Monthly Archives: September 2013

The FSP: Functional Service Provider in Pharmaceutical Research

A Functional Service Provider (FSP) offers a variety of clinical trial services on an “a-la-carte” type basis – as opposed to a full suite of services. This allows large Pharmaceutical companies to outsource only what they need to fit their budget (and other factors).

This blog article discusses how a COLLABORATIVE APPROACH to understanding the clients’ needs and GOOD LISTENING SKILLS on the part of the service provider, make offering a partial selection of services (as opposed a full suite of services) a practical and cost effective approach to pharmaceutical drug development in this economic climate.

FSP Group Conference

FSP’s are able to plug-in to all parts of a study; Criterium’s a-la-carte menu of services offers sponsors the ability to get expert personnel for just what is needed.

As more and more pharmaceutical companies are outsourcing the management of clinical trials to Functional Service Providers (FSPs) there is a need for constant and competent communication between the Sponsor and the FSP’s who are providing specific clinical trial services.  This is not something to take for granted as communication will be the key to a successful project. The pharmaceutical company owns the project, while the FSP manages some aspect of it. Although a solid contract that is legally binding is always negotiated between the pharmaceutical company and the FSP, both entities will find that a good working relationship depends on open communication and collaboration.

Collaboration is a Must
Collaboration simply means working together to create something new. There are many different ways that the management of clinical trials can be outsourced to FSPs, but all require collaboration between at least two entities. The involved companies must have a shared plan as well as the right people and tools to work on the project.

When pharmaceutical companies outsource clinical trials, even though they still own the project, they must work together with the FSP. In fact, a pharmaceutical company may outsource different parts of a project to different FSPs. In order to create a satisfactory end product, they must all collaborate and set up parameters to delineate which entity is responsible for which tasks. In addition to emails, telephone calls and regular reporting, face-to-face meetings must be part of the collaboration process.

Need for Clear and Constant Communications
Collaboration requires clear communication. Just some aspects of the FSP agreement that must be communicated include:

  • The agreement may include the temporary transfer of certain employees knowledgeable about the project to temporarily work with the FSP. This limits the need for new workers to spend time and money to familiarize themselves with the project. When this happens, clear communication with the employees is imperative so they know who is in charge and what the expectations are for everyone on the project. This will relieve the FSP of potential personnel problems and concerns.
  • Plan in advance for contingencies. Anticipate potential problems during the management of clinical trials and establish protocol as to how those problems will be solved. For example, what happens if there is a lull in the workload at the FSP due to a glitch at the pharmaceutical company?
  • The FSP and pharmaceutical company need to agree on the vision for the project to be sure they are both on the same page headed for the same goal.
  • If the project is confidential, this needs to be clearly communicated to the FSP and all employees who will be working on the project.

Need for listening skills
As basic as it seems, communication and collaboration involve listening. When one entity owns the project and the other entity is the chosen vendor for outsourcing, conflict is not uncommon. Experience has shown that while the formal contract outlines the responsibilities of the entities and governs who has the authority, the key to the success of the project is the ongoing communication and the willingness of each entity to listen to the concerns of the other. It is this active communicative relationship that guarantees the ultimate success of the project.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com

Orphan Drug Development – Why They Are SO Important

Orphan drugs treat diseases so rare that sponsors are often unwilling to follow the usual pharmaceutical drug development marketing conditions. Most rare diseases are genetic, and therefore present throughout the sufferer’s life, even when symptoms are not immediately apparent. Many diseases appear early in life, and a total of 30 percent of children with orphan diseases die before the age of five. Global estimates put the number of different diseases between 5000 and 7000, with an average of five new conditions discovered every week. Unfortunately, in total, only 5 percent of orphan diseases have FDA approved treatment. 

Record Growth Shows Clear Commitment

Although the market is small for orphan drugs, pharmaceutical drug development in this area has seen notable growth in recent years. Currently, 350 orphan drugs are approved for sale in the U.S., including not only pharmaceutical and biological products but also medical devices and dietary products. A record number (10) of new drugs were approved by the FDA in 2011 along with five new drugs by the European Medicines Agency (EMA).

Proven Examples of Success

Orphan Drugs Find a Home

Orphan Drugs Find a Home at Criterium Global CRO

Many large pharmaceutical companies are expanding their orphan drug development and even establishing entire business units dedicated to rare diseases. Although orphan drugs treat only a small number of patients, they can receive a weighty revenue, and companies get a significant competitive advantage by being the first to market. A good example is Rituxan® from Genentech, the second most profitable drug in the world, given orphan status to treat B-cell Non-Hogkin’s lymphoma. In 2010, it yielded $5.24 billion in sales for its use as an orphan drug and for extended usage for other types of cancer and rheumatoid arthritis. It is quite possible to more than compensate for the smaller number of patients an orphan drug may help, through the increased market share, lower marketing costs, higher pricing, longer exclusivity period, and faster returns.

There is an even greater potential for profit when drugs have multiple orphan disease indications or if they can later go on to be used for more widespread non-orphan indications; for example, Gleevec® from Novartis Oncology resulted in sales of $2.4 billion in 2010. In addition, a number orphan drugs are biologics, meaning they are less likely to have generic equivalents, which extends the value to sponsors even after patent expiration.

Economically Feasible – Shorter Development Timelines

Investing in orphan drugs is at least as economically feasible as non-orphan pharmaceutical drug development due to the higher rates of approval and the shorter development times. For instance, the chances of approval for orphan drugs is very high, at 82 percent, compared to non-orphan drugs, at just 35 percent. Additionally, the time taken from Phase II to market is often shorter due to both smaller clinical trials and to the FDA Fast Track designation. On average, the timeline for orphan drugs is 3.9 years while traditional drugs typically take 5.4 years to reach the market.

With new orphan diseases being discovered every week, the potential for pharmaceutical drug development in this area is huge. While initially the market for these drugs may appear small, this is more than counterbalanced by the revenue opportunities and the quick time-to-market.

Got Questions? We have Answers! Contact us at CriteriumBlog@criteriuminc.com