Experience

Lassogen, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Chief Development Officer

  • Jun 2020 - Present

  San Diego, California, United States Lassogen, Inc. is a preclinical biotechnology company formed to advance lasso peptides as a new modality to diagnose and treat disease.



Hiroko Masamune Consulting

• Product Development Consultant

  • Aug 2019 - Jun 2020

  California, United States Strategic consulting on CMC, PharmTox, DMPK, Regulatory affairs, and Discovery



Viking Therapeutics, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Chief Development Officer

  • Jul 2018 - Jul 2019

  San Diego, CA Primarily focussed on NASH. Responsible for CMC (drug substance and drug product), pharmacology, toxicology, DMPK, bioanalytical, regulatory affairs, and drug discovery

• SVP, Pharmaceutical Development

  • Jun 2014 - Jun 2018

  Oversee discovery and non-clinical development pipeline for Viking's entire portfolio. Lead compound is a thyroid receptor beta agonist for NASH



Aires Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing

• VP, Product Development

  • Nov 2010 - Jan 2014

  Greater San Diego Area Venture-backed start-up company (8 employees). Partnered with Novartis. Inhaled sodium nitrite for the treatment of Pulmonary Arterial Hypertension (orphan indication). Design and conduct of Phase 1 multiple dose studies in humans to establish the maximum tolerated dose. Characterization of the pharmacokinetic and pharmacodynamic interaction of inhaled sodium nitrite with a concomitantly administered oral therapeutic agent, and selection of the drug doses and the drug delivery… Show more Venture-backed start-up company (8 employees). Partnered with Novartis. Inhaled sodium nitrite for the treatment of Pulmonary Arterial Hypertension (orphan indication). Design and conduct of Phase 1 multiple dose studies in humans to establish the maximum tolerated dose. Characterization of the pharmacokinetic and pharmacodynamic interaction of inhaled sodium nitrite with a concomitantly administered oral therapeutic agent, and selection of the drug doses and the drug delivery device for a Phase II proof-of-concept (POC) study. Ongoing Phase 2 POC and OLE (open label extension) studies (40 sites, 14 countries, including several Eastern European countries, up to 90 subjects). Responsible for API synthesis, drug product manufacture (sterile liquid in glass vials and BFS ampules), drug delivery device selection and characterization, IV and inhalation chronic toxicology studies, multiple IND and IMPD amendments, bioanalytical assay development and sample analysis, supply chain for both drug product and device, inhalation device support to clinical trials (in lieu of specialty pharma CRO), substantial contributions to clinical protocols. Show less



Palkion Inc.

• United States
• Pharmaceutical Manufacturing

• VP, Product Development

  • Jul 2008 - Mar 2011

  Venture-backed start-up company (3 employees), focused on late stage discovery and early drug development. Hypoxia Inducible Factor (HIF) - prolyl hydroxylase small molecule inhibitor for the treatment of anemia associated with chronic kidney disease. Responsibilities included API synthesis, drug product manufacture (oral capsule), toxicology and safety pharmacology studies, bioanalytical assay development and sample analysis, IND preparation, and contributions to clinical… Show more Venture-backed start-up company (3 employees), focused on late stage discovery and early drug development. Hypoxia Inducible Factor (HIF) - prolyl hydroxylase small molecule inhibitor for the treatment of anemia associated with chronic kidney disease. Responsibilities included API synthesis, drug product manufacture (oral capsule), toxicology and safety pharmacology studies, bioanalytical assay development and sample analysis, IND preparation, and contributions to clinical protocol Numerous presentations of scientific information to support financing efforts Show less



Neurogen Corporation

• Biotechnology Research
• 1 - 100 Employee

• Senior Director, Pharmaceutical Sciences

  • Aug 2005 - May 2008

  Small public “microcap” company (150 employees) Provided project management for all drug development teams Created a pharmaceutical sciences group (8 scientists) Developed oral controlled-release formulations for two Phase II compounds Developed initial oral dose formulations for Phase I compounds Provided analytical and formulation support for discovery-stage compounds


Pfizer, Inc.
• United States
• Non-profit Organization Management
• Associate Project Manager, Senior Research Investigator

  • 1987 - 1999