Tags: 18th september, best fit, biovitrum, business development director, current market, current trends, deal structures, draft agenda, focus day, healthcare consultant, landmark deal, market dynamics, new deal, pharma, president wilson hotel, president wilson hotel geneva, qualitative approach, quantative, risk and reward, selection criteria,
16th-18th September 2008,
President Wilson Hotel, Geneva
Draft Agenda
16th September Focus Day 1: Partnering Skills
9.00 Evaluate The Mechanisms And Models Used By Big Pharma To Determine Deal Value And Assess The Impact Of Current
Market Dynamics
· Assessing the main models used by big pharma to gauge value in traditional partnerships
· Examining current trends in the market and the effect recent landmark deal values have had on subsequent partnerships
· Using existing pharma models to calculate the value of your own product
James Williams, Business Development Director, Roche
09.30 Maximise Future Partnering Opportunities Through The Implementation Of A Strategic Selection Criteria
· Defining strategic partnering objectives to understand which deal opportunity will be the best fit for your co-development project
· Maximising the benefits of partnering with
o Big pharma
o Mid-sized pharma
o Biotechs
· Assessing the implications of a quantative vs qualitative approach: should you focus all your efforts on a few established partners or
broaden your search?
Invited: Hans Orstrom, Head of BD&L, BioVitrum
10.00 Lessons Learnt From Recent Complex Deal Structures And The Potential For Creativity Within Your Own Negotiations
· Examining examples of increased complexity in deal structures over the last 12 months
· Analysing big pharma's approach to new deal structures; what are their key criteria to support shared risk and reward?
· Implementing the right infrastructure in your alliance to support effective co-promotion or extended marketing rights
· Evaluating the benefits and disadvantages of taking on increased risk in your partnerships
To Be Invited: Leading Healthcare Consultant
10.30 Break
11.00 Developing Strategies And Implementing Best Practice In Preparation For Due Diligence To Ensure A Smooth
Transition To Partnership
· Pinpointing areas for improvement within your own organisation to pass the
due diligence process
· Deciding where confidentiality boundaries should lie within your partnership
· Understanding the expectations of pharma companies when entering into collaborations
· Managing swift procedural and operational change throughout your organisation
Jeremy Carmichael, Head of Business Development, Astex
11.30 Workshop: Accurately Allocate Limited Resources To Produce A Successful Framework For Alliance Management
· Developing clarity at negotiation and contract stages to create a strong framework for alliance
· Understanding the level of development and management support you can expect from a pharma partner
· Assigning responsibilities for alliance management within your own decision-making structure
· Anticipating the unplanned challenges required for effective alliance management and adequately preparing for them
Onno van de Stolp, CEO, Galapagos
Kevin Fitzgerald, CEO, Isogenica
Tobias Keichle, Head of Alliance Management, Roche
12.30 Lunch
13.30 Negotiation Skills: Reaching The Right Solution For Both Partners
· Recognizing your partner's needs and key objectives to determine your own priorities for negotiation
· Overcoming key obstacles, including:
o Governance
o Sharing risk
o Patenting
o Follow-ups
· Ensuring a speedy and suitable resolution in clause negotiation
David Colpman, SVP Business Development, Shire Pharmaceuticals
Elias Papatheodorou, CEO, Novosom
Invited:
Barbara Zink, Head of Corporate Development, Basilea Pharmaceuticals
14.00 Align Your Offering With The Current Demands And Expectations Of Big Pharma
· Exploring the trends and therapeutic areas which pharma will be actively pursuing over the next 12 months
· Making contact: evaluating the best ways to approach pharma BD&L experts with your proposition
· Identifying the regulatory hurdles which you should have passed or be preparing to overcome to make your development more
attractive to pharma
· How can you stand out? Assessing the key criteria big pharma are currently using to source innovation
Confirmed:
Denise Goode, Executive Director, Strategic Transactions, AstraZeneca
John Cantello, Head of BD&L, GSK
Invited:
Alex Chanas, Director of Licensing & Development, Pfizer
14.30 Combine Partnering With Financing To Leverage Ongoing Growth Of Your Organisation
· Assessing the industry drivers for increased financing within partnerships
· Investigating how seed funding can be obtained through creative deal structures
· Evaluating the available structures for a finance-based deal structure and determining which is most applicable to your business
· Examining existing financing collaborations and measuring the success of these deals for both partners
Leading Law Firm
15.00 Break
15.30 Workshop: Examine The Key Contract Clauses Which Will Make Or Break Your Alliance
· IP who controls your IP, will it be integrated into a development package or can you retain control? What about future research?
What will you do in case of termination?
· Due Diligence Clauses your partner wants as much flexibility as possible; you want commitment. Can you have competing
programmes? What rights can you control?
· Termination You want something valuable back, whatever the outcome how can you guarantee this? What obligations can be
imposed on the licensee?
· Control Over Development Who controls the development of your product? How much control can you expect to have in the
partnership?
To Be Invited:
Stephen Mahoney, Senior Corporate Council, Genzyme
Leading Global Law Firms
17.00 End of Focus Day
16th September Focus Day 2: Emerging Markets
9.00 China Focus:
Evaluating The Regulatory Framework In China To Ensure A Successful Transition To Partnerships In The Region
· Examining the legal framework in place in China to protect IP and assessing recent examples of this in force
· Evaluating the recent experiences of multi-nationals in China to determine how secure potential collaborations will be
· Identifying key challenges for you to overcome to build effective contracts and overcome local legal issues
Leading IP expert in China
09.30 The Pharma Landscape in China: Align Your Business With Chinese Biotechs
· Uncovering sources of early stage funding and state-led incentives for innovation
· Understanding the development objectives of Chinese biotechs and the current exit strategies in place
· Assessing the internal and external pressures to collaborate and in- or out-license their products
· Identifying the optimal `partner of choice' for a Chinese biotech based on requirements in research expertise and global influence
Leading Chinese Biotechs
10.00 Access The Key Tools To Locate Innovation In China, Including Consultants, Associations And Directories: Ensure You
Get First Access To `Hidden Jewels'
· Examining how local pharma organisations successfully source innovation in China
· Analysing the success of multi-national companies in locating Chinese biotechs and understanding what tools are in place to help
this process
· Leveraging local industry bodies and organisations to help identify exciting research
· Setting realistic KPIs and timescales for screening in China to ensure you deliver best in class results.
Leading Chinese Biotechs
10.30 Break
11.00 India Focus:
Investigate The Development Of IP Protection Laws And The Influence Of International Protocols in India
· Assessing the legal framework in place in India to protect IP and evaluating how strongly this is enforced
· Examining the implications of an inconsistent track record in IP protection on Indian biotechs and CROs and assessing the industry
measures taken to combat this
· Reviewing recent collaborative successes in India to gauge the security of your investment in the area
Vijay Soni, Global Head IPM, Glenamrk Pharma
Assess The Innovation And Potential For Growth In India To Determine Your Screening Strategy In This Area
· Evaluating the impact of Indian innovation on a local and global scale
· Assessing the success of Indian biotechs in leveraging CROs resources and reputation to grow innovation
· Tracking the support and funding frameworks for Indian biotechs to gauge how much local innovation is supported
· Analysing the therapeutic areas most prevalent among Indian biotechs and finding the key mechanisms in development there
Examine Indian Biotechs' Objectives To Understand How Best To Form Effective Collaborations
· Pinpointing the size and capabilities required by Indian biotechs in their `partner of choice'
· Analysing Indian pipelines to determine where and when collaboration can be optimised
· Investigating how Indian innovators prioritise global commercial markets to align your own offering
· Assessing the type of deal which has proved most successful in India and the best fit options for working with partners in this area
Dr. Koteswara Rao Kollipara, MD, Transgene Biotech
Gary Deeb, Vice President, Global Licensing and Business Development, Glenmark Pharma
12.30 Lunch
13.30 CEE Focus:
Identify Genuine CEE Innovation Before Your Competitors To Guarantee Maximum Benefit To Your Pipeline
· Examining the geographical spread of innovation across the CEE region
· Mapping out the therapeutic focus of CEE biotechs to identify the highest value for your organisation
· Evaluating the industry bodies and tools in place to support partnering in the area
· Assessing how you can best leverage these tools to source innovation
· Analysis of the biggest deals done in the area
To Be Confirmed: CEOs of CEE Biotechs
How Will European Accession Affect The Regulatory Landscape Of The CEE Biotech Industry?
· Evaluating the regulatory changes imposed on EU member countries
· Assessing governmental initiatives and funding which support research in CEE countries
· Governmental initiatives on overcoming corruption and IP infringement in the pharmaceutical industry in this area and the impact on
your own partnerships
· Mapping the regulatory landscape in non-EU CEE countries and determining how to best invest in the region
Top European Lawyer
Examine The Existing `Partners Of Choice' For Local Biotechs In Order To Appropriately Align Your Deal Offering
· Examining the types of deals biotechs in the CEE are currently participating in
· Gauging biotech priorities for:
o Development expertise
o Commercialisation experience
o Global reach
o Payment
· Evaluating the key criteria for making your organisation and deal terms more attractive to CEE biotechs
Invited: CEOs of CEE Biotechs
15.00 Break
15.30 Latin America Focus:
Analysis Of Current High-Profile Local And International Partnering Deals In Latin America
· Highlighting the most successful recent deals to take place in Latin America
· Pinpointing the most successful local pharma companies for biotech partnering in the region
· Tracking deal value in Latin America and drawing comparisons with typical valuations in Europe and the US
· A growing market: Are Latin American biotechs currently looking to partner outside the region?
Leading Latin American Pharma Expert
Uncover The Hottest Potential Deals For Your Own Pipeline: Maximise Use Of Local Consultancies, Associations And
Directories
· Local insight: which tools do regional pharma companies find most effective?
· Drawing from multi-national pharma learnings in the region to build a `toolkit' of effective sourcing services
· An overview of the commercial search and evaluation agencies operating in the area
· Examining the channels local biotechs choose to promote their own licensing opportunities
Invited: Marco Antonio de Campos Fernandes, Business Development, Aché Laboratórios Farmacêuticos S/A
Examine The Success Of Latin American Biotechs Getting Research Into The Clinic To Gauge The Value In Investing
Resources There
· Quantifying the value of Latin American-developed drugs in the local market
· Exploring the potential of local pipelines to make an impact on the global market
· Identifying key areas for improvement to bring Latin American opportunities in line with western regulatory guidelines
· Overcoming country-specific cultural challenges to release the full potential in partnerships
Invited: Paulo Vidigal, Head of Business Development, Biomm
17.00 End of Focus Day
17th September Conference Day 1
9.00 Assess The Latest Trends In Deal Making And Align Your Business With The Global Economic Climate
· Examining how the prevalence of early-stage collaborations is affecting deal values across research phases
· Anticipating the impact of the upcoming US elections on the pharma environment in the US and preparing for the wider global
implications
· Counting the cost of the credit crunch: who are the winners and losers in leaner financial times?
· Identifying the hottest areas for growth and investment in the current partnering environment
Simon Best, Former Chair, BIA
9.40 Deal Case Study: Merck/GTX Establishing A Partnership To Develop A New Class Of Drugs
· Determining the key drivers for Merck to invest in an early stage deal
· Detailing how the alliance has been constructed to facilitate maximum communication
· Collaborating for success through management of combined drug candidates and key resources
· Creating opportunities to further the partnership
Invited: Senior Representatives From Merck/GTX
10.20 Deal Case Study: Holding for Pfizer
11.00 Break
11.50 Establishing The Potential And Assessing The Research Landscape Of Oligoneucleotides
· Comparing results from key areas:
o Antisens
o RNAi
o SiRNA
· Reviewing the major challenges facing development in this molecular class and identifying potential solutions
· Applying the technology to therapeutic areas and disease states
· Predicting the next step for oligoneucleotides and their potential impact on the market
Elias Papatheodorou, CEO, Novosom
Dr. Frank Morich, Chief Executive Officer, Noxxon
12.30 Deal Case Study: Novexel/Forest Assessing The Impact Of A Reciprocal Partnering Agreement To Measure How This
Will Impact Your Deal Making Opportunities
· Exploring the negotiation process to reach the allocation of licensing agreements
· Managing the alliance: strategies put in place by both partners to ensure shared development is successful
· Investigating the key internal drivers for a two-way collaboration being chosen in this situation
· Addressing the industry factors which will encourage more deals in this model
Invited: Wael Fayad, VP Business Development, Forest
13.10 Lunch
Therapeutic Stream
14.30 Oncology: Evaluating The Benefits Of Pursuing Niche Indications Over Blockbusters To Overcome Regulatory Hurdles
And Meet Market Demand
· Evaluating which approved oncology treatments are currently dominating the market
· Getting approval: is saturation in oncology trials making approval harder to find?
· Examining how trends in the oncology drugs getting to market has evolved in the past 5 years
· Highlighting the niche indications which will deliver maximum market potential over the next 5 years
Invited: Senior Representative, TopoTarget
15.00 Cardio-Vascular: Uncovering Current Cardio-Vascular Pipelines And Areas Of Unmet Medical Need To Identify Where
The Biggest Market Potential Lies
· Mapping the development of the therapeutic area and where best to target for the next 12 months
· Identifying the key areas of unmet medical need in this area
· Pipeline analysis: an overview of cardio-vascular research currently in the clinic
· Evaluating the market potential for a successful drug in this area
Leader in Cardio-Vascular Field
15.30 Discussion Roundtables:
Oncology
Cardio-Vascular
16.00 Break
16.30 CNS & Pain: Assessing The Recent Deal Landscape To Identify Key Areas For Growth And Promising Deal Prospects
· Analysing the current deal landscape to track potential value in new collaborations
· Which critical factors in the market have contributed to the rapid growth of this therapeutic area?
· An overview of exciting pain research currently in the clinic
· Evaluating the scope for innovation in this space: how much current research is `me too' and how much is groundbreaking?
Invited: Senior Representative, Eisai
17.00 Discussion Roundtables:
CNS
Pain
Innovation Stream
14.30 Stem Cells: Drawing Effective Conclusions From Recent Research To Identify Potential Deals And The Impact Stem Cell
Technology Could Have On Your Pipeline
· Mapping successes of current research and predicting where future developments will lead
· Identifying future scientific and regulatory roadblocks which will need to be overcome for cell therapy to achieve maximum potential
· Reviewing the impact of deals which have taken place in stem cell research
· Applying this technology to the market: which therapeutic areas and diseases will be most affected by cell therapy?
Confirmed:
David Colpman, SVP Business Development, Shire
Michael Hunt, CEO, Reneuron
Invited:
Nick Higgins, CEO, Intercytex
15.00 Peptides: Identifying The Innovation And Track How This Is Shaping The Future Of Protein Technology
· Pinpointing the key sources of innovation in peptide research globally
· Overcoming the scientific and regulatory hurdles currently facing peptide development
· Examining the potential impact of peptides on a range of therapeutic areas
· Predicting the development of the role of peptides over the next 5 years
Confirmed:
Kevin Fitzgerald, CEO, Isogenica
Mette Kristine Agger, CEO, 7TM
15.30 Discussion Roundtables:
Stem Cells
Peptides
Oligoneucleotides
16.00 Break
16.30 Identify The Innovation And Collaboration Potential With Four Of The World's Top Universities To Ensure You Are
Ahead Of The Technology Curve
· What research is coming out of top universities and how will it affect the deals you do in future?
· Making the transition from bench to commercial enterprise: how are universities making research more commercially accessible?
· Analysing recent industry/academic deals to understand how innovation is being successfully harnessed by pharma
· Evaluating the upcoming opportunities for in-licensing and collaboration and how your pipeline can benefit
Confirmed:
Dominique Kleyn, Head of BioPharma Business Development, Imperial College
Olivier Wenker, Director of Technology Discovery, The University of Texas MD Anderson Cancer Center
Laura MacDonald, Head of Licensing, University of Leiden
18th September Conference Day 2
9.00 Deal Case Study: GSK/Oncomed Assessing The Effect A Landmark Monoclonal Antibody Deal Will Have On The Market
· Examining the drivers for GSK entering into collaboration with a technology-focused partner
· Investigating the strategic and scientific goals put in place for the collaboration
· Considering the impact this large technology-based deal will have on future collaborations
· Evolving and achieving partnership goals to ensure maximum benefit for both partners
Invited Senior Representatives From GSK/Oncomed
9.40 Deal Case Study: Sanofi-Aventis/Regeneron Examining The Drivers For An Incremental Growth In Collaboration And
Equity
· Assessing the terms of the original deal and the successes which drove further collaboration
· Identifying the potential for further collaboration in this deal
· Positioning the partnership with Regeneron in Sanofi-Aventis' overall strategic goals
· Understanding the Regeneron perspective on the partnership and its evolution
Invited: Jean-Michel Levy, Director, BD&L, Sanofi-Aventis
10.20 Leverage Big Pharma Experience And Biotech Techniques To Boost Innovation In Clinical Trials
· Tracking the challenges which have faced drug research in the past to outline the state of clinical trials today
· Specifying the key strategies in place to increase productivity in recent spin-outs
· Drawing conclusions from recent successes to map out the critical therapeutic areas most suited to adaptive clinical trial design
· Drawing lessons from biotech success and prioritising key areas for change in pharma research
11.00 Break
11.50 Deal Case Study: Wyeth/Haptogen Evaluating The Drivers Behind The Acquisition Of A University Spin-Out And
Assessing The Success In Driving Innovation In Large-Scale R&D
· Identifying the strategic fit and internal drivers for both partners
· Establishing the specific frameworks put in place to ensure continued high levels of innovation in a collaborative environment
· Evaluating the success of this acquisition to determine the shape of future M&A activity in this space
· Understanding the market factors and deal-making criteria which led to acquisition
Invited: Bob Smith, Head of Business Development, Wyeth/Haptogen
12.30 Panel Discussion: Map The Current Trends In VC Investment To Determine Which New Science Will Yield Highest
Commercial Success
· An overview of key VC investments in the last 12 months: identifying patterns in investment
· Gauging VC opinion on the technologies and research which will shape pharma deals over the next 5 years
· Pinpointing the development hotspots and individual organisations which could change the shape of medicine
Denise Pollard-Kinght, Managing Director, Nomura 4 Ventures
13.10 Lunch
14.30 Understanding The Regulatory Landscape To Assess Value In Upcoming Deals: An Overview Of Current Thinking At
NICE
· Identifying the key areas of unmet medical need which NICE is currently addressing
· Assessing which therapeutic areas will be prioritised over the next 10 years
· The NICE perspective on adaptive clinical trials: when can they be implemented to maximum effect?
· Key criteria for gaining approval for your research
Invited: Senior Representative From NICE
15.00 Perspective From The FDA Identifying Key Criteria For Approval
· Identifying the key therapeutic areas currently being prioritised by the FDA
· The FDA's vision of the future: how will the approval process evolve in the next 10 years?
· Mapping the ideal product submission and identifying common pitfalls
Invited: Senior Representative From FDA
15.30 Discussion Tables Around Key Regulatory Issues
16.30 End of conference