Joerg Heyer

Experienced pharmaceutical industry leader with strong expertise in Translational Medicine, Clinical and Preclinical Research. Strategic value creation through scientific excellence and personal integrity. • Responsible for various aspects of clinical development of the following drugs: o Approved: tivozanib: oncology RCC o Phase III: CP101: infectious disease C. diff o Phase II: tivozanib: oncology BC; CP101 infectious disease C. diff o Phase I: oncology ficlatuzumab, Immuno-Oncology DCBY02, DCSZ11; autism FIN211 • Clinical Translational Medicine o Developed Biomarker strategies (tivozanib, ficlatuzumab, BY02, DCS11, CP101 and FIN211) o Modalities: antibodies, Small Molecules, Microbiome o Developed and validated clinical biomarker assays o Analysis of clinical biomarker assays and data (CP101, BY02 and DCS11) o Authored phase II Biomarker reports for FDA submission (CP101) o Developed PD/PK strategy for antibodies, small molecules and non-traditional modalities o Developed and implemented strategy to incorporate standardized biomarker assays into Investigator Sponsored Trials o Led CTA/CDx (multigene expression) assay development with CRO to CLIA laboratory testing stage o Recommended therapeutic options and clinical trials based on patients’ mutation profile o Developed NGS variant curation algorithm with 5x improvement in throughput o First to integrate HPV testing into NGS-Cancer testing • Preclinical Research o Devised dosing strategies strategy for multiple drug combinations o Developed Mechanism of Action for targets o Part of small team prioritizing target pipelines o Designed Preclinical Toxicology/IND enabling GLP Toxicology studies o Led target discovery and validation matrix efforts o Developed IP strategies and assisted in successful patent prosecution at PTO o Invented technology to generate engineered chimeric mouse models resulting in a Nature Biotechnology publication and in two major pharmaceutical partnerships o Established Histo-Pathology laboratories o Established and led Animal Care Program as IACUC Chair from inception to AAALAC accreditation • Corporate o Presented company data at national and international scientific meetings o Member of Global Development Teams o Member of Executive Management Teams o Member Medical Affairs/Investigator Sponsored Trials committee o Managed pharmaceutical collaboration over 3-year with $25M bonus milestones achieved o Team building and retention (groups from 1-20 FTEs) o Built teams across sites US and China o Led pre-IDE meeting team and represented CDx team at FDA/CDRH pre-IDE meeting