About ABC
ABC is a scientific-minded, global firm partnering with start-up, small to mid-sized drug developers to overcome high stake, unique and complex challenges associated with regenerative medicine, immunotherapy, drug delivery systems and companion diagnostics.
With more than 30 years in regulatory and clinical strategy, trial execution, agency filings and negotiation and project leadership, ABC is suited to partner with any sponsor in the biotech and medtech space.
Deep breadth and depth of experience
Proven successful track record
Trusted partner with global regulatory bodies
Cell therapy and Gene therapy BLA approvals
First to gain ATMP MAA Approval
First and only approval of cell therapy xenotransplant
Multiple regenerative medicine IND and CTA filings and subsequent approvals
Multiple M3/IMPD Amendments
Numerous successful face to face/teleconference/written response FDA Type B and Type C meetings, EU Scientific advice and protocol assistance, and EU member state competent authority meetings.
Multiple clinical hold strategy employments and agency negotiations leading to clinical “green light”
Numerous ODD and RPDD filings and approvals
Multiple successful PIP filings and negotiations with PDCO including exemptions and waivers
Presenter/Chair at major conferences including NORD, ARM, ASCGT, ESCGT, ADVAMED, DIA, ICRS, AAOS, Informa, Eurodis, RAPS
Industry expert presenter on regulatory and quality topics to regulatory bodies including FDA/CBER, China sFDA, Mexico COFEPRIS and India CDSCO.