Science Technology Policy Advisor /Technical Writer /SME

Linda C Duffy, PhD, MPH...

301-***-**** • Wells, ME • *****.*****@*****.**.*** • www.linkedin.com/in/linda-duffy-830197193/ Highly versatile Translational Science Technology and Clinical Advisor, Subject Matter Expert, and Thought Leader who leverages a distinguished career in public, private, and academic sectors to advance research initiatives in the life sciences and support new products development (i.e., novel ingredients, medical devices, drug safety). Creative problem solver and calculated risk taker bringing innovation, ethical best practices, and regulatory insights to the development of programs and public/private collaborations. Transformational leader progressing through roles of increased impact leading up to thought leader advising and influencing US science policy.

Extensive Network: Designed and led key initiatives as Scientific Advisor for interagency Roadmap and Grand Challenge programs working with 27 institutes/centers within the National Institutes of Health (NIH), US Department of Health and Human Services (DHHS), and partnered agencies. Collaborations included: US FDA, FTC, USDA, CDC, SBA, DoD, DoE, EPA, OSTP, and the Institute of Medicine.

Science Policy Development: Instrumental to a large number of funded public/private organizations securing grants from NIH to conduct biomedical research, utilizing in-depth knowledge of science, research protocols, and NIH policy requirements.

National Program Development: Launched and chaired the Transnational NIH Probiotics, Prebiotics, and Microbiome Interagency Work Group to identify research gaps and challenges within those areas and seek compelling submissions from both public and private agencies/organizations.

Public Sector Recognition: Received the DHHS/NIH and Office of the Secretary Interagency Innovation Award, resulting in an expanded role with international influence working with USDA and EFSA (European Food and Safety), and with NIH, USDA, DoD, and FDA in developing prototypes for genomic and biomarker safety in real- time biosurveillance.

Innovation: Championed development of a digital monitoring system for standards in areas of expertise (i.e., best practice microbial ecology and safety biomarkers) and delivery prototype for pre-AI systems.

Thought Leadership Subject Matter Expertise (SME): Authored more than 150 publications, many addressing science policy challenges, including Emerging Infections, Probiotic and Prebiotics Microbiome, Microecology, Genomic Medicine, Epidemiology, regulatory safety, and risk management. Executive Strengths and Subject Matter Expertise to Improve Outcomes

Life Sciences Biotechnology Healthcare Verticals

Strategic Planning Health Science Administration

Science Public Policy Development and Advisory

Risk Management Regulatory Compliance

Senior Scientific and Technical Writer

Scientific Advisory Boards Strategic Partnerships

Relationship Management: Public and Private Sectors, Interagency, and Cross-Disciplinary

Mentor and Team Leader to Scientific, Research, and Academic Staff

Relevant Experience Serving as Scientific Advisor

and Building Private/Public Collaborations

MARS RESEARCH REVIEW BOARD (MRRB) 2020 – Present

SCIENTIFIC ADVISORY BOARD MEMBER

Thought leader providing expertise on safety, bioethics, science policy, and governance practices for one of the largest food companies in the world. Technical writer preparing and presenting reports for the MRRB on a quarterly basis.

Offer SME-level expertise during the development of novel food ingredients (human and animal consumption) to ensure adherence to the highest scientific and ethical standards set by MARS and external regulatory bodies.

Play a vital role in ensuring novel ingredients developed by MARS secure best practice standards and meet regulatory compliance with the FDA and USDA.

Advise and make recommendations on new or changing regulatory mandates and science codes.

Review research findings and comment on the design of scientific studies (i.e., preclinical, clinical) and results. ADVANCING RESEARCH AND FACILITATING

INNOVATION IN THE LIFE SCIENCES

Linda C Duffy, PhD, MPH Page 2

INSTITUTE FOR SCIENCE ON GLOBAL POLICY (ISGP) 2020 – Present SCIENTIFIC ADVISORY BOARD MEMBER

Invited by ISGP to serve as Science Technology Advisor and board member for the international invitation-only conference sponsor. Collaborate with other prominent thought leaders and advisory board members in supporting public/private relationships.

Review and author reports on submissions from government agencies, industry leaders (i.e., food manufacturers, pharmaceutical), distinguished scientists, and technologists that inform ISGP and facilitate selection of topics for forums, conferences, and workshops.

KIBOW BIOTECH, INC 2020 – Present

SCIENTIFIC ADVISOR

Invited to serve as advisor and SME on the latest delivery systems for the biotechnology company specializing in patented and proprietary probiotic and prebiotic dietary supplements. NATIONAL INSTITUTES OF HEALTH (NIH), Bethesda, MD 2004 – 2020 THOUGHT LEADER, US Department of Health and Human Services (DHHS), Office of the Secretary HEALTH SCIENTIST ADMINISTRATOR, National Center for Complementary and Integrative Health (NIH/NCCIH) SCIENTIFIC DIRECTOR, Interagency Program Initiatives Held dual roles as Health Scientist Administrator for NCCIH and Interagency NIH Scientific Director for one of the nation’s foremost medical research centers and the largest public funder of biomedical research in the world. Progressed as thought leader in primary areas of expertise influencing science and technology policy for the US and globally. Directed multiple programs, including Trans-NIH and DHHS Interagency Validation and Technology Consortium, interagency committees, workgroups, and Probiotics/Prebiotics Microbiome. Chairperson for the Probiotic and Microecology Review Board.

Collaborated with multiple groups within NIH in setting the standards for probiotics, prebiotics, and delivery systems that covered all prerequisites (i.e., safety and toxicity) to enable organizations to successfully navigate through regulatory processes and secure NIH funding.

Collaborated with DoD affiated agencies in Inter-agency educational conferences and workshops on Best Practice standards including microbiome discovery and research developmenrt; biodefense; global health security; emerging infections and HIV/AIDS programs.

Built national programs in areas of expertise and scientific issues (i.e., emerging infection), crafting funding announcements, recommending grant recipients, and monitoring progress for continued funding.

Mentored scientific investigators working on probiotics, nutritional ingredients, biologics, and dietary supplements around the country to ensure studies met stringent protocols and products were tested for safety, toxicity, tolerance for humans, and demonstrated effectiveness of health outcomes.

Gained extensive experience working on SOPS and SOWs in translational medicine testing biosafety quality standards, IND and BLA regulatory protocols, validation testing for biomarkers, devices, with the NIH nd FDA to ensure trial quality. Research initiatives included HIV-AIDS and Covid-19 protocols with NIH grantees and SBIR investigators.

Selected as Chairperson for multiple NIH Science Program Review Boards and most recently, the NIEHS Board of Advisors that evaluates the quality of science for field topics in microecology, emerging infection, and probiotics, and makes final decisions on grants.

Invited Science/Technology Board Advisor to the Institute on Science for Global Policy Conference Series: including the recent COVID-192023 Conference titled: Foresight from the COVID-19 Pandemic: Science, Policy, Communication

https://www.bing.com/search?q=ISGP+Covid19+Conference&form=ANSPH1&refig=0be5850a948f49a1be4f6f01ba6 983e2&pc=HCTS text=Web,Foresight%20from%20the%20COVID%2D19%20Pandemic%3A%20Science%2C%20Polic y%2C%20Communication%20(COVID%2DSPC),-COVID%2DSPC%3B%20... Additional Experience

UNIVERSITY AT BUFFALO (SUNY/UB): Dual Appointments – Tenured Fulltime Professor, Senior Scientist, and University-Medical Center Consortia Leader

Broad multifunctional role developing programs, defining strategic vision for key areas, managing budgets for optimal ROI, and providing leadership to a team of 50+ research and training staff. Linda C Duffy, PhD, MPH Page 3

Built national consortia programs in infectious disease, microbial pathogenesis science research, and pediatrics health outcomes that included both academic medicine departments and clinical research hospital-wide systems.

Succeeded with competitive awards totaling over $30M in funding from public and private sponsors during major merger of UB Women and Children’s Hospital Health System.

Taught curriculum on Epidemiology, Laboratory Validation Strategies, and Risk Management Methodologies to graduate, medical students, and post-doctoral candidates.

Trained graduates, fellows, and junior faculty in Molecular Epidemiology, Infectious Disease, and Pediatrics.

Served as NIH and USDA/DRI Grant Investigator and ad hoc Expert Reviewer for NICHD, FDA, and the USDA. LANDMARKWORLDWIDE.COM: Program Introduction Leader and Volunteer Coach (2013 – Present) WCHRF INSTITUTE: Early Career Research Director and Executive Officer, Kaleida Health System PEACE CORPS: Returned volunteer focused on epidemiology training and monitoring in Cote d'Ivoire West Africa. Education and Executive Leadership Development

Dual PhD, University at Buffalo (SUNY), Buffalo, New York - 1987 Pre-and Post-Doctoral NIH/NCI Training Fellowships, Medical Sociology and Infectious Disease Epidemiology Masters in Life Science and Pre-Doctorate [MALS], Medical Anthropology and Microecology, Dartmouth College, Hanover, NH - 1978

Masters of Public Health [MPH], University at Buffalo (SUNY) and University of Massachusetts Amherst - 1983 Executive Training – Transformative Leadership Program, Landmark Worldwide 2009-2024 Federal Leadership Development Programs Certificates 2004-2018 Federal Government Merit and Director Distinction Awards 2008, 2010, 2014, 2016, 2018 Addendum – Thought Leadership (Selected from 150+ Peer-Reviewed Publications) Khalsa, J, Duffy, LC, Hubbard, V, Starke-Reed, P, Riscuta G. “Omics for Understanding the Gut-Liver Microbiome Axis and Precision Medicine.” [In review from NIDA Workshop Proceedings Special Ed. [CPDD Sept/Oct 2016]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410496/ (July 2016) Maruvada P, Lampe J; Wishart D; Barupal D; Chester D; Duffy, LC.; Pamela Starke-Reed, P; et.al. “Microbiome and Epigenetics in the Era of Precision Medicine” Methods in Molecular Biology Book Series 1856:141-156 (May 2019). Maruvada P, Lampe JW, Wishart DS, Barupal D, Chester DN, Dodd D, Djoumbou-Feunang Y, Dorrestein PC, Dragsted LO, Draper J, Duffy LC; et.al. Advanced Nutrition 2020 Mar 1;11(2):200-215. Khalsa, J, Duffy, LC, Hubbard, V, Starke-Reed, P, Riscuta G. “Omics for Understanding the Gut-Liver Microbiome Axis and Precision Medicine.” [In review from NIDA Workshop Proceedings Special Ed. [CPDD Sept/Oct 2016]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410496/ (July 2016). Duffy LC, Raiten D, Hubbard V, Starke-Reed P. “Progress and challenges in developing metabolic footprints from diet in human gut microbial co-metabolism.” Journal of Nutrition; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4410496/

(Accepted for publication Aug 2014; published online Apr 2015; printed issued May, 2015). Duffy, LC. NIH Advisory Member: NIH Probiotics White Paper - “Federal regulation of probiotics: An analysis of the existing regulatory framework and recommendations for alternative frameworks” NIH/NHGRI Grant Award: 5R01HG005171 http://www.law.umaryland.edu/programs/health/events/probiotics/ (Oct 2013). Duffy, LC. NIH Advisory Member: AHRQ Evidence Report: Probiotic Safety - Safety Report/Technology Assessment #200 http://www.ahrq.gov/downloads/pub/evidence/pdf/probiotics/probiotics.pdf (Jun 2011). Duffy, LC “Interactions Mediating Bacterial Translocation in the Immature Intestine, Journal of Nutrition, 2000 Feb;130(2S Suppl):432S-436S. doi 0.1093/jn/130.2.432S.PMID: 10721921 Review. Debater Duffy, LC - SME Public-Private Policy Forum: Foresight from the COVID-19 Pandemic: Science, Policy, Communication (COVID-SPC) – institute on Science for Global Policy Proceedings ISGP (scienceforglobalpolicy.org); Feb 27-Mar 2, 2023.

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