Expert Details

Expert in Pharmaceutical and Biopharmaceutical Product Development, Formulation and Stabilization Technology

Expert ID: 726936 Ohio, USA

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Expert has fifteen years of experience in product development, formulation development, and drug delivery for pharmaceutical and diagnostic industries. She has thoroughly developed skills in research planning, product formulation, and analytical problem solving. Expert has expertise in the fields of invention and innovation, as well as due-diligence, technology and intellectual property assessment, freedom-to-operate analysis, licensing and commercialization. She also has worked in regulatory strategy development, and IND and NDA submission; including CMC planning, execution, and documentation.

Expert is an expert in the area of protein stabilization technology for pharmaceutical products, diagnostic reagents and bioprocessing. She has extensive pharmaceutical formulation development: pre-formulation, solubility, stability studies and optimization for pulmonary, parenteral, topical, transdermal, sublingual and intranasal formulation of small molecules and biologics. Expert is highly experienced in trouble shooting of unstable formulations for both small organic and larger protein drugs. She has developed expertise in the development of quick-dissolve, controlled-release, particle and emulsion technology, and application of natural and synthetic polymers and surfactant systems to product formulations in the pharmaceutical industry. Expert has given talks at professional conferences and taught professional courses in the pharmaceutical industry. She held one issued patent, six pending patents, and sixteen publications in peer-reviewed journals.


r. Expert has extensive expertise in protein stabilization for pharmaceutical products, diagnostic reagents and bioprocessing, as well as expertise in protein purification (method development, scale up, and trouble shooting), characterization and modification.

Expert is also experienced in chemical and biochemical analysis of protein and nucleic acid: chromatographic properties (HPLC, GC, MS), immunological properties (SDS-PAGE, Western Blots, ELISA assays), and enzyme assays, Nuclear Magnetic Resonance (NMR) using different nuclei, Electron Paramagnetic Resonance (EPR), Gas Chromatography (GC), Mass Spectrometry (MS), UV Absorption, Fourier Transform Infrared Spectroscopy (FTIR), Circular Dichroism (CD), Isothermal Temperature Coefficient (ITC), Differential Scanning Calorimetry (DSC), fluorescence quenching, Amplified-Fluorescence Labeling, Metal Analysis, Chip Array Detection, HPLC, Enzymatic and Protein Assays, Mechanistic Studies (kinetic and binding), Adduct and Complex Analysis, Radioisotope Labeling, and Electrochemical Measurements.

Expert has experiences in proteomics: Ciphergen SELDI Mass Spectroscopy to perform high throughput screening of protein biomarkers and bacterial growth (aerobic and anaerobic), protein purification, DNA and RNA purification, mutation/cloning.

Expert is a consultant for a pharmaceutical company in the area of formulation and CMC development.Expert is a consultant for a consulting firm with different pharmaceutical clients in the area of formulation, technology due diligence.Expert is a consultant for a small biotech in the area of developing a antimicrobial product.Expert is a consultant for a small biotech in the area of developing a inhalation product.Expert is a consultant for an international pharmaceutical company to perform IP landscape analysis and due diligence.

Expert may consult nationally and internationally, and is also local to the following cities: Columbus, Ohio - Cincinnati, Ohio - Toledo, Ohio - Akron, Ohio - Dayton, Ohio - Canton, Ohio - Lorain, Ohio - Springfield, Ohio - Hamilton, Ohio - Elyria, Ohio

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Education

Year Degree Subject Institution
Year: 1994 Degree: PhD Subject: Chemistry/Biochemistry Institution: The Ohio State University
Year: 1996 Degree: Post Doct Subject: Biochemistry Institution: MIT
Year: 2005 Degree: MBA Subject: MBA Institution: The Ohio State University

Work History

Years Employer Title Department Responsibilities
Years: 2003 to 2009 Employer: Battelle Title: Formulation Leader200 Department: Responsibilities: Managing a Formulation Laboratory
Years: 2000 to 2003 Employer: Ventaira Title: Formulation Director Department: Responsibilities: Managing teh Formulation Group
Years: 1999 to 2000 Employer: Battelle Title: Principal Research Scientist Department: Responsibilities: - Participated in strategy development of novel drug delivery
technologies and inhalation formulations
- Managed a number of R&D programs
Years: 1997 to 1999 Employer: Battelle Title: Research Scientist Department: Responsibilities: - Led Advanced Protein Stabilization, Pulmonary Delivery and
Advanced Inhalation Formulation.
- Developed technologies for long-acting enzyme, therapeutic
biomolecules and enzyme bioreactor
- Developed proprietary protein stabilization technologies for
protein therapeutics.
Years: 1994 to 1996 Employer: MIT Title: Postdoctoral Fellow Department: Responsibilities: - Investigated molecular recognition of antitumor drugs with
sequence-specific DNA targets using multi-dimensional NMR
techniques (1H, 13C, 31P and 19F) and molecular dynamics
calculations.
- Determined the cleavage sites and the binding affinity of DNA
targets by bleomycin using a variety of biochemical methods
such as amplified-fluorescence quenching, Maxam-Gilbert
sequencing, radioisotope labeling and HPLC.
Years: 1989 to 1990 Employer: Hong Kong Productivity Title: Chemical Consultant Department: Responsibilities: - Supervised an analytical chemistry laboratory with 7
technicians and issued quality control certificates of
electroplating products and corrosion testing
- Provided technical advice to local metal-finishing industry
regarding productivity, quality control, new design

International Experience

Years Country / Region Summary
Years: 2009 to 2009 Country / Region: China Summary: Expert is a consultant to perform a high level of GMP auditing of a Pharmaceutical CMO.
Years: 2009 to Present Country / Region: China Summary: Expert is a consultant to a small device start-up to develop a pharmaceutical device.
Years: 2010 to Present Country / Region: India Summary: Expert is a consultant to a Pharmaceutical company to conduct IP landscape analysis and due diligence.

Additional Experience

Training / Seminars
Expert has given professional training courses to:
(1) “Biophysical Analysis of Biologics” October 2009 in San Francisco,
CA - 2 days course
(2) “Biophysical Analysis of Biologics” October 2009 in Boston, MA -
2 days course
(3) “Strategies for Stabilizing Protein Formulations” in a conference
titled “Formulation Strategies for Protein Therapeutics”, October
13-15, 2009, Raleigh, NC
(4) “Biophysical Analysis of Biologics” May 2010 in Genencor
International, Inc. Palo Alto - 2-days course for 30 staff at
Genencor
Vendor Selection
Expert has expereinces in identifying and evaluating vendors and suppliers for pharmaceutical product development
Marketing Experience
Brings intelligent and practical ideas to technology development and commercialization, and to the formulation of new business development strategies.
Other Relevant Experience
Due diligence of IP and technologies evaluation for potential investment

Extensive knowledge and experience to serve the unique scientific, product development, and regulatory needs (CMC for IND and NDA submission) of the pharmaceutical and biopharmaceutical industry.

Language Skills

Language Proficiency
Chinese
English
Cantonese

Fields of Expertise

biopharmaceutical product development, dosage form, drug development, drug dosage form development, drug formulation, drug stability, formulation, intellectual property due diligence, new product development, pharmaceutical industry, pharmaceutical drug, pharmaceutical product development, pharmaceutical product formulation, pharmaceutical research, pharmaceutical research and development, pharmaceutical technology, product formulation, protein characterization, protein drug, protein drug delivery, protein formulation development, protein physiochemical property, protein stabilization, stability testing, stabilization, active pharmaceutical ingredient, biochemical separation, biochemistry, enzyme, enzyme purification, metalloprotein, protein, protein analysis, protein purification, protein isolation, protein biochemistry, protein chemistry, protein assay development, sublingual administration, intranasal administration, inhalation administration, due diligence, Chemistry, Manufacturing and Controls, nano drug delivery, analytical instrumentation, analytical method optimization, investigational drug procedures, amino acid sequence, amino acid analysis, nasal spray, drug container, drug release polymer, intravenous drug delivery, protein component, drug degradation, delivery system, lead stabilization, biophysical chemistry, protein concentration process, macromolecule, injectable pharmaceutical product, controlled-release oral drug delivery, antiviral agent, stability prediction, stability, electrophoretic protein purification, polymer drug-delivery microsphere, topical antimicrobial product, analytical method validation, parenteral drug delivery, protein functionality, protein modification, protein biology, excipient, topical drug, topical drug therapy, emulsion stability, recombinant protein, drug analysis, delivery, controlled-release drug delivery technology, analysis, due-diligence investigation, drug delivery, drug-delivery microsphere, design optimization, emulsion (mixture), chemical reaction, high-performance liquid chromatography, physical stabilization, chemical stabilization, chemical reaction mechanism, analysis technique, enzyme engineering, protein engineering, polypeptide, amino acid, transdermal drug delivery, protein synthesis, protein lyophilization, project management, nasal drug delivery, injectable drug, chromatography, buccal drug delivery, assay, analytical chemistry, affinity chromatography

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