Gordon W. Grant

510-***-**** ***** Kaywood Lane Escondido CA 92026 ad29li@r.postjobfree.com

Summary Scientific Experience

Over twenty-five years of strategic pre-clinical and clinical leadership in dynamic environments. Exceptional background in strategic planning, design, implementation and administration of studies specializing in interventional cardiology and peripheral vascular interventions. Leadership presence and experience with US and OUS regulatory agencies. Significant consulting experience.

Extensive experience and strategic leadership with US and OUS regulatory agencies

Expertise in pre-clinical and clinical study design and implementation, including pathology

In depth knowledge of GLP, GCP and GMP

Database design and management

Project management

Strong leader; team focus

Highly skilled in-vivo surgeon and pathologist

Well developed planning, analytical and communications skills

Experience in clinical research management

Experience

MedAlliance, LLC Newport Beach CA

MedAlliance is a medical device company focusing on changing standard of care in the interventional arena. Their focus is drug eluting balloon (DEB) angioplasty in peripheral artery disease and coronary disease. Their approach is to use DEB rather than stenting which is overused today.

Senior Clinical Field Specialist 2022 – 2023

A field specialist is responsible for site support in a FDA regulated clinical trial. This includes performing site initiation visits (SIV) for training PI’s/CI’s and research coordinators to the protocol. Onsite support during interventional procedures to help research staff and physicians obtain all the necessary data required for the trial. MedAlliance has four IDE trials ongoing and as the field specialist they have to be the resident expert on all the I/E criteria to assure protocol compliance.

Consultant (Self Employed) 2002 - 2022

Worked with several companies in Pre-Clinical and Clinical Device Development or R&D with animal models, regulatory strategies, in-vivo product testing (surgeries), pathologic services and reporting. Companies I consulted with include the following;

Transvascular, Inc.1

Biosensors Int1,2,3,4,5,6,7

Edwards Lifesciences6

Dio Corporation1,2,3,4,5

Ensure Medical1,3,4,5

Ablation Frontiers2

Embrella Inc. 5

Genesis Medical1,3,4,5

Gynesonics1

Reliant Technologies

Acuity Medical5

Ventrica1

BioAssist Inc. 3

Biotronik1,2,3,4,5,6,7

LyChron, Inc.3

Sahajanand Medical Technologies Limited1,2,3,4,5

BabCo (Covance) 3,6

Target Therapeutics6

1 Pathology, 2 Regulatory Strategies, 3 Surgeon, 4 Protocols/Reporting, 5 In-Vivo Modeling, 6 Database/Training, 7Clinical

Biosensors International, Newport Beach CA 2003 - 2015

The Biosensors International group of companies develops, manufactures and markets innovative medical devices for interventional cardiology and critical care procedures. In 2000 the company started focusing their R&D efforts on what the industry refers to as a second and third generation drug-eluting stent systems. This unique combination product contained an anti-restenotic drug (Biolimus A9™) with and without a biodegradable PLA polymer. In 2010 the company decided to close US operations and focus on OUS regulatory strategies.

Director Pre-Clinical Research

As Director of the pre-clinical research program for the company, managed a staff of Research Scientists and Research Associates in various disciplines including a GLP compliant (21 CFR 58) histology laboratory and in-vivo animal researchers. Research involved study designs, protocol development and implementation of in-vivo animal experiments. Acted as both study surgeon as well as principal investigator/study director. Required interaction with regulatory agencies such as FDA, Japan Ministry of Health, EU (notified body) and Canada Health. Following implementation of in-vivo studies, the data and tissues received from these studies were submitted to our in-house histology/morphometry laboratory; then following my pathological analysis I issued final reports and presented results to senior management and outside agencies. Data from these studies supported filings to multiple agencies and subsequently supported approval in the European Union (CE Mark), China, Japan, and India and BioFreedom in US.

Mid year 2015, Biosensors closed all U.S. operations and all personnel were laid off.

EMBOL-X, Inc., Mountain View, CA 1998 - 2002

Embol-X, Inc focuses on the development of proprietary medical devices to manage emboli and prevent stroke, neurological damage and other complications caused by embolic debris. The EMBOL-X intra-aortic filter was 510(k) cleared by the FDA following a panel meeting in October 2002.

Senior Manager, Pre-Clinical Research

Led small group of research assistants in testing the intra-aortic filter in-vivo by simulating a cardiothoracic surgical procedure in various species (bovine, porcine and ovine) to test thrombogenicty and feasibility of new medical devices. Animal studies included the use of catheter based (over the wire) technologies with fluoroscopic guidance and conventional open chest cardiac surgery and implementation of cardiopulmonary bypass.

Designed and implemented comprehensive pathological and clinical databases which were used in a European prospective registry, a US IDE trial, and a PME for the EMBOL-X products. This data played a critical role in publications, FDA submissions and FDA panel presentation. Because of the novel and complexity of the aortic filter I supported clinical with physician training, clinical database management, site monitoring and panel preparation committee. The produce was 510K cleared by the FDA following an unusual requirement of FDA Panel review. The program/product was subsequently sold to Edwards Lifesciences.

A second product known as the percutaneous arterial filter designed for use in carotid endarterectomy procedures underwent similar thrombogenicity testing in pre-clinical animal testing. I advanced the percutaneous filtration project from pre-clinical to clinical stage and trained surgeons and staff on usage, clinical protocols and CRF’s.

Performed pathologic evaluations on both clinical and research tissues associated with EMBOL-X product.

By 2002 both products were sold to Edwards Lifescience (intra-aortic filter) and Boston Scientific (percutaneous filter) and the company closed. I was retained to coordinate transfer of intellectual property and closure of all clinical sites.

LocalMed Inc., Palo Alto CA 1992 - 1998

LocalMed Inc, focused on prevention and treatment of restenosis complications inherent to angioplasty. LocalMed's InfusaSleeve(TM) catheters were used in conjunction with standard angioplasty balloons to deliver drugs into the coronary arteries during percutaneous transluminal coronary angioplasty (PTCA) procedures, effectively converting the PTCA balloon into a local drug delivery device. The Infusasleeve was 510(k) cleared by US FDA and functioned very well, however since a drug must be FDA approved by the route of administration the company eventually ran out of funding before they could get an effective drug approved.

Head of Biolab

Developed a quantitative in-vitro whole artery porcine model used to evaluate the drug delivery efficacy of a novel local delivery sleeve used in angioplasty procedures. Interpreted compiled data from research assistants and presented final data to engineering. Recommended catheter improvements.

Performed in-vivo angioplasty and local delivery studies in porcine peripheral and coronary arteries using various agents from collaborations with pharmaceutical companies. Trained clinicians and research scientists in the use of the LocalMed catheters.

Responsible for the overall management of a biological research laboratories. Wrote protocols for all biological experiments for in house in-vitro studies and off site in-vivo studies. Coordinated research collaborations with numerous university institutions and pharmaceutical companies.

In 1998 funding ran out for the company and they filed Chapter 11 and all personnel were laid off.

Division of Cardiovascular Medicine, Stanford University, Stanford CA 1986 – 1994 Cardiovascular Medicine along with Cardiovascular Surgery formed the Falk Cardiovascular Research Center. The two divisions shared their professors and trained the fellows and research staff to form a state of the art foundation headed by Drs. Norman Shumway and Victor Dzau. The Falk center had a complete animal research facility supporting both cardiac surgeries, interventional cardiology, vascular and molecular biology research.

Staff Research Associate

Supported research activities of several investigators. Pathology liaison for cardiac research. My areas of interest were as follows:

Pathology of balloon trauma in failed angioplasty patients

Pharmacological vasomotor responses to human and non-human coronary/carotid vessels in-vivo and in-vitro

Arterial platelet thrombus formation and the effects of arterial injury upon vasomotor behavior

Antithrombotic agents and their effects on the vessel wall

Radiolabeled In111 platelets

Transmission and scanning electron microscopy, 2D echo and fluoroscopy

In 1992 LocalMed was founded and I supported the startup facility part time however in 1994 I left academia to head up the research program at LocalMed full time .

Department of Pathology, Stanford University, Stanford, CA 1981 - 1984

The Department of Pathology was headed at the time by Dr. Claus Bensh and consisted of three branches, clinical, anatomic and the largest was surgical pathology. Surgical Pathology was co-headed by Drs. Richard Kempson and Ronald Dorfman where they successfully pulled together significant research scientists and support staff to provide cutting edge cancer and cellular research and diagnostic techniques such as immunohistochemistry and ultrastructural pathology.

Pathology Electron Microscopy Technician

Technician in a busy university clinical pathology electron microscopy laboratory. Proficient in tissue processing, embedding, thin and ultrathin plastic sectioning, photomicroscopy, frozen sectioning, immunofluorescent staining, ultrastructural interpretation of neoplasia and renal diseases.

Education

Bachelor of Science, California Polytechnic State University, 1981

Concentration: Anatomy and Physiology

Invited Lecturer

Trans Catheter Techniques (TCT) 2007

Risk factors associated with Drug Eluting Stents

American Heart 2005

Development of Medical devices in the USA. New Orleans, LA.

ACC 2005

PCI Device Development.

TCT 2004

Cardiopath.

TCT 2003

Cut to the future: Early experience with a new atherectomy device - The ReFORM debulking catheter system.

Terumo Executive meeting 2001

Development of Medical devices in the USA. Frankfurt Germany.

Gilead 2000

Atherogenesis

Gilead 1998

Local Delivery of Heparin inhibits neointimal proliferation

Publications

Manuscripts:

I. Shemish, G.W. Grant, J. Ross, B. Meyers. Nature of Glomerular Injury in Human Membranous Glomerulopathy. J Clin Invest Vol 77: 868-877, 1986.

A.V. Kaplan, G.W. Grant, L.L.K. Leung, W-H. Leung, I.R. McDougall, T.A. Fischell. "The roles of thrombin and platelet membraned glycoprotein IIb/IIIa in platelet-subendothelial deposition in an ex vivo angioplasty model." 1991 Circulation 84:1279-1288.

T.A. Fischell, G.W. Grant, M.A. Abbas, R.J. Siegel. "Ultrasonic Energy, Effects on Vascular Function and Integrity." Circulation 1991; 84:1783-1795.

W-H. Leung, A.V. Kaplan, G.W. Grant, L.L.K. Leung, T.A. Fischell. "Local Delivery of an antrithrombin agent by an infusion balloon catheter reduces platelet deposition at the site of balloon angioplasty." Coronary Artery Disease 1991;2:699-706.

A.V. Kaplan, T.A Fischell, W-H. Leung, G. Grant, S. Bunting, L.L.K Leung. Local Intramural Thrombin Inhibition with Argatroban is More Effective than Heparin in Reducing Platelet Thrombus Formation at trhe site of Angioplasty. (Submitted to Circulation)

T.A. Fischell, G.W. Grant, D.E. Johnson. "Determinants of Smooth Muscle Injury During Balloon Angioplasty." Circulation 1990; 82: 2170-2184.

T.A. Fischell. G.W. Grant, "Ex-Vivo Evaluation of the Mechanisms of Celiprolol Mediated Vasodilatation." Submitted to J of Cardiovascular Pharm.

A Moura, G.W. Grant, JYT Lam, D Hebert, J Kermode, D Robitaille, E Klein, P Yock, JB Simpson, AV Kaplan. Local Heparin Delivery Decreases the Thrombogenicity of the Balloon Injured Artery. Circulation 1995 92 Pages 2299-2305.

Wei-Xing Li, Aaron V. Kaplan, Gordon W. Grant, John J. Toole, and Lawrence L.K. Leung. A Novel Nucleotide-Based Thrombin Inhibitor Inhibits Clot-Bound Thrombin and Reduces Arterial Platelet Thrombus Formation. “Blood.” 1994 Vol 83, No. 3: Pages 667-682.

Michael K. Banbury, MDa*, Nicholas T. Kouchoukos, MDb, Keith B. Allen, MDc, Mark S. Slaughter, MDd, Neil J. Weissman, MDe, Gerald J. Berry, MDf, Keith A. Horvath, MDg, Gordon W. Grant, ICEM 2000 Investigators Emboli capture using the Embol-X intraaortic filter in cardiac surgery: a multicentered randomized trial of 1,289 patients.

Norio Tada, Renu Virmani, Gordon Grant, Lauren Bartlett, Alexander Black, Claudia Clavijo, Uwe Christians, Ron Betts, Doug Savage, Shih-Horng Su, John Shulze and Saibal Kar. Polymer-Free Biolimus A9-Coated Stent Demonstrates More Sustained Intimal Inhibition, Improved Healing, and Reduced Inflammation Compared With a Polymer-Coated Sirolimus-Eluting Cypher Stent in a Porcine Model Circ Cardiovasc Interv 2010;3;174-183.

Abstracts:

T.A. Fischell, A.V. Kaplan, W-H. Leung, G.W. Grant, L.L.K. Leung. Pharmacologic Inhibition of Subendothelial Platelet Deposition after Arterial Injury. J Cell. Biochem., Suppl. 15C:105, 1991.

T.C. Lee, F.J. Fleischhauer, G.W. Grant, M.L. Stadius, T.A. Fischell. Quantitative angiography is not an accurate method to Assess Coronary Luminal Cross-sectionalAreas After Balloon Angioplasty. Clin Res 37(1):96A, 1989

T.A. Fischell, G.W. Grant. Balloon Angioplasty Causes Vasoconstriction in Isolated Perfused Human Coronary Arteries. Circulation 80(4, Suppl. II):549, 1989

F.J. Fleischhauer, T.C. Lee, G.W. Grant, T.A. Fischell, Quantitative Angiography Overestimates Coronary Artery Luminal Area After Balloon Angioplasty. Circulation 80(4, Suppl. II):357, 1989

T.A. Fischell, M.A. Abbas, G.W. Grant, R.J. Siegel. Ultrasonic Energy Causes Dose-Dependant, Endothelium-Independant Smooth Muscle Relaxation. Circulation 82(4, Suppl. III):219, 1990.

W-H. Leung, A.V. Kaplan, G.W. Grant, L.L.K. Leung, T.A. Fischell. "Local Delivery of antrithrombin agent at the site of balloon angioplasty reduces platelet deposition." Circulation 1990 82-III:428.

A.V. Kaplan, L.L.K. Leung, W-H. Leung, G.W. Grant, I.R. McDougall, T.A. Fischell. "The effect of thrombin inhibition and antiplatelet membraned glycoprotein IIb/IIIa monoclonal antibody 7E3 on platelet deposition in a new ex vivo angioplasty model." J Amer Col Cardiology 1991;17:51A

A.V. Kaplan, T.A. Fischell, W-H. Leung, G.W. Grant, L.L.K. Leung. Argatroban reduces platelet deposition at the site of balloon angioplasty in an ex vivo whole artery model. J Amer Col Cardiology 1991;17:144A

A.V. Kaplan, T.A Fischell, W-H. Leung, G. Grant, S. Bunting, L.LK Leung. "Local Infusion of the Thrombin Inhibitor Argatroban Reduces Platelet Thrombus Formation at the Site of Angioplasty." Circulation 1991 84-II:727.

S. Bunting, A.V. Kaplan, L.L.K. Leung, T.A. Fischell, W-H. Leung, G.W. Grant, S. Bullens, J. Hasko, M. Lipari, C. Muir, R. Pitti, M.A. Napier. "The synthetic cyclic peptide G4120 reversibly inhibits GPIIb/IIIa and reduces platelet deposition at the site of balloon angioplasty." Arteriosclerosis and Thromb 1991;11:1587a.

MA Azrin, JF Mitchell, LM Bow, TV Alberghini, G.W. Grant A.V. Kaplan, DD Waters, RG McKay. "Local Delivery of Urokinase to Porcine Coronary Arteries using the LocalMed Infusasleeve." Journal of the American College of Cardiology 1995;Vol 25, 347 A.

A.V. Kaplan, J Kermode, G.W. Grant, E Klein, J Vetter, T Hinohara, JB Simpson. Intramural Delivery of Marker Agent in Ex-vivo and In-vivo Models Using a Novel Drug Delivery Sleeve. Journal of the American College of Cardiology 1995;Vol 23, 187 A.

G.W. Grant, A Moura, JYT Lam, D Hebert, G Letchacovski, D Robitaille, AV Kaplan. Local Heparin Delivery Decreases the Thrombogenicity of the Balloon Injured Artery. Circulation 1994 90-I:449.

J-F Tanguay, KR Kruse, AV Kaplan, BA Armstrong, GW Grant, R Virimani, HR Phillips, JP Zidar. Local Delivery of Heparin Prior to Intracoronary Stenting Reduces Platelet Deposition. Journal of the American College of Cardiology Vol 27 85 A.

G Grant, M Stadius, J Premereur, A Kaplan. Enoxaparin Delivered Locally Decreases Platelet Thrombus Formation at the Site of Balloon Angioplasty in a Porcine Model. Submitted Circulation 1996

Gordon Grant, Andrew J. Carter, DO, Kenneth Rosenfield, MD, Eberhard Grube, MD, and Peter Fitzgerald, MD PhD. A Novel Low Profile Over the Wire Intravascular Distal Protection Filter with Guidewire Mobility Circulation 90(4, Suppl. II):357, 2000.

Gordon Grant, Andrew Carter, DO, Kenneth Rosenfield, MD, Eberhard Grube, MD, and Peter Fitzgerald, MD PhD. A Novel Over the Wire Intravascular Filter with Full Wire Mobility Circulation 90(4, Suppl. II):118, 1844.

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