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 Expert  726936

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


Available for your Consulting and Expert Witness Needs

Ohio (OH)
USA
Education Work HistoryPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise: Listed with other top experts in: 
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.

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biopharmaceutical product development

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dosage form

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drug development

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drug dosage form development

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drug formulation

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drug stability

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formulation

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intellectual property due diligence

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new product development

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pharmaceutical industry

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pharmaceutical drug

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pharmaceutical product development

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pharmaceutical product formulation

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pharmaceutical research

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pharmaceutical research and development

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pharmaceutical technology

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product formulation

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protein characterization

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protein drug

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protein drug delivery

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protein formulation development

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protein physiochemical property

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protein stabilization

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stability testing

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stabilization

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active pharmaceutical ingredient

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biochemical separation

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biochemistry

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enzyme

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enzyme purification

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metalloprotein

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protein

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protein analysis

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protein purification

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protein isolation

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protein biochemistry

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protein chemistry

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protein assay development


Show Secondary and Basic Areas of Expertise
Localities:
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;  and Elyria, Ohio.

Often requested
with this expert:

Chemistry R&D and cGMP Manufacturing, Pharmaceutical...
Pharmaceutical Development & Validation
Drug Delivery, Formulation Development of NCE's,...
Medicine, Pharmacy, Pharmacology/ Toxicology with Emphasis...

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

Work History:
Years   Employer   Title   Responsibilities

2003 to 2009

 

Battelle

 

Formulation Leader200

 

Managing a Formulation Laboratory

2000 to 2003

 

Ventaira

 

Formulation Director

 

Managing teh Formulation Group

1999 to 2000

 

Battelle

 

Principal Research Scientist

 

- Participated in strategy development of novel drug delivery technologies and inhalation formulations - Managed a number of R&D programs

1997 to 1999

 

Battelle

 

Research Scientist

 

- 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.

1994 to 1996

 

MIT

 

Postdoctoral Fellow

 

- 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.

1989 to 1990

 

Hong Kong Productivity

 

Chemical Consultant

 

- 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


Publications:
Publications and Patents Summary

Expert has one issued patent, six pending patents, and sixteen publications in peer-reviewed journals.


Consulting Services:
Selected Consulting Examples:
  • 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.
Recent Client Requests:
  • Expert for consulting on review of accelerated stability testing.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Recent Litigation Client Requests:
  • Expert for consulting on Pharmaceutical Patent Litigation.
  • Expert pharmaceutical formulation and stability for loss lititgation.
  • Expert in pharmaceuticals.
  • Expert protein purification equpment for Patent litigation.
  • Expert witness on immunology blood assays for consulting on ELISA spot assay analyzer.
  • Expert for consulting on Inquiry.
  • Formulation expert for generic pharmaceutical patent litigation.
  • Expert in Clinical Trial Management company's required FDA/CFR compliance.
  • Expert in homogeneous and hetrogeneous testing for patent case involving a taxane direvative.
  • Expert for consulting on clinical trial involving asthma biofeedback device.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

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

Language Skills:
Foreign Language  
Chinese  
English  
Cantonese  

Market Research:
Brings intelligent and practical ideas to technology development and commercialization, and to the formulation of new business development strategies.

Click the green button above to contact Expert for a free initial screening call regarding your marketing research, industry research, and company research needs.  For research needs involving multiple experts or secondary research, a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.  Remember, your initial screening call to speak with Expert is free.

Additional Skills and Services:
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

Supplier and Vendor Location and Selection

Expert has expereinces in identifying and evaluating vendors and suppliers for pharmaceutical product development

Other Skills and Services

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.


 

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