XP Pharma Consulting provides Clinical Pharmacology & PK/PD services in all phases of drug development.
Experience includes several therapeutic areas (oncology, hematology, rare genetic disorders, rheumatology, infectious disease, CNS, and neurology) and various classes of drug entities (small molecules, biologics including proteins and monoclonal antibodies, and oligonucleotides).
Dr. Amy Zhang (PhD and MD) has diverse cross-functional experience over 21+ years in small and large pharmaceutical companies with an established tracking record of clinical and regulatory success within the pharma industry. Her experiences include strategic planning, executing, and reporting clinical pharmacology and clinical studies from Phase 1 to Phase 3. She had direct experiences in 60+ international and domestic clinical trials. She has worked on numerous NDAs/BLAs, INDs, IMPDs, MAAs, and other regulatory documents, plus client representation at FDA and EMA meetings including advisory board meetings and EU hearings. She has authored 70+ PK, PK/PD and clinical study publications.
XP Pharma Consulting can provide expert clinical pharmacology and PK/PD services to guide you for your drug development success.