Catalyst Oncology Consulting is focused solely on the development of new treatments in oncology. Catalyst Oncology Consulting provides a unified expert platform to support biotech companies through all phases of development from lead optimization through NDA. We partner with clients to effectively develop their assets by utilizing the best emerging science and regulatory support to improve cancer diagnosis and treatment
Services we offer
Drug Development Strategy Workshops provide a unified framework to assess risk, identify gaps and lay out an optimum development pathway for FIH or investor targets
Flexible Access to highly experienced regulatory, preclinical, toxicology, pharmaceutical development partners and oncology SMEs.
Bespoke Consulting Project Teams offer an integrated collaboration to support clients’ key milestones and provide flexible, complementary knowledge and resources
“Catalyst clearly demonstrated they have the expertise and connections to evaluate this scenario thoroughly. They were very easy to work with and the quality of the output we received, together with its speed, was impressive.”
Clinical Pharmacology Leader
US Biopharmaceutical
Industry-leading experts
Offering the opportunity to assemble experts and partners, with an average of 20 years experience, to advise clients on minimum & optimal development pathways, including:
Pharmaceutical development
Biomarker development
CMC
Medical writing
Pharmaceutical physicians
Biostatisticians
Medical scientists
Translational scientists
Regulatory experts
PD/PK experts
Toxicologists
Clinical operations/Clinical oncologists
We are your partners in product development, serving as an extension of your study team
“A fabulous job – many thanks all. A clear basis around which to plan our transition from discovery to development.
CEO
UK Biopharmaceutical
Exploratory
Preclinical development strategy and planning
Portfolio assessment and prioritization
In-licensing due diligence
Vendor identification and oversight
Program management
Non-Clinical
Regulatory pathway assessment
Toxicology assessment
PK/PD analysis
Preclinical study modeling
Preclinical study design and protocol development
Bioequivalence strategy
CMC
IND/CTIS/MHRA/ TGA preparedness review
Process development scoping
Product development plan
Manufacturing compliance assessment
QMS planning and implementation
GMP review
Pre-IND
Agency liaison
Clinical development strategy
Clinical study design and protocols
Pre-IND meeting plan, preparation & attendance
Special designation requests
IND/BLA/CTIS/ MHRA/TGA preparation and submissions
IND/CTA
IND/BLA/CTIS/ MHRA/TGA preparation and submissions
Protocol amendments
Labeling review
EOP2A
Review and assess clinical trial results
Clinical hold review and response
Pediatric study plan
Meeting plan, preparation, attendance and follow-up
Pre-NDA/BLA
Phase III study review
Meta-analysis
Meeting plan, preparation, attendance and follow-up
Regulatory
Global agencies
Preparation and submission
Regulatory compliance
We can help
Develop and deliver optimized drug development plans to deliver the best asset to patients and investors
Deliver a gap analysis report to frame an asset’s technical, clinical and commercial risks and likelihood of success
Assess the challenges and unique questions through a unified SME platform
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