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This profile was last updated on 10/19/15  and contains information from public web pages and contributions from the ZoomInfo community.

Mr. John R. Manthei

Wrong John R. Manthei?

Partner

Phone: (202) ***-****  
Email: j***@***.com
Local Address:  Washington , District of Columbia , United States
Latham & Watkins LLP
885 Third Avenue Suite 1000
New York , New York 10022
United States

Company Description: Latham & Watkins is a global law firm with more than 1,900 attorneys in 24 offices, including Barcelona, Brussels, Chicago, Frankfurt, Hamburg, Hong Kong, London,...   more
Background

Board Memberships and Affiliations

Education

  • BA
    Miami University
  • JD
    University of Wisconsin
  • JD
    University of Wisconsin Law School
  • JD
    University of Wisconsin School of Law
  • law degree
    University of Wisconsin Law School
140 Total References
Web References
A discussion draft of the Cures ...
www.bioworld.com [cached]
A discussion draft of the Cures reforms, which are likely to change the drug and device development process, is expected to be rolled out in January, leading to the passage of comprehensive legislation later in the year, said John Manthei, partner and global co-chair of Latham & Watkins' health care and life sciences practice.
"This will be an ambitious undertaking," he said of the Cures initiative. "I think the energy from both the Republicans and Democrats is there. The initiative has enjoyed strong bipartisan support in the House Energy and Commerce (E&C) Committee, as well as in its Health Subcommittee.
As a result of that support, Manthei predicted 2015 will see the broadest scope of FDA reforms ever for a year in which Congress isn't re-authorizing the five-year drug and device user-fee package.
Some of the measures likely to be included in the reforms include modernization of clinical trials, use of real world evidence in drug and device development, streamlined reviews of combination products, more expedited approval paths, improved scheduling of controlled substances, and use of biomarkers and statistical models. Manthei also expects Congress will consider how and when the FDA should regulate phone apps as medical devices.
Along with those reforms, he thinks the new Republican-controlled Congress will exercise more oversight of the FDA, seeking greater transparency, predictability and accountability in the agency's dealings with industry and in its handling of resources.
Over the past few years, the FDA has seen significant funding increases, largely due to new and expanded user fees. The 114th Congress, which will be seated in January, will take a hard look at how the agency is using that money, especially when it comes to hiring the staff needed for its increased authorities, Manthei said during a media briefing on the impact Tuesday's election could have on the life sciences sector.
...
With the Republicans at the Senate helm, Manthei expects Sen.
...
Adding to their loss will be the departure of their experienced staff, Manthei said.
A discussion draft of the Cures ...
www.bioworld.com [cached]
A discussion draft of the Cures reforms, which is likely to change the drug and device development process, is expected to be rolled out in January, leading to the passage of comprehensive legislation later in the year, said John Manthei, partner and global co-chair of Latham & Watkins' health care and life sciences practice.
"This will be an ambitious undertaking," he said of the Cures initiative. "I think the energy from both the Republicans and Democrats is there. The initiative has enjoyed strong bipartisan support in the House Energy and Commerce (E&C) Committee, as well as in its Health Subcommittee.
As a result of that support, Manthei predicted 2015 will see the broadest scope of FDA reforms ever for a year in which Congress isn't re-authorizing the five-year drug and device user fee package.
Along with those reforms, Manthei expects the Republican-controlled Congress to exercise more oversight of the FDA, seeking greater transparency, predictability and accountability in the agency's dealings with industry and in its handling of resources.
...
With the Republicans at the helm, Manthei expects Sen.
...
Henry Waxman (D-Calif.). Pallone, the current ranking member of the Health Subcommittee, is in line for the leadership seat in terms of seniority, but House Minority Leader Nancy Pelosi (D-Calif.) is expected to campaign for Eshoo, Manthei said.
...
Adding to their loss will be the departure of their experienced staff, Manthei said.
A discussion draft of the Cures ...
www.bioworld.com [cached]
A discussion draft of the Cures reforms, which are likely to change the drug and device development process, is expected to be rolled out in January, leading to the passage of comprehensive legislation later in the year, said John Manthei, partner and global co-chair of Latham & Watkins' health care and life sciences practice.
"This will be an ambitious undertaking," he said of the Cures initiative. "I think the energy from both the Republicans and Democrats is there. The initiative has enjoyed strong bipartisan support in the House Energy and Commerce (E&C) Committee, as well as in its Health Subcommittee.
As a result of that support, Manthei predicted 2015 will see the broadest scope of FDA reforms ever for a year in which Congress isn't re-authorizing the five-year drug and device user-fee package.
Some of the measures likely to be included in the reforms include modernization of clinical trials, use of real world evidence in drug and device development, streamlined reviews of combination products, more expedited approval paths, improved scheduling of controlled substances, and use of biomarkers and statistical models. Manthei also expects Congress will consider how and when the FDA should regulate phone apps as medical devices.
Along with those reforms, he thinks the new Republican-controlled Congress will exercise more oversight of the FDA, seeking greater transparency, predictability and accountability in the agency's dealings with industry and in its handling of resources.
Over the past few years, the FDA has seen significant funding increases, largely due to new and expanded user fees. The 114th Congress, which will be seated in January, will take a hard look at how the agency is using that money, especially when it comes to hiring the staff needed for its increased authorities, Manthei said during a media briefing on the impact Tuesday's election could have on the life sciences sector.
...
With the Republicans at the Senate helm, Manthei expects Sen.
...
Adding to their loss will be the departure of their experienced staff, Manthei said.
Alliance for Safe Biologic Medicines: Media Room
safebiologics.org [cached]
The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA's progress implementing the Biosimilars Price Competition and Innovation Act (BPCIA).
Alliance for Safe Biologic Medicines: Media Room
www.safebiologics.org [cached]
The panel was moderated by John Manthei, partner, Latham & Watkins, who also gave a brief overview of the FDA's progress implementing the Biosimilars Price Competition and Innovation Act (BPCIA).
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