Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc Email and Phone Number

Scientific Consultant @ Commonwealth Health Research Board
Washington, DC, US
Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc's Location
Washington DC-Baltimore Area, United States, United States
Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc's Contact Details

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc work email

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc personal email

About Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc

I am a scientific and regulatory leader with expertise in all facets of scientific research, clinical trials, drug, therapy, vaccine, and medical device development and regulatory approval. With my broad knowledge and skills with the lab and clinical trial development and operations, I am able to effectively test cutting-edge novel medical products for infectious diseases, virology, microbiology, immunology, vaccinology, and oncology. I am also skilled in managing research projects, programs, functional areas, and Clinical Research Organizations (CROs). I have experience in directing cross-functional teams across multiple platforms while successfully accelerating the development and regulatory approval of innovative medical products and digital health technologies. I lead scientific affairs, clinical affairs, Qa/Qc, regulatory affairs, and policy development and implementation for the successful conduct of modern trials such as Decentralized Clinical Trials using innovative Digital Health Technologies. I am an a biomedical innovator, strategist, influencer and communicator who successfully leads organizations’ functional areas, programs and projects with P&L over $1B.Core Competencies:♦ Leadership♦ Strategic Planning♦ Decentralized Clinical Trials ♦ Clinical Trial Design♦ Clinical Research Strategy♦ Clinical Research ♦ Clinical Operations♦ CRO management♦ Drug Development♦ Vaccine Development♦ Infectious Diseases♦ Immunology♦ Virology♦ Viral Oncology♦ Pre-Clinical Research ♦ Research & Development ♦ Policy Development ♦ Clinical Laboratory Assay Development♦ Clinical Laboratory Operations ♦ Digital Medicine Strategy and Operations♦ Digital Health Technologies Strategy and Validation♦ Digital Biomarkers Strategy and Validation ♦ Digital Endpoints Strategy and Validation♦ Public Speaking♦ Regulatory Affairs ♦ Quality Control (QC) ♦ Quality Assurance (QA) ♦ Project Management ♦ Program Management♦ Cross-Functional Team Management♦ Grants Management♦ Contracts Management♦ Budget Management♦ Biomedical Business Development♦ Business Analysis♦ Training

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc's Current Company Details
Commonwealth Health Research Board

Commonwealth Health Research Board

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Scientific Consultant
Washington, DC, US
Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc Work Experience Details
  • Commonwealth Health Research Board
    Scientific Consultant
    Commonwealth Health Research Board
    Washington, Dc, Us
  • Independent Consultancy
    Independent Consultancy
    Washington, Dc, Us
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  • Independent Consultancy
    Independent Consultant
    Independent Consultancy Jan 2023 - Present
    Us
    I lead a scientific, clinical, regulatory, quality, and digital medicine consulting firm. I offer a comprehensive suite of services designed to propel medical product development. Deliver consulting services on:♦ Boosting R&D and Clinical Success: Strategic Planning: Mastermind R&D, translational, and preclinical research, accelerating your path to market.Clinical Trial Design & Operations: Navigate GCP, GLP, GMP, GPV, GXPs and more, ensuring flawless drug, biologic, vaccine and medical device trials (Phase I-IV). I champion modern approaches like DCTs and RWE studies.Scientific Affairs: Craft impactful communications for medical and scientific audiences, and spearhead literature reviews for robust scientific foundations.♦ Ensuring Regulatory and Quality Compliance: Expert Regulatory Applications: Lead development and submission of regulatory filings (INDs, BLAs, NDAs, IDEs, 510(k)s, PMAs, etc.) for regulatory approvals.Regulatory Strategy: Master the art of interacting with regulatory authorities, from initial submissions to post-market support.Quality Management: Implement robust QA/Qc systems and conduct audits, ensuring optimal operations in clinical research and healthcare.♦ Embracing Digital Transformation:Digital Health Expertise: Advise on validation and qualification of digital endpoints, biomarkers, and technologies for successful regulatory navigation.Tech Strategy & Implementation: Guide the design and integration of innovative technological architectures for clinical research.Technology Transfer Leadership: Oversee IP portfolio valuation and license negotiations to maximize your digital assets.My expertise spans diverse therapeutic areas, including oncology, infectious diseases, and rare diseases.Contact me to unlock the full potential of your medical breakthroughs.
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  • California Institute For Regenerative Medicine (Cirm)
    Scientific Reviewer & Grants Review Working Group Member
    California Institute For Regenerative Medicine (Cirm) Jul 2024 - Present
    South San Francisco, California, Us
    My role as a Grants Review Working Group Member is to evaluate and review grant applications submitted to CIRM, ensuring that the most promising and impactful research projects in stem cell and regenerative medicine receive funding and support. I assess these grant applications based on their scientific, clinical, and regulatory affairs, and digital medicine merit, while applying priciples of equity, diversity and inclusion. This ad hoc, voluntary role allows me to contribute to advancing stem cell research while maintaining my primary job as an independent consultant.
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  • Bezyl®
    Strategic Board Advisor
    Bezyl® Oct 2024 - Present
    Phoenix, Az, Us
    Bezyl's mission is to empower individuals and communities by providing accessible, personalized mental health support through a simple, secure, and supportive toolbox, fostering a culture of People Helping People. I provide strategic, operational and implementation advisory services in clinical research, regulatory affairs and digital health technologies associated with mental health and CNS pathologies to Bezyl.
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  • Bluecloud® By Healthcarepoint.Com
    Strategic Board Advisor
    Bluecloud® By Healthcarepoint.Com Jan 2023 - Present
    Cedar Park, Texas, Us
    The mission of BlueCloud by HealthCarePoint is "to unify healthcare and clinical research through connections, modernizing the global ecosystem by empowering every stakeholder to work more productively towards accelerating and improving diagnostics, therapies and cures."I provide strategic advice to the company on innovations related to healthcare systems and the modernization of clinical research enabled by technology while embracing equity, diversity and inclusion.
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  • Reveles, Inc.
    Strategic Board Advisor
    Reveles, Inc. Feb 2023 - Mar 2024
    Dallas/Fort Worth, Texas, Us
    Served as a Strategic Advisor at the Board of Directors for Reveles Inc., to advise on matters related to modern clinical trials development, operations and regulatory affairs such as Decentralized Clinical Trials and customized technologies while fostering equity, diversity and inclusion.
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  • Icon Plc
    Svp, Scientific & Clinical Affairs, Head, Decentralized Clinical Trials & Digital Medicine Strategy
    Icon Plc Nov 2020 - Dec 2022
    Dublin, Ie
    ICON is a leading global contract research and intelligence healthcare organization, providing outsourced clinical development and data solution services to the biotechnology and pharmaceutical industries.Notable Contributions Include:♦ Lead all facets of global corporate strategy to modernize clinical research, implementing decentralized clinical trials (phase II – IV) enabled by novel digital health technologies across all therapeutic areas. ♦ Develop scientific and clinical strategies to implement digital medicine solutions (i.e., digital health technologies or wearable devices, digital endpoints, digital therapeutics, and digital clinical outcome assessments [COAs]) in modern trials such as decentralized clinical trials and real-world evidence. This includes the design of studies for device and digital endpoint verification, validation and usability in compliance with regulations.♦ Lead the strategy for scientific and clinical business growth, increasing profitability and implementing clinical research (DCTs) as a health care option (CRAACO) leveraged with standard health care systems. ♦ Lead medical asset development, consulting on scientific, clinical and regulatory affairs♦ Manage cross-functional scientific and medical affairs relative to DCTs and Digital Medicine, providing direction for customized solutions in clinical trials, programs and projects globally.♦ Represent ICON as a corporate spokesperson in public speaking events to drive the transformative modernization and adoption of decentralized clinical trials and novel technologies in the field, showcasing clinical services and engaging the scientific and medical communities.♦ Develop strategic relationships with regulatory agencies, and pharmaceutical and biotechnology companies, establishing partnerships to create and launch novel medical products.♦ Lead the strategic management and ownership of bid defenses, awards, and project tracking, increasing corporate profitability margins.
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  • Fda
    Fda Officer, Clinical Research Methodology, Regulatory Compliance And Medical Policy Development
    Fda Jul 2018 - Nov 2020
    Silver Spring, Md, Us
    "The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation".Notable Contributions Included:♦ Provided scientific expertise in clinical research methodologies, regulatory compliance and medical policy development of national scope and significance at the Center for Drug Evaluation and Research (CDER).♦ Led medical policy development and a program for Decentralized Clinical Trials using Digital Health Technologies.♦ 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 (BLAs) for compliance with policy, regulatory requirements and licensure and/or approval. ♦ 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 DCTs using DHTs and RWD/RWE. ♦ 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. ♦ Oversaw, research, analyzed and developed strategic plans and goals for programs related to clinical research methodologies that involved complex and high-priority matters, influencing the mission of the FDA.
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  • 4Biosolutions Consulting
    Ceo, Founder
    4Biosolutions Consulting Jan 2017 - Jul 2018
    As the CEO / Founder, I was responsible for leading and directing all operations for a biomedical consulting firm. I provided extensive support to multiple organizations throughout the area, helping with the development and execution of comprehensive and innovative pre-clinical studies and clinical trials. One area of focus was conducting operational management while supporting clinical trial phases (1- 4), lab operations, and monitoring all quality control processes. I was also in charge of business development and acquisitions, where I coordinated work to secure funding for various research projects and clinical trials.As an executive leader, I developed, implemented, and monitored clinical trials across organizations for clients. I partnered and managed Clinical Research Organizations (CROs). With each of these, I analyzed study results and prepared submissions for FDA and EMA licensure of vaccines, drugs, therapies, assays, and devices. I also performed operational management functions, including supervising lab operations and optimizing commercial product development.Notable Contributions Include:♦ Drafted, edited, and proposed various high-level documentation, including grant applications, contract proposals, and scientific documents designed to securing sponsor funding and showcased scientific advances.♦ Streamlined and enhanced operational processes, including improving procedures by which FDA licensure is obtained for lab and medical devices, increasing lab productivity and efficiency.♦ Represented the consulting firm in multiple public speaking engagements, driving business profitability and establishing collaborative partnerships in clinical research. ♦ Consultant and advisor to WHO/PAHO on HPV vaccines and treatments, vaccination programs, and medical policies for the Americas
  • Texas Biomedical Research Institute
    Vice-President For Research
    Texas Biomedical Research Institute Aug 2016 - Jan 2017
    San Antonio, Texas, Us
    Texas Biomedical Research Institute is a non-profit organization conducting basic, pre-clinical and clinical research on chronic and infectious diseases to solve health problems through cutting edge technologies.As the Vice President for Research, I was responsible for developing, implementing, and managing enterprise strategic plans and policies for designing and leading dynamic research for infectious diseases, immunology, virology, vaccines, cancer and genetics. I also led and directed all operations for the lab and research infrastructure, where I worked to reduce costs throughout the organization. I was also in charge of the comprehensive quality control program, where I directed the quality control and quality assurance compliance across the company. In this role, I oversaw and managed all GLP and GCP standards, enabling an increase in data integrity and regulatory compliance within all clinical studies.Notable Contributions Include:♦ Improved organizational management, policy and research operations in Biosafety Level 2, 3 and 4 laboratories for pre-clinical and animal rule studies. ♦ Optimized business and operational processes of 23 staff in 9 units to foster innovation and entrepreneurship, producing 20 new pre-clinical studies.♦ Revitalized and enhanced organizational and research operations, ensuring all regulatory affairs, quality control, and quality assurance functions executed seamlessly to yield more effective compliance and reproducibility of results.♦ Promoted scientific research and entrepreneurship, filing 8 patents. Seeded pilot projects in grants and oversaw management of research funds, stimulating research excellence.
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  • Nih, National Institute Of Dental And Craniofacial Research
    Director, Aids & Immunosuppression Program
    Nih, National Institute Of Dental And Craniofacial Research Aug 2008 - Aug 2016
    Bethesda, Md, Us
    The NIDCR’s mission is "to improve dental, oral, and craniofacial health through research, research training, and the dissemination of health information".During my tenure, I was responsible for directing a national and international program in infectious diseases, virology, microbiology, mycology, oncology, immunology, and vaccines. Within this role, I successfully managed thousands of research projects, pre-clinical studies, and clinical trials (phase 1-3). I also developed a dynamic research vision and strategic plan for the organization. Utilizing the concepts and objectives from these plans, I was able to effectively lead cross-functional teams working on developing drugs, therapies, diagnostics kits, and vaccines. These helped propelled the advancement of health initiatives across various organizations. I also successfully managed and doubled the research budget to $50M during my tenure as Director.Notable Contributions Include: ♦ 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.♦ Enforced clinical trial protocols and regulations while successfully managing comprehensive quality control policies and GLP/GCLP/GMP/GCP procedures, ensuring data integrity across all trial networks while reducing operating costs by $100M.♦ Led the development of policy and optimization of innovative lab diagnostic kits, resulting in the design and research-stage implementation of 10 rapid tests.
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  • Schering-Plough Research Institute
    Senior Clinical Scientist
    Schering-Plough Research Institute Jan 2008 - Aug 2008
    Kenilworth, New Jersey, Us
    Schering-Plough was bought out by Merck & Co., Inc., which mission is “to discover, develop and provide innovative products and services that save and improve lives around the world”. As the Senior Clinical Scientist for the Clinical Program, I successfully launched and directed a phase 2-3 clinical pediatric research program with a $100M budget. In this role, I was responsible for identifying the causes and potential treatments for various respiratory diseases, inflammation, and immunology. I also led the in-depth development of comprehensive strategic plans which introduced genomics and proteomics to clinical trials while directing and managing 10 clinical research associates. My work helped propel six clinical trials to successful outcomes.Notable Contributions Include:♦ 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.♦ Wrote, 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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  • The National Institutes Of Health
    Director, Niaid Hiv Vaccine Research Portfolio - Program And Project Officer - Senior Scientist
    The National Institutes Of Health Jul 2004 - Jan 2008
    Bethesda, Md, Us
    The "NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases". During my tenure, I directed a $100 million program of pre-clinical and clinical HIV/AIDS research in grants, cooperative agreements, and contracts, resulting in hundreds of funded projects in virology, immunology, and vaccinology.Notable Contributions Include:♦ Led program management, yielding the first world’s assay to distinguish HIV infection from vaccine reaction.♦ Led QA/QC proficiency testing of 2 virology and 3 immunology assays in 50 labs, improving results in 100 trials. ♦ Optimized clinical lab operations by issuing the first U.S. guidelines on Good Clinical Laboratory Practice. ♦ Oversaw 5 R&D HIV vaccine contracts valued at ~$50 million, guiding development of vaccine prototypes.♦ Created partnerships between government, industry, academia and non-profit organizations, developing and transferring technologies applied to HIV/AIDS diagnostics and treatment.
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  • The National Institutes Of Health
    Postdoctoral Scientist At Nci
    The National Institutes Of Health Jan 2000 - Jul 2004
    Bethesda, Md, Us
    The “NCI is the federal government's principal agency for cancer research and training”.I conducted basic, translational and clinical research focused on HIV/AIDS and Kaposi’s sarcoma, which is one of the most common AIDS defining cancers. My goal was to understand events leading to HIV infection and virus-induced cancer, and to determine immune response mechanisms that can be harnessed against HIV and viral induced cancers.Notable Contributions Include:♦ Defined the mechanism of action of IP-10 against Kaposi’s sarcoma, activating killing in Natural Killer cells. ♦ Determined activity of Interleukin-12 in AIDS-related Kaposi’s sarcoma, yielding 73% remission in a Phase I clinical trial.♦ Tested Cidofovir in a Phase I clinical trial of AIDS patients with Kaposi’s sarcoma, blocking late viral gene expression.
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  • The National Institutes Of Health
    Postdoctoral Scientist At Nia
    The National Institutes Of Health May 1999 - Jan 2000
    Bethesda, Md, Us
    The NIA “leads the federal government in conducting and supporting research on aging and the health and well-being of older people”.I conducted basic and translational research on HIV/AIDS linking virology and immunology approaches to aging. My goal was to understand how aging and immune-senescence impairs biological functions on immune defense cells, enabling HIV infection and systemic viral dissemination. Notable Contributions Include:♦ Showed that dendritic cell maturation increases susceptibility to HIV infection, increasing systemic spread. ♦ Contributed to the development of a clinical research blood donor program for the city of Baltimore, MD.
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Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc Skills

Immunology Infectious Diseases Clinical Trials Molecular Biology Vaccines Cell Biology Oncology Clinical Development Microbiology Life Sciences Assay Development Gcp Cell Cancer Biotechnology Clinical Research Science Cell Culture Regulatory Affairs Data Analysis R&d Laboratory Fda Lifesciences Genetics Protein Expression Drug Development Elisa Genomics Scientific Writing Pharmaceutical Industry Biochemistry Drug Discovery Neuroscience Flow Cytometry Global Health Quality Assurance Validation Epidemiology Technology Transfer Qa/qc Business Development Program Management Strategic Planning Leadership Team Management Virology Protocol Translational Medicine Science Management Global Regulatory Compliance

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc Education Details

  • University Of Delaware
    University Of Delaware
    Animal Science: Virology And Immunology Fields
  • Duke University School Of Medicine
    Duke University School Of Medicine
    Health Sciences In Clinical Research
  • Venezuelan Institute For Scientific Research -Ivic
    Venezuelan Institute For Scientific Research -Ivic
    Microbiology And Virology
  • Universidad Central De Venezuela
    Universidad Central De Venezuela
    Major In Biology - Minor Microbiology

Frequently Asked Questions about Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc

What company does Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc work for?

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc works for Commonwealth Health Research Board

What is Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc's role at the current company?

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc's current role is Scientific Consultant.

What is Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc's email address?

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc's email address is mh****@****plc.com

What schools did Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc attend?

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc attended University Of Delaware, Duke University School Of Medicine, Venezuelan Institute For Scientific Research -Ivic, Universidad Central De Venezuela.

What skills is Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc known for?

Isaac R. Rodriguez-Chavez, Phd, Mhsc, Msc has skills like Immunology, Infectious Diseases, Clinical Trials, Molecular Biology, Vaccines, Cell Biology, Oncology, Clinical Development, Microbiology, Life Sciences, Assay Development, Gcp.

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