Open Source Pharma and Prizes

I’m involved in a meeting happening next month in Italy that is asking “Can we develop a new open source pharmaceutical industry?” We’ll be talking amongst other things about incentives (such as prizes) and new ideas for the structure of pharma (legal and economic) and trying to come up with some pilot projects. This post serves as an announcement of the meeting and a description of the agenda – true to the philosophy underlying the idea, the agenda is open to input from anyone (please just comment below). This page may therefore change in response to input from people, so any changes will be tracked.

Context: A while back, when my lab first started working on open source research for neglected tropical diseases, I was contacted by Jaykumar Menon, formerly of the X-Prize and now professor of practice at McGill University. He was interested in whether we’d considered prizes to stimulate activity. This got me to thinking about ways we might be able to combine prizes and completely open ways of working. Jay has now managed to secure funding from the Rockefeller Foundation to host a meeting to start looking at these ideas in detail. It’s taking place at the Rockefeller Bellagio resort on Lake Como, July 2014. Only 23 people can come, and we’re trying to create a diverse mix of attendees from across research, policy and philanthropy. Besides generating the funding and momentum for the meeting, Jay has driven the gathering together of a diverse set of people, and I’ve chipped in where I’m able, since we’ve learned a lot in recent years about how open source drug discovery works as part of Open Source Malaria (including how we’re operating the consortium) and in previous work with WHO on open source drug synthesis. I also gathered a group at WHO last year to ask “Is Open Source Drug Discovery Practical?” and though I’ve not yet uploaded the recordings of the session, and though there are many issues to work through, the answer to that question looked to be “yes”.

Below is the current status of the blurb about the meeting and a draft agenda, derived from Jay’s original concept note. Please feel free to comment/criticise below. We’d love to hear about anything we might be missing, or relevant literature or people we should be talking to. An objective of the meeting is to discuss but also to create viable project proposals that we could take to possible funders for formal comment.

On a personal level, despite my finding this general concept immensely exciting, there are so many questions one can ask and discuss specifically on prizes – how would prizes be awarded? For what? Who might fund a prize, and why? How would a prize be governed so that it is compatible with open ways of working? What is the role of the private sector in prize-driven, open projects? How would a prize alter the motivations for people to participate? I’ve also become increasingly interested in an important feature of open source I have noticed over the last two years in operation: an open arena is a way to combine competition and collaboration. I hope we can explore this at the meeting and beyond.

The purpose of the meeting is to nurture the growing but powerful field of open source pharma. Items for discussion:

1) What does “open” mean, for example the difference between open source and open innovation? My view on this is that open source means something very specific – that all data and ideas are shared openly, that anyone may participate in a project at any level. Open innovation refers to a competition in which there is no requirement for competitors to share anything. These two approaches are therefore polar opposites in terms of workflow).

2) The relevance and prospects of open source for pharma, at each stage of the pipeline and including the role of generics manufacture or commercial pharma as partners/contractors.

3) Open source pharma in the context of other approaches already being discussed or developed, including push mechanisms (traditional grants + Product Development Partnerships) vs pull mechanisms (Advance Market Commitments, priority review vouchers). Also patent pooling. The focus of the meeting needs to be distinguished from other initiatives that are attempting to find new drugs but which are not adopting open models.

4) A possible global incentive prize for an open source, patent-free drug candidate (initial target: probably TB (the TB bacillus resides in nearly 1/3 of humanity), but the ideas are more generally applicable to e.g. malaria, antibiotics. Open source is a way of doing research, but prizes could incentivise it.

5) Consider forming a light touch network/consortium for the largely on-line and nationally-based open source pharma communities

6) Work jointly to draft a project for taking the field forward, to be finalized with inputs from funders in the 4 months post-meeting

7) Jointly author a paper to be published in a journal on the contours, promise, and a way forward for open source pharma

Taking these points, we can draft an agenda for the 2.5 days:

Session 1: Setting the scene- what’s wrong in the kingdom of drug R&D

• Current needs and gaps
• Whether and why the current system fails
• Illustration: peculiarities of TB (possibly also malaria, antibiotics)

Session 2: Other existing incentives and enabling mechanisms

• Incentives: Push and pull mechanisms
• Models: PDPs, pharma spin offs and initiatives (e.g. Lilly Chorus model)
• Example: Piero Olliaro to speak about current initiatives in TB drug discovery/development. What have they delivered? What are they promising to deliver? Are such initiatives solutions, or partial solutions?

Session 3: Open source research: what does it really mean?

• Examples of Open Source (OS) drug dIscovery/development
• Strengths and weaknesses of OS research
• Can we develop minimum criteria for what counts as OS?
• What would OS Pharma look like?

Session 4: New ideas for incentives & mechanisms

• Prizes: example of past experiences; proposals that have been made
• Innovative management of IP: patent pooling to facilitate research (examples from other areas)
• Combining these ideas (e.g. the MSF 3 P proposal)

Session 5: Exploring an end to end system based on incentives and enabling mechanisms

• Can push, pull and pooling work with open source research?
• What would be the business model? Can this work in TB? can this work beyond TB?
• Proposal for a light touch consortium
• Proposal for a draft project

Status of Invitees
1. Jaykumar Menon, McGill
2. Matthew Todd, University of Sydney and Open Source Malaria
3. Manica Balasegaram, MSF
4. Els Torreele, OSF
5. Piero Olliaro, WHO/TDR
6. Zakir Thomas, OSDD
7. Tanjore Balganesh, OSDD
8. UC Jaleel, OSDD
9. R. Venkat, TATA Trusts, Dorabji Trust
10. Arun Pandhi, TATA Trusts
11. Peter Kolb, University of Marburg
12. John Wilbanks, Sage Bionetworks
13. Bernard Munos, Innothink/Faster Cures
14. Tomasz Sablinski, Transparency Life Sciences
15. Sherwood Neiss, Crowdfund Capital Advisors
16. John McKew, NIH/NCATS
17. [MMV]
18. Melinda Richter, head of Janssen Labs
19. Samir Brahmachari, Chief Mentor, OSDD
20. Rob Don, DNDi
21. [Free]
22. [Journalist]
23. Sarah Dennis, McGill University (logistics)

Collection of Relevant Links/Ideas:
MSF summary of alternative financing/research models, includes: “When DNDi developed ASAQ in partnership with sanofi-aventis they insisted that the newly developed medicine not be patented. In doing so they have now been able to start work on transferring technology to an additional African industrial partner to produce and sell the medicine.” and “As these prizes only take the research so far, it is important that adequate measures are put in place to make sure that when a final product relying on this innovation is developed, access for the populations in need is secured.”

Impact of patents, and the new Trans Pacific Partnership

Guardian Global Dev article on advice on how to develop drugs

Patent Pooling

CASMI

The EU PreDiCT-TB Consortium (not open as far as I know).

The Critical Path to TB Drug Regimens (also not open as far as I know).

The Stop TB Partnership

Guardian letter from MSF on “Big Pharma’s Ransom for New Drugs”

Toll-access review on “Curing TB with Open Science”

Guardian article (9th May 2014) on problem of antibiotic resistance

Kauffman Foundation report on economic incentives that might help in repurposing efforts by pharma (May 2014)

The Accelerating Medicines Partnership (relevant to non-infectious diseases)

WHO/TDR’s ongoing interest in alternative financing mechanisms. May 2014

DNDi’s views on the advantage of the PDP model. May 2014

State of play on NCEs for NTDs, with shared data from DNDi. Feb 2014

(Updated 21/5/14 with input by email from Manica Balasegaram from MSF, including the first draft agenda)

The Original Concept Note Description:
TOWARDS A NEW, GLOBAL, OPEN SOURCE PHARMACEUTICAL INDUSTRY, JULY 16-18, 2014. ROCKEFELLER FOUNDATION CENTER, BELLAGIO, ITALY

Overview: A small gathering of a maximum of 23 people on the shores of Lake Como at the Rockefeller Foundation Center in Bellagio, Italy on July 16-18, 2014, on the subject of open source pharmaceuticals.

Where: The Rockefeller Bellagio Center is a renowned spectacular site – the former villas of a princess, literally on the shore of Lake Como.

Who: A diverse and meaningful set of parties. Convening organizations include the Rockefeller Foundation, the Open Society (Soros) Foundations, and McGill University. Other attendees include representatives from the Tata Trusts (India’s largest philanthropic organization), the World Health Organization, Cipla (the global pharmaceutical manufacturer and generics giant), Medicins Sans Frontieres (Doctors Without Borders), Open Source Malaria, OSDD (the Open Source Drug Discovery initiative, an India-based consortium of 50+ universities, software giant Infosys, and the national supercomputer system of India; OSDD has already sequenced for the first time the TB genome), private sector entrepreneurs, and a crowdfunding pioneer.

When: The meeting is Wednesday through Friday, July 16-18, 2014; participants are encouraged to attend all three days. Most participants will arrive the evening of Tuesday July 15, and leave Saturday morning, July 19.

Logistics: Milan airports (LIN or MXP) are closest. Local transportation, food (all meals), and lodging (in the villas) will be provided.

What’s It All About: Truly radical innovation to meet health needs. An inspiration: “Linux for drugs.” Specifically, a move away from closed-door, market based systems, towards an open source (meaning crowdsourced, and patent free) pharmaceutical industry, an emerging avenue drawing from extreme advances in computational technologies, collaborative methodologies, and Linux-type approaches to IP.

The need of course is dire. Despite the efforts of the philanthropic, government, and private sectors, the health needs of billions globally are still going unmet, and research is still incommensurate with the scale of the problem. For example, only 1% of new approved drugs are for diseases of the developing world. And in high income countries, research into high impact but low-revenue drug classes such as antibiotics is too sparse, and overall drug development costs are extremely high, resulting in a lack of affordability. A variety of alternative approaches exist – we will focus here on the emerging open source movement. Imagine a new crowdsourced patent free drug candidates, going through publicly funded preclinical and clinical trials (funding interest has already been expressed), then being taken up by generics manufacturers on a market basis to create affordable cures for billions. Questions: How real is open source pharma? What are its prospects? And what is the path forward?