Medical Impact DAO to Govern Retroactive Funding of Public Good Medicines
Estimated lifetime funding received
~$9,000
This number should not be used for accounting purposes.
About
Imagine if we can treat depression with an off-patent psychedelic-assisted therapy or cancer with a ketogenic diet?
Crowd Funded Cures is an Open Source Medical Impact DAO (partnered with VitaDAO, Molecule, PsyDAO, & LabDAO and receiving advisory support from Protocol Labs and the Health Impact Fund) whose mission is to create a financially innovative Impact Market to re-align private incentives in the medical industry away from monopoly-priced patented medicines and towards low-cost, open-source therapies that can treat and potentially cure millions of patients and improve global health and well-being.
Please note that we have two grants. The one you are reading is our grant application for the Open Source Medical Impact DAO, Crowd Funded Cures. We have a separate grant application for our Medical Prize Fund, which you can find here: https://gitcoin.co/grants/7516/open-source-medical-prize-fund-for-retroactive-fu
Currently, 1000s of otherwise viable unmonopolizable therapies are ignored by the pharmaceutical industry because a monopoly price cannot be enforced. We call them public good medicines because once the treatment protocol is published, it is not possible to stop people accessing the therapy from multiple sources (non-excludable) and use of the treatment protocol does not prevent others from using it (non-rivalrous).
Unfortunately, this causes a tragedy of the commons which means that pharma companies will not fund the large clinical trials needed for them to be reimbursed by health insurers or obtain regulatory approval. Governments and health insurers also do not want to take on the political risk of paying for large clinical trials in case they fail, which means these treatments will typically not be accepted by the mainstream medical establishment. They include repurposed off-patent generic drugs, supplements, plant medicines, psychedelics, diets, and non-pharmaceutical / lifestyle interventions.
We can solve this tragedy of the commons and provide a high impact use case for web3 that unlocks billions of dollars in social value for relatively low cost by establishing an Impact Market that incentivises impact investors to fund IP-NFTs representing public good medicines. Successful clinical trial data that validates the safety and efficacy of such public good medicines converts the IP-NFTs into Hypercerts eligible to receive outcome payments from a crowdfunded Open Source Medical Prize Fund proportional to improved patient outcomes validated in clinical trials (see Medical Prize fund figure below). The Impact Market also de-risks the funding of clinical trials for donors / public. The result would be that investors fund new public good medicines that are off-patent, unmonopolizable, and available to the entire global community at low cost, while obtaining a standard return on investment.
However, in order to bring this open source business model to pharma, we need to crowdfund a source of retroactive (and quadratic) funding of the Impact Market through our Medical Prize Fund, which is governed by our Medical Impact DAO. Together, by supporting our Medical Impact DAO, the community can usher in a new era of medicine which does not ignore otherwise viable therapies because they are not profitable under the traditional patent system. Unlike donations to traditional charities (which often receive the majority of their funding from big pharma), through this novel “pay-for-success” mechanism, you can also be sure that your donations will only fund successful clinical trials.
The following presentation by founder Savva Kerdemelidis at DeSci Berlin hosted by Molecule on 24 May 2022 explains the problem of this tragedy of the commons and how to solve it using "prize-like" Pay-For-Success contracts x IP-NFTs to create an impact market for open source medicine:
Your GR15 donations will be used to:
1. Build out the core infrastructure for our Medical Impact DAO, which will govern our Medical Prize Fund, a source of retroactive funding for Phase 2 clinical trials of public good medicines.
2. Support our operating expenses and key contributors to build out the DAO infrastructure and achieve milestones, as described below.
Problem: A Lack of Incentives for the Clinical Development of Public Good Medicines
The pharmaceutical industry’s reliance on patents have led to a massive market failure: affordable and potentially life saving therapies are missing the incentives for robust clinical evaluation and development, ultimately keeping potential cures out of the hands of patients.
An estimated 7500 generic drugs and 50,000+ nutraceuticals, plant medicines, diets and lifestyle interventions could be studied to treat and potentially cure diseases for 1/100th of the cost and up to 10x faster than patented drugs as their safety profile and often mechanism of actions are known from use over many years.
However, without monopolistic pricing and/or royalties secured by patent protection, investors are unable to get a return on their investment for the large Phase 2 and Phase 3 clinical trials that identify new therapeutic uses for these treatments, so these treatments have almost zero chance of getting the funding needed to gain regulatory approval and be prescribed by physicians.
We therefore need new ways to fund these Phase 2 and Phase 3 trials to get these therapeutics to patients.
Solution: Our Medical Prize Fund Incentivizes Phase 2 Randomized Controlled Trials of Public Good Medicines
Gitcoin Grants supports the development of open-source tools by providing direct crowdfunding or “push” incentives. Impact Markets transfer the risk of funding clinical trials to impact investors, by crowdfunding a Medical Prize Fund that acts as a retroactive (and quadratic) funding “pull” incentive to optimize treatment protocols in Phase 2 randomized Controlled Trials (RCTs) for patients that are off-patent, unmonopolizable, and potentially curative, but ignored by the pharmaceutical industry. RCTs are used to compare the treatment to a placebo or standard of care to determine if the treatment is effective.
Phase 1 RCTs are to determine safety, and typically not required for public good medicines such as generic drugs, nutraceuticals, plant medicines or diets which have already passed Phase 1 or are generally recognised as safe (GRAS) compounds.
Phase 2 RCTs are typically more than 100 patients and used to establish efficacy - these are also typically at the highest risk of failure (e.g. 50%).
Phase 3 RCTs assess the safety and efficacy of a therapeutic regimen and are required to get regulatory approval and market access of those therapies, so physicians can prescribe them to patients. These typically comprise more than 1000 patients.
RCTs must be conducted by independent Contract Research Organisations (CROs) to ensure high quality and exclude manipulation. Regarding costs, a good rule of thumb is around $10k per patient, but can vary by indication (e.g. cancer RCTs might cost $50k or more per patient, due to the requirement of ongoing tests and monitoring).
RCT treatment protocols must also be pre-approved by the Medical Impact DAO to ensure ethics approval.
Go-To-Market
Stage 1: Medical Impact DAO crowdfunds Medical “De-Risking” Prize Fund for Retrospective Funding of Phase 2 RCTs (see Figure 1 below)
Step 1.
The Medical Prize Fund will be supported by crowdfunding and sales of Medical Impact NFTs.
Step 2.
IP-NFTs are then minted to secure funding from impact investors for Phase 2 RCTs that generate treatment protocols with the most impact, as measured by % improved clinical outcomes vs. standard of care, which will be allocated impact points that determine the right to receive outcome payments from the Medical Impact Fund, through a flexible prize mechanism (e.g. 50% improvement in clinical outcomes vs usual care provides 50 impact points).
The higher the impact, the more impact points and more proportion of the annual 20% outcome payment received. This incentivizes incremental improvements and medical breakthroughs and “de-risks” Phase 2 RCTs and to determine the optimal treatment protocol for a public good medicine.
It also means that the Medical Prize Fund is scalable - the larger it is the more RCTs are registered before “market equilibium” is reached. This also ensures the efficient pricing and delivery of impact by the markets.
Treatment protocols that are less efficacious/safe than standard of care will not be rewarded.
Step 3.
Successful clinical trial data validating safety and efficacy of a certain treatment protocol converts IP-NFTs to Hypercerts which has the rights to register to the fund and receive outcome payments for a period of time (e.g 5 years), proportional to Impact Points generated, as validated by an independent contract research organization and multisig oracle. IP-NFTs owners receive exclusivity over their treatment protocol, as long as they are actively conducting the RCT.
Figure 1. Our Medical Prize Fund acts as a retroactive (and quadratic) funding “pull” incentive to optimize treatment protocols in Phase 2 Randomized Controlled Trials (RCTs) for public good medicines that are off-patent, unmonopolizable, and potentially curative.
Stage 2: Medical Impact DAO establishes Public Good Pharma Ltd to negotiate Advance Market Commitments (AMCs) for funding Phase 3 RCTs needed for Regulatory Approval of Public Good Medicines (see Figure 2 below)
Once the optimal treatment protocol for Phase 2 RCTs is obtained by the Medical Impact DAO (see Stage 1 above), a Public Good Pharma company owned by the Medical Impact DAO will negotiate Advanced Market Commitments from Payers, e.g., healthcare payers - private and public - government, etc. ensure that funding the Phase 3 RCTs are rewarded with an exclusive commitment to purchase a “branded” therapy, e.g., $100m for Open Ketamine for treatment-resistant depression. The Public Good Pharma company can also leverage method of use / dosing regime patents and reformulations to strengthen its IP position although these would primarily be enforceable against payers but not against doctors and patients (hence the tragedy of the commons) - so open source is "baked-into" the model.
AMCs provide financial incentives for Impact Investors to back a Phase 3 RCT which costs around $50m, and also conduct post marketing surveillance to check the therapy’s performance in real life scenarios, to study the long-term risks and benefits of using the therapy and to discover any rare side effects.
The amount of the AMC will be less than the cost savings for Payers that successful treatment protocols derived from these clinical trials provide, which allows the business model to scale.
As part of the Advanced Market Commitment, Phase 3 RCTs that fail to show efficacy/safety vs. standard of care will not receive a payout from the AMC.
Figure 2. Our Medical Impact DAO will establish a Public Good Pharma Ltd to negotiate Advance Market Commitments for the funding of Phase 3 RCTs required for regulatory approval (e.g., FDA, EMA) of public good medicines.
Explainer Video by Life Noggin showing for Advance Market Commitments or "Pay-For-Success" contracts work to incentivise generic drug repurposing
Roadmap & Milestones
Step 1. (completed)
Our blockchain developer, Brahma P Sen, has developed an initial smart contract for issue of Medical Impact NFTs: https://github.com/brahmapsen/CFC
Step 2. (completed)
Our front end developer, Zack West is building the site to crowdfund our general Medical Prize Fund as well as landing pages for disease specific funds such as our Open Source Longevity Prize Fund, which is live on our website (ongoing maintenance and optimisation of website).
Your donations will also support:
Step 3.
MVP for Hypercert / IPFS integration with Protocol Labs’ Hypercert project team (2-3 months).
Step 4.
Development of UX/UI and user journey for crowdfunding landing page to issue Medical Impact NFTs as Advance Market Commitments for unmonopolizable therapies in specific disease classes (2-4 weeks).
Step 5.
Build of an API that allows issuance of IP-NFTs to impact investors via Molecule.to platform, crowdfunding of Medical Impact NFT fund via Syndicate.io held in Gnosis multisig within 3 weeks’ time, by our back end / blockchain developers, Brahma P Sen, Daniel Dohne, and Cyrus of Eden. (2-4 weeks).
Step 6.
Launch of our live minimal-viable-product (MVP) on crowdfundedcures.org, syndicate.io, Gitcoin and Giveth to crowdfund Medical Impact NFT fund in specific disease class, e.g. Open Psychedelic NFT for treatment-resistant depression partnered with PsyDAO (2-4 weeks).
DAO Roadmap & Milestones
Over the next two quarters, our DAO building efforts will focus on the following:
Building community and forming Working Groups
Community & Partnerships
DAO Governance (Discourse / Snapshot)
Ethics
Executive Team / Operations
Legal & Policy
Public Good Medicine Dealflow
Payer & Donor Engagement
Technology / Tokenomics
OKR development
DAO & Fund
Weekly town hall
To enable community members to create and contribute to proposals and have a voice in DAO governance.
Onboarding a Core Partner Network
Including payers, contract research organizations and other service providers, researchers, patient groups, policy makers, health care systems, generics manufacturers, healthcare practitioners, regulators, academia and non-profit, funders, health technology assessment organizations (e.g. ICER).
Establishing
Medical Prize Criteria Committee
Ethics Advisory Board
Writing
White Paper
Sourcing
Promising research projects (e.g. generic drug and nutraceutical repurposing use cases) that will advance public good medicine development Clinical Trial “Deal Flow” (on-going, includes Open Ketamine).
Preparing
Token Launch (Q4 2022 / Q1 2023)
Our Core Team (A-Z, currently volunteers)
Amir Amraie is a registered UK Pharmacist. He graduated from University College London (UCL) and has experience stemming across hospital, general practice (GP) and community. He also has experience operating a health-tech conference and working with various tech companies.
Andrew Horton, an IT security professional with 10+ years experience providing ethical hacking services to various clients and open-source software contributions to the security community, included within Kali Linux. He has advised public companies and blockchain projects.
Ariella Coler-Reilly, an MD Ph.D. candidate at Washington University in St. Louis and an experienced science writer and illustrator. She studied Molecular Cell Biology and Japanese at UC Berkeley. As a managing editor at VitaDAO, she strives to promote health literacy, decentralized science, and diversity in STEM.
Brahma P. Sen, Veteran health IT professional advising and implementing blockchain, cloud, machine learning, data and system architecture services to US federal government and private industries. Graduated from New Jersey Institute of Technology and IT consultant for Centers for Medicare & Medicaid Services.
Nicholas C. Fiorenza, a published molecular biologist with 6+ years of life science startup industry experience. He is passionate about merging healthcare with the nascent web3 ecosystem. His MSc Molecular Medicine research focused on repurposing off-patent anti-psychotic drugs for anti-cancer therapy.
Savva Kerdemelidis, Commercial/IP Consultant Legal Counsel and a NZ and Australian Patent and Trade Mark Attorney with 18+ years experience advising in relation to IP, commercial law and crypto. He conducted his LLM thesis on alternatives to the patent system for developing medicines.
Zack West, a marketing professional with 10+ years of experience in design, website development, and digital marketing. He holds a BSc in Graphic Communications from North Carolina State University and is currently a BSc Computer Science candidate at Western Carolina University.
Zan Lowe-Skilern, a business development professional with experience in VC investment sourcing, strategic partnerships, and B2B sales. Experienced with international market entry and navigating the Silicon Valley tech ecosystem.
Advisors (A-Z, currently volunteers)
Cyrus of Eden, a multidisciplinary founder, systems designer, and software engineer. The multichain guy at Velodrome Finance and the co-architect of Syndicate Protocol V2, he has been researching and hustling in public goods and regenerative finance since 2021.
Daniel Dohne, who since 2017 has been involved in investing, building and growing businesses in the crypto space and accumulating know-how in the cryptocurrency industry. He is proficient in Agile Methodologies, JS, Java, C#, .NET, SQL and has spent years developing Tax Reporting software with first-hand experience in IT, Fintech, RegTech, Financial Markets and Banking.
Dominic Nutt, a communications specialist interested in funding and accelerating clinical trials. He worked with Maurice Saatchi to deliver a UK Act of Parliament speeding up medical innovation within the NHS and has written peer-reviewed papers for the BMJ on new ways of funding clinical trials.
Edward Kahn, who founded EKMS, Inc. in 1986 and is pioneering systems and novel approaches to IP portfolio policing and mining. He has over 20 years experience with generic drug repurposing at Cures within Reach and Rediscovery Life Sciences. He has spoken and written extensively on licensing and IP strategy.
Stephen Bigelsen, MD is an allergist-immunologist in New Jersey with 34 years of experience in the medical field. In July 2016 at the age of 55, he was diagnosed with stage 4 pancreatic cancer and began treatment with chemotherapy, and adjunct IV Paricalcitol (an analog of Vitamin D) and realized a complete response.
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