Patrick Colin

PCC Inc. is a Montreal based consulting firm specialized in drug development, from preclinical to Phase IV clinical. PCC inc. focuses on the strategic aspects of overall drug development programs. Drug development services offered in more than 10 Therapeutic Areas, including Gastroenterology, Cardiology, Metabolic Diseases, Oncology, Vaccines, etc...Strong expertise in GI-liver disease drug development. Experience in conducting international Phase 2 and 3 trials. Experience in clinical research in Eastern Europe, as well as developing countries such as Peru and Dominican Republic. Expertise in Clinical Pharmacology (Phase I SAD and MAD studies, PK, Biosimilar PK profiling, Bioequivalence, etc...) Provides privileged access to a large international Clinical Investigators-KOLs Network, including Poland and other Central and Eastern Europe countries.

Laurent Pharma develops an innovative form of fenretinide (LAU-7b), a synthetic retinoid which corrects lipidomic imbalance in Cystic Fibrosis(CF) patients and favours inflammation resolution. This technology originates from McGill University and has been first evaluated in a Phase Ib clinical study. The company is currently conducting a large, international Phase 2 adult CF clinical trial (APPLAUD). Laurent also initiated a Phase 2 study in hospitalized COVID-19 patients, in light of the antiviral (host oriented) and anti-inflammatory properties of LAU-7b.

Giiant Pharma is a new, Montreal based, gastroenterology(GI)-focused company with a gut-restricted, colon-specific PDE4 inhibitor prodrug as lead program, to treat and manage inflammatory bowel diseases (IBD). The Company is also creating a Drug Hunting Club to identify and acquire GI-liver focused assets in order to build a strong franchise in Precision Therapeutics.

Verlyx Pharma was a Montreal, Canada, based clinical stage biotech specialized in the development of innovative products designed to treat inflammatory liver diseases such as Non Alcoholic Steatohepatitis ( NASH) , Acute Alcoholic Hepatitis ) AAH) and other prevalent hepatic disorders.

Gicare Pharma was a clinical stage Canadian biopharmaceutical firm specialized in the development of innovative, orally administered colonic analgesic drugs designed as an alternative to IV sedation for patients under going full colonoscopy.

GInova was a new biotech founded by 7 former pharma executives ( 3 from Axcan, including myself...). We have been trying to close a Series A round of financing of $ 20 M CDN for the last 18 months. We managed to successfully secured $ 15 M so far ( Term Sheet established with 3 VCs). However, we had to terminate this project, because we could not our reach our $ 20 M objective. The current financial context is extremely challenging, and GInova is now trying to license out its 3 promissing technologies. GInova 's innovative drug technologies address unmet medical needs for Celiac Disease, Ulcerative Colitis , and Sedation for Colonoscopy. As the CDO of the company, I was responsible for all aspects of the drug development programs, from pre-clinical tox to Phase II clinical.

This position was responsible for all aspects of Axcan's GI and liver disease drug development programs, including preclinical (CMC and tox), as well as Phase I, II and III clinical development. During my 12 years at Axcan, our team managed to obtain 12 marketing approvals in Canada, USA and EU (NDAs, SNDAs, NDS, etc...) A strong collaboration was also established between R & D and other key departments, such as Marketing, BD and Medical Affairs. R & D efforts at Axcan led to the approval of 12 regulatory filings, between 1994 and 2007 ( NDAs, SNDAs, NDSs, SNDSs, MAs, PMAs) I also actively participated to Axcan 's IPO in 1995, as well as Nasdaq listing in 1999.

Responsible for Phase 2 clinical development, in the areas of dyslipidemia and peripheral vascular disease.

Contributed to Phase 1-2 clinical development of pravastatin, a hypocholesterolemic drug.

Responsible for biopharmaceutical development, therapeutic equivalence clinical studies, and bioanalytical development.

38 years experience in drug development, from preclinical to Phase IV clinical. Expertise in gastroenterology and hepatology. Worked in a large pharma ( BMS), mid-size ( Axcan), start-up ( Purecell Technologies, Ginova, Gicare, Laurent Pharma, Verlyx, Angany) .