|
1 December 2009, Tuesday - Pre Conference Innovation Forum
|
08.00 | Registration and refreshments
|
09.00 | Chairman's opening remarks
|
09.10 | Keynote: Driving drug innovation in India to bring it at the forefront of drug discovery in Asia and globally
- Market trends and drivers of India’s biopharmaceutical industry
- Looking into the emerging innovations from India and their impacts
- India’s biopharmaceutical industry: Evolving from generics to innovation drugs
|
| | Dr M.K. Bhan, Secretary, Ministry of Science & Technology, Department of Biotechnology, Government of India, India
|
09.40 | Paving the way for India's innovations and enriching its biological research
- Establishing C-CAMP as a catalyst for bioscience research and development in India
- Supporting India’s biomedical industry to encourage innovation from academia and the industry
- Assessing C-CAMP’s impact in the industry and its long term objective
|
| | Dr Taslimarif Saiyed, Director, Strategic Alliances & Business Development Centre for Cellular and Molecular Platforms (C-CAMP), National Centre for Biological Sciences (NCBS), India
|
10.10 | Morning refreshments
|
| Developing new and next generation vaccines from India |
|
10.40 | Nano Particles: A boon to immunologist
- Using nano particles as an alternate approach to conventional vaccines
- Explaining the step by step process of this alternate approach
- Highlighting the importance of an alternate approach for plague vaccine using protective epitopes in nano particles
|
| | Dr D.N. Rao, Professor, Department of Biochemistry, All India Institute of Medical Sciences, India
|
11.10 | Expression of HPV L1 protein in planta for the production of recombinant vaccine against cervical cancer
- Cost effective systems for large-scale production of proteins
- Expressing the HPVL1 gene in transgenic Nicotiana
- Signal peptides for targeting the protein
|
| | Dr EV Soniya, Scientist, Rajiv Gandhi Centre for Biotechnology, India
|
11.40 | Networking lunch
|
| Stem cells and regenerative medicines: where is India heading? |
|
13.30 | Biological properties and therapeutic potential of embryonic and adult stem cells
- Differentiation bias of human ES cells
- Differentiation of umbilical cord derived mesenchymal stem cells (UCMSCs)
- Potential therapeutic applications of human ES cells and UCMSCs
|
| |
|
14.00 | Modulating stem cell functions in vitro
- The concept : Creation of a suitable microenvironment might allow modulation of stem cell functions in vitro
- Demonstrating the "proof of principle" using Hematopoietic Stem Cells
- Possible advantages of Microenvironment Technology
|
| | Dr Vaijayanti Kale, Scientist F, Stem Cell Biology , National Center for Cell Sciences, India
|
14.30 | Realising clinical potential of human embryonic stem cells
- Embryonic stem cell lines and research in India
- Lineage specific differentiation of Embryonic stem cells
- Efforts to conduct pre-clinical studies in non human primates
|
| | Dr Deepa Bhartiya, Scientist, National Institute of Research in Reproductive Health , India
|
15.30 | Afternoon refreshments
|
| Innovative gene therapy from India |
|
16.00 | Targeted approach for cancer therapy
- Focusing on gene therapy
- Discussing ligand directed drug delivery
- Presenting the important findings and their implications
|
| |
|
16.30 | Nano Highways: Trends in molecular diagnostics
- A glimpse into the ever improving molecular diagnostics
- Presenting case study: HLL Lifecare R&D
- Assessing the impact of molecular diagnostics in the healthcare industry
|
| | Dr K.R.S. Krishnan, Senior Executive Director, Research and Development and Strategic Planning, HLL Lifecare Limited , India
|
| Diagnostics from India |
|
17.30 | Chairperson's closing remarks
|
17.40 | End of Innovation Forum
|
|
2 December 2009, Wednesday - Conference Day One
|
08.00 | Registration and refreshments
|
08.40 | Organiser's welcome remarks
|
08.45 | Chairman's opening remarks
|
| | Dr Dinesh Dua, Chief Executive Officer, Nectar Lifesciences Ltd, India
|
| India biopharma business outlook and opportunities for global and Indian players |
|
09.00 | Global Biopharmaceutical Leaders’ Panel: Assessing the outlook of biopharmaceutical industry in an era of globalization
- Looking into the different business models of global pharmas with the rising affluence in emerging markets like India and China
- Evaluating the impact of globalization in the growth of the biopharmaceutical industry in emerging markets in Asia
- Targeting India as an important market to integrate in the global biopharmaceutical supply chain
|
| | Dr Theodore Torphy, Chief Scientific Officer & Head External Research & Early De, Johnson & Johnson, United States Mr Lubor Gaal, Executive Director, Strategic Transactions, Bristol Myers Squibb Pharma Research Institute, United States Dr Gunther Winkler, Senior Vice-President, Strategic Initiatives, Biogen Idec, United States Dr Mervyn Turner, Chief Strategy Officer, Merck & Co. Inc, and Senior Vice President, World Wide Licensing and External Research, Merck Research Laboratories
|
09.40 | India’s Biopharmaceutical Leaders’ Panel: Discussing how India can successfully leverage on a growing biologic business
- India’s biopharmaceutical development outlook: trends, drivers and future opportunities
- Looking into India’s biopharmaceutical industry in the next 5 years – will it be biosimilars or innovative biopharmaceuticals?
- Comparing India’s competitiveness against other Asia Pacific players in the global biopharmaceutical industry
|
| |
|
10.20 | Morning refreshments
|
| Going global: Business models and expansion strategies |
|
10.50 | Innovation: Ideas know no boundaries
- In a connected world, innovation is global.
- Winners go to the ideas and do not wait for ideas to come to them.
- Partnerships across geographies and across industries will become the norm.
- Merck is open for business in this networked world
|
| | Dr Mervyn Turner, Chief Strategy Officer, Merck & Co. Inc, and Senior Vice President, World Wide Licensing and External Research, Merck Research Laboratories
|
11.20 | Developing new collaborative research models that expand global business opportunities
- Exploring different strategies to penetrate regulated markets such as EU and US
- Evaluating when would be best to acquire, forge partnership or offshore satellite office in these regulated markets
- Choosing the right company to acquire or partner with in order to support business strategy in expanding to international markets
|
| |
|
11.50 | Innovation, a global resource: Navigating product development priorities for sustainable profitability in both local and international markets
- Making decisions on where to source innovation
- Sharing Bristol Myers Squibb’s experience in India
- Determining the driving factors in deciding how much to invest in specific drug development
|
| | Mr Lubor Gaal, Executive Director, Strategic Transactions, Bristol Myers Squibb Pharma Research Institute, United States
|
12.20 | A novel approach to strengthen the position of Daiichi Sankyo in the global arena
- Accelerating the growth of Daiichi Sankyo through the hybrid business model in the global arena
- Leveraging on innovation throughout the value chain
- Forging strategic partnerships and collaborations to bring forward Daiichi Sankyo’s long term goals
|
| | Dr Tsutomu Une, Chairman of the Board, Ranbaxy Laboratories,Member of the Board, Senior Executive Officer of Corporate Strategy, Daiichi Sankyo, Japan
|
12.50 | Networking lunch
|
| Opportunities and challenges in the Asian and Indian biopharmaceutical business |
|
14.00 | Reconfiguring the pharmaceutical R&D business model
- New business models and innovative partnerships required to reverse the decline of R&D productivity in the pharmaceutical industry
- These new models will incorporate the principles of Open Innovation, and will rely on flexibility, capital efficiency, and the creation of extensive networks of innovators, investors and highly skilled contract research organizations (CROs)
- All constituencies of our R&D ecosystem – academia, CROs, venture capital, biotech and big pharma – will have critical roles in creating a new paradigm for bringing pharmaceuticals to the marketplace
|
| | Dr Theodore Torphy, Chief Scientific Officer & Head External Research & Early De, Johnson & Johnson, United States
|
14.30 | Overcoming local and international regulatory barriers to effectively expand biopharmaceutical business
- Key local regulatory challenges that are unique to the India market
- Identifying the main licensing and partnership opportunities with Indian biopharmaceuticals
- Effectively breaking through barriers to achieve maximum speed to market
|
| | Dr Gunther Winkler, Senior Vice-President, Strategic Initiatives, Biogen Idec, United States
|
15.00 | Speed networking
|
15.30 | Afternoon refreshments
|
| Strategies in penetrating international biosimilar business |
|
16.00 | Follow-on biologics: From Biosimilars to Biobetters
- Market potential for follow-on biologics
- Biobetters- Creating products with a substantially superior profile than the innovator biologics
- Technologies at the forefront of developing Biobetters
- Case studies on successful biobetters in the marketplace
|
| | Dr Bharatt Chowrira, Chairman, Nektar Therapeutics India, Chief Operating Officer, Nektar Therapeutics
|
16.30 | Innovative strategies to drive rapid adoption of biosimilars
- Pulling through sales by bundling biologics within the latest treatment regimens
- Pushing adoption through compliant post approval studies
- Providing discounts directly to patients through compliant co-pay assistance programs
|
| | Mr John Maki, President and Chief Executive Officer, Vicus Therapeutics, United States
|
17.00 | Challenges in developing biosimilar molecules
- Understanding the challenges in developing biosimilar therapeutics.
- Overview of the market trends and future opportunities for biosimilar
- Strategies to achieve success in global biosimilars business
- Understanding the existing regulatory concern about biosimilar therapeutics
|
| | Dr V K Vinayak, President, Biopharmaceutical R&D, Panacea Biotec, India
|
17.30 | Biosimilars Pricing: Balancing the innovation and cost of biologics in America
- US regulators are debating on provisions of new biosimilars act
- Fierce controversy remains as to the appropriate data exclusivity to be granted to innovator companies
- The current vote favors 12 years of protection for innovation biotech, but the ultimate vote comes in December
|
| |
|
17.50 | Chairman's closing remarks
|
18.00 | End of conference day one
|
|
3 December 2009, Thursday - Conference Day Two : Breakout stream 1 - Biomanufacturing
|
08.00 | Registration and refreshments
|
09.00 | Chairman's opening remarks
|
| Advanced manufacturing for biosimilars |
|
09.10 | CMC aspects to consider for development of biologicals and biosimilars for international markets
- Development and manufacturing of mammalian cell-derived biopharmaceuticals
- Issues that emerging biosimilar-developing companies in India and China are likely to face versus established biotech manufacturers
- Looking closer into the considerations for development of biologics for international markets
|
| | Dr Sunil Gupta, Vice President, Downstream Process Sciences Global Biological Development, Bayer Healthcare LLC, United States
|
09.40 | Overcoming the challenges in advancing manufacturing of biosimilars
- Integrating new systems in the manufacturing plan for advanced biologic drugs production
- Developing a cost effective and time efficient process in incorporating new technology platforms to advance production capability
- Challenges in managing a diverse portfolio of biologic drugs
|
| |
|
10.10 | Development and commercialization of biosimilar products: challenges and opportunities
- Critical gaps that exist with respect to our understanding of how the different quality attributes of a protein product impact its safety and efficacy
- Lack of standardization of ways in which clinical and process data is collected and shared
- Complexity of protein products with respect to the numerous quality attributes, structural heterogeneities and molecule to molecule differences
- Complexity of the processes that are used to manufacture protein products along with the raw materials that are used
- Recommended steps that could partially alleviate these challenges and accelerate their resolution
|
| | Dr Anurag Rathore, Consultant, Biotech CMC Issues & Faculty at Department of Chemical Engineering, Indian Institute of Technology, India
|
10.40 | Morning refreshments
|
| Operation, qualification, construction and engineering |
|
11.10 | Creating flexible facility design to cater to multi-product manufacturing
- Understanding the challenges of managing multi-product facility
- Effective strategies on developing facilities that can handle processes of different nature
- Optimization of capacity in multi-product facility
|
| |
|
11.40 | Developing a cost and time effective process with new technology platforms for production of vaccines
- Emergence of safer and reliable vaccines, trends and growth pattern
- Improved production technology for vaccines especially combination vaccines
- New drug delivery system including use of Nano technology for better vaccine delivery
|
| |
|
12.10 | Manufacturing planning in biopharmaceutical operations for global expansion
- Identifying the key factors in deciding to build or retrofit your manufacturing facility or outsource all together
- Assessing the impact of disposable technology on facility design, start-up and validation
- Incorporating process flexibility and advances in technology
|
| |
|
12.30 | Cost effective qualification for Indian biopharmaceutical companies to comply with western standards on their manufacturing plant
|
| |
|
12.50 | Networking luncheon
|
| Optimising biomanufacturing capability and competency |
|
14.00 | Cell based recombinant vaccine development to address scale-up issue on production
- Understanding the advantages and disadvantages of moving into cell culture for vaccine production
- How does cell culture based production impact on quantity produced and timelines?
- Understanding the necessary steps in transitioning to cell culture production
- Investigating the impact of disposable technology on facility design, start-up and validation of a cell culture facility
|
| |
|
14.30 | Biopharmaceutical manufacturing operations and process development in Asia
- Opportunities and challenges in designing a robust manufacturing facility in Asia
- Building an economical and versatile biologics manufacturing system
- Developing an efficient and innovative strategies for manufacturing biosimilars
|
| | Dr Green Zhang, Vice President, Biologicals, ActoKine Therapeutics, United States
|
15.00 | Achieving operational excellence in designing and operating manufacturing facility in India
- Understanding the best approach in expanding your manufacturing plans in India
- Setting all necessary measures and controls to ensure continuous improvement in manufacturing operations
- Assessing the challenges and opportunities in achieving operational excellence
|
| |
|
15.30 | Preparing for operational excellence: Focusing on successful strategy execution
- Effective operational excellence cannot be realized unless a company can formulate and successfully execute the right strategies.
- Most strategies formulated by companies around the globe today fail to realize their original purpose and intent.
- Understanding the risks associated with successful execution of the strategy can enable companies to increase the probability of successfully launching and benefiting from strategic initiatives
|
| | Dr Fadel Hamed, Associate Director, PROP Operational Excellence, Genentech, United States
|
16.00 | Afternoon refreshments
|
| CMO showcase |
|
16.30 | CMO Showcase: Presentations from key global and Asian contract manufacturing organizations
Leading global and Asian CMOs will be showcasing their latest and cost effective manufacturing methodologies. Each will highlight the advantages in collaborating with CMOs globally and locally. Find out what they have to offer to suit your business needs.
|
17.30 | Chairman's closing remarks
|
17.40 | End of conference
|
|
3 December 2009, Thursday - Conference Day Two: Breakout stream 2 - R&D and Clinical Development
|
08.00 | Registration and refreshments
|
09.00 | Chairman’s opening remarks
|
| Driving drug research and development in India |
|
09.10 | Evaluating India’s strengths and weaknesses for preclinical and clinical development
- India is fast emerging as a “sweet spot” compared to most emerging markets with a robust 31% p.a. growth over the last four years.
- India is ranked 3rd amongst emerging markets and is also growing the fastest in number of industry sponsored Phase II-III sites
- India participates in over 7% of all global III and 3.2% of all global Phase II trials
- India needs to further expand its base for trained GCP Investigators, sites and improve regulatory system especially in the area of Pharmacovigilance
|
| | Dr S.K. Gupta, Director General & Dean, Institute of Clinical Research India, India
|
09.40 | Public health is a driver of bioscience research, development, and evaluation
- Public health is an ally of the bioscience industry. They share many of the same goals and objectives, which include reducing the amount of disease and premature deaths, and resulting discomfort and disability in the population; and changes in biotechnology are reflected in public health. Due to their synergies, public health can attract the necessary means to achieve sustainability for biopharmaceuticals.
- Immunization is one of the basic preventive tools of public health, and its importance is likely to grow in the next decade. Together, biotechnology and immunization provide an explosion of new opportunities for effective infection control. The impact of public health working hand-in-hand with bioscience should be examined closely in order to bridge the gaps in the bioscience industry in India.
- Public health institutions possess significant capability in providing vaccines and vaccination programs, and monitoring and evaluation. Their resources can be important contributions to bioscience and should be leveraged to support overall bioscience research
|
| | Dr Michael Favorov, Deputy Director-General, Director of Translational Research Division, International Vaccine Institute
|
10.10 | Morning refreshments
|
| Strengthening India's competitiveness for drug discovery and development |
|
10.40 | Developing India’s preclinical and clinical development capabilities to strengthen its position in drug development
- Identifying the key factors to develop for India to be a viable hub for partnerships and outsourcing preclinical and clinical development
- Assessing India’s opportunity to take advantage of the booming demand for outsourced preclinical and clinical development in Asia
- Taking the necessary steps to strengthen India’s drug development capabilities
|
| |
|
11.10 | Introducing the latest state-of-the-art preclinical standards in India to compete globally
- Different paradigms of preclinical development and critical factors driving the design of the studies
- Translational biomarkers and strategies to decrease timelines in development
- Understanding what India needs to do in order to find its niche in the preclinical development
|
| | Dr Matt Devalaraja, Director, of Pharmacology, Pharmacokinetics and Toxicology, Human Genome Sciences, United States
|
11.40 | Finding practical solutions to a safe and high quality clinical trials in India
- Addressing IP protection issues and its impact on India’s clinical development
- Understanding the important factors for India to lead in clinical development
- Leveraging on India’s resources to increase its competitiveness for clinical development globally
|
| |
|
12.10 | Networking luncheon
|
| Cost effective clinical trials in India: Methodologies, partner selection and site management |
|
13.30 | Finding the best strategy to expand your clinical operations in India
- Functions and factors to consider while establishing clinical presence in India
- Challenges in setting up a clinical center in India
- Opportunities in operational and strategic implementation
- Integrating India center into global organization
- Lessons learnt and summary
|
| | Dr Mohan Bangalore, Senior Director & Site Head, Wyeth Pharmaceuticals, India Clinical Research Center, India
|
14.00 | Developing a cost effective clinical management strategy in India
- Streamlining clinical trial design to optimize operations in India
- Effectively managing multi-territory clinical trials sites to expedite drug development
- Overcoming the challenges in conducting trials in various parts in India
|
| |
|
| Opportunities and challenges in preclinical and clinical development |
|
14.30 | Unique challenges and opportunities in preclinical and translational areas of biologic development
- What differentiates biologics from small molecules?
- Point out the unique challenges and opportunities for biologics during their preclinical and clinical development
- Highlight potential areas of opportunity for India in this arena
|
| |
|
15.00 | Meeting the challenges and actualizing the potential of preclinical and clinical development in India
- Understanding India’s complexity to ensure efficient and timely drug development
- Sustaining India’s competitiveness in global drug clinical development
- India as one of the leading countries in Asia for preclinical and clinical development
|
| | Dr Mita Nandy, Vice President - Medical Services & Clinical Research, LG Life Sciences India Pvt. Ltd, India
|
15.30 | Practical solutions to safe and high quality clinical trials in India
- Challenges in performing clinical studies in India
- Upholding ethical standards in India – Obtaining proper informed consent from Indian patients
- Developing investigational sites and internal clinical research professionals
- Navigating the regulatory approval process
|
| | Dr Rajat Goyal, Country Director, International AIDS Vaccine Initiative, India
|
16.00 | Afternoon refreshments
|
| CRO and clinical service providers showcase |
|
16.30 | CRO Showcase: Presentations from key global and Asian clinical research organizations
Leading clinical service providers such as CROs, data management and clinical supplies will be showcasing their drug development capabilities. Each will highlight the advantages of bringing preclinical and clinical development in India and the Asia Pacific region. They will talk about their successful partnerships with global pharmaceuticals and biotech companies expediting drug development in Asia.
|
17.20 | Chairperson’s closing remarks
|
17.30 | End of conference
|
|
4 December 2009, Friday - Post conference masterclass
|
| Analytical methods for characterisation and comparability analysis of bioproducts |
|
09.00 | Masterclass details:
This masterclass will provide an overview of analytical physicochemical techniques for the characterisation of biopharmaceuticals, particularly using mass spectrometry and other sophisticated instrumentation.
Characterisation strategies for glycoprotein products including antibodies will be covered, with reference to appropriate regulatory guidelines. Appropriate techniques for comparison analysis of biosimilar and reference products will be described. This masterclass will seek to address common questions asked of product characterisation such as why, when, what, how and how much to do?
Topics covered will include:
- regulatory requirements (ICH guidelines etc.)
- process and product development analysis
- what to characterise: post-translational modifications, including glycosylation etc.
- instrumental methods for protein (primary and higher order) and carbohydrate structure analysis including a detailed overview of a variety of mass spectrometry techniques.
- comparability analysis
- biosimilars
- structural characterisation case studies: Glycoprotein Mapping, Carbohydrate analysis, MS/MS sequencing.
|
| | Dr Fiona Greer, Director, Biochemical Services & Quality Assurance, M-scan Group
|
|
|
Dr Theodore Torphy,
Mr Murtaza Khorakiwala,
Dr Tsutomu Une,
Dr M.K. Bhan,
Dr Rayasam (Ray) Prasad,
