The Pfizer Approach To Clinical Outsourcing: Develop Capabilities And Align Objectives

By Ed Miseta, Chief Editor, Clinical Leader

Pam Garzone, executive director of biotechnology and clinical development at Pfizer WRD

Pam Garzone, executive director of biotechnology and clinical development at Pfizer WRD (worldwide research & development), is instrumental in implementing her company’s outsourcing strategy. As the clinical team lead, she is accountable for the clinical development strategy for programs originating at Rinat, a research unit within Pfizer. Her duties include working with different functional expert groups such as biologists, clinicians, both MDs and non-MDs, toxicologists, clinical pharmacologists, and statisticians. “I ensure that everyone on the asset team is in the same boat and rowing in the same direction,” she says.

Pfizer operates two types of Development Models. One is known as the CRO Alliance Partner (AP) Model and the other is the Pfizer Run Studies (PRS) Model. For the AP Model, teams can use the full services of a CRO. Pfizer currently has two alliance partners – ICON and PAREXEL. The PRS Model is used in the early development space and allows teams a bit more flexibility by using a hybrid of Pfizer resources and those of a select number of CROs. “In most cases, the teams use inVentiv Health as a limited Functional Service Provider (FSP) to identify sites and investigators, prepare and assemble the necessary documents, and send the package to those sites,” says Garzone. “This option allows the team to engage the CRO to manage some but not all activities in a clinical study. For Phase 1 studies, our internal groups, such as data management, provide the support for the remaining activities. The choice of CRO depends upon a number of factors such as experience with and expertise of the CRO, how aggressive are the timelines for completion, and the efficiencies of a particular program (i.e. do we want to use the partner for a single study or for the entire program.)

Success Depends On The Right Partner

When making the outsourcing decision, the asset team, which includes development operation leads, will meet to discuss the needs for a particular study or project. The team will then determine what activities are outsourced and to whom. According to Garzone, the team will discuss timelines, the complexity of the study, availability of internal resources, and prior experiences with CRO partners. “We recognize that in this age of austerity and industry downsizing, outsourcing is a major trend,” she notes. “However, we also recognize that teams can’t be successful without the right partner. We need to do the right study at the right time and within our budget. Therefore the relationship with the CRO partner is very important. You need to be able to call them at any time, ask questions, and get straight and honest answers.”

Over the past two years, Pfizer has focused its outsourcing on a smaller number of providers. As part of that process, the company has gone through extensive work to qualify and onboard its CROs. The goal was to reduce the amount of non-valued activities and focus more on developing capabilities and aligning objectives between the CRO partners and Pfizer. Garzone states Pfizer will solicit bids and proposals from alliance partners. Asset team members of clinical and development operations review the proposals, looking at experience in the therapeutic area, the global regulatory and clinical trial footprint and the individual resumes of personnel who will be in key leadership positions. Quality is a big factor in Pfizer’s clinical development plans, so familiarity with Pfizer’s internal processes is a definite plus.  

Anyone involved in outsourcing knows that no matter how much time you spend selecting a partner, occasionally problems will still arise. Garzone believes communication is the key to avoiding those problems. “It is important to be very clear and concise on what is needed for the project,” she says. “Pharma companies should be clear on the required experience of the CRO in a particular therapeutic area, and assist in the selection of personnel to fill key roles. Additionally, I recommend building in quality from the very beginning, and communicating often and honestly. The key to avoiding problems is to work collaboratively as a team. The sooner you can do away with the whole ‘us versus them’ mentality, the better the study will go. However, if after repeated attempts a problem is not resolved, do not be hesitant to make needed changes. If you have to make that move, it is better for everyone to make it as early as possible. I have found that the consequences of delaying the decision increase with the amount of time you delay the necessary action.”

Declining Recruitment Remains A Problem

When asked about trends occurring in the clinical space, Garzone stated declining patient recruitment for studies as one of the most critical. She cites metrics such as sites enrolling 0.2 subjects per month and notes these stats are not uncommon. Gone are the days when companies could rely on one site to recruit for a study. To complete enrollment in a reasonable amount of time it now takes multiple sites, regardless of whether the study is for early or late stage development. Other trends include the increasing complexity of clinical trials including identifying subjects of a particular genotype to either stratify by or enroll in the study, the increasing use of technology such as imaging techniques, and the use of various patient outcome and health economics assessments that would support payer-related activities.

“The patient recruitment challenges are multifaceted,” notes Garzone. “Protocols are more complex and restrictive and there is more competition for the same types of patients. In addition, we are having recruitment issues because of a lack of communication. Patients are simply not aware of many clinical trials that are enrolling patients.”

Social Media Cannot Solve All Challenges

With the recruitment challenges the industry faces, will social media be the solution firms need? Garzone says yes and no. While many age groups are Internet savvy and go online looking for clinical trial information, there are privacy concerns as well as concerns regarding the accuracy of the online information. She notes patient advocacy groups are taking the lead in communicating clinical trial information to patients, but it will take more dedicated efforts for those efforts to have a significant impact. Currently it seems to be easier to recruit patients into cancer trials, but she believes we need to do a better job of getting the word out in other therapeutic areas as well.  

In addition, depending on the therapeutic area, social media may not be the best way to communicate information. For example, she notes some studies will require the enrollment of aged patients such as those 65 years of age or higher. Garzone believes only a small fraction of people in later decades of life even have a Facebook page or Twitter account. Many who do may not use them as regularly as a high school of college student. Therefore, for the elderly, these communication vehicles are simply not going to be successful.

Is there a solution to the recruitment problem? If there is, Garzone believes it lies with the doctors and pharmacists who interact with patients regularly and understand their conditions. “Studies indicate primary care doctors can do the most to improve the communication effort,” she adds. “They need to be informed of what clinical trials are available, so they can relay that information to patients. They also have the knowledge and expertise to properly advise patients on whether or not they would be suitable candidates for a clinical trial. Another group that can effectively communicate trial information to patients is community pharmacists. I personally believe these pharmacists are an untapped resource as they can easily provide trial information to patients when they visit the pharmacy to pick up their prescriptions. By not engaging with these folks the industry is missing out on a large, valuable, and relatively untapped resource.”