Brian Laing, Phd Email & Phone Number

San Diego, California, United States

• Technical responsibility process development and manufacturing.
• Subject matter expert (SME) guidance for Oligonucleotide process development and scale-up.
• Developing and executing late-stage manufacturing strategy.
• Author relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
• Manage tech transfer activities between CMOs and/or within CMOs for scale-up.
• Technical support for Oligonucleotide OOS, OOT, deviations, change controls and nonconformance investigations.

United States

• Executed technology transfers for process and analytical functions to support manufacturing scale-up and optimization.
• Reviewed and approved manufacturing batch records and executed batch records.
• Served as key subject matter expert for process development, characterization, and validation activities.
• Managed the analytical development function for Vir’s oligonucleotide portfolio.
• Authored and reviewed CMC regulatory filings for oligonucleotide products.
• Drove the implementation of new processes and analytical technologies to improve quality and yield, reduce the cost of goods, and reduce environmental impact.

San Francisco Bay Area

• Developed overall analytical control strategy for Oligonucleotide Drug Substances and Drug Products.
• Served as primary oligonucleotide subject matter expert, providing technical support and knowledge sharing for various CMC functions, including process development, quality control, regulatory affairs, and manufacturing.
• Managed external testing and manufacturing activities at CMO/CRO sites, including technology transfers, process development, process optimization, manufacturing campaigns, quality audits, routine testing, and.
• Assessed, optimized, and developed analytical test methods for analyzing oligonucleotide therapeutic intermediates, drug substances, and products.
• Supported method validation and qualification of test methods.

North Carolina, United States

• Served as overall analytical project manager for multiple clinical stage and commercial Antisense Oligonucleotide (ASO) products supporting internal and external GMP manufacturing campaigns.
• Authored and reviewed analytical sections of CMC regulatory filings for ASO and small molecule products.
• Trained scientists in executing complex LC-MS methods for QC testing of oligonucleotide starting materials, intermediates, drug substances, and drug products.

Raleigh-Durham, North Carolina Area

• Coordinated method optimizations, method validations, and method transfer for in-country testing of commercial ASO products to support worldwide regulatory filings.
• Managed QC testing at CMOs and CLOs, including transfer of methods and OOS investigations.
• Identified and implemented new analytical technologies for QC testing small molecules and ASO Products.

Foster City, CA

• Managed clinical small molecule API projects across multiple sites as analytical lead, providing analytical support and oversight for developing, validating, and transferring analytical methods for GMP Manufacturing.
• Authored GMP test methods and specifications for QC release testing of raw materials, intermediates, and APIs at different phases of clinical development.
• Supported structure elucidation for reference material qualification by HRMS and NMR spectroscopy.
• Developed methods for detection and low-level quantitation of Potential Genotoxic Impurities (PGIs) in drug substances and intermediates.
• Initiated the use of dedicated LC method development tools for rapid screening and optimization using Fusion, Drylab, and Empower on a dedicated LC system

Chapel Hill, NC

• Synthesized novel lipid and peptide oligonucleotide conjugates for applications in nanomedicine, including various stability-inducing modifications such as: 2’ OMe, 2’ –F, Phosphorothioate, LNA, peptide and fluorescent.
• Analysis, purification, and characterization of molecules by HPLC, NMR, UV-Vis, LC-MS, MALDI-MS, DLS, fluorescence spectroscopy
• Authored research manuscripts and review articles
• Served as Co-Chair of the UNC Postdoctoral Association

Chestnut Hill, MA

• Synthesized modified purine nucleotides for incorporation into Peptide Nucleic Acids (PNA) as potential novel DNA targeting therapeutic agents
• Synthesized modified nucleosides and oligonucleotides
• Analyzed and characterized molecules by NMR spectroscopy (1H, 13C, 31P, COSY), UV-Vis, LCMS, MALDI-MS, IR, and HPLC analysis.

West Lafayette, IN

• Reviewed and verified QC reports from outsourced contract laboratories
• Analyzed NMR, IR and MS data for structure elucidation and confirmation
• Performed molecular modeling and structure prediction/verification

West Lafayette, IN

• Developed modified nucleic acids to improve therapeutic potential
• Improved method for the synthesis and purification of Folate-AMP conjugates for functionalizing RNA nanostructures
• Analyzed and characterized molecules by NMR spectroscopy (1H, 13C, 31P, COSY), UV-Vis, LCMS, MALDI-MS, IR, and HPLC analysis.

Rahway, NJ

• Performed preparative chiral chromatography using SFC and HPLC to separate enantiomers
• Analyzed, characterized, and developed methods for the purification of process intermediates during the synthesis of pharmaceutical targets in the Process Research Analysis and Preparative Separations (PRAPS).

Columbia, South Carolina, United States

• Development of method for quantification of hormone titer levels in insect hemolymph using gas chromatography mass spectrometry (GC-MS).
• Assayed the levels of hormones in Porcine Ovaries to elucidate the role of 17 beta Hydroxysteroid Dehydrogenase/ Ketosteroid Reductase (17HSD/KSR) in steroidogenesis.

Atlanta, Georgia, United States

• Conducted research on triplex DNA formation and stabilization using the DNA intercalating agent coralyne.
• Performed UV-Vis melting temperature studies on DNA triple helices and HPLC purification of DNA.

Ph.D., Medicinal Chemistry And Molecular Pharmacology

Activities and Societies: Graduate Student Association

B.S, Chemistry

Activities and Societies: Pre-Health Club - President

Education record

Activities and Societies: Chess Club, School Band, School's Challenge Quiz