A JUGGLING ACT: MULTI-TASKING IN CLINICAL TRIALS OPERATIONS

ON ANY GIVEN DAY, KATHYYurkow may change hats more thansome of the world's most celebratedfashionistas?and she likes it that way.

As the associate director of clinicaloperations at Johnson & JohnsonConsumer and Personal Products onthe company's campus in Skillman,NJ, Yurkow, who received her pharmacydegree from Rutgers University,is required to constantly change herfocus in order to keep her sectionmoving forward.

"The most challenging aspect ofmy job is the same reason that I likeit?you are spread across multiplefunctions," Yurkow says. "You will betalking about the clinical aspect ofvision and eye drops, and then havesomeone from the wound care sectiontalking about how their clinicalsupplies are not labeled. You need tomake the transition from thinkingabout how one team is scoring somethingto how come a batch record wasnot done right. They are not connectedat all."

Back when she was considering hercareer options, Yurkow's first choicewas to be a teacher. When it becameapparent that there were not a lot ofjobs open, she shifted her focus topharmacy?a profession that, in theend, is all about helping people. Priorto accepting this position, she workedas a data management specialist forPharmaceutical Research and Developmentat Johnson & Johnson. "Thatjob involved overseeing all of the datamanagement aspects of the drugsthat we were working on," sherecounts. "That started with thedevelopment of the case record formsand the imaging system, to data management,data entry, and edit checkspecifications?I oversaw that pieceof it and brought it to the table forwhen we were making decisions."Before that, Yurkow worked inTitusville, NJ, also in data management,including data transfers andcoding. This post called for experiencein data management, clinical trials,and clinical supplies, and themove into the clinical side of thingsstemmed from a desire to witness trialsup close and personal.

"I thought that being up closer atthe front of the trial and being able todecide how the trial was going to berun was where I wanted to be,"Yurkow explains. "Also, it is a smallercompany; I get to see a lot more rightnow than I did when I was in the biggerpharma company. You got to seedata management, but you did notget to see a lot of the different areas.Here, the people who actually do theformulations are in the labs nextdoor.You get to see the wider breadthof what the whole drug developmentprocess is."

Yurkow beginseach day with answeringphone messages and correspondencefrom her counterparts in Europe.As of press time, Yurkow's sectionwas working ontrials in France andDenmark, for which they are responsiblefor clinical supplies. This takesher to about 11:00 AM, when the workdayin Europe comes to a close. Followingthat, she addresses any obstaclesthat her team?which consists ofa trial manager for the dermatologygroup, a trial manager for the woundcare group, and an individual responsiblefor coordinating clinical supplies,packaging and labeling for toiletries,and vendor management?is facing,so that they can get on with their day."I try to handle whatever issues theyare dealing with in the morning,because if I do not handle them, thenthey get stuck for the rest of the day onthat one piece," she explains.

Yurkow's campus generally conductstopical studies and some studiesinvolving devices. Currently, her sectionis running a trial on a topicalproduct on cold sores both in theUnited States and Europe; Yurkow wasexpecting an interim analysis by mid-November. The team also was performinga trial study for the administrationof an Rx drug; the trial was inphase 4 as of press time. "It's a preferencetype study," Yurkow explains. "It'san Rx drug, but we are testing the preferencebetween using a pump versus atube, versus [another device]." Sheadded that they also are running aphase 3B eye drop study.

Yurkow reports to the director ofclinical operations, medical writing,and worldwide finance. "She is rightnow submitting an NDA [new drugapplication] for a new product, so ifthere is anything she needs to supportthe submission, I research thatinformation and provide it to her,"she explains. "She also looks at all ofthe timelines for all of the projects, tomake sure we are meeting interimanalysis, and so on."

After these matters are taken careof, Yurkow consults the messagesand e-mails that fly back and forthbetween those involved in the currenttrials that are taking place. Thenit is time to attend meetings, or, inthe event there is not one, to reviewminutes from previous gatherings.The ultimate goal: to plan wellenough in advance so that everythingruns as smoothly as possible.

This is not always easy, consideringthat one must factor in a marginfor human error, Yurkow concedes,referring to a problem her teamencountered before her interviewwith Pharmacy Times. "We hadtrained one of the sites on this onescale, and when the monitor gotdown there, she looked at theresults in the casebook, and it wasobvious to her that they hadn't beenfollowing the directions," she relays."We had to make a decision on whatwas to be done with that data." Atthis point, the question became:Was there any way that we couldsalvage the data and use it in thestudy? "With this one, we werelucky?there were pictures. Theywere able to use the pictures torecalculate their answer."

While looming deadlines areYurkow's least favorite part of the job,it is worth it when she witnesses theprogress that the pharmaceuticalindustry is making. "My favorite partis being involved in the set-up of theclinical trials, because you get to seethe new drugs that are out there," shesays. "These are not curing anybodyyet, but they are still cutting edge forwhat they are doing, and that is thebest part of it?being able to get thattrial started and see how that drug isworking."

Yurkow observes that her fieldhas undergone a significant changeover the last several years, demandingmore experienced professionalsto fill positions like hers. "There arenot a lot of entry-level positions inthis area because we don't have thetime to train people," she notes."What you actually see are peoplewho have several years of experiencethat are being brought inrather than people who don't haveexperience. You are overseeing vendors,and if you don't know whatthey are supposed to be doing, thenyou really can't manage them." Sheattributes the lack of entry-leveljobs, in part, to the use of cheaperlabor in other countries, such asChina and India.

That is not to deter those seekingto pursue a similar career path,however. Yurkow believes that thosewho earn pharmacy degrees arewell positioned to go after a vastrange of jobs. "With a pharmacybackground, you can go between alot of different jobs within thepharmaceutical industry," sheadvises. "It pays to go and get adegree where you can do more thanone job, rather than focusing on apure science that limits you."

Ms. Heinze is a freelance writer based inVancouver, British Columbia.