Expert Details

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

Expert ID: 728719 Massachusetts, USA

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ExpertJung 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.

ExpertJung 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.

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.

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.

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 - Providence, Rhode Island

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Education

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

Work History

Years Employer Title Department Responsibilities
Years: 2009 to 2010 Employer: Alnara Pharmaceuticals, Inc. Title: Contract Scientist/Consultant Department: Responsibilities: To complete technology transfer of Liprotamase to CRO/CMO and get NDA (New Drug Application) filed.
Years: 2000 to 2009 Employer: Altus Pharmaceuticals, Inc. Title: Director of Analytical Chemistry Department: Responsibilities: Played major role in building company through two rounds of V.C. financing and IPO (2 offerings raised $220MM). The company folded in 2009.
Years: 1989 to 1999 Employer: AMAG Pharma (formerly Advanced Magnetics) Title: Senior Scientist/Director MRI Lab Department: Responsibilities: 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.
Years: 1987 to 1989 Employer: Dupont Medical Department Title: Senior Research Chemist Department: Diagnostic Imaging Division Responsibilities: Leader of Neurolite formulation group and continued Cardiolite analytical development.
Years: 1980 to 1987 Employer: Dow Chemical Co. Title: Group Leader Department: Central Research (New England Lab-closed) Responsibilities: 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 and Patents Summary
He has more than 20 peer reviewed publications and more than 12 patents.

Additional Experience

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

Fields of Expertise

analytical instrumentation, analytical method optimization, assay development, carbon-13 nuclear magnetic resonance, cation-exchange chromatography, chemical characterization, chromatography applications, chromatography method development, drug analysis, electrospray ionization, Fourier transform infrared spectroscopy, gas chromatography, liquid chromatography/mass spectroscopy, material characterization process, nuclear magnetic resonance, paramagnetic shift reagent, particle characterization, peptide sequencing, physical characterization, protein mass spectrometry, proton magnetic resonance, biomedical imaging, colloid characterization, colloidal particle coating process, drug development, drug product approval, dynamic light scattering spectroscopy, investigational drug, laser light scattering, magnetic material, magnetic resonance imaging, nano drug delivery, nanobiotechnology, nanoparticle, nanotechnology, particle coating process, particle surface modification procedure, particle-size analysis, radionuclide imaging, surface characterization, colloid technology, enzyme activity assay, applied biotechnology, enzyme technology, parenteral drug delivery, pharmaceutical drug, pharmaceutical product development, protein chemistry, protein drug delivery, drug release polymer, intravenous drug delivery, parenteral product, polypeptide, drug delivery, drug targeting, protein drug, active pharmaceutical ingredient, investigational drug procedures, pharmaceutical technology, pharmaceutical coating material, delivery system, polymer drug-delivery method, mass spectrometer, mass spectroscope, nuclear spin, high-performance liquid chromatography/mass spectroscopy, multinuclear nuclear magnetic resonance spectroscopy, drug stability, analysis instrument, chromatography data handling system, particle surface area determination, particle-size measurement, particle-size distribution determination, magnetic resonance imaging contrast agent, high-performance liquid chromatography, analytical reagent, multinuclear nuclear magnetic resonance, analysis technique, nuclear magnetic resonance spectroscopy, pharmaceutical manufacturing, nuclear magnetic resonance biomedical imaging, mass spectrometry, magnetics, magnetic property, dosage form, colloid, colloid and interface chemistry, biotechnology, assay

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