Tag Archives: Sourcing

Case Study – Sourcing Flu Vaccines for a Global Study

Request
CSI was approached to support a quadrivalent flu vaccine study running in multiple countries in the Northern Hemisphere. The sponsor also wanted to use the same product in the trial across all participating countries.

Due to the seasonal nature of this vaccine, there is only one production run per year (in the Summer), manufacturers look at predictions from the WHO of what the dominant flu strain will be in the Winter and then produce vaccines accordingly. The vaccine doses are typically booked well in advance (approximately in January) by customers and there is very little oversupply.

CSI Approach
When our client was ready to run the study, several USA manufacturers were already overbooked versus their production and would not have been able to support the requirements of the trial in all regions alongside their current orders.

CSI was able to leverage its relationship with a EU manufacturer that could supply the product in the quantity required for the whole trial. Working with this manufacturer CSI demonstrated the equivalency between the EU an USA products. The trial also ran in some South East Asian countries, to bypass tricky import requirements CSI sourced the product locally in these countries.

Challenges and Results
With a flu vaccine trial, the cost of getting the sourcing wrong is very significant. Failure to secure supplies would postpone the trial by a full calendar year as the Southern Hemisphere is a poor option to run a flu vaccine trial (less countries, and poorly defined flu strains circulating).

CSI provided sound scientific and regulatory guidance alongside a robust sourcing option that ultimately safeguarded the study.

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.

Webinar – Comparator Sourcing in Clinical Trials: Complexities and Bespoke Solutions

Register for a Webinar hosted by CSI on Comparator Sourcing in Clinical Trials with Dr. Vanessa Dekou:

Comparator sourcing is a fast-growing industry in clinical trials that has doubled within the last five years. As most drug candidates are being studied against the existing standard of care (comparator), the need for secure and transparent sourcing of comparator drugs and non-investigational medicinal products (NIMPs) on a global scale is likely to rise significantly.

However, this is a very complex process and designing an efficient and agile supply chain is challenging. Often poorly designed supply chains result in tremendous wastage and even worse, lack of medication at the site might delay studies and put patients at risk.

There are many important questions to be addressed upfront; extensive planning and pharmaceutical supply knowledge on a global scale is required.

In this webinar, our speaker will provide a comprehensive overview of the complexities and challenges of sourcing comparators while addressing protocol requirements. She will also provide expert science-based advice on bespoke solutions for successful comparator sourcing.

Read more information about the webinar here:

https://xtalks.com/webinars/comparator-sourcing-in-clinical-trials-complexities-and-bespoke-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.