Dr. Liping Zhou

Formulation and drug delivery of small molecules and peptides

Winchester, MA

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About

A highly motivated pharmaceutical scientist and technical leader with over 15 years’ collective experience in drug discovery and development. Main skills and areas of expertise include: • Managing research/development projects and leading cross-functional teams; comprehensive experience in interacting with multi-disciplinary teams to advance projects. • Overseeing CRO/CDMO activities, managing formulation development, tech transfer and DP manufacturing. • Hands-on experience in formulation design and DS/DP characterization of small molecules and peptides; Expertise on solubility/bioavailability enhancement of poorly water soluble drugs and developability assessment of drug candidates. • Authoring & review of drug product section of CMC regulatory document, supporting pre-IND, IND, NDA & life-cycle management. • Invited speaker at multiple national and international scientific conferences; author of 20+ publications, book chapter and patent.

Ask me about
formulation
preformulation
drug delivery
peptide
small molecule
CRO collabration
control release
preclinical project management
Work experience
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Dec 2020 - Present

A2A Pharmaceuticals

Head of Pharmaceutical Development

At A2A, our mission is to leverage proprietary computational systems, including A.I., to accelerate development of novel drug alternatives for life threatening diseases like cancer, bacterial infections and muscular dystrophy.

Nov 2020 - Present

Leader in formulation development and drug delivery

Independent Consultant

- Preclinical and clinical formulation development, focusing on small molecules and peptides; - Controlled release formulation design - Overseeing CRO/CDMO activities - Authoring and review of drug product section of CMC regulatory document, supporting pre-IND, IND, NDA and life-cycle management

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Jan 2019 - Sep 2020

DigiM Solution

General Manager - Pharmaceuticals, Partner

• Managed all pharmaceutics service accounts and led collaborations with leading pharmaceutical & biotech companies, government agencies and research institutes including Merck, Genentech, BMS, US FDA, and UCONN. • Provided microstructure characterization and optimization solutions for clients to visualize, quantify, and predict properties of DS/DP/delivery devices via proprietary high-resolution-imaging technologies. • Coordinated internal and external research activities, authoring and reviewing project reports. • Supported business development and technology advocation by attending conferences, presenting technologies at various venues and writing scientific manuscripts.

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Jul 2018 - Feb 2019

Neon Therapeutics

Associate Director

• Led formulation development & managed external drug product activities for Neon’s personalized vaccine and selected programs in preclinical & clinical settings. • Built the internal formulation capability by introducing lipid nano-particle and liposome formulation technology to enable & improve neoantigen delivery. • Conducted due diligence on various external drug formulation and delivery technologies; Identified partners and managed the outsource projects. • Managed tech transfer to CMO and supported the non-GMP/GMP productions.

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Jul 2017 - Jul 2018

Ra Pharmaceuticals

Head of Formulation Development

• Conducted the novel formulation and new drug delivery technology evaluation activities; Developed sustained release formulation utilizing state-of-art technologies including but not limited to liposomes, PLGA microspheres, hydrogels, liquid crystals. • Managed multiple collaborations with CRO companies and service labs. • Led preformulation and formulation development of in-house peptide and small molecule assets at various stages. • Authored formulation development and DS/DP stability sections for IND; led the review of the Quality sections for IND & NDA documents.

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Jan 2014 - Jul 2017

Ipsen

Senior Scientist

• Served as the CMC representative, supporting all US-based research and development projects for injectable and/or implant peptide drug candidates. • Oversaw project transfer from research/development to clinical trials. • Led innovative formulation/technology evaluation applied to the life-cycle management of Ipsen portfolio. • Developed subcutaneous sustained and controlled release formulations of peptide drug candidates. • Performed drug candidate characterization and assess drug candidate’s solubility and stability using a variety of analytical tools. • Designed formulation to support in vivo pharmacology, pharmaco-kinetics and toxicology studies.

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Dec 2010 - Jan 2014

Novartis

Principal scientist

• Served as a chemical and pharmaceutical profiling representative in multiple research teams, interacting with cross-functional team members • Performed solid characterization; form optimization/selection; crystallization; polymorph screening; salt/co-crystal screening • Assessed developability of lead drug candidate including both small molecules and peptides • Designed formulation strategies; coordinate and plan for PK/PD/Tox studies • Applied GastroPlus simulation to estimate oral absorption of drug candidates • Evaluated suitable novel delivery technologies based on needs of projects • Lead an interdisciplinary discussion group on species difference, human dose prediction and formulation strategy design • Participated in the development of an amorphous stability in silico prediction tool

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Dec 2002 - Jan 2011

Novartis

Investigator II

• Set up physiochemical compound (PCC) profiling lab in Cambridge ; Managed a group of 3 people including 1 PhD and 2MS level scientists • Designed and validated the new generation high throughput thermodynamic solubility assay • Expert in high quality profiling services (high throughput (HT)-solubility, HT-permeability, pKa, LogP/D, thermodynamic solubility, solubility pH-profiling, chemical stability, formulation study, and aggregation study etc.) for compounds from diverse sources ranging from early hits of to selective proof-of-concept. • Designed a UV probe based assay for rate of dissolution determination and performed proof-of-concept studies • Built in silico-in vitro and in vitro-in vivo correlation models on solubility; developed solubility local models to support lead selection and lead optimization. • Developed a novel screening assay for early prediction of phospholipidosis. • Served as a metabolism and pharmacokinetic representative in research project; Obtained hands-on experience in pharmacokinetic data interpretation and experimental design.

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Jul 1998 - Dec 2002

University of Connecticut

graduate student

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