Day Two - 24 March 2011
09.00 Welcome back from the Chair
Jo Pisani, Partner Strategy, PricewaterhouseCoopers
| The ever-changing generics landscape |
09:05 Identifying the global bases for generics
• Analysing the market for growth opportunities
• Identifying the winning strategies in generic markets: Mergers, acquisitions and market consolidation
• Gaining ground in generics markets: Where will your products be the most successful?
• Overcoming challenges in global pricing and reimbursement pressures
Alan Sheppard, Principal, Global Generics Thought Leadership, IMS Health
09:35 Fine tuning an IP protection strategy suited to regulated market to drive profit maximisation strategy
• Developing a global air tight IP protection and risk mitigation strategy
• Working directly with scientists to cover all angles and clearly communicate the characteristics of the innovative drug
• Creating a robust contract with outsourcing partners to ensure compliance
• Geo assessment of time limits of IP rights and how it influences market entry strategies
Philip Datlow, Director and Senior Counsel II IP, Boehringer-Ingelheim
Ulrich Kebekus, Boehringer-Ingelheim
10:05 Questions
10:20 Outsourcing trends 2011: Who do you rely on for quality and compliance?
• Mastering the industry trend of virtualising pharma through outsourcing research, trials and manufacturing
• Are firms consolidating or isolating the API, intermediate and formulation services?
• Contracting with low cost country manufacturers and the legalities of the agreement
• Is there a pull away from China? Identifying the new hosts for research and manufacturing
• Performing quality system audits: Reliance on common audits as opposed to individual
Stuart Hadley, R&D Pharmaceutical Development, AstraZeneca
Ulrich D. Korneck, Managing Consultant, Camelot Management Consultants
Molly Bowman, Manager, Small Molecule Research, Thomon Reuters
Silvia Di Benedetto, PhD, Contract Manufacturing Division, Fabbrica Italian Sintetici
10:50 Refreshments
Effects of government involvement in creating pharma strategy |
11:20 China
• Government’s role in Business Growth/ Innovation in China.
• Understanding the regulatory and IP environment in China and designing commercialisation strategies.
Qinghong Xu, Partner, Lung Tin International Intellectual Property Agent Ltd.
11:50 Russia
• Government establishment of local targets: Why multinationals are rushing in to set up base
• Analysis of government’s protectionist efforts: Will this save home grown products?
• Will we see API innovation take off in Russia?
Molly Bowman, Pharmaceutical Research Analyst, Healthcare & Science, Thomson Reuters
12:20 Japan
• Current Generic Status & Trend
• How to increase your Market Positioning -- World’s second largest market
• Government Policies & Reimbursement Challenges
Gurpreet Sandhu, Managing Director, Reva Pharma
12:50 Questions and answers
13.00 Lunch
| Trends in Therapeutic Areas |
14:00 Oncology
• Global Market Overview – Growth Trend
• Generic Prospective --- How it will impact – Lowering cost of treatment.
• Industry Perspective on Challenges and Growth Opportunities
• Market Dynamics and Drivers
Gurpreet Sandhu, Managing Director, Reva Pharma
14:30 Developing a licensing strategy to boost growth and market potential
• Utilising collaborative research: Is sharing the data and security a risk you are willing to take?
• Optimising licensing opportunities: Negotiating robust contracts
• Establishing milestones to identify clear equity stakes in co-development deals
• Identifying the advantages to using flexible alliance structures
Dr. Anna Lisa Picciolo-Lehrke, Director Business Development, UCB Pharma GmbH
15:00 Roundtable Sessions and coffee
Roundtable 1: CMO
• Is it better to manufacture in low cost countries or close to home?
• What criteria is used to identify a quality partner
• Common audits or personal audits? What is more reliable
• Ensuring traceability: Who is your CMO using as a supplier? Are they on the preferred supplier list?
Joaquin Santos Benito, Senior Director External Manufacturing, Janssen Cilag | Roundtable 2: CRO
• Where is the industry moving with regard to clinical trial host countries
• How to manage and ensure a partner upholds the agreements
• Performing constant risk mitigation to guarantee quality trial and IP protection
Jo Pisani, Partner Strategy, PricewaterhouseCoopers |
15:40 Closing Conference Panel
Selecting the right partner: The criteria and metrics utilised by Big Pharma
• Identifying the critical criteria needed from a supplier to meet the specific needs of Big Pharma
• Renegotiating contracts: Knowing when to update your agreements in accordance with global changes
• Performing audits and ensuring all parties are upholding the agreement: Preventing critical items being lost in translation
• When is your guard up? Fear in outsourcing proprietary products
• Ensuring traceability throughout the supply chain: Enforcing the adherence to agreements and standards with data collection and tracking
• Health, safety and environment contracts: Establishing the requirement and incorporating into the audit process
16:10 Chairman’s closing remarks
16:10 Close of Conference
