About XP Pharma Consulting

XP Pharma Consulting was founded in 2019 by Dr. Amy Zhang.

After two decades of experience at several major pharmaceutical companies, Dr. Zhang realized that there was a growing need for greater expertise in the areas of clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and modeling and simulation (M&S) in pharmaceutical companies. XP Pharma Consulting was founded with the goal of providing expert services to clients in these focused areas of drug development.
We have helped 10+ clients within the past three years to accelerate development of their products by facilitating the understanding of the PK and PD of their drugs and by aiding in the planning of focused and optimized study designs that use good clinical pharmacology practice principles. XP Pharma Consulting’s client base has grown dramatically since its founding. XP Pharma Consulting’s client list includes both major pharmaceutical and smaller companies

The Company utilizes a flexible structure to provide you with quality services. We hand-pick our consultants, all of whom have 20+ years of experience and advanced degrees (PhD, M.D, or Pharm D) in their respective fields. Our consultants can work as an extension of your team and/or to provide support for your complex projects that require broader experience and expertise.

Testimonials

XP Pharma has played a significant role in supporting the early clinical development programs of several novel molecules. Dr. Zhang’s PK assessments, modeling & simulation have provided us with important information that has helped us to determine safe and optimal dosing and dosing regimens for our Phase 1 and 2 clinical trials. In addition, Dr. Zhang’s knowledge of FDA requirements around clinical pharmacology and data evaluation (drug‐drug interaction studies, special population studies, TQT study waiver) have helped us to design our Clinical Development plans more accurately by allowing us to incorporate these NDA required studies optimally or waive the studies. Dr. Zhang is available on short notice and provides timely and detailed analyses. We continue to work closely with XP Pharma as our clinical development programs move forward

Executive Director - Clinical Development

XP Pharma Consulting provided leading edge clinical pharmacology and development advice and services that led to several successful IND approvals and the implementation of several clinical development programs. Dr. Zhang and her team engaged early and provided rapid, high quality, high science plans and analyses. They have also assisted us on translational research programs at pre-IND to IND stage. We really appreciate all of their hard work and advice to our development program. We look forward to continued collaboration and hopefully more regulatory IND and NDA approvals in the months and years to come.

Director - Clinical Development

About Dr. Amy Zhang

Areas Of Specialization

  • Clinical Pharmacology
  • Pharmacokinetics (PK)
  • Pharmacodynamics (PD)
  • Modeling and Simulation (M&S)
  • Clinical Drug Development
  • Clinical Trial Design
  • Multiple Therapeutic Areas
2-About -Amy Zhang

Education

  • Doctor of Philosophy (Ph.D.) in Pharmacokinetics, University of Witten-Herdecke, Germany 1994
  • Doctor of Medicine (M.D.) in Clinical Medicine, Shanxi Medical University, China, 2018
  • Master of Science (M.Sc.) in Pharmaceutical Chemistry & Molecular Modeling, Shanxi University, China 1988
  • Bachelor of Science (B.Sc.) in Pharmaceutical Chemistry, Shanxi University, China, 1983

Current And Previous Positions

President and Chief Executive Officer (CEO)
XP Pharma Consulting, LLC, Stoneham, MA, 2019 - present

Worked with over 10 Clients since founding of XP Pharma Consulting LLC, offering clinical pharmacology and drug development services to industry, including strategic planning, pharmacokinetics (PK), pharmacodynamics (PD), population PK and PK/PD modeling and simulation, clinical development, and writing from IND to NDA/BLA submissions. and project management.

Responsible for new business development, client relations, and oversight of all scientific and business activities at the company.

Senior Consultant- Clinical Pharmacology and Pharmacometrics
Nuventra Pharma Sciences, Inc., Cambridge, MA, 2019-2020

Senior Director- Clinical Pharmacology and Pharmacometrics
Alnylam Pharmaceuticals, Inc., Cambridge, MA. 2017-2019

Global Leader and Director - Clinical Pharmacology and Pharmacometrics
Alexion Pharmaceuticals, Inc., New Haven, CT, 2015-2017

Clinical Team Leader / Head of Clinical Pharmacology
Kyowa Hakko Kirin Pharma, Inc., Princeton, NJ, 2012-2015

Sr. Director/Head Clinical Pharmacology-Inflammation
Hoffmann-La Roche, Inc., Nutley, NJ, 2001-2012

Honors & Awards

  • 2 Shooting Star Awards for the successful launch of Onpattro (patisiran) in Canada and Japan (including submissions and responses to questions from FDA, EMEA and PDMA). Alnylam Pharmaceuticals, Inc., Cambridge, MA. 2019.
  • Outstanding Scientific Contribution Award. The 21st SAPA-NE Scientific Symposium for Next generation of Gene and Cell Therapy. Oral Presentation: Onpattro (Patisiran): The First Approved RNAi Therapeutics. Nov 3, 2018. Boston, MA.
  • Special Recognition for “Delivered tangible results, behaviors, and values, and future potential”. Alnylam Pharmaceuticals, Inc., Cambridge, MA. 2018.
  • Steller Supernova Award for Passion for Excellence. Alnylam Pharmaceuticals, Inc., New. Cambridge, MA. 2017.Stellar All-Star Award for Sense of Urgency supporting Patisiran Filing Working Group, Alnylam Pharmaceuticals Inc., Cambridge, MA. 2017.
  • Oscar Award for the best synopsis entitled “A Multicenter, Dose-Escalation, Phase 1 Study of Samalizumab to Evaluate the Pharmacokinetics, Safety, and Tolerability in Patients with Advanced Cancer” (ClinicalTrials.gov Identifier: NCT02987504). Alexion Pharmaceuticals Inc., New Haven, CT. March 2017.
  • Alexion Innovator’s Award for scientific contribution to the treatment of a rare genetic disorder (mucopolysaccharidosis type IIIB) using enzyme replacement therapy. Alexion Pharmaceuticals, Inc., New Haven, CT. December 2016.
  • Presidential Award for Outstanding Achievement in Significant Clarification and Clinical Understanding of Human Monoclonal anti-FGF23 Antibody (KRN23) in Treating Adults with X-Linked Hypophosphatemia. 2014 European Society of Paediatric Endocrinology Annual Meeting. Dublin, Ireland.
  • Presidential Award for Innovative Clinical Research on human monoclonal anti-FGF23 antibody (KRN23) to patients with X-linked hypophosphatemia. Annual Meeting for American Society of Bone and Mineral Research. Baltimore, Maryland. 2013.
  • Presidential Award for the Outstanding Poster and Abstract for development of Inverse Gaussian pharmacokinetics model for subcutaneous administration of enfuvirtide in treating HIV patients. Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics. Washington DC, April 2-5, 2003.
  • Pharmaceuticals Olympiad Gold Award for Innovation, Speed, and Growth Applied to the Team Approval of Enfuvirtide in EU and US, Hoffmann-La Roche, Inc., Nutley, NJ. 2003.
  • First Prize for Best Student of Class 1983 at Shanxi University, Taiyuan, China.