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G2G Bio Bulletin – September 20, 2026

Upcoming Public Comment Deadline

Small Business Size Standards: SBA will be accepting comments until tomorrow, September 21, on proposed changes that among other provisions, would expand the definition of a ‘small business’ to encompass firms with revenue of up to $1 B and 3000 employees. A summary of the proposal can be found here, and you can access a comment letter template here.

G2G Highlights

G2G Founder and CEO Liz Powell was at the MedtechVISION Annual Conference in Menlo Park, CA on Tuesday 9/15, where she spoke at the Catalyzing Change in Women’s Health fireside chat. On Wednesday, Liz was at the BioHealth Capital Region Forum in Rockville, MD where she moderated the Turning Breakthrough Medical Innovation into Impact for Military and Civilian Markets breakout session.

Funding Opportunity

  • On Thursday, ARPA-H announced the Systems for Phenotypic Evaluation, Clinical Trajectories, Response, and Agency (SPECTRA) program, which will support research efforts to transform how autism is understood, diagnosed, and supported across the lifespan. First deadline is October 18.
  • ARPA-H also recently announced the Unifying​ Imaging with​ Quantum​ Entanglement (UNIQUE) program, which aims to develop a next generation biomedical imaging paradigm that integrates anatomical, functional, molecular, and quantum-derived information. Registration for the proposers day is October 13, first deadline is October 30.

Reminders

Congress: The House adjourned early on Wednesday, and will not meet again until after the election. The Senate returned to session on Monday, and will remain in Washington until October 5.
  • HHS Appointee Hearings:
    • Chris Klomp, the Deputy HHS Secretary nominee faced the Senate Finance Committee on Tuesday and the Senate Health, Education, Labor & Pensions (HELP) Committee on Wednesday. The former has the authority to bring the nomination for a floor vote, and its Ranking Member Ron Wyden (D-OR) indicated opposition to the nominee, citing alleged irregularities with Klomp's tax returns, a lack of transparency around the Administration’s drug pricing deals and vaccine policy. Klomp has affirmed the safety of vaccines, but has not entirely denounced vaccine skepticism.
    • Dr. Nicole Saphier, the Surgeon General nominee and Dr. Timothy Westlake the Assistant Secretary for Mental Health and Substance Use nominee were also considered at Wednesday’s Senate HELP hearing. As with prior HHS nominees Dr. Saphier was pushed by the committee chair, Sen. Bill Cassidy (R-LA) to firmly support the scientifically-backed consensus on vaccines and effectively counter the positions of HHS Secretary Kennedy.
  • Other Committee Hearings & Legislation: 
    • On Tuesday, the House Energy & Commerce’s Health Subcommittee convened a hearing to consider bills focused on Medicare physician payments, rural healthcare access, pharmacies, diabetes care, kidney disease care, and establishing a national strategy for epilepsy care and research.
    • The House by a vote 217-207 passed the PROOF Act, which would compel states to provide the Department of Justice with data from Medicaid and other social safety net programs as part of fraud investigations. All but six Democrats voted against, and all but one Republican voted in favor.
    • The House also overwhelmingly voted to reauthorize tick and mosquito-borne disease prevention programs, as well as narcotics bills on drug classification, testing and counterfeits.
    • The House Ways & Means Committee marked up several pieces of legislation. It unanimously passed a bill on Alzheimer’s disease screening and prevention, and by party-line votes cleared Republican bills on cost-benefits comparisons of Medicare Advantage vs. fee-for-service and codifying the Trump Administration’s Moms.gov resource for expectant mothers.
    • The House Science, Space & Technology Committee’s Investigations and Oversight Subcommittee on Wednesday convened a hearing entitled: Balancing Biotechnology Innovation and Biosecurity: Securing U.S. Leadership in a Global Race. Key highlights and discussion topics:
      • Witness Testimonies:
        • Dr. Anemone Franz of the American Enterprise Institute recommended measures like mandatory screening of synthetic nucleic acid orders and support for pathogen-agnostic biosurveillance.
        • Josh Hodges of the Hoover Institution warned of China outpacing the U.S. through its whole-of-nation approach to biotechnology, and advocated for measures strengthening biological intelligence capabilities and outbound investment restrictions on biotechnology.
        • Dr. Gigi Gronvall of Johns Hopkins, highlighted how federal policies and actions are putting American biotechnology leadership at risk.
      • Executive Order 14292 which restricted federal funding of gain of function and other high-risk life sciences research. Republicans on the subcommittee were broadly in favor of it, while Ranking Member Rep. Emilia Sykes (D-OH) criticized it as being too broad.
      • Biotechnology Standards: Rep. April McLain Delaney highlighted her bill the SCALE Biology Act that would establish a biometrology program at NIST. Multiple members expressed the need for U.S. leadership in standards development.
      • Workforce Development: Chair Rich McCormick (R-GA) highlighted his bill, the Biotechnology Workforce Alignment Act, that would direct NSF to support job training pathways in high-demand fields and Rep. Bill Foster (D-IL) highlighted his bill, the Keep STEM Talent Act that would provide international students pursuing STEM graduate degrees with a direct path to permanent residency.
    • Other Activity:
      • Senate Appropriations Vice Chair Patty Murray (D-WA) and LHHS Subcommittee Ranking Member Tammy Baldwin (D-WI) have written to HHS Secretary Kennedy demanding answers on how research funding for the Agency for Healthcare Research and Quality (AHRQ) is being utilized, amid concerns that appropriated funds will not be spent by the end of the fiscal year and/or re-allocated to other agencies.
Administration & Agencies:
  • CDC: The agency has continued to defer inclusion of measles-linked deaths in Pennsylvania as a part its enumeration of the outbreak. The number of cases now stands at over 3400.
  • FDA: The agency is accepting applications from sponsors for the Expedited Investigational New Drug (IND) Pilot Program, aims to accelerate first-in-human clinical trials in the U.S.
  • White House, Other HHS Agencies & Departments:
    • Federal Funding Cuts & Terminations:
      • The White House is reportedly drafting an executive order that would stand up a new external committee that would have the ability to terminate NIH awards. This comes after a meeting at the White House on Friday, where OMB Director Russell Vought accused the NIH Director, Jay Bhattacharya, of failing to comprehensively cut funding to researchers and institutions misaligned with Administration priorities. Vought is the driving force behind the proposed OMB rule that if implemented would entirely overhaul federal grant-making. Bhattacharya reportedly defended his stewardship of NIH funds, federal support for biomedical research, and resisted taking specific punitive actions against Harvard University.
      • A coalition of researchers have filed a lawsuit against the NIH, challenging on administrative and free speech grounds, the cuts and terminations of grants deemed to be misaligned with Administration priorities,
      • A federal judge dismissed a lawsuit by two family planning groups challenging the Trump Administration’s changes Title X grant eligibility. Other lawsuits in this space are still ongoing.
    • Drug Pricing:
      • The Administration has announced that all 50 state Medicaid programs would be able to access most-favored-nation (MFN) pricing for hundreds drugs, yet to be specified, through its deals with drug companies and under the auspices of the CMS GENEROUS Innovation Model that launched in January. The Administration has touted that the effort would generate $63.4B in savings. However, external analyses suggest that savings will be substantially lower, as state Medicaid programs may already pay for drugs at below MFN prices, and have discretion over which drugs they include under their GENEROUS schemes.
      • On Friday, Public Citizen released partly redacted copies of drug pricing deals the Administration signed with Pfizer and Eli Lilly. Notably, Pfizer’s deal has provisions by which the company will share revenues with HHS that emanate from increased prices it may charge for its products outside the U.S. The agreements have limited information on the companies’ participation in the GENEROUS Model, and do not mention exemptions, if any, the companies receive from participating in other CMS drug pricing schemes like GLOBE and GUARD.
    • HHS Secretary Kennedy:
      • Announced eight new appointments to the U.S. Preventive Services Task Force (USPSTF), some of whom are notably aligned with Administration positions and over half of whom are specialist physicians rather than generalists. The panel which is tasked with providing evidence based recommendations on clinical preventative services, has not met since March 2025.
      • Spoke this past week at a Children’s Health Defense event, re-affirming his vaccine skepticism and relevant HHS initiatives.
      • Has come under scrutiny for his travel expenses and planned activities at the MAHA Summit on September 29, funded by individual and corporate donors.

Updates from Washington

  • Request for Information on Changes to Reporting Outcomes from NIH Peer Review due October 13
  • Don’t miss the monthly GBG Report call every third Thursday of the month at 12 pm ET where the team discusses the latest federal life sciences funding opportunities. G2G has raised $624M and is eager to share our expertise to help companies grow and accelerate bringing innovations to patients.
  • G2G's 2026 MHSRS Report is now live!