DAY 1 TUESDAY 21 SEPTEMBER – REGULATION & REIMBURSEMENT IN EUROPE DAY 1 TUESDAY 21 SEPTEMBER – REGULATION & REIMBURSEMENT IN EUROPE
8.30am Registration and coffee9.30am Chairman’s opening remarks
Executive Director, Innovative Medicines Initiative
CLARIFYING THE GLOBAL MARKET FOR TARGETED CANCER THERAPIES9.40am A decade of Herceptin and other targeted therapies: understanding the shift in the oncology market
- Mapping the scientific, clinical and commercial progress of Herceptin as a targeted cancer therapy.
- How the early success of Herceptin and other targeted therapies has shaped Big Pharma approaches to personalised medicine.
- Placing the current market for targeted cancer therapy in the context of Herceptin and other early blockbusters.
Head of Pharma Research and Early Development, Roche
10.10am Shifting the paradigm: making a case for the increased importance of early-stage development of targeted cancer therapies
- Understanding the necessity for an industry-wide focus shift towards early development procedures – scientifically, commercially and strategically.
- Implications for respective industry profiles – considering the roles of pharma, government, biotech and academia in changing the paradigm.
- Negotiating an industry-wide strategy for improving early-stage development of targeted cancer therapy, and the subsequent acceleration of products into the marketplace.
Chief Medical Officer & Senior Vice President Global Clincial Sciences, ImClone Systems, a wholly-owned subsidary of Eli Lilly & Co
UNDERSTANDING EUROPEAN REGULATORY EVALUATION STRATEGIES10.40am Taking a global approach to regulatory streamlining: integrating European guidelines into drug development programmes
- Understanding the current EU regulatory guidelines with regard to targeted drugs.
- Case studies of EMEA approvals for targeted drugs: what constitutes an approvable product?
- How do the EMEA requirements for approval differ from the FDA, and how can these be managed in global development programmes?
Muriel Edith Rickman Chair in Breast Oncology, University of Manchester; Scientific Director Oncology, Karolinska University Hospital; Scientific Advisory Group on Oncology, Committee for Medicinal Products for Human Use, EMEA
11.10am Morning refreshments11.40am Case study: the approval of Removab as EpCAM-targeted cancer therapy
- Defining an indication by the expression of the target antigen – implications and things to consider from a regulatory perspective.
- Understanding the step-by-step procedure to the approval of Removab as EpCAM targeted cancer therapy.
- Continuing beyond approval – life cycle management and indication optimisation.
Chief Scientific Officer and Executive Vice President, Fresenius Biotech GmbH
MEETING THE REQUIREMENTS FOR ACCEPTABLE REIMBURSEMENT12.10pm Developing an early strategy for improved product efficacy and acceptable reimbursement
- Providing a global overview of efficacy requirements for new targeted cancer therapies on the market.
- Best practice advice for contending with the fragmented nature of global regulatory and reimbursement guidelines.
- Outlook on the future of these procedures: is a globally unified approach to government reimbursement for these therapies a reality?
Associate Director Scientific Advice Programme, NICE
12.40pm Panel discussion with Q&A: negotiating regulation, reimbursement and early TCT development
- Considering the fragmented nature of the disease vs the fragmented nature of the regulatory landscape.
- Incorporating the early-stage development of combined targeted cancer therapies into the existing regulatory model.
- Developing an industry-wide strategy for the improved data-streamlining, regulatory environment and reimbursement options of targeted cancer therapeutics.
Muriel Edith Rickman Chair in Breast Oncology, University of Manchester; Scientific Director Oncology, Karolinska University Hospital; Scientific Advisory Group on Oncology, Committee for Medicinal Products for Human Use, EMEA Associate Director Scientific Advice Programme, NICE Head of Pharma Research and Early Development, Roche Chief Medical Officer & Senior Vice President Global Clincial Sciences, ImClone Systems, a wholly-owned subsidary of Eli Lilly & Co
PRODUCT MARKETING: IMPROVING TCT ACCESS2.10pm Product marketing: a new approach
- The strategy: advocating physicians in emerging economies by leveraging the expertise of physicians in developed countries.
- Commercial implications: identifying high volume prescribing centres, promoting the product through a new treatment paradigm and improving relationships with world health authorities.
- What has this unique approach achieved to date, and how will it stimulate the market for targeted cancer therapies in the coming decade?
Director, Global Oncology, Bayer Healthcare
2.40pm Panel discussion: improving targeted cancer therapy patient access
- What are the main concerns for market access to targeted therapies for cancer? Considering payers, prescribers and patients.
- How can companies work more closely with patients to improve market access?
- Developing innovative and holistic approaches to solving TCT access challenges: what is the way forward?
Director, Global Oncology, Bayer Healthcare
ERASING REDUNDANT TCT R&D3.10pm Erasing redundant R&D investment: standardising cancer biomarkers via an innovative new IP model
- The problem: Big Pharma is independently and redundantly investing in R&D for the same biomarkers.
- Understanding the role and mission of the Life Sciences Consortium.
- Introducing pre-competitive IP pooling as a potential solution – practical and future applications.
Principal Scientist, AstraZeneca
4.40pm Close of Day 1 followed by networking drinks reception |
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Conference:
Day 1
September 21, 8:30am - 5:30pm
Day 2
September 22, 8:30am - 5:30pm
Day 3
September 23, 9am - 5:30pm
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