CatalystBio – A global life sciences advisory firm

Integrated life sciences consulting

Powering biotech progress from product discovery to approval

CatalystBio is designed to provide end-to-end advisory services and fractional leadership to biotech companies to catalyze the product development lifecycle. We help companies reach value inflection points and critical milestones faster by bringing technologies to the clinic more efficiently. We pride ourselves on providing both strategic direction and operational execution to bring value exactly where needed.

End-to-end product development support

Our Services

Regulatory

We streamline regulatory filings based on global experience and proven track record

To do this, we prepare regulatory submissions, facilitate regulatory interactions, and align product development milestones with regulatory requirements.

CMC

We define phase-appropriate process and product scale up strategies

We design and execute analytical method validation plans; we draft manufacturing batch records and design process scale-up strategies; we perform CQA and CPP assessments.

Quality

We design phase appropriate quality systems to support development

We build and implement quality systems, provide inspectional readiness assessments and strategic plans, remediate PAI and 483 observations and concerns, and ensure value-added quality is maintained.

Pre-Clinical

We ensure impactful and IND-enabling preclinical study design

We draft, review, and edit study reports; we design IND-enabling pre-clinical data packages that support intended clinical studies, and manage preclinical and toxicology vendors.

CLINICAL

We architect efficient clinical trial designs

We benchmark and design clinical trials with registrational endpoints in mind from the beginning; we implement adaptive trial designs towards accelerated approvals, and we streamline enrollment and trial management.

Project Management

We bring value exactly where needed

We develop and manage cross-functional product development plans, timelines, budgets, and contracts, prepare scientific presentations, and implement processes to support efficient product development.

Diligence & Fundraising

We lead external and internal diligence efforts

We draft and review diligence questions and responses, meet with investors and KOLs, define diligence strategy, perform 3rd party search and evaluation, and generate pitch materials.

Company Buildout

We serve as fractional, operational, C-Suite executives

We support early-stage companies during company formation and oversee key inflection points, define stage-appropriate strategic hiring plans, and manage resource allocation.

Who we are

MEET THE EXECUTIVE TEAM

Greta Wodarcyk

Co-Founder & Principal

PhD in Biological Sciences, Northwestern University
BA in Chemistry and Music, St. Olaf College

Greta is a biotech executive with expertise bridging product development, preclinical/toxicology, CMC, and clinical operations with a record of successful regulatory filings and clinical operational efficiency.

Michael Boyne

Co-Founder & Principal

PhD in Chemistry, University of Illinois, Urbana Champaign
BA in Chemistry, Northwestern University

Michael is a biotech executive and former regulator with expertise in manufacturing, quality, research and development, regulatory drug development and CMC strategy with a successful track record of company buildout and regulatory approvals.

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