Expert Details
Scientific, Clinical, Medical, and Regulatory Affairs
ID: 738668
Maryland, USA
Expert is a leader in strategic planning and in implementing transformative change management within high-profile organizations. He possesses broad knowledge and expertise in clinical trial design, execution, operations, and completion, working across functional environments and multiple therapeutic areas. He leads all aspects of work at clinical laboratories and the design and conduct of Real-World Evidence and Decentralized Clinical Trials using digital health technologies, artificial intelligence, and machine learning to test cutting-edge medical products in the fields of infectious diseases, virology, microbiology, immunology, vaccinology, and oncology.
Expert is skilled in directing Clinical Research Organizations, vendors, and cross-functional teams across multiple functional units, leading the development of innovative biomedical products. Collaborative communicator with success managing programs and leading thousands of projects from conception through completion worth over $1 billion.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1999 | Degree: PhD | Subject: Virology and Immunology | Institution: University of Delaware |
| Year: 2007 | Degree: MHS | Subject: Health Sciences and Clinical Research | Institution: Duke University, School of Medicine |
| Year: 2003 | Degree: MS | Subject: Microbiology | Institution: Venezuelan Institute for Scientific Research, IVIC |
| Year: 1988 | Degree: BS | Subject: Biology | Institution: Central University of Venezuela, UCV |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2020 to Present | Employer: Undisclosed | Title: Senior Vice President, Scientific, Clinical and Regulatory Affairs | Department: Drug Development Services |
Responsibilities:Expert is Head of Decentralized Clinical Trials and Digital Medicine.In this capacity, he leads the scientific, clinical, regulatory, and business strategy for a global functional center of excellence on decentralized clinical trials (DCT's) and Digital Medicine. He has also led the strategic development and deployment of modern trial designs with the use of digital health technologies (DHT's), digital therapeutics (DTx), leveraging them with healthcare systems in a broad range of therapeutic areas for drugs, biologics, vaccines, medical devices, and clinical data solution services for the industry worldwide. Expert clinically leads all aspects of global corporate strategy and clinical trial designs and operations to modernize trials, implementing multiple DCT's (phase I – IV) enabled by DHT's across therapeutic areas. He also leads the strategy for scientific and clinical business growth, increasing profitability (P&L) by over $1 billion and implementing clinical trials as a healthcare option (CRAACO) leveraged with standard healthcare systems. Expert leads over 100 employees in cross-functional teams for scientific, medical, and regulatory affairs, providing direction for customized solutions in clinical trials, programs, and projects globally. He also represents this company as a corporate spokesperson to drive the transformative modernization and field adoption of DCT's, DHT's, and DTx, showcasing clinical services and engaging with biomedical communities. Expert develops strategic customer relationships with pharmaceutical and biotechnology companies, establishing partnerships to create and test efficacy and safety of novel medical products. He also leads regulatory submissions and establishes strategic relationships with regulatory agencies, contributing to medical policy development to support the implementation of modern trials enabled by technology. Expert is responsible for leading the strategic management and ownership of bid defenses, awards, and project tracking, increasing corporate profitability margins. Finally, he leads publication and reports for multiple scientific projects and clinical trial results in peer-review journals and present findings in conferences. |
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| Years | Employer | Title | Department |
| Years: 2018 to 2020 | Employer: Food and Drug Administration | Title: Senior Office | Department: Clinical Research Methodologies, Regulatory Compliance, Medical Policy Development |
Responsibilities:Expert provided scientific, clinical research, and regulatory leadership to develop, communicate, implement and coordinate medical and health science policy, procedures, policy initiatives, and programs across the FDA.This work included supporting drugs, vaccines, biologics, and devices development and approval, monitoring bioresearch activities, appraising the protection of human subjects, evaluating post-market surveillance procedures, overseeing 503a/b facilities, and assessing science and efficacy of interventional and non-interventional clinical research (phase I – IV clinical trials) nationwide. Expert led the development of regulations and policies for clinical research methodologies, keeping consistency with statutory requirements and existing policies. He a team of 12 employees and headed FDA’s clinical research modernization projects for drugs, vaccines, biologics, and devices in decentralized clinical trials, digital health technologies, electronic platforms used in clinical trials, AI, and digital intelligence; real-world data and evidence (RWD and RWE), and electronic systems, records and signatures used in clinical investigations. During this time, Expert also provided regulatory, scientific, and clinical research expertise regarding the design adequacy of proposed clinical trials and clinical programs submitted to the FDA under Investigational New Drug (IND) Applications and Biologics License Applications (BLA's) for compliance with policy, regulatory requirements and licensure and/or approval. He also served as a recognized, senior government-wide expert, advising FDA officials and outside stakeholders about FDA statutes and regulations regarding the modernization of clinical trials, including DCT's using DHT's, RWD/RWE, as well as regulations for medical compounding activities under FDA 503a/b licensure. During this time, Expert also represented the FDA when disseminating medical, clinical research, and health science information, regulatory views, and new policies in scientific, medical, and regulatory meetings in the U.S. and overseas, fostering public health safety and engaging outside organizations with the FDA for the licensure and/or approval of products. He also oversaw, researched, analyzed, and developed strategic plans and goals for programs related to clinical research methodologies that involve complex and high-priority matters, influencing the mission of the FDA. |
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| Years | Employer | Title | Department |
| Years: 2017 to 2018 | Employer: (Undisclosed) | Title: CEO and Founder | Department: |
Responsibilities:Expert directed a biomedical consulting firm, providing comprehensive support to various organizations to improve pre-clinical studies and clinical trials (phase I – IV). In this capacity, he monitored lab operations, optimized regulatory compliance, enhanced quality assurance (QA) and control (QC), and secured funding for research projects and clinical trials.Expert developed, implemented, and monitored clinical trials, analyzing study results and preparing submissions for FDA and EMA licensure and/or approval of vaccines, drugs, assays, and devices. He also conducted operational management functions, supervising CRO's, pre-clinical and clinical lab operations, and optimizing commercial product development. In this role, Expert drafted, edited, and proposed various high-level documentation, including grant applications, contract proposals, and scientific documents designed to securing sponsor funding and showcase scientific advances. He also supervised multiple contractors for the conduct of pre-clinical, clinical, QA and QC, and fundraising projects worth over $10 million. |
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| Years | Employer | Title | Department |
| Years: 2016 to 2017 | Employer: Texas Biomedical Research Institute | Title: VP of Research | Department: |
Responsibilities:Expert developed and implemented TBRI’s strategic plan and policies to lead complex research for cancer, infectious diseases, vaccines, and genetics. He directed lab operations and research infrastructure, reducing costs. He also managed $80 million in research projects and clinical trials, increasing scientific revenue.During this time, Expert increased TBRI’s innovative projects in vaccine and drug development by 30%, attracting $24 million in projects. He also initiated and managed cutting-edge program management processes, leading strategic business and drug development initiatives, resulting in 20% increase in successful grant and contract submission and a 20% decrease in clinical operation costs. Expert directed QA and QC compliance throughout the organization, managing all GLP and GCP standards to increase data integrity and FDA and EMA compliance across pre-clinical and clinical studies. He also optimized business and operational processes of 23 staff in 9 units to foster innovation and entrepreneurship, producing 20 new pre-clinical studies and clinical trials. |
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| Years | Employer | Title | Department |
| Years: 2008 to 2016 | Employer: National Institute of Dental and Craniofacial Research | Title: Director, AIDS and Immunosuppression Program; Health Scientist Administrator | Department: |
Responsibilities:Expert irected a national and international oncology, immunology, and infectious diseases program for HIV/AIDS and comorbidities, effectively managing 2,000+ research projects, pre-clinical studies, and clinical trials (phase I-III). He established a research vision and strategic plan and managed and doubled research budget to $50 million.During this time, Expert coordinated with cross-functional teams, directing the development of various drugs, therapies, diagnostics kits, and vaccines to drive the advancement of health initiatives across organizations. He collaborated with area organizations to design and implement 2 clinical trial networks utilizing GCP, implementing 12 clinical trials, increasing program scope from 3 to 10 fields of science, and improving business opportunities. Expert also enforced clinical trial protocols and regulations while successfully managing comprehensive quality control policies, CRO's, and GLP/GCLP/GMP/GCP procedures, ensuring data integrity across all trial networks while reducing operating costs by $100 million. During this time, Expert published 31 funding documents and delivered 40 presentations to attract scientific and clinical business, leading to 2,000+ funded research projects for the organization. He led the development of policy and optimization of innovative lab diagnostic kits, resulting in the design and implementation of 10 rapid tests. |
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| Years | Employer | Title | Department |
| Years: 2008 to 2008 | Employer: Schering-Plough Corporation | Title: Senior Clinical Scientist | Department: Clinical Program, Respiratory Diseases |
Responsibilities:Expert launched and directed a $100 million phase II-III clinical pediatric research program, identifying causes and potential treatments for respiratory diseases, inflammation, and immunology.He also led strategic planning, introducing genomics and proteomics to clinical trials. He directed the work of a CRO and 10 clinical research associates, driving success in 6 clinical trials. During this time, Expert developed and implemented multiple documents and plans, including policies, procedures, trial protocols, management strategies, and operational plans, governing and directing clinical trials, maximizing efficiencies, and enhancing success rates. He also drafted, reviewed, and edited various regulatory submission documents to support clinical trial data, leading to approved FDA and EMA licensure of 2 products. |
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| Years | Employer | Title | Department |
| Years: 1999 to 2008 | Employer: Various | Title: Various | Department: |
Responsibilities:Expert served the National Institute of Allergy and Infectious Diseases as Director of HIV Vaccine Pre-clinical and Clinical Research from 2004 to 2008.Previously, he was Post-Doctoral Researcher in Viral Oncology at the National Cancer Institute from 2000 to 2004. Before this time, Expert was Post-Doctoral Researcher in Viral Immunology at the National Institute on Aging from 1999 to 2000. |
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Career Accomplishments
| Associations / Societies |
|---|
| Full memberships: International AIDS Society (2012-present) American Association of Dental Research and International Association for Dental Research (2010-present) American Association of Immunologists (2004-present) American Society for Virology (1998-present) American Society for Microbiology (1998-present) American Association for the Advancement of Science (1998-present) Association of Clinical Research Professionals (2004-present) New York Academy of Sciences (1999-present) Society of Quality Assurance (2008-present) The Poultry Science Association and World Poultry Science Association (1998-present) American Association of Avian Pathologists (1998-present) Digital Medical Society (2019-present) Regulatory Affairs Professional Society (RAPS) (2020-present) IEEE association for standards (2020-present) Infectious Diseases Society of America (2022-present) American Federation for Medical Research (2022-present) |
| Licenses / Certifications |
|---|
| FAC-COR Certification |
| Professional Appointments |
|---|
| Digital Medicine Society (2019-present) Board Member, Scientific Leadership Board and Co-Chair, DiME's Research Committee The Digital Medicine Society (DiMe) is a global non-profit and the professional home for all members of the digital medicine community. Together, we drive scientific progress and broad acceptance of digital medicine to enhance public health. Spheres: Science, digital medicine tools and approaches, and technology In this capacity, Expert serves as an advisor for regulatory science, scientific programs, modern clinical research projects, and digital health technology initiatives for DiME's agenda. IEEE Standards Association: Decentralized Clinical Trials (2019-present) Regulatory Science Officer and Vice Chair for the IEEE: SA Decentralized Clinical Trials Science, Technology, and Regulatory Affairs IEEE SA-DCTs include members representing technological innovation, global participation, and dedication to the ongoing advancement and promotion of new concepts on Decentralized Clinical Trials (DCT's) enabled by Digital Health Technologies (DHT's). IEEE SA continues to be proactive in meeting industry needs and responsive to worldwide standards issues. Expert is a Regulatory Science Officer, Advisor, and Vice Chair of the IEEE SA-DCTs/DHTs. He advises the program on regulatory, scientific and clinical research matters for the development of peer-reviewed publications and ISO standards relative to DCTs enabled by DHTs. Decentralized Trials and Research Alliance (DTRA) (2020-present) Council Board Member Health, Science, Technology, and Modern Clinical Research The Decentralized Trials and Research Alliance enables the collaboration of stakeholders to accelerate the adoption of patient-focused, decentralized clinical trials (DCT's) and research within life sciences and healthcare through education and research. DTRA's vision is to make research participation accessible to everyone, enabled by the consistent, widespread adoption of appropriate decentralized research methods. Expert is involved in collaborative work under DTRA with multiple stakeholders from the industry, government, and non-profit organizations to accelerate the implementation of decentralized clinical trials and patient-centric clinical research approaches within life sciences and healthcare through education and research. Expert is a member of the leadership committee for DTRA's Regulatory Science Initiatives, which addresses regulatory science and medical policy advocacy projects. DIA Global Forum Magazine (2020-present) Editorial Board Member and Editor for Regulatory Science Health and Regulatory Policy Under the leadership of the Editor-in-Chief, Global Forum, the Global Forum Editorial Board consists of Content Stream Editors and Regional Editors whose role is to develop materials for online publication and connect the pharmaceutical industry and biomedical community with contemporary topics of common interest. Expert provides leadership as a content editor for regulatory science -- the science of developing new tools, standards, evidence, and approaches necessary to assess the safety, efficacy, quality, and performance of regulated products. Global Genes, RARE Health Equity Council (2021-present) Board Member Health, Equity, Diversity, and Inclusion The RARE Health Equity Leadership Council's goal is to better understand the persistent gaps in diagnostic challenges for underserved/underrepresented patient communities and align on how to take action to address the health inequities of the rare disease community. The council is focused on building a more equitable paradigm for access, care, and research for patients, families, and advocates in the rare disease community. Expert is instrumental in informing and guiding the Global Genes' programs, content, and advocacy to support more equitable access, care, and research for patients, families, and advocates in the rare disease community as well as supporting health equity capacity building for patient organizations. Hypertrophic Cardiomyopathy Association (HCMA) (2020-present) Board Member Health HCMA provides support, advocacy, and education to patients, families, the medical community, and the public about hypertrophic cardiomyopathy while supporting research and fostering the development of treatments. Expert is actively involved in health policy development and the education of patients, families and the medical community about hypertrophic cardiomyopathy (HCM) while raising awareness about research and fostering the development of treatments. The National Association Of Hispanic Federal Executives (2015-2016) President, PhD Chapter Education NAHFE’s goal is to seek partnerships with federal agencies to disseminate information and provide training to enhance Hispanic member qualifications leading to promotion into the Senior Executive Service (SES). Expert led NAHFE’s efforts to train and enhance competencies of PhD professionals to obtain senior leadership positions in the federal government, including SES jobs. |
| Awards / Recognition |
|---|
| FDA award for excellence in employee performance (2019) NIDCR Director’s award for excellent in scientific leadership (2016) NIH Director’s award for outstanding public health service (2015) NIDCR award for work excellence in Virology and Immunology (2015) 7th World Workshop on Oral Health and Disease in AIDS (WW7) -- four awards for scientific work conducted for this congress. NIH Office of the Director, two honor awards for re-designing the NIH-wide extramural training core curriculum, and for developing an online training curriculum for NIH health scientist administrators. Special NIDCR award for creating a strategic roadmap for a sponsored clinical network –OHARA (2010). NIDCR award for excellence in employee performance (2009, 2011, 2012, 2013, 2014) 6th World Workshop on Oral Health and Diseases in AIDS (WW6) award for scientific leadership. NIAID Director’s award for excellence in employee performance. NIH Office of the Director’s award for employee volunteer of the year. NCI Office of the Director’s full honors scholarship for Master of Health Sciences and Clinical Research. NCI Office of the Director’s training award for excellence in cancer research as a post-doctoral fellow. NIA Office of the Director training award for excellence in HIV/AIDS research as a post-doctoral fellow. University of Delaware, Alpha Zeta Science Honor Society’s award for student research excellence. University of Delaware’s full honors scholarship for Doctor of Philosophy. Pediatric AIDS Foundation’s award for research excellence as a young Investigator. Venezuelan Institute for Scientific Research’s full honors scholarship for Master of Science in Microbiology. Central University of Venezuela’s full honors scholarship for Bachelor of Science. |
| Publications and Patents Summary |
|---|
| Expert has 21 scientific publications, 22 scientific abstracts, 31 technical publications, and over 100 invited presentations. |
Additional Experience
| Expert Witness Experience |
|---|
| None |
| Training / Seminars |
|---|
| Not applicable |
| Vendor Selection |
|---|
| Not applicable |
| Marketing Experience |
|---|
| Not applicable |
| Other Relevant Experience |
|---|
| Not applicable |
Language Skills
| Language | Proficiency |
|---|---|
| Spanish | Native |
| English | Fluent |
Fields of Expertise
clinical research, clinical diagnostics, clinical laboratory, clinical flow cytometry, clinical immunology, clinical laboratory regulation, clinical medicine, clinical microbiology, clinical protocol, Clinical Quality and Accreditation, clinical serology, clinical study, clinical trial design, clinical trial, Clinical Trial Management Systems (CTMS), Good Clinical Practice, clinical virology, medical device clinical research, preclinical research, science management, life science research, medical science, telemedicine, molecular medicine, virology, retrovirology, cancer immunology, cellular immunology, comparative immunology, diagnostic laboratory immunology, humoral immunology, molecular immunology, infectious disease, infectious disease diagnosis, infectious disease transmission, infectious disease treatment, infectious lymphatic system disease, infectious systemic disease, pediatric infectious disease, genetics, vaccines, diseases and health, mRNA vaccines, mucosal vaccine, vaccine delivery, vaccine development, vaccine, vaccine research, vaccine vector, medical microbiology, microbiology, microbiology laboratory, molecular microbiology, healthcare regulatory compliance, regulatory affairs, regulatory approval, regulatory compliance, regulatory compliance auditing, regulatory organization, antiviral agent, antiviral drug, viral assay, viral disease, viral culture, viral hepatitis, viral pneumonia, oncology, dental oncology, cancer diagnosis, cancer immunotherapy, cancer research, cancer treatment, oral cancer