TUCSON, Ariz., April 17, 2024 — Critical Path Institute (C-Path) today announced the appointment of Amanda Klein, Pharm.D., as Executive Director for its two newest public-private partnerships: the Critical Path for Lysosomal Diseases (CPLD) and the Critical Path for Alpha-1 Antitrypsin Deficiency (CPA-1) consortia . Klein brings a wealth of experience, having previously served as Executive Director of C-Path’s Transplant Therapeutics Consortium (TTC), where she orchestrated successful composite biomarker qualification submissions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency.
Dr. Klein’s tenure at C-Path has been marked by her results-driven approach and her collaboration across consortia leadership to accelerate the drug development process, addressing unmet needs across various therapeutic areas. Her background as a clinical pharmacist and her direct patient care experience over more than a decade enriches her perspective on the urgent needs within drug development.
“In her time at C-Path, Amanda has demonstrated a unique ability to quickly navigate complex learning curves, a remarkable capacity for leadership, and a deep commitment to our mission of accelerating the path to drug development through collaboration,” said Klaus Romero, M.D., M.S., FCP, Chief Executive Officer of C-Path. “Her expertise and evidence-based approach will be invaluable as we continue to advance our work with CPLD and CPA-1, addressing critical areas in lysosomal diseases and alpha-1 antitrypsin deficiency.”
The CPLD Pre-Consortium, established in 2023, aims to forge dynamic public-private partnerships to enhance the drug development process for lysosomal diseases, improving the quality of life for those affected. Likewise, the CPA-1 Consortium, launched in March 2024, focuses on accelerating drug development for alpha-1 antitrypsin deficiency through collaborative efforts that leverage data and develop regulatory-grade solutions across CDER, CBER, and CDRH within the FDA.
“Taking on the roles of Executive Director for CPLD and CPA-1 is an immense honor and responsibility,” said Klein. “I am excited to continue advancing the impactful work of these consortia, building on the collaborative foundation laid by the dedicated professionals at C-Path and our partners. Together, we will continue to make significant strides in drug development for lysosomal diseases and alpha-1 antitrypsin deficiency.”
For more information about CPLD and CPA-1, please visit c-path.org.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit established in 2005 as a public-private partnership, in response to the FDA’s Critical Path Initiative. C-Path’s mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path’s global headquarters is in Tucson, Arizona and C-Path’s Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
Critical Path Institute is supported by the Food and Drug Administration (FDA) of the Department of Health and Human Services (HHS) and is 54% funded by the FDA/HHS, totaling $19,436,549, and 46% funded by non-government source(s), totaling $16,373,368. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government.
Contacts:
Roxan Triolo Olivas
C-Path
520.954.1634
rolivas@c-path.org
Kissy Black
C-Path
615.310.1894
kblack@c-path.org
