Laura S. Kaufman, Ph.D., D.A.B.T. 258 DeRose Court 862-266-4027 lk12a1daa@westpost.

net SUMMARY OF EXPERIENCE GLP Toxicology Programs (IND/NDA/BLA Support) * Humanized monoclonal antibody: anthrax anti-toxin * Monoclonal antibodies: enzyme replacement therapy * Synthetic peptide: antidepressant * VEGF inhibitor * Atypical benzodiazepine: antidepressant (2 enantiomers) * Photodynamic therapeutic: tumor debulking agent * Photodynamic therapeutic: topical psoriatic agent * Photodynamic therapeutic: vulnerable plaque * Photodynamic therapeutic: macular degeneration * Radiolabeled diagnostic imaging agent (dopamine transporter) * Endothelin antagonist (N = 2) * Combination endothelin and angiotensin receptor antagonist * Monoclonal antibody: oncology * NMDA antagonists: stroke (N = 3) * Antibiotics: quinolones, cephalosporins, tetracyclines * Extended duration local anesthetic (topical) * Angiotensin II antagonist * Antidiabetic (buccal administration) * Osmotic laxative (OTC switch) * Antiobesity Cardiovascular Safety Pharmacology (IND/NDA Support) * Heparin antagonist * Dopaminergic partial antagonist (associated with QT prolongation in animals) * Photodymanic therapeutic: vulnerable plaque * NMDA antagonist * Cytokine inducer * Antibiotics (N=2) * Potassium channel opener * Antihypertensive (pharmacologically active metabolite) * 5HT1a silent antagonist Discovery Toxicology with or without accompanying exploratory cardiovascular stu dies * recombinant bovine adenosine deaminase * heparin antagonists * HDL Elevators (N = 3) * Muscarinic antagonist (m1): Alzheimer's Disease * Tissue selective estrogen: oncology * Tissue selective estrogen: hormone replacement therapy * Potent estrogen: contraception * Carbapenem (oral): broad spectrum antibiotic * Glycylcyclines: IV, drug resistant infections; N = 14 * 5-HT1a silent antagonist: Alzheimer's, schizophrenia * EGFR (Epidermal growth factor receptor) inhibitor: oncology * rhuFlt3L: stem cell mobilizer for oncology * rhuIL-15: oncology * rhuCD40L: oncology * Antiviral: anti-herpes simplex virus * Antiviral: anti-respiratory sincitial virus (N=5) * Potassium channel opener: urinary incontinence (N=3) * Immunosuppressant

* * * *

Sodium channel blocker/NMDA antagonist: antiepileptic NMDA antagonist: stroke DA partial antagonist: schizophrenia Anticoagulant (N = 3)

ACCOMPLISHMENTS * Played a pivotal role in strategic design and conduct of nonclinical safety st udies in most therapeutic areas, including large and small molecules, for over a dozen successful IND, NDA, and BLA submissions * Subspecialities include the nervous system, cardiovascular safety pharmacology , infectious diseases * Designed and executed "high throughput" in vivo studies to screen an entire cl ass of novel anti-infectives and designed pivotal IND-enabling studies resulting in a successful IND and ultimately a marketed product * Set up first telemetry laboratory for cardiovascular safety pharmacology (Wyet h) * Involved in strategic design, execution, and submission of neurotoxicology stu dies facilitating lift of clinical hold for an early NMDA antagonist * Have interacted with FDA on several key nonclinical safety issues and programs EMPLOYMENT HISTORY Elusys Therapeutics, Inc, Pinebrook, NJ. 2010 - 2011. Director, Nonclinical Stud ies. Responsibilities include: strategic guidance to company for nonclinical saf ety and efficacy studies performed under "Animal Rule"; design and CRO monitorin g of nonclinical safety and pharmacology studies; data analysis; PK and PK/PD an alysis for selection and justification of human dose; FDA interactions; preparat ion of regulatory documents; participation in project teams. Consultant, Glen Ridge NJ (Safetytox); Bridgewater NJ (CANTOX USA); Chatham, NJ (Hurley Consulting) 1999 - 2002; 2004 - 2010. Advised large and small pharma cli ents on nonclinical drug development strategies including program and study des ign in the areas of nonclinical safety and cardiovascular safety pharmacology, l arge and small molecules; IND/NDA/BLA preparation; CRO selection and monitoring; representation at FDA. Vela Pharmaceuticals, Inc, Lawrenceville, NJ 2003 - 2004: Director, Toxicology. Responsibilities included: nonclinical toxicology/ bioanalytical/ ADME/ safety p harmacology support at CROs for company assets and due diligence evaluation of p otential in-licensing/partnership programs; CRO negotiation/contracts/monitoring ; FDA interactions; project team representation; regulatory document review and preparation. Innapharma, Park Ridge, NJ 2002 - 2003, Director, Nonclinical Safety. Advised co mpany on strategic use of nonclinical toxicology in an environment that outsourc ed all study work. Responsibilities included FDA interaction, management of seri ous and unexpected nonclinical toxicity, selection and management of CROs, inclu ding contract/cost negotiation. Reason for leaving: serious and unexpected noncl inical toxicology safety issues resulted in FDA-imposed clinical hold; company f iled for Chapter 11. Purdue Pharma L.P., Ardsley, NY, 1998. Senior Manager, Drug Safety Evaluation. R esponsible for design and implementation of GLP toxicology programs for biotechn

ology products and novel formulations of extended-release anesthetics; responsib ilities included oversight of CRO-conducted immunohistochemical cross reactivity studies with monoclonal antibodies; due diligence review of in-licensing candid ates; project team representation; report review and submission preparation. American Home Products/ American Cyanamid Company, Pearl River, NY; 1992 - 1997 1995 - 1997 Associate Director, Exploratory Toxicology, Wyeth-Ayerst Research, A merican Home Products, Pearl River, NY. Responsible for toxicology support for all Wyeth-Ayerst Research discovery candi dates (in-house, affiliates, and in-licensing) and cardiovascular safety pharmac ology. Established a cardiovascular safety pharmacology group that designed, con ducted, interpreted, and reported single- and multiple-dose investigative and re gulatory cardiovascular telemetry studies in rats, dogs, and cynomolgus monkeys at IND, NDA, and early Discovery stages. Introduced telemetry technology, respon sible for SOP development and implementation. Three direct reports. Served on Pr oject Teams, as a Departmental Internal Expert for review of IND and NDA regulat ory submissions, and on internal Animal Care and Use Committee. Received three W yeth-Ayerst Research Teamwork awards. Yearly budget of approximately $750,000. 1992 - 1995 Principal Research Toxicologist, American Cyanamid Company, Toxicolo gy Evaluation, Pearl River, NY. Study Director for GLP studies in mice, rats, d ogs, and cynomolgus monkeys in support of IND, CTX, and NDA submissions; reviewe d regulatory submissions. Study Director for No.1 priority program, enabling it to progress into Phase I. Hoffmann-La Roche, Inc, Nutley, NJ, 1987 - 1992 1989 - 1992 Senior Scientist. Study Director for GLP and Investigative Toxicolog y studies, including FDA-requested special neurotoxicology safety studies for NM DA antagonists and IND studies in-house and in CROs. Project team representative . 1987 - 1989 Senior Medical Writer, Clinical Research and Development. Prepared C linical Investigator Brochures, minutes of Clinical Investigator's meetings, and final study reports in the following areas: antiviral, inflammatory bowel disea se, oncology, and cardiovascular; review of antimetabolite-induced peripheral ne uropathy for comparison with dideoxycytidine. Introduced use of desktop publishi ng for Clinical Investigator Brochures. CERTIFICATION 1994 Diplomate, American Board of Toxicology (recertified 1999 and 2004)

COMMITTEES 1996 - 2000 Steering Committee, General Pharmacology/ Safety Pharmacology Study Group 1991 - 1992 PMA Drusafe Neurotoxicology Committee

MEMBERSHIP 1982 - 1998 Society for Neuroscience 1989 - present Society of Toxicology 1996 - 2001 General Pharmacology/Safety Pharmacology Study Group 2001 - 2004 Safety Pharmacology Society

INVITED PRESENTATIONS/ CHAIRS 1. The Nonclinical Safety Evaluation of Anti-Toxins. Part of Symposium: Biodefen se Medical Countermeasure Development: A New Science of Toxicology and Safety As sessment; American College of Toxicology, November 6, 2010, Baltimore, MD. 2. Methods for Evaluating the Potential Neuropathology Associated with Anti-Toxi ns for Treatment of Anthrax. Added Benefit Meeting, sponsored by BARDA (Biomedic al Advanced Research and Development Agency, July 21, 2010, Washington DC. 3. Symposium Chair, Outsourcing Practices in Nonclinical Safety; 8th Internation al Outsourcing of Pharmaceutical Chemistry and Drug Discovery, Sponsored by Stra tegic Research Institute, to be held July 14 - 15, 2004, Philadelphia, PA. 4. Panel Participant, Outsourcing Practices in Early Drug Discovery and Early De velopment Research, 7th International Outsourcing of Pharmaceutical Chemistry an d Drug Discovery, Sponsored by Strategic Research Institute, September 29 - 30, 2003, Cherry Hill, New Jersey. 5. Co-Chair, Poster Session: Cardiovascular System, 37th Annual Meeting, Society of Toxicology, March 1 - 5, 1998, Seattle, Washington. 6. Preclinical Toxicology in the Pharmaceutical Industry. October 19, 1994. Pres ented at Mercy College, Dobbs Ferry, NY. 7. The Effect of Acute Administration of PCPA on Selected Parameters of Sleep an d Waking in Albino rats. Twenty-Seventh Oholo Conference, Zichron Ya'acov, Israe l, March 28 - 31, 1982. EDUCATION 1982 - 1986 Postdoctoral Fellow in Neuroendocrinology, The Rockefeller Universit y, NY, NY. Studied estrogenic modulation of muscarinic receptors in rat hypothal amus and female mating behavior using receptor autoradiography, intracranial app lication of drugs and hormones, and behavioral assessments. 1977 - 1982 University of Pennsylvania, Philadelphia, PA. Ph.D. in Anatomy (Neur oscience). Thesis title: Ponto-Geniculo-Occipital Spikes in Rats: An Electrophys iological Indicator of State-Dependent Sensory Responsiveness. Studied electroph ysiologic, pharmacologic, and behavioral aspects of sleep and auditory sensory r esponsiveness in rats. 1973 - 1977 Oberlin College, Oberlin, OH, A.B. with Honors in Psychobiology. The sis: Ponto-Geniculo-Occipital (PGO) Spikes in Rats. AWARDS 1998 Wyeth-Ayerst Research Teamwork Awards (2): CYA-246 Discovery/Drug Safety & Metabolism Troubleshooting Team; Glycylcycline Discovery Team 1997 Wyeth-Ayerst Teamwork Award: Acute Neurodegeneration Discovery Team 1983 - 1986 Individual NIMH Postdoctoral National Research Service Award

1982 - 1983 NIH Institutional Postdoctoral Fellowship, The Rockefeller Universit y, NY, NY. 1982 - 1983 Postdoctoral Fellowship from the Weizmann Institute of Science, Isra el. Declined. 1982 - 1983 Postdoctoral Fellowship from the Salk Institute. Declined. 1981 - 1982 Adelia Johnston Alumni Fellowship from Oberlin College, Oberlin, Ohi o. 1981 - 1982 Individual NIMH Predoctoral National Research Service Award. TEACHING 1981 - 1982 Veterinary Neuroanatomy, School of Veterinary Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (Laboratory Assistant) 1978 Mammalian Physiology, Department of Biology, University of Pennsylvania, Ph iladelphia, Pennsylvania (Lecturer) PUBLICATIONS 1. Kaufman, LS and Detweiler, DW: A Method for Recording Electrocardiograms in C onscious Unrestrained Cynomolgus Monkeys with Emphasis on Maximization of T Wave Amplitude. Toxicology Methods 9:285-292:1999. 2. Meschter, CL; Mico, B; Mortillo, M; Feldman, D; Garland, WA; Riley, JA, and K aufman, LS: A Thirteen-Week Toxicologic and Pathologic Evaluation of Prolonged C ytochromes P-450 Inhibition by 1-Aminobenzotriazole in Male Rats. Toxicology and Applied Pharmacology 22;369-381:1994. . 3. Kaufman, LS; McEwen, BS; and Pfaff, DW: Cholinergic Mechanisms of Lordotic Be havior in Rats. Physiology & Behavior 43;507-514:1988. 4 Kaufman, LS: PGO Waves in Rats in the Nonparadoxical Sleep States. Brain Resea rch 276;73-80:1983. 5. Kaufman, LS. Parachlorophenylalanine Does Not Affect Pontine-Geniculate-Occip ital Waves in Rats Despite Significant Effects on Other Sleep-Waking Parameters. Experimental Neurology 80;410-417:1983. 6. Kaufman, LS and Morrison, AR: Spontaneous and Elicited PGO Spikes in Rats. Br ain Research 241;61-72:1981. BOOK CHAPTERS 1. Kaufman, LS and Morrison, AR: Ponto-geniculo-occipital waves in rats reflect the state-dependent modulation of sensory input to the locus coeruleus. In: Beha vioral Models and the Analysis of Drug Action, MY Spiegelstein and A Levy (Eds), Elsevier, Holland, 1982: 459-465. 2. Kaufman, LS and Morrison AR: PGO spikes in rats: The effects of PCPA and a co mparison with the acoustic startle response in rats. In: Sleep 1982, W Koella (E d), Karger, Basel, 1982, 253-256.

PRESENTATIONS/ABSTRACTS 1. Kaufman, L; Reynolds, D; Yates, D; Hausner, B; Detweiler, D: A Method for Rec ording Electrocardiograms in Conscious Unrestrained Cynomolgus Monkeys with Emph asis on Optimization of the T Wave. Toxicological Sciences 42,1-S;1998:200. 2. Subramanyam, M; Kaufman, LS; Leal, M: Toxicokinetics of CL 331,928, an Antiba cterial, in Rats. Presented at the American Association of Pharmaceutical Scienc es, Orlando, Florida, 1993. 3. Arceo, RJ; Kaufman, L; Feldman, D; Ruben, A; and Anderson, T: A Time Sequence Study of Neuronal Vacuoles Induced by Dextrorphan Hydrochloride (DH) in the Rat : Light and Electron Microscopic Observations. Toxicol. Pathol. 13 (1):213; 1993 . 4. Ruben Z, Anderson TD, Arceo RJ, Kaufman LS: Scopolamine prevents neuronal cyt oplasmic vacuoles induced by dextrorphan in retrosplenial/ posterior cingulate c ortex of rat brain. The Toxicologist 13 (1):213;1993. 5. Meschter, CL; Kaufman, LS; Mortillo, M: Garland, WA, and Mico, BA: Thirteen-w eek Toxicologic Evaluation of the Effects of Sustained Cytochromes p450 Inhibiti on by 1-Aminobenzotriazole (ABT) in Male Rats. The Toxicologist 12;404:1992. 6. Kaufman, LS. Antimetabolites and Peripheral Neuropathy. Internal company repo rt presented at Hoffmann-La Roche Inc, 1989. 7. Kaufman, LS; Pfaff, DW; and McEwen, BS: Effects of Intracranial Application o f Various Cholinergic and Estrogenic Agents on Lordotic Behavior in Hooded Rats. Neurosci Absts 11:1985. 8. Kaufman, LS; Pfaff, DW; and McEwen, BS: Cholinergic Mechanisms of Lordosis in Rats in the Basomedial Hypothalamus as Revealed by Intracranial Application of Scopolamine. Neurosci Absts 10: 1984. 9. Kaufman, LS and Morrison, AR: A Comparison of Elicited Ponto-Geniculo-Occipit al (PGO) Spikes with the Acoustic Startle Response in the Albino Rat. Presented at the Sixth European Congress on Sleep Research, Zurich, Switzerland, March 2326, 1982. 10. Kaufman, LS and Morrison, AR: PGO Waves in Rats: Their Relationship to State -Dependent Processes of Sensory Responsiveness. Neurosci Absts 8:1982. 11. Kaufman, LS and Morrison, AR: PCPA Dramatically Alters Spontaneous Locomotor Activity and Sleep-Staging but not PGO Spikes in Albino Rats. Sleep Res 11: 198 2. 12. Kaufman, LS and Morrison, AR: Pontine PGO Spikes in Albino Rats are not an E xclusive Indicator of Paradoxical Sleep. Sleep Res 10:1981. 13. Kaufman, LS and Morrison, AR: PGO Spikes in Rats: A Component of the Alertin g Response. Neurosci Absts 4:1978.