Expert in Drug Development (Small Molecules, Peptides, Biologics, Parenteral Nanoparticles); Drug Delivery
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
|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|
|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.|
|Associations / Societies|
|ACS, AAPS, ASMS|
|Publications and Patents Summary|
|He has more than 20 peer reviewed publications and more than 12 patents.|
|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.
|Expert builds state-of-art analytical facilities for contract research to PAT for large-scale cGMP manufacturing at CMO located on 3 continents.|
|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.|