Hiroko Masamune

Hiroko Masamune Email and Phone Number

Chief Executive Officer @ San Diego, CA, US
San Diego, CA, US
Hiroko Masamune's Location
San Diego, California, United States, United States
Hiroko Masamune's Contact Details

Hiroko Masamune personal email

n/a
About Hiroko Masamune

Drug Development executive with extensive experience in taking late discovery assets through Phase 1 and Phase 2 clinical developmentStart up specialist providing scientific, strategic, and regulatory guidance, hands-on project management, and team leadershipSpecialties: Team leadership, scientific direction, and hands-on project management

Hiroko Masamune's Current Company Details
Kissaki Biosciences, Inc.

Kissaki Biosciences, Inc.

Chief Executive Officer
San Diego, CA, US
Hiroko Masamune Work Experience Details
  • Kissaki Biosciences, Inc.
    Chief Executive Officer
    Kissaki Biosciences, Inc.
    San Diego, Ca, Us
  • Hiroko Masamune Consulting
    Pharmaceutical Development Consultant
    Hiroko Masamune Consulting Aug 2019 - Present
    Strategic consulting on CMC, PharmTox, DMPK, Bioanalytical, Regulatory affairs, and Discovery. Clients include numerous early stage / start up companies
  • Lassogen, Inc.
    Chief Development Officer
    Lassogen, Inc. Jun 2020 - Dec 2023
    San Diego, California, Us
    Lassogen, Inc. is a preclinical biotechnology company formed to advance lasso peptides as a new modality to diagnose and treat disease. Key stakeholder in establishing strategic direction and corporate goals. Oversaw the external pharmacology and PK studies
    View
  • Viking Therapeutics, Inc.
    Chief Development Officer
    Viking Therapeutics, Inc. Jul 2018 - Jul 2019
    Primarily focussed on NASH.Responsible for CMC (drug substance and drug product), pharmacology, toxicology, DMPK, bioanalytical, regulatory affairs, and drug discovery
  • Viking Therapeutics, Inc.
    Svp, Pharmaceutical Development
    Viking Therapeutics, Inc. 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.
    Vp, Product Development
    Aires Pharmaceuticals, Inc. Nov 2010 - Jan 2014
    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.
  • Palkion Inc.
    Vp, Product Development
    Palkion Inc. Jul 2008 - Mar 2011
    Us
    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 protocolNumerous presentations of scientific information to support financing efforts
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  • Neurogen Corporation
    Senior Director, Pharmaceutical Sciences
    Neurogen Corporation Aug 2005 - May 2008
    Us
    Small public “microcap” company (150 employees)Provided project management for all drug development teamsCreated a pharmaceutical sciences group (8 scientists)Developed oral controlled-release formulations for two Phase II compoundsDeveloped initial oral dose formulations for Phase I compoundsProvided analytical and formulation support for discovery-stage compounds
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  • Pfizer, Inc.
    Associate Project Manager, Senior Research Investigator
    Pfizer, Inc. 1987 - 1999

Hiroko Masamune Skills

Drug Development Clinical Development Biotechnology Pharmaceutical Industry R&d Drug Discovery Ind Formulation Product Development Cro Toxicology Cmc Life Sciences Assay Development Start Ups Pharmacokinetics Pharmaceutics Clinical Trials Drug Delivery Regulatory Submissions Protocol Organic Chemistry Technology Transfer Biopharmaceuticals Project Management Regulatory Affairs Chemistry Medicinal Chemistry Lifesciences Analytical Chemistry Quality System

Hiroko Masamune Education Details

  • Massachusetts Institute Of Technology
    Massachusetts Institute Of Technology
    Organic Chemistry
  • Ucla
    Ucla
    Organic Chemistry
  • University Of Wisconsin-Madison
    University Of Wisconsin-Madison
    Chemistry

Frequently Asked Questions about Hiroko Masamune

What company does Hiroko Masamune work for?

Hiroko Masamune works for Kissaki Biosciences, Inc.

What is Hiroko Masamune's role at the current company?

Hiroko Masamune's current role is Chief Executive Officer.

What is Hiroko Masamune's email address?

Hiroko Masamune's email address is hi****@****zer.com

What schools did Hiroko Masamune attend?

Hiroko Masamune attended Massachusetts Institute Of Technology, Ucla, University Of Wisconsin-Madison.

What skills is Hiroko Masamune known for?

Hiroko Masamune has skills like Drug Development, Clinical Development, Biotechnology, Pharmaceutical Industry, R&d, Drug Discovery, Ind, Formulation, Product Development, Cro, Toxicology, Cmc.

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