Dot Colagiovanni, PhD (DABT), MT (ASCP)

Experience

• 

  University of Colorado

  Jan 1989 - Jan 1994

  Graduate Student
• 

  Synergen

  Jan 1994 - Jan 1994

  Post-doctoral fellow
• 

  Amgen

  Jul 1994 - May 1998

  Post-Doctoral Fellow/Research Scientist

  Post-doctoral fellowship in the anti-inflammatory division evaluating the immunotoxicity of novel proteins. This postion became a permanent position in the pharmacology group at Amgen-Boulder, CO

• 

  Verde Research Consulting

  Jun 1998 - Nov 2019

  President

  Assisting small and virtual biotech companies with their nonclinical development needs,

• 

  Gilead Sciences

  Dec 1998 - Dec 2000

  Research Scientist

  Research Scientist in the anti-infectives division assessing novel compounds.

• 

  OSi Pharmaceuticals

  Jan 2001 - Nov 2004

  Senior Scientist II

  Toxicologist specializing in GLP animal studies that were conducted on-site. This function supported 4 nonclinical programs for targeted oncology. Responsible for all aspects of study conduct including protocol development, overseeing research associates in live phase activities, and study report completion. Oversaw contracted CRO studies for specialty toxicology purposes. Additionally, wrote IND, IB, and EMEA supporting regulatory documents.

• 

  Replidyne

  Nov 2004 - May 2008

  Assoc Director, Toxicology

  Associate Director responsible for all toxicology related-activities. These include NDA, IND and IB preparations; managing contracted toxicology and safetypharmacology studies; project team representation, and departmental employee management. Four projects, from NDA-stage to discovery, are overseen and supported.

• 

  N30 Pharmaceuticals

  Jun 2008 - Mar 2016

  Senior Director of Toxicology

  As Senior Director of Toxicology responsible for all aspects of safety pharmacology and toxicology. Regulatory document preparation from IND to NDA. Leads the program projects for GSNOR inhibitors. Due diligence for strategic partnering including document development, review, and presentations.

• 

  Nivalis Therapeutics, Inc.

  Feb 2015 - Mar 2016

  Senior Director of Product Development

  Nivalis Therapeutics' lead clinical candidate, N91115, is being investigated in cystic fibrosis patients. The intent is to modulate CFTR by stabilizing it at the membrane in conjunction with CFTR potentiators and correctors. Nivalis was formerly known as N30 Pharma, just rebranded.

• 

  Next Frontier Biosciences

  Mar 2016 - Jul 2020

  As an advocate for the benefits of cannabis as a component of wellness modalities, I have lead our scientific team's focus to create new and novel formulations for maximum delivery of cannabinoids. These products have launched as the Verra Wellness and Verra Health brands. These products have statewide uptake in the legal cannabis industry in Colorado and California and a national presence with our hemp-derived CBD product line.

  • Vice President

    Oct 2017 - Jul 2020

  • Senior Director of Pharmaceutical Development

    Mar 2016 - Oct 2017
• 

  Pfizer

  Jul 2020 - Dec 2023

  Senior Director of Toxicology

  Advances novel small molecule oncology targets through nonclinical development to NDA; in-house nonclinical work and oversight of outsourced Safety Pharmacology and Toxicology studies supporting five projects. Management of five employees from early discovery to the clinic; due diligence of licensing assets in infectious disease; site head for student STEM program and mentor

• 

  Metsera

  Feb 2024 - now

  VP of Safety and Toxicology

  Metsera is advancing a broad portfolio designed to accelerate innovation and shape the future of treatment for weight loss, obesity-related conditions, and metabolic diseases.