David Smith

Carlsbad, CA

858-***-**** t actvyj@r.postjobfree.com

Ph.D. with 13 years of experience in developing and implementing corporate strategies for leading biotechnology, medical device, and diagnostic companies, building strategic partnerships with the Mayo Clinic, Beth Israel, Harvard Medical School, etc. Exceptional understanding of how to develop business through education, training, and innovations. Committed to delivering solutions that drive positive outcomes and build sustainable revenue growth. CORE COMPETENCIES

Organizational Management t Business Development t Strategic Partnerships t Research & Development Biotechnology t Medical Devices t Diagnostic Equipment t Genomic Sequencing t Technology Implementations t Communication Skills t Cross-Functional Teamwork EXPERIENCES AND ACHIEVEMENTS

BIOREGENERATIVE SCIENCES, INC., San Diego, CA 2015 – Present Chief Science Officer

Leading development of technologies for creating novel disease therapies from induced pluripotent stem cells (iPSCs).

• Development of procedures and protocols for harvesting molecules released from iPSCs (both soluble and contained in exosomes)

• Leadership of team to scale up to commercial production Building alliances with other companies and universities

• Management of preclinical trials

• Providing access to facilities and technologies necessary for completion of R&D Leading development and testing (preclinical and clinical trials) toward FDA submission Family obligations 2014 - 2015

AVIVA BIOSCIENCES CORPORATION, San Diego, CA 2012 - 2014 Executive Vice President

Directed the overall strategy at a biotech firm with the goal of building sustainable revenue generation results. Led a team of one VP, a finance director, and 9 supporting employees.

• Successfully generated $2.5MM annually as a result of leadership.

• Completed R&D for novel blood filter/rare cell enrichment technology for flow cytometry. o Built alliances with Beckman Coulter, Thermo Fisher, and LabCorp for sale and use of filter.

• Re-built relationship with primary corporate partner, Molecular Devices, as the only sales and marketing channel for flagship product (gigaseal technology for automated ion channel electrophysiology). ILLUMINA, INC., San Diego, CA 2009 - 2011

Director, Alliances (Business Development)

Focused on creation of new alliances for sustaining business applications for sequencing: bioprocess monitoring, synthetic biology, forensics, and veterinary biology. Implemented newly acquired assay technology, leading to new diagnostic assays.

• Drove team to exceed annual revenue targets every year: by 33% in 2009, 36% in 2010, and 15% in 2011.

• Led cancer genomic sequencing alliances for discovery and validation of novel biomarkers with: o Mayo Clinic - ovarian cancer.

o National University of Singapore - gastric cancer. o Ludwig Institute for Cancer Research - colorectal cancer. o Fred Hutchinson Cancer Research Center - prostate cancer.

• Led corporate team of ~8 in the implementation of new isobase technologies, leading to new diagnostic products and new application areas.

• Led a cross-functional team of 6 people for $10MM/year collaboration with Life Technologies for synthesis and sale of oligonucleotides.

o Exceeded revenue projections by 15%.

DAVID SMITH Resume, Page 2

LUMINEX CORPORATION, San Diego, CA 2006 - 2009

Associate Director, Scientific Awareness

Worked with ad-hoc cross-functional teams to create external scientific alliance arrangements.

• Interfaced with the Marketing team to create scientific content.

• Collaborated with the sales team to add scientific content and rigor and to make scientific presentations for sales events.

Created and led external scientific teams to create new technologies and products for the company.

• Led 31 strategic alliances/collaborations, resulting in new content and technology enhancements. o Beth Israel Deaconess Medical Ctr/Harvard Medical School: diagnosis of AML; stratification of ALL. o University of Chicago Pritzker School of Medicine: detection of mutations predictive of resistance to imatinib.

o Privately held company: use of tRNA for multiplex detection of amino acids.

• Memberships: Chair, Scientific Alliances Committee; Product Advisory Board Member; Executive Secretary, Scientific Advisory Board; Patent Review Committee Member. THE BINDING SITE, INC., San Diego, CA 2004 - 2006

Senior Technical Director – Freelite™

Led a team of 6 Ph.D. and M.D. specialists.

• Designed and managed medical research projects with major cancer centers throughout the U.S.

• Coordinated publication of results from medical research projects.

• Delivered professional presentations (Grand Rounds and Continuing Medical Education). Responsible for scientific affairs pertaining to medical research on serum free light chain assays for diagnosis and monitoring of B-cell dyscrasias, e.g. myeloma and primary amyloidosis.

• Led all scientific affairs pertaining to medical research on serum free light chain assays

• Coordinated activities with sales representatives to drive sales of serum free light chain assays, resulting in 25% growth in revenue year over year.

• Collaborated with the Mayo Clinic; Northwestern Hospital; University of California, San Diego/VA Medical Center; University of Washington Medical Center; Veterans Administration Medical Center – Puget Sound; University of Arkansas Medical Center, Myeloma Institute for Research and Therapy; Infinity Pharmaceuticals; Novartis; and Covance, Inc.

NICHOLS INSTITUTE/QUEST DIAGNOSTICS, INC., San Diego, CA 2002 – 2004 Genomics and Esoteric Testing Specialist

Drove success of sales force through working hand-in-glove with the sales force, marketing, and the technical staff.

• Delivered professional talks (Grand Rounds, Continuing Medical Education, and Continuing Educational Units) at hospitals throughout the region, including large academic hospitals (e.g., UCLA, USC, UCSD, Loma Linda) on subjects regarding genomics and esoteric diagnostic testing.

• Provided consultative services to doctors and hospitals regarding the availability, applicability, and interpretation of medical diagnostic tests.

• Developed and maintained relationships with hospital clients (i.e., department chairs for oncology, obstetrics and gynecology, infectious disease, gastroentoerology, pediatrics, internal medicine, and pathology). EDUCATION

Ph.D., Neurosciences, University of California, San Diego M.S. Coursework (Computer Science), San Diego State University M.A. Coursework (Political Science), Georgetown University B.S., Oceanography, U.S. Naval Academy

Certified Nuclear Engineer, U.S. Department of Energy DAVID SMITH Resume, Page 3

Publications and Presentations

Original Papers:

Smith, D.E., Rapp, P., McKay, H., Roberts, J., and Tuszynski, M.H. Memory impairment in aged primates is associated with focal death of cortical neurons and atrophy of subcortical neurons. Journal of Neuroscience. 2004 May 5;24(18):4373-81. Smith, D.E., Roberts, J., Gage, F.H., and Tuszynski, M.H. Age-associated neuronal atrophy occurs in the primate brain and is reversible by growth factor gene therapy. Proceedings of the National Academy of Sciences of the United States of America. 1999 96, 10893-8.

Tuszynski, M.H., Smith, D.E., Roberts, J., McKay, H., and Mufson, E. Targeted intraparenchymal delivery of human NGF by gene transfer to the primate basal forebrain for 3 months does not accelerate beta-amyloid plaque deposition. Experimental Neurology 1998 154, 573-82.

Manuscripts in Preparation

Maguire, G., and Smith, D.E. The Nature of Biology: Genomics as a Theory of Principle Maguire, G., and Smith, D.E. A Systems Therapeutic Approach to Restoration of Molecular Homeostasis Unpublished Manuscripts

Smith, D.E., Rapp, P., and Tuszynski, M.H. Hemispheric asymmetry of neuronal number in prefrontal cortex of young adult and aged primates.

Smith, D.E., Rapp, P., and Tuszynski, M.H. Nerve growth factor elicits different cellular and morphological responses in young adult and aged primates.

Book Chapters and Reviews:

Tuszynski, M.H., Conner, J., Blesch, A., Smith, D., Merrill, D., and Vahlsing, L. (2002) New Strategies in Neural Repair. In Progress in Brain Research

Smith, D.E., and Marshall, S.P. (1996) Applying Hybrid Models of Cognition in Decision Aids. In Naturalistic Decision Making: Research and Applications, G. Klein and C. Zsambok, eds. (Hillsdale, NJ: Erlbaum) Grand Rounds and CME Presentations

Cedars-Sinai Medical Center, Los Angeles, California - The Future of Laboratory Medicine (May 14, 2004) University of California, San Diego (UCSD), La Jolla, California

- West Nile Virus: Coming to a Town Near You! (May 29, 2003)

- Chlamydia and Gonorrhea: Current Thoughts, Methodologies, and Guidelines (October 15, 2003) University of California, Los Angeles (UCLA), Los Angeles, California

- West Nile Virus: Coming to a Town Near You! (April 28, 2003)

- The Future of Laboratory Medicine (April 20, 2004) Harbor-UCLA Medical Center, Torrance, California

- West Nile Virus: Coming to a Town Near You! (May 22, 2003)

- Human Immunodeficiency Virus (September 18, 2003) DAVID SMITH Resume, Page 4

- CRP, BNP, and Homocysteine in Diagnosis and Management of CVD and CHF (December 4, 2003)

- Human Immunodeficiency Virus (Update) (April 1, 2004)

- Flow Cytometry: Morphology, Morphometry, and Immunophenotype (May 20, 2004)

- Transmissible Spongiform Encephalopathies (June 17, 2004)

- Alzheimer’s Disease (July 15, 2004) Irvine Regional Medical Center, Irvine, California

- Diagnostic Testing Using Genetic Methods (April 20, 2004)

- Flow Cytometry: Morphology, Morphometry, and Immunophenotype (June 9, 2004) Sharp Spectrum Laboratory Science Symposium, San Diego, California

- Alzheimer’s Disease (May 21, 2004) Arizona Society of Clinical Laboratory Scientists Symposium (John C. Lincoln Hospital, Phoenix, Arizona)

- West Nile Virus: Coming to a Town Near You! (June 2, 2004)

- Flow Cytometry: Morphology, Morphometry, and Immunophenotype (June 3, 2004) California Association for Medical Laboratory Technology, Northern California Division, Fresno, California

- Cystic Fibrosis (February 29, 2003)

- Ashkenazi Jewish Syndrome (February 29, 2003) California Association for Medical Laboratory Technology, Southern California Division, Orange, California

- The Future of Laboratory Testing (April 3, 2004)

- Flow Cytometry: Morphology, Morphometry, and Immunophenotype (April 3, 2004) Banner Health Symposium, Phoenix, Arizona

- The Future of Laboratory Testing (November 3, 2003) Banner Mesa Medical Center, Phoenix, Arizona

- West Nile Virus: Coming to a Town Near You! (June 15, 2004) Banner Baywood Medical Center, Phoenix, Arizona

- West Nile Virus: Coming to a Town Near You! (June 15, 2004) Boulder City Hospital, Boulder City, Nevada

- CRP, BNP, and Homocysteine in Diagnosis and Management of CVD and CHF (December 4, 2003)

- Chlamydia and Gonorrhea: Current Thoughts, Methodologies, and Guidelines (December 4, 2003) Flagstaff Medical Center, Flagstaff, Arizona

- West Nile Virus: Coming to a Town Near You! (July 13, 2004) Fountain Valley Regional Hospital and Medical Center, Fountain Valley, California

- Genetic Medical Diagnostic Testing (June 29, 2004) Garfield Medical Center, Monterey Park, California

- West Nile Virus: Coming to a Town Near You! (May 15, 2003) Kaiser-Permanente, Pasadena, California

- Cystic Fibrosis (May 15, 2004) Kaiser Permanente – Harbor City, Los Angeles, CA

- The Future of Laboratory Medicine (April 22, 2004) Kaiser Permanente – Fontana, Fontana, California

- Laboratory Methods (August 12, 2004)

- Flow Cytometry: Morphology, Morphometry, and Immunophenotype (September 16, 2004) Lancaster Community DAVID SMITH Resume, Page 5

Hospital, Lancaster, California

- West Nile Virus: Coming to a Town Near You! (May 16, 2003)

- The Role of Genetic Techniques in the Diagnosis and Management of HCV (August 13, 2003)

- SARS, An Update (November 11, 2003) Martin Luther King, Jr. – Drew Memorial Medical Center, Los Angeles, California

- Cystic Fibrosis (June 26, 2003)

- Genetic Testing for Cytochrome P450 (July 14, 2004)

- Tumor Markers (August 31, 2004) Mike O'Callaghan Federal Hospital, Nellis Air Force Base, Nevada

- Genetic Diagnostic Testing (March 18, 2004) Mission Hospital, Mission Viejo, California

- The Future of Laboratory Testing (March 9, 2004) Monterey Park Hospital, Monterey Park, California

- West Nile Virus: Coming to a Town Near You! (July 8, 2003)

- The Role of Genetic Techniques in the Diagnosis and Management of HCV (September 23, 2003)

- Flow Cytometry: Morphology, Morphometry, and Immunophenotype (March 25, 2004) Pioneers Memorial Hospital, Brawley, California

- Human Immunodeficiency Virus (March 18, 2004)

- Cystic Fibrosis (May 25, 2004)

- Flow Cytometry: Morphology, Morphometry, and Immunophenotype (June 22, 2004) Southern California CLMA, San Diego, California

- West Nile Virus: Coming to a Town Near You! (May 16, 2003) Verde Valley Hospital, Cottonwood, Arizona

- The Future of Laboratory Testing (August 5, 2004) General Conference Presentations:

Viral Encephalitis: Medical Diagnostic Assays for West Nile Virus. American Association for Clinical Chemistry (AACC), Los Angeles, CA. July 27 – 29, 2004.

Conference Platform Presentations:

Working Memory Impairment in Aged Monkeys is Associated with Localized Loss of Cortical Neurons and Selective Degeneration of Cholinergic Basal Forebrain Neurons (2001) Society for Neuroscience, San Diego, CA Abnormalities in Prefrontal Cholinergic Innervation Correlated with Age-Related Impairments in Working Memory in Primates (2000) Society for Neuroscience, New Orleans, LA Delivery of Nerve Growth Factor by Ex Vivo Gene Transfer to the Basal Forebrain (1999) Society for Biological Psychiatry, Chicago, IL

Abstracts:

Smith, D.E., McKay, H.L., Gage, F.H., Roberts, J.A., and Tuszynski, M.H. (1998) Intraparenchymal delivery of NGF by ex vivo gene transfer reverses age-related loss of expression of p75NTR in basal forebrain cholinergic neurons. Society for Neuroscience Abstracts (Los Angeles, CA)

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Smith, D.E., Mufson, E.J., Gage, F.H., Roberts, J.A., Rosetti, A.M., Merrill, D.A., and Tuszynski, M.H. (1997) Intraparenchymal delivery of NGF to the basal forebrain by gene transfer does not increase beta-amyloid immunoreactivity. Society for Neuroscience Abstracts (New Orleans, LA) Tuszynski, M.H., Smith, D.E., Gage, F.H., and Roberts, J.A. (1996) Effects of NGF-secreting cells on cholinergic neurons in aged primates. Society for Neuroscience Abstracts (Washington, D.C.) Rossen, M., Smith, D.E., Jones, W. Bellugi, U., and Korenberg, J. (1995) New perspectives on brain-behavior links in a genetically-based syndrome: spared face processing in Williams syndrome. Society for Neuroscience Abstracts (San Diego, CA)

Invited Talks:

“Alterations in hemispheric asymmetry of neuronal number with advancing age in primate prefrontal cortex”. Neuroscience Conference. La Jolla, CA: June 7, 2002

“Working memory impairment with age is accompanied by focal loss of cortical neurons and selective degeneration of subcortical neurons”. Neuroscience Conference. La Jolla, CA: June 8, 2001

“Decision-making schemas in rapidly changing and ambiguous situations”. Neural Constraints on Cognitive Architectures. University of Michigan: December 13 – 15, 1994

“Applications of hybrid models of cognition in decision aids”. Naturalistic Decision Making Conference. Dayton, OH: June 13 – 15, 1994

“ A schema-based TADMUS decision aid”. Accelerated Research Initiative on Hybrid Models of Complex Human Learning. Washington, DC: June 10, 1994

“A new paradigm for decision support systems”. Conference of the Human Factors Engineering Technical Group. San Diego, CA:November 15 – 18, 1993

“Artificial intelligence in biomedical decision support”. Telemedicine Seminar and Workshop, American Registry of Pathology. Rockville, MD: May 15 – 16, 1993

“Neural network models of decision-making schemas in rapidly changing and ambiguous situations”. Neural Network Conference. San Diego, CA: February 2 – 3, 1993

“The tactical decision-making under stress program and the future of military decision aids”. Armed Forces Communications and Electronics Association (AFCEA) Conference. San Diego, CA: September 29, 1992

“Applications of hybrid symbolic-connectionist models of complex human learning”. Hybrid Symbolic- Connectionist Models Workshop at the National Academy of Sciences. Woods Hole, MA: September 2- 4, 1992 Conference Articles:

A new paradigm for diagnostic decision aids. Proceedings of the 1993 Telemedicine Seminar and Workshop. American Registry of Pathology, Rockville, MD.

Neural net models of decision-making schemas. Proceedings of the 1993 Neural Network Conference, San Diego, CA Technical Reports:

Monteleon, V., Mirabile, C., and Smith, D.E. (1991) C3 and counter C3 for the surface combatant 2030 (Secret). Naval Ocean Systems Center, San Diego, CA

Smith, D.E., and Siegfried, D. (1988) Technical report on combat system readiness assessment and reporting. Naval Ocean Systems Center, San Diego, CA

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Other:

Session Chair: Uncertainty and Courses of Action, 11th Annual Conference on Command and Control Decision Aids. June 21

– 23, 1994. Monterey, CA.

Session Chair: Cognitive Science and Decision Support, 10th Annual Conference on Command and Control Decision Aids. June 30 – July 1, 1992. Washington, DC.

Session Chair: Decision Support Systems, 9th Annual Conference on Command and Control Decision Aids. June 8 – 9, 1992. Monterey, CA.

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