Going Global

Pfizer's Diane Jorkasky champions the use of geographically diverse clinical research units to transform the conduct of phase I trials. EHM found out why.

High degree of technology

“Women make up less than 30% of the top echelons of pharma companies”
-Diane Jorkasky, Pfizer

In her role as Vice President for Worldwide Clinical Research Operations at Pfizer, Diane Jorkasky ensures that all exploratory development, clinical pharmacology, translational medicine and clinical technology studies are conducted in accordance with good clinical practices standards and are delivered on time and on budget. Quite a task, but Jorkasky is proud of her team’s achievements in this area.

“We do achieve this far more than one would expect, given the complexity of working with 10 different therapeutic areas, with all of them organized separately. We have many, many customers, and yet we’ve been able to achieve this through constant interaction with the customers. We have terrific people within my department who bend over backwards to ensure that the work gets done, that we get things done on time.

“It takes a lot of planning on the part of the staff and the research units. We are very careful about the budget and making sure that we are as efficient as we possibly can be in keeping costs to a minimum, and we have brought in a high degree of technology that takes away much of the human component that’s often required in research settings. So we don’t have to worry about quality assurance anywhere near what most companies have to worry about because we bake all of this into the infrastructure systems that we have.”

In her current position, Jorkasky oversees all phase I studies for Pfizer, with the exception of oncology, and all clinical pharmacology studies independent of their stage of development, including small early proof of concept studies. Most of these studies are conducted in three clinical research units located in Singapore; New Haven, Connecticut; and Brussels, which act as one unit with three locations under standard procedures, policies and principles.

“The greatest challenge I face in this position is ensuring that the in-house resource is utilized to its maximum,” she says. “This means some flexibility in the way one schedules. The other challenge is trying to overcome people’s resistance to the concept of working at global sites with which they may not have had first hand knowledge. The resistance is overcome with demonstrating performance with a strong emphasis on frequent communication."

Innovation

Jorkasky has championed the highly efficient management of global clinical research units – CRUs – all of which deploy state-of-the-art technology to drive progress forward. How have these radically transformed the conduct of phase I trials?

“We are able to do very complex studies across all three units simultaneously, and to the same level of medical integrity, the same level of standardization of the quality of the methodology involved, the assays, the evaluations by the medical staff and the nursing staff, and we have a standardized database that’s a technology coupled with a disciplined behavior by our staff such that everything is done according to the highest standards.

“This gives us a phenomenal opportunity to be innovative, because if you collect your data in a way that is standardized, no matter what that data are, you can still have great degree of flexibility in evaluating it. If you can collect that data in a way that allows you to do anything with it, you have a great capability that goes beyond what any other company is able to do. As a result of that, the big innovation that we’ve been able to accomplish is that on a moment’s notice, for example, you can tell exactly what the adverse event rate is among phase I volunteers across every study conducted.”

Jorkasky says this allows researchers to tell, day-to-day, what the latest subject count is, and this can be parsed out according to where that subject is in the world, what kind of pharmacological agent they were exposed to, whether they were on placebo and whether they were on a biologic. Pfizer has found this to be so valuable that they are working with the NIH now to have all this data analyzed and published, since this information is lacking in the literature.

Equality

Behind every exciting new discovery are the men and women who made it happen. While many women work as researchers and in other roles in the pharmaceutical industry, as you move higher up the ladder, the representation of women and people from diverse tends to dry up. For this reason, Jorkasky, as an advocate for the Women’s Leadership Network, has been an enthusiastic supporter for greater roles for women both within Pfizer and elsewhere.

“The pharmaceutical industry is trying to improve its track record in ensuring opportunities for women and diverse candidates. Across the pharmaceutical industry, probably the majority of employees are women, and yet as you go to higher levels of the organization, you will see far fewer women than you will men. In most companies, women make up less than 30% – sometimes less than 20% – of the top echelons of the company.

“There is a huge amount of work still to be done in this regard, and the unfortunate thing is that the industry loses out by not having that female perspective at the table. Women are the major care providers across the world and the ones who will often remind folks to use our drugs and to make sure medical care is achieved. We don’t even think about the impact that not having women at the table within our industry has on our products in the marketplace.”

Where next?

The pharmaceutical industry is at a crossroads, with extraordinarily high attrition rates and there are many attempts to get that next big breakthrough that leads to increased productivity. The cost of doing studies is rising, along with the expectations of those studies in terms of the quantity of data and the safety of the drug in the minds of regulators and the public.

“The challenge we all face is continuing to support R&D research at a time of enormous pressure on the healthcare system, including this industry,” Jorkasky says. “We are looking at how we do business and what we need to dramatically change to continue to bring medicines to patients.

“We’re going to see tremendous flux in all companies, where they start to work more in a virtual way with a variety of suppliers and vendors and support organizations, including CROs. We’re going to see stronger decision-making on what drugs should not be taken forward, which I think is really important to an organization’s survival. The sooner you can stop a drug that’s not working, the better off you will be. And we will see smaller, leaner companies, more virtual in their operation than what we’re seeing today.”

Diane Jorkasky is Vice President for Worldwide Clinical Research Operations at Pfizer. She is responsible for ensuring that all exploratory development, clinical pharmacology, translational medicine and clinical technology studies are conducted in accordance with good clinical practices standards. She has been instrumental in providing the leadership and the vision of Pfizer's Clinical Research Units (CRUs), which have radically transformed the conduct of phase I trials.