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 Expert  728719

Expert in Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery


Available for your Consulting and Expert Witness Needs

Massachusetts (MA)
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 analytical instrumentation and analytical methods development and validation, especially for drug regulatory filings with the FDA and EMEA according to all FDA and ICH guidelines. He established a state-of-art core instrument department at Altus Pharmaceuticals to solve all problems in biocatalysts (micro- and mesoporous colloidal enzyme microcrystals; organic chemistry, chiral separations of enantiometric drug precursors) and development of crystalline protein drugs (biologics). After Altus folded, he continued the development of Liprotamase, which he started at nine years earlier, until Alnara Pharma filed the NDA.

From his experience at Dow Central Research and AMAG Pharma, Expert is also an expert in material science, colloid chemistry and surface science. This expertise lead to 3 approved magnetite nanoparticle drugs (Feridex, FeriHeme, GastroMARK) and 1 approvable drug (Combidex). He is still the only person to have gotten intravenous magnetite nanoparticles approved for human use. This feat required the development of new colloid, material and surface science techniques for physicochemical characterization and education of FDA and EMEA personnel. After the GarstroMARK IND application, these agencies never had a single technical or scientific question on any of his numerous drug applications for AMAG.

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analytical instrumentation

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analytical method optimization

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assay development

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carbon-13 nuclear magnetic resonance

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cation-exchange chromatography

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chemical characterization

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chromatography applications

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chromatography method development

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drug analysis

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electrospray ionization

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Fourier transform infrared spectroscopy

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gas chromatography

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liquid chromatography/mass spectroscopy

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material characterization process

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nuclear magnetic resonance

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paramagnetic shift reagent

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particle characterization

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peptide sequencing

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physical characterization

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protein mass spectrometry

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proton magnetic resonance

Expert has more than 15 years of experience in the development and application of medical diagnostic imaging agents (MRI, SPECT, CT). He helped develop 4 marketed agents and 1 approvable agent. These imaging/contrast agents are for increasing conspicuity of small tumor metastases to liver and lymph nodes in MRI and blood perfusion in ischemic tissues (MRI and SPECT).

As head of the MRI Lab at AMAG, he used his MR Scanner to develop techniques for noninvasive lymph flow imaging (lymphangiography). To get regulatory approvals (IND/NDA) for magnetite nanoparticle drugs, Expert had to teach material and nanoscience to agency reviewers. After the Feridex application, all subsequent IND and NDA CMC Sections were automatically approved.

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biomedical imaging

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colloid characterization

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colloidal particle coating process

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drug development

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drug product approval

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dynamic light scattering spectroscopy

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investigational drug

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laser light scattering

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magnetic material

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magnetic resonance imaging

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nano drug delivery

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nanobiotechnology

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nanoparticle

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nanotechnology

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particle coating process

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particle surface modification procedure

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particle-size analysis

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radionuclide imaging

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surface characterization

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colloid technology

Expert played a major role in transforming Altus Biologics from a small biocatalysis CRL/CMO to a therapeutic protein development company with an IPO (2 rounds raising $220MM). The therapeutic proteins were enzyme replacement therapies and a sustained release human growth hormone (hGH) formulation. Expert started the development of the lead candidate, Liprotamase, in 2000 and spearheaded its continued development at Alnara after Altus folded in 2009. The NDA was filed in March 2010, and Alnara is being acquired by Eli Lilly.

Based on his expertise in colloidal drug development, Expert led the development of the sustained release formulation of hGH at Altus. This is a subcutaneous, once-a-week drug product based on monomolecular layer of polyelectrolyte coating hGH crystals. Expert other expertise in parenteral drug development include use of polymer (pioneered use of dendrimers), polysaccharides and nanoparticles for controlled and/or targeted delivery of small molecules (antivirals), nucleic acids and proteins. All 3 delivery vehicles are currently being used for siRNA delivery.

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enzyme activity assay

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applied biotechnology

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enzyme technology

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parenteral drug delivery

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pharmaceutical drug

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pharmaceutical product development

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protein chemistry

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protein drug delivery

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drug release polymer

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intravenous drug delivery

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parenteral product

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polypeptide

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drug delivery


Show Secondary and Basic Areas of Expertise
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Boston, Massachusetts;  Worcester, Massachusetts;  Springfield, Massachusetts;  Lowell, Massachusetts;  Cambridge, Massachusetts;  Brockton, Massachusetts;  New Bedford, Massachusetts;  Hartford, Connecticut;  Manchester, New Hampshire;  and Providence, Rhode Island.

Education:
Year   Degree   Subject   Institution   Honors
2008   Two MIT Sloan Executive Certificates   Innovation Management   UCLA  
1978   Ph.D.   Chemistry   UCLA  
1972   BS and MS   Chemistry   Polytechnic Institute of Brooklyn   Unified Honors Program

Work History:
Years   Employer   Department   Title   Responsibilities

2009 to 2010

 

Alnara Pharmaceuticals, Inc.

 


 

Contract Scientist/Consultant

 

To complete technology transfer of Liprotamase to CRO/CMO and get NDA (New Drug Application) filed.

2000 to 2009

 

Altus Pharmaceuticals, Inc.

 


 

Director of Analytical Chemistry

 

Played major role in building company through two rounds of V.C. financing and IPO (2 offerings raised $220MM). The company folded in 2009.

1989 to 1999

 

AMAG Pharma (formerly Advanced Magnetics)

 


 

Senior Scientist/Director MRI Lab

 

All analytical development for magnetite nanoparticle drugs. Development of targeted polysaccharide-conjugated antiviral drugs. Leader of MRI research lab for angiographic and lymph flow and lymph node imaging, including metastses to lymph nodes.

1987 to 1989

 

Dupont Medical Department

 

Diagnostic Imaging Division

 

Senior Research Chemist

 

Leader of Neurolite formulation group and continued Cardiolite analytical development.

1980 to 1987

 

Dow Chemical Co.

 

Central Research (New England Lab-closed)

 

Group Leader

 

R&D in homogeneous and heterogeneous catalysis (mesoporous ceramic and polymer supports). Medical applications of Starburst or dendrimer polymers: conjugates of therapeutic agents and MRI contrast agents.


Career Accomplishments:
Associations/Societies

ACS, AAPS, ASMS


Publications:
Publications and Patents Summary

He has more than 20 peer reviewed publications and more than 12 patents.

Selected Publications and Publishers  
 - Pharmaceutical Research  
 - Expert Opinion on Biological Therapy  
 - Magnetic Resonance Imaging  
 - Bioconjugate Chemistry  

Consulting Services:
Selected Consulting Examples:
  • Expert worked with a privately held drug contract manufacturer in Shanghai with headquarters in Woburn, MA. Offered expertise in CMC and regulatory issues.
  • Expert worked with a venture capital backed biotech startup on CMC and regulatory issues related to bringing a polymer-based delivery system or device to phase I clinical trials.
  • Expert worked with former Altus Pharma collegues to finish all NDA-enabling activities so that Alnara Pharma can finish the development of Liprotamase that he started 9 years earlier. The NDA was filed in March 2010. Alnara is a virtual company founded by his former boss at Altus. Alnara is being acquired by Eli Lilly in June 2010.
  • He worked with a small magnetite nanoparticle company in Indianapolis to develop release assays using a minimum of instrumentation.
Recent Client Requests:
  • Expert in IND enabling package for a new MRI contrast agent.
  • Expert for consulting on Nanoparticles
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:
  • Analytic Chemist to analyze particle size in pharma patent dispute involving Prevacid Solu Tab.
  • Pharmaceutical manufacturing expert for trade secret litigation case.
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:
He is an expert in practical biologic and small molecule drug development, including meeting many obscure regulatory requirements. Special insight into drug delivery systems using macromolecule-conjugates and nanoparticle or colloids, including colloid stabilization and surface science, especially explaining these concepts to FDA and EMEA reviewers.

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

1) Development, properties and biological and medical applications of magnetite nanocolloids. 2) Industrial scale protein crystallization. 3) Analytical development, characterization and CMC trouble-shooting for large-scale cGMP manufacture of crystalline therapeutic proteins. 4) ICH requirements for assay development for biologics and nanocolloid drugs, including PAT.

Supplier and Vendor Location and Selection

Expert builds state-of-art analytical facilities for contract research to PAT for large-scale cGMP manufacturing at CMO located on 3 continents.

Other Skills and Services

Expert is also an expert in material science and has the ability to explain esoteric scientific concepts to laymen, including medical reviewers, marketing and business development people. His expertise is molecular modelling has been useful in preparing molecular graphics for marketing posters and presentations to investors.


 

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