Rafael E. Gama, Ph.D.

Email: ac6qva@r.postjobfree.com or ac6qva@r.postjobfree.com

OBJECTIVE

A leadership role that combines my financial and operational skills, with my scientific and technical expertise

EDUCATION

Ph.D. Molecular Biology, 1991 University of Essex-England.

B.Sc. Biology; 1987, Universidad Metropolitana, Puerto Rico.

EMPLOYMENT HISTORY

The Cell and Gene Therapy Catapult Center at Guy’s Hospital, London UK. 2018 -

Consultant

The Cell and Gene Therapy Catapult is a center of excellence in innovation, with the core purpose of building a world-leading cell and gene therapy sector in the UK as a key part of a global industry. Supported by Innovate UK, the mission is to drive the growth of the industry by helping cell and gene therapy organizations across the world translate early stage research into commercially viable and investable therapies.

Provide access to business expertise, grants and investment finance so that commercially viable products are progressed and investable propositions are generated

Provide technical expertise and infrastructure to ensure products can be made to GMP and delivered cost effectively

Provide regulatory expertise to ensure that products can get to the clinic safely, in the shortest amount of time

Coordinate and support meetings with regulatory agencies

Provide opportunities for collaboration, both nationally and globally

Identify ways to lower the costs of manufacturing products

Report providing a full review and gap analysis of the non-clinical programs and a recommendation for a path to clinical trial application

Provide methods to accelerate and support clinical trials

The Feinstein Institute for Medical Research, Northwell Health 2015 - 2018

Director, Scientific Core Services

The Feinstein Institute for Medical Research is the research branch of the Northwell Health enterprise. Northwell Health is the largest integrated healthcare system in New York State with 21 hospitals. The Institute is composed of more than 1,500 clinicians, scientists and staff who work in laboratories and clinical research programs in collaboration with clinicians and patients throughout the many facilities of Northwell Health. The Institute provides a number of core laboratory facilities, to assist investigators with their research and promote the highest quality research. The facilities are staffed with full-time professionals who can assist with training in use of the instruments, conduct of the assays and analysis of the data.

Responsible for oversight the administrative, financial, operational and technical activities of all core facilities at The Feinstein Institute for Medical Research

Participate in preparation and monitoring of annual budgets (total operating cost for each core)

Project cores revenue and expenses and develop budget models

Work with core directors/managers to create business plans

Build alliances across the organization to integrate business, science and technology into a single value proposition

Maintain all files on cores budgets, capital equipment request and programs related to operational issues.

Meet with core directors monthly to review operations (expenses, revenue, usage and billing)

Meet with core directors quarterly to prepare and submit quarterly financial reports (revenue and expenses)

Prepare cost analysis for proposed changes to cores. (New services increased staffing). Review and approve rates

Negotiate all capital purchases and service contracts while overseeing non-capital purchases

Participate in developing and maintaining objectives, policies, procedures and Identify and implement technology to improve operations

Coordinate activities including space allocation, procurement of technological equipment, data planning, developing goals and objectives and capital requirements

Improve awareness of core capabilities among local and external users; develop and deploy promotional materials (core brochures, booklets newsletters)

Responsible for initiatives to expand core facilities and enhance collaborations between the institute with other institutions and industry partners

Maintain active faculty & staff engagement (annual surveys, core tours, annual core fairs and workshops)

Review grant proposals (Pre-Post awarded grants) for appropriate usage of all core facilities and billing charges

Maintain/ update websites and links of all cores facilities (internal/external); develop written communication materials

Oversee and review all aspects of safety within the core facilities (health and safety training)

Establish processes, to comply with Environmental, Health and Safety policies and regulations; monthly safety meetings and Inspections, quarterly training

Interact with: The office of Research Finance (ORF), The office of Animal Research Program (ARP), Grants Management Office (GMO), Institutional Biosafety Committee (IBC), Research Information Systems (RIS) and Technology Transfer (OTT)

Hire, train, supervise, discipline, terminate and promote staff, evaluate performance and ensures efficiency in their roles and perform appraisals

Make sure that the staff understands their roles and responsibilities, support continued growth of staff and offer opportunities for advancement

City of Hope and Beckman Research Institute 2011 - 2015

Director, Core Facilities

City of Hope’s Core Facilities provide laboratory research services and access to specialized research equipment and expertise in support of a wide spectrum of research activities. I was responsible for providing daily management of the core facilities and advising on institutional investment in shared resources, facility policy development, operational management and strategic planning. Participated in core facility development and strategic planning, provided for unit budget development and justification, guided space planning initiatives, contributed to policy development, enforced existing divisional policies and prepared annual operational reports to the division and the core facilities.

Provided direct oversight and leadership to all shared resources operations; worked with directors and managers to ensure that user needs are met on a timely basis

Ensured that all shared resources were accessible, efficient and cost effective

Maintained open dialogue and interactions with faculty and investigators to evaluate current operations and research support to help them achieve their research initiatives

Assessed immediate and long term plans including facilities, instrumentation and staffing needs of each shared resource, facilitate planning processes to develop business plans for each shared resource

Worked with campus departments including Occupational Safety and Health, Purchasing, Accounting, and Sponsored Research to facilitate operations and compliance with internal policies and federal regulations

Implemented new institutional policies and oversee the execution of existing policies

Developed and implemented business plans, strategies, revenue and expenditure goals for all cores

Provided oversight and guidance to facility directors regarding utilization of financial resources including meeting budgetary targets, identifying funding sources, and complying with fiscal policy implementation

Interfaced with center grant Director, Office of Sponsored Research (OSR) to insure appropriate planning for operational impacts on existing cores and implementation of developing cores

Responsible for overall budget request and justification

Preparation of annual report on finance and operations to be presented to the Senior Vice President of Basic Research Operations

Projection of and support of funding goals in order to close gap between recharge income, institutional funding and operating expenses

Responsible for administrative support of core facility grant applications including shared instrumentation grants and inclusion in center grants and program project grants

Supervised annual Laboratory Safety Training for all Shared Resources personal to ensure compliance with Environmental Health & Safety regulations

Developed and implemented policies, procedures and specific programs to ensure a safe and healthy environment for all our staff

Made sure that the staff understands their roles and responsibilities, support continued growth of staff and offer opportunities for advancement

University of Chicago 2007 - 2011

Technical Director, Functional Genomics Facility

The Functional Genomics Facility (FGF) is a shared resource laboratory within the Biological Sciences Division at the University of Chicago. The FGF provides resources for investigating gene functions with a focus on applying DNA/RNA/protein microarray and sequencing technology. The mission of the FGF is to provide investigators with the expertise and equipment for all phases of array-based and sequencing services to pursue developmental projects designed to enhance the utility of the technology for investigators, and to serve as an educational resource by offering training, workshops, and seminars.

Responsible for executing the overall mission of the FGF and provided for strategic planning in technology development and implementation

Identify, develop, implement and integrate new genomic technologies for target discovery and validation; gene expression (microarrays, real-time PCR, RCA), antisense, siRNA (synthetic, in-vitro transcribed vector and retrovirus based). Next-generation sequencing platforms (AB Solid, Illumina HiSeq2000, GAIIx and Roche 454) and the Sanger sequencing pipeline

Provided for overall management of resources including budget oversight, capital equipment acquisition, personnel structure and function

Consulted with faculty/investigators regarding experiment design as well as assessing the overall technology needs of UC investigators (and implementing the corresponding solutions)

Pursued developmental projects designed to enhance the utility of the technology to investigators

Serve as an educational resource for UC investigators by conducting ongoing training courses both formal and informal

Acted as liaison with the developing bioinformatics initiative as well as other genomics groups on campus with regards to technology and service planning

Prepared funding proposals and Shared Instrumentation grants as needed

The Karolinska Institute, Center for Genomics and Bioinformatics, Sweden 2001 - 2007

Senior Consultant (based in San Diego, CA)

At CGB, the area of genomic technologies developed novel methodologies for DNA microarray, DNA sequencing and protein localization efforts. The area of functional genomics was primarily focused on the development of tools for in vivo use. Such tools included novel antisense oliogonucleotides, plasmid and viral vectors for gene delivery. The area of clinical genomics explored the relationship between genome variation and complex disease etiology. In the area of bioinformatics, we elucidated functional and evolutionary patterns by integrated analyses of genomic, proteomic and chemical data. In addition I plaid a role as a Senior Product Manager of Omics (proteomics, genomics and toxicogenomics). Also developed and implemented marketing plans, competitive analysis, presentations, demos, product updates and trade event advertising.

Identify, develop, implement and integrate new genomic technologies

Project management of multidisciplinary teams of scientists involved in all aspects of functional genomics and drug discovery

Provided facilities for high-throughput genome technologies and imaging, coupled to robust data integration

Provided leadership in evaluation of new technologies and alternative platforms of strategically importance for CGB

Strength links between basic, applied science and the clinic

Managed the development of new technology platforms identified as likely to generate new spin-off opportunities for CGB

Developed goals, objectives, time lines, and budgets for assigned projects

Prepared development reports summarizing in-house investigations

Build collaborative relationships with management, partners and peers from diverse backgrounds

Analyzed market opportunities and competitive positioning

Devised and implement marketing strategies and tactics to expand market adoption of product line

Participated within a multi-disciplinary team supporting new product development

Provided feedback from customers to help guide continual development of Omics (proteomics, genomics, toxicogenomics etc.) products that more effectively address customers needs

Concept, develop and write original marketing support materials such as data sheets, direct mail, web content, and marketing promotional brochures

Contributed to corporate marketing goals and revenue targets by actively supporting the sales team through lead generation and visit/presentations to customers

Gave formal and informal scientific presentations to prospective partners and collaborators

Established national and international links with academic and industrial colleagues

Sanofi-Aventis (formerly, Rhone Poulenc) 1998 - 2000

Senior Research Scientist, Genomics Section, Asthma/Inflammation Department

At Rhone-Poulenc Rorer (currently Sanofi-Aventis) I was part of the target identification/target validation groups. We used Affymetrix GenChip, Amersham MTAP micro-array system and anti-sense technologies to profile gene expression and target validation. We used these technologies to profile eosinophil gene expression in tissue from donors that have been clinically characterized as normal, mild and severe asthmatics. In addition we designed our own custom Chips with Affymetrix. My two areas of focus were to profile our proprietary sequences and to establish and validate an array of tox genes. I was also involved in setting up anti-sense technologies in house for use in target validation. We had set up a generic-high- throughput method for selection of potent anti-sense molecules for use in validation as well as target identification.

British Lung Foundation (BLF). Southmead Hospital, Bristol UK. 1997 - 1998

Postdoctoral Research Fellow Medical School Unit

National Science Foundation (NSF), University at Albany, SUNY 1993 - 1996

Postdoctoral Research Fellow, Department of Biological Sciences

University at Albany, SUNY Department of Biological Sciences 1992 - 1993

Postdoctoral Research Associate

Essex University 1988 - 1992

Doctoral Candidate in Molecular Biology

Under the supervision of Dr. Glen Stanway studying human rhinovirus structure.

University of Puerto Rico, Biology Department 1987 - 1988

Research Assistant

Project: differential requirement of tRNA genes for expression of a spider fibrogen gene.

PUBLICATIONS

Gama, R.E., Hughes, P.J., Bruce, C.B., and Stanway, G. (1988) Polymerase chain reaction amplification of rhinovirus nucleic acids from clinical material. Nuc.Acids.Res. 16:9346.

Gama, R.E., Horshell, P.R., Hughes, P.J., North, C., Bruce, C.B., Al-Nakib, W., and Stanway, G. (1989) Amplification of rhinovirus specific nucleic acid from clinical samples using the polymerase chain reaction - a novel detection procedure. J. Med. Virol. 28:73-77.

Bruce, C.B., Gama, R.E., Hughes, J., and Stanway, G. (1990) A novel method of typing rhinoviruses using the product of a polymerase chain reaction. Archives of Virology 113:83-87.

Horsnell C, Gama RE, Hughes PJ, Stanway G. (1995) Molecular relationships between 21 human rhinovirus serotypes. J Gen Virol 10: 2549-2555.

Gama, R.E., Du, Y.L., Bauman, J., Chan, T., and McCormick, P.J. (1996) Novel Mouse Repetitive Element Structures in an Embryonal Carcinoma Mutant Cell Line. Oncology Reports 3: 171-174.

Gama, R.E., Du, Y.L., Bauman, J., McCormick, P.J. (1996) Identification of Exons in a Novel Embryonal Locus Using the GRAIL Program. Oncology Reports 3: 371-374.

Gray, J., Acevedo, C., Gama, R.E., and McCormick, P.J. (1997) A t-complex associated embryonic cell surface antigen homologous to mLAMP-1.I.Biochemical and molecular analyses. Exp Cell Res 6: 501-509.

Acevedo, C., Gray, J., Gama, R.E., and McCormick, P.J. (1997) A t-complex associated embryonic surface antigen homologous to mLAMP-1:II Expression and Distribution Analyses. Exp Cell Res 6: 510-518.

Hancock, A., Armstrong. L., Gama, R.E., Millar, A. (1998) Production of Interluking-13 by Alveolar Macrophages from Normal and Fibrotic Lung. A.m. J.. Respir. Cell Mol. Biol 1: 60-65

Gama, R.E., Du, Yun-Long, Chan, T., Bauman, J., and McCormick, P.J. Identification of a unique mouse locus regulating multiple EC cell phenotypes. For Genes and Development. Accepted.

Brenner, V., Lindauer, K., Parkar, A., Fordham, J., Hayes, I., Stow, M., Gama, R., Pollock, K., Jupp, R. (2001) Analysis of cellular adhesion by microarray expression profiling. J. Immunol Methods. 1: 250(1-2): 15-28.

Lijian Shao, Wei Feng, Yan Sun, Hao Bai, Jun Liu, Caroline Currie, Jaejung Kim, Rafael Gama, Zack Wang, Zhijian Qian, Lucy Liaw, Wen-Shu Wu (2009) Generation of iPS cells using defined factors linked via the self-cleaving 2A sequences in a single open reading frame. Cell Research

6: 1-11

PRESENTATIONS AT SCIENTIFIC MEETINGS

Armstrong, L., Gama., R.E., and Millar, A.B. (1997) Interaction between IL-10 and IL-13 in normal human lung alveolar macrophages. Interleukin-10 Workshop. Glasgow, Scotland

Armstrong, L., Hancock, A.L., Gama, R.E., Foley, N., Rankin, E., and Millar, A.B. (1997) Production of Interleukin-13 by alveolar macrophages from healthy subjects and patients with fibrotic lung disease. American Thoracic Society, International Conference. San Francisco, California.

Gama, R.E., Du, Y.L., and McCormick, P.J. (1995) Analysis of a mutant teratocarcinoma cell line created via retroviral insertion. 86th Annual Meeting of the American Association for Cancer Research. Ontario, Canada.

Gama, R.E., Khan, M.A., and Stanway, G. (1991) Rapid accumulation of rhinovirus sequence data using PCR. The Seventh Meeting of the European Study Group on the Molecular Biology of Picornaviruses, Kent at Canterbury, United Kingdom.

Khan, M.A., Gama, R.E., and Stanway, G. (1990) Rapid accumulation of picornavirus sequence data following amplification using conserved primers. VIIIth International Congress of Virology, Berlin, Germany.

Gama, R.E., Bruce, C.B., and Stanway, G. (1990) Analysis of human rhinoviruses using PCR. VIIIth International Congress of Virology, Berlin, Germany.

GRANT SUPPORT

British Lung Foundation (BLF-RAI-P9616). Does the inappropriate regulation of tumor necrosis factor alpha (TNF-alpha) play an important role in the development of cryptogenic fibrosing alveolitis (CFA)? 2/7/97- 1/30/99,direct costs £77,922

National Science Foundation (NSF BIR - 9308040). Genetic analysis of a non-tumorigenic embryonal carcinoma cell line. 10/1/93 - 9/30/96, direct costs $105,000.

HONORS AND AWARDS

1997 - 1998 British Lung Foundation Postdoctoral Fellow.

1993 - 1997 National Science Foundation Postdoctoral Fellow.

1988 - 1991 ORS Award (U.K.) England for Overseas Research.

1984 - 1988 First class honors (Magna Cum Laude), Biology.

Universidad Metropolitana, Puerto Rico, U.S

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