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2016-03-12T00:00:00.000Z

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Wrong John Manthei?

Mr. John Manthei R.

Partner

Latham & Watkins LLP

Direct Phone: (202) ***-****       

Email: j***@***.com

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, Los Angeles, Madrid, Milan, Moscow, Munich, New Jersey, New York, Northern Virginia, Orange ... more

Find other employees at this company (4,229)

Background Information

Affiliations

Board Member
Neediest Kids Inc

Member of the Advisory Committee for Drugs
The Food and Drug Law Institute

Member
District of Columbia Bar

Majority Counsel for the Committee
U.S. House of Representatives

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

Web References (140 Total References)


Board of Directors | Neediest Kids

neediestkids.org [cached]

John Manthei, Esq., Latham & Watkins


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).


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.

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