Philip T. Lavin PhD, FASA, FRAPS
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` September 1, 2015
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`PHILIP T. LAVIN
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`Principal
`Lavin Consulting LLC
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`Founder and Executive Director
`Boston Biostatistics Research Foundation Inc.
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`Special Government Employee
`FDA
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`Name:
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`Industry Experience:
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`Summary: Forty years in clinical trials serving as an expert biostatistician, regulatory strategist, and executive
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`2013 – Present
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`1988 – Present
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`1983 – Present
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`Current responsibilities include:
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`Senior biostatistics (strategic planning, study design, endpoint construction, modeling, analysis, and
`representation), regulatory strategy (agency interaction and presentation), helping sponsors secure approval for
`drugs, biologics, and devices and reimbursement leading to 58 regulatory approvals (40 PMAs, 14 NDAs, 3
`BLAs, and 1 HDE), and serving as an FDA advisor and panel member for drugs, devices, and biologics.
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`2011 – 2013
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`2007 – 2011
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`1983 – 2007
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`Past responsibilities included:
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`Executive management, strategic management, regulatory strategy, biostatistics, talks, publications, and
`collaborations in pre-clinical studies, clinical trials, and innovative approaches for study design, longitudinal
`modeling, meta and mega analyses, epidemiology, cost-benefit modeling, and health care reimbursement.
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`Academic Experience:
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`1989 – 2005
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`1983 – 1989
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`1977 - 1983
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`1974 - 1977
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`Executive Vice President, Strategic Planning and Innovation Center
`Aptiv Solutions
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`Executive Chairman and Vice Chairman of the Board
`Averion International
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`Founder and CEO
`Averion International (formerly Boston Biostatistics Inc.)
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`Adjunct Associate Professor, Clinical Associate Professor
`Harvard Medical School, Boston, MA 02115
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`Associate Professor
`Harvard School of Public Health Boston, MA 02115
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`Assistant Professor
`Harvard School of Public Health Boston, MA 02115
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`Research Assistant Professor, Statistical Laboratory,
`Statistical Science Division, SUNY at Buffalo, Buffalo NY
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`Philip T. Lavin PhD, FASA, FRAPS
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`1972 – 1974
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`Assistant Professor of Research, Division of Applied Mathematics,
`Brown University, Providence RI
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`September 1, 2015
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`Responsibilities included:
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`Teaching, research, cooperative group (ECOG, GITSG) collaborations, and publications
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`Education:
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`Brown University, Providence RI
`PhD, Applied Mathematics (Statistics), 1972
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`Presentations:
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`2015
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`2014
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`2013
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`2012
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`2011
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`2010
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`2009
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`2008
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`2007
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`2006
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`2005
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`2003
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`2002
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`University of Rochester, Rochester NY (Summa Cum Laude)
`AB, Mathematics, 1968
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`SOCRA: The Statistics Behind Risk Based Monitoring
`MDIC: Optimizing Medical Device Study Designs
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`SABSC: Nomogram for Breast Cancer Diagnosis
`RAPS: Adaptive Designs for Regulatory Submissions
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`AIUM: Opto-acoustics for Breast Cancer Detection
`RAPS: Maximizing Good Relationships with Regulatory Agencies
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`Q1 Productions: Planning and Executing Adaptive Designs
`Q1 Productions: Statistical Strategies for Medical Device Studies
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`Q1 Productions: Statistical Strategies for Medical Device Studies
`IBC: Reimbursement Planning Strategies using Phase 3 Data
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`IBC: Adaptive Designs for Biologics and Drugs
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`IBC: Statistical Designs for Biomarkers
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`JSM: Quasi-non-inferiority Designs for Medical Devices
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`Mass BioTech Council: “Statistical Challenges Supporting DMCs”
`Neonatology Summit: “Mortality and LOS Modeling Issues Comparing Surfactants”
`American Statistical Association: “Designing Quasi-superior Device Studies”
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`American Statistical Association: “Common Themes in Medical Device Studies”
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`MassMEDIC: “Designing Combination Studies”
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`Clinical Trials Congress: “Data Monitoring Committees: Making Them Work”
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`New England Business and Technology Association: “Clinical Trials: Speeding
`Drugs to Patients.”
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`7th Annual Clinical Trial Strategies for Medical Devices: “The Three A’s of Data
`Monitoring Committees (DMCs): Administration, Authorization, and Analysis.”
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`Biologics:
`Burns
`Decubitis Ulcers
`Hepatitis B and C
`Huntington’s Disease
`Liver Assist Device
`Melanoma (OncoVex)
`Multiple Sclerosis
`Oncology (ONTAK)
`Psoriasis
`Renal Assist Device
`Rheumatoid Arthritis
`Sepsis
`Transplants
`Vaccines (OspA)
`Wound Healing
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`Philip T. Lavin PhD, FASA, FRAPS
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`Clinical Trials Experience:
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`Drugs:
`Acid Reflux (Pepcid)
`Acne (Estrostep, Azelex)
`AIDS
`ARDS
`Asthma (Albuterol)
`Cystic Fibrosis
`Cushing Syndrome
`Diabetes
`Endometriosis
`Epilepsy
`Gastric Ulcers
`Hyperlipids disorders (Cholestagel)
`Hyperkalemia
`Hypertension
`Infection (Ciprofloxacin)
`Lipidemia (Lipitor)
`Motion Sickness
`Multiple Sclerosis
`Nutrition (enteral, obesity)
`Oncology (Adriamycin)
`Onychomycosis
`Ophthalmology (Timolol)
`Osteo-arthritis (Flurbiprofen)
`Pain Relief (EMLA)
`Pulmonary
`Renal (Renagel)
`Rosacea (Finacea)
`Substance Abuse (Naltrexone)
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`September 1, 2015
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`Devices:
`Adhesion Prevention (ADCON-L)
`Angina (TMR)
`Artificial Organs (Heart, Kidney, Liver)
`Biomarkers (CA-125, PSA, sIL2r)
`Breast Cancer Imaging (Imagio)
`Cardiac Adhesions (REPEL-CV)
`Cervical Disc (Mobi-C [1,2], ProDISC-C [1,2])
`Cervical Dysplasia Detection (LUNA)
`Cryoablation (FROSSTY)
`Dermal Filler (RADIESSE)
`Diabetes (monitoring)
`Diagnostics (breast, CRC [Cologuard], DR)
`Femoral Artery Closure (VCD [3])
`Finger Implant (PCP)
`Fracture Healing (SAFHS)
`Hip Implant (C/C)
`Imaging (US, CT, MRI, MGA, OA, SPECT)
`Knee Implant (C/C)
`Knee OA IA (OrthoVisc, Synvisc, SUPARTZ,
`Gel-One, Monovisc, GenVisc850, Hymovis)
`Lumbar Disc (ProDISC [1,2])
`Metastatic Pain Relief (Quadramet)
`Neurological Impulses (Neurometrix)
`Ophthalmology (glaucoma, macular disease)
`Osteoporosis Detection (SAHARA)
`Periodontal Regeneration (GEM 21S)
`Rib Spacer (VEPTR)
`Sacral Implants
`Spinal Fusion Cage (BAK)
`Ulcers (Decubitis, Venous Stasis)
`Wound Healing (APPLIGRAF)
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`Research Expertise:
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`Clinical:
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`Biomarkers
`Transplantation
`Devices
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`Combination Products
`Drugs
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`Imaging
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`Biologics
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`Quality of Life
`505(b)2
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`Bioequivalence
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` Methodology:
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` Applications:
` Sequential analysis
` Multiple endpoints
` Longitudinal modeling
` Composite endpoints
` Multi-study modeling Exact inference
` Cost-benefit modeling
` Prediction
` Optimization models
` Survival analyses
` Instrument validation
` Time series
` Meta analyses
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` Markov processes
` Cost reimbursement
` Bayes modeling
` Adaptive modeling
` Adaptive design
` Bayes analyses
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` Survey sampling
` Registries
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` Epidemiology
` Predictive models
` Missing data
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` Classification
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`September 1, 2015
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`MS Word, PowerPoint, Excel, SAS, StatXact, nQuery, EaSt, ADDPLAN
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`RAPS Fellow
`ASA Fellow
`Earl Robinson Award, The American Society of Periodontology
`Who’s Who in the World
`Earl Robinson Award, The American Society of Periodontology
`The American Society of Reproductive Surgery
`Who’s Who in America
`Who’s Who in International Medicine
`Who’s Who in Cancer Research
`Who’s Who in Technology Today
`Who’s Who in American Men of Science
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`National Science Foundation (NSF) Fellowship
`Phi Beta Kappa
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`Philip T. Lavin PhD, FASA, FRAPS
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`Technical Experience:
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`Software:
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`Honors/Awards:
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`2009
`2008
`2007
`2007-
`2006
`2000
`1999 -
`1985 -
`1984 -
`1981 -
`1976 -
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`1968 - 1972
`1968
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`Public Service:
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`1987 – 1993 NASCO, Continuing Education
`1986 – 1997
`Statistical Editor, Antimicrobial Agents and Chemotherapy
`1986 – 1989
`Editorial Board, Drug Information Association (DIA)
`1983 -
`FDA Special Government Employee
`1981 – 1999 NIH Grants and Contracts Reviewer
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`Affiliations/Memberships:
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`2013-
`2012-
`1986-
`1984-
`1979-
`1976-
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`Publications
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`American Society of Nephrology
`World Molecular Imaging Society
`Regulatory Affairs Professional Society
`Drug Information Association
`Biometrics Society
`American Statistical Association
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`ORIGINAL ARTICLES
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`1. Douglass HO, Jr., Lavin PT. A Study of Nitrosourea Toxicity in Gastrointestinal Protocols of the Eastern
`Cooperative Oncology Group, Cancer Treatment Reports, 60:769-780, 1976.
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`2. Schein P, Lavin P, et al for the Gastrointestinal Tumor Study Group, Randomized Phase II Clinical Trial of
`Adriamycin, Methotrexate, and Actinomycin D, in Advanced Measurable Pancreas Carcinoma, Cancer,
`42:19-22, 1978.
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`Philip T. Lavin PhD, FASA, FRAPS
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`September 1, 2015
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`3. Falkson G, Moertel C, Lavin P, for the Eastern Cooperative Oncology Group, Chemotherapy Studies in
`Primary Liver Cancer, A Prospective Randomized Clinical Trial, Cancer, 42:2149-2156, 1978.
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`4. Douglass HO, Jr., Lavin PT, et al. for the Eastern Cooperative Oncology Group, Chemotherapy of Advanced
`Measurable Colorectal Cancer, Cancer, 42:2538-2545, 1978.
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`5. Carbone PP, Davis TE, Zelen M, Lavin P, Eastern Cooperative Oncology Group - Progress Report of
`Activities and Plans, Cancer Clinical Trials, 1:65-75, 1978.
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`6. Schapira D, Hall T, Bennett J, Lavin P, Schnider B, for the Eastern Cooperative Oncology Group, A Phase II
`Study in Estradiol Mustard, Cancer Clinical Trials, 1:5-8, 1978.
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`7. Chu, TM, Lavin P, Day J, Evans J, Mittelman, A, Holyoke, E, Vincent, R, Carcino-Embryonic Antigen:
`Prognosis and Monitoring of Cancer, Carcino-Embryonic Proteins, Vol. I, Elsevier/North Holland Biomedical
`Press, 1979.
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`8. Lokich J, Lavin P, Moertel C, et al, for the Gastrointestinal Tumor Study Group, A Multi-Institutional
`Comparative Trial of Radiation Therapy Alone and in Combination with 5-Fluorouracil for Locally
`Unresectable Pancreatic Carcinoma, Annals of Surgery, 189:205-208, 1979.
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`9. Moertel CG, Engstrom P, Lavin PT, Gelber R, Carbone P, for the Eastern Cooperative Oncology Group, An
`Evaluation of 5-FU, Lactones, and Nitrosoureas in Patients with Advanced Non-Measurable Gastric and
`Pancreas Cancer, Journal of Surgery, 85:509-513, 1979.
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`10. Douglass HO, Lavin PT, Evans J.T, Mittelman A, Carbone PP, Phase II Evaluation of
`Diglycoaldehyde, VP-16-213, and the combination of Methyl-CCNU and Beta-2'-
`Deoxythioguanosine in Previously Treated Patients with Colorectal Cancer: An Eastern Cooperative
`Oncology Group Study (EST-1275), Cancer, 63:1355-1357, 1979.
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`11. Lavin P, Holyoke D, Zamcheck N, for the Gastrointestinal Tumor Study Group, A CEA
`Standardization Experiment for the Conduct of Multi-institutional Trials, Cancer Treatment Reports,
`63:2031-2033, 1979
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`12. Moertel CG, Lavin PT, for the Eastern Cooperative Oncology Group, Phase II-III Chemotherapy
`Studies in Advanced Gastric Cancer, Cancer Treatment Reports, 63:1863-1869, 1979.
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`13. Lavin PT, and Moertel CG, for the Gastrointestinal Tumor Study Group, Phase II-III Chemotherapy
`Studies in Advanced Gastric Cancer, Cancer Treatment Reports, 63:1871-1876, 1979.
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`14. Lokich JJ, Childs DS, Kalser M.H, Lavin PT, Douglass HO, et al, for the Gastrointestinal Tumor
`Study Group: Comparative therapeutic trial of radiation with or without chemotherapy in pancreatic
`carcinoma, Int J Radiat Oncol Biol Phys 5:1643-1647, 1979.
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`15. Lavin PT, and Flowerdew G, Studies in Variation Associated with the Measurement of Solid Tumors,
`Cancer, 46:1286-1290, 1980.
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`16. Lavin PT, Mittelman A, Douglass H, Engstrom P, Klaassen D, Survival and Response to
`Chemotherapy of Colorectal Adenocarcinoma, Cancer, 46:1536-1543, 1980.
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`Philip T. Lavin PhD, FASA, FRAPS
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`September 1, 2015
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`17. DeWys W, Begg C, Lavin PT, et al, for the Eastern Cooperative Oncology Group, Prognostic Effect
`of Weight Loss Prior to Chemotherapy in Cancer Patients, American Journal of Medicine, 69:491-
`497, 1980.
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`18. Kinsella TJ, Bloomer W.D, Lavin PT, Knapp RC, Stage II Endometrial Carcinoma: 10 Year
`Followup of Combined Radiation and Surgical Treatment, Gynecologic Oncology, 10:290-297, 1980.
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`19. Falkson G, Moertel C, MacIntyre J, Lavin P, Engstrom P, Carbone P, The Value of Cytostatic Agents
`in the Treatment of Patients with Primary Liver Cancer, Diagnosis and Treatment of Upper
`Gastrointestinal Tumors, International Congress Series No. 542, 455-459, 1980.
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`20. Osband M, Lipton J, Lavin P, Levey R, Vawter G, Greenberger J, McCaffrey R, Parkman R,
`Histiocytosis-X: Demonstration of Autoimmunity, Suppressor Cell Deficiency and Successful
`Treatment with Thymic Extract, New England Journal of Medicine, 304:146-153, 1981.
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`21. Lavin P, Day J, Holyoke ED, Mittelman A, Chu TM, An Evaluation of Baseline and Followup CEA
`in Patients Undergoing Resection for Cure for Colorectal Carcinoma, Cancer, 47:823-826, 1981.
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`22. Osband M, Shen Y, Shlesinger M, Lavin P, et al, Successful Tumor Immunotherapy with Cimetidine
`in Mice, Lancet, 1:636-638, 1981.
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`23. Wagoner M, Albert D, Lavin P, Corneal Donor Material Selection, Ophthalmology, 83:139-144,
`1981.
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`24. Moertel C, Lavin PT, et al, for the Gastrointestinal Tumor Study Group, Therapy of Locally
`Unresectable Pancreatic Carcinoma: A Randomized Comparison of High Dose Radiation Along,
`Moderate Dose Radiation + 5-FU, and High Dose Radiation + 5-FU, Cancer, 48:1705-1710, 1981.
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`25. Lavin P, Alternative Measures of Anti-Tumor Activity in the Evaluation of Solid Tumors, Cancer
`Clinical Trials, 4:451-459, 1981.
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`26. Engstrom P, Lavin P, Douglass HO, Adjuvant Therapy of Gastric Carcinoma using 5-Fluorouracil
`and Semustine, European Journal of Cancer, 31-35, 1981.
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`27. O'Fallon J, Lavin P, O'Connell M, Moertel C, et al, for the Gastrointestinal Tumor Study Group, A
`Comparative Clinical Assessment of Combination Chemotherapy in the Phase II-III Evaluation of
`Combination Therapy with Management of Advanced Gastric Cancer, Cancer, 49:1362-1366, 1982.
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`28. Karp DD, Ervin TJ, Tuttle S, Gorgone B, Lavin PT, Yunis E.J, Pulmonary Complications During
`Granulocyte Transfusions: Incidence and Clinical Features, Vox Sanguinis, 42:57-61, 1982.
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`29. Harmon W, Lavin P, Parkman R, Ingelfinger J, Grupe W, Levey R, The Correlation of Early Acute
`Rejection Episodes with Long-Term Renal Transplant Outcome, Transplantation, 33:648-649, 1982.
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`30. Bruckner H, Lavin P, Plaxe S, Storch JA, Livstone E, for the Gastrointestinal Tumor Study Group,
`Absolute Granulocyte, Lymphocyte, and Monocyte Counts. Useful Determinants of Prognosis for
`Patients with Metastatic Cancer of the Stomach, JAMA, 247:1004-1006, 1982.
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`31. Moertel CG, Lavin PT, Hahn G, Phase II Evaluation of Adriamycin in Islet Cell Carcinoma, Cancer
`Treatment Reports, 66:1567-1569, 1982.
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`Philip T. Lavin PhD, FASA, FRAPS
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`September 1, 2015
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`32. Harmon W, Parkman R, Lavin P, Grupe W, Ingelfinger J, Yunis E, Levey R, Comparison of Cell
`Medicated Lympholysis and Mixed Lymphocyte Culture in the Immunological Evaluation for Renal
`Transplantation, Transplantation, 129, 4:1573-1577, 1982.
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`33. Lavin PT, Bruckner, H, Plaxe, S, Studies in Prognostic Factors Relating to Chemotherapy for
`Advanced Gastric Cancer, Cancer, 50:2016-2023, 1982.
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`34. Gonder JR, Shields JA, Albert DM, Augsburger JJ, Lavin PT, Uveal Malignant Melanoma
`Associated with Ocular and Oculodermal Melanocytosis, Ophthalmology, 89, 8:953-960, 1982.
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`35. Lavin PT, Structure Preserving Image Restoration, IEEE Pattern Analysis and Machine Intelligence,
`5:14-24, 1983.
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`36. Bruckner H, Lavin P, Plaxe S, Storch JA, Livstone E, for the Gastrointestinal Tumor Study Group,
`Routine Clinical Chemistries as Improved Determinants of Prognosis for Patients with Metastatic
`Cancer of the Stomach, Oncology, 40:31-35, 1983.
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`37. Johnson LA, Lavin P, Moertel CG, et al, Carcinoids: The Association of Histologic Growth Pattern
`and Survival, Cancer, 51:882-889, 1983.
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`38. Bast RC, Reinherz EL, Mayer C, Lavin P, Schlossman SF, Contrasting Effects of Cyclophosphamide
`and Prednisolone on the Phenotype of Human Peripheral Blood Leukocytes, Clinical Immunology
`and Immunopathology, 28:101-114, 1983.
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`39. Lavin PT, Practical Considerations in the Coordination of Clinical Trials, in Issues in the Conduct of
`Clinical Trials, T. Louis and S. Shapiro (Eds.), Marcel Dekker, New York City, 129-153, 1983.
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`40. Albert D, Searl S, Lavin P, Uveal Findings in Patients with Cutaneous Melanoma, American Journal
`of Ophthalmology, 95:474-479, 1983.
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`41. Engstrom, PF, Lavin PT, Klaassen, DJ, Phase II Evaluation of Mitomycin and Cisplatin in Advanced
`Esophageal Carcinoma, Cancer Treatment Reports, 67, 7-8:713-715, 1983.
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`42. Albert DM, Searl SS, Forget B, Lavin PT, Kirkwood J, Nordlund JJ, Uveal profile in patients with
`cutaneous melanoma, Am J Ophthalmol. 95(4):474-479, 1983.
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`43. Seddon, J, Albert, D, Lavin P, A Prognostic Factor Study of Disease-Free Interval and Survival
`Following Enucleation for Uveal Melanoma, Archives of Ophthalmology, 101:1894-1899, 1983.
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`44. Lavin P, Albert, D, Seddon, J, A Deficit Survival Analysis to Assess the Natural History of Uveal
`Melanoma, Journal of Chronic Diseases, 37, 6:481-487, 1984.
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`45. Engstrom PF, Lavin PT, Moertel CG, Folsch E, Douglass HO, Jr., Streptozotocin plus Fluorouracil
`vs. Doxorubicin Therapy for Metastatic Carcinoid Tumor, Journal of Clinical Oncology, 2, 12:1255-
`1259, 1984.
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`46. Douglass HO, Lavin PT, Goudsmit A, Klaassen DJ, Paul AR, An Eastern Cooperative Oncology
`Group Evaluation of Combinations of Methyl-CCNU, Mitomycin C, Adriamycin and 5-Fluorourail in
`Advanced Measurable Gastric Cancer, Journal of Clinical Oncology, 2, 12:1372-1381, 1984.
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`Philip T. Lavin PhD, FASA, FRAPS
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`September 1, 2015
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`47. Bast RC, Klug, TL Schaetzl E, Lavin PT, Niloff J, Greber, T Zurawski, V Knapp, R Monitoring
`Human Ovarian Carcinoma with a Combination of CA-125, CA19-9, and Carcinoembryonic
`Antigen, Obstetrics and Gynecology, 149, 5:553-9, 1984.
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`48. Williamson JW, Goodenough SH, Liberati A, Patterson WB, Lavin P, Zelen M, Setting Priorities for
`Cancer Control: An Approach, Progress in Clinical and Biological Research, 156:75-86, 1984.
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`49. Johnson LA, Lavin P, Moertel C, Wieland L Dayal, Y Doos, WG Geller, SA Cooper, HS Nime, F
`Masse, S Simson, IW Sumner, H Foelsch, E Engstrom, P Carcinoids: The Association of Histologic
`Growth Pattern and Survival, 1984 Year Book of Cancer, R.L. Clark, R.W. Cumley, R.C. Hickey,
`editors. Year Book Medical Publishers, Chicago, 229-230, 1985.
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`50. Engstrom PF, Lavin PT, Douglass HO, Brunner K.W, Postoperative Adjuvant 5-Fluorouracil plus
`Methyl-CCNU Therapy for Gastric Cancer Patients, Eastern Cooperative Oncology Group Study,
`Cancer, 55:1868-1873, 1985.
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`51. Stoll DB, Lavin PT, Engstrom PF, Hematologic Toxicity of Cisplatin and Mitomycin in Combination
`for Squamous Cell Carcinoma of Esophagus, American Journal of Clinical Oncology, 8:231-234,
`1985.
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`52. Lavin PT, Problems with Tumor Response Criteria, Biology and Treatment of Colorectal Cancer
`Metastasis, Mastromarino, A.(Ed.), Martinus Nijhoff, Boston, 211-224, 1985.
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`53. Novis BH, Gluck E Thomas P, Steele GD, Zurawski VR, Stewart R, Lavin PT, Zamcheck N, Serial
`Levels of CA 19-9 and CEA in Colonic Cancer, Journal of Clinical Oncology, 4, 6:987-993, 1986.
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`54. Johnson L, Lavin P, Moertel C, et al, Carcinoids: The Prognostic Effect of Primary Site Histologic
`Type Variations, Primary Site Histoprognostic Type Occurrence Rate Variations, Journal of Surgical
`Oncology, 33:81-83, 1986.
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`55. Niloff JM, Knapp RC, Lavin PT, Malkasian GD, Berek JS, Mortel R, Whitney C, The CA 125 Assay
`as a Predictor of Clinical Recurrence in Epithelial Ovarian Cancer, American Journal of Obstetrics
`and Gynecology, 155:56-60, 1986.
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`56. Berek J, Knapp RC, Malkasian G, Lavin PT, et al, CA 125 Serum Levels Correlate with Second Look
`Operations among Ovarian Cancer Patients, Obstetrics and Gynecology, 67:685-89, 1986.
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`57. Johnson LA, Lavin PT, Dayal YY, Geller SA, Doos WG, Cooper HS, Gerber JE, Masse ST, Weiland
`LH, Moertel CG, et al, Gallbladder Adenocarcinoma: Prognostic Significance of Tumor Acid
`Mucopolysaccharide Content, Journal of Surgical Oncology, 33, 4:243-243, 1986.
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`58. Lavin PT, A Consultant's View of the Draft Guidelines for the Statistical and Clinical Content of the
`New Drug Application, American Statistical Association Proceedings, Biopharmaceutical Section,
`136-138, 1986.
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`59. Johnson LA, Lavin PT, Dayal YY, Geller SA, Doos WG, Cooper HS, Gerber JE, Masse SR, Weiland
`LH, Moertel CG, Engstrom PF, Gallbladder Adenocarcinoma: The Prognostic Significance of
`Histologic Grade, Journal of Surgical Oncology, 34:16-18, 1987.
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`60. Lavin P, Knapp RC, Malkasian G, Whitney CW, Berek JC, Bast RC, CA 125 for the Monitoring of
`Ovarian Carcinoma During Primary Therapy, Obstetrics and Gynecology, 69:223-227, 1987.
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`61. Kendall K, Mundorf T, Nardin G, Zimmerman TJ, Hesse R, Lavin PT, Tolerability of Timolol and
`Betaxolol in Patients with Chronic Open Angle Glaucoma, Clinical Therapeutics, 9, 6:651-655, 1987.
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`62. Osband ME, Lavin PT, Rubin LS, Carpinito GA, Hamilton D, Krane RJ, The Correlation of Survival
`with Serum Levels of Interleukin-2 Receptor (IL2-R) and Immunosuppressive Acidic Protein (IAP) in
`Patients with Metastatic Renal Cell Carcinoma Treated with Autolymphocyte Therapy, 1987.
`
`63. Hochberg FH, Lavin PT, Portney R, Roberts D, Tinney C, Hottleman K, Wanger F, Topical Therapy
`of Localized Inflammation in Musicians: A Clinical Evaluation of Aspercreme versus Placebo,
`Medical Problems for Performing Artists, 3, 1:9-14, 1988.
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`64. Kanders BS, Lavin PT, Kowalchuk MB, Greenberg I, Blackburn GL, An Evaluation of the Effect of
`Aspartame on Weight Loss, Appetite, 11, Supplement, 73-84, 1998.
`
`65. Chandler B, Lavin PT, Efficacy and Tolerability of Enalapril and Its Effect on Serum Lipids in
`Patients with Mild Uncomplicated Essential Hypertension, Current Therapeutic Research, 43, 6:1143-
`1149, 1988.
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`66. Finkler NJ, Benacerraf B, Lavin PT, Wojciechowski C, Knapp RC, Comparison of CA-125, Clinical
`Impression, and Ultrasound in the Preoperative Evaluation of Ovarian Masses, Obstetrics and
`Gynecology, 72:659-664, 1988.
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`67. Malkasian GD Jr, Knapp RC, Lavin PT, Zurawski VR Jr, Podratz KC, Stanhope CR, Mortel R, Berek
`JS, Bast RC Jr, Ritts RE. Preoperative evaluation of serum CA 125 levels in premenopausal and
`postmenopausal patients with pelvic masses: discrimination of benign from malignant disease. Am J
`Obstet Gynecol. 159(2):341-6, 1988.
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`68. Weir MR, Krichten C, Urick A, Saunders E, Lavin PT. Comparison of enalapril and
`hydrochlorothiazide in mild hypertension and changes in plasma lipid concentrations during therapy”
`Clin Ther. 1988;10(6):712-24.
`
`69. Warner KG, Khuri SF, Marston W, Sharma S, Butler MD, Assousa SN, Saad AJ, Soiuffi,SY, Lavin
`PT, Significance of the Transdermal Diminution in Regional Hydrogen Ion Production After
`Repeated Coronary Artery Occlusions, Circulation Research, 64:616-628, 1989.
`
`70. Jenison EL, Montag AG, Griffiths CT, Welch WR, Lavin PT, Greer J, Knapp RC, Clear Cell
`Adenocarcinoma of the Ovary: A Clinical Analysis and Comparison with Serous Carcinoma,
`Gynecologic Oncology, 32:65-71, 1989.
`
`71. Blackburn GL, Morgan J, Lavin PT, Noble R, Funderburk F, Istfan N, The Determinants of the
`Pressor Effect of Phenylpropanolamine in Healthy Subjects, Journal of the American Medical
`Association, 261:3267-3272, 1989.
`
`72. Blackburn GL, Kanders B, Lavin PT, Norton D, Peterson F, The Improvement of Diabetes,
`Hypertension and Cardiovascular Conditions in Obese Subjects Following Very Low Calorie Diets,
`Clinical Nutrition, 1989.
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`73. Kanders BS, Blackburn GL, Lavin PT, Norton D, Weight Loss Outcome and Health Benefits
`Associated with the Optifast Program in the Treatment of Obesity. International Journal of Obesity,
`2, 13:131-134, 1989.
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`74. Wolf BC, Salem RR, Sears HF, Horst DA, Lavin PT, Herlyn M, Itzkowitz SH, Scholm J, Steele, GD,
`Jr, The Expression of Colorectal Carcinoma-Associated Antigens in the Normal Colonic Mucosa. An
`Immunohisto-Chemical Analysis of Regional Distribution, American Journal of Pathology, 135,
`1:111-119, 1989.
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`75. Blackburn GL, Wilson GT, Kanders BS, Stein LJ, Lavin PT, Adler J, Brownell, KD, Weight Cycling:
`The Experience of Human Dieters, American Journal of Clinical Nutrition, 49, 5:1105-1109, 1989.
`
`76. Montag AG, Jenison EL, Griffiths C.T, Welch WR, Lavin PT, Knapp RC, Ovarian Clear Cell
`Carcinoma. A Clinicopathologic Analysis of 44 Cases, International Journal of Gynecological
`Pathology, 8, 2:85-96, 1989.
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`77. Warner KG, Khuri SF, Marston W, Sharma S, Butler, MD, Assousa SN, Saad AJ, Siouffi SY, Lavin
`PT, Significance of the Transmural Dimunution in Regional Hydrogenion Production after Repeated
`Coronary Artery Occlusions, Circulation Research. 64:616-628, 1989.
`
`78. Wells CL, Jechorek RP, Erlandson SL, Lavin PT, Cerra FB, The Effect of Dietary Glutamine and
`Dietary RNA on Ileal Flora, Ileal Histology, and Bacterial Translocation in Mice, Nutrition, 6, 1:70-
`75, 1990.
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`79. Wells CL, Jechorek, RP, Lavin PT, Cerra FB, The Effect of a Uniquely Formulated Diet
`(Supplemented with Arginine, RNA, and Menhaden Oil) on Ileal Flora, Ileal Histology, and Bacterial
`Translocation in Mice, Nutrition, 6, 1:76-80, 1990.
`
`80. Osband ME, Lavin PT, Ross S, Krane RJ, A Pilot Study to Evaluate the Safety and Efficacy of
`Autologous Lymphocyte Therapy in the Treatment of Advanced Metastatic Renal Cell Cancer,
`Journal of Urology, 1990.
`
`81. Weir MR, Cassidy CA, Hall PS, Lancaster A, Schubert C, Urick A, Saunders E, Kong B.W, Jenkins
`P, Lavin PT, Efficacy and Tolerability of Enalapril and Sustained-Release Verapamil in Older
`Patients with Mild to Moderate Essential Hypertension, Clinical Therapeutics, 12, 2:139-148, 1990.
`
`82. Krane RJ, Carpinito GA, Ross SD, Lavin PT, Osband ME, Treatment of Metastatic Renal Cell
`Carcinoma with Autolymphocyte Therapy. Low Toxicity Outpatient Approach to Adoptive
`Immunotherapy without Use of in vivo Interleukin-2, Urology, 35, 5:417-422, 1990.
`
`83. Wexler HM, Lavin PT, Molitoris E, Finegold SM, Statistical Analysis of Trial, Reader, and
`Replicates on MIC Determination for Cefoxitin, Antimicrobial Agents and Chemotherapy, 34,
`11:2246-9, 1990.
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`84. Osband ME, Lavin PT, Babayan RK, Graham S, Lamm DL, Parker B, Sawczuk I, Ross, S, Krane RJ,
`Effect of Autolymphocyte Therapy on Patients with Advanced Metastatic Renal Cell Carcinoma (see
`comments), Lancet, 335, 8696:994-998, 1990.
`
`85. Hunter VJ, Weinberg JB, Haney AF, Soper JT, Lavin PT, Metsch L, Knapp RC, Bast RC, Jr., CA
`125 in Peritoneal Fluid and Serum from Patients with Benign Gynecologic Conditions and Ovarian
`Cancer, Gynecologic Oncology, 36:161-165, 1990.
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`86. Weir MR, Haynie R, Vertes V, Pinson R, Kong BW, Jenkins P. Efficacy and Tolerability of Enalapril
`and Sustained-Release Diltiazem in Mild to Moderate Essential Hypertension, Clinical Therapeutics,
`12, 6:473-481, 1990.
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`87. Weir MR, Lavin PT, Comparison of the Efficacy and Tolerability of Lisinopril and Sustained-Release
`Verapamil in Older Patients with Hypertension, Clinical Therapeutics, 13, 3:401-8, 1991.
`
`88. Bank S, Greenberg RE, Magier D, Lavin PT, The Efficacy and Tolerability of Famotidine and
`Ranitidine on the Healing of Active Duodenal Ulcer and During Six-Month Maintenance Treatment,
`with Special Reference to NSAID/Aspirin-Related Ulcers, Clinical Therapeutics. 13, 2:304-18, 1991.
`
`89. Weir MR, Kong BW, Jenkins, P, Lavin. PT, Comparison of the Efficacy and Tolerability of
`Lisinopril and Sustained-Release Verapamil in Black Patients with Hypertension, Clinical
`Therapeutics, 13, 3:409-16, 1991.
`
`90. Kwasnik EM, Siouffi SY, Lavin PT, Khuri SF, Hemodynamic and Metabolic Responses to Graded
`Microvascular Occlusion; Journal of Vascular Surgery, 13, 6: 867-74, 1991.
`
`91. Daly JM, Lieberman MD, Goldfine J, Shou J, Weintraub F, Rosato EF, Lavin PT, Enteral Nutrition
`with Supplemental Arginine, RNA, and Omega-3 Fatty Acids in Post-Operative Patients:
`Immunologic, Metabolic, and Clinical Outcome, Surgery, 1:56-67, 1992.
`
`92. Kwolek CJ, Miller A, Stonebridge PA, Lavin PT, Lewis KP, Tannenbaum GA, Gibbons GA,
`Pomposelli FB, Freeman DV, Campbell DR, LoGerfo FW, Safety of Saline Irrigation for
`Angioscopy: Results of a Prospective Randomized Trial, Annals of Vascular Surgery, 6:62-68, 1992.
`
`93. Schlain BR, Lavin PT, Hayden CL, Using an Autoregressive Model to Detect Departures from Steady
`States in Unequally Spaced Tumour Biomarker Data, Statistics in Medicine, 11:515-532, 1992.
`
`94. Lahey SJ, Borlase B, Lavin PT, Levitsky S. Preoperative Risk Factors that Predict Hospital Length of
`Stay in Coronary Artery Bypass Patients over 60 Years of Age, Circulation Nov, 86 (5 Suppl): II181-
`5, 1992.
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`95. McPherson R, Bedard J, Connelly P, Curnew G, Davignon J, Echenberg D, Lavin PT, Leiter L, Lenis
`J, McQueen M, Montigny M, Munoz C, O'Leary T, Ooi T, Rouleau J-L, Spence D, Tan M, Theroux
`P. Comparison of the Short-Term Efficacy and Tolerability of Lovastatin and Pravastatin in the
`Management of Primary Hypercholesterolemia, Clinical Therapeutics, 14, 2:276-290, 1992.
`
`96. Graham S, Babayan RK, Lamm DL, Sawchuk I, Ross SD, Lavin PT Osband ME, Krane RJ. The Use
`of Ex Vivo Activated Memory T-cells (Autolymphocyte Therapy), in the Treatment of Metastatic
`Renal Cell Carcinoma: Final Results from a Randomized, Controlled, Multi-Site Study, Seminars in
`Oncology, 1992.
`
`97. Muto MG, Finkler NJ, Kassis AI, Howes AE, Anderson LL, Lau CC, Zurawski VR, Weadock K,
`Tumeh SS, Lavin PT Knapp RC. Intraperitoneal Radioimmunotherapy of Refractory Ovarian
`Carcinoma Utilizing Iodide-131-Labeled Monoclonal Antibody OC 125, Gynecologic Oncology,
`45:265-272, 1992.
`
`98. Cady B, Stone MD, McDermott WV, Jenkins RL, Bothe A, Lavin PT, Lovett GJ, Steele GD.
`Technical and Biological Factors in Disease-Free Survival after Hepatic Resection for Colorectal
`Cancer Metastastes, Archives of Surgery, 127, 5:561-568, 1992.
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`September 1, 2015
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`99. Bower RH, Lavin PT, LiCari, JJ Jensen, GO VanBuren CT, Cerra FB, Rothkopf MP, Daly JO. A
`Modified Enteral Formula Reduces Hospital Length of Stay in Patients in Intensive Care Units,
`Clinical Nutrition, Special Supplement, Vol. 11, 1992.
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`100. Lavin PT, Maar R, Franklin M, Ross S, Martin J, Osband ME. Autologous Lymphocyte Therapy for
`Metastatic Renal Cell Carcinoma: Initial Clinical Results from 335 Patients Treated in a Multisite
`Clinical Practice, Transplantation Proceedings, 24, 6:3057-3062, 1992.
`
`101. Miller A, Marcaccio EJ, Tannenbaum GA, Kwolek CJ, Stonebridge PA, Lavin PT, Gibbons GW,
`Pomposelli, FB, Freeman, DV, Campbell, DR, LoGerfo, FW. Comparison of Angioscopy and
`Angiography for Monitoring Infrainguinal Bypass Vein Grafts: Results of a Prospective Randomized
`Trial, Annals of Vascular Surgery, 6:62-68, 1992.
`
`102. Miller A, Maracaccio EJ, Tannenbaum GA, Kwolek CJ, Stonebridge PA, Lavin PT, Gibbons GW,
`Pomposelli FB, Jr, Freeman DV, Campbell DR, et al, Comparison of