8th Annual Clinical Trials Summit 2017
Offering our customers the knowledge and connections for a profitable business
Speakers
  • K. BANGARURAJAN

    K. BANGARURAJAN CDSCO

  • RAJENDRA H. JANI

    RAJENDRA H. JANI Zydus Cadila

  • ARUN BHATT

    ARUN BHATT Consultant - Clinical Research & Development

  • SUMIT MUNJAL

    SUMIT MUNJAL Takeda Pharmaceuticals (UK)

  • VIVEK GUPTA

    VIVEK GUPTA Acceliant

  • SRIRUPA DAS

    SRIRUPA DAS Abbott

  • CHIRAG TRIVEDI

    CHIRAG TRIVEDI Sanofi

  • TAPANKUMAR M. SHAH

    TAPANKUMAR M. SHAH AstraZeneca

  • EMRAN KHAN

    EMRAN KHAN Cipla

  • MUKESH KUMAR

    MUKESH KUMAR Dr. Reddy's Laboratories

  • NARESH TONDARE

    NARESH TONDARE Glenmark Pharmaceuticals

  • ARUNKUMAR S

    ARUNKUMAR S Acceliant

  • MILIND ANTANI

    MILIND ANTANI Nishith Desai Associates

  • JYOTSNA PATWARDHAN

    JYOTSNA PATWARDHAN Novartis

  • ABHAY PHANSALKAR

    ABHAY PHANSALKAR Cipla

  • PRAVIN GHADGE

    PRAVIN GHADGE Reliance Life Sciences

24th May 2017, Kohinoor Continental Hotel, Mumbai, India

“A critical guide for successfully conducting clinical trials”

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CONFERENCE INTRODUCTION:- 

Virtue Insight’s 8th Annual Clinical Trials Summit will bring together leaders from across pharma, biotech and academia to share case studies and best practices on effective clinical trial management and vendor oversight. The 2017 program focuses on key issues and opportunities in the clinical trial industry, including Patient Recruitment, Site Selection, Data Integration, Existing Data Sources, Mobile Tech, Project Management, Outsourcing, Vendor Management, Risk-Based Monitoring, Clinical Auditing, Regulatory Authorities, pharmaceutical industries, contract research organizations, patient associations, and academic groups are represented. This conference is known to facilitate the interaction between all stakeholders, speakers and participants, thus encouraging lively Q&A sessions without cultural barriers. In addition, as usual, this Conference represents a great opportunity to network with all players involved in drug and device development.

The fast change of our working environment - be it regulatory or scientific - requires an accurate update for those with accumulated experience wanting to gain new competencies, but in particular also for the young stakeholders who will contribute to the development of the next generation of drugs and devices.

Virtue Insight also offers comprehensive sponsorship packages, which includes presentation opportunities, exhibit space, branding and networking with specific prospects. Sponsorship allows you to achieve your objectives before, during, and long after the event. Any sponsorship can be customized to meet your company’s needs and budget. Signing on early will allow you to maximize exposure to qualified decision-makers.

It gives us immense pleasure in welcoming you to the 8th Annual Clinical Trials Summit 2017. I wish and pray that all our efforts will be beneficial to our industries and to our country at large

 

KEY THEMES DISCUSSED:-

  • Key drivers behind achieving a successful and sustainable clinical trails strategy in 2017
  • Develop faster, more effective strategies by setting up big data with the power of sophisticated analytics
  • Outsourcing early stage manufacturing
  • Benefits and challenges with using local and international vendors
  • Develop trial design and elaborate patient access
  • Span all phases of clinical and observational research
  • How we use mobile in clinical trials nowadays? What is the present barrier?
  • Integrated approaches to using digital as a clinical Tool: Real world trials and population health in the east India
  • The Impact of in-life unjust information on clinical trials execution
  • Observing operational progress and efficiency of a study or an asset in critical for drug development success
  • Strategic partnerships between Sponsor-CRO and how the industry has evolved in the past 5 years
  • DATA – Collection, Design, Storage, Execute and Manage clinical trials - an architect’s perspective
  • Possibilities for transforming data into quantifiable knowledge and growth in the quantity of clinical data collected
  • Human factors trial design and management
  • Understanding new e-clinical technologies to improve data quality and optimise clinical outcomes
  • What are the expectations of regulatory authorities and what type of regulatory structure does India currently have?
  • Updates on development for safety reporting in Indian clinical trial regulation
  • Next generations of clinical trials – How big will the market be?
  • Be part of a major networking opportunity

 

WHO SHOULD ATTEND:-

CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of:

  • Clinical Research & Development 
  • Clinical Research Services 
  • Clinical Operations 
  • Clinical Data Management 
  • Clinical IT
  • Clinical Trials
  • Medical Affairs
  • Regulatory Affairs
  • Compliance
  • Quality control / Assurance/GCP
  • Clinical Study Design
  • Safety Surveillance
  • Subject Recruitment
  • E-Clinical Systems

 

WHY SHOULD YOU ATTEND?

 
8th Annual Clinical Trials Summit 2017 - “A critical guide for successfully conducting clinical trials” - 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 drinks time, meet the leading international vendors expand your knowledge of the latest business models and strategies in the high-level conference. Show casing the products of tomorrow in the co-located exhibition.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:20 – Chairperson opening remarks

MARKET OVERVIEW & ANALYSIS

09:30 – ICH GCP Integrated Addendum  2016 : Implications for India

  • Amendment objectives
  • Responsibilities of Sponsors – Quality management, Risk Based Monitoring, 
  • Responsibilities of Investigators
  • Implications for India

Arun Bhatt, Consultant – Clinical Research & Development

 

10:00 How next generation Technologies can help you take your product faster in market

VIVEK GUPTA, Worldwide VP, Acceliant

 

10:30 – Morning Coffee/Tea & Discussion

 

CHALLENGES & OPPORTUNITIES
 

10:50 – Develop trial design and elaborate patient access

  • Span all phases of clinical and observational research
  • Expand and influence on physician therapeutic decisions
  • Databases and clinical records, which can improve patient recruitment for clinical and observational research
  • Patients with longitudinal clinical records, which can be used for real-world evidence studies that deliver clinical, financial, and humanistic outcomes
  • Clinical trial environment where patient-specific clinical information can be easily transferred and shared within a payer system
  • Improved patient access to coverage and reimbursement for new healthcare technologies
  • Integrate value-focus across the product lifecycle
  • Identify market trends that are causing a move to a value based reimbursement and decision model
  • Explain the value of gaining payer input into clinical trial design


Moderator:
CHIRAG TRIVEDI, Director & Head of Clinical Study Unit, Sanofi
  

Panellists: 

RAJENDRA JANI, Advisor/ Independent Subject Expert, Zydus Cadila 

MUKESH KUMAR, Global Head- Clinical Management, Dr. Reddy's Laboratories

ARUNKUMAR S, Functional Lead, Acceliant

 
IMPACT OF TECHNOLOGY

11:40 – How we use technology in clinical trials nowadays? What is the present barrier?

  • How to enrich patient occurrence; experiences, BYOD, travel, etc.
  • How to improve data capture
  • Technical barrier - Is the technology ready?
  • Regulatory obstacle, do officials limit adoption?
  • Discuss the disconnect among hype and evidence


12:10 Integrated approaches to using digital as a clinical tool: Real world trials and population health in the east India

  • Public-private pre-competitive partnerships
  • Need to approach data analysis differently
  • Share the load, work together
  • What does this new model look like?


12:40 Networking luncheon
 

Afternoon chair person

14:00 – DISCUSSION WITH EXPERTS: Strategic partnerships between Sponsor-CRO and how the industry has evolved in the past 5 years

  • How is the partnership model trending?  Are collaborating arrangements still increasing in number and/or scope, or is the model in decline? What are the key reasons behind current trends?
  • How well do Sponsor and CRO expectations of these relationships align? Do we still see the gaps we observed in 2012? Have expectations increased or decreased due to the experiences of the past 5 years?
  • Have partnerships delivered on the prospective benefits of enhancing R&D productivity and/or efficiency? What is preventing us from accelerating progress?
  • To what extent do Sponsor/CRO relationships impact prevailing topics in clinical development such as enhanced patient engagement, leveraging big data, novel approaches to protocol design, and utilization of quality management systems?
  • What does the future hold for Sponsor/Provider relationships? Do we expect measured, incremental change, or are there disruptive paradigms that could alter the landscape?


Moderator:

Panellists:  
TAPANKUMAR M. SHAH, Country Head – Site Management & Monitoring, AstraZeneca

SUMIT MUNJAL, Medical Director Lead, Global Medical Safety, Head of Mature Established products, Takeda Pharmaceuticals (UK)

EMRAN KHAN, Head-R&D Outsourcing Services Procurement, Cipla

 

DATA MANAGEMENT

14:50 – DATA – Collection, Design, Storage, Execute and Manage clinical trials - an architect’s perspective

  • Era of big data
  • Speed of data movement, accessibility of current data sources and emergence of new technology frameworks
  • Opportunities on which trials can be designed and executed faster, better and much more economically
  • Discussing used cases, accessible technologies & programs based on big data that can applied in the environment of modern clinical trials.
  • Possibilities for transforming data into quantifiable knowledge and growth in the quantity of clinical data collected
  • Clinical trial data sharing and data privacy


15:20 – Afternoon Tea/Coffee

15:40 – Differentiated clinical trial designs for a branded genetics portfolio
SRIRUPA DAS, Associate Director - Medical Affairs, Abbott

REGULATORY

16:10 – DISCUSSION WITH EXPERTS: Clinical trial regulatory challenges

  • Challenges faced by Sponsors and CROs
  • Updates on development for safety reporting in Indian clinical trial regulation
  • Overview of the regulation on risk-adapted trials and key factors
  • IMA regulations and policies - how are patients and ethics committees impacted and do the regulations meet their needs?
  • Regulatory challenges and constraints when evaluating vaccine clinical trials
  • Present situations in the regulation of vaccines and how they are being addressed
  • Improve patient safety, reporting timeliness of critical adverse events including deaths during clinical trials, and the payment of compensation to patients
  • Trial design and applicable regulatory guidance strategies to overcome
  • Regulatory considerations for a trial being run across different regions


Moderator:
MILIND ANTANI, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associates
 

Panellists:

K. BANGARURAJAN, Deputy Drugs Controller (India), CDSCO

SRIRUPA DAS, Associate Director - Medical Affairs, Abbott
NARESH TONDARE, Head– India and Nepal Regulatory Affairs, Glenmark Pharmaceuticals
JYOTSNA PATWARDHAN, Head Development QA, Novartis
ABHAY PHANSALKAR, Head Clinical Trials, Cipla  
PRAVIN GHADGE, Head - Medical Writing & Pharmacovigilance, Reliance Life Sciences

17:00 – Chairperson’s closing remarks and end of conference

17:10 – 18:10 – Networking Drinks Session

K. BANGARURAJAN

Deputy Drugs Controller (India)

CDSCO

RAJENDRA H. JANI

Advisor/ Independent Subject Expert

Zydus Cadila

Summary

  • Presently Advisor to large pharmaceutical companies,
  • Worked for large global Pharmaceutical companies,
  • Unique blend of R&D management skills combined with business management experience,
  • More than 37 years’ experience with healthcare system of government, global companies and also possess hardware, software and networking across the globe.


Skills

  • Extensive experience in R&D system management as well as team building and negotiation. Able to motivate and move a group toward a consensus in the clinical research.
  • As a member of senior management teams of pharmaceutical companies, extensive exposure also to strategies, medico-marketing, formulation development, manufacturing, etc.
  • Detail oriented, strong analytical skills.
  • Proven history of solving complex operational problems and getting success

ARUN BHATT

Consultant - Clinical Research & Development

Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases.

Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited.
Dr Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is joint Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR.

In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for the Honorary Fellowship of Institute of Clinical Research.

Dr Bhatt is the recipient of Drug Information Association outstanding Service award 2012 for his immense contributions in his field of specialization.

Dr Bhatt delivered the prestigious Prof U K Sheth Oration in 2013.

Dr Bhatt is a qualified assessor for NABH Accreditation for Clinical Trials.

Dr Bhatt has more than 100 publications in national and international journals.  He runs a regular monthly column on “Good Clinical Practice – Question Answers” and has published a book “Clinical Trials and “Good Clinical Practice in India – Questions and Answers”.

SUMIT MUNJAL

Medical Director Lead, Global Medical Safety, Head of Mature Established products

Takeda Pharmaceuticals (UK)

Dr Sumit Munjal, a physician by training and an Indian by background has been associated with

Academic organizations such as London School of Hygiene & Tropical Medicine, Faculty of Pharmaceutical Medicine of the Royal College of Physicians and DSRU Southampton;

Government organizations such as NHS UK and MHRA;

And Pharmaceutical industry such as Johnson & Johnson, Millennium Oncology Pharmaceuticals Inc, Nycomed and Takeda Pharmaceuticals.

He is keen and remains committed to promote public health, patient safety and meet healthcare needs around the globe. He is currently based out of Central London.

Nov 2015, Dr Sumit Munjal

VIVEK GUPTA

Worldwide VP

Acceliant

SRIRUPA DAS

Associate Director - Medical Affairs

Abbott

CHIRAG TRIVEDI

Director & Head of Clinical Study Unit

Sanofi

Chirag Trivedi is currently working in Sanofi as Director and Head of Clinical Study Unit (CSU) in India. The CSU manages the Clinical trials (for R&D and marketed Products) from Phase II-IV, Observational studies and Bioequivalence studies. It also plays a strategic and operational role in the Life Cycle Management of products.

He has been with Sanofi since May 2006 and has handled various roles and responsibilities in these years. Prior to Sanofi, he has worked in a CRO and prior to that, in a Central Lab.

He is a Ph.D. in Pharmacology from Mumbai University and is experienced in the fields of Clinical Research, Clinical Quality Assurance & Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development.

TAPANKUMAR M. SHAH

Country Head - Site Management & Monitoring

AstraZeneca

EMRAN KHAN

Head-R&D Outsourcing Services Procurement

Cipla

MUKESH KUMAR

Global Head- Clinical Management

Dr. Reddy's Laboratories

NARESH TONDARE

Head - India and Nepal Regulatory Affairs

Glenmark Pharmaceuticals

Dr. Naresh Tondare is a Regulatory Expert with 11 years of experience in the areas of Regulatory Affairs/strategy, Product/Formulation Development, New Drug Delivery/Technologies  and Clinical Research.

He has completed a post graduate degree (MD) in Ayurvedic/Herbal Pharmacology and Pharmaceutical from Govt. Ayurvedic Medical College in 2004.   He has also completed a PGDIM from School of Management Studies (SOMS), New Delhi in 2009 and a Black Belt in Six Sigma (BBSS) programme from Indian Statistical Institute (ISI) in 2008.

Currently, he is working with Glenmark Pharmaceuticals Ltd, Mumbai as a Head- India and Nepal Regulatory Affairs (Senior Manager) since 2011. He is responsible and accountable for regulatory strategy and regulatory submissions of New Drug, NCE, Subsequent New Drug, OTC, Food Supplements, Herbal Products and Cosmetics for India and Nepal Region. Prior to Glenmark, he has worked with several organizations such as AccuMED, SmartAnalyst etc.

ARUNKUMAR S

Functional Lead

Acceliant

MILIND ANTANI

Partner In-Charge - Pharma LifeSciences

Nishith Desai Associates

Dr. Milind Antani is a Partner in charge of the Pharma & Healthcare Practice a at the multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi and Mumbai – BKC, Munich and New York. He is also partner in-charge of Social Sector practice and Nanotechnology practice.

Dr. Antani represents clients on strategy matters including corporate mergers and acquisitions, investments, regulatory and transactional matters, intellectual property prosecution and litigation, collaborations including joint ventures and formation of new companies. He also advises clients in e-Health and tele-medicine on business strategy from legal and regulatory perspective.

He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS, and Pharma and Life science. The have also contributed a chapter on India in ‘Commercialization of Healthcare-2nd Edition Global Guide’ published by Thompson Reuters in 2015. He is a regular speaker and panelist at various national and international forums on the subjects of pharma, biotech, IP, clinical trials, healthcare, CSR, FCRA. He is also a visiting faculty at many institutions in Mumbai.

He has been included as one of the world's leading practitioners in ‘Who's Who Legal’ for Life Sciences 2014 and 2015 in the ‘Regulatory’ section as only lawyer from India.

Dr. Antani practiced as an ENT surgeon for 14 years prior to joining Nishith Desai Associates as a lawyer.

He has also successfully attended "Managing and Transforming Professional Service Firms-India” an executive training program organized by HARVARD BUSINESS SCHOOL.

JYOTSNA PATWARDHAN

Head Development QA

Novartis

ABHAY PHANSALKAR

Head Clinical Trials

Cipla

Medical Physician with approx. 10 years of drug development experience in biopharmaceutical industry in Clinical Development, Medical Affairs, Pharmacovigilance and Medical Writing functions.

Worked across therapeutic areas including Respiratory Medicine, HIV, Cardio-metabolic, Gastroenterology, Nephrology, Oncology, Immunology, Transplantation and Infectious diseases, Vaccines, Hematology, Critical Care, Orthopedics and Pain Management, and Gynaecology.

Role in Clinical Development & Pharmacovigilance

  • Currently, responsible for the design, conduct and publication of clinical trials in India and Emerging Markets.
  • Clinical strategy for Portfolio planning and development.
  • Protocol and clinical trial documents (safety narratives, CRF, IB, Safety Management Plan) development of Biosimilars in collaboration with various stakeholders.
  • Medical review of Statistical Analysis Plan & Trial Data Analysis and development of Clinical Study Report.
  • Medical Safety Monitoring of the clinical trials including regulatory safety reporting, medical coding using MeDRA & liaison with Data Safety Monitoring Board (DSMBs) for medical safety reviews   
  • Medical Writing and review of Development Safety Update Reports (DSUR), Risk Management Plans (RMPs), and Clinical trial report database (CTRDs), and Annual Safety Update Reports (ASRs).
  • Presentation of Study results to Regulatory (DCGI) expert committees for marketing authorization approvals and in medical conferences.
  • Vendor Management & Budget Management of Phase 3 & 4 Studies

Role in Medical Affairs

  • Product Portfolio Development: Collaboration with various stakeholders for product identification, review & finalization.
  • Development of Medical Strategy for the brand life cycle management 
  • Identification & Engagement of Key Opinion Leaders & Medical Associations in India
  • Regional Medical Affairs Team management

PRAVIN GHADGE

Head - Medical Writing & Pharmacovigilance

Reliance Life Sciences

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Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.


What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.


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  • Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
  • Enjoy our informal networking at drinks and lunch
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Kohinoor Continental Hotel

Address: Andheri Kurla Road, Andheri ( E ), Mumbai 400059 - India
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Testimonials from our past Clinical Trials Summit Conferences

 

 

Over all good - Buddha Siva Kumar, Safety physician, Sciformix

It was good & interadity sessions - Shubhada Wakade, Quality lead, PV, Sciformix Tech pvt.ltd

1. Very useful to network with sponsors and CRO. 2. Good place to know the progress of competition - Basheerun sheikh, Manager - eclinical, DDi

Great conference for networking and relationship - Jaidip vyus, Officer, Spilcsun Pharma

It was great experience attending this clinical trial summit 2015. It Learned lot of new updates in clinical trial industry as well as regulatory - Shankaranarayanan. J, Sr. Manager Clinical Research, OmniActive Health Technologies

Since Pharama companies have ventured into Biologicals/ Biosimilars business, the conference could have focused on discussing case stdies in Biosimilars Clinical trails, challenges in CTS in New Biologicals& Vaccines - Tanushree Bhattacharya, Regulatory Affairs Biologicals-Cipla New Ventures, Cipla

Very interactive informative and time managed session - Kirti Ratolikar, Manager - QA &RA, Sanofi Pasteur

The sessions was informative on products and the discussions was fantastic. It has given a better idea on where the industry is heading. To start a new era of clinical trials, this seems to be a promising start for the industry. The second innings for the clinical trials seems promising technically as well as operationally - Rajesh Krishnan, Senior Business Analyst, HCL Technologies

Well Organized - Babu, Team Leader, Lotus Labs

This conference was informative. There was good exchange of information. It provided current and actual seminar in india regarding Clinical Trials would like to attend this conference in future - Satish A Gaikwad, Clinical Research Associate, Lambda Therapeutic Research

Many presentations covered were eye openers and being from a typical IT Service provider company, the conference really added value in terms of clarifying the business processer and challenges of Pharma industrials - Souvik Bit Associate Business Manager, HCL Technologies Ltd

Topic was very good huge on current seminar, Location is very good to Aelequase, Speaking was good to deliver current situation, Very on panel discussion and due and Answer session - Rajesh Telawade, Sr. CRA, Lambda Therapeutic Research

“Fen and his team from Virtue insight have done a great job in bringing everyone together to share their ideas and experiences for clinical research industry in India- the past, present and future. It was nice meeting old contacts again as well as making some new ones at the event. I wish all the very best to the scientific mind and organizing execution committee for making this conference successful with all its share of challenges.” - Dr. Deepti Sanghavi, Senior Medical Writer-Medical Writing, SIRO Clinpharm

Over all good experience and well conducted - Dr. Devas Seth, Manager Clinical Ops, Dr. Reddy's Laboratories

Summit was well organized and very interesting panel of discussion - Rituja Doiphode, Business Development Manager, Clinical Research, Metropolis Healthcare

Great administration of entire programme session by session, pleasant surprise is that 95% of speakers as planned turned up - Joe Jacob, Director Operations, GSS HR Solutions

Excellent Organisation and facilities - Jessy George, Sr. CRA, GlaxoSmithKline

Conference was informative, a great opportunity to converse and interact with esteemed and prominent delegates and speakers from renowned organisations. Being a trainee it helped me out in understanding CR industry diversely and scenario globally - Swati Jha, Trainee CRC, Trisha Trauma Centre

This is a really well managed, informative, interactive and learning event also allowing us to network together and its absolute a value for money. I wish them the “All is The Best”. Keep up the “GOOD SHOW” - Jatin Dhulla, General Manager, Accutest Research

Very Insightful.... - Dr. Arvind Gunput, CEO, EOS Medical Research

Very good forum to network and an overall good set of information shared with the attendees - Aparna Shirodka, Project Executive, SRL

Its a good conference and the approach of new ideas get a merge in single pool without any barriers - Preetam Chavan, Research Associate, Lupin Bioresearch Center

This conference gave a good insight of current challenges in running clinical trials in india – relating to regulatory, investigators, sites, training etc.... - Ritika Sugand, Business development, Karmic Life sciences

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