What are the Problems Involved in Comparator Drugs Sourcing?
It is natural for manufacturers to be reluctant to supply their product as a comparator for a clinical trial as ultimately using them in this way could lead to their drug being superseded by a competitor’s product and eventually lead to lost revenue. However, the pharma industry does accept that comparator drug testing is essential in drug development as the industry pushes research boundaries and improves patient care, saving lives. It’s a moral dilemma between profit maximisation and medical advancement. For Trial Sponsors, comparator sourcing is, therefore, challenging both politically and from a supply chain perspective.
Finding the right strategy and the right partner is essential to success; here we look at the pros and cons of using a CT sourcing partner, such as ADAllen Pharma, to enable procurement of comparators direct from the manufacturer or an approved supplier versus the alternative of acquisition via the wholesale markets.
The Pros and Cons of Direct Manufacturer Procurement using a CT Sourcing Partner
- Finding and procuring drugs can be faster for small batches with a short shelf life.
- Initial costs could be lower.
- Reliability of supply and consistency of quality can be difficult to achieve as it may be necessary to use more than one wholesaler due to shortages of stock available.
- Extended shelf life and consistency of batches can be more difficult to procure.
- The management of multiple wholesalers can be time consuming and costly across the lifetime of a trial.
- Understanding of CT trial regulation and compliance standards can be low.
- Risks in terms of cost and legal compliance.
- Inability to obtain Certificate of Analysis on all orders.
The Pros and Cons of Wholesale Procurement
- Working with a CT sourcing partner provides anonymity for trial sponsors and confidentiality about the trial.
- A CT sourcing partner is close to the market and can manage your expectations, risks and changes in schedule, provide sourcing strategies and offer the best advice.
- A CT sourcing partner with a strong global supply network can help source the ‘hard to buy’ products via their network so that the trial is not impacted with regards to time.
- Sourcing directly from the manufacturer enables acquisition of large batches with long shelf life, increasing consistency and allowing for trial extension.
- Product recalls are easier to manage.
- CT sourcing partners have a detailed knowledge of the regulatory framework within the Clinical Trial sector.
- Inspection of product prior to shipment, peer checking and QP sign off is automatically provided by the CT sourcing partner.
- Specialist services for global distribution and ambient / cold chain management is inherent within the skill set of a CT sourcing partner.
- A CT sourcing partner can advise on single sourcing which presents unique challenges (i.e. where one source is used to provide a comparator to multiple countries and trial sites).
- By working with manufacturers, a CT sourcing partner helps to achieve a consistent, flexible and compliant supply of comparators throughout the trial, meaning that the overall cost of procurement may well be reduced as the procurement is less likely to cause delays itself and more likely to be flexible if the trial is delayed.
- The trial sponsor must invest time in the selection and briefing of a CT sourcing partner.
- The CT sourcing partner will approach, confidentially, the manufacturer which alerts your competitor to the development of a competitive drug.
- Sourcing directly from the manufacturer, via a CT sourcing partner, can mean higher initial product cost.
- The trial sponsor must plan ahead in order to make use of a CT sourcing partner.
- Direct procurement from the manufacturer makes the use of a CT sourcing partner highly recommended, meaning that it is something trial sponsors cannot do themselves.
Legislation and Quotation Difficulties
Legislations and regulatory processes affecting the industry continue to grow ever more onerous. The movement of products across borders is complicated further with differing national and continental regulations.
Trial Sponsors typically ask numerous vendors for quotations from manufacturers which they obtain whilst maintaining the anonymity of the Trial Sponsor. This seems like good business sense but can muddy the waters with the manufacturer then not knowing if there are multiple requirements or is it just one trial searching for products. The outcome can mean that demand is inaccurately predicted by the manufacturer resulting in longer quoted lead-times and potentially higher prices as the drug is perceived to be in high demand by the manufacturer.
Effective comparator drugs sourcing requires knowledge of the global market, international trade, clinical research and regulatory constraints, whilst always keeping in mind cost effective processes without compromising quality.
Conclusion: Which is the Best Way of Comparator Drugs Sourcing?
Reviewing the pros and cons of the procurement of comparator drugs, the evidence weighs strongly in favour of engaging a CT sourcing specialist who will deal directly with manufacturers and navigate the complexity of comparator sourcing. The key to success is consistent, flexible and efficient supply, ensuring that the trial and its sponsors are not operationally or financially damaged due to delay, inconsistent supply, or the need to constantly re-stock. Although the initial product cost of wholesale sourcing may seem attractive, it is a far riskier, and potentially more expensive, way of comparator sourcing.
If you would like to find out more about using a CT sourcing partner to procure comparator drugs for you, contact us today.