Robert Faulkner Email and Phone Number

• Clinical pharmacology / DMPK / toxicology / bioanalytical consultant, providing strategic planning and scientific and operational expertise across multiple therapeutic areas with both small and large molecule R&D. including bispecific antibodies for NSCLC, solid tumors, nanvuaranlat a LAT-1 inhibitor for BTC. • Contributed scientific expertise, analytical skills, experience, and insight to study design, analysis / interpretation of study data, development strategies, preparation of reports, and production of regulatory documents in clinical PK / clinical pharmacology, pop PK / PD, nonclinical DMPK / TK, and bioanalytical according to applicable guidelines and company policies. • Provided clinical pharmacology / DMPK support on PIND, IND, and NDA / 505(b)(2) / BLA programs.

• Served as head of clinical development for specialty generics division responsible for conduct of clinical studies for SpecGx products in support of ANDA / 505(b)(2) submissions. • Managed clinical operations function for coordination / conduct of clinical BA / BE studies in U.S. and overseas.• Conducted and facilitated PK modeling / IVIVC analysis (WinNonlin) and PBPK modeling / simulations (GastroPlus, PK-Sim) to support formulation development. • Collaborated and worked with formulations and analytical chemistry functions to help develop generic formulations primarily for opioid medications.

• Served as head of clinical pharmacology and DMPK responsible for clinical pharmacology, DMPK, biopharmaceutical, and bioanalytical support of oncology programs (rivoceranib, camrelizumab). • Oversaw external CROs responsible for conduct of clinical Phase 1, bioanalytical, and DMPK studies. • Prepared DMPK and clinical pharmacology summaries.

• Served as global head of clinical pharmacology and biopharmaceutics responsible for clinical pharmacology and biopharmaceutical support of new chemical entities and biologics as well as complex generic projects across multiple therapeutic areas and indications (i.e., TKI for CML, Parkinson disease, tikdrakizumab for psoriasis, PSA, anti-infective, cardiovascular, pain, inflammation, ophthalmology, and dermatology).• Developed clinical pharmacology plans and protocols to support global drug submissions (i.e., 505[b][2], NDA, BLA).• Collaborated with CROs to set up clinical studies and provide clinical study reports and bioanalytical and pharmacometrics (pop PK / PD) support for 505(b)(2) / NDA / BLA programs. • Authored clinical pharmacology / biopharmaceutical summaries for global drug submissions (i.e., IND, CTC, NDA, PMDA, BLA, EMEA, and 505[b][2]) as well as responses to regulatory queries on global drug submissions. • Represented clinical pharmacology at meetings with FDA, PMDA, and Health Canada.

• Served as head of Clinical Pharmacology responsible for clinical pharmacology and biopharmaceutical support of both generic and specialty branded projects (i.e., inflammation, gout, endocrine, analgesia, anti-malaria, and cardiovascular). • Directed translational medicine program (PRiSM) to provide new preclinical (i.e., P450 isozymes, transporters, and biomarkers) and clinical discoveries to improve safety profile of marketed products and / or provide life-cycle opportunities. • Provided due diligence review of potential new products / licensed candidates.