55th Edition of the A.I. Healthcare Report

Main Ideas

• The Department of Health and Human Services (HHS) published a notice regarding an upcoming meeting on Human Research Protections.
• Samsung Biologics signs $1 billion production deal with unnamed US Pharma.
• ELFABRIO is undergoing the process of a regulatory review period and is being made public by the FDA as is required by law.
• A recent notice published by the FDA informed the public that VYVGART is undergoing the process of a regulatory review period and is being made public by the agency as is required by law.
• FY 25 Approps continue with markups expected on Wednesday (subject to change).

This Week on The A.I. Healthcare Report

Welcome to the Fifty-Fifth of the AI Healthcare Report!

Welcome to the Fifty-Fifth Edition of the A.I. Healthcare Report! I hope everyone is enjoying their summer! I am trying to get to the golf course as much as possible! We are now less than 50 days from college football! The Texas Rangers are still in third place in the AL West, while the Astros are still in second place in the division. Please be mindful that this edition of the A.I. Healthcare Report is shorter because of the holiday weekend and Congress not being in session as much as we head into August Recess.

Weekly Question

The Department of Health and Human Services (HHS) published a notice regarding an upcoming meeting on Human Research Protections.

The meeting is open to the public and will be held on July 23rd from 11:00 a.m. until 4:00 p.m. EST and July 24, 2024, from 11:00 a.m. until 4:00 p.m. EST.

The agenda will be posted on the Secretary's Advisory Committee on Human Research Protections (SACHRP) website.

What do you think that HHS should know about protecting human beings during healthcare research?

For more information, please click here.

Healthcare Market Watch

High-flying Samsung Biologics inks $1B production pact with unnamed US pharma

FDA commissioner heralds end to US shortfall of chemo drug cisplatin

10 clinical trials to watch in the second half of 2024

Eli Lilly inks another radiopharma deal, gaining option to buy startup

Roche gains FDA approval for Vabysmo prefilled syringe

Healthcare Policy Watch

1.Determination of Regulatory Review Period for Purposes of Patent Extension; ELFABRIO

ELFABRIO is undergoing the process of a regulatory review period and is being made public by the FDA as is required by law.

ELFABRIO is used for those with Fabry disease and is manufactured by Chiesi Farmaceutici S.p.A.

Please submit comments by September 3, 2024.

2.Determination of Regulatory Review Period for Purposes of Patent Extension; KIMMTRAK

The FDA published a mandatory notice notifying the public that KIMMTRAK is undergoing its regulatory review period.

KIMMTRAK is used for those with uveal melanoma and is manufactured by Immunocore.

Please submit comments by September 3, 2024.

3.Determination of Regulatory Review Period for Purposes of Patent Extension; VYVGART

A recent notice published by the FDA informed the public that VYVGART is undergoing the process of a regulatory review period and is being made public by the agency as is required by law.

VYVGART is used to treat those who have myasthenia gravis and is manufactured by Argenx SE.

Please submit comments by September 3, 2024.

4.Determination of Regulatory Review Period for Purposes of Patent Extension; XENPOZYME

XENPOZYME is undergoing the process of a regulatory review period and is being made public by the FDA as is required by law.

XENPOZYME is used to treat those who have acid sphingomyelinase deficiency (ASMD) and is manufactured by Sanofi.

Please submit comments by September 3, 2024.

5.Determination of Regulatory Review Period for Purposes of Patent Extension; ZYNYZ

The FDA published a mandatory notice notifying the public that ZYNYZ is undergoing its regulatory review period.

ZYNYZ is used to treat those who have Merkel cell carcinoma and is manufactured by Incyte Corporation.

Please submit comments by September 3, 2024.

Congressional Updates

No pertinent updates or new bills at this time.

State Updates

Texas 2036 Newsletter Signup

Coming up

House

July 10

Markup: Fiscal Year 2025 Labor Health and Human Services Education and Related Agencies Transportation Housing and Urban Development and Related Agencies and Agriculture Rural Development and Food and Drug Administration Bills and Revised Subcommittee Allocations

9:00 AM?|?2359 Rayburn HOB

Host:?Committee on Appropriations

Hearing: Legislative Hearing on: H.R. 2971 Veterans Claims Education Act of 2023; H.R. 6362 Protecting Benefits for Disabled Veterans Act of 2023; H.R. 6507 Mark Our Place Act; H.R. 7729 Dennis and Lois Krisfalusy Act; H.R. 8792 Flowers for Fallen Heroes Act of 2024; H.R. 8854 Ensuring Veterans Final Resting Place Act of 2024; H.R. XXXX Dayton National Cemetery Expansion Act of 2024; H.R. XXXX Preserving Veterans Legacy Act of 2024; H.R. XXXX Modernizing All Veterans and Survivors Claims Proce

10:15 AM?|?360 Canon HOB

Host:?Committee on Veterans' Affairs | Subcommittee on Disability Assistance and Memorial Affairs

Senate

July 9

Health, Education, Labor, and Pensions

10:00 AM – SD-562 Subcommittee on Children and Families

Hearings to examine everyday expenses and everyday Americans, focusing on how high costs impact children and families.

?

Budget

10:00 AM – SD-608

Hearings to examine CBO's updated 2024-2034 budget and economic outlook.

What I Am Reading

Stanford Human-Centered Artificial Intelligence is a great resource for diving deeper into AI and Healthcare. I have provided the signup page for their free newsletter here.

I am also reading a book called Superintelligence, which examines the potential power of intelligent machines.

For the book, click here.

Writing Projects

Below are a few writing projects I have done.

• The Southern United States: A Case Study on AI and Healthcare Unions
• Dallas vs. Lubbock Obesity Rates: A mini-case Study of AI in Healthcare
• Avoiding a Cautionary Tale: Policy Considerations for Artificial Intelligence in Health Care Hearing: 11/8/23
• Case Study: AI in Healthcare in Mississippi with model built by Peter Skuta

Follow Me

Below are my social channels to read the AI Healthcare Report/listen to the AI HealthcarePodcast

• Youtube:@TheAIHealthcarePodcast

All podcast episodes can be found on Apple Podcasts and Spotify too.

• Spotify Link: https://lnkd.in/ezH2yzEj
• Apple Podcasts Link:https://lnkd.in/efvkbkDh