Written by James Love
Wednesday, 07 January 2009
Program and Agenda
(Draft 7Jan09)
Roundtable on De-linking R&D Incentives from Prices
Designing Innovation Inducement Prizes for Diagnostics, New Drugs and Vaccines for Type II and III diseases and conditions, with a particular focus on TB and Chagas Disease
DATE: January 16-17, 2009 (Weekend before the WHO Executive Board)
LOCATION: Geneva, Switzerland – MSF Office – Rue de Lausanne, 78
Co-Sponsors: KEI, HAI, MSF, UAEM, OXFAM and IQsensato
Program for the meeting: This is a two day technical meeting on issues relating to the design of innovation inducement prizes for low cost rapid point of delivery diagnostic tests (day 1), and for the development of new drugs and vaccines (day 2), for TB and Chagas Disease.
The meeting is designed to cover diagnostics on day one, and drug development on day two. The issues are similar, but there are also a number of differences, as will be evident from the discussion.
Rather than consume time with detailed power point presentations and formal speaking roles, the meeting will mostly be a moderated discussion of a list of topics relating to the design of one or more prizes. Each topic will be briefly introduced by a resource person, and then the group will explore the topic. The plan is to cover every topic at least somewhat, even if the issue cannot be fully resolved at this event. One objective of the meeting is to allow the participants to ask questions, debate and think about the prize design issues in a focused but informal setting. There will be a meeting report outlining the discussions, and reporting consensus where consensus exists, but there will be little pressure on participants to come to conclusions on topics. The primary benefit of the meeting is to introduce the technical topics to the participants, to stimulate discussion and debate, and to build capacity on prize design.
The draft agenda below is accurate in terms of the subjects to be discussed, but not overly specific on how much time each issue will receive.
AGENDA
DAY 1 (January 16, 2009)
Prizes for Development of Low Cost Rapid Point of Care Diagnostic Tests
Friday Chairs, Michelle Childs, MSF and Jamie Love, KEI
0900 – 0930 Introduction, welcome and plan of the meeting
0930 – 1000 The Rationale for Prizes for Low Cost, Rapid, Point of Care Diagnostic Tests
1000 – 1100 Overview of Issues in the design of Prizes for Diagnostic Tests
Relationship between push and pull
Medical, technological and economic criteria for prizes
Hard or flexible end points
First Past the Post
Best of
Minimum Requirements
Preferred outcomes
Near misses
Changes in rules
One prize or several prizes?
Single Prize: One winner – Multiple winners
Prizes for Stages or Elements: Milestone prizes – Optional Outcomes
Interim results prizes: Specific Technological Challenges – Periodic “best of”
Follow-on innovation
Incentives for open sharing knowledge and technologies
Open source/Access to knowledge dividend
Evaluation of contestants
Clinical trials to evaluate contestants for grand prize
Evaluation of prizes for stages or elements
Evaluation of Interim results prizes
Evaluation of Open Source/A2K dividend
Licensing of patents, know-how and other intellectual property
Size of the prize(s)
Period of time when offer stands
1100 -1120 Coffee/tea break
1120 – 1230 Design of Diagnostic Prizes (cont.)
The Barbados/Bolivia TB diagnostic prize proposal
The X-Prize work on a TB diagnostic prize
Other approaches
Governance
1230 – 1400 LUNCH
1400 – 1530 Design of diagnostic prizes (cont.)
1530 – 1550 Coffee/tea break
1550 – 1730 Wrap-up and actions steps
1900 Group dinner
DAY 2 (January 17 2009)
Prizes for Development of New Drugs and Vaccines for TB and Chagas Disease
Saturday Morning Chairs, Sophie Bloemen, HAI and Michael Behan
Saturday Afternoon Chairs, James Love, KEI and Sisule Musung, IQsensato
0900 – 0930 Rationale for Prizes for Development of New Drugs and Vaccines
0930 – 1030 Overview of Issues in the design of Drug Development and Vaccines Prizes
Relationship between push and pull
Prizes for specific outcomes vs. prizes to reward all products that improve outcomes
The early APC/AMC approach – Focus on standards for qualifying projects
The 2002/Aventis proportional reward approach – Low threshold to qualify for rewards, with fixed prize fund, proportional allocation of funds on the basis on the relative impact of products on health outcomes
Modifications of the proportional reward approach: Fixed credit for new products – Declining credit for additional DALY/QALY
Valuation of products with low expected current utilization: Inventory and option pricing models /Antibiotics/ Stockpiles for possible threats to public health
Prizes for interim results: Solving discrete problems- Milestone rewards- Valuation of interim results
Evaluation of Outcomes: Evidence – Governance –
Competitive Intermediaries: Selection and funding of intermediaries – Transparency and evidence – Terms of reference
Licensing of patents, know how and other intellectual property
Follow-on innovation
Incentives for open sharing of knowledge and technology
Open source/access to knowledge dividends
Size of prize funds
1030 – 1050 Coffee/tea break
1050 – 1230 Design of Drug Development and Vaccines Prize Funds (cont.)
Specific Proposals
The Barbados/Bolivia Chagas Prize Fund Proposal
The Barbados/Bolivia Licensed Products Prize Fund (LP/pf) for Donors
The Barbados/Bolivia Priority Medicines and Vaccines Prize Fund (PMV/pf)
The FDA Priority Review Voucher
HIF
Advanced Market Commitments for pneumococcal vaccine
Other approaches
1230 – 1400 LUNCH
1400 – 1530 Models for multilateral commitments for sustainable financing
Biomedical R&D Treaty
International Financing Facility (IFF)
UNITAID/PEPFAR/Global Fund
WTO Agreement on Supply of Public Goods
Sui generis funding commitments
1530 – 1545 Coffee/tea break
1545 – 1730 Wrap-up and actions steps
1730 Close