Non-Clinical

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

Getting You To The Clinic.

Every non-clinical 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 and to ensure you can conduct your non-clinical program 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 program 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.

e info@3d-pxc.com
t +31 1 353 482 72

Maidstone 48a, 5026 SK Tilburg,
The Netherlands

Pivot Park, RK Building, room 2326,
Kloosterstraat 9,
5349 AB Oss,
The Netherlands

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Our solutions

Navigating milestones successfully is critical for your drug development program to move forward. Besides a focus on quality, our teams aim to ensure that your plans are executed efficiently, cost-effectively, and are ready to partner with you to develop a program customized to your needs. 

Our senior experts can also take on leadership roles to answer to your development program’s specific requirements. Whether they are Non-Clinical, Clinical, CMC, or Regulatory experts they all have hands-on experience with leading large development teams and toward market approval.

Read more about our Leadership Roles.

Non-Clinical

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CMC

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Clinical

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Regulatory Affairs

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Leadership Roles

Our senior experts are selected based on their ability to answer to your development program’s specific requirements. Whether they are Non-Clinical, Clinical, CMC, or Regulatory experts they all have hands-on experience with leading large development teams and toward market approval.

Without exception, we are concerned with the seniority and experience of our candidates required to lead multi-disciplinary teams and to provide you with a balanced expert collaboration that matches your needs.

About us

A company where small dedicated teams and a high level of ownership are the key to success. That is why we treat our clients’ project as if they are our own. From a genuine interest we maintain a close relationship with our clients, in which we value open and honest communication, in order to provide high quality tailored solutions.

Main Office
Maidstone 48a
5026 SK Tilburg
The Netherlands

Satellite Office
Pivot Park RK Building Room 2326
Kloosterstraat 9
5349 AB Oss
The Netherlands

Careers at 3D

No drug is developed by a single person. We understand that it takes teamwork, perseverance to realize something this big. The 3D team works hard with room to laugh and is looking to expand.

At 3D, we believe knowledge needs to be shared to further develop clinical programs, increase market access, and to meet unmet patient needs. This is why we share publications, blogs, and other insights here. Feel free to leave us a message if you’d like more information on a certain topic.