With 20+ years of hands-on experience in small molecule CMC development, I assist drug developers with the management of the Chemistry, Manufacturing, and Controls aspects of drug development, from pre-clinical development of small molecules and peptides, to formulation development, clinical manufacturing, and scale-up. Clients typically use me as their virtual VP/Director/Project Manager of Manufacturing & Development, whereby I organize, coordinate and execute comprehensive drug development… Show more With 20+ years of hands-on experience in small molecule CMC development, I assist drug developers with the management of the Chemistry, Manufacturing, and Controls aspects of drug development, from pre-clinical development of small molecules and peptides, to formulation development, clinical manufacturing, and scale-up. Clients typically use me as their virtual VP/Director/Project Manager of Manufacturing & Development, whereby I organize, coordinate and execute comprehensive drug development plans on behalf of my clients.I specialize in synthetic organic chemistry, small molecules (chiral and achiral drugs), peptides, peptidomimetics, solid dosage form, and intranasal (powder) delivery. I am trained in organic synthesis, peptide synthesis, cGMP manufacturing, and CMC writing for INDs.Examples of where I typically offer assistance: Pre-IND meeting requests, authoring of CMC sections and documentation for regulatory submission, qualification and management of CDMOs, oversight of cGMP manufacturing activities, establishment of API and drug product specifications, authoring and review of batch records, review of non-conformance reports, analytical method development and validation, control and stability of drug product and drug substance, powder characterization (particle size, hygroscopicity, powder flow properties, thermal behaviour, XRPD, solubility, plume geometry, spray pattern), impurity characterization and synthesis, solid oral dosage forms, tech transfer, CMC gap analysis, risk assessment. Show less

Providing CMC-related assistance to Kinexum's national and international clients: CMC gap analysis, management of drug substance and drug product development programs across multiple therapeutic areas.Co-authoring of Pre-IND meeting requests, and INDs (Module 3).Technical due diligence on late-stage drug development programs.

Leading Find Therapeutics' drug substance and drug product CMC development program; development and manufacture of clinical drug substance supply, development and manufacture of clinical drug product supply. Authoring of regulatory submissions (Module 3).

Management of TIXiMED's drug substance and drug product development and clinical manufacturing programs. Authoring of regulatory submission.

Leading Kaerus' drug product development and manufacturing program. Authoring of regulatory submission (CMC).

Maresins Pharma/SPM Therapeutics develops disruptive treatments for detrimental inflammation and pain by harnessing the natural power of maresin compounds.I've been leading the company's drug substance and drug product development activities since July 2019.

Reporting to the VP Technical Operations and CEO, I provided CMC oversight to one of Levo’s drug substance and drug product development programs. Levo Therapeutics was acquired by Acadia Pharmaceuticals (San Diego) in 2022.

Member of Ovensa's Scientfic Advisory Board

Helping Innovative Firms Grow in Canada through Funding and Advice. Specialty: bio+pharma.Industrial Technology Advisor (biotech/pharma) at the National Research Council's Industrial Research Assistance Program (IRAP). Provided technical and business assessments, strategic advisory services and funding to High Potential Firms. Expert on non-dilutive funding for innovative Canadian companies. Project assessor for Build in Canada Innovation Program and Strategic Innovation… Show more Helping Innovative Firms Grow in Canada through Funding and Advice. Specialty: bio+pharma.Industrial Technology Advisor (biotech/pharma) at the National Research Council's Industrial Research Assistance Program (IRAP). Provided technical and business assessments, strategic advisory services and funding to High Potential Firms. Expert on non-dilutive funding for innovative Canadian companies. Project assessor for Build in Canada Innovation Program and Strategic Innovation Fund.Team Lead Eastern Canada, NRC Concierge Advisory Services Show less

BioQuadrant Inc: a chemistry-based Contract Development & Manufacturing Organization (CDMO) catering to very specific needs of clients in the biopharma industry. 2006 Graduate CQIB Life Sci incubator, Laval, Canada. As BioQuadrant's CSO, I led the successful execution of 80+ milestone-driven projects in the Life Sciences field.Examples:2009-2013: LY900018/Baqsimi (Locemia Inc/Eli Lilly). NASAL POWDER FORMULATION FOR TREATMENT OF HYPOGLYCEMIA; US Patent 20180000904… Show more BioQuadrant Inc: a chemistry-based Contract Development & Manufacturing Organization (CDMO) catering to very specific needs of clients in the biopharma industry. 2006 Graduate CQIB Life Sci incubator, Laval, Canada. As BioQuadrant's CSO, I led the successful execution of 80+ milestone-driven projects in the Life Sciences field.Examples:2009-2013: LY900018/Baqsimi (Locemia Inc/Eli Lilly). NASAL POWDER FORMULATION FOR TREATMENT OF HYPOGLYCEMIA; US Patent 20180000904. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-severe-hypoglycemia-can-be-administered-without-injection. FDA approval July 2019.2004-2006: ID1101 (Adyvia®), ID1576, ID1135 (Innodia Inc): Scale-up synthesis of hydroxylated amino acids for the treatment of diabetes. Published in US patents 20100048545, 200602238842006-2007: EV-077 (Evolva Inc), targeting diabetic nephropathy; Work published in WO2008089461A12003-2004: R-954 (IPS Pharma); bradykinin antagonist, targeting diabetic peripheral neuropathy; http://www.ncbi.nlm.nih.gov/pubmed/24361511 2010-2013: UCM765 (Cosmas Therapeutics): Melatonin receptor ligands 2008: NVT-0275 (NorVison Inc); mono-trisubstitued trisulfonated porphyrazine for photodynamic therapy of cancer; 2008: Theratechnologies; Tesamorelin - work on impurities2006: BA-1049 (BioAxone); Rho kinase inhibitor; potential treatment of cerebral vascular disorders and degenerative eye disease; http://bioaxonebio.com/technology-overview/pipeline/2005: Elamipretide (Bendavia, SS-31, D-Arg-dimethylTyr-Lys-Phe-NH2), http://biotechnologyfocus.ca/an-ircm-breakthrough-leads-to-a-potential-drug-for-a-rare-disease/ 2003-2005: PL-100/PPL100/Mk8122/TMB-607 (Ambrilia/TaiMed Biologics); second generation HIV Protease inhibitor; Performed chemical synthesis route optimization and scale-up; http://www.taimedbiologics.com/pipeline/352000-2001: CCI1004 (ConjuChem Inc); long acting thrombin inhibitor; Show less

Key tasks: strategic scientific planning (budgets, protocol development,...) of Insymbiosis' pre-clinical chemistry programs; project management of all chemistry-related projects; preparation of R&D proposals for international clients; analogue syntheses and scale-up of experimental drugs; consultation on CMC-related issues; development of a comprehensive pre-clinical and clinical chemical/analytical development plan for a small molecule therapeutic to treat renal disease.

Development and scale-up of a novel synthesis route for a thrombin inhibitor.

Solid-supported synthesis of azasugar peptide mimetics. Laboratory for Organic Chemistry; Director: Prof. Dr. William D. Lubell