Pharma and Biotech
Medical imaging

Medical imaging consulting

We have significant expertise maximizing the utility of medical imaging for the development of novel therapeutics, including oncology, osteoarthritis, rheumatoid arthritis, osteoporosis, endocrinology, pediatric diseases, theranostics and new diagnostics.

We supplement our internal expertise of medical imaging consultants with a substantial network of contacts in the imaging space. This can be leveraged for our clients, for example, through contacts with key radiology practices or services providing Imaging Core Labs (ICL).

Medical ICL’s are used extensively in clinical and diagonstic development and whilst many have scientific and medical staff, we can provide an independent source of expertise that supports your clinical team before needing to engage an ICL. We can then help identify the optimum ICL for your study or program and monitor their activities, providing valuable imaging insights. Such activities include:

• reviewing and editing the key medical imaging documents
• ensuring the ICL technologists understand the medical imaging
• ensuring the read systems are designed correctly
• working with the ICL and radiology team to ensure the inter-reader evaluations are conducted correctly
• providing regulatory support
• general supporting of the radiology team.

The medical imaging consultants at Alacrita are highly familiar with the regulatory requirements for submitting imaging endpoints for clinical trials. We have even provided briefings and been involved in discussions with key FDA personnel in the development of relevant guidelines. For example, we have presented to the FDA new imaging techniques and regulatory pathways for new imaging biomarkers.

Our medical imaging consultants also provide support to hardware companies and those developing novel image segmentation and endpoints. Working through Foothold America, the team has helped new technology companies develop their company profile in the USA. Examples of what we can provide in this area are:

• strategic planning and execution for the development of medical imaging diagnostics and companion diagnostics
• creating comprehensive development plans for the management of all development functions from target to clinic
• establishing external networks for execution and interpretation of results for decision-making
• serving as a liaison between clients and CROs to ensure correct development of imaging protocols, including regulatory submissions and execution of imaging studies
• strategic planning to establish multimodal (MRI, PET, SPECT, CT, DXA, ultrasound and optical imaging) imaging facilities.

In the last few years the use of medical imaging has increased exponentially in routine clinical practice. This has been reflected in a rapidly increasing use of medical imaging in clinical trials, through all phases. The FDA identified Medical Imaging as one of the key 6 points in the Critical Path initiative which was launched in 2004. This puts a keen focus on the role of imaging and the need to clearly identify and understand this aspect of clinical trials.

Case study: Designing and monitoring anti-NGF imaging endpoints

Challenge

Anti-nerve growth factor (NGF) therapeutics are a new class of powerful analgesics in clinical development. They were put on clinical development hold by the FDA in 2012 due to joint-destruction that was observed in a small subset of patients.

The leader in the development of this class of compounds, Pfizer, needed help to develop a way of evaluating all major joints in subjects entering the new Phase III program.

Solution

Our medical imaging consultant Colin Miller has substantial experience in NGF-targeting therapies and was therefore specifically sought out by Pfizer.

Colin assembled a team of radiologists and together they developed a new radiographic technique to evaluate joints in these patients. Through this ground-breaking work we built a strong academic team that published a landmark Imaging Atlas in 2015, which described the technique and serves as a key clinical reference. We co-authored this publication and helped roll out the new program.

Our medical imaging consultant continues to be the team liaison for the radiologists involved in this trial, coordinating the team and ensuring sufficient imaging quality to enable the success of this trial.

Further case studies regarding medical imaging consulting are available here.