{"id":2131,"date":"2024-12-10T00:21:48","date_gmt":"2024-12-10T00:21:48","guid":{"rendered":"https:\/\/www.homeworld.bio\/?p=2131"},"modified":"2024-12-12T03:13:06","modified_gmt":"2024-12-12T03:13:06","slug":"lead-roadmaps-and-800-million-children","status":"publish","type":"post","link":"https:\/\/www.homeworld.bio\/blog\/lead-roadmaps-and-800-million-children\/","title":{"rendered":"Lead, Roadmaps, and 800 Million Children"},"content":{"rendered":"\n

Today we are releasing our target product profile (TPP) report for blood level lead testing<\/a>, in partnership with Renaissance Philanthropy<\/a> and Pahl\u00e9 India Foundation<\/a>. To our knowledge, this is the first ever such profile targeting an environmental contaminant, which we have devised to promulgate the urgent need for better measurement tools for this pollutant, particularly in low-resource settings where children are disproportionately affected. The TPP is a platform for funders+practitioners to collaboratively scale lead monitoring to meet the magnitude of the challenge and to broadly mobilize the biotech community to tackle the challenges of pollution.\u00a0<\/em><\/p>\n\n\n\n

In this essay, we share why we chose Lead, why we believe we can rapidly scale new technologies and share a few technical highlights of the target product profile for blood lead level.<\/em><\/p>\n\n\n\n

To join us in this critical work or learn more about upcoming funding opportunities, reach out to Pollution@homeworld.bio<\/a>.<\/em><\/p>\n\n\n\n

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Leading into Lead<\/h2>\n\n\n\n

The health effects of pollution are too big to see. We observe with shock, but little agency, what these abiotic stresses do to our fertility<\/a>, our obesity<\/a>, our children\u2019s neural development<\/a> and the collapse of ecosystems<\/a>. In our opinion, scientific efforts around pollution have biased towards policy work and  under-resourced the technological work to detect and remediate. Policy is important and has had some success, but the status quo continues to get worse. So if we really are serious about creating change, of protecting the biosphere and ushering in a future in which life and industry can co-exist, then it\u2019s time to go straight to building solutions. We must empower the community of technologists and front-line practitioners to show what is possible in pollution management.<\/strong>
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\u201cWhen I worked on the brain, I worked on things that were too small to see.
Now that I work for the planet, I work on things that are too big to see.\u201d<\/em><\/p>
Paul Reginato<\/cite><\/blockquote><\/figure>\n\n\n\n

Lead (Pb2+) alone impacts 800 million children<\/a> worldwide (yes, that\u2019s one in three children), robbing generations of fully developed brains and leaving them with chronic health issues. Because of this immense challenge and well-understood disease causality<\/a>, lead is a high impact problem area within the broad theme of pollution. Lead poisoning has the dual challenges of detection and treatment, and we believe the higher leverage starting point is detection1<\/a><\/sup>. The gold standard method for lead detection, inductively coupled plasma mass spectrometry (ICP-MS), is a highly accurate lab-based test but requires expensive instrumentation and an invasive venous blood draw that must be taken by a trained phlebotomist. The status quo approaches won\u2019t scale without new technology breakthroughs.<\/p>\n\n\n\n

There is just one portable lead detection device on the market, called LeadCare II<\/a>, but it uses a 20-year old technology that is less sensitive and less trustworthy than what we need. The device is too expensive to scale and incompatible with many resource-constrained settings.  Researchers at the Center for Global Development published a seminal white paper, <\/a>with a roundtable of lead experts, which described  the current state of blood lead level testing and showcased the need for new types of methods. But, creating a new device requires a long FDA regulatory journey and innovators are constrained by funds that bias against low-cost tests. Government buyers currently pay around $18 per lead test<\/a> whereas leading diagnostic startups are drawn toward diseases that warrant payments orders of magnitude higher. So despite the flaws of the LeadCare II device,  it still has a monopoly on the market. <\/p>\n\n\n\n

Target Product Profiles are a proven method of catalyzing innovators to solve high-impact problems. TPPs have a rich history as a form of roadmapping that synchronizes the needs of clinicians with the capacity of innovators and the impact targets of funders. Perhaps the best example is the pneumococcal vaccine that ultimately rallied the $1.5B needed to vaccinate 300M kids around the world. We at Homeworld Collective, Renaissance Philanthropy and Pahl\u00e9 India set out to create a Target Product Profile (TPP) for a Blood Lead Level Test.<\/strong><\/p>\n\n\n\n

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Click here to read the Homeworld\/Pahle\/RenPhil Target Product Profile for Blood Lead Level Testing<\/a>.<\/figcaption><\/figure>\n\n\n\n

Behind the TPP is the rich collaboration of over 50 biotechnologists, clinicians, public health implementers, and funders, funneled into 1:1 conversations and virtual convening of experts from across the globe so that we could receive their in-depth feedback. This is the first step in building a call for funding, with upcoming opportunities for innovators to build to these product requirements outlined in the TPP.<\/p>\n\n\n\n

Inspiration from COVID Testing and Carbon Dioxide Removal<\/h2>\n\n\n\n

In the past four years, we have seen two powerful spikes of innovation around COVID Testing and Carbon Dioxide Removal. We can bring these lessons to rally biotech into the challenges inside the lead problem. <\/p>\n\n\n\n

In 2018, the funding for carbon capture was virtually non-existent, but in 2022, it shot to over a billion dollars. This funding was spearheaded by the flagship Frontier Advanced Market Commitment<\/a> to be the first customer to companies building carbon capture products. The catalyst for this was a NASEM report<\/a> and internal leadership from leading philanthropies that changed funders’ minds that CDR was both imminent and addressable. <\/p>\n\n\n\n

Similarly, within a year of the COVID-19 pandemic the US went from zero testing capacity to millions tested, with some tests dropping from around $200 to as low as ~$10 per test<\/a>, depending on the type and location\u200b. This was partly overseen by a presidential task force, partly by the NIH\u2019s Rapid Acceleration of Diagnostics (RADx\u00ae) initiative<\/a> and also by a vibrant community of volunteer practitioners (including Homeworld\u2019s co-founder Dan Goodwin and Garden Grantees Pranam Chatterjee and Jenny Molloy) who responded in force to the acute threat of the pandemic. <\/p>\n\n\n\n

But market forces and government funding do not yet exist at sufficient levels to drive a similar 20x cost reduction and massive scale-up. This is partly because of substantial technology challenges, and partly because potential innovators have to navigate both technical and deployment challenges. Bringing the policy and funding expertise from Renaissance and Pahl\u00e9, and combining it with the technical roadmap expertise of Homeworld, we created a structured approach that aligns funders, innovators, and clinicians.<\/p>\n\n\n\n

Target Product Profile as a Tool in the Field-Builders Toolbox<\/h2>\n\n\n\n

For those outside of medical technology development, the TPP might be a foreign concept. Here are three big wins of TPPs:<\/p>\n\n\n\n