Tag Archives: Safeguarding

Case Study – Delivering Enormous Cost Savings by Providing Sourcing Options for Oncology Products.

Request
A client approached us with a request for a large quantity of an expensive oncology product, documentation such as Certificate of Analysis (CoA) was required for import into several of the countries involved in the trial.

CSI Approach
Due to the high value of the product and the importance of choosing a suitable strategy for the trial and sponsor CSI decided to investigate a range of options with different advantages and disadvantages so that the client could decide what best suited their trial. The solutions presented to the customer where;

1. Directly contact the marketing authorization holder (MAH) of the branded product.
Advantages: Guaranteed supply, single batch, full documentation, midlength lead time.
Disadvantages: Highest price of the options.

2. Source from authorized wholesalers in the open market.
Advantages: Cheaper than option 1.
Disadvantages: Susceptible to market changes – supply is less secure, longest lead time, CoA only available form some (small) markets – increases risk to supply chain.

3. Source a Biosimilar product registered in the USA and Europe directly from the biosimilar manufacturer.

Advantages: Cheapest price, guaranteed supply from manufacturer, quickest lead time
Disadvantages: Using a biosimilar in a trial can introduce pressure from regulators to prove equivalent clinical effect as the branded product.

CSI worked closely with the manufacturer of the biosimilar and was able to provide an extensive metaanalysis alongside equivalency statements to prove that the biosimilar was equivalent to its branded counterpart.

Challenges and Results
Using the meta-analysis and equivalency statements provided by CSI the sponsor was able to justify the use of the biosimilar option for the trial. This option allowed timely sourcing with full documentation at a massive cost saving, over the course of the study the sponsor saved in excess of €7 million compared to the branded option.

This was a remarkable achievement for CSI and our client. We demonstrated our scientific knowledge, expertise, and ability to deliver novel solutions.

Case Study – Delivering Devices to Sites in Russia, Ukraine, Belarus and Georgia

Request
CSI was contacted by a client that urgently required medical devices to be delivered to Russia, Ukraine, Belarus, and Georgia for a large oncology trial.

These devices/markers were required during the patient screening visit. These devices are only applied to a very limited number of patients under a standard of care; however, due to the increased level of follow up required in the environment of the clinical trial, the devices were being applied to all patients. The client thought initially that the sites would be able to source themselves, but the quantities required were higher than UK and German joint monthly consumption, and deliveries had to be arranged on demand to 100 sites.

CSI Approach
The quantities were so large compared to normal demand that they placed strain on the manufacturer’s own production and supply chain capability.

CSI worked closely with the client’s medical team to identify options for products with the same characteristics as a secondary solution. Using a combination of primary and secondary solutions CSI presented an option that had feasible sourcing timelines. Working closely with local partners in each country CSI developed a distribution strategy at the site level in a just in time model.

Challenges and Results
A just in time distribution model is dependent on robust and dependable sourcing, adding a secondary solution to the trial relieved pressure from the manufacturer of the primary solution – this meant that there was always a solution available when a site required resupply of devices. Liaising with the manufacturers of the devices, the client, and importantly couriers was a logistically challenging task but one that had to run smoothly to safeguard the continuation of the trial.

The model developed by CSI was successful in ensuring sites never ran out of stock of these devices, using a primary and secondary solution was a novel approach that operated efficiently. CSI provided that all required documentation for smooth import and distribution, forecasted demand, and developed a safety net stock level to respond to variable patient recruitment levels – avoiding delays to patient recruitment.

Whitepaper – Oncology Trials Comparator Sourcing

Comparator Sourcing for Oncology Trials – Current Trends and How to Safeguard Trial Progress

This is an exciting time for oncology trials, year on year record numbers of therapeutics are launched and the indications for many drugs on the market are increasing rapidly. Immunotherapies and next generation biotherapeutics are being approved for more tumour types and a growing percentage of the late stage oncology pipeline are targeted biologics.

However, with growth comes increased risk. Trials are more complex than ever, with more locations in new geographies and adaptive trials becoming more common. This complexity is affecting trial success rates which are routinely lower than other therapy areas. Post-trial oncology products also experience difficulty entering the market. Immunotherapies and next generation biotherapeutics may be the future of oncology but they are significantly more expensive than older non-specific therapies on the market.

Positive results from health technology assessments, used to inform purchasing decisions, are becoming less and less common in oncology as costs of therapies skyrocket and specificity

increases. For a clinical trial to demonstrate the added value of the IMP it is now essential that it is compared to the standard of care rather than a placebo.

This increases costs and therefore risks of a trial but is a necessary component for a novel therapies’ success. It is therefore imperative that a clinical trial is well managed and efficient with resources to minimise risks and ensure that the IMP goes to market positively.

There are some encouraging trends, biomarkers and selecting patients from prescreened pools have increased productivity of trials and lowered costs. Streamlining comparator sourcing is another strategy that can dramatically affect the efficacy of an oncology clinical trial.

Comparator selection is a vital component of a sourcing strategy. Using biosimilars or generics where available can decrease the cost of comparators in a trial by as much as 50%. However, this can be a complicated solution, licensing on biosimilars is dependent on proven pharmaceutical similarity to the reference drug, this can be different between markets potentially affecting the sourcing strategy.

Different sourcing strategies have positives and negatives, local sourcing can be an effective strategy for a small phase I trial in a handful of countries but can be very challenging in a global phase III trial spanning many countries and regulatory bodies. Regulatory complexity is compounded by logistical complexity, working with stakeholders across the globe to deliver products in a timely manner can be especially challenging. There is not a one fits all solution in comparator sourcing, it is therefore important that extensive research is undertaken to find a range of options. With CSI as a partner you will be receiving gold standard service to de-risk comparator supply in your clinical trial.