Pay for Success Contracts — A New Model to Develop New Therapies from Old Drugs

Pay for success model to create incentives to repurpose off-patent drugs

The problem — lack of private incentives to repurpose off-patent drugs

A golden opportunity is frequently being missed due to lack of financial incentives to study old inexpensive generic drugs for new indications. Imagine that you discovered that a combination of off-patent (“generic”) drugs worked to better treat pancreatic cancer, which otherwise kills 95% of sufferers within five years of diagnosis. This may sound like science fiction, but it was the experience of Dr. Steven Bigelsen, who was diagnosed with stage 4 pancreatic cancer and used 2 inexpensive generic drugs in addition to his chemotherapy to become a 5-year survivor, now 4 years in complete remission [1]. It was the scientists at the Salk Institute for Biological Studies, not big pharma, that made the discovery that paricalcitol, a form of vitamin D, used by Bigelsen, might be useful to treat pancreatic cancer. Without the ability to perform human trials themselves, and without the ability to profit from their discovery, it has taken well over 20 years since their discovery to finally begin significant clinical trials on this extremely safe and inexpensive drug.

The investment required to develop a new drug is increasing exponentially: estimated to cost USD $1–2 billion and take over 10–15 years from discovery until regulatory approval [2]. By comparison, it can cost less than $10–15 million to obtain regulatory approval for repurposing a generic drug or nutraceutical, because it has already been proven safe in animals and humans [3]. For this reason, generic drug repurposing saw heightened interest during the COVID-19 pandemic [4]. However, easy access combined with a lack of private incentives to conduct large “gold standard” randomized controlled trials (RCTs) has caused significant public harm and ongoing controversies around efficacy, with Hydroxychloroquine (HCQ) [5] and Ivermectin [6] being key examples. Without patent protection, no pharmaceutical company will fund the large and expensive clinical trials required to definitively prove these safe and inexpensive treatments are effective in humans [7].

This is not a small nor isolated problem. There are thousands of generic drugs, with sometimes over a dozen or more being added to the generic drug armamentarium every year as branded drugs fall off the so-called “patent cliff”. This results in their price dropping close to the marginal cost of production due to competition by generic drug companies [8]. There are even more off-patent Generally Recognized As Safe (GRAS) compounds, referred to as dietary supplements or “nutraceuticals” [9]. This vast dataset of safe and affordable off-patent compounds is available to be prescribed by doctors immediately to treat new diseases. However, they are all but ignored by the pharmaceutical industry: once a medicine goes off-patent, its chance of obtaining regulatory approval to treat a new disease indication drops to almost zero [10]. Therefore, such repurposed generic drugs and nutraceuticals are considered “financial orphans” that lack private incentives to conduct clinical trials in humans, despite the potential for billions of dollars in healthcare cost savings for repurposing off-patent drugs [11]. Like Dr Bigelsen’s proposed off-patent treatment protocol for pancreatic cancer [12], they usually sit on a laboratory bench, the only evidence of potential efficacy in a few obscure papers, case studies or small, poorly-funded or controlled trials.

These “unmonopolisable therapies” forming a mountain of generic drugs are essentially public goods suffering from a “tragedy of the commons” under the patent system [13]. In particular, since a public good can be used without paying for it, a free rider problem arises. This means that if one company pays for the expensive clinical trials showing that a specific treatment protocol for an off-patent drug works in a new indication, they cannot prevent others from “free riding” on this valuable information, which is a “non-rivalrous non-excludable” public good once it is published online. Even if a new use or formulation was patented, people would know they could take the “old” generic drug off-label, rather than paying a higher price for the company’s “new” branded version of the drug (which has the same or similar active ingredient as the generic). Accordingly, there are currently no mechanisms to reimburse a pharmaceutical company for their costs of repurposing an off-patent medicine, even if this could lead to significant healthcare cost savings and public benefit. Governments and charities have attempted to address the gap through direct grant funding, but these tend to focus on basic research with the pharmaceutical industry expected to fund large clinical trials, due to the relatively high costs and risk of failure, and the risk of political backlash if the clinical trial fails [14]. Meanwhile, public and private payers bear the significant financial burden of treatment, hospitalization, chronic and end-of-life care. This results in a real tragedy, putting roadblocks in the way of medical innovation to more safe and affordable treatments and cures.

The current model for development of medicine is viewed through the lens of the centuries-old patent system, rather than as public goods. We believe that implementing new incentives holds the promise of blunting the age-old tragedy of the commons and redefining private incentives necessary to develop therapies like the one that saved Dr. Steven Bigelsen’s life. Meanwhile, millions of others will continue to suffer and die from this illness and others like it because researchers struggle to obtain funding for large clinical trials involving off-patent medicines.

Solution — using pay for success contracts to repurpose off-patent drugs

Crowd Funded Cures (https://crowdfundedcures.org) propose a market-driven incentive mechanism to fund research for therapies that cannot attract private capital due to the inability to enforce patent protection. This leverages innovative “pay for success” funding models (e.g., Social Impact Bonds (SIBs), flexible prize funds or retroactive public goods funding) that transfer risk of generic drug repurposing to the market [15]. Pay for success contracts are designed to incentivize impact investors to fund large Phase II/ III randomized controlled trials (RCTs) for a specific indication in return for outcome payments from the fund if successful (see Fig 1 above). Impact investors will be motivated by the market ROI (5–10% p/a) paid over a period of time (e.g. 5–10 years) and subject to Phase IV surveillance trials showing the safety and efficacy of the off-patent treatment protocol is maintained over time. The impact investment opportunity can be made more attractive (above market ROI) if payers such as govts, health insurers or philanthropy also provide matched funding without an expectation of return — effectively acting as follow on investors but relying on the impact investors to act as lead investors and pick the winners (i.e. market generates the “signal” for which promising off-patent repurposing RCTs to fund). This can be compared to the current system of traditional direct grant funding for generic drug repurposing where payers take on all the risk of RCT failure and rarely results in new and useful discoveries because payers are risk averse and do not have the best experts (although the NHS-funded RECOVERY trials and discovery of repurposed dexamethasone to treat Covid is a salient recent exception).

To ensure unbiased and high quality RCTs that can have the biggest health impact for payers and on patient standards of care, independent Contract Research Organisations (CROs) are provided with the off-patent treatment protocol (e.g., the generic drug(s) and their dosing regimen) that fulfils robust RCT design criteria (e.g., high thresholds for statistical significance, fixed inclusion/exclusion criteria and clinical outcomes). The CROs then recruit patients into the RCTs, randomise them into treatment and control arms, analyse the raw RCT data and report on whether the clinical outcome(s) were achieved.

Outcome payments are disbursed from the fund to impact investors according to the value of the treatment protocol RCT data and/or a subsidised price for repurposed generics achieving regulatory approval with a new label for a certain period equivalent to what would have been the monopoly price (e.g. 5–10 years). The latter is a kind of quasi-“advance market commitment” which solves the last mile problem by incentivising impact investors to convince doctors to prescribe the repurposed generic to patients, who only pay for the marginal cost, and the impact investor gets the subsidised price for each prescription from the fund. It also ensures if there are safety or long term efficacy issues, the repurposed generic will no longer be prescribed. The value of the RCT data and/or subsidised “monopoly” price of the repurposed drug is determined by standard pharmacoeconomic assessment that payers undertake for standard patented drugs (e.g., $50k per QALY, or Quality-Adjusted-Life-Year) that considers the incremental cost savings [16]. “Prize-like” pull-incentives to address market failures for development of new drugs for rare, paediatric or neglected diseases, or antibiotics have been implemented in the past, such as transferrable priority review vouchers that can be sold for between $50–350 million as they can add 6 months to the period that a drug is on patent, and advance market commitments that pay a subsidised price for new drugs that would otherwise not be profitable enough to develop [17]. However, vouchers are somewhat crude “lump sum” fixed prizes are susceptible to gaming because they are not linked to the QALY impact of the medicine, and advance market commitments have not been proposed for repurposing off-patent medicines [18]. As noted above, it is over 100x cheaper to repurpose generic drugs, so the cost per QALY under a pay for success model should be much better value for money (e.g. $500–5k per QALY) vs patented drugs ($50k–150k+ per QALY), which means repurposed generics would outcompete patented drugs based on price, unless they are true medical breakthroughs providing exceptional value for society.

Leveraging Blockchain: Retroactive Public Goods Funding, DAOs and IPNFTs

We envision administering pay for success or SIB smart contracts (which is referred to as Retroactive Public Goods Funding by Vitalik Buterin, founder of Ethereum) as a distributed autonomous organisation (DAO), a novel type of organisation that runs autonomously on a blockchain protocol and enables participation by virtually any person or entity across the globe via CFC Tokens. CFC Token holders interact with pay for success smart contracts on the DAO’s open distributed ledger (blockchain) to ensure transparency and immutability across a variety of inputs (e.g., research protocol, success criteria) and deterministic outputs (e.g., outcome payments). Administering pay for success smart contracts on a blockchain also enables intellectual property (e.g., RCT results) to be encrypted and locked to the distributed ledger as a non-fungible token (IPNFT). The IPNFT enables fractionalized licensing of IP rights and access to third parties that could benefit from the research findings [19]. Access to successful RCT data represented by the IPNFT is locked until fulfilment of the clinical outcome criteria for an outcome payment under the pay for success smart contract, but unsuccessful RCT data is automatically unlocked and published as useful “negative information” showing which off-patent treatments do not work. If the criteria for an outcome payment includes achieving regulatory approval for the new indication, the newly labelled generic will be eligible to receive a subsidised price for each prescription. IPNFTs can be locked as a trade secret until an appropriate outcome payment or subsidy for the repurposed generic can be determined, which allows a market mechanism for price discovery. CROs and regulators are already required keep RCT data involving patented drugs secret, so the concept is not usual. Outcome payments can also be determined in advance according to clinical outcomes such as regulatory approval, statistically significant improvement vs usual care, and percentage reduction in rates hospitalisation vs usual care.

Therefore, IPNFTs provide a source of revenue for the DAO’s treasury by funding successful RCTs for off-patent therapies. CFC Token holders can act as impact investors that fund RCTs for off-patent therapies in return for eligibility to receive an outcome payment under the pay for success smart contract in proportion to their fractional ownership of the IPNFT if the RCT data represented by the IPNFT fulfils the success criteria for payout. This validation of the raw RCT data is determined by a Results Oracle operated by the independent CRO that generated the RCT data by applying the off-patent treatment protocol. By allowing CFC Tokens to be purchased and sold on crypto exchanges, those impact investors that are most able to fund successful RCTs are more likely to purchase CFC Tokens which are eligible for an outcome payment, which helps drive up the price. Conversely, those CFC Token holders less likely to fund successful RCTs are more likely to sell their CFC Tokens. This will result in markets driving aggregation of CFC Tokens to those impact investors that are the most efficient at allocating resources towards funding successful RCTs [20]. Thus, using blockchain technology, it is possible to conduct real-world economic experiments in financial innovation to allow stakeholders to co-operate in a self-interested way to solve the public goods problem for off-patent medicines [21]. The main bottleneck to implementing a pilot is to find a payer willing to purchase successful off-patent RCT data or a subsidy for repurposed generic drugs represented by IPNFTs in order reduce disease burden for a specific indication (e.g., COVID-19, pancreatic cancer, depression, alzheimers, multiple sclerosis, amyotrophic lateral sclerosis, Crohn’s disease, longevity [22]). It is also possible to fundraise the repurposing fund through the issue of standard NFTs that represent tiered donation amounts (e.g. bronze, silver, gold, platinum, diamond) locked into pay for success smart contracts that either (a) provide funding for particular RCTs a donor supports on the impact investor side or (b) form part of the outcome payments made to impact investors for successful RCT data encoded within an IPNFT on the payer side.

Trillion dollar market opportunity unlocked by pay for success contracts

The goal is to open up R&D within the pharmaceutical sector to new incentive models with respect to unmonopolisable therapies, which has the potential to disrupt an industry via the generation of valuable off-patent RCT data. There is a total addressable market of $1.67 trillion in cost savings for payers in the US alone [23]. If we can convince payers to transfer only 1% percent of these cost savings into repurposing SIBs, there is an untapped arbitrage opportunity to capture potential revenue of over USD$16.7 billion to drive generic drug repurposing innovation. Assuming it is over 100x cheaper to repurpose generics versus developing new drugs, this creates a scalable business model instead of relying on inefficient and risky direct grant funding where you need to pick which RCTs are likely to succeed. Payers don’t want to fund large RCTs directly: they aren’t designed to innovate new products and fail fast. There is also a free-rider risk for payers that directly fund RCTs. A SIB administered by Crowd Funded Cures can engage with a syndicate of multiple payers to share costs and create a microeconomic ecosystem that outsources this innovation for impact investors to save overall costs and reduce free riding. With payers backing a SIB, it will be possible to build a scalable business model and private investment opportunity where none existed in the past.

Main Obstacles

  1. Healthcare Payers do not pay for cost savings

We understand that the main obstacle to obtaining backing for a generic drug repurposing SIB is that healthcare payers such as the NHS do not pay for innovation that results in health savings (e.g. RCT data showing that a generic drug in a new indication reduces hospitalisations). In addition, large health insurers (particularly in the US) often own hospitals and are not incentivised to reduce healthcare costs. Everyone in the healthcare industry is making too much money from the status quo, but this will soon become unsustainable due to an ageing baby boomer population. With the trillions of dollars available in healthcare cost savings from repurposing low cost generic drugs and nutraceuticals to treat new diseases, we need to to find a forward thinking payer willing to purchase successful RCT data validating the safety and efficacy of off-patent treatment protocols that can reduce their healthcare costs.

2. Pay for success contracts / Social Impact Bonds are a novel mechanism

Over USD$500m has been raised in SIBs globally, but only approximately USD$74m has been raised in 30 health-related SIBs according to the INDIGO database operated by the Oxford GO Lab [24] and 57 health-related SIBs in Insper Metricis Research Group (Brazil) Database [25]. From our review of these databases, health-related SIBs mostly relate to delivery of healthcare services and none relate to incentivising RCTs for medical research such as repurposing generic drugs. This would be a novel mechanism to incentivise impact investment into ‘public good’ medicines. It may be possible to find outcome payers with sufficient budget for generic drug repurposing (including government agencies such as NHS, NIH, Veteran’s Administration (VA), Medicare/Medicaid and BARDA, health insurers such as UnitedHealthcare, CVS Health, Anthem, Cigna, and large philanthropy such as Gates Foundation, Wellcome Trust and Chan Zuckerberg Initiative). However, it is a significant challenge to overcome institutional inertia from payers and limited scope to try new models.

Conclusion

Economists argue there are no bad people, only misaligned incentives. In the same way, we should not blame the pharmaceutical industry for gaming the patent system to maximise profits [24], but our failure to upgrade a reimbursement system that mainly relies on patents to develop new medicines. With pay for success contracts, we can provide more flexible and cost-effective incentive mechanisms alongside patents to take advantage of the biotech innovations of the last 40 years, including genetic engineering, personalised medicine (informed by blood tests and low-cost DNA sequencing), blockchain, artificial intelligence [25], and telemedicine, and help pull our broken system for incentivising medical innovation into the 21st century.

TL;DR

Creating new private incentives to repurpose generic drugs via pay for success contracts are a significant opportunity for private industry compared to the estimated USD $1–2 billion over 10–15 years to develop a new drug, as it can cost less than $10–15 million to obtain regulatory approval for repurposing a generic drug or nutraceutical (100x lower cost), because it has already been proven safe in animals and humans.

A pay for success contract for repurposing generic drugs to treat new diseases has the potential to create $1.67 trillion in cost savings for payers (e.g. govts, health insurers) in the US alone. If we can convince payers to transfer only 1% percent of these cost savings into pay for success contracts, there is an untapped arbitrage opportunity to capture potential revenue of over USD$16.7 billion to drive generic drug repurposing innovation.

Significant cost-savings available for payers that agree to a pay for success contract. By way of example only, repurposing the off-patent NSAID ketorolac as a prevention treatment resulting in 10% reduction in breast cancer recurrence would cost $5 million annually (100,000 cases at $50 per case for ketorolac and its administration). The savings would be over $1 billion annually (10,000 patients at approximately $100,000 per patient for the treatment of metastatic disease).

References:

[1] https://letswinpc.org/my-treatment/2017/02/14/different-approach-pancreatic-cancer-treatment/

[2] https://www.sciencedirect.com/science/article/abs/pii/S0167629616000291?via%3Dihub. This USD$1–2 billion figure is controversial (see https://www.lse.ac.uk/News/Latest-news-from-LSE/2020/c-March-20/Average-cost-of-developing-a-new-drug-could-be-up-to-1.5-billion-less-than-pharmaceutical-industry-claims), but could also be a conservative estimate due to costs of finding new patented drugs doubling every 9 years — a phenomenon referred to as “Eroom’s Law” — https://en.wikipedia.org/wiki/Eroom%27s_law. Some industry commentators suggest it could cost from USD$4–10 billion to develop a new drug — see https://www.proclinical.com/blogs/2020-9/why-does-it-cost-so-much-to-develop-new-drugs.

[3] https://dndi.org/wp-content/uploads/2019/10/DNDi_ModelPaper_2019.pdf. See Figure 1 on page 17: Out-of-pocket costs per stage of development for eight projects in DNDi’s portfolio.

[4] See https://www.healthaffairs.org/do/10.1377/hblog20201204.541050/full/ citing https://www.nature.com/articles/s41586-020-2577-1.

[5] https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or

[6] See https://www.nature.com/articles/d41586-021-02081-w which highlights difficulty with conducting RCTs for off-patent drugs where the science is highly-politicised and leads to self-medicating. See also https://www.theguardian.com/world/2021/aug/30/australian-imports-of-ivermectin-increase-10-fold-prompting-warning-from-tga

[7] It may be possible to patent a reformulation of your generic drug(s), but this will not be commercially viable if you cannot prevent doctors prescribing the “old” generic drug(s) off-label, or if patients can buy it cheaply in a pharmacy or online. Reformulating drugs has also been criticised as “evergreening” (which the pharmaceutical industry refers to by the euphemism of ‘pharmaceutical patent life-cycle management’). This is where pharmaceutical companies try to game the patent system by patenting a reformulation just before their old drug goes generic and then using marketing to encourage prescribing of the new formulation and discouraging substitution with the old generic drug which may be just as effective. Classic examples include reformulation of AstraZeneca’s heartburn drug Prilosec into the heavily-marketed ‘purple pill’ Nexium. On the other hand, reformulations that result in incremental improvements to medicines are not a bad thing if they lead to significant improvements over time. Whether evergreening strategies are adequate to ‘rescue’ unmonopolisable therapies is discussed in Chapter 3 of Mr Kerdemelidis’ 2014 masters thesis (https://ir.canterbury.ac.nz/handle/10092/9826).

[8] https://medium.com/the-biotech-social-contract/kolchinsky-tbsc-1-dafc2fe803e5.

[9] https://www.mskcc.org/cancer-care/diagnosis-treatment/symptom-management/integrative-medicine/herbs/search

[10] https://pubmed.ncbi.nlm.nih.gov/33397471/

[11] https://www.healthaffairs.org/do/10.1377/hblog20140306.037370/full/ — Article by Dr Vikas Sukhatme, Dean of Emory School of Medicine, discussing ‘financial orphan’ therapies. The article mentions that the repurposing the off-patent NSAID ketorolac as a prevention treatment resulting in 10% reduction in breast cancer recurrence would cost $5 million annually (100,000 cases at $50 per case for ketorolac and its administration). The savings would be over $1 billion annually (10,000 patients at approximately $100,000 per patient for the treatment of metastatic disease). In addition, US Army agreed to pay Merck $1.2 billion for 1.7 million courses of molnupiravir, should regulators approve (https://www.reuters.com/business/healthcare-pharmaceuticals/merck-says-us-govt-buy-about-17-mln-courses-cos-covid-19-drug-2021-06-09/ and https://www.keionline.org/36698). Why not pay a fraction of that amount for RCTs that prove generic drugs can treat Covid19 (see . Why not pay a fraction of that amount in pay for success contracts for relatively safe and low cost repurposed generic drugs to treat Covid19 (e.g. L-arginine — https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00405-3/fulltext).

[12] https://pubmed.ncbi.nlm.nih.gov/30034255/.

[13] “Unmonopolisable therapies” are a subset of ‘financial orphan’ therapies, the latter which can be considered a broader class of unprofitable therapies that lack a sizable market such as rare disease, tropical diseases and antibiotics. These are also discussed in Chapter 3 of Mr Kerdemelidis’ 2014 masters thesis (https://ir.canterbury.ac.nz/handle/10092/9826), that cited the work of Professors Kapczynski & Syed, who also referred to them as “highly non-excludable therapies” (https://www.yalelawjournal.org/essay/the-continuum-of-excludability-and-the-limits-of-patents).

[14] https://apnews.com/article/virus-outbreak-health-us-news-ap-top-news-92e6cabd8834e6865eee67f116b006c1 — Pepcid-COVID Study Raised Red Flags Weeks After $21M Grant. Ironically, direct grant funding can lead to even more risk and wasted taxpayer funds, such as US$150 million of federal funding on the dietary supplement curcumin studied in more than 120 clinical trials, with no tangible evidence that it is an effective treatment for any medical condition — https://theconversation.com/ivermectin-shows-us-how-hard-it-is-to-use-old-drugs-for-covid-heres-how-to-do-better-next-time-168192. Further, conservative estimates of the expense of the clinical trials component for repurposing a specific class of existing drugs (phospholipidosis-inducing CADs) to treat Covid-19 may be over $6 billion US dollars — https://www.science.org/doi/full/10.1126/science.abi4708. A market mechanism would have been more efficient or at least not expose taxpayers to the risk of failed RCTs.

[15] https://en.wikipedia.org/wiki/Social_impact_bond, https://en.wikipedia.org/wiki/Health_Impact_Fund and https://medium.com/ethereum-optimism/retroactive-public-goods-funding-33c9b7d00f0c (these mechanisms proposed use cases of “pay for success” contracts).

[16] https://en.wikipedia.org/wiki/Incremental_cost-effectiveness_ratio

[17] https://en.wikipedia.org/wiki/Priority_review. See also https://www.nature.com/articles/nbt.4193 which discusses the authorisation of the US agency The Biomedical Advanced Research and Development Authority (BARDA) to use prizes such as “market entry rewards” (MERs) or priority review vouchers/TIPRs to incentivise development of new antibiotics. See also 6-months patent extensions granted for researching effect of drugs in pediatric populations (https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.1340). For Advance Market Commitments (AMCs), see https://en.wikipedia.org/wiki/Advance_market_commitments. On Feb. 9, 2007, five countries (Canada, Italy, Norway, Russia, the United Kingdom), and the Bill & Melinda Gates Foundation backed a US$1.5 billion AMC to pay a subsidised price for the first vaccine for pneumococcal disease, a major cause of pneumonia and meningitis that kills 1.6 million people every year.

[18] Social Impact Bonds for repurposing generic drugs to treat rare diseases have been proposed by Bruce Bloom at the US charity Cures within Reach (https://ssir.org/articles/entry/repurposing_social_impact_bonds_for_medicine) and the UK charity Findacure (https://www.findacure.org.uk/the-rare-disease-drug-repurposing-social-impact-bond/) in the context of rare diseases. However, the use of social impact bonds and other pay for success contracts such as advance market commitments for repurposing generic drugs have not received payer backing to date.

[19] See proposal by Paul Kohlhaas at Vitadao to cryptographically tokenise clinical trial data and patents as IPNFTs to allow distributed ownership of IP and incentivise investment in early stage biopharma research (see https://medium.com/molecule-blog/an-open-bazaar-for-drug-development-molecule-protocol-a47978dd914).

[20] This was a core advantage of the Health Bond proposal by Ronnie Horesh, the NZ economist who first conceived of SIBs in 1988 (available at https://www.socialgoals.com/health.html). By allowing tradeable SIBs, the markets will ensure the most efficient allocation of resources to those best able to maximise health impact (and outcome payments under the SIB). See proposal to trade a “Health Impact Token” on the crypto markets (see https://healthimpacttransfer.org/). Crowd Funded Cures (https://crowdfundedcures.org) proposes creating SIB smart contracts backed by payers where CFC Token holders can act as impact investors and fund the generation of off-patent RCT data encrypted into IPNFTs, which are unencrypted upon achieving success criteria for an outcome payment, as determined by an oracle managed by an independent CRO. This is inspired by the tradeable Health Bond proposal by Ronnie Horesh, the NZ economist who first conceived of SIBs in 1988 (available at https://www.socialgoals.com/tradeable-health-outcome-bonds.html). By allowing CFC Token holders to invest in off-patent IPNFTs and trade their rights to receive outcome payments under SIBs on crypto exchanges, the markets will ensure an efficient allocation of resources to the CFC Token holders that are best able to invest in generation of successful RCT data via IPNFTs that maximises health impact (and outcome payments under the SIB), by tending to aggregate CFC Tokens due to their increase in market value.

[21] See proposal by Vitalik Buterin to use DeFi/Web3 technology to help solve the public goods problem (https://medium.com/ethereum-optimism/retroactive-public-goods-funding-33c9b7d00f0c).

[22] Repurposing off-patent drugs (e.g., metformin, resveratrol, NMN, rapamycin, etc) to improve longevity by addressing the direct causes of aging (e.g., DNA damage, intra/extracellular junk and senescent cells) has the potential to result in massive reduction of overall disease burden as most diseases are associated with these causes, including cancer, dementia, cardiovascular disease and arthritis.

[23] https://accessiblemeds.org/resources/blog/2017-generic-drug-access-and-savings-us-report

[24] https://golab.bsg.ox.ac.uk/knowledge-bank/indigo/impact-bond-dataset-v2/

[25] https://docs.google.com/spreadsheets/d/1sskkubuQsuT3q4TD8pl-E67_aK7tuMcxaCibD4acS5Q/edit#gid=244876241

[24] See note [7] above discussing patent ‘evergreening’.

[25] Artificial intelligence (AI) or machine learning (ML) approaches to drug discovery allow the rapid review of hundreds of thousands of scientific papers and medical records to determine drug-disease interactions and discover new drugs via in-silico modelling. See for example, the US charity RebootRx using AI to find non-cancer generic drugs to treat cancer (https://rebootrx.org/), Healx using AI to repurpose drugs to treat rare disease (https://healx.io/), and DeepMind solving the 50-year old protein folding challenge using AI (https://deepmind.com/blog/article/alphafold-a-solution-to-a-50-year-old-grand-challenge-in-biology).

IMPORTANT DISCLAIMER:

This document does not constitute a prospectus nor offer document of any sort and is not intended to constitute an offer or solicitation of any investment or other product or service in any jurisdiction. Crowd Funded Cures is an initiative of a registered NZ charity and NGO, the Medical Prize Charitable Trust (Charity No. CC49977). All donations would be used to support their mission to help establish pay for success contracts to repurpose generic drugs to treat specific indications (e.g. Covid-19). Crowd Funded Cures will partner with other NGOs, consulting firms and service providers to achieve this goal.

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About Crowd Funded Cures — Team:

Savva Kerdemelidis, LLM (1:1 Hons), BSc(Hons), Founder & CEO, Crowd Funded Cures

Savva is a Commercial/IP Consultant Legal Counsel and a NZ and Australian Patent and Trade Mark Attorney with 18+ years experience advising software, medical device and technology companies in the UK, EU, US, AU and NZ in relation to IP, commercial contracts, software licensing, crypto, data protection and GDPR compliance. He conducted his LLM thesis in 2014 on alternative incentive mechanisms to develop off-patent medicines (see
https://ir.canterbury.ac.nz/handle/10092/9826).

https://www.linkedin.com/in/savvak/

Amir Amraie, MPharmS, COO, Crowd Funded Cures

Amir is a registered UK Pharmacist. He graduated from University College London (UCL). He has experience stemming across hospital, general practice (GP) and community. He is also an entrepreneur with experience operating a health-tech conference and working with various tech companies, incubators and startup competitions.

https://www.linkedin.com/in/amiramraie/

Andrew Horton, CKA, CTO, Crowd Funded Cures

Andrew is a cyber security professional with 10+ years experience. He has developed open-source security tools that form part of the standard arsenal of penetration testers, including multiple tools within Kali Linux. His research is included in textbooks, cited in academic papers, and offensive security methodologies (OWASP, PTES, etc). He has consulted to clients globally, including many banks, energy companies, telcos, listed companies, NGOs, and blockchain/cryptocurrency projects. He currently serves on the advisory boards of multiple startups.

https://www.linkedin.com/in/andrewhortonsecurity/
https://github.com/urbanadventurer

Spyridon Antonopoulos, PhD, Partnerships Advisor, Crowd Funded Cures Associate Director in Financial Services, Guidehouse

Spiro has 15+ years of experience as a consultant in the health insurance and banking industry. Spiro spent two years as a founding member of crypto startup Kuva.com and currently advises on the intersection of digital assets and the decentralized finance (DeFi) economy with emerging federal and state regulations.

https://www.linkedin.com/in/spiroantonopoulos/

Edward Kahn, Strategic Advisor, Crowd Funded Cures
Founding Partner, Rediscovery Life Sciences
Director, Strategic Business Development, Cures within Reach

Edward Kahn, founded EKMS, Inc. in 1986, pioneering systems and novel approaches to IP portfolio policing and mining. He was president from 1986 until EKMS was sold to UTEK (AMEX) in 2004. Kahn was the Director of Strategic Business Development at Landon IP, Inc. He has spoken and written extensively on licensing, patent litigation and IP strategy for John Wiley, Euromoney Publishing, Forbes, the Wall Street Journal, the Boston Globe, Mass HiTech, the Licensing Executives Society (LES) and the Boston Patent Lawyers’ Association.

https://www.linkedin.com/in/ed-kahn-81b26b3/

Dr Steven Bigelsen, Medical Advisor, Crowd Funded Cures
Physician, Assistant Clinical Professor, Rutgers New Jersey Medical School

Dr. Stephen Bigelsen is an allergist-immunologist in New Jersey and is affiliated with Morristown Medical Center and Saint Clare’s Denville Hospital. He received his medical degree from Chicago Medical School at Rosalind Franklin University in 1987 and has over 34 years of experience in the medical field. In July 2016 at the age of 55, he was diagnosed with stage 4 pancreatic cancer. He began treatment with chemotherapy, and adjunctive therapies of IV Paricalcitol (an analog of Vitamin D) and hydroxychloroquine (a generic malaria drug) and realised a complete response in less than one year. Dr. Bigelsen has had no evidence of disease since that time, and has worked as a patient advocate by publishing articles, giving talks, encouraging research, and assisting a variety of cancer foundations.

https://www.linkedin.com/in/steve-bigelsen-57b79698/

Dr Michael Tombros, BSc(Hons), BM, FRACGP, FRNZCGP, PGDipOccMed, MAvMed(Dist), Medical Advisor, Crowd Funded Cures, Physician

Dr Tombros is an experienced Family Physician/GP. In addition to his medical studies he holds degrees in Pharmacology, Occupational Medicine and Aviation Medicine. He has worked for 17+ years internationally in the UK, Australia and New Zealand in various roles including a CAA NZ Aviation Medical Examiner, Medical Educator and Medical Advisor to the ACC. He maintains a private practice in Christchurch, New Zealand with a focus on Occupational & Environmental Medicine.

https://www.linkedin.com/in/michael-tombros-91122a17/

Our non-profit’s mission is to use pay for success contracts to repurpose off-patent medicines https://crowdfundedcures.org