Center for Drug Evaluation and Research

Index

• Fall honor awards
• Awards listing
• OCPB Science Day
• Presentations
• Science team game

Fall Honor Awards recognize striving for excellence: 54 individuals, 40 work teams celebrated at ceremony

At the Center's Fall Honor Awards ceremony held Nov. 22 in Gaithersburg, 54 individuals and 40 groups were recognized. Center Director Janet Woodcock, M.D., Deputy Center Director Steven Galson, M.D., and senior managers handed out the awards. The Montgomery County Police Color Guard presented the colors, and Kevin Barber sang the national anthem.

"Our staff continues to exceed all expectations and strive for excellence as evidenced by the wide range of achievements and disciplines represented here today," Dr. Woodcock told the awardees. "A true spirit of innovation and cooperation is apparent at all levels and in every work unit at CDER. Both as individuals and as vital members of work teams, your commitment to CDER's important public health mission is evident in your fine accomplishments."

Rita Thompson, the director of the Division of Management Services in the Office of Management, introduced each award. Office directors provided an explanation of individual achievements, and Thompson read the citations for the individual and team achievements.

The awards were:

Active Control Non-Inferiority Trial Design/Analysis Development Statistics Team: Hsien-Ming James Hung, Ph.D., Yi Tsong, Ph.D., and Sue-Jane Wang, Ph.D.

Alosetron Risk Management Team: Suliman I. Al-Fayoumi, Jane A. Axelrad, Julie G. Beitz, M.D., Allen D. Brinker, M.D., Jason Brodsky, Bronwyn E. Collier, Anne Corken-Mackey, R.Ph., Heidi Forster, J.D., Hugo E. Gallo-Torres, M.D., Lahn Green, R.Ph., Maureen A. Hess, David Hoberman, Ph.D., Florence Houn, M.D., M.P.H., Donna Katz, J.D., Joyce A. Korvick, M.D., Scheldon Kress, M.D., Karen J. Lechter, Ph.D., Paul E. Levine Jr., R.Ph., Zili Li, M.D., Thomas J. Permutt, Ph.D., Toni D. Piazza-Hepp, R.Ph., Victor F. Raczkowski, M.D., and Crystal L. Rice. PHS companion award nomination: CAPT David B. Banks, LT Marci C. Kiester, LCDR Mary E. Kremzner and CAPT Thomas H. Perez.

Personnel Operations Branch, DMS/OM: Pheobe A. Brooks, Joseph M. Cejmer, Jennifer G. Chung, Diana L. Dycus, Patricia L. Gathers, Mary F. Goodson, Lucinda R. Hall, Angela N. Harris, Blossom M. Harrison, Cynthia A. Hart-Burge, Ellen A. Johnsey, Leah M. Mader, Sharon L. Miller, Kristin L. Montgomery, Denise M. Riggs, Ruth M. Skinner, Joyce A. Seawright, Margie Stewart-Rivers, Tabitha L. White, Jessica V. Wilcox

Schering Injunction Compliance Review Team: Frederick W. Blumenschein, Joseph C. Famulare, Diane J. Kelley and Barry Rothman.

International Visitors Facilitation Team: Marie Dromerick and Barry W. Poole. PHS companion award nomination: LCDR Mary E. Kremnzer and CAPT Justina A. Molson.

OTCOM QWL Team: Debra L. Rose and Jennifer L. Snellings.

Casodex Review Team: Rajiv Agarwal, Ph.D., Jeanine A. Best, Maryann Gordan, M.D., David Hoberman, Ph.D., Alexander W. Jordan, Ph.D., Scott E. Monroe, M.D., Nancy S. Scher, M.D., Daniel A. Shames, M.D., Michael E. Welch, Ph.D., and Peiling Yang, Ph.D.

Clarinex Pediatric Safety Team: Badrul A. Chowdhury, M.D., Ph.D., and Sandra Suarez-Sharp, Ph.D.

Dutasteride Review Team: Sayed Al Habet, Ph.D., George S. Benson, M.D., Jeanine A. Best,, Barbara S. Chong, Jennifer Fan, Evelyn R. Farinas, R.Ph., Maryann Gordon, M.D., Mark S. Hirsch, M.D., David Hoberman, Ph.D., Alexander W. Jordan, Ph.D., Margaret Kober , David T. Lin, Ph.D., Karl K. Lin, Ph.D., Laurie L. McLeod-Flynn, Ph.D., Ameeta Parekh, Ph.D., Bryan S. Riley, Ph.D., Jean Salemme, Ph.D., and Daniel A. Shames, M.D.

Webmasters Subcommittee of the Support Staff Coordinating Committee: Dannette M. L. Alpern, Lisa Champion, Velma L. Cunningham, Juanita I. Fastman, Linda C. Hukle, Myrna-Yvette King, Susan H. O'Malley, Dawn M. Reid, Christine Shipe, Barbara J. Townsend and Krista C. Yazdani.

Office of Pediatric Drug Development Administrative Team: James L. Angel, Pilar A. Martinez, Raya S. McCree and Karen D. Smith.

Division of Drug Information Team Leaders: Brenda J. Kiliany, Pharm.D. PHS companion award nomination: LCDR Mary E. Kremzner

Drug Substance and Drug Product Specification Workshop Working Group: Craig M. Bertha, Ph.D., Chi-wan Chen, Ph.D., Yuan-yuan Chiu, Ph.D., Jon E. Clark, Eric P. Duffy, Ph.D., Bonnie B. Dunn, Ph.D., June S. Ewing, Allan H. Fenselau, Ph.D., Ravi S. Harapanhalli, Ph.D., Martha R. Heimann, Ph.D., Charles P. Hoiberg, Ph.D., Richard T. Lostritto, Ph.D., Dale L. Koble, Ph.D., Mehul U. Mehta, Ph.D., Stephen Miller, Ph.D., Linda L. Ng, Ph.D., Guiragos K. Poochikian, Ph.D., Nancy B. Sager, Norman R. Schmuff, Ph.D., Alan Schroeder, Ph.D., John E. Simmons, Ph.D., John L. Smith, Ph.D., Kasturi Srinivashachar, Ph.D., Rajendra Uppoor, Ph.D., and Duu-Gong Wu, Ph.D.

Executive Operations Staff: Christine M. Bechtel, Rose E. Cunningham, Anne M. Henig, Maureen A. Hess, Vikki S. Kinsey, Coralee G. Lemley, Theresa M. Martin and Mary L. Ortuzar.

KI Antidote Preparation Team: Carol S. Assouad, Patrick E. Clarke, Joanne M. Holmes, Ajaz S. Hussain, Ph.D., Theresa M. Martin, Kathrin L. McConnell, Nancy L. Muir, Francis R. Pelsor, Pharm.D., R.Ph., and Sally Winthrop.

OGD Good Review Practices Executive Summary Development Team: Upinder S. Atwal, Ph.D., Sema Basaran, Ph.D., Rosario D'Costa, Ph.D., Lynne A. Ensor, Ph.D., John D. Franolic, Ph.D., Kenneth J. Furnkanz, Ph.D., Ruth Ganunis, Ph.D., Robert W. Trimmer, Ph.D., Tao-Chin L. Wang, Ph.D., and Kathy P. Woodland-Outlaw.

Systems Based Compliance Program Presentation/Coordination Team: Frederick W. Blumenschein, Nicholas Buhay, Robert C. Coleman, Erik N. Henrikson, Susan F. Laska, Erin D. McCaffery, Maridalia Torres Irizarry and Rebecca Rodriquez.

Team for Assuring the Safe Use of Albuterol: Sandra L. Barnes, Gary J. Buehler, R.Ph., Deborah J. Henderson, Colette C. Jackson, Claudia B. Kawoski, Pharm.D., Marianne C. Mann, M.D., Theresa M. Martin, Guiragos K. Poochikian, Ph.D., Eugene J. Sullivan, M.D., Joyce P. Weaver, Pharm.D., and Robert L. West, R.Ph. PHS Unit Commendation: CAPT Timothy W. Ames, LT Peter Chen, LCDR Michelle Dillahunt and CAPT Joslyn R. Swann.

DAIDP OIT-DIMS Team: Monif Alqarshi and Hartsell L. Whitacre Jr.

Web Document Delivery System Implementation Team: Sylvia A. Bullock, Wendy W. Cheng, Nichelle Cherry, Carol Knoth Lytle, R.Ph., Kathrin L. McConnell, Monica A. Unger and William B. Woodard Jr., Ph.D.

Active Pharmaceutical Ingredient Team: Susan Jenney, Anjanette P. Smith, Duckhee Y. Toler, Benjamin J. Westenberger and Anna M. Wokovich.

CDER Outlook Implementation Training Team: Heather A. Chafin, Lana G. Kostecka and Nancy J. Shermer.

Chemistry Review Teams co-located with the Division of Reproductive and Urologic: Rajiv Agarwal, Ph.D., Jila H. Boal, Ph.D., Swapan K. De, Ph.D., David T. Lin, Ph.D., Amit K. Mitra, Ph.D., Moo-Jhong Rhee, Ph.D., Jean Salemme, Ph.D., and Suong T. Tran, Ph.D.

DAIDP Supplemental Review Team: John J. Alexander, M.D., James G. Blank, Ph.D., David C. Bostwick, Alma C. Davidson, M.D., Maureen P. Dillon-Parker, Elizabeth A. Duvall-Miller, Frances V. LeSane, Judith R. Milstein, David B. Ross, M.D., Susmita Samanta, M.D., Albert T. Sheldon, Ph.D., Harold B. Silver and Janice M. Soreth, M.D. PHS Unit Commendation: CAPT Lillian Gavrilovich and LTJG Raquel A. Peat.

Division of New Drug Chemistry III Chemists co-located with Division of Special Pathogen and Immunologic Drug Products: Gene W. Holbert, Ph.D., Dorota M. Matecka, Ph.D., Norman R. Schmuff, Ph.D., and Mark R. Seggel, Ph.D.

Division of Pharmaceutical Evaluation II Exposure-Response Group: Suliman I. Al Fayoumi, Ph.D., Sang M. Chung, Ph.D., Suresh Doddapaneni, Ph.D., Venkateswa R. Jarugula, Ph.D., and He Sun, Ph.D.

IND Reform-Chemistry, Manufacturing and Controls Working Group: Raman K. Baweja, Ph.D., Yuan-yuan Chiu, Ph.D., Charles P. Hoiberg, Ph.D., Stephen K. Moore, Ph.D., Nancy B. Sager, Ph.D., Eric P. Sheinin, Ph.D., and Toy Ping C. Taira.

Matulane Review Team: LT Sean K. Bradley, John Z. Duan, Ph.D., and Cheng Yi Liang, Ph.D.

Office of Drug Safety IMS Health Process Improvement Team: Jeanine A. Best, Katrina S. Garry, Martha L. O'Connor, Carol A. Pamer, R.Ph., Judy A. Staffa, Ph.D., R.Ph. PHS Unit Commendation: CAPT George D. Armstrong Jr. and CAPT Joslyn R. Swann.

Office of Drug Safety New Drug Utilization Resources Team: Allen D. Brinker, M.D., Min C. Chen, R.Ph., Katrina S. Garry, Gurminders J. Khalsa, Cynthia J. Kornegay, Ph.D., Zili Li, M.D., M.P.H., Carolyn A. McCloskey, M.D., M.P.H., Parivash Nourjah, Ph.D., Martha L. O'Connor, Carol A. Pamer, R.Ph., Marilyn R. Pitts, Pharm.D., Paul F. Reinstein, Leslie L. Saveland, Judy A. Staffa, Ph.D., R.Ph., and Lynette Swartz. PHS Unit Commendation: CAPT Joslyn R. Swann.

Office of Generic Drugs Productivity Measures Team: Raymond L. Brown, James M. Fan, Florence S. Fang, Shing Hou Liu, Michael Smela Jr., Glen J. Smith and Ruth A. Warzala.

Patient Prescription Drug Information Advisory Committee: Melissa L. Bates, Christine M. Bechtel, Jeanine A. Best, Kathleen F. Bongiovanni, Karen J. Lechter, Ph.D., Melodi McNeil, R.Ph., Ellen R. Tabak, Ph.D., M.P.H., and Kimberly L. Topper. PHS Unit Commendation: CAPT Thomas J. McGinnis, CAPT Thomas H. Perez, CDR Anne E. Trontell

Peroxisome Proliferator-activated Receptor Agonist Working Group: Hae-Young Ahn, Ph.D., Fred K. Alavi, Ph.D., John B. Colerangle, Ph.D., James T. Cross, Jeri D. El-Hage, Ph.D., Zhaolong Gong, Ph.D., David J. Graham, M.D., Lanh Green, M.P.H., Steven B. Johnson, Ph.D., Elizabeth A. Koller, M.D., William A. Lubas, M.D., Joy D. Mele, Robert I. Misbin, M.D., Stephen K. Moore, M.D., David G. Orloff, M.D., Lee-Ping Pian, Ph.D., Herman J. Rhee, Ph.D., Dragos G. Roman, M.D., Dragos G. Roman, M.D., J. Todd Sahlroot, Ph.D., Bruce V. Stadel, M.D., Jena M. Weber, Da Lin Yao, Ph.D., Xavier J. Ysern, Ph.D., and Joanna K. Zawadzki, M.D.

Pleconaril Review Team: Narayana Batula, Ph.D., Cynthia A. Bigger, Ph.D., James G. Farrelly, Ph.D., Russell D. Fleischer, M.D., Lesley-Anne Furlong, M.D., Zi Qiang Gu, Ph.D., Thomas S. Hammerstrom, Ph.D., Katherine A. Laessig, M.D. Stephen Miller, Ph.D., Julian J. O'Rear, Ph.D., Kellie S. Reynolds, Pharm.D., Guoxing Soon, Ph.D., Kathleen Whitaker, Ph.D., and Jenny H. Zheng, Ph.D. PHS Unit Commendation: LT Destry M. Sillivan,

Post-Marketing Commitments Development Team: Gary M. Anderson, Sheila K. Andrew, Mary L. Guilderson, Cheryl J. Marshall, Robert L. Reinwald, Kathy Smith, Binh C. Ta, Jennifer A. Wagner and Jerry Yokoyama.

Potassium Iodide Evaluation Team: James F. Brower, Lucinda F. Buhse, William H. Doub, Joseph Famulare, Pat Alcock Lefler, Terra G. Lipe, John C. Reepmeyer, Larry K. Revelle, Anjanette P. Smith, Kimberly D. Story, Duckhee Y. Toler, Benjamin J. Westenberger and Anna M. Wokovich.

Pulmonary Inhalation Products Assurance Post 9-11 Team: Sandra L. Barnes, Ladan Jafari, Robert J. Meyer, M.D., Michael J. Verdi. PHS Unit Commendation: CAPT Harvey A. Greenberg, CDR Valerie E. Jensen and LCDR Craig Ostroff.

Soltara NDA Review Team: Craig M. Bertha, Ph.D., Young Moon Choi, Ph.D., Emmanuel O. Fadiran, Ph.D., James R. Gebert, Ph.D., Robert J. Meyer, M.D., Guiragos K. Poochikian, Ph.D., Curtis J. Rosebraugh, M.D., M.P.H., Lawrence F. Sancilio, Ph.D. PHS Unit Commendation: CAPT Mary E. Purucker, CAPT Ching-Long J. Sun and LCDR Craig Ostroff.

Time Reporting System Development Team: Sheila K. Andrew, George D. Clanton, Charlene Do, Richard J. Johnson, Marta L. Locklear, Weizhen Lu, Cheryl J. Marshall, Paul J. McCarthy, Stacey L. Nichols, Colleen F. Ratliffe, Timothy L. Rigg, Scott M. Shippey, Linda A. Sigg and Binh C. Ta.

Two Chemistry Review Teams co-located with the Division of Neuropharmacological Drug products: Thomas A. Broadbent, Ph.D., Danae D. Christodoulou, Ph.D., Gurpreet K. Gill-Sangha, Ph.D., Maria E. Guzewska, Ph.D., Martha R. Heimann, Ph.D., Christy S. John, Ph.D., Donald N. Klein, Ph.D., Richard T. Lostritto, Ph.D., Sherita D. McLamore, Ph.D., Thomas F. Oliver, Ph.D., Hasmukh B. Patel, Ph.D., Lorenzo Rocca, Ph.D., Waclaw J. Rzeszotarski, Ph.D., Robert Seevers, Ph.D., and Mona R. Zarifa, Ph.D.

Return to January February 2003 News Along the Pike.

OCPB Science Day: Clinical pharmacologists focus on appropriate dosing issues

The 11th Science Day sponsored by the Office of Clinical Pharmacology and Biopharmaceutics enthusiastically celebrated the theme "Optimizing Dose" on Nov. 1. Events included:

• The keynote address from a best-selling author on dose optimization.
• Presentation of new research on post-marketing safety-related dose changes for NMEs approved 1980-1999.
• Six podium and 16 poster presentations from OCPB staff.
• An entertaining and educational science team game.

Jay S. Cohen, M.D., the keynote speaker, gave his presentation on "Dose Optimization and Preventing Adverse Events: A Clinical Physician's Perspective on Improving Safety." He is the author of the best-selling book, Over Dose: The Case Against The Drug Companies, published in October 2001. He is an associate professor of family and preventive medicine and of psychiatry at the University of California at San Diego.

Dr. Cohen has been an active researcher in the area of adverse reactions in drug research, FDA regulation and physician's methods that have contributed to the serious problem of drug safety. He has been interviewed by major newspapers about his book. He is an appealing speaker and very good at presenting his case to both the scientific community and to the lay public.

In his book, he maintains that the recommended doses found in FDA approved labeling are too high for many people and are causing many unnecessary adverse reactions. Drug reactions in hospitals are among the nation's leading causes of death, killing more than 100,000 Americans every year. Dr. Cohen says the "side effect epidemic" causes many people-as high as 50 percent of those on blood-pressure medication-to discontinue treatment.

In his book, Dr. Cohen attributes the problem not only to poor research on the part of the drug companies but also to their effort to create easy, one-size-fits-all dosages that both appeal to doctors and produce artificially inflated effectiveness statistics.

He began his presentation at Science Day by mentioning that the most important piece of medical writing is the package insert. He said a physician assumes that it contains all the useful information he or she needs to prescribe a drug accurately and, particularly, that the dose recommended is indeed the best dose.

He believes that the dosage and administration section of labeling as currently written is "too wordy" considering that a physician spends less than 22 seconds with any given patient's prescription. He prefers very brief, focused information regarding dosing, for example, by bulletining this information.

He is a proponent of separating out major drug-drug interaction information from "minor" ones by highlighting the former in a prominent section of labeling up front, similar to the highlights in the proposed labeling rule.

Another view he espouses is that the Agency should require sponsors to provide exposure-response information in their submissions, justify dose selection more and, further, define the lowest effective dose. Introducing a mechanism for adding Phase IV data and highlighting all new warnings into the labeling of an approved drug were some of his other suggestions.

Robert Temple, M.D., director of the Office of Medical Policy, presented the FDA counterpoint by mentioning that the ICH E-4 document, Dose-Response Information to Support Drug Registration, does outline that both the shape and location of the exposure-response curve are important. Furthermore, selection of doses is based on dose response together with judgment about the relative importance of desirable and undesirable effects.

The labeling of many drugs frequently mentions use of the lowest effective dose as the possible starting dose. He acknowledged that problems do exist in life-threatening illnesses where we have been led to use higher doses because of the nature of absence of response. Dose response, in his view, is the most important aspect after safety and efficacy. The E-4 guidance is at http://www.fda.gov/cder/guidance/iche4.pdf.

James Cross, M.S., a consumer safety officer in the Division of Metabolic and Endocrine Drug Products, presented the results of research on postmarketing dosage changes in drug labels, which he conducted while he was at Georgetown University's Center for Drug Development Science.

He and his coauthors evaluated postmarketing changes in drug dose recommendations for the initially approved indications in 354 of the 499 new molecular entities approved between 1980 and 1999. They found that dosages for one in five of the NMEs changed and that four in five changes were safety reductions.

The median time to change following approval fell from 6.5 years at the beginning of the study period (1980-1984) to 2.0 years (1995-1999). The researchers found that the 1995-1999 NMEs were 3.15 times more likely to change in comparison to the 1980-1984 NMEs.

The authors said reasons for the increased changes include a decrease in foreign marketing experience prior to U.S. approval and the common industry practice of evaluating drugs in Phase III at or near the maximum-tolerated doses established in Phase 1. Their work was published in Pharmacoepidemiology and Drug Safety (2002; 11:439-446).

The podium presentations included research results from individuals who presented on:

• The microbiological and clinical efficacy of fluoroquinolones in patients with infections.
• Utilization of exposure-response knowledge in regulatory decision-making.
• Simulation characteristics of a new formulation for an oncology agent.
• Survey of transdermal NDAs.
• Review of calcium channel blockers and their interaction with ketoconazole and grape fruit juice.
• Genetic polymorphism of PgP versus exposure of PgP substrates.

The podium session was followed by a formal three-minute presentation made by the principal author of each poster. Posters covered a wide variety of issues such as:

• Evaluating the clinical effectiveness of analgesics, optimal dose selection for pediatric patients.
• In vitro-in vivo correlations of parenterals.
• Demographic considerations in bioequivalence studies.
• Assessment of bioequivalence in fed studies.
• Issues related to renal and hepatic insufficiency.
• In vitro evaluation of relative inhibitory potency of macrolides to PgP.
• Dermal microdialysis as a regulatory tool for topicals.
• Understanding schedule dependence of aromatase inhibitor via simulations.
• Comparing various heart rate correction formulas for QT.
• Dosage regimen adjustments based on exposure-response relationships.
• Grapefruit interactions and their labeling.
• Population pharmacokinetic perspectives.
• Pediatric exclusivity issues.
• Survey of pharmacogenetic and pharmacogenomic information in INDs and NDAs.

Return to January February 2003 News Along the Pike.

The finale of the day was the participation by all attendees in the game, "Science Funstation." Teams involving eight to 10 individuals were randomly formed. The game was conducted like a TV game show; however, the questions were all relevant to clinical pharmacology and biopharmaceutics. It was a very close race to the finish, and fun was had by all while, of course, learning was taking place.

Science Day, which first started in 1996, features scientific podium and poster presentations by FDA staff, a plenary lecture from a distinguished scientific guest speaker in clinical pharmacology and participation by all in the scientific funstation game.

Over the years the event has been attended by clinical pharmacologists from the Uniformed Services University of Health Sciences, CDER's Office of Generic Drugs, CBER, the Center for Drug Development Science at Georgetown and the National Institutes of Health.

Overall, the latest Science Day was another exciting event where everyone left educated and invigorated.

Return to January February 2003 News Along the Pike.

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