Oncology expertise
Whitepaper: Project Optimus
Project Optimus aims to significantly change how early-phase oncology drug development and clinical trials are conducted, with this shift promising to enhance patient well-being by minimising side effects, improving treatment adherence and ensuring accurate drug dosing.
However, oncology drug developers face several challenges when implementing Project Optimus, including varying awareness and more complex clinical trial designs.
Our latest whitepaper explores Project Optimus in more detail.
Phase I-III
oncology expertise
The teams at Simbec-Orion have more than 27 years of experience in the conduct of clinical oncology trials, including rare oncology.
From First in Human, Phase I/II adaptive trials, through to Phase III studies, our deep understanding of managing complex hospital-based studies, supported by a world-leading, independent oncology advisory board, ensures we deliver exceptional CRO services every time. In the last 5 years Simbec-Orion has been involved in 45 oncology studies. Around 86% of the studies we have conducted in that time have been in solid tumour indications.
We work with you from the ground up, designing, implementing, and delivering oncology clinical trials from conception to completion. With experts in early phase oncology trials through to phase III experience, at every level and within every department of the organisation, we deliver at every stage, including the design of your trials, sourcing appropriate clinicians and institutions, and managing the programme. We have established relationships with an international network of oncology Key Opinion Leaders (KOLs) and experts who have specific experience in conducting Phase I to III trials at world-class oncology sites.
One team, together
An effective Contract Research Organisation (CRO) doesn’t operate separately from your team but works in partnership with you to meet the needs and specific requirements of your oncology clinical development programme. They listen to your needs as a business, the questions you’re trying to answer, the challenges you anticipate and the resources you have. From there, they develop a clinical oncology trial to meet your goals.
Deep understanding
Everyone involved in your project from Simbec-Orion will have in-depth knowledge of the protocol. The Clinical Research Associates (CRAs) working on each oncology project are assigned according to their specialties in oncology. This ensures they understand the therapies and treatment modalities involved in the programme.
Blending the demands
No oncology clinical research programme is separate from the human needs or the business goals. At Simbec-Orion, we understand both; we consider the commercial aspects as well as the patients. We then deliver oncology development programmes that make a difference to people, care for patients and work for your company.
Approximately 25% of our studies have been in ATMPs (Advanced Therapy Medicinal Products)
Including Genetically Modified Organisms (GMOs), vaccines, oncolytic viruses, antisense therapy, peptides, antibodies), and T-Cells
Examples of our experience include:
A phase IIb, open-label, randomized study of Gemcitabine and NabPaclitaxel plus/minus X in Patients with Metastatic Pancreas Cancer
A Phase 1b/2, open label study to evaluate the safety, tolerability, and efficacy of X in combination with Romidepsin in patients with relapsed or refractory cutaneous T-cell lymphoma and peripheral T-cell lymphoma
In-house oncology clinical development experts
Oncology drug development requires flexibility and determination at study sites with close study management guidance. Our team of clinicians and scientists will support your clinical development strategy with:
- Trained by Board-Certified oncologists in the therapeutic area and the specifics of your study protocol, our Clinical Research Associates (CRAs) are regionally based, for a flexible, cost-effective, and fully integrated approach.
- Clinical research specialist medical personnel, regulatory experts, and project managers with extensive practical experience in managing the most challenging oncology studies, ensure quality of data as well as speed of delivery
- Our analytical scientists provide customised central laboratory services. Both standard and bespoke assay panels, including an extensive range of validated biomarker assays are available, and can be tailored to the specific needs of your development program.
- Decades of interactions have provided extensive experience in obtaining clinical trial approvals internationally
- Preparation and submission of requests for Pre-IND and EMA scientific advice / protocol assistance meetings
- Attendance at meetings with regulatory authorities
- Data-driven, optimised site feasibility assessment process
- In-house specialised legal team works with global investigative sites
Read our blog on what makes oncology clinical trials different from other therapeutic areas.
Agility and
resilience
- Our size and low-hierarchy management structure makes for agile, flexible processes and allows us to rapidly respond to challenges or escalate issues quickly when required.
- For example, a study was needed to ensure first-in patient success in Europe – in a highly competitive oncology field amongst sites and patient availability. There was also a minimum enrolment of 42 patients required to complete the study.
Through a combination of strong site relationships, optimised study design, agile cohort expansion and forward thinking IMP management, we helped our client communicate the results to the scientific and business communities earlier than anticipated with a larger data set of 90 patients rather than 42 patients originally planned.
Your oncology study:
from conception to delivery
Alain Thibault, Chairman of the Oncology Advisory Board
To support our clients and our delivery of oncology clinical projects, we retain an independent panel of international clinical experts who form our Oncology Scientific Advisory Board. Members of our Board provide advice and guidance on the development in the oncology field from a both clinician and clinical development perspective and provide added value into protocol design and general methodology.
Our Advisory Board includes renowned oncology experts and is chaired by Dr Alain Thibault board-certified Medical Oncologist who trained at the US National Cancer institute and who has more than 22 years’ experience in oncology drug development in North America and Europe, including regulatory drug approvals of small molecules and biologics.
With more than 27 years of experience in oncology study delivery, our expertise enables us to successfully combine your business needs with those of the patients. Discover how.
Drug Types
We have managed clinical trials with all product types including vaccines, new chemical entities (NCEs), antisense therapy, small molecules, peptides, antibodies, genetically modified organisms (GMOs) and biologics, and gene therapy. Whatever the focus of your oncology clinical trial, we can deliver.
