Glenn J Smits, PhD

Dr. Glenn J. Smits brings 40 years of experience in preclinical and nonclinical research, with a strong focus on medical device, combination products and drug development, and regulatory strategy. As Vice President of Global Preclinical Research Services at NAMSA, he leads NAMSA’s global preclinical program, supporting early feasibility testing, pilot studies, and Good Laboratory Practice (GLP)-compliant pivotal studies. His expertise includes many therapeutic areas, with extensive experience in large animal models critical to surgical/interventional implantable device and combination product evaluation.

Dr. Smits has partnered with Sponsors to design and execute complex preclinical programs across medical devices, combination products, biologics, and small molecules. He has held senior leadership roles at organizations including vivoPharm (Vyant Bio), MPI Research, Charles River Laboratories, Biogen, and others, where he advanced translational research, interventional and surgical models, and global development strategies. His work includes establishing clinically relevant in vitro and in vivo models, supporting early product development and driving cross-functional collaboration across Contract Research Organizations (CROs) and regulatory bodies including the U.S. Food and Drug Administration (FDA) and international agencies.

Dr. Smits earned his MS in Physiology from the Medical College of WI and his PhD in Pharmacology from Saint Louis University and has authored numerous peer-reviewed publications and patents. He is recognized for his leadership in translational science, global operational strategy, and delivering high-quality preclinical data to support regulatory approval pathways.

CORE COMPETENCIES

• Global Preclinical Strategy & Operations
• GLP-Compliant Safety Assessment (FDA, OECD)
• Medical Device & Combination Product Development
• Large Animal & Translational Disease Models
• Interventional Cardiology Models
• Regulatory Submissions
• CRO Oversight & Vendor Management
• Program & Portfolio Management
• Strategic Planning & P&L Leadership
• Cross-Functional Team Leadership

RECENT PROJECTS

• Mitral Valve Replacement Program (Large Animal Model): Designed and executed a GLP-compliant porcine model to evaluate catheter-based mitral valve technologies, generating safety and performance data to support regulatory submission.
• Global Preclinical Service Harmonization Initiative: Led cross-site alignment of preclinical capabilities and workflows to deliver a unified global service model and improve operational efficiency.
• IND-Enabling Safety Program (Combination Product): Advised and managed multi-study preclinical program including pharmacology, toxicology, and device evaluation to support first-in-human clinical entry.

PUBLICATIONS

2016

• Tofovic SP, Salah EM, Smits GJ, Whalley ET, Ticho B, Deykin A, Jackson EK. “Dual A1/A2B Receptor Blockade Improves Cardiac and Renal Outcomes in a Rat Model of Heart Failure with Preserved Ejection Fractions” J Pharmacol Exp Ther. 2016 Feb; 356(2): 333-340

2006

• Vu CB, Kiesman WF, Conlon PR, Lin KC, Tam M, Petter RC, Smits G, Lutterodt F, Jin X, Chen L, Zhang J. “Tricyclic imidazoline derivatives as potent and selective adenosine A1 receptor antagonists.” J Med Chem. 2006 Nov 30;49(24):7132-9.
• Kiesman WF, Zhao J, Conlon PR, Dowling JE, Petter RC, Lutterodt F, Jin X, Smits G, Fure M, Jayaraj A, Kim J, Sullivan G, Linden J. “Potent and orally bioavailable 8-bicyclo[2.2.2]octylxanthines as adenosine A1 receptor antagonists.” J Med Chem. 2006 Nov 30;49(24):7119-31.
• Kiesman WF, Zhao J, Conlon PR, Petter RC, Jin X, Smits G, Lutterodt F, Sullivan GW, Linden J. “Norbornyllactone-substituted xanthines as adenosine A(1) receptor antagonists.” Bioorg Med Chem 14(11): 3654-3661.

2005

• Vu CB, Pan D, Peng B, Kumaravel G, Smits G, Jin X, Phadke D, Engber T, Huang C, Reilly J, Tam S, Grant D, Hetu G, Petter RC. “Novel diamino derivatives of [1,2,4] triazolo [1,5-a][1,3,5] triazine as potent and selective adenosine A2a receptor antagonists.” J Med Chem 48(6): 2009-18.

2004

• Vu, CV, Peng B, Kumaravel G, Smits G, Jin X, Phadke D, Engber T, Huang C, Reilly J, Tam S, Grant D, Hetu G, Chen L, Zhang J, Petter RC. “Piperazine derivatives of [1,2,4] triazolo [1,5-a][1,3,5] triazine as potent and selective adenosine A2a receptor antagonists.” J Med Chem 47(17): 4291-9.
• Auchampach JA, Jin X, Moore J, Wan TC, Kreckler LM, Ge ZD, Narayanan J, Whalley R, Kiesman W, Ticho B, Smits G, Gross G. “Comparison of three different A1 adenosine receptor antagonist on infarct size and multiple cycle ischemic preconditioning in anesthetized dogs.” J Pharmacol Exp Ther. 308(3): 846-56.

2003

• Ticho B, Whalley E, Gill A, Lutterodt F, Jin X, Auchampach J, Smits G. “Renal Effects of BG9928, an A1 adenosine receptor antagonist, in rats and nonhuman primates.” Drug Development Research 58(4): 486-492.

2002

• Lucas DG Jr., Hendrick JW, Sample JA, Mukherjee R, Escobar GP, Smits GJ, Crawford FA Jr., Spinale FG. “Cardiorenal effects of adenosine subtype 1 (A1) receptor inhibition in an experimental model of heart failure.” J Am Coll Surg 194(5): 603-9.

2001

• Lucas D.G. Jr., Patterson T., Hendrick J.W., Holder J., Sample J.A., Joffs C., Davis J., Goldberg A., Mukherjee R., Smits G.J., Spinale F.G. “Effects of adenosine receptor subtype A1 on ventricular and renal function.” J Cardiovasc. Pharm 38(4): 618-624.
• Jackson EK, Kost CK Jr., Herzer WA, Smits GJ, Tofovic SP. “A(1) receptor blockade induces natriuresis with a favorable renal hemodynamic profile in SHHF/Mcc-fa(cp) rats chronically treated with salt and furosemide.” J Pharmacol Exp Ther. 299(3):978-87.

1999

• Mc Vey MJ, GJ Smits, BF Cox, JM Kitzen, KL Clark, MH Perrone. “Cardiovascular Pharmacology of the Adenosine A1/A2-Receptor Agonist AMP 579: Coronary Hemodynamic and Cardiovascular Effects in the Canine Myocardium” J Cardiovasc. Pharm 33(5): 703-710.
• Smits GJ, MJ Mc Vey, BF Cox, MH Perrone, and KL Clark. “Cardioprotective Effects of the Novel Adenosine A1/A2 Receptor Agonist AMP 579 in a Porcine Model of Myocardial Infarction” J. Pharmacol. Exper. Ther 286: 611-618.

1998

• Merkel, L, ED Hawkins, D Colussi, CJ Rojay, L Hamel, MF Jarvis, C Fink, R Studt, A Spada, BF Cox, GJ Smits, MH Perrone, and KL Clark. “Pharmacological Characterization of AMP 579, A Novel Adenosine A1/A2 Receptor Agonist and Cardioprotective” Drug Devel Research 45: 30-43.

1997

• Smits, GJ, MH Perrone, BF Cox. “Regional Hemodynamic Dose-Response of Lemakalim and Glybenclamide in Anesthetized Rats” J. Cardiovasc. Pharm. 29(1): 49-56.

1996

• Cox, BF and GJ Smits. “Regional Hemodynamic Effects of Purinergic P2 Receptor Subtype Agonists in Rats” J. Pharmacol. Exper. Ther 277(3): 1492-1500.

1995

• Merkel, LA, ED Hawkins, DJ Colussi, BD Greenland, GJ Smits, MH Perrone, BF Cox. “Cardiovascular and Antilipolytic Effects of the Adenosine Agonist GR79236” Pharmacology 51: p224-236.

1993

• Smits, GJ, JM Kitzen, MH Perrone, BF Cox. “Angiotensin Subtype-1 Blockade Selectively Potentiates Adenosine Subtype-2 Vasodilation” Hypertension 22: p221-230.
• Merkel, LA, LM Rivera, DJ Colussi, MH Perrone, GJ Smits, BF Cox. “In Vitro and In Vivo Characterization of an A1-Selective Adenosine Agonist, RG14202” J Pharmacol Exper Ther 265(2), p699-706.
• Huang, HC, DB Reitz, TS Chamberlain, GM Olins, VM Corpus, EG McMahon, MA Palomo, JP Koepke, GJ Smits, DE McGraw et al. “Synthesis and Structure-Activity Relationships of Nonpeptide, Potent Triazolone-Based Angiotensin II Receptor Antagonists” J. Med. Chem. 36(15): 2172-2178.
• Bovy, PR, DB Reitz, JT Collins, TS Chamberlain, GM Olins, VM Corpus, EG McMahon, MA Palomo, JP Koepke, GJ Smits et al. “Nonpeptide Angiotensin II Antagonists: N-Phenyl-1H-Pyrrole Derivatives are Angiotensin II Receptor Antagonists.” J. Med. Chem. 36(1): 101-110.
• Olins, GM, VM Corpus, ST Chen, EG McMahon, MA Palomo, DE McGraw, GJ Smits, et al. “Pharmacology of SC-52458, an Orally Active, Nonpeptide Angiotensin AT1 Receptor Antagonist” J. Cardiovasc. Pharm. 22: p617-625.
• Olins, GM, GJ Smits, JP Koepke, HC Huang, DB Reitz, RE Manning, EH Blaine. “In Vivo Pharmacology of SC-51316, a Nonpeptidic Angiotensin II Receptor Antagonist” Am. J. Hypertens. 6: p619-625.

1991

• Smits, GJ, JP Koepke, EH Blaine. “Reversal of Low Dose Angiotensin Hypertension by Angiotensin Receptor Antagonists” Hypertension 18(1), p17-21.
• Trapani, AJ, GJ Smits, DE McGraw, EG McMahon, EH Blaine. “Hemodynamic Basis for the Depressor Activity of Zaprinast, a Selective Cyclic GMP Phosphodiesterase Inhibitor” J Pharmacol Exper Ther 258(1), p269-274.

1990

• Smits, GJ, DE McGraw, AJ Trapani. “Interaction of ANP and Bradykinin During Endopeptidase 24.11 Inhibition: Renal Effects” Am J Physiol 258 (5 Pt 2), pF1417-24.
• Smits, GJ, DE McGraw, AJ Trapani, EH Blaine. “Effect of Endopeptidase 24.11 Inhibition in Conscious Cardiomyopathic Hamsters” J Pharmacol Exp Ther 254 (1), p176-179.
• Bovy, PR, JM O’Neal, GM Olins, DR Patton, EG McMahon, M Palomo, JP Koepke, KS Salles, AJ Trapani, GJ Smits, et al. “Structure-Activity Relationships for the Carboxy-Terminus Truncated Analogues of Angiotensin II, a New Class of Angiotensin II Antagonists” J Med Chem 33(5), p1477-1482.
• Bovy, PR, JM O’Neal, E McMahon, M Palomo, GJ Smits, AJ Trapani, D McGraw. “Synthesis and Biological Activity of N-Terminus Modified Ile-8 Angiotensin II Analogues” Eur J Med Chem 25(7), p589-94.

1989

• Trapani, AJ, GJ Smits, DE McGraw, KL Spear, JP Koepke, GM Olins, EH Blaine. “Thiorphan, an Inhibitor of Endopeptidase 24.11, Potentiates the Natriuretic Activity of Atrial Natriuretic Peptide” J Cardiovasc. Pharmacol 14(3), p419-424.

1986

• Smits, GJ, RJ Roman, JH Lombard. “Evaluation of Laser-Doppler Flowmetry as a Measure of Tissue Blood Flow” J Appl Physiol 61(2), p666-72.
• Sheldahl LM, FE Tristani, PS Clifford, JH Kalbfleisch, G Smits, CV Hughes. “Effect of Head-Out Water Immersion on Response to Exercise Training” J Appl Physiol 60(6), g1878-81.