Clerk of the House of Representatives
Legislative Resource Center
135 Cannon Building
Washington, DC 20515
http://lobbyingdisclosure.house.gov 		Secretary of the Senate
Office of Public Records
232 Hart Building
Washington, DC 20510
http://www.senate.gov/lobby
LOBBYING REPORT

Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

1. Registrant Name Organization/Lobbying Firm Self Employed Individual
Biotechnology Innovation Organization

2. Address

Address1
1201 New York Avenue NW
 Address2
​Suite 1300
City
Washington
 State
DC
 Zip Code
20005
 Country
USA

3. Principal place of business (if different than line 2)

City
​
State
​
Zip Code
​
Country
​
4a. Contact Name b. Telephone Number c. E-mail
​Mrs.
​Aiken Hackett
​4043087749
​ahackett@bio.org
5. Senate ID#
​6245-12
7. Client Name Self Check if client is a state or local government or instrumentality
​Biotechnology Innovation Organization
6. House ID#
​325050000
TYPE OF REPORT 8. Year
​2025
 Q1 (1/1 - 3/31) Q2 (4/1 - 6/30) Q3 (7/1 - 9/30) Q4 (10/1 - 12/31)

9. Check if this filing amends a previously filed version of this report

10. Check if this is a Termination Report Termination Date
​
11. No Lobbying Issue Activity
INCOME OR EXPENSES - YOU MUST complete either Line 12 or Line 13
12. Lobbying 13. Organizations
INCOME relating to lobbying activities for this reporting period was: EXPENSE relating to lobbying activities for this reporting period were:
Less than $5,000
Less than $5,000
$5,000 or more $
​
$5,000 or more $
​890,000.00
Provide a good faith estimate, rounded to the nearest $10,000, of all lobbying related income for the client (including all payments to the registrant by any other entity for lobbying activities on behalf of the client). 14. REPORTING Check box to indicate expense accounting method. See instructions for description of options.
Method A. Reporting amounts using LDA definitions only

Method B. Reporting amounts under section 6033(b)(8) of the Internal Revenue Code

Method C. Reporting amounts under section 162(e) of the Internal Revenue Code

Signature
Digitally Signed By: Aiken Hackett
 Date
4/21/2025 4:24:31 PM

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code AGR

16. Specific lobbying issues

Avian Flu
---General

Climate Change
---FY 2025 Appropriations
---FY 2026 Appropriations
---Climate Issues & impact on the agriculture and food sectors

Efforts to expand the Bio Economy & Bio Manufacturing
---S.144/H.R.1719 - Farm to Fly Act

Farm Bill
---Farm Bill Reauthorization

Food & Ag National Security
---China Biotechnology Regulations
---Mexico Decree Banning Genetically Modified Corn

Funding for the USDA
---FY 2025 Appropriations
---FY 2026 Appropriations

Genetically Engineered (GE) Animals
---Climate Issues & impact on the agriculture and food sectors
---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---International Consistency of Regulations for Gene Edited Products
---USDA Proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering

Genetically Engineered (GE) Plants
---Climate Issues & impact on the agriculture and food sectors
---EPA proposed revisions to regulations related to the oversight of certain plant-incorporated protectants (PIPs)
---EPA Regulatory Approach to Gene Editing
---FDA Proposed guidance on Gene Editing
---International Consistency of Regulations for Gene Edited Products
---USDA Regulatory Approach to Gene Editing

Interagency Coordination
--- H.R.1326 - DOE and USDA Interagency Research Act

Synthetic Biotech

Pharmaceutical and Ag Biotech Tariffs

USDA/APHIS Agricultural Biotechnology Regulations
--- Regulatory Treatment of Gene Edited Products
--- USDA proposed Regulation of the Movement of Animals Modified or Developed by Genetic Engineering
--- Regulatory Treatment of Biostimulants

United States-Mexico-Canada Agreement (USMCA)
---Implementation of USMCA
---USMCA Review

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. Trade Representative (USTR), Agriculture - Dept of (USDA), U.S. SENATE

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
Elisabeth
Fox
​
​
John
Torres
​
​
Praneel
Jadav
​
​
Amber
Manko
​
​
Kristin
Murphy
​
​
Bailey
McCue
​
​
Chris
Jones
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ANI

16. Specific lobbying issues

Avian Flu

Farm Bill
---Farm Bill Reauthorization

Genetically Engineered (GE) Animals
---Climate Issues & impact on the agriculture and food sectors
---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations
---Farm Bill Reauthorization
---FDA Approvals, Guidance, & Regulations
---International Consistency of Regulations for Gene Edited Products

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
John
Torres
​
​
Praneel
Jadav
​
​
Emily
Wheeler
​
​
Amber
Manko
​
​
Kristin
Murphy
​
​
Elisabeth
Fox
​
​
Chris
Jones
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code BUD

16. Specific lobbying issues

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 Appropriations
---FY 2026 Appropriations
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2025 Appropriations
---FY 2026 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---FY 2025 Appropriations
---FY 2026 Appropriations
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2025 Appropriations
---FY 2026 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for EPA - Office of Biopesticides and Pollution Prevention Division
---FY 2025 Appropriations
---FY 2026 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for FDA
---FY 2025 Appropriations
---FY 2026 Appropriations
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2025 Appropriations
---FY 2026 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Health Resources and Services Administration (HRSA)
---FY 2025 Appropriations
---FY 2026 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for National Institutes of Health
---FY 2025 Appropriations
---FY 2026 Appropriations
---Advanced Research Projects Agency for Health (ARPA-H)
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for Renewable Material/Bio-based Products
---FY 2025 Appropriations
---FY 2026 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

Funding for the USDA
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Biotechnology and Agriculture Trade Program
---Farm Bill Programs Energy Title IX
---Implementation of the Inflation Reduction Act (IRA) of 2022
---FY 2025 Appropriations
---FY 2026 Appropriations


Pandemic Preparedness
--- Implementation of the Inflation Reduction Act of 2022

Funding for Department of Energy
---Bioenergy Technology Office
---FY 2025 Appropriations
---FY 2026 Appropriations

Funding for Department of Transportation
---Environmental Energy R&D
---NextGen Aircraft Technology - Fuels & Metrics
---FY 2025 Appropriations
---FY 2026 Appropriations

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Health & Human Services - Dept of (HHS)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Emily
Wheeler
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
Elisabeth
Fox
​
​
John
Torres
​
​
Praneel
Jadav
​
​
Bailey
McCue
​
​
Chris
Jones
​
​
Kristin
Murphy
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CHM

16. Specific lobbying issues

Funding for Renewable Materials/Bio-based Products
---FY 2025 Appropriations
---FY 2026 Appropriations
---Implementation of the Inflation Reduction Act (IRA) of 2022

Renewable Chemicals/Bio-based Products (Non-Funding)
---Biomanufacturing and Jobs Act
---Investment Tax Credit

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
John
Torres
​
​
Bailey
McCue
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code CPT

16. Specific lobbying issues

Antitrust Legislation
---Oversight Pharmacy Benefit Managers

Artificial Intelligence (AI)
---Patentability of AI-Aided inventions

Bayh-Dole Act/Tech Transfer
---Invent Here, Make Here Act of 2023 (Baldwin)
---Bayh-Dole Act
---March-In Rights
---NIST RFI Regarding the Draft Interagency Guidance Framework for Considering the Exercise of March in Rights
---Reasonable Pricing Clause

Compulsory Licensing

Data Privacy Issues
---BIOSECURE Act
---American Privacy Rights Act
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain

Diversity in Patenting
--- Inventor Diversity for Economic Advancement (IDEA) Act

Drug Patenting
---Interagency Patent Coordination and Improvement Act of 2025
---Prescription Pricing for the People Act
---Preserve Access to Affordable Generics and Biosimilars Act
---Stop STALLING Act
---Affordable Prescriptions for Patients Act
---A bill to establish special rules relating to information provided with respect to drug applications concerning method of use patents
---Medication Affordability and Patient Integrity Act
---A bill to address patent thickets
---A Bill to Amend the FTC Act to Prohibit Product Hopping
---A Bill to Amend U.S.C. Title 35 to Address Infringements of Patents Claiming Biological Products
---Interagency Patent Coordination and Improvement Act of 2025
---Prescription Pricing for the People Act
---Prohibiting Adversarial Patents Act of 2023 (Fitzgerald - WI)
---Protecting Consumer Access to Generic Drugs Act
---FTC Orange Book Delisting Initiative
---Orange Book Listing
---PTO Proposed Rules on Terminal Disclaimer Practice
---Restrictions on Intellectual Property Rights

Foreign Drug Data Protection Law
---BIOSECURE Act
---Protecting Americans Data from Foreign Adversaries Act of 2024
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain

Intellectual Property Enforcement
---China

Patent Reform
---Prohibiting Adversarial Patents Act (PAPA)
---Interagency Patent Coordination and Improvement Act
---Patent Eligibility Restoration Act (PERA)
---Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act
---Patent Litigation Reform
---The USPTO Request for Comments: Experimental Use Defense 89 Fed. Reg 53963

Patenting of Biological Inventions
---Patent Eligibility Restoration Act (PERA)
---Section 101 Modernization
---RESTORE Patent Rights Act

World Health Organization (WHO)
---WHO Pandemic Preparedness Accord

World Intellectual Property Office (WIPO)
---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge

World Trade Organization (WTO)
---TRIPS Waiver

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Patent & Trademark Office (PTO)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
David
Lachmann
​
​
Hans
Sauer
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
Kristin
Murphy
​
​
Praneel
Jadav
​
​
Chris
Jones
​
​
Elisabeth
Fox
​
​
Justin
Pine
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ENG

16. Specific lobbying issues

Biofuels and SAF (Non-Funding)
---FY 2025 Appropriations
---FY 2026 Appropriations
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit
---IRA Tax Credits
---S.144/H.R.1719 Farm to Fly Act

Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture and food sectors

Biorefineries (Non-Funding)
---Agricultural Biorefinery Innovation and Opportunity
---Climate Issues & impact on the agriculture and food sectors

Climate Change
---FY 2025 Appropriations
---FY 2026 Appropriations
---Climate Issues & impact on the agriculture and food sectors
---Fighting Climate Change through Biotechnology Innovation

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---Agricultural Biorefinery Innovation and Opportunity Act
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture and food sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Treasury - Dept of, Agriculture - Dept of (USDA)

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
John
Torres
​
​
Elisabeth
Fox
​
​
Bailey
McCue
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FOO

16. Specific lobbying issues

Farm Bill
---Farm Bill Reauthorization

Genetically Engineered (GE) Animals
---Efficient Science-Based Review of Biotech Products, FDA Approvals, Guidance, & Regulations
---FDA Approvals, Guidance, & Regulations
---International Consistency of Regulations for Gene Edited Products

Pharmaceutical and Ag Biotech Tariffs

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
John
Torres
​
​
Praneel
Jadav
​
​
Bailey
McCue
​
​
Elisabeth
Fox
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FUE

16. Specific lobbying issues

Biofuels and SAF (Non-Funding)
---FY 2025 Appropriations
---FY 2026 Appropriations
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit
---IRA Tax Credits
---S.144/H.R.1719 Farm to Fly Act

Biomass Programs (Non-Funding)
---Climate Issues & impact on the agriculture and food sectors

Biorefineries (Non-Funding)
---Agricultural Biorefinery Innovation and Opportunity Act of 2023
---Climate Issues & impact on the agriculture and food sectors

Climate Change
---FY 2025 Appropriations
---FY 2026 Appropriations
---Climate Issues & impact on the agriculture and food sectors
---Mitigating Climate Change through Biotechnology Innovation

Funding for Biofuels, Biomass Crop Assistance, and Biorefineries
---Agricultural Biorefinery Innovation and Opportunity Act
---Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act
---Climate Issues & impact on the agriculture and food sectors
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Incentives for Sustainable Aviation Fuels

17. House(s) of Congress and Federal agencies Check if None

U.S. HOUSE OF REPRESENTATIVES, U.S. SENATE, Treasury - Dept of

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
John
Torres
​
​
Elisabeth
Fox
​
​
Bailey
McCue
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HCR

16. Specific lobbying issues

340B Drug Discount Program
---Executive Order on Access to Affordable Life-Saving Medications
---Program & Oversight

Accelerated Approval

Artificial Intelligence (AI)

Alternative Funding Programs

Biodefense Research, Development and Procurement Issues (Non-Funding)
---S.854 Risky Research Review Act
---Bio COMPETES (Draft)
---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft)
---House GOP RFI on Supply Chain
---American Pandemic Preparedness Plan (AP3)
---MCM PRV Program Reauthorization
---NDAA
---Reasonable Pricing Clauses in BARDA Contracts
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
---Tropical Disease Priority Review Voucher (PRV) Program
---CICP
---White House National Biodefense Strategy
---WHO Pandemic Preparedness Accord

Biosimilars
---Bio COMPETES (Draft)
---Biosimilar Copay
---House GOP RFI on Supply Chain
---Interchangeability and Pharmacy Substitution
---Reimbursement

Cell & Gene Therapy
---H.R.1672: MINI Act

Climate Change
---FY 2025 Appropriations
---FY 2026 Appropriations

Data Privacy
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Data Privacy
---Clinical Trial Data in China

Diagnostics and Personalized Medicine Regulation and Oversight

Diversity & Inclusion
---Decentralized Clinical Trials
---Clinical Trial Diversity

Drug Evaluation and Review
---Promising Pathway Act
---COVID-19 Lessons Learned
---FDA Hiring Flexibility

Drug Importation

Drug Manufacturing, Quality & Distribution
---Advanced Manufacturing
---Drug Shortages
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---Supply Chain Integrity and Traceability
---Compounded Medicines
---House GOP RFI on Supply Chain


Drug Patenting
---Interagency Patent Coordination and Improvement Act of 2025
---Prescription Pricing for the People Act of 2025
---Preserve Access to Affordable Generics and Biosimilars Act
---Stop STALLING Act
---Patent Thickets
---Restrictions on Intellectual Property Rights


Drug Pricing
---FY 2025 Appropriations
---FY 2026 Appropriations
---ORPHAN Cures Act
---Maintaining Investments and New Innovation (MINI) Act
---Ensuring Pathways to Innovative Cures (EPIC) Act
---Interagency Patent Coordination and Improvement Act of 2025
---Prescription Pricing for the People Act of 2025
---Pharmacy Benefit Manager Transparency Act of 2025
---Preserve Access to Affordable Generics and Biosimilars Act
---Stop STALLING Act
---CMMI Authority
---COVID-19 Pricing Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---National Coverage Determination
---PBM Reform
---Patient Cost-Sharing and Implementation
---Strengthening Innovation in Medicare and Medicaid Act

Efforts to expand the Bio Economy & Bio Manufacturing

Foreign Drug Data Protection Laws
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 Appropriations
---FY 2026 Appropriations

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2025 Appropriations
---FY 2026 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---MCM PRV
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2025 Appropriations
---FY 2026 Appropriations
---VICP
---CICP


Funding for FDA
---FY 2025 Appropriations
---FY 2026 Appropriations
---User Fees

Funding for Health Resources and Services Administration (HRSA)
---FY 2025 Appropriations
---FY 2026 Appropriations

Funding for the HHS Office of Infectious Disease and HIV/AIDS Policy
---FY 2025 Appropriations
---FY 2026 Appropriations

Funding for National Institutes of Health
---FY 2025 Appropriations
---FY 2026 Appropriations
---Advanced Research Projects Agency for Health (ARPA-H)
---Funding for Womens Health Research

International Reference Pricing

Medicaid
---Pharmacy Benefit Manager Transparency Act of 2025
---Alternative Payment Arrangements for Gene Therapies
---Average Manufacturer Price Calculations
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act
---Medicaid Drug Rebate Program Rule
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule

National Defense
---National Defense Authorization Act of 2025

Opioid Crisis
---SUPPORT Act
---Non-Opioid Analgesics
---Transparency
---Coverage and Reimbursement

Orphan Drug Issues
---H.R.1262: Give Kids a Chance Act
---H.R.946: ORPHAN Cures Act
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Pediatric Priority Review Voucher Program
---Orphan Drug Tax Credit

Pandemic Preparedness
---Drug Supply Chain Management
---Monoclonal Antibody Coverage and Utilization
---R&D Funding for Medical Countermeasures
---Restrictions on Intellectual Property Rights
---Supply Chain Issues
---Temporarily Refundable R&D Credit
---TRIPS Waiver
---WHO Pandemic Preparedness Accord
---Medical Countermeasures PRV Reauthorization

Pharmaceutical and Ag Biotech Tariffs

Precision Medicine Initiative

Reimbursement and Coverage of Innovative Products
---S.864: HELP Copays Act
---Administration Rebate Rule
---CMMI Authority
---Implementation of the Inflation Reduction Act (IRA) of 2022
---In-Home Administration of Part B Drugs
---Lower Costs, More Cures Act
---Medicare Part B Physician-Administered Products
---National Coverage Determination
---Patient Cost-Sharing and Smoothing
---Protected Classes
---Support of Patient Premiums and Cost-Sharing Obligations
---Value-based Contracting and Communications

Vaccines and Infectious Diseases
---FY 2025 Appropriations
---FY 2026 Appropriations
---Adult Immunization
---Countermeasures Injury Compensation Program
---Maternal Immunization
---MCM Manufacturing & Capacity
---MCM PRV Reauthorization
---Monoclonal Antibody Coverage and Utilization
---National Coverage Determination
---Vaccine and Antimicrobial Resistance Product Development and Incentives
---Vaccine Injury Compensation Program
---Vaccine Safety and Quality
---Vaccine Safety net and Vaccine Infrastructure
---Value of Vaccines and Vaccine Confidence
---VICP Loopholes

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
Hans
Sauer
​
​
Phyllis
Arthur
​
​
Kristin
Murphy
​
​
David
Lachmann
​
​
Emily
Wheeler
​
​
Amber
Manko
​
​
Elisabeth
Fox
​
​
Praneel
Jadav
​
​
Emily
Michael
​
​
Chris
Jones
​
​
Bailey
McCue
​
​
Justin
Pine
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code HOM

16. Specific lobbying issues

Biodefense Research, Development and Procurement Issues (Non-Funding)
---State Strategic Stockpile Act
---To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate
---BIOSECURE Act
---Risky Research Review Act
---Bio COMPETES (Draft)
---Gene Editing
---MCM PRV Program
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
---Tropical Disease Priority Review Voucher (PRV) Program
---WHO Pandemic Preparedness Accord
---Executive Order on Achieving Efficiency Through State and Local Preparedness
---Executive Order on Withdrawing the United States from the World Health Organization
---HHS Reorganization
---FY 2025 Appropriations
---FY 2026 Appropriations

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 Appropriations
---FY 2026 Appropriations
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2025 Appropriations
---FY 2026 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)


17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
Amber
Manko
​
​
Kristin
Murphy
​
​
Praneel
Jadav
​
​
Emily
Wheeler
​
​
Elisabeth
Fox
​
​
Bailey
McCue
​
​
Chris
Jones
​
​
Justin
Pine
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MED

16. Specific lobbying issues

Biodefense Research, Development and Procurement Issues (Non-Funding)
---To amend the Public Health Service Act to strike the requirement that the Director of the Centers for Disease Control and Prevention be appointed by and with the advice and consent of the Senate
---Biosecurity Infrastructure for Operational (BIO) Early Warning Act (Discussion Draft)
---Bio COMPETES (Draft)
---Gene Editing
---MCM PRV Program
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)
---Risky Research Review Act
---Tropical Disease Priority Review Voucher (PRV) Program
---HHS Reorganization
---Executive Order on Achieving Efficiency Through State and Local Preparedness

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 Appropriations
---FY 2026 Appropriations
---Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act

Funding for Biodefense/Biomedical/Emergency Preparedness Research, Development and Procurement
---FY 2025 Appropriations
---FY 2026 Appropriations
---Funding for Strategic National Stockpile
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Reauthorization of Pandemic and All-Hazards Preparedness and Advancing (PAHPA)

Funding for the Centers for Disease Control and Prevention Vaccine Programs
---FY 2025 Appropriations
---FY 2026 Appropriations

Funding for National Institutes of Health
---FY 2025 Appropriations
---FY 2026 Appropriations
---Advanced Research Projects Agency for Health (ARPA-H)
---Womens Health Research

Pandemic Preparedness
---R&D Funding for Medical Countermeasures
---MCM PRV


17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Emily
Wheeler
​
​
Kristin
Murphy
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
Praneel
Jadav
​
​
Elisabeth
Fox
​
​
Bailey
McCue
​
​
Chris
Jones
​
​
Emily
Michael
​
​
Justin
Pine
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MMM

16. Specific lobbying issues

340B Drug Discount Program
---340B Accountability Act
---Executive Order on Access to Affordable Life-Saving Medications
---Program Implementation & Oversight

Accelerated Approval

Artificial Intelligence (AI)

Alternative Funding Programs

Biosimilars
---Biosimilar Copay
---BSUFA Negotiations
---Implementation of BSUFA Agreement
---Interchangeability and Pharmacy Substitution
---Reimbursement
---General

Cell & Gene Therapy
---H.R.1672 MINI Act

Climate Change
---FY 2025 Appropriations
---FY 2026 Appropriations

Clinical Trial Data in China

Data Privacy
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Data Privacy
---General

Diversity & Inclusion
---Decentralized Clinical Trials
---Clinical Trial Diversity
---General

Drug Evaluation and Review
---Promising Pathway Act
---COVID-19 Lessons Learned
---FDA Hiring Flexibility

Drug Importation

Drug Manufacturing, Quality & Distribution
---Advanced Manufacturing
---Drug Shortages
---Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy
---Supply Chain Integrity and Traceability
---Compounded Medicines

Drug Patenting
---Interagency Patent Coordination and Improvement Act of 2025
---Prescription Pricing for the People Act of 2025
---Preserve Access to Affordable Generics and Biosimilars Act
---Stop STALLING Act
---Patent Thickets
---Restrictions on Intellectual Property Rights

Drug Pricing
---FY2025 Appropriations
---FY 2026 Appropriations
---S.1097: Interagency Patent Coordination and Improvement Act of 2025
---H.R.946: ORPHAN Cures Act
---H.R.1672: Maintaining Investments and New Innovation (MINI) Act
---PBN Reform
---H.R.1492: Ensuring Pathways to Innovative Cures (EPIC) Act
---S.526: Prescription Pricing for the People Act of 2025
---S.527: Pharmacy Benefit Manager Transparency Act of 2025
---S.1096: Preserve Access to Affordable Generics and Biosimilars Act
---S.1095: Stop STALLING Act
---CMMI Authority
---COVID-19 Pricing Related Provisions
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Patient Cost-Sharing and Implementation
---Strengthening Innovation in Medicare and Medicaid Act
---International Reference Pricing

Foreign Drug Data Protection Laws
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain
---Regulatory Harmonization

Funding for Antimicrobial Resistance (AMR) Programs
---FY 2025 Appropriations
---FY 2026 Appropriations

International Reference Pricing

Issues Relating to Medical Research and Animal Testing Models

Medicaid
---S.526: Pharmacy Benefit Manager Transparency Act of 2025
---Alternative Payment Arrangements for Gene Therapies
---Average Manufacturer Price Calculations
---Coverage of Accelerated Approval Products
---Drug Benefit Design
---Encouraging Innovation Benefit Design to Lower Costs for Seniors Act
---Medicaid Drug Rebate Program
---Pricing and Rebates
---Value-Based Purchasing (VBP) Rule

National Defense
---National Defense Authorization Act of 2025

Opioid Crisis
---SUPPORT Act
---Non-Opioid Analgesics
---Transparency
---Coverage and Reimbursement

Orphan Drug Issues
---H.R.946: ORPHAN Cures Act
---H.R.1262: Give Kids A Chance Act
---S.705: Innovation and Pediatric Drugs Act of 2025
---Pediatric Priority Review Voucher Program Reauthorization
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Orphan Drug Tax Credit
---General

Precision Medicine Initiative

Reimbursement and Coverage of Innovative Products
---S.864: HELP Copays Act
---Administration Rebate Rule
---CMMI Authority
---In-Home Administration of Part B Drugs
---Medicare Part B Physician-Administered Products
---National Coverage Determination
---Patient Cost-Sharing and Smoothing
---Protected Classes
---Support of Patient Premiums and Cost-Sharing Obligations
---Value-based Contracting and Communications

Vaccines and Infectious Diseases
---FY 2025 Appropriations
---FY 2026 Appropriations
---Adult Immunization
---Countermeasures Injury Compensation Program
---Vaccine Injury Compensation Program
---Maternal Immunization
---MCM Manufacturing & Capacity
---MCM PRV Reauthorization
---Monoclonal Antibody Coverage and Utilization
---National Coverage Determination
---Vaccine Safety and Quality
---Vaccine Safety Net and Vaccine Infrastructure
---Value of Vaccines and Vaccine Confidence
---VICP Loopholes

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
Kristin
Murphy
​
​
Amber
Manko
​
​
David
Lachmann
​
​
Emily
Wheeler
​
​
Praneel
Jadav
​
​
Elisabeth
Fox
​
​
Emily
Wheeler
​
​
Hans
Sauer
​
​
Chris
Jones
​
​
Bailey
McCue
​
​
Justin
Pine
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code SMB

16. Specific lobbying issues

Banking Policy Impacting Emerging Companies
---Regulatory Burden

Capital Formation Incentives
---American Innovation Act
---Putting Investors First Act
---Fair Investment Opportunities for Professional Experts Act
---Accredited Investor Definition Review Act
---To amend the Federal securities laws to specify the periods for which financial statements are required to be provided by an emerging growth company, and for other purposes.
---To amend the Securities Exchange Act of 1934 to specify certain registration statement contents for emerging growth companies, to permit issuers to file draft registration statements with the Securities and Exchange Commission for confidential review, and for other purposes.
---Helping Startups Continue to Grow Act
---American Innovation and R&D Competitiveness Act
---Small Entity Update Act
---Equal Opportunity for All Investors Act
---Expanding Access to Capital Act
---Infectious Disease Therapies Research and Innovation Act
---American Innovation and Jobs Act
---Adjusting the well-known seasoned issuers definition to allow for a larger financing round using
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window
---Net Operating Loss Advance Refunds
---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards
---Update public float threshold triggers to align with current market conditions

Capital Market Enhancements
---Accredited Investor Definition
---Amended Definition of Smaller Reporting Company
---JOBS Act 4.0
---Market Liquidity Proposals
---Public Float Threshold Update
---SEC Small Business Forum
---Small Business Capital Formation Enhancement Act

Mergers and Acquisitions

Reform of SEC Regulation D
---Accredited Investor Certification

Sarbanes Oxley Section 404 (b)
---Small Issuer Exemption

Small Business Innovation Research (SBIR) Program
---Reauthorization of SBIR and STTR
---Implementation of the SBIR and STTR Extension Act of 2022

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Amber
Manko
​
​
David
Lachmann
​
​
Aiken
Hackett
​
​
Kristin
Murphy
​
​
Elisabeth
Fox
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TAX

16. Specific lobbying issues

Biofuels (Non-Funding)
---Incentives for Sustainable Aviation Fuels
---Sustainable Aviation Fuels Tax Credit

Capital Formation Incentives
---American Innovation Act
---Helping Startups Continue to Grow Act
---American Innovation and R&D Competitiveness Act
---Small Entity Update Act
---Expanding Access to Capital Act
---Equal Opportunity for All Investors Act
---Infectious Disease Therapies Research and Innovation Act
---Adjusting the well-known seasoned issues definition to allow for a larger financing round using
---American Innovation and Jobs Act
---Convert public float thresholds to soft triggers from hard triggers to avoid surprise expenses by implementing a rolling average window
---Implementation of the Inflation Reduction Act (IRA) of 2022
---Net Operating Loss Advance Refunds
---Update Form S-3 holding period from 12 months to six months to reflect Wall Street standards
---Update public float threshold triggers to align with current market conditions

Orphan Drug Issues
---Orphan Drug Tax Credit (Camerons Law)
---General

Pandemic Preparedness

Renewable Chemicals/Bio-based Products (Non-Funding)
---Climate Issues & impact on the agriculture and food sectors

Research & Development Tax Credit Reforms
---American Innovation and R&D Competitiveness Act
---Tax Relief for American Families and Workers Act
---American Innovation and Jobs Act
---Expensing of R&D Expenditures
---R&D Payroll Credit

Vaccine Injury Compensation Program
---FY 2025 Appropriations
---FY 2026 Appropriations
---Let Injured Americans Be Legally Empowered (LIABLE) Act
---Countermeasure Injury Compensation Fund Amendment Act
---Vaccine Injury Compensation Modernization Act
---Vaccine Access Improvement Act
---VICP
---CICP

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
Aiken
Hackett
​
​
Kristin
Murphy
​
​
Amber
Manko
​
​
Elisabeth
Fox
​
​
John
Torres
​
​
David
Lachmann
​
​
Emily
Michael
​
​
Bailey
McCue
​
​
Chris
Jones
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TRD

16. Specific lobbying issues

CFIUS and Foreign Investment

Drug Importation

Drug Pricing
---Reference Pricing in Drug Reimbursement

Foreign Agricultural Biotechnology Laws and Regulations
---China Biotechnology Regulations
---EU Ag-Biotech Policies and Regulations
---International Consistency of Regulation for Gene Edited Products
---Korea Biotechnology Regulations
---Mexico Decree Banning Genetically Modified Corn

Foreign Drug Data Protection Laws
---BIOSECURE Act
---Protecting Americans Data from Foreign Adversaries Act
---A bill to prohibit contracting with certain biotechnology providers, and for other purposes.
---Bio COMPETES (Draft)
---Executive Order on Preventing Access to Americans Bulk Sensitive Personal Data and United States Government-Related Data by Countries of Concern
---House GOP RFI on Supply Chain


Genetically Engineered (GE) Animals
---International Consistency of Regulation for Gene Edited Products

Genetically Engineered (GE) Plants
---International Consistency of Regulation for Gene Edited Products

Global Supply Chain Resiliency
---B5 Coalition on Supply Chain Resiliency
---Issues Relating to Non-Human Primate Shortages

Intellectual Property International Enforcement
---China

S.2115/H.R.4307 - Medical Supply Chain Resiliency Act

Synthetic Biotech

Pharmaceutical and Ag Biotech Tariffs

US-China Trade Agreement
---Ag-Biotech Provisions
---IP Provisions

World Health Organization (WHO)
---WHO Pandemic Preparedness Accord

World Intellectual Property Office (WIPO)
---Treaty on Intellectual Property, Genetic Resources, and Associated Traditional Knowledge

World Trade Organization (WTO)
---TRIPS Waiver

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES

18. Name of each individual who acted as a lobbyist in this issue area

First Name Last Name Suffix Covered Official Position (if applicable) New
David
Lachmann
​
​
Aiken
Hackett
​
​
Amber
Manko
​
​
John
Torres
​
​
Praneel
Jadav
​
​
Elisabeth
Fox
​
​
Kristin
Murphy
​
​
Phyllis
Arthur
​
​
Chris
Jones
​
​
Emily
Wheeler
​
​
Justin
Pine
​
​

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

​

Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

Address
​
City
​
State
​
Zip Code
​
Country
​

21. Client new principal place of business (if different than line 20)

City
​
State
​
Zip Code
​
Country
​

22. New General description of client’s business or activities

​

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

First Name
Last Name
Suffix
First Name
Last Name
Suffix
1
​Emily
​Michael
​
3
​
​
​
2
​Justin
​Pine
​
4
​
​
​

ISSUE UPDATE

24. General lobbying issue that no longer pertains

​
​
​
​
​
​
​
​
​

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

Name Address Principal Place of Business
(city and state or country)
Street Address
City State/Province Zip Country
City
State Country

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

1 2 3

FOREIGN ENTITIES

27. Add the following foreign entities:

Name Address Principal place of business
(city and state or country) 		Amount of contribution for lobbying activities Ownership percentage in client
Street Address
City State/Province Country
City
State Country
%

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization

1 3 5
2 4 6

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?

Lobbyist Name Description of Offense(s)