Court filing
Exhibit B — USA v. Edwards et al (Dkt. 49.2)
Filed January 6, 2023 in USA v. Edwards et al; one of 112 filings from this case.
Record facts
| Court | U.S. District Court for the Middle District of Florida |
|---|---|
| Filed | 2023-01-06 |
Full text
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
ADDRESS
Psychiatric Affiliates, P.A.
2300 Maitland Center Parkway, Suite 211
Maitland, Florida 32751
Phone (407) 679-6400 Fax (407) 679-7988
CERTIFICATION
Diplomate, National Board of Medical Examiners, July 1, 1983
American Board of Psychiatry and Neurology:
Board Certified in Psychiatry, July 1988
Board Certified in Forensic Psychiatry, December 1994
Recertified April 2013 – Meeting MOC Requirements
Board Certified in Geriatric Psychiatry, October 1995
Recertified April 2015 – Meeting MOC Requirements
Board Certified in Addictions Psychiatry, April 1997
Recertified December 2017 – Meeting MOC Requirements
LICENSURE
Florida Medical License ME 49703
PROFESSIONAL
Premedical: Harvard College, Cambridge, Massachusetts, B.A. Biology,
Graduated June 1978, Magna Cum Laude with Highest Honors in Biology
Medical: University of Miami School of Medicine, Miami, Florida,
Graduated May 1982, Medical Honor Society – Alpha Omega Alpha
Internship: Washington University/Barnes Hospital, St. Louis, Missouri,
Psychiatry, July 1982 through June 1983
Residency: Washington University/Barnes Hospital, St. Louis, Missouri
Psychiatry, June 1983 through June 1986
Faculty: One-year appointment as Chief Resident and Faculty Instructor
Washington University/Barnes Hospital, Department of Psychiatry,
St. Louis, Missouri, July 1986 through June 1986
PRIVATE PRACTICE
Psychiatric Affiliates, P.A., Maitland, Florida
Adult, Geriatric, and Forensic Psychiatry, December 1989 - Current
Florida Psychiatric Associates, Winter Park, Florida
Adult, Geriatric and Forensic Psychiatry, July 1987 - December 1989
POSITIONS HELD
Ali A. Kashfi, M.D., P.A.
Orlando, Florida
Principal Investigator
2013 – 2014
Florida Clinical Research Center, LLC (formerly CORE Research)
Maitland, Florida
Investigator
2008 – 2011
Functions as, or under the direction of, the Principal Investigator
for assigned studies performing medical oversight for study subjects.
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 2 OF 9
UPDATED JUNE 2020
CORE Research INC
Maitland, Florida
Medical Director
2004 – 2007
Winter Park Hospital
Winter Park, Florida
Medical Director, Psychiatric Unit
1996 – 2000
University of Central Florida
Orlando, Florida
Consultant, Student Health Services
1997 – 1999
John E. Polk Correctional Facility
Sanford, Florida
Contracted Psychiatrist
1997 - 1999
Winter Park Hospital
Winter Park, Florida
Medical Director, Medical-Psychiatric Unit
1995 – 1999
University Behavioral Center
Orlando, Florida
Medical Director, Adult Services
1993 – 1998
Health Management Associates
Naples, Florida
Corporate Medical Director of Psychiatric Services
1993 – 1997
West Lake Hospital
Longwood, Florida
Director, Psychiatric Intensive Evaluation Unit
1991 – 1993
Winter Park Memorial Hospital
Winter Park, Florida
Director, Special Medical Unit
1990 - 1991
La Amistad Foundation (Psychiatric Services)
Fern Park, Florida
Medical Director
1989 – 1991
Winter Park Pavilion
Winter Park, Florida
Director, Mood Disorder Unit
1989 – 1991
Florida Psychiatric Associates
Winter Park, Florida
Assistant Medical Director
March 1989 – Dec 1989
Florida Psychiatric Associates
Winter Park, Florida
Adult, Geriatric and Forensic Psychiatry Private Practice
1987 – 1989
Washington University/Barnes Hospital, Department of Psychiatry
St. Louis, Missouri
Chief Resident and Instructor in Psychiatry (Faculty)
1986-1987
HONORS AND AWARDS
Orlando Magazine – Top Doctors 2001, 2002, 2003, 2004, 2005, 2006, 2008, 2011, and 2012
Orlando Magazine – The Best 70 Doctors in Central Florida 2000
Guide to America’s Top Physicians – 2003, 2004 & 2008
Doctors Across America – Top Doctors 2002
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 3 OF 9
UPDATED JUNE 2020
Florida Monthly Magazine – Florida’s Top Doctors 2002
Selinsky Award (Outstanding Medical Student in the field of psychiatry) 1982
o Guttenberg Prize: 1978
o Outstanding Senior Research Project, Mather House, Harvard College
FORENSIC PSYCHIATRY
Testimony and written opinions given on civil and criminal matters in Federal, Circuit and County
Courts: Middle District Court of the United Sates and the State of Florida counties of:
Orange, Seminole, Osceola, Volusia, Brevard, Lake, Polk, Miami-Dade,
St. Johns, Collier, Columbia & Escambia Counties, as well as Federal Court.
INVESTIGATOR EXPERIENCE
Attention-Deficit/Hyperactivity Disorder
A Randomized, Double-blind, Placebo-controlled, Phase II Dose-Ranging Study of the Safety and Efficacy of XXX in
Adults with ADHD
An Open Label, Dose Titration, Long Term Safety Study to Evaluate XXX in Adults with ADHD
A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group, Forced Dose Titration, Safety
and Efficacy Study of XXX in Adults with Attention-Deficit Hyperactive Disorder
A Long Term Open Label and Single Arm Study of XXX in Children ages 6-12 with ADHD
A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group, Safety and Efficacy Study of
XXX with an Open-Label Extension in Adolescents with Attention-Deficit Hyperactivity Disorder (ADHD)
A Phase III, Multi-center, 12-Month, Open-Label Safety Study of XXX in Adults with Attention-Deficit Hyperactivity
Disorder
A Phase III, Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group, Safety and Efficacy Study of
XXX in Adults with Attention-Deficit Hyperactivity Disorder (ADHD)
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-Ranging Study of the Safety and
Efficacy of XXX in Adults with Attention Deficit-Hyperactivity Disorder
The Long-Term Safety and Tolerability of XXX in Adults with Attention Deficit-Hyperactivity Disorder: An Open-
Label Extension Study
A Double-blind, Randomized, Multi-center, Flexible Dose Study Evaluating the Efficacy and Safety of XXX in
Children Aged 6-12 with Symptoms of Oppositionality and a Diagnosis of Attention Deficit- Hyperactivity Disorder
A Prospective, Open-Label, Multi-center, Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of
XXX in Children aged 6-12 Diagnosed with ADHD
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 4 OF 9
UPDATED JUNE 2020
Anxiety
An Eight-Week, Multi-center, Randomized, Double-blind, Placebo-controlled Study, With XXX as an Active Control,
To Evaluate the Efficacy, Safety and Tolerability of a XXX in Patients with GAD
A Multicenter Randomized, Double-blind, Parallel Group, Placebo-controlled, Active Controlled Study of the Efficacy
And Safety of Sustained Release XXX Compared With Placebo in the Treatment of Generalized Anxiety Disorder
A Comparison of XXX, XXX Extended Release, and Placebo in the Treatment of Generalized Anxiety Disorder
The Efficacy of XXX as Adjunctive Therapy in Subjects with Insomnia Related to Generalized Anxiety Disorder
An Eight Week, Double-blind, Placebo-controlled, Multi-center Study with XXX as Positive Control, Evaluating the
Efficacy, Safety, Tolerability of a Fixed Dose of XXX in outpatients with Generalized Anxiety Disorder (GAD)
A Multi-center Randomized, Double-blind, Parallel-group, Placebo-controlled, Active-Controlled Study of the Efficacy
and Safety of Sustained Release XXX Compared with Placebo in the Treatment of Generalized Anxiety Disorder
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of XXX
Extended-Release Compared with Placebo as an Adjunct to Treatment in Patients with Generalized Anxiety Disorder
who Demonstrate Partial or No Response to a Selective Serotonin Reuptake Inhibitor or Serotonin-Norepinephrine
Reuptake Inhibitor Alone or in Combination with a Benzodiazepine
Bipolar Disorder
A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept, Phase II Study to Evaluate the Efficacy and Safety
of once a day. TAK-375 SL 0,1 mg, 0.4 mg, and 0.8 mg as an Adjunctive Therapy to Treatment-as-Usual in the
Maintenance Treatment of Bipolar I Disorder in Adult Patient
A Randomized, Double-blind, Placebo-controlled, Proof-of-Concept, Phase II Study to Evaluate the Efficacy and Safety
of Once a Day, TAK-375 (Ramelteon) Tablet for Sublingual Administration (TAK-375SL Tablet) 0.1 mg, 0.4 mg, and
0.8 mg in the Treatment of Acute Depressive Episodes Associated with Bipolar I Disorder in Adult Patients who are on
Lithium and/or Valproate
A Confirmatory, Multi-center, Double-blind, Randomized, Placebo-controlled Study of the Use of XXX in the
Treatment of Patients with Bipolar Depression
A Randomized, Double-blind, Placebo-controlled, Multi-center Study To Evaluate The Efficacy And Tolerability Of
XXX in the Treatment of Manic Episodes Of Bipolar Disorder Over 3 Week, and 52 Week, Open Label Extension
Study to Evaluate the Safety and Tolerability of XXX in the Treatment of Manic Episodes of Bipolar 1 Disorder
A Multi-center, Randomized, Parallel-group, Double-blind, Phase IV Comparison of the Efficacy and Safety of XXX to
Placebo as Adjunct Therapy to Mood Stabilizers (XXX or XXX) in the Treatment of Bipolar I Disorder and Alcohol
Dependence in Adult Patient Receiving Treatment for 12 Weeks
Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Research Study to Evaluate the Safety and
Efficacy of XXX in Patients with Acute Mania in Bipolar Disorder
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 5 OF 9
UPDATED JUNE 2020
A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Response, Multi-center Study to Evaluate the
Efficacy and Safety of Three Fixed Doses of Extended Release XXX in the Treatment Of Subjects with Acute Manic
and Mixed Episodes Associated with Bipolar I Disorder
A Multi-center, Randomized, Parallel-group, Double-blind, Phase III Comparison of the Efficacy And Safety of XXX to
Placebo When Used as Adjunct to Mood Stabilizers in the Maintenance Treatment of Bipolar I Disorder in Adult
Patients
A Phase IIIb, Randomized, Double-blind, Parallel-group Study in Bipolar I Patients to Assess the Efficacy and Safety of
XXX Administered Once-Daily vs. Twice-Daily in the Treatment of Manic Symptoms
A Phase IIIb, Open-Label Observational Safety Study of Extended-Release XXX Used in Combination with Other
Psychotropic Medications for the Treatment of Bipolar I Disorder
An International, Multi-center, Double-blind, Randomized, Parallel-group, Placebo-controlled, Phase III Study of the Efficacy and
Safety of XXX and XXX as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and XXX in Continuation
Treatment for 26 up to 52 weeks
Efficacy of XXX in Combination with XXX or XXX in the Treatment of Manic Patients with Bipolar I Disorder
Partially Nonresponsive to XXX or XXX Monotherapy
A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, Phase III Study of the Efficacy and
Safety of XXX Sustained Release as Monotherapy in Adult Patients with Acute Bipolar Depression
A Phase III, Randomized, 6-Month, Double-blind Trial in Subjects with Bipolar I Disorder to Evaluate the Continued
Safety and Maintenance of XXX Plus a Mood Stabilizer (versus Placebo Plus a Mood Stabilizer) Following a Minimum
of 2 months of Response to Open Label Treatment with Both Agents
A Multi-center, Randomized, Parallel-group, Double-blind, Phase IV Comparison of the Efficacy and Safety of XXX to
Placebo as Adjunct Therapy to Mood Stabilizers in the Treatment of Bipolar I Disorder and Alcohol Dependence in
Adult Patient Receiving Treatment for 12 Weeks
Controlled Trial of Safety and Efficacy of XXX Versus Placebo in Patients with Bipolar Depression
Controlled Trial of XXX versus Placebo in Patients with Bipolar Disorder in Manic or Mixed States
Depression
A Phase II, Multicenter, Double-blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-
ranging Efficacy and Safety Study of XXXX in Combination with an Antidepressant in the Treatment of Adults with
Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant 2012
A Phase III, Open-label, Multi-center, 12-month Extension Safety and Tolerability Study of XXXX in Combination with
an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Residual Symptoms or Inadequate
Response Following Treatment with an Antidepressant 2012
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study to Evaluate the
Efficacy and Safety of XXXXXXX (1 and 3 mg/day) as Adjunctive Treatment in Elderly Patients with Major
Depressive Disorder with an Inadequate response to Antidepressant Treatment 2013
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 6 OF 9
UPDATED JUNE 2020
A Multi-center, Double-blind, Parallel Group, Fixed Dose, 4-Arm, Placebo and XXX Controlled 8 Week Efficacy Study
of 2 Oral Doses of XXX in Adult Outpatients With MDD
A Multi-center, Double-blind, Randomized, Parallel-group, Placebo-controlled and Active Controlled Phase III Study of
the Efficacy and Safety of XXX Sustained Release as Monotherapy in the Treatment of Patients with Major Depressive
Disorder
A Multi-center, Randomized, 30- To 52 -Week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy,
Safety, and Tolerability of XXX in the Prevention Of Relapse or Recurrence of Depressive Symptoms in Outpatients
with Major Depressive Disorder Who Maintained Clinical Stability After an Initial Response to Open-label Treatment
With XXX
An Eight Week, Multi-center, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability
of One Fixed-dose of XXX in Subjects with Major Depressive Disorder
A Randomized, Double-blind, Placebo-controlled Study of XXX in the Treatment of Patients with Bipolar I Disorder
with a Major Depressive Episode
An Extension to A Randomized, Double-blind, Placebo-controlled Study of XXX in the Treatment of Patients with
Bipolar I Disorder with a Major Depressive Episode
A Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of XXX as Adjunctive
Therapy in the Treatment of Patients with Major Depressive Disorder
A Ten Month Open Label Evaluation of the Long Term Safety of XXX SR in Outpatients with Major Depressive
Disorder
A Multi-center Randomized Double-blind Placebo-controlled Parallel-group Efficacy and Safety Study if a Flexible
Dose of XXX SR in Adult Outpatients with MDD
An Eight Week, Multicenter, Double-blind, Placebo-controlled Study of XXX in Elderly Outpatients with Major
Depressive Disorder
Weekly Enteric-Coated XXX vs. Daily XXX or Placebo in the Continuation Treatment of Major Depressive Disorder
XXX Alone and In Combination with XXX vs. Placebo in Major Depressive Disorder With Psychotic Features
A Double-blind, Randomized, Multicenter, Parallel Design Study to Evaluate The Efficacy and Safety of Three Dose
Ranges of a Novel Agent Vs. Placebo and Active Control in Outpatients with Major Depressive Disorder
A Double-blind Study, XXX vs. Placebo, in Child and Adolescent Major Depressive Disorder
A Double-blind Study, XXX vs. Placebo and Active Control, in Major Depressive Disorder
A Multi-center, 10-Week, Randomized, Double-blind, Placebo-controlled, Flexible Dose Outpatient Study of XXX in
Child/Adolescent Major Depressive Disorder
A Fixed-dose Comparison of the Safety and Efficacy of XXX, XXX and Placebo in Major Depressive Disorder
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 7 OF 9
UPDATED JUNE 2020
A Placebo-controlled Evaluation of the Safety and Efficacy of XXX in the Presentation of Relapse in Major Depressive
Disorder
A Double-blind, Placebo-controlled Efficacy Study of XXX vs. Active Control in Producing Remission in Outpatients
with Major Depressive Disorder
Evaluation of the Safety and Efficacy of XXX in the Prevention of Recurrence in Major Depressive Disorder
A Phase IIB, Six-Week, Double-blind, Placebo-and XXX-Controlled Multi-center Study to Evaluate the Safety and
Efficacy of an Oral XXX in Outpatients with Major Depressive Disorder
A Seven-Week, Double-blind Extension Of A Phase IIB Six-Week, Double-blind, Placebo- And XXX-Controlled
Multi-center Study to Evaluate the Safety and Efficacy of an Oral XXX In Outpatients with Major Depressive Disorder
A Double-blind, Multi-center, Placebo-controlled, Acute and Extension Study of Two Doses of XXX in Major
Depressive Disorder
A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Phase III Study of the Efficacy and Safety
of XXX as Mono-therapy in the Treatment of Adult Patients with Major Depressive Disorder
An Eight-Week, Multicenter, Double-blind, Placebo-controlled Study Evaluating the Efficacy, Safety and Tolerability of
One Fixed 100 mg Dose of XXX in Patients with Major Depressive Disorder
An Eight-week, randomized, Double-blind, Fixed-dosage, Placebo-controlled, Parallel-group, Multi-center study of the
Safety and Tolerability of XXX in the treatment of Major Depressive Disorder (MDD) followed by a 52-week open-
label extension
A Multi-center, Double-blind, Parallel Group, Fixed Dose, 4-arm, Placebo and XXX-Controlled 8 Week Efficacy Study
of 2 Oral Doses of XXX in adult outpatients with Major Depressive Disorder
A Multi-center, Randomized, 8-week Double-blind Acute Phase Followed by a 6-month Continuation Phase (Open-
label or Double-blind) Study to Evaluate the Efficacy, Safety, and Tolerability of XXX versus XXX in Post-Menopausal
Women with Major Depressive Disorder
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy of XXX in Patients with Major Depressive
Disorder
XXX versus Placebo in Patients with Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD
A Phase IIa, Multi-center, Randomized, Double-blind, Double-dummy, and Placebo- and Active-Controlled Study to
Investigate the Safety and Efficacy of XXX Administered to Subjects with Major Depressive Disorder
A Double-blind, Randomized, Placebo-controlled Study Examining, the Safety, Efficacy, and Tolerability of XXX in
Subjects with Major Depressive Disorder (including Atypical and Melancholic Features)
An Eight-Week, Double-blind study to evaluate the efficacy, Safety and Tolerability of Two Fixed Doses of XXX Once
Daily in combination with XXX once daily compared to placebo in combination with XXX once daily in patients with
Major Depressive Disorder
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 8 OF 9
UPDATED JUNE 2020
Insomnia
A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel Groups, Efficacy and Safety Extension Study of
XXX in the Treatment of Adult Outpatients with Primary Insomnia
A Comparison of XXX vs. Placebo in the Treatment of Insomnia Associated with Newly Diagnosed Major Depressive
Disorder (MDD) or Untreated MDD Relapse, When Used Concomitantly with Escitalopram
A Long-Term Safety and Efficacy Study of XXX in Elderly Subjects with Primary Chronic Insomnia
Efficacy and Safety of 2 mg/day of XXX on Sleep Maintenance Insomnia with a Sub-Study of the effect of XXX on
Stable Type II Diabetes Mellitus: a 12 week Multi-center, Randomized, Double-blind, Placebo-controlled Study
A 6-Month, Double-blind,Rrandomized, Placebo-controlled, Parallel-group Out-Patient Trial, Investigating the Efficacy
and Safety of XXX in Adult Patients with Chronic Primary Insomnia
Schizophrenia
A Randomized, Double-blind, Placebo-controlled, Parallel, 26-Week, Phase 3 Study of 2 Doses of an Alpha-7, Nicotinic
Acetylcholine Receptor Agonist (EVP-6124) or Placebo as an Adjunctive Pro-cognitive Treatment in Schizophrenia
Subjects on Chronic Stable Atypical Antipsychotic “Therapy,” Protocol No. EVP-6124-016, (“Protocol”) to be
Conducted at Institution and to Involve Trial Subjects (“Trial”)
A Multi-center 26-Week Extension Study to Evaluate the Safety and Clinical Effects of Prolonged Exposure to 1 and
2 mg Doses of EVP-6124, an Alpha-7 Nicotinic Acetylcholine Receptor Agonist, as an Adjunctive, Pro-cognitive
Treatment in Subjects with Schizophrenia on Chronic Stable Atypical Antipsychotic “Therapy,” Protocol
No. EVP-6124-017, (“Protocol”) to be Conducted at Institution and to Involve Trial Subjects (“Trial”)
Efficacy of High Dose XXX in A Controlled Fixed Dose Response Trail for Treatment of Schizophrenia and
Schizoaffective Disorders
A Double-blind, Randomized, Multi-center, Parallel-group Design Study to Evaluate the Safety and Efficacy of Two
Dose Ranges of a Novel Antipsychotic Agent vs. Placebo and Active Control in Schizophrenia
A Double-blind, Five-Armed, Fixed-dose, Active- And Placebo-controlled Dose Finding Study with Sublingual XXX in
Subjects with Acute Phase Schizophrenia
Allelic Variations in Schizophrenia
Other Indications
Double-blind, Placebo-controlled Trial of XXX in Panic Disorder, 12-Weeks, With a Continuation Phase
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate a Novel Agent in Patients with
Probable Alzheimer’s Disease of Mild to Moderate Severity
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Range Finding Study to Evaluate
the Safety and Efficacy of Four Doses of XXX in Patients with Social Phobia
CURRICULUM VITAE
Jeffrey A. Danziger, M.D.
PAGE 9 OF 9
UPDATED JUNE 2020
A 12-Week, Randomized, Double-blind, Placebo-controlled, Flexible Dose Study of XXX in Social Anxiety Disorder
A Double-blind, Randomized, Parallel-group, Active- and Placebo-controlled Study to Evaluate the Safety and Efficacy
of XXX in Social Phobia
Open-Label Trial of XXX in Obsessive-Compulsive Disorder
Open-Label XXX Continuation Study
Multi-center, Parallel-group, Double-blind, Placebo-controlled, Dose Ranging Study of the Efficacy and Tolerability of
XXX in the Prophylaxis of Migraine Headache and Open Label Extension
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