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 Expert  725062

Expert in Pharmaceutical Development, cGMP, Formulation, Analytical Development, Poorly Soluble compounds


Available for your Consulting and Expert Witness Needs

Oregon (OR)
USA
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness Market Research

Summary of Expertise:

Listed with other top experts in: 

Expert is an expert in pharmaceutical development. He has 20+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to completion, and has over 20 patents in the area of drug delivery and drug delivery materials development. His drug delivery expertise includes oral, parenteral, discovery support, formulation, dosage form development (IR and CR), process design, and in vivo study design. He designed and built a cGMP facility for drug formulation and dosage form manufacturing and has extensive experience with cGMP management and documentation. He has extensive project management experience in all phases of drug development. Expert also has extensive project management experience, having led a group of 20 scientists in the development of these drug delivery technologies. He also has extensive experience in market/competitive analysis and prior-Art assessment for new products/technologies in the drug delivery area.

Expert is an expert in delivery of poorly soluble drugs. He has 15+ years experience solving commercially relevant problems in the pharmaceutical industry. He has extensive experience managing multi-disciplinary drug delivery projects from inception to completion, and has over 20 patents in the area of drug delivery and drug delivery materials development. His drug delivery expertise includes oral, parenteral, discovery support, formulation, dosage form development (IR and CR), process design, and in vivo study design. In support of these areas, he has extensive solid and liquid analytical method design and characterization experience (e.g., thermal, X-ray, SAXS, NMR, optical spectroscopy, fluorescence, particle sizing, surface characterization, ultracentrifugation, confocal microscopy, optical and electron microscopy, and GPC). Much of his work included analyzing crystallization, including X-ray analysis, morphology control (size, shape, habit, and polymorph), thermodynamics/kinetics of crystallization, and salt-form selection. In addition, he has a strong background in a variety of nanotechnologies for drug delivery, including liposomes, micelles, nanocrystals and polymeric nanoparticles. He has extensive experience in the delivery of poorly soluble drugs, including development of new technology, stability assessment, performance prediction, and process development (e.g., SEDDS, polymer dispersions, nanocrystals, and cyclodextrin complexes). Expert also has extensive project management experience, having led a group of 20 scientists in the development of these drug delivery technologies. He also has extensive experience in market/competitive analysis and prior-Art assessment for new products/technologies in the drug delivery area. Expert has extensive experience developing a variety of nanotechnologies for delivery of poorly soluble drugs. These technologies include liposomes, micelles, nanocrystals and polymeric nanoparticles. Specifically, these technologies have been designed to deliver compounds for a wide variety of compound properties and therapeutic applications, and have been demonstrated in the clinic. The nanotechnologies he developed were demonstrated in vivo for oral, topical, IV, and ocular administration. Much of the efforts on oral drug delivery were directed at the delivery of poorly soluble drugs. In addition, these nanotechnologies were formulated into solid dosage forms and subsequently successfully dosed in the clinic. Expert also has extensive experience in stability assessment, performance prediction, and process development for these nanotechnologies.

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analytical laboratory

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biodegradable system

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capsule packaging process

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cellulose coating material

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chewable tablet

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clinical trial documents generation

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combination drug therapy

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computer-assisted drug therapy

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controlled-release drug delivery

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controlled-release oral drug delivery

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cross-platform development

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development process

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dosage form

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drug degradation

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drug development

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drug dosage form development

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drug targeting

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drug therapy

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enteric-coated tablet

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excipient

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gelatin capsule

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intellectual property strategy

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liposome

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micelle

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nanocapsule

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pharmaceutical analytical chemistry

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pharmaceutical capsule

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pharmaceutical drug

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pharmaceutical industry

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pharmaceutical manufacturing

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pharmaceutical solution

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pharmaceutics

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softgel capsule

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solid pharmaceutical product

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tablet

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technology development

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X-ray diffraction analysis

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drug delivery

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oral drug delivery

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nano drug delivery

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polymer drug-delivery method

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dosage

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pharmaceutical product development

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pharmaceutical product formulation


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Portland, Oregon;  Eugene, Oregon;  Salem, Oregon;  Springfield, Oregon;  and Bend, Oregon.

Education:
Year   Degree   Subject   Institution   Honors
1993   PhD   Material Science, Optical and Chemical Physics   U. of Oregon  
1988   MS   Physics   U. of Oregon  
1987   BS   Physics   Boise State University   Magna Cum Laude, Top Ten Student in Graduating Class

Work History:
Years   Employer   Title   Responsibilities

2013 to

 

(Undisclosed)

 

President and Founder

 

Topo provides broad consulting and project management services for drug development. Expert leads and runs day-day operations and is the primary consultant.

2008 to 2012

 

Agere Pharmaceuticals, Inc

 

Founder and CSO

 

Founded company focused on providing solubilization services to the pharmaceutical industry. Designed, built, and managed a cGMP spray drying manufacturing facility with a cGMP analytical lab. Managed day-day operations, raised capital, organized and lead business development team, and developed proprietary technologies.

1993 to 2008

 

Bend Research, Inc.

 

Executive management team for pharmaceutical drug delivery research

 

1) Nanotechnology, Targeting and Drug Discovery technologies 2) Drug Delivery Technologies, including Oral Solubilization, Parenteral, Topical Technologies 3) Optical materials/systems group, responsible for obtaining funding (over $3MM) through SBIR grant writing

2016 to

 

Serán BioScience, Inc.

 

CEO and Founder

 

Seraán provides broad consulting and project management services for drug development. Expert leads and runs day-day operations. Serán provides laboratory services, including formulation, discovery, analytical development for the biotechnology and pharmaceutical industry, as well as consulting and project management services.


Career Accomplishments:
Associations/Societies

AAPS, APS, AAAS, ACS


Publications:
Publications and Patents Summary

He has 30 patent and patent applications and 24 publications

Selected Publications and Publishers  
 - Journal of molecular pharmaceutics-in preparation  
 - World Intellectual Property Organization Application  

Consulting Services:
Selected Consulting Examples:
  • He guided selection of dosage forms for a large pharma client
  • He helped guide selection of lead compounds for a Discovery start-up company
  • He selected appropriate technologies for delivery of insoluble compounds for a large pharma client
  • He developed a summary of available oral and topical drug delivery technologies for a large pharma client
  • He developed a detailed survey of nanotechnology companies for targeting of drugs for a large pharma client
Recent Client Requests:
  • Oral dosage form expert for consulting on formulation development.
  • Oral drug formulation expert for consulting on Oral formulation.
  • Hair related topicals.
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:
  • Pharmaceutical steroid production expert for consulting and expert witness.
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.

Market Research:
Key understanding of drug discovery and drug delivery trends in the pharmaceutical industry. Extensive understanding of how active pharmaceutical ingredients interact with dosage forms Leader in utilizing mathematical modeling to guide drug delivery

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:
Supplier and Vendor Location and Selection

Selected key pharmaceutical excipients for various drug delivery systems, including dispersions, nanoparticle formulations, oral dosage forms, and injectibles. Evaluated suppliers of critical pharmaceutical excipients from several vendors. Managed multiple in vivo outsources

Other Skills and Services

He provides a unique combination of consulting, mathematical modeling, and laboratory analysis in the pharmaceutical and materials industries. He has extensive experience in intellectual property strategy, assessment, and development.


 

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