Tag Archives: Oncology

Case Study – Supplying Specific Tested Batches of Oncology Product from the Market

Request
Client approached us with a very specific request to test samples of an expensive oncology product and then purchase the same batches that had passed the testing stage. This was a challenging request as it required visibility of batches currently on the market before purchasing. This is only possible in certain markets where product availability is moderate. Due to the nature of the trial the client was not willing to disclose trial details and required documentation (Certificate of analysis and pedigree).

CSI Approach
Without the possibility of disclosure, we had to source from the open market. This was challenging because we had to fulfill four requirements:

  • batch testing
  • advance visibility of batch
  • product of specific batch available
  • documentation

The most effective solution was to work with our audited suppliers with a ‘hit list’ of batches that had a positive result from
testing. This relied on working closely with suppliers in markets where batch visibility and documentation is possible, to keep an up to date list of what batches are on the market at a given time, and if they have had a positive or negative test.

Challenges and Results
A sourcing strategy such as this is dependent on very close communication between client, CSI, and suppliers. As the suitable markets usually have limited availability, product had to be collected over a period of time before being delivered to the client. At all times the most important thing was to guarantee a stable supply chain to the client and ultimately the patient. CSI leveraged all good relationships with suppliers to keep stock on hold with the promise to purchase if the batch testing was successful. Such undertaking is only possible when there is mutual trust, understanding of the specific requirements and a united team with the grit and perseverance to deliver for the benefit of the patient.

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.

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.