INSTITUTE FOR ADVANCED CLINICAL TRIALS FOR CHILDREN

 

MISSION, VISION AND VALUES At I-ACT for Children

We are an independent non-profit organization and believe that children of all ages deserve innovative medical therapies that are developed with the same level of urgency and commitment afforded to adults. The Institute works to assure that studies are designed to generate sufficient data to allow safe and effective use of new medications and devices in pediatric populations.

A key factor in making this a reality is to optimize and accelerate biomedical innovation using child-centered clinical trial networks and collaboration with like-minded institutions, trial sponsors and other stakeholders.



On behalf of children everywhere, we are building the first multi-therapeutic area clinical trials network dedicated solely to advancing development of new medicines and devices for children.

We are an independent, globally collaborative organization that enables the planning and completion of clinical trials that generate robust scientific and clinical evidence to support the safe and effective use of medicines and devices in children.

Together with parents, patients, investigators, foundations, regulators, other government agencies, biopharmaceutical sponsors and children’s networks, we work to catalyze improvements in the quality and timely completion of global pediatric studies to address the gap in evidence for best use of therapeutics in children.


Patients, caregivers and health care providers will have better prescribing information for an increasing number of innovative drugs, biologics and devices, helping to extend and enhance the lives of children around the world. This information will be generated according to the highest scientific and ethical standards and will inform the safe and effective use of therapies valued by children and their families.


  • Children’s unmet medical needs drive our agenda and all of our work supports the development of innovative medicines and devices for children that are most needed to improve and preserve children’s health and wellness.

  • We are an independent voice in innovative medicines and devices development, focused on optimal impact on child health.

  • We are collaborative and synergistic with other elements of the clinical research ecosystem – finding common ground and aligning common values, with children at the center.

  • Our standards are grounded in regulatory requirements, providing the basis upon which we deliver scientifically strong, clinically relevant and ethically sound advice and manage high-quality, timely conduct of clinical trials.

  • We are focused on creating actionable data – meaning data that can be utilized to improve the safe and effective use of therapies, support robust regulatory submissions and enhance the information used by pediatric healthcare providers.

  • Because children are waiting, we must shorten the time it takes to bring innovative medicines and devices to them. Streamlining operations, reducing burdensome processes and optimizing the use of resources are fundamental principles that guide us.

  • We are committed to utilizing innovative clinical trials design and execution to maximize the value and impact of clinical trials for children’s health.

“I-ACT for children”  because children deserve high quality evidence to support optimal use of new medicines and approximately 50% of drugs used in children and 90% used in newborns have not been adequately studied in these populations.
Will you ACT for children?

 

LEADERSHIP TEAM

Edward Connor

Edward Connor, MD, MBE, FAAP

Chairman, Board of Directors and President

  • Executive Director and Scientific Lead, Pediatric Trials Consortium, Critical Path Institute
  • Emeritus Professor Pediatrics, Microbiology and Tropical Medicine, George Washington University School of Medicine & Health Sciences & Children's National Health System
  • Former Executive VP Clinical Development and Chief Medical Officer MedImmune, Inc.
  • Dr. Connor is Executive Director and Scientific Lead for the Pediatric Trials Consortium at Critical Path Institute, President of Clinical Research Alliance LLC, and Emeritus Professor of Pediatrics, Microbiology, Immunology and Tropical Medicine at George Washington University School of Medicine and Health Sciences and Children’s National Health System in Washington DC. He has more than 35 years of experience in pediatric clinical trials and drug/biologics development in academia and the biotechnology industry. He was Chair of the Pediatric AIDS Clinical Trials Group and Principal Investigator of ACTG 076 that led to FDA approval of zidovudine for prevention of mother-to-infant transmission of HIV. Dr. Connor served as Executive Vice President, Clinical Development and Chief Medical Officer at MedImmune and most recently, Director of the Office of Innovation Development at Children’s National Health System and member of the executive team at the Clinical and Translational Science Institute at Children’s National. He served in advisory roles in pediatrics and drug and biologics development with many public and private organizations including, the National Institutes of Health, the US Food and Drug Administration, the Centers for Disease Control and Prevention, the World Health Organization, and the American Academy of Pediatrics. Dr. Connor received an MD and Masters in Bioethics from the Perelman School of Medicine at the University of Pennsylvania, and was a resident and chief resident in Pediatrics at Northwestern School of Medicine, and fellow in Pediatric Infectious Diseases at the University of Rochester School of Medicine and Dentistry.

    Robert Ward

    Robert Ward, MD, FAAP

    Vice Chairman, Board of Directors and Vice President

  • Emeritus Professor of Pediatrics, University of Utah School of Medicine
  • Former Director, Pediatric Pharmacology Program, University of Utah School of Medicine
  • Former Chair, American Academy of Pediatrics Committee on Drugs
  • Bob Ward, MD recently retired from the University of Utah where he was Professor of Pediatrics and Adjunct Professor, Pharmacology/Toxicology, in the College of Pharmacy. He was an attending Neonatologist at the University of Utah College of Medicine, and attending Neonatologist and Medical Director of Newborn Intensive Care Unit at Primary Children's Medical Center (1989-1997). Dr. Ward was also the Chair of the American Academy of Pediatrics Committee on Drugs (1997-2001); Director, University of Utah Pediatric Pharmacology Program (1997-2011), member of the FDA Pediatric Advisory Committee (2006-2010), and member of the Institute of Medicine Committee on Review of Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Prior to working at the University of Utah he was Assistant Professor of Pediatrics and Pharmacology, Attending Neonatologist at Pennsylvania State University College of Medicine.

    Dr. Ward trained in Pediatric Clinical Pharmacology at the University of Minnesota conducting basic and clinical trial research. He started a pediatric clinical trials program at the University of Utah. Dr. Ward collaborated with several members of the faculty of the College of Pharmacy and the department of Pharmacology/Toxicology in a study to determine potential causes of inadequate responses of children with asthma, to treatment with inhaled corticosteroids (ICS). The study of children with asthma enrolled 1550 patients at PCH.

    Dr. Ward has been honored by the American Pediatric Society and received the Utah American Academy of Pediatrics Lifetime Achievement Award. He has been invited to participate in several FDA Pediatric Advisory Committee’s, and NIH and NICHD programs. His contributions in the area of pediatrics have been extensive.

    Dr. Ward graduated with a B.S. in Chemistry from Southern Methodist University and received his MD at Johns Hopkins University Medical School.

    Martha Brumfield

    Martha Brumfield, PhD

    Secretary/Treasurer, Board of Directors

  • President and CEO, Critical Path Institute
  • Chair of the Board of Directors, Regulatory Affairs Professional Society
  • Former Senior VP Worldwide Regulatory Affairs and Quality Assurance, Pfizer
  • Dr. Martha Brumfield is President and Chief Executive Officer of the Critical Path Institute, an Arizona-based non-profit (501(c)(3)). In this role, Brumfield leads the institute in its mission to catalyze the development of new tools to advance medical product innovation and regulatory science, which is accomplished by leading teams that share data, knowledge, and expertise resulting in sound, consensus-based science. Brumfield assumes the role of CEO after most recently serving as Critical Path Institute’s Director of International and Regulatory Programs. In that position, she helped guide international program development and provided regulatory expertise to consortia. She is also a Professor at College of Pharmacy, The University of Arizona.

    She also has her own consulting practice (Martha A. Brumfield LLC) focusing on concordance in global regulatory initiatives and regulatory science qualification programs. Other areas of focus in her practice include excellence in clinical trial conduct and pharmacovigilance, facilitation of scientific consortia, and programs supporting patient access to medicines.

    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 lifecycle pharmaceutical research, development, and commercialization through creation and implementation of regulatory strategies and quality assurance oversight. Brumfield also played a key role in managing the broader company relationships with global regulators, trade associations, academics, and others on regulatory policy issues. She served on corporate governance initiatives including the planning and implementation of mergers and acquisitions, and led her departments through these periods of significant change.

    She is Chair of the Board of Directors for the Regulatory Affairs Professional Society, and chaired the Global Curriculum Coordinating Committee with FDA’s Office of International Policy, which oversaw the development of a competency framework for regulators in developing countries. She is also active with global nonprofits, including the Regulatory Harmonization Institute and GlobalMD, where she delivers educational workshops on regulatory and clinical trial topics in Asia. She has served on and contributed to the Institute of Medicine consensus committees, which were commissioned by U.S. FDA focusing on global regulatory systems and on falsified and substandard drugs. She also serves on the Steering Committee of the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard.

    Brumfield earned a Bachelor of Science degree and a Master of Science degree in Chemistry from Virginia Commonwealth University, a Ph.D. in Organic Chemistry from the University of Maryland, and served as a post-doctoral fellow at The Rockefeller University.

    Caroline Dorsa

    Caroline Dorsa, MBA

    Member, Board of Directors and Chair Audit & Compensation

  • Chair of the Audit and Compensation committees of I-ACT for Children’s Board of Directors
  • Board of Directors, Biogen
  • Former EVP and CFO, Public Services Enterprise Group, Inc.
  • Former SVP Marketing Strategy and VP and Treasurer, Merck
  • Caroline Dorsa, MBA is a recently retired financial executive with over 30 years of diverse business leadership in biopharmaceuticals, power generation/regulated utilities, telecommunications and the public sector. Ms. Dorsa has extensive experience in finance, corporate development, accounting and controls, budgeting and planning, internal audit, treasury, investor relations and strategy. Experience on Audit (chair), Finance, Governance, Risk and Compensation Committees. She is currently on the Board of Directors of Biogen and Intellia and was a Board member of Public Service Enterprise Group, Inc. from 2003 to 2009. While she was at Public Service Enterprise Group, Inc., she was active in civic activities as a Board of Trustee of Junior Achievement and Edison Electric Institute CFO Committee. She was on the NJ Board of Trustee of Drumthwacket (NJ Governor’s Mansion).

    Ms. Dorsa was the Executive VP & CFO at Public Service Enterprise Group, Inc. from 2009 until her retirement in 2015. She was responsible for finance, accounting, treasury, risk management, internal audit, strategy, corporate development and investor relations. Public Service Enterprise Group, Inc. is an integrated provider of regulated utility electric and gas distribution services.

    Ms. Dorsa also worked at Gilead Sciences and Avaya as the Senior VP and CFO. She spent 21 years at Merck, including as a Senior VP of Global Human Health and for 13 years in the position of VP and Treasurer. Prior to working at Merck, Ms. Dorsa worked for the city of NY in the Finance organization and the Mayor’s Office.

    Ms. Dorsa received her B.A. in History from Colgate University and her MBA in Finance and Accounting from Columbia University.