Jia-Hao (John) Xiao

Senior Manager/Principal Scientist @ Reata Pharmaceuticals, Inc.

About

Project Management & Execution: Effectively manage R&D projects and preclinical studies with high levels of complexity in a wide range of environments for many companies; Expert in the fit-for purpose designing of in vitro assay and in vivo pivotal IND-enabling studies for emerging novel therapeutics; Expediently assess situations and deliver solutions according to changes in scopes and timeline based on interim results, regulatory agency reviews, and available resources; Outstanding record in contribution to moving drug candidates in tight timelines into the Phases 1 and 2a trials to maximize the future market exclusivity at launch. Drug Discovery, Research & Development (R&D): Specialized in drug discovery assay platforms and cutting edge preclinical testing of innovative drugs including cell therapeutics (stem/progenitor/immune cells), AAV/lentiviral vector-based gene therapeutics, small molecules, oncolytic virus, multigene plasmids coupled with electroporation delivery; bivalent antibodies, and nanoparticle-embedded mRNA; Fast development and adaptation to the use of novel in vitro assays and animal models in testing as required by innovative natures of novel drugs; Streamlined clinical sample acquisition and analysis; 100% on time report delivery. Process Management: Advise and execute work flow from the drug discovery to IND filing phases while ensuring the high quality and integrity of study data in compliance with SOPs and regulatory guidelines; Leverage and integrate expertise from various internal and external teams including scheduling, chemistry, biology, formulation, analytical, in life, veterinary care, infusion, surgery, ophthalmology, safety pharmacology, flow cytometry, PET/CT imaging, clinical pathology/PK/TK analyses, post-life, anatomical pathology, sample management and analysis, data processing and archiving, contributing PIs/scientists, subcontractors, CROs, and Sponsors; Implemented 3 R’s in animal use and institutional biosafety regulation in study execution.

Country

United States

City

Kalamazoo

Industry

Biotechnology

Skill

Contract Management, Contract Negotiation, Lead Optimisation, Study Monitoring, Molecular Pharmacology, Animal Models, Preclinical Pharnmacology, Cell Therapeutics Development, Preclinical Development, Preclinical Toxicity/Safety/Biodistribution/Tumorigenicity Studies, CRO, GLP Studies, Stem Cell Research, Pharmacology, Oncology, Life Sciences, Cell, Clinical Development, Biotechnology, Pharmaceutical Industry

Experience

Senior Manager/Principal Scientist

Reata Pharmaceuticals, Inc.

2021-3 - Present · 5 yrs 7 mos

Plano, Texas, United States

In this position within the Nonclinical Development team, Dr. Xiao is responsible for delivering all nonclinical study programs (Pharmacology, PK-ADME, and Toxicology) to support clinical development plans and all regulatory filings (IND and NDA) across Reata’s pipeline consisting of small molecules based on scientifically sound hypotheses for clinical indications in areas of high unmet needs. Responsibilities • Plan and coordinate the execution of nonclinical studies to support early development programs • Work closely with the team to prioritize studies and identify appropriate vendors to execute them • Contract and manage nonclinical studies at external vendor(s) • Design nonclinical study protocols (pharmacology, PK-ADME or toxicology) • Interpret study results and generate summaries and presentations to the team • Author and review summaries of all nonclinical modules for IND & NDA submission and other annual safety reporting documents • Review and interpret results of nonclinical pharmacology, PK-ADME and safety studies • Assist in managing all resources to implement and execute nonclinical development programs to meet key milestones • Report writing, including regulatory document summaries

Owner/Sole Proprietor

PRECLINICAL DRUG DISCOVERY & DEVELOPMENT CONSULTING

2019-12 - 2021-2 · 1 yr 3 mos

Kalamazoo County, Michigan, United States

• Overall planning and outsourcing preclinical GLP toxicology/safety evaluation and pharmacology efficacy testing of novel therapeutics on behalf of clients; • Study designs, proposal writing, contract negotiation with CROs, and study monitoring on behalf of clients; • Serve as in interim supervisory role, mentorship, and leadership for client’s laboratory managers, project leaders, and scientists; • Service clients in product line initiation, scientific auditing, partnership, strategic evaluation, and preclinical development; • Client communication, management, and service expansion.

Director, Onclogy & Cell Therapeutics/Senior Study Director, Safety Evaluation

Charles River Laboratories

2007-4 - 2019-11 · 12 yrs 8 mos

Mattawan

As Director of Oncology & Cell Therapeutics, Dr. Xiao was responsible for overall prodct line service capability development and client account management. In the role of Senior Study Director, he was responsible for the overall planning and conduct of non-clinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice. He focused primarily on IND-enabling, pivotal preclinical safety studies and pharmacology PoC efficacy studies of cell and gene therapeutics as well as small molecules in various disease models. He operated within the essential functions of the Study Director role under GLP guideline, particularly with respect to client communications, scientific expertise, and accounty management, while expanding a sustained client base and serving in a mentoring relationship to other laboratory scientists.