Michele Bronson

Board Observer @ Ten63 Therapeutics

About

Results-oriented C-level executive with 20+ years at start-up to medium-sized biotechnology companies, contributing to the approval of 8 products. I have a proven track record in building stage-appropriate organizations, improving corporate infrastructure, accurate budget planning and management, and effective project and alliance management. My contributions span both strategic and operational domains. I’m particularly passionate about fostering excellence within teams—mentoring, coaching, and creating growth opportunities for employees at all levels. I bring broad expertise in drug development, including both small molecules and biologics, across all stages (pre-IND through post-licensure) and disciplines (clinical, nonclinical, manufacturing), and in diverse therapeutic areas (immunology, oncology, neurology, respiratory, sepsis, rheumatology). Central to many of my successes has been the ability to build productive relationships with development partners as well as regulatory authorities—resulting in effective resolution of complex issues, successful inspections, and accelerated regulatory approvals.

Country

United States

City

San Francisco

Industry

Biotechnology

Skill

Board Operation, Board Governance, Global Regulatory Compliance, Quality System, GMP, Regulatory Affairs, Project Management, Oncology, Biologics, Clinical Operations, biologics, Risk Management, Manufacturing, Standard Operating Procedure (SOP), Due Diligence, Clinical Trials, nonclinical, Biopharmaceutics, Neurology, IND

Experience

Board Observer

Ten63 Therapeutics

2020 - Present · 6 yrs

Working with company leadership, providing strategic development expertise and representing IndieBio investment interests.

Chief Development Officer (CDO)

Ventus Therapeutics

2023-4 - 2024-12 · 1 yr 9 mos

Led the company's transition to the clinic, resulting in 3 IND-ready assets in 18-months and successful completion of First-in-Human studies. Supported partnering program with Novo Nordisk, including serving on Joint Steering Committee. Built robust development organization to support activities, including program management, toxicology, regulatory, CMC, compliance, clinical operations, and clinical pharmacology.

Senior Vice President, Preclinical Development, Regulatory Affairs and Compliance

Ventus Therapeutics

2022-1 - 2023-4 · 1 yr 4 mos

Ventus Therapeutics is a structure-based drug design company. The ReSOLVE platform enables a highly differentiated pipeline of small molecule therapeutics for both inflammation as well as neurology targets.

Chief Development Officer

Nuvation Bio

2019-7 - 2020-2 · 8 mos

San Francisco and New York

A next-generation biotech company currently in stealth mode

Vice President Program Management and Development Operations

Portola Pharmaceuticals

2014-11 - 2019-5 · 4 yrs 7 mos

South San Francisco

As Project Team Leader, contributed to US and EMA approval of andexanet, a reversal agent for apixaban- or rivaroxaban-treated patients with life-threatening or uncontrolled bleeding. Built Development Operations organization (program management, medical writing, clinical operations, and biometrics), leading to US approval of the Factor Xa inhibitor (betrixaban), as well as supporting development of cerdulatinib, a dual syk-jak kinase inhibitor in oncology indication.

Vice President, Regulatory & Quality

Labrys Biologics

2013-3 - 2014-9 · 1 yr 7 mos

San Mateo, CA

Joined as one of 10 employees in venture back-company developing a monoclonal antibody that binds the calcitonin gene-related peptide (CGRP), being developed for the prevention of migraine. Labrys was acquired by Teva Pharmaceuticals for $825 million in July 2014.

VP, Regulatory, Quality and Project Management

Medivation

2006 - 2012 · 6 yrs

San Francisco Bay Area

Joined company as employee number six, building Regulatory, Quality, and Project Management organization. Led team for MDV3100 (enzalutamide) NDA in prostate cancer, which was approved in 3 months by FDA and prepared company for launch through timely institution of commercial compliance procedures. Negotiated approval strategies with FDA and EMA. Created quality systems and project management standards.

Director, Regulatory

Chiron Corporiation

1999 - 2006 · 7 yrs

5,000 person international biotechnology company with commercial products, acquired by Novartis in 2006. Promoted to levels of increasing responsibility within the organization. Managed regulatory, compliance and life cycle strategy for marketed product Proleukin®. Built oncology regulatory group, including hiring and training staff, creating and managing cost-center budgets, and the submission of multiple original INDs.