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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.

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.

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.