1 Charles M. Beasley, Jr., M.D. 8161 Beech Knoll Indianapolis, IN 46256-2107 +1.317.435.5330 Mobile [email protected]First-tier, executive level experience in the design, conduct, analysis, and successful submission of multiple Phase II-IV development programs. Additional work with select Phase I studies in various areas especially cardiac electrophysiology assessment. Extensive experience in the domain of drug safety evaluation in response to high-profile challenges to the safety profiles of several drugs. Published widely in the scientific literature while in industry, gaining the respect of the academic community as exemplified by being elected to the highly competitive and prestigious American College of Neuropsychopharmacology. Training and research in computer science and statistics facilitate accurate and efficient collaboration with data scientists and statisticians, enhancing quality in progressing from study protocols to submissions and scientific manuscripts. PROFESSIONAL POSITIONS Eli Lilly and Company July 1987-30/Apr/2015 Global Patient Safety (GPS) April 2004-30/Apr/2015 Distinguished Lilly Scholar (Vice-Presidential level)Oct. 2004-30/Apr/2015 Distinguished Lilly Fellow April 2004-Oct. 2004 Consulted for individual projects to the Vice-President GPS and Medical Director GPS Engaged in activities relevant to the assessment of drug safety of my choosing Designed comprehensive assessments incorporated work ranging from in vitro research, through toxicology, Phase 1 studies, clinical trials (Phase II- IV), post-marketing surveillance, and large database pharmacoepidemiology studies tailored to address topics of special relevance for select drugs (additional detail confidential) Performed in-depth due diligence from a safety perspective for potential collaboration molecules Internal committee participation
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First-tier, executive level experience in the design, conduct, analysis, and successful submission of multiple Phase II-IV development programs. Additional work with select Phase I studies in various areas especially cardiac electrophysiology assessment. Extensive experience in the domain of drug safety evaluation in response to high-profile challenges to the safety profiles of several drugs. Published widely in the scientific literature while in industry, gaining the respect of the academic community as exemplified by being elected to the highly competitive and prestigious American College of Neuropsychopharmacology. Training and research in computer science and statistics facilitate accurate and efficient collaboration with data scientists and statisticians, enhancing quality in progressing from study protocols to submissions and scientific manuscripts.
PROFESSIONAL POSITIONSEli Lilly and Company July 1987-30/Apr/2015
Global Patient Safety (GPS) April 2004-30/Apr/2015Distinguished Lilly Scholar (Vice-Presidential level) Oct. 2004-30/Apr/2015Distinguished Lilly Fellow April 2004-Oct. 2004
Consulted for individual projects to the Vice-President GPS and Medical Director GPS Engaged in activities relevant to the assessment of drug safety of my choosing Designed comprehensive assessments incorporated work ranging from in vitro research, through
toxicology, Phase 1 studies, clinical trials (Phase II-IV), post-marketing surveillance, and large database pharmacoepidemiology studies tailored to address topics of special relevance for select drugs (additional detail confidential)
Performed in-depth due diligence from a safety perspective for potential collaboration molecules Internal committee participation
o Global Product Labeling Committee: committee making final decisions regarding contents of Core Data Sheets (CDSs) for drugs
o Hepatic Safety Advisory Committeeo Cardiovascular Safety Advisory Committee (CvSAC) o ECG Sub-Committee (of CvSAC)o Psychobehavioral Advisory Committeeo Laboratory Data Analysis Working Groupo Adverse Events Analysis Working Groupo Standards Control Board: group assuring that data collection / case report forms are
consistent with CFAST/CDISC standards Participated in design, analysis, and interpretation of Thorough QT (TQT) studies Developed revised and consistent reference limits for numerical hemodynamic parameters and
quantitative ECG findings Revised the set of possible qualitative ECG findings used during the interpretation of qualitative ECG
observations to minimize ambiguity and inconsistency across ECGs
Contributed to revision of interpretive standards (i.e., diagnostic criteria) for the set of possible qualitative ECG findings and documented academic literature supporting those interpretive standards
Designed the analytical methods resulting in summary statistical tables for qualitative ECG data Supervised extensive research on reference limits for standard safety laboratory analytes optimized
for use in analysis of outliers in randomized clinical trials, in contrast to limits optimized for individual patient care (research ongoing)
Authored the clinical sections of the external CFAST/CDISC Therapeutic Area for TQT Studies Served as an author for a cross-industry PhUSE whitepaper recommending standard analyses for
TQT studies Collaborated with statisticians to design the standardized analyses and output for the Summaries of
Clinical Safety / Integrated Summaries of Safety for NDAs / European submissions / internal major safety update reviews
Developed internal standardized methods for use of data from multiple clinical trials in the development of the list of adverse reactions for incorporation into CDSs
Worked hands-on with most teams bringing molecules forward for initial submission and therefore CDS with organization of studies, their analysis, and interpretation with regard to identifying Adverse Reactions
Authored / co-authored several academic manuscripts in the areas of QT, assessment methods in drug safety, safety topics for specific drugs
Designed a Phase I study to sensitively assess weight gain potential for a new molecular entity
Neuroscience Business Unit Jan. 2003-April 2004Distinguished Lilly Fellow
Consulted to the President of the Business Unit Was available for consultation to other therapeutic area business units on matters of both efficacy
(experimental design) and safety (methods of assessment, interpretation) Designed comprehensive assessments that incorporated work ranging from in vitro research, through
toxicology, Phase 1 studies, clinical trials (Phase II-IV), post-marketing surveillance, and large database phrmacoepidemiology studies tailored to address topics of special relevance for select drugs (additional detail confidential)
Consulted to the program phase development teams developing metabotropic glutamate receptor platform compounds as antipsychotics and a selective norepinephrine uptake inhibitor as an adjunctive antidepressant in depression non-responsive to a serotonin uptake inhibitor
Tadalafil (Cialis®) Product Team July 2001-Jan. 2003Distinguished Lilly Fellow and Medical Director
Supervised the design and execution of all activities required to achieve regulatory approval in the EU and the US for tadalafil for the treatment of erectile dysfunction subsequent to the initial US NDA and EU submission documents
Planned analyses to address multiple and distinct questions from both US and European regulators regarding tadalafil submission as well as a multiple component plan to address a topic of special interest to European regulators (additional detail confidential)
Designed additional Phase I studies to support the initial indication for tadalafilo Length of activity study to document activity for at least 36 hourso Interaction with nitrates study to demonstrate magnitude of effect under controlled and safe
circumstances
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o Interaction with alcohol study to demonstrate magnitude of any additive hypotensive effecto TQT study
Designed and initiated Phase IV studies intended to support the commercialization of tadalafil in the treatment of erectile dysfunction
Outlined potential development programs for tadalafil in the treatment of additional indications, including diabetic gastroparesis, benign prostatic hypertrophy, and pulmonary hypertension
Directly supervised and managed 4 physicians in support of the activities listed above
Olanzapine (Zyprexa®) Product Team Jan. 1995-July 2001Distinguished Lilly Fellow July 1999-July 2001Medical Advisor Jan. 1995-July 1999
Following US and European approval of olanzapine for schizophrenia / psychosiso Consulted on additional olanzapine indication development programs: various phases of
bipolar disorder, dementia / manifestations of dementia and alternative formulation development programs: rapidly dissolving tablet, rapid acting intramuscular formulation
o Designed and executed the study to demonstrate maintenance / long-term antipsychotic efficacy of olanzapine
o Supervision and assessment of any and all safety topics of special relevance regarding olanzapine that included developed multiple in-depth safety reports for safety topics of special relevance for olanzapine and interacted with US and international regulatory authorities with regard to these topics with successful outcomes (additional detail confidential)
o Participated in design of glycemic clamp studies to assess impact of olanzapine on glycemic control
o Interface with Japanese investigators and direct planning and writing of Japanese olanzapine submission (Giyo) for schizophrenia
o Management of all clinical aspects of initial Japanese development program for olanzapineo Consulted to marketing on post-approval activities for olanzapineo Transitional team leader for metabotropic glutamate receptor platformo Designed and executed a successful Phase III study for a metabotropic glutamate receptor
compound after 5 failed Phase II studies Prior to US and European approval for schizophrenia / psychosis
o Supervised the analysis and writing of US and European regulatory submission documents for olanzapine that resulted in simultaneous approval in 13 months following submissions
o Consulted to marketing on preapproval activities for olanzapine
Neuroscience / Psychopharmacology Division of Clinical Investigation July 1987-Jan. 1995Senior Clinical Research Physician March 1992-Jan. 1995Research Physician Aug. 1989-March 1992Associate Clinical Research Physician July 1987-Aug.1989
Olanzapine Phaseo Oversaw all medical aspects of design and implementation of the 5 Phase II-III studies for
olanzapine in the treatment of psychosis / schizophrenia Fluoxetine (Prozac®) and tomoxetine Phase
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o Had overall medical responsibility for fluoxetine including efficacy, safety, advancement of scientific understanding and marketing support, including design and execution of 10 Phase IV studies
o Had overall medical responsibility for Phase III development tomoxetine as an antidepressant (program terminated and molecule developed with generic name atomoxetine [Strattera®] for attention deficit hyperactivity disorder), including design and execution of 3 Phase II studies
o Initiated a program for publication of multiple never-published fluoxetine study results as well as post-hoc data mining from fluoxetine studies to clarify important clinical and scientific aspects of the activity of fluoxetine in order to increase medical knowledge of fluoxetine, provide marketing support, and increase personal academic stature
o Successfully lead the data analysis effort in 1990-1991 to clarify and rebut, if warranted, the assertion that fluoxetine induces suicidal ideation of unique clinical characteristics and distinct from other antidepressants
o Conducted in-depth review and evaluation of the problem of placebo response in antidepressant trials
o Completed routine regulatory safety review documents for fluoxetine and prepared special reports to address safety topics of special relevance for fluoxetine
o Provided marketing support and review for fluoxetine
Group Health Associates, Cincinnati, OH May 1987-June 1987 Physician, Psychiatric Disorders
Eating Disorders Center, Cincinnati Medical Center July 1985-March 1987Consultant, Medical Support for Bulimia Clinical Trial, Psychiatry Dept.
Affective Disorders Center, University Of Cincinnati Medical Center June 1985-May1986Physician, Sub-Investigator for Antidepressant Clinical Trial, Psychiatry Dept.
Neuropsychology Laboratory, Yale University School of Medicine July 1978-Aug.1979Associate In Research, Database And Software Designer, Neurology Dept.
Dept. Psychology, Yale University June 1977-July 1978Research Programmer, Software Developer in Machine Learning Artificial Intelligence Research
ACADEMIC APPOINTMENTSVoluntary Assistant Professor Jan. 1989-June 1996Department of Psychiatry, University of Cincinnati
POSTGRADUATE TRAININGUniversity of Cincinnati 1984-87Department of Psychiatry; PGY-II-IV, General Psychiatry residencyYale University 1983-84
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1983-84Department of Psychiatry; PGY-I Flexible intern at the Hospital of St. Raphael
EDUCATION M.D., University of Kentucky College of Medicine 1983
1983B.A., Psychology Yale University 1977
CERTIFICATION AND LICENSURENational Board of Medical Examiners Diplomate 1984American Board of Psychiatry and Neurology Diplomate (Psychiatry) 1988Medical License: Ohio; Indiana; Maine
AWARDS AND HONORSSandoz Pharmacology Award 2nd year medical schoolPromoted with distinction 2nd and 3rd years medical schoolElected to AOA and AOA president 3rd year medical schoolAMA-ERF Rock Sleyster Memorial Scholar 4th year medical schoolCornelia B. Wilbur Psychiatry Departmental Award 4th year medical schoolNeurology Departmental Award 4th year medical schoolGraduated medical school with high distinction 1983Laughlin Fellow American College of Psychiatrists, 19871st place, Maurice Levine Essay Award Cincinnati Psychiatric Society, 19874th Year Resident’s Award Department of Psychiatry, University of Cincinnati, 1987Resident’s Research Award Department of Psychiatry, University of Cincinnati, 1987Founder’s Day Resident Award Paper Ohio Psychiatric Association, 1987
PROFESSIONAL SOCIETY FELLOWSHIPSAmerican Psychiatric AssociationAmerican College of PsychiatristsAmerican College of NeuropsychopharmacologyRoyal College of Physicians of the United Kingdom
PROFESSIONAL SOCIETY MEMBERSHIPSIndiana Psychiatric SocietyAmerican Federation for Clinical ResearchAmerican Society of Clinical Psychopharmacology
EDITORIAL BOARD MEMBERSHIPSSection Editor, Psychopharmacology The Open Pharmacology JournalEditorial Board Current PsychopharmacologyEditorial Board World Journal of PsychiatryEditorial Board The Scientific World JournalEditorial Board ISRN PsychiatryEditorial Board Journal of Cardiovascular Disorders
REVIEWERJournal of Clinical PsychopharmacologyArchives of General PsychiatryPsychological Bulletin
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Psychological MedicineBiological PsychiatryNeuropsychiatric Diseases and TreatmentProgress in Nero-Psychopharmacology & Biological PsychiatryAmerican Journal of Psychiatry
OTHER PROFESSIONAL ACTIVITIESCo-chairperson History Committee American College of Neuropsychopharmacology 2008-2010 Co-chairperson PMA Education & Research Institute Pharmacology Training Series: Central Nervous System Pharmacology Washington, D.C. Sep 29-30, 1993Co-chairperson Paper Session 41: Comorbidity in affective disorders American Psychiatric Association Annual Meeting Montreal, Canada May 12, 1988
PATENTS ISSUED5605897 2-Methyl-Thieno-Benzodiazepine (Olanzapine)5817656 Method for Treating Mental Disorders (Olanzapine)5817657 Method for Treating Psychoactive Substance Disorders (Olanzapine)5776928 Method for Treating Dyskinesia (Olanzapine)6071902 Method for Treating Excessive Aggression (Olanzapine)6159963 Method for Treating Substance Abuse (Olanzapine)6274636 Method of Treating Tic Disorder (Olanzapine)6506746 Method for Treating Cognitive Dysfunction (Olanzapine)
BOOK CHAPTERS
1. Beasley C, Grundy S, Gannon K, Berg P
Overview of the safety of olanzapine
In Tran P, Bymaster F, Tye N, Herrera J, Breier A, Tollefson G (Eds.)
Olanzapine (Zyprexa): A Novel Antipsychotic
Philadelphia: Lippincott Williams & Wilkins, 2000
2. Tran P. Sutton V, Beasley C, Tollefson G
Efficacy of olanzapine
In Tran P, Bymaster F, Tye N, Herrera J, Breier A, Tollefson G (Eds.)
Olanzapine (Zyprexa): A Novel Antipsychotic
Philadelphia: Lippincott Williams & Wilkins, 2000
3. Anderson J, Kline P, Beasley C
A general learning theory and its application to schema abstraction
In Bower G (Ed.)
The Psychology of Learning and Motivation, Vol 13.
New York: Academic Press, 1979
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4. Anderson J, Kline P, Beasley C
Complex learning processes
In Snow R, Federico P & Montague W (Eds.)
Aptitude, Learning, and Instruction, Vol 2: Cognitive Process Analysis of Learning and Problem
Solving
Hillsdale, NJ: Lawrence Erlbaum and Associates, 1980
ARTICLES
1. Crowe B, Brueckner A, Beasley C, Kulkarni P
Current practices, challenges, and statistical issues with product safety labeling
Statistics in Biopharmaceutical Research 5:180-193; 2013
2. Loghin C, Haber H, Beasley CM, Kothare PA, Kauffman L, April J, jin L, Allen AJ, Mitchell MI
Effect of atomoxetine on the QT interval in healthy CYP2D6 poor metabolizers
Br J Clin Pharmacol 75:549-564; 2013
3. Beasley C, Benson C, Xia J, Young S, Haber H, Mitchell M, Loghin C
Systematic decrements in QTc between the first and second day of contiguous daily ECG
recordings under controlled conditions
PACE 34:1116-1127; 2011
4. Millen BA, Campbell GM, Beasley CM
Weight changes over time in adults treated with oral or depot formulations of olanzapine:
a pooled analysis of 86 clinical trials
J Psychopharmacol 25:639-645; 2011
5. Meyer RE, Salzman C, YoingstromEA, ClaytonPJ, Goodwin FK, Mann JJ, Alphs LD, Broich K,
Fluoxetine vs. Placebo: long-term treatment of MDD
Annual Meeting of the American College of Neuropsychopharmacology. Honolulu, HA, Dec. 15,
1993.
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109. Beasley C, Tollefson G, Tye N, Moore N
Olanzapine: a potential “atypical” antipsychotic agent
Annual Meeting of the American College of Neuropsychopharmacology. Honolulu, HA, Dec. 15,
1993.
110. Sayler M, Pande A, Beasley C, Tollefson G
Antidepressant efficacy and severity of depression
American Psychiatric Association Annual Meeting. San Francisco, CA, May 26, 1993.
111. Tye N, Moore N, Rees G, Sanger G, Calligaro D, Beasley C
Preclinical pharmacology of olanzapine: a novel ‘atypical’ antipsychotic agent
Second International Conference on Schizophrenia. Vancouver, Canada, July 21, 1992.
112. Beasley C, Montgomery S, Tye N
Olanzapine: an open-label study in schizophrenia
Second International Conference on Schizophrenia. Vancouver, Canada, July 21, 1992.
113. Beasley C, Sayler M
Fluoxetine: activating and sedating effects at multiple fixed doses
CINP. Nice, France, June 29, 1992.
114. Bergstrom R, Beasley C, Levy N, Dubey A, Blumenfield M, Goodman A, Solomon R
Fluoxetine pharmacokinetics after daily doses of 20 mg fluoxetine in patients with severely
impaired renal function
Pharmaceutical Research 8:S294; 1991.
115. Heiligenstein J, Coccaro E, Potvin J, Beasley C, Dornseif B, Masica D
Fluoxetine not associated with violent behavior in controlled clinical trials
Clinical Research 39:768A; 1991.
116. Beasley C, Faries D, Sayler M, Potvin J
Fluoxetine not associated with suicidality in international controlled clinical trials in
depression
Clinical Research 39:767A; 1991.
117. McDermott B, Beasley C, Kelly K, Hirschowitz J, Garver D
Confounds of neuroendocrine challenge tests
American Psychiatric Association Annual Meeting. Montreal, Canada, May 10, 1988.
118. Garver D, Beasley C, Kelly K, Magnusson M, Johnson C, Chopra Y
Antipsychotic response latencies: separate diseases
American Psychiatric Association Annual Meeting. Montreal, Canada, May 9, 1988.
119. Garver D, Beasley C, Sautter F, Chopra Y
Early antipsychotic response with neuroleptics and dopamine psychosis
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Annual Meeting of the American College of Neuropsychopharmacology. San Juan, PR, Dec. 8,
1987.
120. Sautter F, McDermott B, Beasley C
Short-term outcome of schizophreniform disorder
American Psychiatric Association Annual Meeting. Chicago, IL, May 12, 1987.
121. Beasley C, Garver D
Growth hormone response and neuroleptic response in neuroleptic naïve patients
American Psychiatric Association Annual Meeting. Chicago, IL, May 12, 1987.
122. Beasley C, Magnusson M, Garver D
TSH response to TRH and haloperidol response latency in psychoses
Society for Biological Psychiatry Annual Meeting. Chicago, IL, May 7, 1987.
GRANT REPORTS
1. Anderson J, Kline P, Beasley C
A theory of the acquisition of cognitive skills
Technical Report 77-1. Yale University, 1978
2. Anderson J, Kline P, Beasley C
Complex learning processes
Technical Report 78-1. Yale University, 1978
INVITED PRESENTATIONS (SELECTED)1. Beasley C
A tale of two profiles: the hemodynamic effects of atomoxetine under clinical observation vs. intensive monitoringCardiac Safety Research Consortium – Pediatric Cardiovascular Safey Drug and Medical Device Development Thinktank. Silver Spring, MD, Dec. 10, 2010.
2. Beasley CHow to characterize the QT effect in the targeted patient population when a TQT study is positiveDIA Conference: Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding. Arlington, VA, Apr. 12, 2009.
3. Beasley CRegulatory, procedural, and statistical considerations in the thorough QT study: the complexity of the design of a thorough QT studyWorld Pharmaceutical Congress. Philadelphia, PA, May 12, 2008.
4. Beasley CConduct & Design of a TQT StudyKeynote address. QT and Drug Development. London, England, Oct. 24, 2007.
6. Beasley CWhy we need improved preclinical predictors and human biomarkers for torsades de pointeKeynote presentation, Cardiac Safety. World Pharmaceutical Congress. Philadelphia, PA, June 12, 2007.
7. Beasley CIs 36,000 ECGs overkill?DIA Conference – Challenges and Practical Aspects of Assessing Clinical QT Prolongation / Proarrhythmia Risk and Implications for the Critical Pathway. Washington, DC, May 9, 2006.
8. Beasley CDo we need a new ear, a new purse, or both? OR What do we need to more effectively and efficiently confirm the absence of risk of torsades?Cardiac Safety and Critical Pathway Initiative Regulatory Think-Tank. Bethesda, MD, Oct. 11, 2005.
9. Beasley CDrug development from the industry perspective: challenges and opportunitiesA Workshop on Clinical Trials in Psychopharmacology. New York, NY, Apr. 12, 2005.
10. Beasley COlanzapineBritish Association for Psychopharmacology Regional Meeting. Guilford, England, Oct. 10, 1997.
11. Beasley COlanzapine: atypical antipsychoticAmerican Society of Clinical Pharmacology and Therapeutics Annual Meeting. Orlando, FL, Mar. 21, 1996.
12. Beasley COlanzapine clinical development: molecule to drug candidateNCDEU Annual Meeting. Orlando, FL, June 1, 1995.
13. Beasley CClinical trial design in depression and anxietyPMA Education and Research Institute Course Drug Development in Depression and Anxiety. Boston, MA, Mar. 15, 1994.
14. Beasley CAtypical antipsychotics: What are they?Grand Rounds, Cleveland Clinic. Cleveland, OH, Nov. 4, 1993.
15. Beasley COlanzapineInternational Congress on Schizophrenia Research. Colorado Springs, CO, Apr. 20, 1993.
16. Beasley CFluoxetine in tricyclic refractory major depressive disorderSecond International Conference on Refractory Depression. Amsterdam, The Netherlands, June 26, 1992.
17. Beasley CFluoxetine: significance of plasma concentrations and impact on psychomotor performance
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1992 Annual Lectureship in Forensic Toxicology. Annual meeting of the American Academy of Forensic Sciences. New Orleans, LA, Feb. 21, 1992.
18. Beasley C, Farries DFluoxetine: worldwide suicidality dataAnnual Meeting of the American College of Neuropsychopharmacology (Study Group). San Juan, PR, Dec. 11, 1991.
19. Beasley C, Farries DStrategies to lower placebo response rates in depressed patients in antidepressant trialsAnnual Meeting of the American College of Neuropsychopharmacology (Study Group). San Juan, PR, Dec. 9, 1991.
20. Beasley C, Dornseif BPlacebo response in depression: associated variables?Annual Meeting of the American College of Neuropsychopharmacology(Study Group). Maui, HA, Dec. 13, 1989.
21. Beasley CTSH response to TRH and differential drug response in psychosisFounder’s Day Resident Award Paper Presentation, Ohio Psychiatric Association. Toledo, OH, Apr. 23, 1988.
22. Beasley CMedication response subtyping of psychoses and neuroendocrine correlatesIndiana University Psychiatric Research Institute Seminar. Indianapolis, IN, Nov. 5, 1987.
23. Beasley CSerotonin uptake inhibitors in psychiatryAnnual Convention of the Central Neuropsychiatric Association. Indianapolis, IN, Oct. 10, 1987.
24. Beasley CTSH response to TRH and medication response subtypes of psychosesMaurice Levine Essay Award Presentation, Cincinnati Psychiatric Society. Cincinnati, OH, Apr. 15, 1987.
25. Garver D, Beasley CHeterogeneity of neuroleptic response in psychosis: implications for subtypingPsychiatric Research Society Annual Meeting. Tampa, FL, Apr. 4, 1987.
26. Beasley C, Garver DThe heterogeneity of schizophrenic illness(es)Annual Meeting & Scientific Symposium, Mental Health Association in Ohio. Columbus, OH, Oct. 10, 1986.
27. Beasley CThe acquisition of procedural knowledge: some linguistic examplesUniversity of Kentucky Linguistics Circle. Lexington, KY, Apr. 9, 1980.