KING OF PRUSSIA, PA — Franklin Biolabs and RareMoon Consulting have formed a strategic partnership aimed at helping drug developers move gene therapy and rare disease programs more efficiently from preclinical research into clinical testing.
The companies announced a joint consulting arrangement that combines Franklin Biolabs’ preclinical contract research capabilities with RareMoon’s regulatory consulting services for orphan drugs and advanced therapies.
The partnership is designed to support biotechnology and pharmaceutical sponsors preparing investigational new drug and biologics license applications by aligning nonclinical development work with regulatory expectations earlier in the process.
Franklin Biolabs Chief Executive Officer Dr. Vatsala Naageshwaran stated that the collaboration is intended to strengthen the company’s ability to design nonclinical programs “that are both scientifically rigorous and directly aligned with regulatory expectations.”
The companies indicated the joint offering will focus on reducing unnecessary studies and data collection that may increase development costs or delay regulatory submissions without materially advancing clinical programs.
RareMoon Consulting Co-Founder and Chief Executive Officer Sabrina Mogle stated that the collaboration is intended to help clients “move from planning to execution in an intentional and focused way” while prioritizing studies regulators minimally require.
Franklin Biolabs operates as a preclinical contract research organization focused on genetic medicine and biologics development, while RareMoon Consulting specializes in regulatory strategy and development support for orphan drugs and advanced therapies.
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