H Stands for Health
And the latest from FedInvent
Hello from FedInvent,
We always start with the links to the latest FedInvent Reports.
Here is the links page that will take you to links to both the FedInvent Reports and the FedInvent Newsletters on Substack.
We also updated the FedInvent patent and patent application counter with year-to-date numbers through the end of Q3 2022. There are 5,224 patents and 6,603 published patent applications.
Today we are sharing thoughts on the Advanced Research Projects Agency for Health (ARPA-H), a new federal R&D institution with a $1 billion budget.
High-Risk High-Reward R&D
ARPA-H is emerging. ARPA-H is the latest transformative high-risk, high-reward research agency designed to drive biomedical and health breakthroughs—from molecular to societal—that would provide transformative solutions for the most vexing healthcare problems. ARPA-H joins the other ARPAs — DARPA, ARPA-E, and IARPA.1
President Biden named an Inaugural ARPA-H Director, Dr. Renee Wegrzyn, Ph.D. Dr. Wegrzyn, a biologist, joined Ginkgo Bioworks, a bio-engineering company in Boston, Massachusetts, in 2020. Before Ginkgo Bioworks, Dr. Wegrzyn spent more than five years as a program manager at DARPA, where her portfolio included projects that used synthetic biology to counter infectious disease and bolster biosecurity. Biosecurity and biodefense are high on the Biden Administration's list of priorities.
ARPA-H is modeled on the Defense Advanced Research Projects Agency (DARPA). Fund high-risk, high-reward projects that involve a high degree of novelty and use interdisciplinary approaches. Do out-of-the-box R&D with a team of innovators that can see the big picture.
ARPA-H is encouraged to follow a program funding using "The Heilmeier Catechism." George H. Heilmeier, an inductee to the National Inventors Hall of Fame, was DARPA director from 1975-1977. Mr. Heilmeier crafted a set of questions known as the "Heilmeier Catechism" to help Agency officials think through and evaluate proposed research programs.
What are you trying to do? Articulate your objectives using absolutely no jargon.
How is it done today, and what are the limits of current practice?
What is new in your approach, and why do you think it will be successful?
Who cares? If you are successful, what difference will it make?
What are the risks?
How much will it cost?
How long will it take?
What are the mid-term and final "exams" to check for success?
.Anyone who has ever responded to funding opportunities for Small Business Innovative Research grants or projects defined in Broad Agency Announcements of R&D priorities should find these questions refreshing. The no jargon rule will be tough.
The Biden Administration's early ARPA-H project targets include:
Cures for cancer, Alzheimer's disease, and diabetes.
Accurate and wearable blood pressure technology
mRNA vaccines against common forms of cancer
Drug or gene therapy delivery systems that can target any organ, tissue, or cell type
Platforms to reduce health disparities in maternal morbidity and mortality.
Congressional recommendations for ARPA-H projects include focusing on technologies rather than specific diseases. (Yes, it contradicts the cures for cancer, Alzheimer's, and diabetes goals, but that's Congress' recommendation.) The agency should also be focused on coordination and collaboration with other researchers to avoid duplicating work already underway at other agencies.
The agency has equity and diversity goals as well. While DEI, diversity, equity, and inclusion sound like a meme these days. For a long time, health R&D and new product development followed a "pink it and shrink it" model for tailoring drugs for women. It wasn't until 1986 NIH established a policy that encouraged researchers to include women in studies. In light of that, it's probably a good idea to keep equity and diversity at the forefront of the ARPA-H efforts.
Sized to be Nimble
The original ARPA-H plan calls for about 100 full-time employees. Thirty to forty of those employees will be program managers able to pitch their programs and projects. Program managers may also be tenure limited. Unlike NIH, ARPA-H won't have an intramural research program.
DARPA was founded in 1958 during the Eisenhower Administration. Sixty-four years later, DARPA has 220 employees. DARPA funded 277 of the taxpayer-funded patents granted so far in 2022. Two hundred and forty-four (244) patent applications show DARPA as the source of R&D funding. In 2021, DARPA funded 386 patents and 369 published patent applications.
To give you a sense of scale, NIH had 18,478 employees in 2021. NIH's FFRDC, Frederick National Laboratory, has another 2,400 employees. In 2022, NIH funded 2,046 patents and 4,236 published patent applications. In 2021 NIH funded 2,875 patents and 2,923 applications. DARPA lives in a single office building in Arlington, Virginia. NIH NIH has more than 75 buildings in a campus-like environment over 300 acres in Bethesda, Maryland. DARPA is like a start-up. NIH is like a college campus.
Congress Weighs In
The Biden Administration wanted $6 billion for ARPA-H over three years. Congress said, how about we start with $1 billion? The initial appropriation funding ends at the end of the government fiscal year 2024, September 30, 2024.
Congress wants ARPA-H to break out of the Science by Committee process used by the National Institutes of Health (NIH). ARPA-H is to shift away from the investigator-driven, consensus-building, and fund researchers with a proven track record who we've funded before processes the NIH uses to decide what R&D projects to support. The goal is to break old habits and solve problems with new ideas.
To that end, Congress may prohibit the ARPA-H director from hiring personnel to the agency who worked at NIH within the three years before the appointment. Congress is looking at a term of four to five years with an option for one consecutive term for the ARPA-H director.
The ARPA-H approach has support from an important constituency. Science and patient advisory groups believe that traditional funding for health-related R&D is too risk-averse and too focused on incremental advances instead of curing diseases now. These groups believe the US taxpayer-funded ecosphere needs to move faster. Moving faster will help maintain US competitiveness in developing new treatments while expediting societal challenges caused by persistent health issues.
Looking for a Headquarters
Congress prohibits ARPA-H from being located on the NIH campus in Bethesda, Maryland. (Congress means business breaking the science bureaucracy.) That means that the ARPA-H move-your-headquarters-here coalitions are in full force. So far, we've seen posts from a North Carolina group near Research Triangle. The Baltimore/Hopkins group includes Johns Hopkins, the University of Maryland Baltimore, the University of Maryland Medical School, Morgan State, an HBCU planning a new for-profit private medical school, and the Baltimore BioPark. Johns Hopkins already has three NIH Institutes, NIA, NIDA, and NHGRI, and 1,000 scientists at its Bayview Campus. Nancy Pelosi is pushing for a California location.
The smart money says that Massachusetts has the inside track. Boston has a deep bench of R&D focused universities, private and public post-doc research institutes, and biotech start-ups on almost every block. Boston is the home base of the new ARPA-H director. Boston is also a quick one-hour shuttle flight away from the Health Complex in Bethesda. Our money is on Boston.
And the HERD is gearing up, too. We came across information from the Rice University Office of Research Creative Ventures Fund noting that "pre-ARPA-H seed funds are available to enable researchers to prepare for ARPA-H." We guess they will be teaching their researchers and grant writers the ins and outs of the DARPA Heilmeier Catechism.
H Stands for Health
Or does it stand for HERD, Higher Education R&D. Will funding go only to the researchers and scientists in America's top academic and post-doc research centers or will it go to spinouts and small biotech businesses building new and emerging technologies?
Congress is encouraging the new agency to make awards to the broadest possible array of researchers — industry, the HERD, nonprofit research institutes, and patient-funded philanthropic research programs. ARPA-H can issue contracts, grants, Cooperative Research and Development Agreements (CRADAs), and OTAs. Other Transaction Agreement/Authority (OTA) is a legal contract with the federal government that is not a grant, cooperative agreement, or a federal contract. The federal government uses OTAs to streamline research and development, prototype development, and other projects with nonprofit research institutions. OTAs are for the federal government’s Nike Proposition — Just Do It.
ARPA-H applicants' data will be considered proprietary commercial and financial information. It will NOT be subject to Freedom of Information Act release requirements. To approach will encourage the broadest possible participation by innovative entities. ARPA-H projects will have broader protection of trade secrets, and privileged and confidential information.
ARPA-H Is a Federal Agency
No new federal agency is without its own bureaucracy. In this case, the Interagency Advisory Groups. The ARPA-H director is tasked with creating advisory groups, an alphabet soup of members of the federal innovation ecosphere and Health Complex.
One list of potential members includes:
NIH
Food and Drug Administration (FDA)
Centers for Medicare & Medicaid Services (CMS)
Agency for Healthcare Research and Quality (AHRQ)
The HHS Assistant Secretary for Preparedness and Response (ASPR)
Biomedical Advanced Research and Development Authority (BARDA)
National Science Foundation (NSF)
Department of Energy (DOE) Office of Science
Centers for Disease Control (CDC)
National Center for Advancing Translational Sciences (NCATS)
The White House Office of Science and Technology Policy
DARPA
DOE's ARPA-E
Another more slimmed-down list includes:
The Office of the Secretary of Health and Human Services
NIH
Food and Drug Administration (FDA)
The HHS Assistant Secretary for Preparedness and Response (ASPR)
DARPA
National Science Foundation (NSF)
Centers for Disease Control (CDC)
Department of Energy (DOE) Office of Science
Missing in action? The United States Army Medical Research and Development Command and the Department of Veterans Affairs. Maybe DARPA will bring members of the Military Health Complex to the meetings.
Either way, there will be lots of PowerPoint slides flying around the government.
We Need Enabling Inventions Too
Don't confuse incremental advances with novel but not flashy inventions. Inventions are also boring and not disruptive. Sometimes enabling technology is what closes the deal.
In 1946, Dick Tracy's creator, cartoonist Chester Gould met Al Gross, an inventor and engineer with many wireless devices to his credit. After the meeting between the two, Dick Tracy started wearing his iconic two-way radio watch. Unfortunately, Mr. Gross was an inventor without enabling technology. The Apple Watch, the modern version of the famous Dick Tracy Watch, wasn't feasible until we had the iPhone, the Internet, WiFi, BlueTooth, tiny batteries, and high-resolution screens. The iPhone was released in 2007.
While the inventors funded by ARPA-H are busy inventing nanoparticles for vaccine delivery, new bioreactors, and CRISPR/CAS 9 gene editing techniques for curing diseases, the National Institute of Standards and Technology (NIST) needs to be busy too. NIST needs to be figuring out how to perform nanoscale measurements that underly the ability to fabricate diverse nanotechnologies, create devices that manipulate photons, phonons, and plasmons at the quantum limit, and probe the structures and functions of atoms, biomolecules, and particles and the physical and chemical properties of the nucleic acids DNA and RNA. Both types of inventions are critical. (Someone needs to bring NIST to the Interagency Advisory Group meetings.)
The coordination and collaboration part of ARPA-H's mission is critical. It doesn't do any good to have flashy new inventions for important health issues if you don't have the infrastructure to get it from the lab to the pharmacy because not everything can be an attention-grabbing gizmo.
Stay tuned for the ARPA-H R&D funding announcements. FedInvent will keep an eye out for the patent applications.
Before We Go
The New External Patent Search Platform Sucks
All we can say here is that it's awful. Like other patentistas, we've lost access to a lot of capabilities that made working with patents easier. We have thousands of links that no longer work. The image versions of the patents and patent applications are almost unusable. You can no longer open more than one patent at a time, so you can look at a rejection, see all of the patents or apps cited by the examiner, and flip back and forth to follow the examiner's logic.
After millions of dollars spent on the Cooperative Patent Classification system, USPTO finally added links to the CPCs and identified which CPCs are inventive and which are additional, non-inventive, but useful for prior art searching. Unfortunately, the new links don't work. (The FedInvent CPC links still work.)
The only entertainment we get these days is reading posts on Twitter, LinkedIn, and other places where patent lawyers and patent people hang out, complaining more than we are. We're working on some solutions, but for now, we're stuck with USPTO's links to their awful new 1990s interface that only works on a laptop or desktop computer with a Chrome browser.
Who built this thing? FIRE THE CONTRACTOR AND START OVER.
And because there's plenty of irony in the federal government, USPTO terminated the old external patent search tools that worked at midnight on September 30, 2022. On October 4, 2022, the USPTO released a request for comment (RFC) titled "Request for Comments on USPTO Initiatives To Ensure the Robustness and Reliability of Patent Rights." USPTO is seeking information to improve prior art search resources for patent examiners while making finding quality patent prior art for the public much more complex. (You can't make this stuff up.)
Now that we've got that out of our system.
As always, if you have questions or ideas, please reach out to us. You can reach us at info@wayfinder.digital. Please share FedInvent with other like-minded innovation enthusiasts. If you aren't a paid subscriber, please consider helping us keep the lights on.
Thanks for reading FedInvent.
The FedInvent Team
FedInvent tells the stories of inventors, investigators, and innovators. Wayfinder Digital's FedInvent Project follows the federal innovation ecosphere, taxpayer money, and the inventions it pays for. FedInvent is a work in progress. Please reach out if you have questions or suggestions. You can reach us at info@wayfinder.digital.
Public Law 117-103 was enacted on March 15, 2022, authorizing the establishment of ARPA-H within the U.S. Department of Health and Human Services.