Day One - 23 March 2011
08:30 Registration and coffee
09.20 Opening remarks from the Chair
Jo Pisani, Partner Strategy, PricewaterhouseCoopers
09:30 Geo-sourcing trends 2011: Analysing the latest sourcing trends and pharmerging markets
• Identifying key regional hubs for specialisation in excipients, intermediates and API supply
• Geographical technology specialisations: Forecasting regional concentration
• European revival: Is the western shift really happening?
• Evaluating and comparing global suppliers on key factors of cost, quality and reliability
• Forecasting the rising costs of India and China and what the prediction for future demand
Molly Bowman, Manager, Small Molecule Research, Thompson Reuters
10:10 Questions
10:15 Global assessment of regulatory influence on quality control and quality assurance
• Is your compliance related to who is at the helm? Address the role of a leader in achieving compliance.
• Addressing new regulations in China and India following the Heparin and Melamine incidences
• Assessing forecasts for finished dose products from China, how will you control your CMO?
• Debating the effects of the increased flow of issued warning letters from the FDA
Dr. Ranjana Pathak, VP, Quality Assurance and Compliance, Endo Pharmaceuticals
10:55 Questions
11:10 Refreshments and Networking.
Innovations and trends in technologies Sponsored by: FIS |
11:30 HPAPIs: No longer niche?
• Clarifying the various forms of highly potent active pharmaceutical ingredients: Small molecule, biologic or antibody drug conjugates
• Identifying the slice of the pie: How large is the HPAPI market
• Projections of future growth and expected therapy areas
• Assessing the added costs of research and manufacture to make an advised decision of whether to enter the market
Justin Mason,Managing Director, SafeBridge Europe, Limited
12:00 Using a CMO to manufacture HPAPIs: Opportunities and Challenges
• Clarifying the criteria necessary to choose your partner or supplier
• Identifying and meeting Occupational Health requirements to guarantee safety
• Outsourcing the manufacturing: specialised consideration in facility design, equipment, operation and process safety
Conrad Roten, Group Leader R&D, Early Phase and Highly Potent API Projects, Lonza
Excipients: The secret champion in drug formulation |
12:30 Ensuring quality, safety and longevity of supply when sourcing excipients and intermediates
• Market analysis of fine chemical sourcing: Moving forward from the Heparin and Melamine crisis
• Know your supplier: Protect your product from economically motivated adulteration and substitutions
• Addressing the EU versus low cost country sourcing: Pharmacopoeia requirements and proposed changes
• Assessing the need for Drug Master Files for excipients in the EU
Darek Lewin, Corporate Quality Manager, JRS Pharma GmbH & Co. KG
13:00 Lunch
14:00 One step ahead, what is new on the excipients regulatory requirements: Incorporating audit process into your excipient sourcing strategy
Merck Case Study
• Lacking of regulation trigger the industries to overcome the new global challenges and (activities and initiatives)
• Latest regulatory initiatives in a attempt to regulate excipients
• An intensive co-operation and information exchange between supplier and manufacturer is needed
• Ensuring (not guaranteeing) transparency and traceability: Realising the benefits of being able to hold your suppliers accountable
• Providing quality dossiers in line with ICH-Common Technical Document formats
• EMPROVE concept
Dr. Najib Sehat, Director PC Global Regulatory Affairs, Merck KGaA
14:30 1:1 Networking
Using our Meeting Manager software, you may have your choice of four meetings with industry peers to catch up, discuss new business opportunities or pitch your idea of collaborating
15:50 Tea and coffee
Biosimilars: The ‘generic’ market everyone wants a piece of |
16:05 Industry perspective on evaluating barriers to entry
- The business development perspective
• Assessing the attractiveness of Biosimilars – is it worth taking such a rough ride
• Developing a Biosimilar strategy – DO’s and DONTs, but definitely don’t do it the generic way
Anjan Selz, CEO, Finox AG
- Comprehensive Strategy for a Biosimilar Registration
• Understanding Biosimilars legislation in Europe / USA
• Bioequivalence and clinical equivalence
• Scientific Advice: ensuring a successful study design
• Special considerations in Biosimilars drug development and approval
Dr. Richard Peck, Director Regulatory Affairs, Finox AG
16:55 Partnering strategies to enter the biosimilar market
• Capitalising on the Indian biosimilars market: Specialisation, technology and knowledge
• Identifying the criteria currently used by Big Pharma when choosing a partner
• Analysing licensing strategies as a substitute
• Global biosimilars market opportunities in the context of licensing and partnering
Rahul Padhye, Head of Corporate Development, Reliance Life Sciences
17.25 Questions
17:40 Close of Day 1
17:45-19:00 Drinks reception
20:00 Dinner
* Click on the link for Day two agenda
