Paul Lewis, MS

Stephen F. Austin State University: Mathematics, B.S.

Stephen F. Austin State University: Statistics, M.S.

University of Texas Health Science Center, Houston – School of Public Health: Biometry, Ph.D. Candidate

Paul Lewis currently serves as Senior Statistician at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. 

He has almost 20 years of experience in clinical research and previously served as Vice President and Senior Statistician at SYNERGOS, Inc., which was acquired by inVentiv Health (VTIV) in 2006. He later served as COO and owner at Emily Graham, DDS PC. Through his consulting experience, he has advised many life sciences companies on statistical methodologies, regulatory affairs, and clinical product development, and has represented clients at the FDA.

Mr. Lewis holds a B.S. in Mathematics and an M.S. in statistics from Stephen F. Austin State University and has completed the course work and qualifying examinations for the PhD degree in Biometry from the University of Texas Health Science Center in Houston, School of Public Health. He has served on the Texas Emerging Technology Fund’s Gulf Coast Regional Center for Innovation and Commercialization (GCRCIC) Advisory Committee. He has also served as an advisor on the Houston Technology Center’s (now Houston Exponential) Life Sciences Screening Committee. He has been involved in numerous clinical trials for medical device and pharmaceutical companies pursuing marketing indications and provided statistical support for NDAs, PMAs, INDs, IDEs, and 510(k) submissions and has participated in several FDA advisory panel meetings.  He has co-authored several academic papers, posters, and abstracts.

Prior to his work in clinical research, Mr. Lewis was a Senior Scientist for Team Environmental Services (formerly Source Environmental Sciences), a company assisting clients to meet regulatory and compliance guidelines for their air, water, and waste emissions. During this time, he received his Registered Environmental Manager credentials through the National Registry of Environmental Professionals.  Mr. Lewis also served on the faculty in the Department of Mathematics and Statistics at Stephen F. Austin State University.

Proxima Clinical Research, Inc., Houston, Texas
Senior Statistician/Consultant‍

Emily Graham, DDS PC, Spring, Texas
COO/co-owner‍

InVentiv Clinical Solutions,  The Woodlands, Texas (a division of inVentiv Health)
Director of Business Development‍

Synergos, Inc.,  The Woodlands, Texas (acquired by inVentiv Health)
Vice President/Senior Statistician/Statistician‍

Team Environmental Services, Inc.,  Houston, Texas (a division of Team, Inc.)
Senior Scientist‍

Source Environmental Sciences, Inc., Houston, Texas (acquired by Team, Inc.)
Senior Scientist/Scientist‍

Stephen F. Austin State University, Nacogdoches, Texas
Lecturer, Department of Mathematics and Statistics

Mr. Lewis has played an important role in the development of the following medical products:

1. Supported development of VNS neurostimulation device for the treatment of epilepsy including support for PMA application and representation at FDA Advisory Panel meeting.
2. Supported development of DBS neurostimulation device for the treatment of Parkinson’s disease including support for PMA application and representation at the FDA Advisory Panel meeting.
3. Phase II and Phase III trial of anti-fungal drug including support for NDA submission.  
4. Phase I Orphan Drug trial for the treatment of APL including support for NDA submission
5. Phase II study of peptide therapeutic for treating diabetic foot ulcers
6. Phase II study of combination product to treat GBM brain tumors
7. Phase II study of gene therapy for the treatment of breast cancer
8. Phase II study of drug for the treatment of osteoporosis
9. Phase II study of peptide therapeutic for the treatment of peripheral arterial disease/claudication
10. Prepared and submitted 510(k) for a device for the treatment of vertigo
11. Supported 510(k) submission for device for the treatment of skin blemishes
12. Phase II study of product to treat dermal defects  
13. Supported 510(k) submission for device for the treatment of hearing loss
14. Pilot study of neurostimulation device for the treatment of depression
15. Pilot study of neurostimulation device for the treatment of Alzheimer’s disease
16. Pilot study of neurostimulation device for the treatment of pain
17. Pilot study of neurostimulation device for the treatment of obesity
18. Pilot study of left ventricular device
19. Phase I study of T-cell vaccine for the treatment of multiple sclerosis
20. Phase I/II study of drug for the treatment of endometriosis
21. Phase I/II study of drug for the treatment of hypogonadism
22. Pilot study of implant for the treatment of knee microfractures
23. Pilot study of nanoparticles for the treatment of head and neck cancer
24. Numerous Phase I/II oncology studies in a variety of indications including breast, brain, colon and ovarian cancers
25. Involved with multiple studies cardiovascular disease
26. Involved with several studies for orthopedic device

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Mr. Lewis has contributed to the following publications:

S. Caroff, P. Lewis, A. Pramanik, E. Goldberg, L. Lundt, E. Franey, M. Bron, C. Yonan, R. Dhanda. Impact of Possible Tardive Dyskinesia (TD) on Physical Ability, Functioning, and Overall Health Status in Patients Aware of their TD Status. American Psychiatric Association, (Abst #5266), 2021 and Society of Internal General Medicine, (Abst. SA-148), 2021.

W. Rosellini, R. Casavant, N. Engineer, P. Beall, D. Pierce, R. Jain, P. Dougherty. Wireless Peripheral Nerve Stimulation Increases Pain Threshold in Two Neuropathic Rat Models. Experimental Neurology 2012; 235(2):621-626.

L. Rogers, J. Rock, A. Sills, M. Vogelbaum, J. Suh, T. Ellis, V. Stieber, A. Asher, R. Fraser, J. Billingsley, P. Lewis, D. Schellingerhout, Brain Metastasis Study Group, E. Shaw. Results of a Phase II Trial of the GliaSite™ Radiation Therapy System for the Treatment of Newly Diagnosed Resected Single Brain Metastases. Journal of Neurosurgery 2006; 105:375-384.

The Deep-Brain Stimulation For Parkinson’s Disease Study Group. Deep-Brain Stimulation of the Subthalamic Nucleus or the Pars Interna of the Globus Pallidus in Parkinson’s Disease. The New England Journal of Medicine 2001; 345(13):956-963.

C. DeGiorgio, J. Thompson, P. Lewis, S. Arrambide, D. Noritoku, A. Handforth, D. Labar, P. Mullen, C. Heck. Vagus Nerve Stimulation: Analysis of Device Parameters in 154 Patients During the Long-Term XE5 Study. Epilepsia 2001; 42(8):1017-1020.

C. DeGiorgio, S. Schachter, A. Handforth, M. Salinsky, J. Thompson, B. Uthman, R. Reed, S. Collins, E. Tecoma, G. Morris, B. Vaughn, D. Noritoku, T. Henry, D. Labar, R. Gilmartin, D. Labiner, I. Osorio, R. Ristanovic, J. Jones, J. Murphy, G. Ney, J. Wheless, P. Lewis, C. Heck. Prospective Long-Term Study of Vagus Nerve Stimulation for the Treatment of Refractory Seizures. Epilepsia 2000; 41(9):1195-1200.

D. Gordon, I. Baird, R. Darouiche, V. Fainstein, L. Juaregui, C. Levy, P. Lewis. Liposomal Nystatin (LNY) vs. Amphotericin B (AMB) for Candidemia in Non-Neutropenic Patients: A Historical Comparison. Infectious Disease Society of America, (Abst #144), 1997.