Toxicology and Safety
Design and preparation of GLP safety studies, from the offer to study report. Active monitoring and trouble shooting, interpretation of nonclinical safety findings.
Advancing your molecule to IND and further.
Terra Nonclinica offers its expertise and support to biotech and pharma companies in nonclinical stages of drug development from proof of efficacy through nonclinical safety to IND and first-in-human.
About
Over 25 years of direct hands-on experience in nonclinical drug development on both sides of Atlantic.
- In pharma and biotech since 2001 in USA, Canada and EU.
- Nonclinical safety strategies: Approaches and studies with IND in mind.
- Effective outsourcing strategies: Expertise, cost, timelines, quality, flexibility.
- Built and led a biotech toxicology team, effective, collaborative and dedicated.
- Latest niche in oncology and ADC: 10 programs with 5 INDs in recent years.
Multiple therapeutic areas: Oncology (ADC, cancer immunotherapies), CNS, pain, diabetes, hematology, medical devices (drug eluting coronary stents) and others.
Designed and executed numerous nonclinical safety programs and over 100 GLP and non-GLP nonclinical studies. I support lean must-do approaches.
Worked with or at up to twenty CROs worldwide. Deep understanding of the CRO business, their pricing strategies, work processes, strengths and weaknesses.
Outsourcing strategies that secure the highest quality, favorable timelines and major cost savings. Understanding the benefits of established relationships.
Work in clinical project teams and co-authorship of relevant sections in regulatory documents: IND/CTA, IMPD, IB, briefing books.
Preparation of data rooms and presentations within partnering activities. Due diligence. Advisory and supervisory board capabilities.
Since 2001in pharma and biotech, in the USA, Canada and the EU
100+GLP and non-GLP nonclinical studies designed and executed
5 INDsMost recently with ADCs and cancer immunotherapies
ERTEuropean Registered Toxicologist
Services
Nonclinical development support from strategy to submission.
Preclinical Strategy
Roadmaps, gap analyses, and clear go/no-go milestones that connect your science to a defensible IND path. We will prepare the list of studies required for your filing to secure the compliance with applicable guidelines.
Nonclinical Program Management
Coordinated oversight of study designs, timelines and budgets across the entire program. With the extensive experience of working at or with many CROs, we will select the most suitable vendors for your studies.
From proof of efficacy to first-in-human.
Each stage has its own questions. The work is to answer them with the fewest studies that will stand up in front of a regulator.
Proof of efficacy
Pharmacology, PK/PD and an early look at target safety, to choose a candidate worth developing.
Nonclinical safety
IND-enabling toxicology, safety pharmacology and genotoxicity, sized to your modality and indication.
IND / CTA
Nonclinical modules, the Investigator's Brochure and a defensible first-in-human starting dose.
First-in-human and further
Answers to questions from the clinic, longer-term toxicology and studies for later phases.
Encore
Articles, interviews and presentations.
Notes on nonclinical drug development, collected in one place.
FAQ
Common questions.
What does “IND-enabling” mean?
IND-enabling studies are the nonclinical studies regulators expect before a new drug is given to people for the first time: pharmacology, pharmacokinetics, safety pharmacology and toxicology, usually under GLP.
Their scope depends on the modality and the indication. Oncology programs follow ICH S9, biologics ICH S6(R1) and most other programs ICH M3(R2).
When should we involve a nonclinical consultant?
Ideally before the first GLP study is placed, when the strategy still shapes the program. The earlier the plan, the fewer studies need to be repeated or added later. A review is also useful at any later point, for example as a gap analysis before a pre-IND meeting.
Do you run the studies yourself?
No. Studies are performed at contract research organisations (CROs) chosen for your program. Terra Nonclinica designs the studies, selects and manages the CROs, monitors the work and interprets the results on your side.
Which regulatory regions do you cover?
Programs heading for an IND with the US FDA and clinical trial applications in the European Union, based on experience in the USA, Canada and the EU.
How does a collaboration start?
With a short call about your molecule, its stage and your timelines. Confidential details can wait until a confidentiality agreement is signed. You then receive a proposal with scope and timelines.
Contact
Let's discuss your path to IND.
Send a brief description of your inquiry. A few sentences about the molecule, its stage and your timelines are enough to start.