BACKGROUND
FOCUS AREAS
AWARDS & HONORS
Over a decade of experience in pharmaceutical sciences and biotechnology, specializing in clinical pharmacology. Integrates expertise in chemistry, pharmaceutical sciences, biology, clinical, clinical pharmacology, statistics and regulatory to support comprehensive decision-making in drug development.
Clinical Pharmacology
BE, Biosimilar, 505 b(2)
Clinical Study Design
Clinical Development Program Strategy
1. Certificate of Fellowship, Division of Pharmacometrics (DPM), Office of Clinical Pharmacology, U.S. FDA, June 2021
2. Member of Rho Chi Pharmacy Honor Society, an international honor society for pharmaceutical sciences, 2017
3. Graduate student of the Year, South Dakota State University, 2019
4. The Member of the Year of American Association of Pharmaceutical Sciences (AAPS) at SDSU chapter, 2019
As a Clinical Pharmacology Specialist and Clinical Consultant at Eliquent Life Sciences, Shenggang Wang oversees all clinical pharmacology-related projects, strategizes efficient clinical protocol design and overall development plans by integrating clinical pharmacology, clinical, regulatory and statistical principles, and takes a hands-on role in authoring key clinical documents, including protocols, Investigator’s Brochures (IBs), Module 2.5/2.7, and Clinical Study Reports (CSRs).
With over a decade of experience in pharmaceutical sciences and biotechnology, including a clinical pharmacology fellowship at the US Food and Drug Administration (FDA), Shenggang Wang has provided expert guidance at Eliquent Life Sciences, successfully achieving dozens of IND submissions across a diverse range of products. These include antibody-drug conjugates (ADCs), monoclonal antibodies (mAbs), bispecific antibodies, peptides, mRNA therapies, gene therapies (AAV), cell therapies (such as tumor-infiltrating lymphocytes (TILs) and induced pluripotent stem cells (iPSCs)), and small molecules.
Shenggang Wang has overseen more than 40 projects, ranging from Phase 1 through Phase 3 and into post-marketing stages. His expertise includes leading Pre-IND (PIND) meetings, Investigational New Drug (IND) applications, End-of-Phase 1 (EOP1) and End-of-Phase 2 (EOP2) meetings, as well as submissions for Fast Track, Breakthrough Therapy, and Orphan Drug Designation, in addition to NDAs, biosimilars, and 505(b)(2) applications. Shenggang Wang has worked across a broad range of indications, including solid tumors, hematologic cancers, autoimmune diseases, obesity, diabetes, and growth disorders.
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Education:
– Ph.D. Pharmaceutical Sciences, South Dakota State University, Brookings, US. 2021
– M.S. Medicinal Chemistry, Qingdao University of Science and Technology, Qingdao, P.R. China. Co-trained by Institute of Medical Biotechnology, Chinese Academy of Medical Sciences, Beijing, P.R. China, 2015
– B.S. Biotechnology, Qingdao University of Science and Technology, Qingdao, P.R. China, 2012Certifications:
– Principle of Clinical pharmacology. Provided by the National Institutes of Health (NIH) -
- Clinical Consultant/Clinical Pharmacology Specialist at Eliquent Life Sciences, US (June 2021 – Present)
- Provide guidance and support in clinical pharmacology across various aspects, including:
- Develop clinical pharmacology plans, clinical strategies, and draft protocols for Phase 1–3 clinical trials that incorporate these strategies.
- Rationalize dose optimization by evaluating data from non-clinical studies, clinical safety and efficacy assessments, population pharmacokinetics (popPK), and exposure-response (ER) analyses.
- Evaluate clinical and clinical pharmacology data to perform gap analysis.
- Develop and draft the initial Pediatric Study Plan (iPSP).
- Prepare and submit regulatory documentation, including:
- Clinical Dossier: clinical protocol, Investigator’s Brochure (IB), Modules 2.5 and 2.7, Global Investigational Plan (GIP).
- Pre-IND (PIND) Package.
- Meeting Packages.
- Requests for Fast Track or Breakthrough Therapy designations.
- SUSAR and Development Safety Update Report (DSUR).
- Provide guidance and support in clinical pharmacology across various aspects, including:
- Fellowship at Office of Clinical Pharmacology at FDA, Division of Pharmacometrics (DPM) (2019 – 2021)
- Conduct regulatory research on clinical pharmacology, especially on oncology drugs, including immune checkpoints inhibitors drugs, and ADC drugs, understand current consideration of FDA on drugs’ dose selection, optimization, DDI study, organ dysfunction, enzyme involved and its contribution to drug’s dose optimization.
- Conduct Exposure-Response (ER) analysis to retrospectively evaluate the patient reported outcomes (PRO) data to complement traditional Exposure- Response (ER) analysis.
- Leverage AI and real-world data to facilitate personalized drug development.
- Assess the enrollment of older adults in clinical trials that supported the approval of medications in the US.
- Clinical Consultant/Clinical Pharmacology Specialist at Eliquent Life Sciences, US (June 2021 – Present)
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