Research & Developments

Three decades of pharmaceutical research, spanning fundamental biochemistry, drug discovery, bioanalytical method development, and regulatory science β€” with proven contributions to programs that reached patients.

Therapeutic & Research Focus Areas

Antecello Pharma supports clients across a broad spectrum of molecular classes and therapeutic areas, grounded in decades of hands-on laboratory and program leadership experience.

Lipid Metabolism & Cardiovascular

Foundational research on microsomal triglyceride transfer protein (MTP), apolipoprotein B assembly, and atherogenic lipoprotein regulation β€” work that helped enable a marketed therapy for hyperlipidemia.

Small Molecules, Peptides & Biologics

Cross-modality experience covering small molecule discovery, therapeutic peptides, and biologics β€” including monoclonal antibodies and complex protein therapeutics from preclinical through clinical phases.

Bioanalytical Method Development

Assay design and validation for pharmacokinetics (PK), anti-drug antibody (ADA), and toxicology samples in both preclinical and clinical settings β€” built on GLP-compliant frameworks.

Regulatory Science

Direct authorship and review experience across IND, NDA, ANDA, and BLA submissions β€” including three INDs filed at Bristol-Myers Squibb and one BLA at NeoPharm.

Generic Drug Development

Supported the development and FDA approval of sixteen generic products at Fresenius Kabi β€” covering bioequivalence, stability, manufacturing scale-up, and regulatory submission.

CMC & Project Management

End-to-end coordination of Chemistry, Manufacturing, and Controls activities β€” from early formulation through commercial launch, on time and within budget across thirty plus client engagements.

From Bench to Bedside: A Marketed Therapy

Years of collaborative research at Bristol-Myers Squibb on microsomal triglyceride transfer protein inhibitors contributed to the eventual development of lomitapide (marketed as Juxtapid by Aegerion Pharmaceuticals) β€” a therapy approved for patients with homozygous familial hypercholesterolemia.

This translational journey, from foundational biochemistry papers in the late 1990s to a real treatment helping patients with a rare and serious condition, reflects the kind of rigorous, end-to-end scientific work Antecello Pharma brings to client engagements today.

3
INDs Filed at Bristol-Myers Squibb
1
BLA Filed at NeoPharm
16
Generic Products at Fresenius Kabi
50+
Validated Pre-clinical & Clinical Assays

Selected Research Portfolio

A snapshot of representative scientific programs and contributions across a thirty plus year career β€” from fundamental protein biochemistry at academic and pharma research institutes to applied drug development and bioanalytical leadership.

Drug Discovery

MTP Inhibitor Program at Bristol-Myers Squibb

Played a central role in the characterization of microsomal triglyceride transfer protein and the discovery and biochemical evaluation of MTP inhibitors β€” research that helped lay the groundwork for lomitapide (Juxtapid), now marketed for homozygous familial hypercholesterolemia.

Bioanalytical

Biologics Bioanalytical Leadership

Led biologics and bioanalytical departments at Charles River, SGS, and NanoInk. Designed and validated more than fifty PK, ADA, and toxicity assays supporting preclinical studies and clinical trial sample analysis.

GMP Operations

New GMP Lab Build at SGS

Established a new GMP-compliant analytical laboratory from the ground up β€” qualifying equipment, authoring standard operating procedures, and recruiting and training a full technical staff to support client programs.

Regulatory

Generic Portfolio at Fresenius Kabi

Led analytical assay development and validation supporting manufacturing, stability testing, and FDA submission for sixteen generic products, contributing to their successful market launches.

Project Management

Cross-Functional Program Delivery

Delivered project management support across more than thirty programs at Baxter, ThermoFisher, AbbVie, Ovation, and NeoPharm β€” coordinating CMC activities, budgets, and cross-functional teams to consistent on-time, on-budget completion.

Consulting

Strategic Consulting at Antecello Pharma

Current consulting practice supporting pharma and biotech clients with feasibility, IND-enabling program design, CRO/CMO selection and oversight, and regulatory document review for IND, NDA, ANDA, and BLA filings.

Selected Publications

A selection of peer-reviewed research contributions across protein biochemistry, lipid metabolism, and pharmaceutical sciences. For a comprehensive list, please visit Dr. Jamil's LinkedIn profile.

1998

An MTP Inhibitor that Normalizes Atherogenic Lipoprotein Levels in WHHL Rabbits

Science, Vol. 282, Issue 5389, pp. 751–754
Wetterau J.R., Gregg R.E., Harrity T.W., Arbeeny C., ... Jamil H., et al.
1998

Backbone and Side Chain Dynamics of Uncomplexed Human Adipocyte and Muscle Fatty Acid-Binding Proteins

Biochemistry, Vol. 37, Issue 22, pp. 7965–7980
Constantine K.L., Friedrichs M.S., Wittekind M., Jamil H., Chu C.H., Parker R.A., Goldfarb V., Mueller L., Farmer B.T.
1997

Apolipoprotein B Binding to Microsomal Triglyceride Transfer Protein Decreases with Increases in Length and Lipidation: Implications in Lipoprotein Biosynthesis

Biochemistry, Vol. 36, Issue 42, pp. 13060–13067
Jamil H., et al. β€” Bristol-Myers Squibb Pharmaceutical Research Institute, Princeton, NJ & Allegheny University of the Health Sciences, Philadelphia, PA
1996

An Inhibitor of the Microsomal Triglyceride Transfer Protein Inhibits ApoB Secretion from HepG2 Cells

Proceedings of the National Academy of Sciences
Jamil H., et al. β€” Demonstrated the pharmacological tractability of MTP as a drug target, a key step in the development of MTP-inhibitor therapeutics.
1996

Crystallization of Microsomal Triglyceride Transfer Protein from Bovine Liver

Acta Crystallographica D52, pp. 224–226
Ohringer S.L., Jamil H., Chu C.H., Tabernero L., Einspahr E., Wetterau J.R., Sack J.S.
1996

Inhibition of the Microsomal Triglyceride Transfer Protein Blocks the First Step of Apolipoprotein B Lipoprotein Assembly but Not the Addition of Bulk Core Lipids in the Second Step

Journal of Biological Chemistry
Gordon D.A., Jamil H., Gregg R.E., Olofsson S.O., BorΓ©n J.
Note: This list highlights selected publications from a broader body of work spanning over thirty years. A complete and current list of publications, presentations, and posters is maintained on Dr. Jamil's LinkedIn profile.

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From early phase study design to bioanalytical method development and regulatory filings β€” Antecello Pharma brings hands-on expertise to every engagement.

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