Jacob Justus Email & Phone Number

·        Experienced in developing and deploying successful and robust Alliance and Program Management functions in early, clinical, and commercial phase biopharma and biotech companies with management of dozens of partnerships and alliances and clinical programs in the cell and gene therapy space·        Business development & management of biotech & biopharma partnerships which have generated over $20 million·        Co-development of $25 million budget for pre-clinical and clinical programs in the cell and gene therapy space·        Successful filing of IND and CTA applications with US FDA, Health Canada, and EU in CGT clinical phase company·        Member of Alliance for Regenerative Medicine Committee (ARM) who is knowledgeable with FDA Title 21 CFR Part 211, 610, and 1271; IND, NDA, CTA, and BLA filings; EMA Regulations; Health Canada (HC) Regulations; ISO 13485 Standards; and ICH GuidelinesSpecialized in: Regenerative Medicine, Cell and Gene Therapy, Small Molecules, Alliance Management, Business Development, Program & Portfolio Management, Corporate Strategy, Financial Forecasting, Clinical Trial Operations, Metrics & Reporting, Data Governance, cGxP, CFR, ICH, FDA Regulations, Compliance, Quality, Regulatory, Data Management, Combination Device, Platform Technology, IND & CTA Enabling Technology, CRISPR, Gene Editing

Listed skills include Leadership, Bioprocessing, R, Consulting, and 46 others.