SELECT Label Comprehension Studies Mevacor ™ Daily
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Transcript of SELECT Label Comprehension Studies Mevacor ™ Daily
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SELECT Label SELECT Label Comprehension StudiesComprehension StudiesMevacorMevacor™™ Daily DailyCapt. Laura Shay, RN, MS, C-ANPCapt. Laura Shay, RN, MS, C-ANPDivision of Nonprescription Clinical Evaluation Division of Nonprescription Clinical Evaluation
Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research
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2Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Overview• Label comprehension (LC) study
• OTC Mevacor Label Development
• CUSTOM LCS
• SELECT LCS
• Muscle Warning LCS
• Summary
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3Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Purpose of Label Purpose of Label Comprehension StudyComprehension Study
OTC labels must:
“. . .be likely to be read and understood by the ordinary individual, including individuals of low comprehension, under customary conditions of purchase and use.”
21 CFR 330.10 (a)(4)(v)
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4Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Purpose of Label Purpose of Label Comprehension StudyComprehension Study
• To evaluate whether or not consumers can comprehend important communication objectives on the label
– Literate and low literate subjects
– Diverse population: Representative of the U.S. population
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5Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Overview• Label comprehension (LC) study
• OTC Mevacor Label Development
• CUSTOM LCS
• SELECT LCS
• Muscle Warning LCS
• Summary
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6Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
OTC Mevacor Label ParadigmsOTC Mevacor Label Paradigms • 2000: 10 mg Mevacor
– Label: Total Chol. paradigm- Total Chol. follow-up
• 2005: 20 mg Mevacor OTC– Label: LDL paradigm-LDL follow-up
• 2007: 20 mg Mevacor Daily– Label 1: LDL paradigm-LDL follow-up – Label 2: Total Chol. paradigm-Total Chol. follow-up
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7Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
OTC Mevacor OTC Mevacor Consumer StudiesConsumer Studies
• 2004: 20 mg Mevacor OTC (Custom Label)– CUSTOM actual use study
• A Consumer Use Study of OTC Mevacor (CUSTOM)– CUSTOM label comprehension study
• 2007: 20 mg Mevacor Daily (SELECT labels)– SELECT LCS – Muscle Warning LCS – SELECT self-selection study
• Self Evaluation of Lovastatin to Enhance Cholesterol Treatment (SELECT)
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8Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Overview• Label comprehension (LC) study
• OTC Mevacor Label Development
• CUSTOM LCS
• SELECT LCS
• Muscle Warning LCS
• Summary
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CUSTOM Label 2004
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CUSTOM Label 2004
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CUSTOM Results: Selection CriteriaCUSTOM Results: Selection Criteria Communication Objectives Communication Objectives
0% 100%20% 40% 80%60%
LDL/HDL (54-59%)
Risk Factor: MI (37%)
Correct Age (57%)
Comprehension
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12Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
CUSTOM Results: CUSTOM Results: Safety Communication ObjectivesSafety Communication Objectives
Comprehension
0% 100%20% 40% 80%60%
breast feeding (77%)
unexplained muscle pain (79%)
allergy to lovastatin (72%) pregnant (74%)
liver disease (69%)
Woman <55 (55%)
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CUSTOM Results: Self-SelectionCUSTOM Results: Self-Selection
• Included a self-selection question
• Of 209 subjects who stated they “could start
Mevacor OTC today”
–1% were correct (n=3) on all the label
criteria (age, LDL, risk factors, medical
history, pregnancy status and
medications)
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Deficiencies Listed in the Deficiencies Listed in the February 23, 2005 Not Approvable LetterFebruary 23, 2005 Not Approvable Letter
• Modify and retest the package label – pregnancy warning– unexplained muscle pain warning – liver disease warning
• Justification if deviate from Drug Facts format (21 CFR 201.66(d))
• Demonstrate that consumers can make an appropriate self-selection decision based on the information contained on the label
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15Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Overview• Label comprehension (LC) study
• OTC Mevacor Label Development
• CUSTOM LCS
• SELECT LCS
• Muscle Warning LCS
• Summary
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SELECT-LDL Label 2007
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17Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Back of the Box
SELECT-LDL Label 2007
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18Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Inside Flap
SELECT-LDL Label 2007
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19Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SELECT-LDL Label 2007
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20Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SELECT-LDL Label 2007
Bottom of Box
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21Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
LDL-Label LDL-Label vs.vs.
Total Cholesterol-Label Total Cholesterol-Label
SELECT Label Paradigms
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22Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
LDL
Women age 55 years or older Man age 45 years or older
LDL between 130-170
Must have one or more risk factors (listed…)
*including low HDL 1 to 39
(*not gender specific)
Total Cholesterol
Women age 55 years or older Man age 45 years or older
Total Chol. between 200-240
Men: No HDL requirement Women: HDL between 1 and 59 Men : No risk factors require Women: At least one or more
risk factors (listed…)
Selection Criteria
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23Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SELECT Label Comprehension SELECT Label Comprehension Study DesignStudy Design
• Primary objective:
To measure consumer comprehension of key communication messages on the label
• Secondary objective:
To test comprehension of two different usage
paradigms based on LDL-C and Total-C
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24Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Study Design Study Design
• Parallel two group design
• Random assignment– LDL label (LDL-C)– T. Chol. label (Total-C)
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SampleSample• Cholesterol concerned individuals• 20 geographically dispersed malls• Inclusion/Exclusion criteria
– 18 years or older, – speak/read English, – have not participated in a market research survey in
the mall in the past 3 months – Not a healthcare provider– Not employed by advertising/marketing/healthcare
product company
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Sample SizeSample Size
LDL Label
• Rep. Sample=307
Total Chol. Label
• Rep. Sample=303
Sample Total n=816
* Augmented
• Low Literate=155* • Low Literate=160*
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27Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Data Collection Data Collection • Trained interviewer/scripted questionnaire
• Open-ended
– Example: “What is Mevacor Daily used to treat?”
• Scenario questions
– Example: Diane has been taking Mevacor Daily for
several weeks. She now is feeling muscle pain that
she can not explain. Is it ok or not ok for her to
continue using Mevacor daily?
– “Why did you say that?”
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Data AnalysisData Analysis• Step 1: Analysis of initial response to “ok or not
ok” question:– Correct – Incorrect
• Step 2: Analysis of follow-up question (“Why did you say that?”):– Correct (“truly” correct-eliminated “guessers”)– Acceptable (“talk to a doctor”)– Correct + Acceptable
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29Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SELECT Labels Results:SELECT Labels Results:Selection Criteria Communication ObjectivesSelection Criteria Communication Objectives
Comprehension
0%100%20% 40% 80%60%
LDL/HDL (64%-78%)
T.Chol/HDL (70%-86%)
Correct Age: both labels (86-92%)
Risk Factor MI: (29%-44%) Overall Scores
T. chol
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30Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SELECT Results (Both Labels): SELECT Results (Both Labels): Safety Communication Objectives Safety Communication Objectives
Comprehension
0% 100%20% 40% 80%60%
Liver Disease (84-94%)
Allergy to lovastatin (91-99%)
Pregnant (94-98%)
Unexplained Muscle Pain (96-98%)
Breast Feeding (94-97%)
Woman <55/Female Subjects (92%)
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31Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Key Communication Objectives Key Communication Objectives
CUSTOM LCS CUSTOM LCS VSVS..
SELECT LCSSELECT LCS
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32Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Results CUSTOM vs. SELECT Results CUSTOM vs. SELECT Selection Criteria Communication Objectives Selection Criteria Communication Objectives
0%100%20% 40% 80%60%
•Age
• LDL/HDL
• T. Cholesterol/HDL
SELECTCUSTOM
54-59% 64-92%
~80%
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33Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Results CUSTOM vs. SELECT Results CUSTOM vs. SELECT Selection Criteria Communication Objectives Selection Criteria Communication Objectives
0%100%20% 40% 80%60%
29-44%
Risk Factor (MI)
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34Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Results CUSTOM vs. SELECT Results CUSTOM vs. SELECT Safety Communication Objectives Safety Communication Objectives
0% 100%20% 40% 80%60%
SELECTCUSTOM
•Liver Disease•Woman <55/Female Subjects•Pregnant/Breast Feeding•Unexplained Muscle Pain•Allergy to lovastatin
55-79% 84-99%
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35Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
CUSTOM vs. SELECTCUSTOM vs. SELECT
• Follow-Up Lipid Testing
• What to do if LDL has not reached goal
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36Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
CUSTOM : When to Retest Lipids
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37Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SELECT: When to Retest Lipids
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38Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Question: When to Retest LipidsQuestion: When to Retest Lipids
• CUSTOM LCS: 71-87% correct*
• SELECT LCS: 45-62% correct
*In the CUSTOM actual use study, ~70% of the subjects obtained a follow-up cholesterol test
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39Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
CUSTOM: CUSTOM: What to do if LDL has not reached goalWhat to do if LDL has not reached goal
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40Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SELECT: SELECT: What to do if LDL/T.C. has not reached goal What to do if LDL/T.C. has not reached goal
Bottom of Box
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41Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Question: What to do if LDL has not Question: What to do if LDL has not reached goalreached goal
• CUSTOM LCS: 54-68% correct*
• SELECT LCS: 59-69% correct
*In the CUSTOM actual use study, ~75% of the
subjects made a correct decision on whether to continue to use Mevacor Daily based on their LDL results
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42Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Overview• Label comprehension (LC) study
• OTC Mevacor Label Development
• CUSTOM LCS
• SELECT LCS
• Muscle Warning LCS
• Summary
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43Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
PurposePurpose
To measure in-depth consumer comprehension of the warning about unexplained muscle pain, tenderness or weakness after starting Mevacor™ Daily contained in the Drug Facts and the internal package materials
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44Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Muscle LCS Label 2007
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45Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Muscle LCS Label 2007
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46Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Quick Quick Start Start
GuideGuide
Muscle LCS Label 2007
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47Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Package Insert/Brochure Package Insert/Brochure
Muscle LCS Label 2007
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48Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
MagnetMagnet
Muscle LCS Label 2007
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49Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Study DesignStudy Design
• One group (LDL label)
• Sample Size:– Rep. Sample=316– Low literacy=104
• Cholesterol interested individuals/malls
• Inclusion/Exclusion
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50Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Data Collection Data Collection
• Trained interviewer/scripted questionnaire
• Questionnaire– Scenario – Open-ended– Closed-ended– All questions not focused on muscle warning
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51Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Muscle LCS ResultsMuscle LCS Results
• Correct responses to questions related to:– the side effect of muscle pain – stop using Mevacor if develop muscle pain
• 97-98%• Correct responses to questions related to:
– What happens if someone who develops muscle pain continues using Mevacor• 75-85%
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52Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Muscle LCS Results cont.Muscle LCS Results cont.
• Responses to question : “how likely would he/she contact a doctor if he/she developed muscle pain while taking Mevacor Daily?”
– Extremely – Very likely– Somewhat likely– Not at all likely– Not too likely
• Unknown whether or not respondents understood if they should talk to a ‘doctor’
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53Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Muscle Results cont.Muscle Results cont.
• Most respondents understood that muscle pain is a side effect of lovastatin and a person who develops unexplained muscle pain should stop taking Mevacor™ Daily (96-98%).
*In the CUSTOM actual use study, 60% of the
subjects who developed unexplained muscle pain (38 out of 63 subjects), stopped using lovastatin. (CUSTOM LCS: 79% correct comprehension )
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54Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Overview• Label comprehension (LC) study
• OTC Mevacor Label Development
• CUSTOM LCS
• SELECT LCS
• Muscle Warning LCS
• Summary
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55Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Summary Summary
• Well designed studies– A lot of useful qualitative data– Validation of correct responses
• The major communication elements on the label were tested with one exception: – The part of the pregnancy warning that describes
women who may become pregnant
• Areas of improved comprehension from CUSTOM label
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56Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SafetySafety
• Correct Responses (~ >90%)– Muscle warning (need to stop taking) (96-98%)– Correct age (86-92%)– Pregnancy* (94-98%) – Breast feeding* (94-97%)– Liver disease (84-94%)– Muscle warning (continue using) (75-85%)
*Of those who were incorrect on the pregnancy and breast feeding questions– Unable to find the pregnancy warning on the label
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57Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Selection CriteriaSelection Criteria
– Age/LDL/T. Chol/HDL (64-92%) (~80%)
– Risk factor MI (29-44%)
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58Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Lipid Testing/Follow-upLipid Testing/Follow-up
• When to retest (45-62%)
• What to do if have not reached goal (59-69%)
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59Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
SummarySummary• The pregnancy/breastfeeding, liver, and muscle
warnings were better understood• There was improved comprehension of the
selection criteria (esp. T. Chol) with the exception of the one risk factor tested (MI)
• There was a decrease in comprehension that lipids should be retested in 6 weeks
• There was no improvement in comprehension what to do if have not reached goal
• Overall comprehension levels were similar for the low literate study population
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60Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
Self-Selection Self-Selection
SELECT Self-Selection Study
Linda Hu, Medical Officer
Division of Nonprescription Clinical Evaluation
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61Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting December 13, 2007December 13, 2007
AcknowledgementsAcknowledgements• Review Team
– Andrea Leonard Segal, M.D.
– Joel Schiffenbauer, M.D.
– Daiva Shetty, M.D.
– Linda Hu, M.D.
– Stan Lin, Ph.D.
– Michael Koenig, Ph.D.
– Matthew Holman, Ph.D.
– Mary Lewis, RN