Paul Sheives
Associate
- T:
- +1 202 414 9210 (Washington, D.C.)
- F:
- +1 202 414 9299 (Washington, D.C.)
- E:
- psheives@reedsmith.com
- Vcard
Paul is a member of the Life Sciences Health Industry Group (LSHI), practicing in the area of healthcare regulatory law. He counsels clients on FDA regulatory and compliance matters relating to drug and device development/approvals and the health care regulatory area, including Medicare and Medicaid coverage, payment, and federal and state regulation of health care matters.
As part of his practice, he has helped clients in the pharmaceutical industry comply with anti-kickback, fraud, government pricing and reimbursement requirements. Paul regularly advises clients on developing creative reimbursement strategies for drugs, devices, and biologics.
He has extensive experience advising clients on a wide range of FDA-related issues, such as regulatory pathway development, pre-clinical and clinical testing, post-market and manufacturing compliance, advertising and promotion, and life cycle management of drugs, devices and biologics. Paul has also advised clients on the approval of food ingredients, and on issues relating to food labeling, marketing, and distribution.
Publications
- "Identification of cells deficient in signaling-induced alternative splicing by use of somatic cell genetics," RNA 12, co-authored with K.W. Lynch (2002)
Experience
| 2009 | Reed Smith |
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| 2003 | Morgan, Lewis & Bockius Regulatory Scientist, FDA/Healthcare Practice Group (July 2003 - March 2008) |
Legal Education
| 2008 | J.D., Georgetown University Law Center |
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Graduate Education
| 2003 | M.S., University of Texas Southwestern Medical Center, Cell & Molecular Biology 2002 Annual Department of Biochemistry Research Symposium - Winner, Research Poster Session |
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Undergraduate Education
| — | B.S., University of Texas at Arlington, Microbiology Microbiology Society - President |
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Professional Admissions / Qualifications
- District of Columbia