Non-Clinical

Make use of our scientific know-how, flexibility and an inherent dedication in non-clinical development to excel to identify and solve potential gaps and give you the competitive advantage you need.

Getting You To The Clinic.

Every non-clinical development expert in our company has at least 20 years of experience in the pharmaceutical and biotech industry and together we cover a broad range of indications and therapies, ranging from small molecules, vaccines and biotechnology-derived products to novel therapies such as oligonucleotides and advanced therapy medicinal products (ATMPs) including gene therapy, cell therapy and tissue engineering products.

Our global network consists of a broad spectrum of KOLs, research institutes and contract research organizations (CROs) with whom we collaborate(d) in the past and present. As we operate totally independent and unbiased, we can efficiently support the CRO selection process to make sure we identified the best partner to execute your non-clinical efficacy and safety studies.

Besides working with you to ensure that all studies are conducted in compliance with all necessary regulations, we can help you compile the necessary non-clinical input in the preparation of regulatory documentation such as an IB, CTA/IND, Briefing Book and MAA/CTD.

Lead Optimization – Selecting With Future Development In Mind

By supporting your lead candidate selection process through a developability assessment where we evaluate the design of your screening studies in terms of safety and efficacy and to identify biopharmaceutical (CMC) hurdles to overcome issues later in development like poor bioavailability.

We believe that the involvement of a toxicologist in designing your in vivo proof of concept studies helps to de-risk your development program early and ensures a smooth transition from the discovery to the development stage.

Non-Clinical Development Strategy – Creating A Roadmap To Success

We can design a ‘roadmap’ or non-clinical development plan that outlines the minimal required non-clinical studies including timelines, costs, and risks. Working in conjunction with other disciplines like CMC, clinical, and regulatory helps to ensure that your non-clinical program is fully integrated. For example, our non-clinical and clinical team of experts work hand in hand to ensure a rapid and smooth transition from safety testing to first-in-human trials.

Due Diligence & GAP Analyis

We can perform due diligence to identify gaps in your development program and present recommendations needed to achieve project milestones. In addition, we can assist in the presentation of your data (dataroom) to make sure your compound is ready for out-licensing purposes.

CRO Selection & Negotiation – Finding A Partner That Suits You

As we operate independently and unbiased, we can efficiently support the CRO selection process to make sure we identified the best partner for your  and to ensure you can conduct your non-clinical development within budget and a specified time frame. As a program manager, we can manage and monitor your studies and serve as a single point of contact to guide the program from one milestone to the next.

Data Analysis & Interpretation – Creating A Roadmap To Success

For evaluation and reporting of non-clinical study outcomes, we consider it pivotal to have a clear understanding of the disease area and your therapy’s mechanism of action. As our experts have experience in a broad range of indications and therapies, we can support the decision-making process and help you to identify critical next steps.

Protocol & Report Support – Compliance Guaranteed

Our involvement in study design and data reporting ensures that your non-clinical development program complies with regulatory requirements, it adheres to ethical standards concerning animal welfare, and provides the quality data for key decision making.

Preparation of Regulatory Submission – Enabling Smooth Submissions

Our non-clinical staff has first-hand experience of working in both a non-GLP and GLP environment as a study director and monitoring scientist. We can deliver the necessary input in the preparation of non-clinical components of key regulatory documents including Investigator’s Brochures, periodic- and expert reports, global product labeling, and product monographs.

Lead Optimization - Selecting With Future Development In Mind

By supporting your lead candidate selection process through a developability assessment where we evaluate the design of your screening studies in terms of safety and efficacy and to identify biopharmaceutical (CMC) hurdles to overcome issues later in development like poor bioavailability.

We believe that the involvement of a toxicologist in designing your in vivo proof of concept studies helps to de-risk your development program early and ensures a smooth transition from the discovery to the development stage.

Non-Clinical Development Strategy - Creating A Roadmap To Success

We can design a ‘roadmap’ or non-clinical development plan that outlines the minimal required non-clinical studies including timelines, costs, and risks. Working in conjunction with other disciplines like CMC, clinical, and regulatory helps to ensure that your non-clinical program is fully integrated. For example, our non-clinical and clinical team of experts work hand in hand to ensure a rapid and smooth transition from safety testing to first-in-human trials.

Due Diligence & GAP Analyis - Lorem ipsum is simply

We can perform due diligence to identify gaps in your development program and present recommendations needed to achieve project milestones. In addition, we can assist in the presentation of your data (dataroom) to make sure your compound is ready for out-licensing purposes.

CRO Selection & Negotiation - Finding A Partner That Suits You

As we operate independently and unbiased, we can efficiently support the CRO selection process to make sure we identified the best partner and to ensure you can conduct your non-clinical development within budget and a specified time frame. As a program manager, we can manage and monitor your studies and serve as a single point of contact to guide the program from one milestone to the next.

Data Analysis & Interpretation - Meaningful Insights From Your Data

For evaluation and reporting of non-clinical study outcomes, we consider it pivotal to have a clear understanding of the disease area and your therapy’s mechanism of action. As our experts have experience in a broad range of indications and therapies, we can support the decision-making process and help you to identify critical next steps.

Protocol & Report Support - Compliance Guaranteed

Our involvement in study design and data reporting ensures that your non-clinical development program complies with regulatory requirements, it adheres to ethical standards concerning animal welfare, and provides the quality data for key decision making.

Preparation of Regulatory Submission - Enabling Smooth Submissions

Our non-clinical staff has first-hand experience of working in both a non-GLP and GLP environment as a study director and monitoring scientist. We can deliver the necessary input in the preparation of non-clinical components of key regulatory documents including Investigator’s Brochures, periodic- and expert reports, global product labeling, and product monographs.

François van Och

François van Och

At 3D, François combines his leadership experience and background in immunotoxicology. He takes responsibility for the company’s operations and leads client projects in toxicology, DMPK, biopharmaceutics and early clinical research.

Interested?

Contact us to enquire about our Non-Clinical expertise.