Director Project

Howard B. Haimes

*** ******** ******

Natick, MA 01760

Phone H. 508-***-****

Cell 508-***-****

******@**.******.***

Objective: Director of Pharmacology/Toxicology for Premier Pharmaceutical Company

Management of preclinical evaluation and assessment of novel therapeutics

Professional

1. Extensive experience directing diverse areas of science, establishing and managing external collaborations and managing preclinical science efforts aimed at moving small molecule therapeutics, cell therapy and medical devices through development and regulatory pathways

2. Twenty five years of research management experience in companies involved in developing innovative solutions to commercialize products. Managed preclinical efficacy, pharmacology and safety assessment through IND and early Phase II development

3. Founding member of Organogenesis Inc.

PROFESSIONAL EXPERIENCE:

Jan. 2011 - present Project Toxicologist

AstraZeneca Pharmaceutical, LP

35 Gatehouse Drive

Waltham, MA 02451

• Manage discovery toxicology, safety pharmacology and in vitro screening studies on oncology and anti-infective NCE’s (Small Molecule)

• Projects include both gram negative and positive agents (both IV and oral formulations). Susceptible microbes include MRSA, E. coli, Kpn, and Pae.

• Have worked on conventional and novel drug targets. (6 projects)

• Serve as key discovery toxicologist on various project teams to facilitate routine screening and development of SAR as well as problem solving and de-risking compounds in development

• Key stakeholder responsible for presentation of safety data to local and senior project management teams.

• Serves to transition compounds through governance process by appropriate documentation and transition to regulatory studies in compliance with ICH, EMEA and FDA guidance.

• Formulate clinical strategy in concert with physicians so as to balance assets and liabilities for Best in Class, First in Class, combination therapy.

Aug 2009-Jan 2011 Discovery Toxicologist

AstraZeneca Pharmaceuticals, LP

35 Gatehouse Drive

Waltham, MA 02451

• Manage discovery toxicology, safety pharmacology and in vitro screening studies on oncology and anti-infective NCE’s

April 2007- Aug 2009 Toxicology Project Leader

AstraZeneca Pharmaceuticals, LP

35 Gatehouse Drive

Waltham, MA 02451

• Manage non-clinical requirements for portfolio of Oncology, Anti-Infectives and Psychiatry small molecule NCE’s

• Responsible for conduct of safety pharmacology, in vitro profiling, genotox assessment and toxicology profiling for regulatory submissions

• Led a problem Solving team of 15 scientists to a successful outcome

• Presentation to governance bodies

• Responsible for CTA, IND, IMPD, Investigator Brochures and HELC submissions to FDA, EMEA & Health Authorities

• Responsible for due diligence for in-licensing opportunities

Feb. 2004 – April 2007 Executive Director Preclinical Sciences

Alteon

6 Campus Drive

Parsippany, NJ 07054

• Responsible for external CRO and Academic preclinical studies

• Responsible for preclinical safety assessment (hERG binding, patch clamp studies, receptor binding assays, carcinogenicity, etc.).

• Managed Intellectual Property Portfolio

• Presentations to multi-national companies, venture capitalists

• Submitted new IND 72, 382 IND 72,382 Alagebrium Chloride (ALT-711), Oral Original IND with Protocol ALT-711-0526 (Heart Failure) responsible for ongoing preclinical, pharmacology and advanced safety assessment including carcinogenicity testing Food and Drug Administration, Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products

• Submitted IND 69,417, Alagebrium Chloride, Oral (Erectile dysfunction) - responsible for ongoing preclinical, pharmacology and advanced safety assessment including carcinogenicity testing. Center for Drug Evaluation and Research, Division of Reproductive & Urologic Drug Product (DRUDP)

• Filed CMC updates and annual report for IND 70,370 ALT 2074 (BXT-51072) Food and Drug Administration, Center for Drug Evaluation and Research, Division of Cardiovascular and Renal Products. Served as regulatory liaison.

• Filed annual reports, CMC updates, informational amendments, etc.

• Filed consolidated study reports, annual reports and additional safety assessment as above for IND 59, 807 ALT-711 Oral for Study of Cardiovascular Disease

Bioheart Inc.

Dec 1999 - Feb. 2004 Various positions (Director of Business Development, VP of Operations, Executive Director of Preclinical Sciences, Chief Scientific Officer of Biopace)

Executive Director - Preclinical Studies

Bioheart Inc.

C/o Mass Biomedical Initiatives

25 Winthrop St.

Worcester, MA 01604

• Responsible for all Preclinical studies for IND submissions and FDA requisites

• Responsible for preclinical studies and regulatory submissions for two INDs (CBER)

• IND 10207 (catheter-based delivery) of autologous myoblasts and IND 10157 (open-chest delivery).

• Filed Intellectual Property for Bioheart/Biopace

• Presentations to Angel & Venture Capitalists

• Raised $8MM in funding

1998 - 1999 President of Akoslogic, Inc.

• Newly incorporated biopharmaceutical firm using small molecule inhibitors for mitigation of transplant rejection and rheumatoid arthritis. (DPP IV)

1996 – 1997 Independent Consultant

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. ML Strategies

One Financial Center

Boston, MA 02111

• Entrepreneurial activities aimed at initiating new biotech/pharmaceutical new ventures, leveraging academic opportunities, etc.

Independent Consultant

Genzyme Tissue Repair

Framingham, MA

VIMRX Pharmaceuticals

Wilmington, DE

Ontogeny, Inc.

Cambridge, MA 02138

• Assessment of Signal Transduction pathway inhibitors (tyrosine kinase)

• Development of Animal Models

• Histopathology

1992-1996 OsteoArthritis Sciences Inc.

1 Kendall Square, Building 200

Cambridge, MA 02139

1994 - 1996 Director of Biological Sciences

• Generated and assembled preclinical documentation in support of an approved IND for a non- steroidal, topical anti-inflammatory agent (LTB4 inhibitor). Coordinated biological efforts to assess and characterize small molecule compounds for disease modifying activity for contact dermatitis, osteoarthritis, wound healing etc.

• Initiated and monitored external collaborative studies on wound healing, drug delivery systems, mechanism of action, pharmacology profile etc.

• Directed the scientific assessment, research and business development of Cell and Molecular Biology, Protein Biochemistry and Animal Pathology Groups. (15 direct reports) Coordination of research, documentation, personnel reviews etc.

• Presentations to Board of Directors, SAB, venture capitalists, multi-national large pharma

1992 - 1994 Director of Animal Pathology

• Established in-house preclinical pharmacology program for evaluation of compounds by Carrageenan Paw edema assay, Randall Sellito, adjuvant arthritis, Contact dermatitis models, septic shock

• Participated in study on transgenic model of OA with Harvard Medical School and Merck.

• Developed and instituted a small animal model of developing osteoarthritis. (Surgical induction of joint instability in Hartley strain guinea pig). Validated drug testing paradigm for evaluation of potential disease modifying compounds by intra-articular route of administration

• Participated in collaboration with Cornell University and New York University on hormonally induced model of cartilage degeneration

• Chairperson of Institutional Animal Care and Use Committee (IACUC)

1985 - 1991 Founding Member / Group Leader Morphology

Organogenesis Inc.

83 Rogers Street

Cambridge, MA 02142

• Generated data that led to the scientific development, licensing, research contracts, financial sourcing for scientific program and involved in business development leading to IPO

• Developed Histopathologic grading system for evaluation of Living Skin Equivalents and Testskin

• Directed research efforts on the morphologic characterization on Dense Fibrillar Collagen

• Responsible for the histopathologic and ultrastructural characterization of blood vessel equivalents prior and subsequent to implantation in dogs.

• Wrote preclinical sections of IDE for investigational product later to be commercialized as Apligraft

1984 - 85 Visiting Scientist, Department of Biology

Massachusetts Institute of Technology

Cambridge, Massachusetts

1981 - 1984 Post-doctoral Research Associate, Anatomy

Research Fellow, Department of Biochemistry

Vanderbilt University School of Medicine, Nashville, TN

PUBLICATIONS

Essner, E., and Haimes, H., Ultrastructural Study of GERL in Beige Mouse Alveolar Macrophages. J. Cell Biol. 75: 381, 1977

Oliver C, Essner E, Zimring A, Haimes H. Age-related accumulation of ceroid-like pigment in mice with Chediak-Higashi syndrome. Am J Pathol. 1976 Aug; 84(2):225-38.

Essner E, Oliver C, Haimes H. Fate of exogenous peroxidase in renal lysosomes of mice with Chediak-Higashi syndrome. Am J Pathol. 1974 Dec; 77(3):407-22.

Stockert, R.J., Haimes, H.B., Morell, A.G., Novikoff, P.M., Novikoff, A.B., Quintana, N., and Sternlieb, I. Endocytosis of Asialoglycoprotein-Enzyme Conjugates by Hepatocytes. Lab. Invest. 43 (6): 556, 1980

Haimes, H.B., Stockert, R.J., Morell, A.G., and Novikoff, A.B., Carbohydrate- Specified Endocytosis: Localization of Ligand in the Lysosomal Compartment. Proc. Natl. Acad. Sci. (USA) 78 (11): 6936, 1981

Topol, B.M., Haimes, H.B., Dubertret, L., and Bell, E., Transfer of Melanososmes in a Skin Equivalent Model In Vitro. Jour. Invest. Dermatol. 87 (5): 642, 1986

Bell, E., Parenteau, N.L., Haimes, H.B., Gay, R.J., Kemp, P.D., Fofonoff, T.W., Mason, V.S., Kagan, D.T., and Swiderek, M., Testskin: A Hybrid Organism Covered by a Living Human Skin Equivalent Designed for Toxicity and Other Testing. Progress in In Vitro Toxicology, Alternative Methods in Toxicology Vol., (Proceedings of a Symposium by the Johns Hopkins Center on Alternatives to Animal Testing) Mary Ann Lieber, Inc., publisher, New York, N.Y. pp. 15-25, 1988

Bell, E., Rosenberg, M., Kemp, P., Parenteau, N., Haimes, H., Chen, J., Swiderek, M., Kaplan, F., Kagan, D., Mason, V., and Boucher. L., Reconstitution of Living Organ Equivalents from Specialized Cells and Matrix Biomolecules. Organes artificiels hybrides Hybrid artificial organs C. Bacquey and B. Dupeys Eds. Collique INSERM, Vol. 177, 1989, pp 13-28, 1989

Bell, E., Gay, R., Swiderek, M., Class, T., Kemp, P., Green, G., Haimes, H., and Bilbo, P. (1989). Use of Fabricated Living Tissue and Organ Equivalents as Defined Higher Order Systems for the Study of Pharmacologic Responses to Test Substances. In Pharmaceutical Applications of Cell and Tissue Culture, edited by G. Wilson, S.S. Davis and L Illum. Plenum Publishing Company Limited. London. Also presented at the NATO Advanced Research Workshop, Pharmaceutical Application of Cell and Tissue Culture to Drug Transport, Bandol, France, Sept. 4-9, 1989

Chen, J-K., Haimes, H.B., and Weinberg, C.B., Role of Growth Factors in the Contraction and Maintenance of Collagen Lattices Made with Arterial Smooth Muscle Cells. Jour. Cell Physiol. Vol. 146: 110-116, 1991.

P.A. Jimenez, P.M. Harlan, A.E. Chavarria, and H.B. Haimes, Induction of Osteoarthritis in Guinea Pigs by Transection of the Anterior Cruciate Ligament: Radiographic and Histopathological Changes. Inflammation Research 1995 44(2): 129-130s

H.B. Haimes, P.A. Jimenez, Y. Li, T. Shinya, B.R. Olsen, Overexpression of the NC4 Domain of Type IX Collagen Induces Osteoarthritis in Mice, Inflammation Research 1995 44(2): 127-128s

P.A. Jimenez, B.G. Steinetz, H.B. Haimes, Radiologic Assessment of Relaxin-Induced Pubic Symphyseal Changes in Guinea Pigs: A Model for Screening Disease Modifying Agents for Osteoarthritis, Inflammation Research 1995 44(2): 164-165s

S.S. Glasson, O.V. Trubetskoy, P.M. Harlan, A.E. Chavarria, H.B. Haimes and P.A Jimenez, Blotchy Mice: A Model of Osteoarthritis Associated with a Metabolic Defect. Osteoarthritis and Cartilage 1996 (4): 209-212

Brown KE, Leong K, Huang CH, Dalal R, Green GD, Haimes HB, Jimenez PA, Bathon J. Gelatin/chondroitin 6-sulfate microspheres for the delivery of therapeutic proteins to the joint. Arthritis Rheum. 1998 Dec; 41(12):2185-95.

Jimenez PA, Glasson SS, Trubetskoy OV, Haimes HB. Spontaneous osteoarthritis in Dunkin Hartley guinea pigs: histologic, radiologic, and biochemical changes. Lab Anim Sci. 1997 Dec; 47(6):598-601.

Glasson SS, Trubetskoy OV, Harlan PM, Chavarria AE, Haimes HB, Jimenez PA. Blotchy mice: a model of osteoarthritis associated with a metabolic defect. Osteoarthritis Cartilage. 1996 Sep; 4(3):209-12

He K-L, Yi G-H, Sherman W, Zhou H, Zhang G, Gu A, Kao R Haimes HB, Harvey J, Roos E, White D, Taylor DA, Wang J and Burkhoff, D Autologous Skeletal Myoblast Transplantation Improved Hemodynamics and Left Ventricular Function in Chronic Heart Failure Dogs

J Heart Lung Transplant 2005; 24:1940-9.

Sherman W, He K-L, Yi G-H, Wang J, Harvey J, Li M-J, Haimes H, Lee P, Miranda E. Kanwal S and Burkhoff D Myoblast Transfer in Ischemic Heart Failure: Effects on Rhythm Stability. Cell Transplantation 2009 (18): 333-341

INVITED PAPERS

Haimes, H.B., Gay, R.G., Kemp, P.D., Fofonoff, T.W., Cavallaro, J.C., Tschumakow, A., Salame, K.G., Swiderek, M.S., Nelson, D., Parenteau, N.L., and Bell, E. TESTSKIN - A Living Human Skin Equivalent for Percutaneous Absorption and Other Skin Tests. Presented at the Sixth Symposium on Cutaneous Toxicity sponsored by the American Academy of Dermatology (Sept 26-28, 1988 Washington D.C.)

PATENTS

5, 597,808 Howard B. Haimes and Pablo A. Jimenez

Use of Pseudopterosins for Promoting Wound Healing

January 28, 1997

6,022,862 Haimes, et al.

Use of Pseudopterosins for promoting wound healing February 8, 2000

EDUCATION

1975 - 1982 Ph.D. in Biochemical Cytology

Department of Pathology

(Drs. Alex B. and P.M. Novikoff)

Sue Golding Graduate Division

Albert Einstein College of Medicine

Yeshiva University, Bronx, New York

1975 - 1978 M.S. in Biochemical Cytology

Sue Golding Graduate Division

Albert Einstein College of Medicine

Yeshiva University, Bronx, New York

1972 - 1975 M.S. in Biology

Long Island University

Brooklyn, New York

1968 - 1972 B.S. in Biology

Union College

Schenectady, New York

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