Regulatory, Preclinical and Clinical Trial Support, Outcomes and Licensing Team
BPP interfaces daily with key advisors who guide us in the delivery of the most effective means to advance our drug development program. Our advisory team offers key regulatory direction on orphan and breakthrough therapy pursuits, on CMC and CTM matters to support our preclinical and clinical studies, on key study and clinical trial processes, including correlated clinical, cognitive and biomarker outcome measures for validating the effect of our therapeutic in our target populations, or educating payers and potential licensees alike to the extended reach of our drug across both neuroinflammation and neurodegenerative diseases. These BPP team members are at the cutting edge of defensible new approaches to ensure that BPP-1001 delivers its therapeutic benefit to the broadest possible populations in the most timely and efficient way.
Executive Vice President, Regulatory and Strategic Development, Clinipace
Clinipace provides BPP with drug development support, CMC strategy, dossier preparation, pre-approval inspection prep; GxP auditing in pre-clinical (GLP), clinical (GCP), and manufacturing (GMP), medical/regulatory writing, strategic biostatistics and quality assurance
Clinipace: Director of Regulatory and Strategic Development
Provides BPP with CMC and CTM coordination for BPP’s preclinical and clinical programs
Chief Technology Officer. CereScan
Developer and FDA Interface for CereMetrix’ FDA-cleared data analytics platform
Daily interface with BPP and and its regulatory, outcome measure and clinical trial
CEO and Regulatory Strategist, RareMoon Consulting
Orphan Product Advisor to BPP for its Orphan Drug filing
|Bill Colston, PhD
Chief Executive Officer, Healthtell
BPP will utilize HealthTell’s ImmunoSignature platform, a high-density peptide array powered by a tiny blood sample, to add significant value to BPP’s Clinical development and clinical trial population stratification processes
|Mark Tommerdahl, PhD
Co-Founder and President, Cortical Metrics
The Brain Gauge cognitive assessment tool is a key outcome measure for BPP’s clinical trial, allowing assessment of each patient’s brain post-therapeutic performance against baseline.
Data from multiple assessments are already embedded in the CereMetrix data analytics platform, enabling defensible stratification of BPP’s clinical trial population.
|Andreas Jeromin, PhD
Chief Medical Officer, Quanterix
Quanterix’ Simoa immunoassay platform for multiple CNS-specific blood-borne proteins
will be utilized to assess post-therapeutic change from baseline in BPP’s clinical trial population.
|Stephen Waterman, PhD
Managing Director, Pharma Ventures, PhD in Neurology
Provides BPP with key counsel and pharma interface regarding licensing of IP for BPP-1001