Mark J. Sarno, BA eJD Scientist, Biostatistician, Inventor, Licensed Patent Agent 19833 Fortuna Del Este Road Escondido, CA 92029 (760) 591-4945 [email protected] http://www.visionbiotechconsulting.com PROFESSIONAL EXPERIENCE
Vision Biotechnology Consulting and Vision Clinical Research President and Founder May 1996-Present Established a consulting practice that provides services in drug and medical device development and intellectual property. Clients range from biotechnology start-up to global diagnostic and pharmaceutical companies. Clinical areas of consultation include cardiovascular disease, diabetes, oncology, rheumatology, metabolic bone disease, infectious disease, gastroenterology, chronic pain management, reproductive hormones, fetal aneuploidies, newborn screening for inherited disorders, and cognitive impairment disorders. Also established a Clinical Research Organization (CRO) providing services in clinical study design and powering, protocol generation, case report form (CRF) and related study document generation including informed consent, institutional review board (IRB) submissions and communication, site training, study management and monitoring, good clinical practice (GCP) compliance, query generation and resolution, database generation and data entry, statistical analysis, quality assurance, and study report generation. Key accomplishments and activities include: • Direction and performance of product development, clinical trial, biostatistical
analysis, and regulatory sciences activities including authoring of regulatory submissions resulting in the approval of seven (7) new drug applications (NDAs), one (1) MAA approval, seventeen (17) approvals or clearances of in vitro diagnostic assays, and two (2) CE Mark certifications for medical devices
• Biostatistical analyses of key epidemiological studies including Atherosclerosis Risk
in Communities (ARIC), the Rancho Bernardo study, and the REasons for Geographic and Racial Differences in Stroke (REGARDS)
• Design and biostatistical analyses of large Phase III drug trials including the
REduction by DUtasteride of prostate Cancer Events (REDUCE)
• Design and biostatistical analyses of multiple pivotal medical device trials • Database development, data management, and biostatistical analysis of large
• Expiration dating analysis for drug substances and drug products in support of
• Pharmacokinetic analyses in support of regulatory submissions
• Direction of GMP manufacturing of investigational drugs • Direction and troubleshooting of process development and scale-up of in vitro
• Design and analysis of CLIA laboratory method validation studies • Extensive publication in high impact journals • Composition of continuing medical education programs • Counsel on patentability of devices, drugs, and methods
NovaDx Incorporated, Director, Product Development March 1995-May 1996 Established and implemented the overall product development process for a start up in vitro diagnostic manufacturer. This task included design and implementation of a project management process, generation of product designs and manufacturing documents, and implementation of Design Control Key accomplishments and activities included: • Managed the development of an immunoassay for YKL-40, a novel biochemical
marker found in high amounts in individuals with Rheumatoid Arthritis and Osteoarthritis
• Managed technical aspects of business development negotiations resulting in
licensing agreements with two corporate partners to manufacture manual and automated versions of the immunoassay for YKL-40
Hybritech Incorporated Research Scientist, Project Team Leader 1986-1995 Led assay and process development teams in the development of multiple immunoassay products. Key accomplishments and activities included: • Developed fourteen (14) in vitro diagnostic immunoassays from antibody selection
through scale-up, regulatory approval or clearance, and commercialization. Products successfully commercialized included: immunoenzymetric and/or immunoradiometric assays for IgE, Ferritin, Thyroid Stimulating Hormone, Prostatic Acid Phosphatase, Luteinizing Hormone, Follicle Stimulating Hormone, Group B Streptococcus, Prostate Specific Antigen, Creatine Kinase MB isoenzyme, and Colorectal Cancer Antigen CA-195.
• 2 years spent in a Manufacturing Technical Support capacity during which I was
responsible for the manufacture of 10 diagnostic products including Hybritech's highest volume products, the Prostate Specific Antigen (PSA) radioimmunometric and enzyme-immunometric assays.
Research Institute of Scripps Clinic Research Assistant 1983-1986
Basic research on folate and methotrexate transport in bacterial and mammalian cell lines ADVISORY BOARDS
Scientific Advisory Board member - Iris Molecular Diagnostics EDUCATION Executive Juris Doctorate (eJD) with Honors Conferred by Concord University December 2008 Focus on Patent Law, Health Law, Bioethics, Medical Products Liability, Contracts, and Civil Procedure Received award for outstanding legal writing Bachelor of Arts (BA) in Biochemistry and Cell Biology Conferred at the University of California at San Diego June 1983 MEMBERSHIPS Aircraft Owners and Pilots Association
National Association of Patent Practitioners United States Patent Bar USA Track and Field
1. Value of NADiA® ProsVue™ on the CAPRA-S nomogram for predicting
postprostatectomy clinical recurrence. Moul JW, Lilja H, Lance R, Vessella R, McDermed JE, Sarno MJ, Adams TH. J Clin Oncol 2013:31:S6.
2. NADIA® ProsVue™ PSA slope is an independent prognostic marker for identifying men
at reduced risk for clinical recurrence of prostate cancer after radical prostatectomy. Judd W. Moul, Hans Lilja, O. John Semmes, Raymond S. Lance, Robert L. Vessella, Martin Fleisher, Clarisse Mazzola, Mark J. Sarno, Barbara Stevens, Robert E. Klem, Jonathan E. McDermed, Melissa T. Triebell, and Thomas H. Adams. Urology 2012;80:1319-27.
3. Robustness of ProsVue™ linear slope for prediction of reduced risk for prostate cancer
recurrence: Simulation studies on effects of analytical imprecision and sampling time variation. Mark J. Sarno and Charles S. Davis. Clin Biochem 2012;45:1479-84.
4. Nucleic acid detection immunoassay for prostate-specific antigen based on immuno-PCR
methodology. Jonathan E. McDermed, Ron Sanders, Stephen Fait, Robert E. Klem, Mark J. Sarno, Thomas H. Adams, and Eleftherios P. Diamandis. Clin Chem 2012;58:732-40.
5. Prostate cancer gene 3 Score predicts prostate biopsy outcome in men receiving
dutasteride for prevention of prostate cancer; results from the REDUCE trial. Sheila Aubin, Jennifer Reid, Mark Sarno, Amy Blase, Jacqueline Aussie, Harry Rittenhouse, Roger Rittmaster, Gerald Andriole, Jack Groskopf. Urology 2011;78:380-5.
6. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at
risk: Validation in the placebo arm of the dutasteride REDUCE trial. Jack Groskopf, Sheila M.J. Aubin, Jennifer Reid, Mark J. Sarno, Amy Blase, Jacqueline Aussie, Harry Rittenhouse, Roger Rittmaster. J Urol 2010;184:1947-52.
7. The Confusing Calculus of the Benefit/Risk Ratio in Pharmaceutical Research – Ethical
Questions and Possibilities for Reform. Mark J. Sarno. Update to Food and Drug Law Journal 2010; Issue 1.
8. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is an independent predictor of
incident coronary heart disease in an apparently healthy elderly population: the Rancho Bernardo Study. Lori Daniels, Gail Laughlin, Mark J. Sarno, Ricki Bettencourt, Robert L. Wolfert, and Elizabeth Barrett-Connor. J Am Coll Cardiol 2008;51:913-9.
9. A multicenter evaluation of the PCA3 molecular urine test: preanalytical effects, analytical
performance, and diagnostic accuracy. Lori J. Sokoll, William Ellis, Paul Lange, Jennifer Noteboom, Debra J. Elliott, Ina L. Deras, Amy Blase, Seongjoon Koo, Mark Sarno, Harry Rittenhouse, Jack Groskopf, Robert L. Vessella. Clin Chim Acta 2008;389:1-6.
10. B7-H4 is over-expressed in early-stage ovarian cancer and is independent of CA125
expression. Iris Simon, Dionyssios Katsaros, Irene Rigault de la Longrais, Marco Massobrio, Andreas Scorilas, Nam W. Kim, Mark J. Sarno, Robert L. Wolfert, and Eleftherios P. Diamandis. Gynecol Oncol 2007;106:334-41.
11. B7-H4 is a novel membrane-bound protein and a candidate serum and tissue biomarker
for ovarian cancer. Iris Simon, Shaoqiu Zhuo, Laura Corral, Eleftherios P. Diamandis, Mark J. Sarno, Robert L. Wolfert, and Nam W. Kim. Cancer Res 2006;66:1570-5.
12. Evaluation of B7-H4 (DD-O110) as a prognostic marker in tissue and serum of ovarian
cancer patients. Iris Simon, Nam Kim, Eleftherios P. Diamandis, Mark J. Sarno, and Robert L. Wolfert. Presented at 2005 American Association for Cancer Research meeting.
13. Circulating 1,5-anhydroglucitol levels in adult patients with diabetes mellitus reflect
longitudinal changes of glycemia: a US trial of the GlycoMark™ assay. Janet B. McGill,
Thomas G. Cole, William Nowatzke, Shannon Houghton, Erika B. Ammirati, Theresa Gautille, and Mark J. Sarno. Diabetes Care 2004;27:8:1859-65.
14. Evaluation of an assay for 1,5-anhydroglucitol (Glycomark™) and determination of
reference intervals on the Hitachi 917 analyzer. William Nowatzke, Mark Sarno, Nathan Birch, Douglas Stickle, Tanya Eden, and Thomas G Cole. Clinica Chimica Acta 2004;350:201-9.
15. Cln101 and Ovr110 as novel serum markers for detection of ovarian cancer. N. W. Kim,
I. Simon, X. Duan, T. Kuo, L. Corral, A. Nguyen, R. A. Macina, M. J. Sarno, R. L. Wolfert, 2004 American Society of Clinical Oncology 40th Annual Meeting Proceedings;23:455.
16. Application of Novel and Traditional Serum Markers in Univariate and Multivariate
Analysis to Improve the Sensitivity and Specificity of Cancer Detection. Iris Simon, Rong A. Fan, Charis E. Lawrenson, Xiaozhu Duan, Theresa Kuo, Laura Corral, Shirley Vong, David Lowe, Danny Terwey, Laurence Fayadat, Roberto Macina , Mark J. Sarno, Robert L. Wolfert, and Nam W. Kim. 2004 EDRN Annual Workshop Abstract.
17. Intermediate-term changes in serum 1,5-anhydroglucitol (GlycoMark) predict long-term
changes in glycosylated hemoglobin (A1c) in patients with Type 1 and 2 diabetes mellitus. Sarno M, Cole T, Nowatzke W, McGill J. Presented at American Diabetes Association Annual Meeting, May 2004.
18. Application of Novel and Traditional Serum Biomarkers in Univariate and Multivariate
Analysis to Improve the Sensitivity and Specificity of Cancer Detection. Iris Simon, Rong A. Fan, Xiaozhu Duan, Charis E. Lawrenson, Theresa Kuo, Laura Corral, Shirley Vong, David Lowe, Danny Terwey, Laurence Fayadat, Roberto Macina , Mark J. Sarno, Robert L. Wolfert, and Nam W. Kim. 2004 ISOBM Annual Meeting Abstract.
19. Detection of novel membrane protein in serum: Ovr110, a potential serum marker for
early detection of ovarian cancer. Iris Simon, Nam W. Kim, Theresa Kuo, Laura Corral, Shirley Vong, David Lowe, Mark J. Sarno, Robert L. Wolfert. 2004 American Association of Cancer Research 95th Annual Meeting Proceedings;45:93.
20. Characterization of Lng105/napsin A in human serum: potential diagnostic utility in lung
cancer. Rong A. Fan, Nam W. Kim, Daniel Bedinger, Paul Miller, Laurence Fayadat, Roberto Macina, Mark Sarno, Robert L. Wolfert. 2004 American Association of Cancer Research 95th Annual Meeting Proceedings;45:93.
21. Detection of Pro108/Spondin-2 protein in serum: A novel serum marker for cancer. Iris
Simon, Charis A. Lawrenson, Nam W. Kim, Daniel Bedinger, Danny Terwey, Mark J. Sarno, Robert L. Wolfert. 2004 American Association of Cancer Research 95th Annual Meeting Proceedings;45:97.
22. Biological variability and specificity of lipoprotein-associated phospholipase A2 (Lp-
PLA2), a novel marker of cardiovascular risk. Robert L. Wolfert, Nam W. Kim, Reed G. Selby, Mark J. Sarno, G. Russell Warnick, Krishnankutty Sudhir. Presented at American Heart Association 2004.
23. Serum 1,5-Anhydroglucitol (GlycoMark™), a New Potential Marker of Glycemia: A
Longitudinal Study of Adult Patients with Diabetes Mellitus. Janet McGill, Thom Cole, William Nowatzke, Shannon Houghton, Theresa Gautille, and Mark Sarno. Presented at Diabetes Technology and Therapeutics Annual Meeting, November 2003.
24. Pharmacokinetics and glucodynamics of rapid, short, and intermediate acting insulins: a
randomized controlled trial comparing jet injection to needle syringe. Mark Sarno, Jo Bell, and Steve Edelman. Diabetes Technology and Therapeutics 2003;4:6:863-6.
25. Serum 1,5-anhydroglucitol (Glycomark™), a new marker of glycemia: cross-sectional
comparison to established markers of glycemia in healthy subjects and patients with diabetes mellitus. Janet McGill, Thomas Cole, William Nowatzke, and Mark Sarno. Presented at American Diabetes Association Annual Meeting, June 2003.
26. Technical Evaluation and Reference Interval Determination of 1,5-Anhydroglucitol using
the GlycoMark(TM) Assay. Nowatzke WL, Sarno M, Stickle DF, Eden TR, Birch NC and Cole TG. Clinical Chemistry 2003; 49 (Supplement):A46.
27. Toxicology and toxicokinetics of acute and subchronic administration of histamine
dihydrochloride in rats. Linda Karavodin, Rodney Jensen, Mark Sarno, and Kurt Gehlsen. Drug and Chemical Toxicology 2003;26:1:35-49.
28. Biological variability of lipoprotein-associated phospholipase A2 (Lp-PLA2), C-reactive
protein (CRP), and traditional lipid markers of cardiovascular risk. Nam W. Kim, Mark J. Sarno, G. Russell Warnick, and Robert L. Wolfert. 2003 American College of Cardiology Annual Proceedings.
29. Pharmacokinetics of histamine dihydrochloride: Implications for combined therapy with
interleukin-2. Mark Middleton, Mark Sarno, Sanjiv S. Agarwala, John Glaspy, Aziz Laurent, Kelly McMasters, Peter Naredi, Steven O’Day, Eric Whitman, Sarah Danson, Rebecca Cosford, and Kurt Gehlsen; Journal of Clinical Pharmacology 2002;42:7:774-81.
30. Histamine pharmacokinetics in tumor and host tissues after bolus-dose administration – a
study in rat. Magnus Rizell, Peter Naredi, Per Lindner, Kristoffer Hellstrand, Mark Sarno, Per-Anders Jansson. Life Sciences 2002; 70:969-76.
31. Excretion of sweat and urine pyridinoline crosslinks in healthy controls and subjects with
established metabolic bone disease; Mark Sarno, Laura Sarno, David Baylink, Barbara Drinkwater, Sally Farley, Michael Kleerekoper, Robert Lang, Joan Lappe, Angelo Licata, Michael McClung, Paul Miller, Susan Nattrass, Robert Recker, Elliot N. Schwartz, Fred Singer, Joseph R. Tucci, Richard Wasnich, Sandi Wolf, Helen Powell, Gayle Tjersland, and G. Russell Warnick. Clinical Chemistry and Laboratory Medicine 2001;39:3:223-8.
32. Clinical immunogenicity of measles, mumps, and rubella vaccine MMRII delivered by the
Injex jet injector: comparison with standard syringe injection; Mark Sarno, Erich Blase, Carl Schirmer, and Daniel Trujillo; Pediatric Infectious Disease Journal 2000; 19:9:839-42
33. A collection method and high-sensitivity enzyme immunoassay for sweat pyridinoline and
deoxypyridinoline crosslinks; Mark Sarno, Helen Powell, Gayle Tjersland, Donald Schoendorfer, Holden Harris, Kimberly Adams, Peggy Ogata, and G. Russell Warnick; Clinical Chemistry 1999; 45:9:1501-9.
34. Clinical utility of Osteopatch™ sweat pyridinoline; R. Nuti, R. Caudarella, E. Fiore, G.
Isaia, X. Ortolani, G. Tjersland, M. Sarno, R. Warnick; Bone 1998;23:S627.
35. Osteopatch™ sweat pyridinoline is elevated in women with established osteoporosis; L.
Sarno, D. Baylink, B. Drinkwater, S. Farley, M. Kleerekoper, J. Lappe, M. McClung, S. Nattrass, R. Recker, E. Schwartz, R. Wasnich, G. Tjersland, G. R. Warnick, M. Sarno; Bone 1998;23:S514.
36. Bone resorption markers quantified by sensitive immunoassays in non-occlusive multi-
day Osteopatch™ sweat collections; G. Russell Warnick, Byron Doneen, Gayle Tjersland, Helen Powell, Mark Sarno, Holden Harris, Peggy Ogata, and Kim Adams; Journal of Bone and Mineral Research 1997;12:Supplement 1:S499.
37. Development of a serum ELISA for YKL-40 (Chondrex™) and it’s application in
Osteoarthritis; Sarno M.J., Scott T.A., Whaley J., Swindlehurst C.A., Price P.A., Cohen, P.; Arthritis & Rheumatism 1995;38:S240.
38. Characterization of a new enzyme immunoassay for Free Deoxypyridinoline in Serum, R.
Nielsen, D. Broyles, S. Harvey, C. Shaffer, B. Bussett, M. Sarno, B. Kress. Journal of Bone and Mineral Research 1995;10:Supplement 1:S270.
39. Activation of a Rabbit Liver Progesterone 6-Beta-Hydroxylase by Substrate or Alpha
Napthoflavone, G. E. Schwab, M. Sarno, J. Singh, L. E. Vickery, E. F. Johnson. Presented at Federal Proceedings of the American Society of Biological Chemists, June 1986.
40. Genetic Evidence for Glucitol-Specific Enzyme III, an Essential Phosphocarrier Protein of
the Salmonella typhimurium Glucitol Phosphotransferase System. Mark J. Sarno, L. Gregory Tenn, Anjana Desai, A. Michael Chin, Frank C. Grenier, and Milton H. Saier, Jr.; The Journal of Bacteriology 1984:953-5.
OTC DISTRIBUTION DISTRIBUTION OTC Celesio’s acquisition of mail-order pharmacy DocMorris has put the spotlight firmly on the anticipated changes in the way medicines are distributed in Europe. Deborah Wilkes looks at the prospects for pharmacy chains. “With this step,Celesio gets hold of the is also bullish about the prospects for liberal-isation in other important cou
Bacteremia associated with naturally occurring acute coliform mastitis in dairy cows John R. Wenz, DVM, MS; George M. Barrington, DVM, PhD, DACVIM; Franklyn B. Garry, DVM, MS, DACVIM;Kevin D. McSweeney, BS; R. Page Dinsmore, DVM, DABVP; Gregory Goodell, DVM; become the predominant form of mastitis in herds inwhich contagious mastitis has been effectively con- Objective —To determine the