Clinical Trials Asia Summit 2010 - August 19th, 20th, Taj Residency, Bangalore, India
"Improving clinical practice and trial success rates with improved technologies, strategies and alliance management"
Key Themes Discussed at this Summit:
- Current trends of clinical trials environment
- How can you take advantage of the global market for clinical trials?
- Discovering technologies and strategies for successful clinical trial management
- Analyzing the successes and challenges of Phase I and Phase II clinical trials
- Setting up clinical trial research hub & techniques for applying risk management principles.
- Discover how to improve your supplier-client relationships
- Complete trials on schedule & budget by overcoming hurdles in investigator/patient recruitment
- Avoiding potential pitfalls of trials agreement
- Gather the latest regulatory updates impacting global and Indian clinical development
- Explore innovative strategies for outsourcing, what should you be looking for in a CRO?
- Improving and optimizing site management and overall productivity of clinical operations
- Data management, CMC SCM, operational requirements & CRO infrastructure in India & South Asia
- Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets
- What are the issues with off-shoring trials to countries such as India & South Asia? – Solutions?
- Working with limited budget to ensure on time study completion
- Motivating and managing clinical project teams to improve timeline and progress
- Exploring the efficacy and safety of new interventions in clinical trials
- Drawing and retaining clinical talent pool to minimise turnover in clinical studies
- Next generation of clinical trials – How big will the market be?
Key Speakers Include:
- Akhilesh Sharma, Vice President & Global head Clinical management & Global Pharmacovigilance, Dr. Reddy’s
- Bakulesh Khamar, Executive Director – Research, Cadila
- Amol Pendse, Clinical Operations Manager, Bio South Asia Clinical R & D, Medical Affairs Biologicals Department, GlaxoSmithKline
- Radhika Bobba, Director Medical Services, Stempeutics Research, Partner & Founder, Anhvita BioPharma Consulting
- S.K.Bhattacharya, Medical Officer, Depart of Communicable Diseases, WHO (World Health Organisation)
- Tarun Puri, Medical Advisor, Eli Lilly
- Shashidhar Rao, India Operations Head (IID and IA&R), Novartis
- Deven Parmar, Vice President - Clinical Research & Pharamacovigilance, Wockhardt
- Mohan Bangalore, Executive Director & Head , R&D Operations-India, Bristol-Myers Squibb (BMS)
- Arun Bhatt, President, Clininvent Research
- Rashmi Sidharthan, Associate Director - Life Science Technology, G7 SYNERGON
- Mandeep S. Oberoi, President & CEO, Clintrials Research
- Yamin ’Mo’ Khan, Executive Vice President, Clinical Development, Pharma-Olam (U.K)
- Parminder Kaur, Managing Director, RegPak BioPharma Consulting, (Netherlands)
- Zinobia Madan, Founder & Managing Director, ClinOma Healthcare
- Ramesh Jagannathan, Director-Clinical Research, AstraZeneca (India)
- Deepti Sanghavi, Medical Advisor - Clinical Research, Wockhardt Limited
- Roopa Basrur, Associate Director - Clinical Writing and Document Quality, Pfizer
- Larisa Nagra Singh,General Manager and Project Director, Voisin Consulting Life Science
- Marcus Hompesch, President – CEO, Profil Institute - Clinical Research, (USA)
- Srini Kalluri, President & CEO, PercipEnz Technologies, (USA)
- Sanjeev Gupta, Head of Operations, Unithink (Belguim)
- Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates
- Darshan Bhatt, Consultant, Patient Safety and Pharmacovigilance
- Thuppil Venkatesh, Prof.St.John's Medical College & Principal Advisor, Quality Council of India
- Mala Srivastava, Partner, Nextvel Consulting
- Lakshmanan Sathappan, Regulatory Affairs Manager, PharmaLeaf
- Shivamurthy Nanjundappa, Director - Clinical Research and Business Development, Quartesian Clinical Research
Conference Summary
The Clinical Trials Asia Summit 2010 recently concluded at the Taj, Bangalore
A well attended event, supported strongly by the industry, Clinical Trials Asia discussed the various issues and challenges with solutions. The summit had its theme as “Improving clinical practice and trial success rates with improved technologies, strategies and alliance management”.
From the role of media to how clinical trials are being done globally and how the Asian market is evolving, with a major focus on India and China, the conference discussed key challenges and the various solutions which will empower the growth of the Indian Clinical Trials Market.
The statistics show a positive growth trend
There has been a dramatic increase in the number of trials that have got officially registered in Clinical Trials Registry-India (CTRI). According to records collected by the Indian Council of Medical Research and the Drug Controller General's office, between July-December 2007, only 11 trials were registered. The number increased to 137 between Jan-Dec 2008 and then to an all-time high of 546 between Jan-Dec 2009. This year, while January saw 58 trials registered, February recorded 60.
Talking about payment process and Site expectations from CRO/ Sponsor, the conference gave a global perspective which puts the audience in splits. Giving the ABCD of relationships there were lots of insights shared at the Clinical Trials Asia 2010:
Agreement
1. Budget
2. Compliance
3. Communication
4. Documentation
While saying that the documentation practices in India India
Talking about global relationships and the complexity, we have some very interesting figures in terms of the size and complexity of such global relationships. Global sponsor expectations have the following expectations:
§ Quality
§ Time
§ Cost
There were many interesting discussions which were discussed, but a key focus was also given to Strategies and Quality considerations. Deep insights into emerging markets and how the development is happening, gave the audience interesting insights into the area.
Talking about the Sponsor CRO partnership, all were of the same view that its a two way street, its responsible from both sides. It has to emerge from a common goal, while identifying metrics, processes etc.
Taking the partnership to a new level, the summit gave a fantastic view into transformation with the following steps:
§ Process harmonization
§ Base Lining
§ Benchmarking
§ Continuous improvement
§ Base transformation
Interesting Business Transformation case studies, were shared which had the audience getting the real value.
§ Helping sponsor to streamline and integrate workflows in all geographies
§ Automation of workflow management
§ Integration of client CTMS with vendor’s CDMS
Quality considerations in outsourcing, were discussed while sharing accountability which gives insights into the Quality agreement and the various partnership metrics with it.
Touching base on the way ahead future partnership models were also discussed:
§ Functional service provisioning
§ Strategic development partnerships
§ One-time transactional outsourcing for specialized needs
Expand and upgrade offerings with:
§ Global Scope
§ Therapeutics expertise
§ Technology Resources
Being a part of the exciting emerging market, the summit sure had an immense value session which had panellists discussing about emerging markets and was well taken.
As commented one of them: “We probably qualify as an emerging country. There is a lot of work we are doing, but still we are very very small. Discussing numbers and timelines, its clear why India India
The summit very keenly touched upon global regions as Europe and other markets which have evolved and are contributing pretty well to the entire ecosystem which was well supported with Cost Arbitrage.
Regulatory Regimes was another topic which was well discussed and talked about.
People experienced in the domain shared fantastic insights while taking on the views of the various corporate entities, which were sharing their challenges with the regulation and the regime, especially in India
“We have a tremendous opportunity. The backbone of our clinical trial is the evidence of our medicine. We are all looking for accredited services. We must have a multi stakeholder network which forms a consortium.”
Talking about regulatory regime in India
The SWOT analysis of the Clinical Trials industry in India
“Doing a SWOT analysis for Clinical Trials in India US , Australia , Western Europe companies etc. Quality has to always come from us.”
Innovation at the Clinical Trials Asia Summit 2010
Talking about transformation of Clinical research with a focused Start-up Group! Why start-up group?
· Managed by dedicated expert group
· Well versed with rapidly evolving regulatory environment
· Structured methodology of processing documents
· Consistency with client requirements
· Availability of monitoring resources for on-sites visits
We start with Regulatory Document preparation/ Review and Submission. Timelines and the quality of documents are going to become more and more important. Its not a simple document, but its a document which we are using repetitively in all our trials all across the world.
The summit also threw some very interesting pointers on:
· Primary research
· Patient Demographics
· Trial design options
· Collaboration – saleable aspects – stakeholders
There were ethical considerations and other related topics discussed with a great interest from the audience. These were supported by thought leadership on innovation:
· Out of the box – doesn’t mean out of mind
· Analgesic can produce analgesia, expectations joint reformation is a much from it
· Anti-arrhymic effects from lipid lowering drug-trying to grasp alien in outer space
· Learning from the past to help predict the future
· Always start with the end in mind- includes strategic commercial values
Patient demographics were touched upon and hence discussed.
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