About Us

Vision

Our vision is bold yet simple: to reduce the Pediatric Gap from 9 to 5 years, because children can’t wait.

Mission

We drive innovation to improve and expedite pediatric drug development for the benefit of children.

History

The Institute for Advanced Clinical Trials for Children is a 501(c)(3) non-profit organization. IACT4C is funded through grants and memberships by biopharmaceutical companies, and philanthropy. IACT4C was founded in 2017. It emerged from the vision of multistakeholder leaders in pediatric drug development assembled by the American Academy of Pediatrics. These stakeholders recognized that children needed better access to safe, effective pediatric drugs, biologics and medical devices. I-ACT4C was established to meet these needs by providing the resources necessary to conduct efficient and effective pediatric clinical trials.

Learning Center

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Regulatory-Quality Trial-Ready Clinical Sites

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Expert Guidance on Strategy, Planning & Compliance

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Quality Improvement Initiatives

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Building the Foundation

The Pediatric Research Site Network

Expert Guidance on Strategy, Planning & Compliance

Expert consultation on the overall approach to pediatric drug development required for Pediatric Study Plans (PSPs), Paediatric Investigational Plans (PIPs), and Proposed Pediatric Study Requests (PPSRs). Expert guidance on pediatric trial design, including age-appropriate methodologies, clinical pharmacology, safety, and compliance with regulatory requirements. Assistance with navigating complex regulatory landscapes, ensuring compliance with pediatric-specific regulations and guidelines.

Learning Center

Quality Improvement Initiatives

Leadership

Our leadership team drives our mission, guides our strategy and leads our people. Learn more about our Executive Team and Board Members.

Executive Team

Vivianna Guzman
Executive Director

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Ms. Guzman joined IACT4C in March 2023. She brings extensive experience as a Not-for-Profit association executive who has provided global strategy, financial and operational leadership over the past 25 years.

Ms. Guzman served as Executive Vice President, Head of the Global Division and Chief Financial Officer for the American Management Association, and Chief Financial Officer for the New York Public Radio and Drug Information Association. Ms. Guzman’s distinguished career spans other sectors, including public accounting, private equity, consulting, and financial services organizations.

Albert “AJ” Allen
Chief Medical Officer

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Albert John “AJ” Allen, MD, PhD, joined IACT4C as its Chief Medical Officer in August 2023. However, AJ was involved in several events leading up to and including its creation. As CMO, AJ will provide medical (pediatric) and product development expertise for IACT4C.

Albert John “AJ” Allen, M.D., Ph.D., is a child and adolescent psychiatrist and pharmacologist with over 75 publications in pharmacology, child psychiatry, human abuse potential assessment, pediatric drug development, drug safety, and bioethics.

In 2000, he joined Lilly as a global research physician, where he held many roles until his retirement in December 2021. AJ's roles centered around developing policies, programs and infrastructure to improve pediatric drug development efforts across Lilly's portfolio.

AJ received a BS in chemistry with general honors and an MS in biochemistry from the University of Chicago in 1980. He received his MD and a PhD in pharmacology from the University of Iowa in 1988.

Laura Lopez
Chief Financial and Administrative Officer

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Laura Lopez joined IACT4C in January 2018. She is an accomplished executive with over 20 years of experience creating and growing start-ups for for-profit and nonprofit organizations. She brings with her a track record of rigor and profound business acumen. As an effective business partner, she excels at creating synergy between financial growth and strategic impact.

Laura has achieved a solid financial performance and strategic operations foundation as a trusted advisor within the Executive Team and the Board of Directors. Laura continues serving as an active committee member of the Greater Washington Society of CPAs, Women’s Leadership, to give back by mentoring other professionals.

Board Members

Elizabeth Garofalo
Chairperson

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Elizabeth Garofalo, MD, is the principal at EAG Pharma Consulting, LLC. Before this position, she served as senior vice president with Novartis Corporation as a Global Development Leadership Team member. During her time at Novartis Pharmaceuticals, Dr. Garofalo provided scientific input to many clinical trials, including several pediatric trials (SMA type 1, heart failure, and retinopathy of prematurity).

Dr. Garofalo’s 25-year career in pharmaceuticals has been focused on clinical development, regulatory affairs, and projects in all stages of drug development, with an emphasis on central nervous system projects.

Dr. Garofalo studied biology at Purdue University and received her MD at Indiana University School of Medicine. She then trained as a fellow in Pediatrics, neurology, and Epilepsy at the University of Michigan School of Medicine. Upon completing these fellowships, she served as an assistant professor in the Department of Pediatrics for several years before joining Parke-Davis (Pfizer) in CNS clinical development.

Daniel M. Jorgensen
Vice Chair

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Dr. Daniel Jorgensen, a seasoned physician executive, has been a driving force in the biopharmaceutical industry for over 26 years. His career has spanned across various sectors, from small to large companies, both public and private. Currently, he serves as a Special Advisor and former CEO of the Critical Path Institute (C-Path), where he has collaborated with a diverse range of investors, strategic partners, and scientific experts while spearheading the development of exceptional teams.

His background includes comprehensive research, development, and commercialization experience for small molecules, biologics/vaccines, and devices across multiple therapeutic areas, particularly infectious diseases, immunology/inflammation, diabetes, and neuroscience.

Dr. Jorgensen was educated at Yale (BS), the University of Wisconsin (MD), the University of Washington (MPH), and Yale (MBA), with specialty training in Pediatrics, Infectious Diseases, and Preventive Medicine.

Martha Brumfield
Secretary-Treasurer

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Dr. Martha Brumfield is the former President and Chief Executive Officer of Critical Path Institute, an Arizona-based nonprofit 501(c)(3). In this role, she led the institute in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science. In 2019, she assumed a new role as Special Advisor to the CEO.

Dr. Brumfield brings 20 years of experience from Pfizer Inc., most recently as Senior Vice President of Worldwide Regulatory Affairs and Quality Assurance. There, she led a global team that supported life-cycle pharmaceutical research, development, and commercialization by creating and implementing regulatory strategies and quality assurance oversight.

Dr. Brumfield earned a BS and MSN in chemistry from Virginia Commonwealth University, a PhD in organic chemistry from the University of Maryland and served as a post-doctoral fellow at Rockefeller University.

James Pomfret
Chair Finance Committee

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James J. Pomfret is the managing director and investment officer at Wells Fargo Advisors. Mr. Pomfret was previously a budget analyst on the staff of the CFO of the Social Security Administration after graduating from the Isenberg School of Business at the University of Massachusetts.

He is actively involved in the community as a member of the Towson Chamber of Commerce, the Society of Financial Service Professionals and the American Society of Pension Professionals & Actuaries. He previously served as president of the Baltimore Harbor Endowment, the American Diabetes Association of Maryland, and as a trustee of the Living Classrooms Foundation.

As a board member for I-ACT for Children, Mr. Pomfret acts completely separate from his position as a financial advisor at Wells Fargo Advisors. Wells Fargo Advisors is a trade name used by Wells Fargo Clearing Services, LLC, Member SIPC.

Barry Brooks
Member at Large

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Mr. Brooks is partner of Paul Hastings, LLP, New York Office, an international law firm. Mr. Brooks is a member of that firm’s Corporate Department and is the chair of its 280-attorney New York office. With a strong presence throughout Asia, Europe, Latin America and the U.S., Paul Hastings, LLP, is recognized as one of the world’s most innovative global law firms.

Mr. Brooks is a member of the State Bars of New York and California and of the American Bar Association. He received his AB, summa cum laude, Phi Beta Kappa, in 1978 from the University of California at Los Angeles and his JD, cum laude, in 1981 from Harvard Law School.

Jeff Barrett
Member at Large

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Dr. Jeff Barrett is the Chief Science Officer at Aridhia, promoting life science partners to collaborate, access, and share secure data to deliver better patient outcomes. Before Aridhia, he was Senior Vice-President at the Critical Path Institute, serving as the Executive Director of the Rare Disease Cures Accelerator, a Data Analytics Platform, and a critical liaison between C-Path and the pharmaceutical industry, foundations and other key stakeholders.

He is co-Specialty Chief Editor of Frontiers in Obstetric and Pediatric Pharmacology Journal, on the International Editorial Board of the Journal of Pediatric Pharmacology and Therapeutics (JPPT) and an active member of the Child Health and Human Development Pediatrics Subcommittee as a study section reviewer. He was a past acting chair of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology.

Jeff received his B.S. in Chemical Engineering from Drexel University and Ph.D. in Pharmacokinetics from the University of Michigan. He has co-authored

Max J. Coppes
Member at Large

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Dr. Max J. Coppes, director of the Renown Institute for Cancer, Director of William N. Pennington Cancer Institute, Professor of Pediatrics and Clinical Internal Medicine at UNR Med, and Clinical Professor of Public Health at UNR, is an experienced academic healthcare leader skilled in program expansion, operations, and leading in an environment with constrained resources.

His areas of research interest have included pediatric tumors (primarily, but not exclusively, pediatric renal tumors), antiemetic treatments and bone marrow transplantation.

Dr. Coppes received his M.D. from the University of Leiden Medical School in the Netherlands and completed his pediatric residency at the Wilhelmina Children’s Hospital, Utrecht, the Netherlands. Subsequently, he worked on his Ph.D. (obtained from the University of Amsterdam) at the Hospital for Sick Children in Toronto and the Cleveland Clinic Foundation in Cleveland. He received an MBA from the Haskayne School of Business in Calgary.

Kristen Swingle
Member at Large

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Kristen Swingle serves as President and Chief Operating Officer of the Critical Path Institute (C-Path). Prior to joining C-Path in 2019, Kristen served as the VP of Stem Cell Operations at Cord Blood Registry where she was responsible for overseeing all operations at CBR’s laboratory in Tucson, Arizona, since 2007.

Kristen has over two decades’ worth of experience in the medical and molecular sciences industry with a strong background in product development and manufacturing, quality and regulatory affairs management, project and fiscal management, and team leadership. As President and COO of C-Path, she is responsible for the daily operations of the organization and the development and implementation of C-Path’s global strategy and goals.
Swingle was elected Chairwoman of the Arizona Bioindustry Association (AZBio) Board of Directors in January 2018 and served as chair until December 2023.

She holds a Bachelor of Science degree in Biology from Northern Arizona University and a Master of Science, Medical Sciences from Texas A&M University.

Stephanie Duggins Davis
Member at Large

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Stephanie Duggins Davis, MD is the Edward C. Curnen, Jr. Distinguished Professor and Chair for the Department of Pediatrics at UNC-Chapel Hill as well as the Physician-in-Chief of UNC Children’s. She has served in several high-profile national leadership roles, including President of the Society of Pediatric Research, Chair of the Board of Directors for the American Board of Pediatrics, and Chair of the Pediatric Assembly for the American Thoracic Society.

She is a NIH funded investigator who has led or co-led several large clinical studies and/or trials. As a pediatric pulmonologist, her research initiatives focus on respiratory diseases affecting very young children including cystic fibrosis, primary ciliary dyskinesia, and respiratory morbidity associated with preterm birth. She investigates the early stages of pathology in these diseases and aims to identify novel predictors of disease initiation or progression. She also evaluates the sensitivity of endpoints in identifying lung disease during childhood. This work has been integral in designing and implementing clinical trials in the youngest population suffering from cystic fibrosis. Through NIH funding and Cystic Fibrosis Foundation funding, she co-led three large multicenter trials evaluating the efficacy of hypertonic saline in the infant and preschool cystic fibrosis population. She is also the contact PI for the Genetic Disorders of Mucociliary Clearance Consortium (GDMCC), an 8-center collaborative funded through NCATS and NHLBI, which is also part of the Rare Diseases Clinical Research Network.

Tamorah Lewis
Member at Large

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Dr. Tamorah Lewis is a physician-scientist, Division Head for Clinical Pharmacology and Toxicology at the Hospital for Sick Children in Toronto. Dr. Lewis helps advance the hospital-wide vision for Precision Child Health in this role and collaborates with multiple clinical divisions to research and implement precision therapeutics. Dr. Lewis also provides clinical care in the level IV NICU at SickKids.

Before this new role, Dr. Lewis worked at Childrens Mercy Kansas City in the Divisions of Neonatology and Pediatric Clinical Pharmacology for 7 years. She was an attending in the CMKC level IV NICU and led translational/clinical research in neonatal pharmacology.

She received her MD from Johns Hopkins University School of Medicine.

Strategic Partners

Members

Sustaining

General

About Us

Vision

Mission

History

Learning Center

Regulatory-Quality Trial-Ready Clinical Sites

Expert Guidance on Strategy, Planning & Compliance

Quality Improvement Initiatives

Building the Foundation

Leadership

Executive Team

Vivianna Guzman Executive Director

Albert “AJ” Allen Chief Medical Officer

Laura Lopez Chief Financial and Administrative Officer

Board Members

Elizabeth Garofalo Chairperson

Daniel M. Jorgensen Vice Chair

Martha Brumfield Secretary-Treasurer

James Pomfret Chair Finance Committee

Barry Brooks Member at Large

Jeff Barrett Member at Large

Max J. Coppes Member at Large

Kristen Swingle Member at Large

Stephanie Duggins Davis Member at Large

Tamorah Lewis Member at Large

Strategic Partners

Members

Sustaining

General

Vivianna Guzman
Executive Director

Albert “AJ” Allen
Chief Medical Officer

Laura Lopez
Chief Financial and Administrative Officer

Elizabeth Garofalo
Chairperson

Daniel M. Jorgensen
Vice Chair

Martha Brumfield
Secretary-Treasurer

James Pomfret
Chair Finance Committee

Barry Brooks
Member at Large

Jeff Barrett
Member at Large

Max J. Coppes
Member at Large

Kristen Swingle
Member at Large

Stephanie Duggins Davis
Member at Large

Tamorah Lewis
Member at Large