PV, Shalina Healthcare
Currently I am working as GM & Head–Medical Affairs, Clinical Research & PV in Shalina Healthcare, an African MNC. Prior to Shalina Healthcare, I was associated with Abbott India Ltd. & Ranbaxy Labs. I have more than 10 years on experience in medical affairs in multiple therapies like Neurology, Psychiatry, Metabolics, Consumer, Infections & Gastroenterology. This also includes 2 years support to International Business in countries like Sri Lanka, Maldives, Nepal & Bhutan which had multiple therapies and brands. I have got 13 awards for my contribution towards the core value of company.
On clinical studies front, I have initiated & executed more than 25 clinical studies of all phases, with more than 15 publications, 8 presentations & 5 therapy guidelines. I have experience of working in CRO for BA/BE studies along with 4 years of clinical practice. I have completed my MBBS from JNMC, Wardha and MD in Pharmacology from Bharati Vidyapeeth, Pune. My interest areas are Post marketing surveillance, Digital healthcare, Medico-marketing, and Finance. My hobbies are travelling, reading, food tours and formula1.
VANDAN T
Cipla
VANDAN T
Cipla
VANDAN TRIPATHI, Sr Brand Manager (Digital), Cipla
Vandan is a multifaceted, data driven and result oriented digital marketing expert with a decade of experience in leading digital strategies across various sectors ranging from Pharmaceuticals, to Medical Devices to IT to Telemedicine and Food & Beverages. Her core forte lies into healthcare marketing where she has led the strategies to establish the digital presence of the brand, increase customer engagement and drive sales through various digital channels for India and international markets like Europe, Latin America, South Africa etc. She has also extensively worked in therapy shaping initiatives that has helped organizations to grow by creating an impact in the consumer’s/ patient’s lives.
PRASHANT B
CliniSearch
PRASHANT B
CliniSearch
PRASHANT BODHE, Director, CliniSearch
Profile Description:
Pharmacologist with 24+ years of experience in Regulatory Affairs; Quality Compliance and Systems; Global Clinical Research (Phase I-III) & Pharmacovigilance; API, Toxicology; Formulation Development; Bioavailability, Bioequivalence Studies, Pharmacokinetics
Professional Experience
Director
CliniSearch; Proprietor; Consultant, Pharmaceutical Research and Development
June 2014 - Present
Director of Operations, Medanta Duke Research Institute (MDRI)
Medanta The Medicity Sector 38, Gurgaon, Haryana, 122001, India; Aug 2013 – June 2014
Associate Director, Clinical Operations & Office Head, Sri Lanka Quintiles Research (India) Pvt. Ltd.; Feb 2011 – June 2012
Director, Clinical Development Center
Advance Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Center, Navi Mumbai; Jan 2008 - May 2010
Vice President
CliniSearch Biotechnologies, Navi Mumbai, India; Dec 2003 - Dec 2007
Deputy General Manager (Senior Clinical Pharmacologist) Lupin Research Park, Pune, India; Dec 2002 - Dec 2003
Head Regulatory Affairs (India Region) Cipla Ltd., Mumbai, India; Jul 2000 - Dec 2002
Assistant Manager, Department of Pharmacology, Toxicology, Research and Development
Cadila Pharmaceuticals Ltd., Ahmedabad, India; Since Dec. 1998 to Jul. 2000
Senior Research Fellow
Liposome Clinical Pharmacology Center, Dept. of Clinical Pharmacology, Seth G.S. Medical College and K.E.M. Hospital, Mumbai, India; Nov. 1991 - Dec. 1998
Research Fellow
Indian Institute of Toxicology, Pune, India; Apr. 1988 - Oct. 1991
Professional Memberships
- Life member of ACTREC Alumni Association, Tata Memorial Center, Kharghar, India
- Indian Pharmaceutical Association (Life Member)
- Registered Pharmacist (Life)
Publications
- 13 scientific papers in indexed International (4) and National publications (9)
- Presentations: http://www.slideshare.net/PrashantBodhe
“A critical guide for successfully conducting clinical trials”
Conference Schedule
Meet and to network with your conference colleagues.
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
09:10 – Welcome Address
EXCELLENCE IN CLINICAL RESEARCH
09:20 – Effective CAPA management, continuous improvement and operational excellence in clinical research
• Why clinical research CAPA is not as effective as GMP CAPA and what are the gaps
• In most of the cases retraining is the CAPA action, is it effective?
• How effective CAPA management can lead to operational excellence
• How TIMELY and effective CAPA can prevent data quality issues
• Case studies for achieving operational excellence throug continuous improvement
DIVAKAR KOLLI, Director - Development Quality Assurance, Cipla
CLINICAL TRIAL MANAGEMENT
10:00 – Evaluating the new opportunities & challenges in rising to the expectations and demands of a postpandemic clinical trial management
• The most impactful clinical trial management changes that were put into place due to the pandemic? Lessons learnt from that which will carry on for betterment
• What are the core fundamentals we need to have in place to achieve excellence in clinical trial management?
• How are we adapting to the new normal and excelling?
• How does RWE and RWD facilitate clinical trial management?
• What are the challenges and future outlook of RWE and RWD?
• Data collection & management: Enhancing compliance, efficiency, and speed to market through effective data integration and management
Moderator
VIPIN SETHI, Vice President, Cadila
Panellists
SANDESH SAWANT, VP Medical Affairs & Head - Clinical Trials, Cipla
ANUP PINGLE, Medical Director - Global Health Access, GSK
ROSHAN PAWAR, Head Medical Affairs, Alkem Laboratories
KAVITA LAMROR, Partner, RWE & Digital Transformation, Maxis Clinical
10:50 – Morning Coffee / Tea & Discussion
PATIENT CETRICITY
11:50 – DISCUSSION WITH EXPERTS: Prioritising Patients – Always placing patients first
• Patient involvement & engagement - Is it a conversation or an obligation?
• Importance of engaging patients in every possible ways
• Meeting new patient expectations and building the expected personalized trial experience
• How should we view patient involvement?
• How will patient involvement change as the clinical trial landscape advances with questions around data and virtual trials etc.
• Understanding what works and what doesn’t from a patient perspective – How is this relayed to regulators?
• Educating stakeholders via patient stories
• Bringing it all together to enhance the patient experience
Moderator
OMPRAKASH S. SADHWANI, Former Joint Commissioner & Controlling Authority, FDA (Maharashtra State)
Panellists
CHIRAG TRIVEDI, Global Head, Clinical Study Units (CSU) Early Operational Strategy, Sanofi
INDRANIL PURKAIT, Senior GM -Medical Affairs, Ipca Laboratories
MAYUR MAYBHATE, Head Medical Affairs, Alkem Laboratories
MANISH MAHAJAN, GM - Lead Medical Affairs BU Biologics, Zydus Lifesciences
SUJAY PATIL, Clinical Project Lead, Clinical & Medical Affairs, Abbott
SHRADDHA BHANGE, Senior Medical Safety Lead, Sandoz
12:40 – Networking luncheon
SPONSOR – SITE – CRO - PATIENTS
13:50 – DISCUSSION WITH EXPERTS: Improving collaboration & transparency: Disruptions have increased the need for strong sponsor-vendor relationships.
• How must collaboration and transparency across the supply chain continue to evolve to meet the rising demand?
• Delivering greater collaboration & transparency in sponsor - vendor relationships to drive future success
• Structural changes that sponsors need to implement to allow them to have more effective relationships with their vendors
• How CROs can benefit from continual improvement analysis and benchmarking?
• How are we moving beyond the world of good intentions and making transparency tangible?
• Organization & preparedness - Moving to another level of site collaboration
• Positive learnings that we can embed to achieve greater success?
Moderator
PRASHANT BODHE, Director, CliniSearch
Panellists
MUKESH GORI, Director ESP Engagement PV & PS, Novartis
MURTUZA BUGHEDIWALA, Sr. Director of MACR, Tech Observer
ASHWANI PANDITA, GM Quality Management & Training, Global Clinical Research Operations, Glenmark Pharmaceuticals
VIVEK GUPTA, Associate Director - Strategic Engagements & Vendor Management - Clinical & Medical Affairs, Organon
SANKET NEWALE, Head Medical Affairs & Business Compliance, Wockhardt
KUSHAL SARDA, GM & Head, Medical Affairs, Clinical Research & PV, Shalina Healthcare
14:50 - Differentiated medicomarketing initiatives for KOL engagements along with evidence generation
• Real world evidence generation
• Re-emphasis and Opinions on developed guidelines
• NCEs and their journey in India
SANKET NEWALE, Head Medical Affairs & Business Compliance, Wockhardt
15:20 – Afternoon Tea / Coffee
15:50 – 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 towards improving trial success rates?
• Effective trial design and improved compliance
OUTSOURCING / PARTNERSHIPS
16:10 – DISCUSSION WITH EXPERTS: Outsourcing in clinical trials: How to build successful partnerships?
• How to choose the right one for our trial?
• What considerations include while choosing your outsourcing model?
• Harmonizing Outsourcing to keep clinical Trials on Track - Charting a course / Strategic alignment / Metrics that drive excellence
• The Synergy of collaboration: Creating a success story
• R&D outsourcing – Key points to look out for
• What is an effective long-term Partnership?
• When to engage with patient advocacy organisations and the value they can bring?
• Benchmarking success in overcoming key operation & strategic barriers
• Discuss alternative site models and benchmark best practice for understanding the relationships between different stakeholders
Moderator
SUYOG MEHTA, Sr.VP & Head - Medical Affairs & Clinical Research, India & Emerging Markets, Sun Pharma
Panellists
NEELAKANT KRISHNAN, Sr. Director - Clinical & Medical Operations (CMO), Dr. Reddy’s Laboratories
GANESH KADHE, Country Lead & SLT Member, Scientific & Medical Affairs, Abbott
ANITHA K, Former Global Head Operations, GDO Data Operations, Novartis
SHALINI MENON, Country Medical Director, South Asia, Sanofi
SUCHETA ROY PANDIT, Head - Clinical Operations, Sun Pharma
SAKHARAM GARALE, Founder & CEO, RENOVARE Healthcare Solutions
17:00 - End of conference Day 01
08:30 – Coffee & Registration – An opportunity to meet and to network with your conference colleagues.
RWE & RWD
09:30 – How is RWE / RWD is transforming Clinical Trials? Challenges & Opportunities?
• How does RWE aids stakeholders to support decision-making and improve safety and effectiveness, and ultimately, patient outcomes.
• How can RWD be applied to gain insight in clinical development? How does it improves clinical trial outcomes?
• Getting real: Who is leading the real-world data charge with clinical trials?
• Decentralisation meets real-world data
• Barriers to adoption of RWD in Clinical Trials and the possible solutions
• Use of real-world evidence among regulators
• Dealing with privacy concerns
SUYOG MEHTA, Sr.VP & Head - Medical Affairs & Clinical Research, India & Emerging Markets, Sun Pharma
DECENTRALISATION
10:00 – Keynote Panel Discussion: Decentralisation - Sustaining DCT adoption in a challenging economic environment
• Decentralized Trials: Ensuring the best blend of decentralized & in-person elements for your trial
• Current key changes & challenges for trials in India
• DCT model as part of protocol design to support organizations to find the right balance operationally and to makes the patients’ lives easier
• Wide range of factors that need to be considered when determining the risk vs the benefit to a study
• Patient-centric sample collection – An essential gateway into the future of DCT
• Impact of allowing people to participate in clinical trials in new ways which enable better access and data for treatments and care management in the future
• Opportunities and challenges of collecting wearable data in decentralized trials
• Role of stakeholders in shaping the ecosystem and making decentralized approach successful
Moderator
DILIP PAWAR, Executive Director, MediLearn India
Panellists
VAIBHAV SALVI, Director & Head – Clinical Study Unit, India & South East Asia, Sanofi
NISHITH VYAS, Associate Director, R&D Strategic Sourcing and Vendor Management, Organon
KEDAR NAYAK, Head - Clinical Development, GSK
PRAVIN GHADGE, AVP and Head - India clinical research, Sun Pharma Laboratories
KAMLESH PATEL, Head - Medical Regulatory Clinical Research & Health Tech, Lupin
10:50 – Morning Coffee / Tea & Discussion
11:20 – Let’s get Back to Basic: Central Laboratory
Safety & efficacy data generation and present changing trend impacting on safety & efficacy data.
GOPAL NANDAN, GM, Head - Clinical Trial, Public Health, Outsourcing & Accessioning, Oncquest Laboratories
INSPECTION READINESS
11:50 - What to expect when you’re inspected?
• Key Learnings from recent inspections to smoothen your inspection readiness plan
• Different approaches to inspection readiness and how these vary across companies and regulatory updates?
• Authorities interactions and how inspections have been conducted pre- and post-pandemic?
• Building a readiness framework that takes into account new technologies and disruptors such as legislative changes, gene therapies, digital health and DCTs.
RENUKA NEOGI, Head & Deputy General Manager – Global Clinical Quality Management, Sun Pharma
12:50 – Networking luncheon
REGULATORY
13:50 – Keynote Panel Discussion: What regulatory changes & developments can help in advancement of Clinical Trials in India
• How are we tracking the evolving regulatory landscape changes and ensuring we stay compliant?
• New drugs and clinical trial rules to prepare for regulatory inspection
• Ratification - New Drugs and Clinical Trial Rules 2023
• New CDSCO Regulatory Document Submission Process
• How should operators and regulators work together to build a regulatory framework that fosters innovation whilst protecting standards?
• Are the regulations sufficient towards Decentralisation and what needs to be done?
• Delays in approval from regulatory agencies. What needs to be done?
• Standardizing and streamlining the regulatory process
Moderator
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates
Panellists
SHIRAZ KANDAWALLA, Associate Director Regulatory Affairs, Ferring Pharmaceuticals
PRIYA CHATTERJEE, Head Regulatory Affairs - South Asia, Bayer Pharmaceuticals
ANIKET RAJE, Head Regulatory Affairs- Vaccines & Specialty Care, Sanofi
HARSHAD KOTHAWADE, Former Director, Head of Regulatory Management & Trade Compliance India, South East Asia, ANZ, Merck Group
MARTINA GOMES, Head, Reg Affairs – CH, Bayer
14:50 – Developing a Novel Measurement of Sleep in Rheumatoid Arthritis: Study Proposal for Approach and Considerations
• Will describe the process outlined in the paper for developing and obtaining regulatory acceptance for a NDE to assess sleep in patients with RA
• Will identify key considerations and challenges for developing novel digital endpoints for use in medical product development
• Will describe approaches to advancing the use of novel digital endpoints for use in medical product development
• Will highlight the importance of regulatory strategy in the development and validation of novel digital endpoints
GODHULI CHATTERJEE, Senior Medical Advisor, India-South East Asia, Sanofi
15:20 – Afternoon Tea / Coffee
OBSERVATIONAL STUDIES
15:40 – Observational Studies: Pros & Cons
• Importance of observational studies in Indian scenario
• What should we expect and not expect from observational studies
• Regulatory scenario as regards observational studies
SADANAND KULKARNI, Head - Medical, Regulatory, Vigilance & Quality (South Asia), Fresenius Kabi
IMPACT OF TECHNOLOGY
16:10 – Keynote Panel Discussion: Technology & Innovation – Impacts & Improvements on Patient Experience
• Impact of Digital Transformation - Digitizing Clinical Trials
• What are the key market trends and challenges driving opportunities
• Trying to define what AI actually means in Clinical Trials
• Need for companies to adapt to digitalisation
• Patient Recruitment: Leveraging digital and mobile technologies to increase patient recruitment
• In what ways can we improve our capacity to anticipate and mitigate disruptive events and how are technological innovations supporting this?
• Does the new technology answer the key needs of ALL the stakeholders and not just for the sponsors/tech companies
Moderator
VISHVAJIT M. KARANDIKAR, Business Unit (BU) Head -Parenteral Nutrition, Fresenius Kabi
Panellists
RASHMI HEGDE, VP Medical Affairs, GSK
SAKSHI SHRIVASTAVA DESAI, Associate Director International PV Strategy Realization, Johnson & Johnson
DEVEN BABRE, Former Director Analytics & Benchmarking, GSK
GODHULI CHATTERJEE, Senior Medical Advisor, India-South East Asia, Sanofi
SEERA DILEEP RAJU, Senior Manager - ML & AI, MSD
GOPINATH MADHU, Senior Client Partner, Digital & Technology, Pfizer
VANDAN TRIPATHI, Sr Brand Manager (Digital), Cipla
17:00 – Closing remarks and End of conference
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Sponsors & Partners
Tech Observer
"Tech Observer is a Global CRO and FSP provider. We have been in this industry for more than 19 years providing end to end solutions in clinical research and medical affairs.
Tech Observer has a global presence with offices in New Jersey, USA; Manchester, UK; Denmark, Europe; Singapore; India (Delhi, Noida, Mumbai, Ahmedabad and Hyderabad). With the help of these offices, we are able to cater in more than 23 countries around the globe and have gained a rich experience in 22 different therapeutic areas. We have more than 350+ employees working tirelessly to achieve the goals of our Pharmaceuticals, Biotechnology, Medical Devices and FMCG sponsors.
Tech Observer is ISO 9001: 2015, 14155: 2020 and 27001:2013 certified.
At Tech Observer, we believe in providing tailored solutions that precisely align with our client's needs, while ensuring quality in everything we do."
Visit our website : www.tech-observer.com
Oncquest Laboratories
Over the 20 years, Oncquest Laboratories Ltd. has been synonymous with trust and confidence in the field of diagnostic services. Oncquest have a comprehensive test menu covering basic routine tests, specialized & super specialized tests, to highly advanced Genomic testing. Oncquest started as a research entity of Dabur Research Foundation way back in 2001 and has been a forerunner in the molecular diagnostics services across India and neighbouring countries.
A favourite amongst clinicians, specialty hospitals, and other path labs, Oncquest is known for second opinion and final diagnosis, using most advanced technology and skills.
Oncquest national footprint spans over 50 Laboratories, 400+ Collection Centres & 2500+ Service Associates. It conducts over 4,000 different tests - from the routine to the most complex, spanning over 200 technologies.
Oncquest has a highly skilled and globally reputed team of qualified doctors with combined experience of 600+ years. Its logistic capabilities and Pan Asia geographical spread makes Oncquest an ideal associate for all clinical activities.
Oncquest is promoted by the Burman family - the promoters of Dabur.
Visit our website: www.oncquestlabs.com
Clinical Research Network India
Clinical Research Network India (CRN India) :-
• Clinical Research Network India (CRN India) is a Global Contract Research Organization with extensive experience in pharmaceutical drugs, Vaccines, Nutraceutical, Medical Devices, Gene Therapy and Stem Cell Product Development Process.
• CRN India provides comprehensive solutions in Project Management, Medical Writing, Data Management, Regulatory Affairs, and other core research solutions.
• We are specialized in designing, conducting, and managing Phase I to Phase IV clinical trials.
• We have experienced in various therapeutic areas like Pulmonary, Dermatology, Cardiovascular, Respiratory, Metabolic and Endocrinology, Gastroenterology, Immunology, Nephrology, Oncology etc.
• The integration of resources at CRN India enables the highest level of quality research services with passion, knowledge, and integrity that makes it a global leader today.
PVG Pharmasciences Pvt Ltd :-
‘A Subsidiary of Clinical Research Network India’
We provide unique and affordable processes and maintain safety data solution for pharmacovigilance services, ranging from Signal detection, Safety data base, development of PSMF, writing of PSUR, RMP, Pharmacovigilance (PV) System Establishment, Global & Regional Literature screening, collection processing & submission of the ADRs (ICSR) and other Pharmacovigilance services.
CRNI’s e-MediDec EDC (Electronic Data Capture) :-
It is the most foremost, vigorous, and protected EDC system for clinical trial site, patient, and lab data capture and management.
Visit our website : www.crnindia.com
Suven Life Sciences
Suven Life Sciences is a biopharmaceutical Company with 22 years of experience in discovering and developing novel pharmaceutical products, for CNS disorders. Our focus is targeting disease areas with unmet treatment opportunities. Suven singularly focuses on the development of “New Chemical Entities” (“NCEs”) molecules for CNS diseases such as Alzheimer’s disease, various forms of Dementia, Narcolepsy, Major Depressive Disorder (“MDD”), Parkinson's disease, Bipolar disorder, and different forms of neuropsychiatry disorders, and pain disorders.
• Masupirdine (SUVN-502; 5-HT6 receptor antagonist): The most advanced clinical candidate. A global Phase-3 clinical trial to evaluate the potential of masupirdine for the treatment of agitation in Alzheimer’s disease patients is in progress.
• Samelisant (SUVN-G3031; Histamine H3 receptor inverse agonist): Efficacy and safety of samelisant has been established in narcolepsy patients in a Phase-2 proof-of-concept (POC) study. Suven is planning to initiate the Phase-3 study to confirm the efficacy and safety.
• Ropanicant (SUVN-911; α4β2 nAChR ligand): Ropanicant has shown robust efficacy in various animal models of depression. A Phase-2a clinical trial for the treatment of moderate to severe MDD is ongoing in the USA.
• Usmarapride (SUVN-D4010; 5-HT4 receptor partial agonist): It shows robust efficacy in animal models of cognition and depression. A Phase-2 POC study evaluating the potential utility of Usmarapride in cognitive deficits is being planned.
- In addition, 3 compounds are in the early stages of clinical development.
Visit our website : www.suven.com
Sclin Soft Technologies
Sclin Soft Technologies is a USA based company, established in 2015, provides a full range of Clinical Operations, Clinical Data Management, Bio- Statistics, Medical Writing and Programming Services on Customer friendly business model. Sclin Soft Technologies closely work with the clients to access their needs and customize a business model.
Our experienced clinical and Bio Statistics Data management teams are committed to maintaining Our customers’ projects on time and within budget by monitoring the quality and study of data performance in real time and providing significant feedback to the project team. Sclin Soft Technologies EDC and Pharmacovigilance software teams will provide a personalized, inexpensive and flexible approach to meeting data management needs.
Visit our website: www.sclintech.com
Techsol Life Sciences
Techsol Life Sciences specializes in offering full-range clinical research services for the clinical development of drugs, biologics, medical devices, and drug/device combination products across various indications. As a trusted scientific solutions provider, we partner with biopharmaceutical, biotech, and medical device companies to accelerate clinical development, navigate regulatory pathways to obtain approvals and provide post-marketing support throughout the product lifecycle. With our deep scientific knowledge across various therapeutic areas, we leverage our extensive site network and use innovative technology solutions to complete clinical studies, generate statistically sound datasets and timely complete regulatory submissions with an unwavering focus on process quality and patient safety.
As an ISO 13485 and ISO 14155 certified organization, we also specialize in delivering value-focused MedTech clinical services that includes regulatory lifecycle management, EU-MDR / IVDR consulting, medical writing, clinical investigations, biometrics, device vigilance, product certification, device labelling, artwork management and conducting different types of post-marketing and real-world evidence studies. Using our deep-domain scientific expertise, we help medical device sponsors to navigate through complex regulatory requirements, gather clinical and safety evidence, launch new products, and proactively perform post-market surveillance reporting across different classes of medical devices.
To know more about the Techsol Life Sciences ,
Email us on : info@techsollifesciences.com
Visit our website : www.techsollifesciences.com
Virtue Insight
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Virtue Insight
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Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
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Testimonials
GSK Medical Director - Global Health Access
Auriga Research Corporate Vice President
Raptim Research Asst. Manager, CT-QA
Lupin Research Scientist
Lupin CRA
Inductive Quotient Analytics - Advisor-International Business Development
Sri Ramachandra Medical College Head Clinical Research
JCDC Head Strategic Partnerships
Abbott Clinical Project Lead, Clinical & Medical Affairs
SDC Clinical (India) Manager, QA – Operational Compliance
CRYOPDP Associate Director, CRO Services
Techsol Lifesciences Associate Director, CRO Services
The content of the presentations was highly informative and thought-provoking. I was particularly impressed by the depth of knowledge showcased by the speakers, who provided practical strategies and solutions to address the challenges faced in the clinical trial landscape. The networking opportunities at the summit were truly exceptional. I must commend the Virtue Insight team for their impeccable organization and attention to detail. From the seamless registration process to the flawless execution of the conference, everything was meticulously planned and executed. The venue was well-equipped, and the logistics were taken care of, ensuring a comfortable and enjoyable experience for all attendees.
Overall, the 14th Annual Clinical Trial Summit 2023 by Virtue Insight was a resounding success. Kudos to the Virtue Insight team for organizing such a remarkable event, and I eagerly look forward to attending future conferences by Virtue Insight!
Tech-Observer Vice President
Geo-Chem Laboratories General Manager – Operations
Capgemini Technology Sr. Director - Lifesciences Portfolio Leader
Prudentia Management and Technology Consulting Manager, Clinical Coding services
Clinievo Technologies Associate Director – Partnerships
Clinievo Technologies Manager – Partnerships
Venue Details
Venue:
Hotel Kohinoor Continental
Address: Andheri Kurla Road, Andheri ( E ),
Mumbai – 400059
Maharashtra, India
Phone: 022 6769 3500
Get Involved
Speaking Opportunities
Fen Castro
fen@virtueinsight.co.in
+91 44 42108101
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