Clinical Research Vice President

BACKGROUND INFORMATION OF RICHARD A. GUARINO, M.D

Present Employment

Oxford Pharmaceutical Resources Inc. President- Legal, (Specializing in Class Action Lawsuits), Clinical and Regulatory Consulting in FDA’s New Drug Approval Process

Past Positions Held

Validus Pharmaceuticals, Parsippany, New Jersey Vice President of Medical Affairs in charge of Clinical Research, Regulatory Affairs and Phamacovigilence

Amneal Pharmaceuticals, Paterson, New Jersey Clinical and Regulatory Consultant

International Services Assistant Fund, Raleigh, North Carolina Clinical and Regulatory Consultant

Oxford Pharmaceutical Services Inc. -

Medical Director

Vicus Therapeutics, Morristown, New Jersey Clinical and Regulatory Consultant

Eduneering, Inc.

Director of Medical Education

Pomerantz LLP New York Consultant

Topical Remedy LLC Lake Oswego OR Consultant

Wolf Haldenstein Adler Freeman & Hertz, LLP Consultant

Schiffrin & Barroway, LLC · Consultant

Oxford Research International Corp. President - CEO

Oxford Bio-Imaging Inc.

Vice President - Medical Director

Revlon Health Care

Division of Revlon

Vice President - Medical Director

Sandoz, Inc. (Novartis)

Director of Clinical Research

St. Barnabas Medical Center Medical Staff

University of Siena Hospital, Siena, Italy

Specialties: Infectious Disease, Gerontology, and Psychiatry

PROFESSIONAL EXPERIENCE

Oxford Pharmaceutical Resources Inc.

Dr. Guarino offers professional consulting in clinical, regulatory, and medical communications to drug, biologic and medical device companies. His expertise in researching clinical data emanating from the research completed for new product development has helped many law firms resolve class action suites.

With over thirty years of experience and success in bringing new products to market, he provides strategic solutions to planning, implementation and management of products in the development and marketing areas for drugs, devices and biologics.

He creates and manages adverse experience reporting systems and reviews company's SOPs on ADE reporting processes so that they can be revised to meet ICH regulations. He develops clinical research protocols for phase 1, 2, 3, 3b, and 4 studies (see Areas of Expertise attached.) He compiles, submits and participates in registering lnvestigational New Drug Applications (IND) and New Drug Applications (NOA) for FDA approvals and submissions of Common Technical Documents (CTDs) globally.

Dr. Guarino reviews and compiles reports for pharmaceutical and venture capital companies and assesses non-clinical and clinical data of potential pharmaceutical products. Recommendations are based on ROI, market potential, market competition, and product life cycle.

He develops and offers nationally and internationally structured, private or group training programs in Good Clinical Practices (GCPs), INDs, NDAs and CTDs. . He also offers courses to IRB/IEC groups on their GCP obligations. He teaches pharmaceutical companies how to select and manage Contract Research Organizations (CROs). These courses all meet FDA and ICH rules, regulations and guidelines.

In addition he offers consulting in:

FDA/Industry meetings

Liaison with global pharmaceutical and advertising companies in

new product launches

Among his research experiences, he has also worked closely with the US Army and Navy in developing strategic plans for new product development. He developed a clinical program that tested 72 vaccines in 170 HIV and Aids related diseases worldwide.

Eduneering. Inc. (now Kaplan Eduneering)

Dr. Guarino was the Director of Medical Education. His responsibilities included the writing of technical modules for Internet learning in the areas of clinical research, regulatory affairs, and legal/ethical directives.

Wolf Haldenstein Adler Freeman & Hertz. LLP

Advised and consulted on the regulations of the clinical and regulatory requirements for the FDA approval process for new drugs, on the overall design and attributes of Good Clinical Practices, attended and contributed to presentations with client. Provided consulting services and expert advice regarding Expert Subject Matter based on review of clinical research.

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Schiffrin & Barroway, LLC

Advised and consulted on the regulations of the clinical and regulatory requirements for the FDA approval process for new drugs, on the overall design and attributes of Good Clinical Practices, attended and contributed to presentations with client. Provided consulting services and expert advice regarding Expert Subject Matter based on review of clinical research.

Oxford Research International Corp.

Responsibilities as President and CEO included overseeing the COO and participating in the direction of Vice Presidents and Directors of Clinical, Regulatory, Statistical, and Medical Communications Departments. Among these responsibilities were: coordinating clinical research development plans with marketing departments to gain NOA approvals while achieving marketing and sales goals, FDA negotiations, assessments of new products for pharmaceutical and venture capital companies, developing business and marketing plans for new products, creating strategic plans for clinical development in order to expedite NDA approvals. His other responsibilities included the management of the Business Development, Finance, Human Resources, and Office Management Departments. He had the overall responsibility of 120 personnel.

His international experience has included submissions of new drug applications in the United Kingdom, Italy, France, Germany and the Scandinavian countries.

USV/Revlon Health Care Group

As Vice President/Medical Director the overall responsibility for clinical research for Phases 1, 2, 3 and 4 were assigned to this position. In addition, the medical services staff in charge of regulated advertising and approval of medical marketing strategies and the Information Services/Medical Literature Departments, were also part of the Vice President's responsibilities. He was also in charge of all approvals for marketing materials used in promotional campaigns.

USV was purchased by Revlon, Inc. At that time there was no Research & Development staff in place. In addition, the products that Revlon purchased from Geigy had no substantial clinical data for efficacy. Therefore the task of the Vice President was to build a research department, conduct clinical research to substantiate the efficacy of these products and support their marketing claims. The VP of clinical research initiated and completed all clinical studies under GCP regulations and substantiated the efficacy of all claims for the products in question. Sales rose with this new data to over 400 percent. Marketing claims were all supported by double-blind clinical data demonstrating effectiveness and reconfirming safety. Marketing strategy was based on the results of this clinical data that all had FDA approvals.

Sandoz. Inc.

Responsible for Phases 2, 3, and 4 clinical research development. In addition, as the medical/marketing liaison, created medical/clinical advertising pieces for the sales force and Medical Services Department. Had overall responsibility of 40 personnel.

While at Sandoz, the DESI reviews were actively in force. After the NAS/NRC ratings of some of Sandoz' products, i.e., probably and possibly effective ratings were allocated for specific indications. These had to be upgraded to effective in a

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very short time. Five supplemental NDAs were submitted and approved within 24 months for the indications of anxiety, depression, schizophrenia (specifically Mellaril/Thioridazine before it was removed from the market in 2005. These included implementing, conducting and managing 48 clinical studies for 5 different indications. Protocols, CRFs, investigator selection, clinical reports were all accomplished under the direction of Dr. Guarino. While at Sandoz, he directed the programs on Hydergine, a product for the treatment of symptoms of senile dementia, Serentil, a major tranquilizer and Guanfacine, an antihypertensive. These all received NOA approvals from FDA.

Dr. Guarino had the major responsibility of training the sales force on major and minor psychiatric disorders. He presented clinical study results at medical meetings on psychotropics to psychiatrists and related professional audiences.

PROFESSIONAL CONSUL TING and TEACHING

2002-Present

1998 - Present

1971 - Present

Consultant as Chief Medical Officer for Amneal Pharmaceuticals in overseeing post-marketing surveillance of generic products. Creating protocols for ANDAs and NDAs in analgesic and psychotropic products.

2007-Present Consultant as Chief Medical Director for Validus Pharmaceuticals specifically for two products, Equetro® (carbamazapine) indicated for Bi-polar 1 disorder and Marplan® (isocarboxazid) indicated for depression. Submitted a clinical summary for a study using Equetro® in pediatrics. In this study the major emphasis was to distinguish the diagnosis of Bi-polar 1 disorder from schizophrenia in the subject selection criteria.

Institute for International Research organizing and participating in Clinical Research Conferences outlining Standard Operating Procedures for the pharmaceutical industry.

The Center for Professional Advancement Director for courses entitled "The Mechanics of Preparing INDs, NDAs, CTDs and FDA Regulations," "Good Clinical Practices," and "Preparing Clinical Protocols and Managing Clinical Investigations," "Selecting and Managing CROs

1985 - Present Lecturing at Universities and Institutions throughout the world on Good Clinical Practices and ICH regulations along with learning systems in the health care field. Teaching IRB/IECs and GCPs.

1975 - 1977 Adjunct Professor at Fairleigh Dickinson

University in the MBA program for pharmaceutical marketing.

EDUCATION

M.D., University of Siena, Italy

M.S., New York University, New York, NY

B.S., Fairleigh Dickinson University, Rutherford, NJ

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PROFESSIONAL AFFILIATIONS -PAST AND PRESENT ACRP/APPI

Bioscience Communications and Health Care Delivery Association National Association of Interns and Residents

Associates of Clinical Pharmacology

Association of Medical Directors

Essex County, New Jersey Heart Association The New York Academy of Sciences

Drug Information Association

Advisory Committee of the National Institute of Health American Academy of Clinical Toxicology Gerontological Society

American Geriatric Society

National Institute of Health/National Institute of Aging American Society of Geriatric Physicians

New Jersey Health Sciences Group

American College of Angiology

Center for Professional Advancement

Fellow, Royal Society of Medicine, London, England Fellow, Royal Society of Arts, London, England American Society of Parenteral and Enteral Nutrition Medical Advisors in the Pharmaceutical Industries

Pharmaceutical Manufacturing Association Scientific Exhibit Reviewer

Pharmaceutical Manufacturing Association Committee on Guidelines for Monitoring Clinical Investigations

Geriatric Neuropsychopharmacology Subcommittee FDA Board of Directors, East Orange General Hospital

The Academy of Medicine of New Jersey

The New York Academy of Medicine

Fairleigh Dickinson University-Adjunct Professor

Fairleigh Dickinson University - Council of Presidential Advisors Editorial Board of "Journal of Geriatric Drug Therapy"

Board of Trustees Columbus Hospital

New Community Foundation, Newark, NJ - Board of Trustees

COMMUNITY AWARDS AND AFFILIATIONS International Kiwanis

1971 Outstanding Young Man in America

Family & Children's Services of North Essex - Board of Trustees - Co-Chairman - Glen Ridge Cultural Committee

President and Board Member - Glen Ridge Historical Society Glen Ridge Public Library Expansion Committee Humanitarian of the Year - Italian Tribune

Man of the Year - League for Family Service

Man of the Year - Federation of Italian-American Societies of New Jersey Pinnacle Award - Fairleigh Dickinson University

Board of Directors - Cystic Fibrosis Foundation

Board of Directors - Lupus Erythematosus Foundation Board of Directors - NorCrown Bank

Board of Directors - Ambassador South Development Corp. Board of Directors - Republican Committee

Board of Trustees - Bloomfield College

Board of Trustees - Chairman of the Board of New Community Foundation Board of Trustees - East Orange General Hospital

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Board of Trustees - Columbus Hospital Board of Trustees - Lacordaire Academy

Advisory Board - Fairleigh Dickinson University; Center for

Radio Pharmaceutical Technology Management

Knight of Malta - American Association of the Sovereign Military Order of Malta Science and Advisory Technology Council of New Jersey

Chairman of the Board - Columbus Hospital Foundation

President's Advisory Committee - Fairleigh Dickinson University

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PUBLICATIONS

1.Guarino RA. The Evaluation of Different Formulations of Psychotropic Drugs Using the Double Placebo Method. Fifth World Psychiatric Congress, Mexico City, Mexico, 1971.

2.Fann WE, Lake CR, Majors LF, Guarino RA. Thioridazine in Neurotic, Anxious and Depressed Patients. Psychosomatics. 1974;15:117.

3.Lowenstam I, Guarino RA. Drug Treatment in the Rehabilitation Center for Chronic Alcoholics. J Chron Dis. 1975;28:431.

4.Guarino RA. Who is the Clinical Research Monitor? BioLog. May 1975.

5.Guarino RA. International Monitoring Guidelines and Guidelines and Managing Clinical Research. Second International Meeting of Medical Advisors in the Pharmaceutical Industry, Florence, Italy, October 1975.

6.Guarino RA. Writing Protocols for New Drugs. Drug and Cosmetic Industry. Dec. 1975;117:50-104.

7.Guarino RA. The Short-term and Long-term Results of Therapy of Occlusive Arterial Disease. American College of Angiology 22nd Annual Meeting. January 1976.

8.Guarino, RA. Double-Blinding Techniques in Drug Testing. Drug and Cosmetic Industry. Feb. 1976; 118:46.

9.Guarino RA. Health Rights of the Patient in Medical Education and Medical Care. Aspen Biosciences Communications Seminars, Oct. 1976, Aspen, Colorado.

10.Guarino RA. Clinical Research: The Obligation of the Investigator, the Sponsor and the Monitor. Drug Information Journal. 12:3, 1978. p. 157.

11.Montero EF, Guarino RA, Monsky JD. Double-Blind Comparative Trial to Reassess Desipramine and lmipramine in Moderate Depressive Illness. Clin Ther. 2:1 1978. p. 50.

12.Mann RD and Guarino RA. Chlorthalidone 25 mg. A Review of Therapeutic Effectiveness in the Management of Mild Hypertension. The Proceedings of the Special Investigators' Symposium, Held at White Plains, New York. September 1978.

13.Oberman A, Schnaper HW, Guarino RA, Monsky JS. Chlorthalidone plus Reserpine versus Methyldopa in a Stepped-Care Approach to the Treatment of Essential Hypertension. Clin Ther. 1979;2:2.

14.Guarino RA. Patient Package Inserts, Food Drug Cosmetic Law J. Feb. 1979.

15.Barnes RJ and Guarino RA. Desipramine Hydrochloride: Single- vs. Multiple-Dose Comparative Trial - Double- Placebo Method. J Clin Pharma. January 1980.

16.Guarino RA. Evaluation and Assessment of Patients with Various Types of Senile Dementia. Microcirculation of lschemic Vascular Diseases. Clinical and Therapeutic Approaches. Proceedings of Congress-Rio de Janiero, 1981.

17.Guarino RA, Cox BS. Practice and Application of Good Clinical Practices, in Cooperation with St. John's University, New York and The American Federation for Clinical Research Eastern Section. October 1982.

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18.Guarino RA. Practice and Application of Good Clinical Practices. Concepts and Strategies in New Drug Development; Clinical Pharmacology and Therapeutic Series. Praeger Publishers, New York, New York, 1983;4.

19.Guarino RA.(Ed.). New Drug Approval Process: Clinical And Regulatory Management.

Marcel Dekker, lnc., New York, New York, 1987;30.

20.Guarino RA. The Credibility of Assessment Scales for Degenerative Dementia. Associates of Clinical Pharmacology 15th Annual Meeting, San Diego, CA, 1991.

21. Guarino RA. Researching Business Success. Meeting the Challenge, Kimstarr Communications, Inc., Morristown, New Jersey, 1993; 2:2.

22.Guarino RA.(Ed.). New Drug Approval Process: Second Edition, Revised and Expanded.

Marcel Dekker, Inc., New York, New York, 1993;56.

23.Guarino RA. Role of the MD in Protocol Design. Applied Clinical Trials Conference and Exhibition, Reston, VA, 1993.

24.Guarino RA. Clinical Study Conduct/Procedures. Drug Information Association Meeting, Chicago, IL, July 1993.

25.Guarino RA. Modern Clinical Research. European Pharmaceutical Contractor, February 1998.

26.Guarino RA. (Ed.). New Drug Approval Process: Third Edition, Revised and Expanded.

Marcel Dekker, Inc., New York, New York, 2000;100.

27.Guarino RA. The Need for Global Standardization for Product Registration. American Academy of Pharmaceutical Physicians Annual Meeting, Miami, FL, November 2003.

28.Guarino, RA. Legal Obligations and Responsibilities of Investigators Conducting Drug, Biologic and Device Clinical Research Trials. Association of Clinical Research Professionals 28th Annual North American Conference and Exhibition, San Diego, CA, May 2004.

29.Guarino RA. (Ed.). New Drug Approval Process: Fourth Edition, Accelerating Global Registrations. Marcel Dekker, Inc., New York, New York, 2004;139.

30.Guarino RA. (Ed.). New Drug Approval Process: Fifth Edition, lnforma Healthcare, New York, New York, 2009; 190

31.Corser B.C., Guarino, RA., Zerhusen, A Safety and Tolerability of the MAO Inhibitor lsocarboxazid (Marplan®) in the Prophylactic Treatment of Migraine, 2009

32.Findling R.L, Ginsberg LO, A Phase IV, Multicenter, Open-Label Study of ExtendedRelease Carbamazepine in the Treatment of Manic or Mixed States in Youths Aged 10-17 Years.

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IND AND NDA EXPERIENCE

During the last 30 years in clinical research and drug regulatory affairs activities, Dr. Guarino has had major input and successes in approvals of INDs and NDAs.

Direct responsibilities include compiling and/or supervising the clinical programs, regulatory submissions and medical writing for IND and NDA filings in the following therapeutic categories. These submissions also involved the liaison with the listed FDA Divisions:

THERAPEUTIC CATEGORY Anti-emetic

Analgesic*

Peripheral vasodilator*

Anti-asthmatic

Radiolabeled Cancer Marker Interferon

Anti-angina!*

Antihypertensive* Anti-arrhythmic

Psychotropic

Cerebrovascular*

Parenteral Multivitamin Anti-malarial Adult and Pediatric Antibiotic

AlDs-Related Drugs

Dental*

Anti-Diabetic*

Urinary Tract Diseases* Birth Control Products*

FDA DIVISION Neuropharmacology

Pulmonary

Medical Imaging & Radio Pharmaceutical Radio Pharmaceutical

Cardio-Renal

Neuropsychopharmacology

Metabolic/Endocrine Anti-infective

Dermatological and Dental Metabolism and Endocrine Reproductive and Urologic Drug

*NDA Submissions and approvals, Supplemental NDA submissions and approvals

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