Expert Details
Detection of Adverse Drug Reactions with a Specialized Focus on Neuropsychiatric Adverse Reactions
ID: 738764
Utah, USA
Expert completed his psychiatry residency at Baylor College of Medicine and a fellowship in psychiatric drug development at Janssen Research & Development. He has also worked as a Medical Officer at the FDA’s Division of Psychiatry Products. His broad experience in clinical, pharmaceutical, and regulatory settings, gives him a comprehensive understanding of risks and benefits of psychiatric medications.
Expert uses his deep knowledge of psychiatry and drug safety to assist in forensic issues concerning neuropsychiatric adverse reactions.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 2020 | Degree: Fellowship in Psychiatric Drug Development | Subject: Psychiatric Drug Development | Institution: Janssen R&D/Drexel College of Medicine |
| Year: 2019 | Degree: Psychiatry Residency | Subject: Psychiatry | Institution: Baylor College of Medicine |
| Year: 2014 | Degree: MBBS (MD) | Subject: Medicine | Institution: University of Queensland |
| Year: 2010 | Degree: BA | Subject: Classical Languages/French | Institution: University of Queensland |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2022 to Present | Employer: Undisclosed | Title: Global Pharmacovigilance Medical Director | Department: Pharmacovigilance |
Responsibilities:- Lead product safety strategy, surveillance, and signaling activities for nirogacestat- Deep understanding of gamma-secretase inhibitors efficacy and safety profile including a strong familiarity with other products in the class and therapeutic space - Lead nirogacestat benefit-risk assessment and presentation to the Safety Review Committee and Global Safety Review Committee and propose actions to mitigate risk - Lead pharmacovigilance representation for nirogacestat clinical development program, including the following: - Strategic advisement on clinical development plans and design of clinical protocols - Responsible for the safety content of IB and ICFs - Responsible for the content of aggregate safety reports and 6-monthly SUSAR line listings - Responsible for the content of NDA submission documents such as the CSR, ISS, and CSS |
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| Years | Employer | Title | Department |
| Years: 2020 to Present | Employer: Undisclosed | Title: Owner | Department: Forensic and Clinical Psychiatric Consulting |
Responsibilities:Forensic Expert Witness:- Subject matter expert on the detection and recognition of adverse behavioral side effects for psychiatric and non-psychiatric products - Consults with law firms and private parties in assessing the role of adverse behavioral side effects for litigation or other hearings Expert in the Management of Neurological Injury Following Benzodiazepine Use - Sees private patients in private practice - Interviewed frequently as a clinical expert in treating this population (See Selected Media Section: https://www.wittdoerringpsychiatry.com/ourphysicians/ ) - Serves on the Medical Advisory Board for the Benzodiazepine Information Coalition and The Alliance for Benzodiazepine Best Practices, both large non-profit organizations that promotes research and recognition of neurological injury following benzodiazepine withdrawal Pharmaceutical Consultant: - Private Consultant for pharmaceutical companies developing treatments for benzodiazepine withdrawal or injury. Provides strategic insight into efficient structure of clinical development program. Provides subject matter expertise on the standard of care in the treatment of benzodiazepine withdrawal |
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| Years | Employer | Title | Department |
| Years: 2020 to Present | Employer: Undisclosed | Title: Medical Director | Department: Emergency Room and Consult Liaison Psychiatry |
Responsibilities:- Promoted to Medical Director in January 2022- Managed 20 direct report psychiatrists working in emergency room and consult liaison settings - Liaised with external medical directors and chief medical officers at over 15 freestanding hospitals and emergency rooms, to ensure efficiency and high quality for the telepsychiatric consultation service - Responsible for the interviewing, hiring and training of new psychiatrists - Engaged in routine consult-liaison psychiatry and emergency room psychiatry |
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| Years | Employer | Title | Department |
| Years: 2020 to 2021 | Employer: Food and Drug Administration | Title: Medical Officer | Department: Division of Psychiatry |
Responsibilities:- Conducted independent assessments of emergent adverse reactions and proposed labelling changes- Served as a subject matter expert for psychiatry for external divisions conducting epidemiologic safety studies - Frequently consulted by other divisions within the agency to assess emergent behavioral adverse reactions of nonpsychiatric compounds - Managed over 20 INDs of different psychiatric compounds by reviewing their protocols, DSURs, PSURs and trial data for emergent safety concerns - Completed a full NDA review, including independent analysis and review of all TEAEs, SAEs, AESI, laboratory analytes, and EKG assessments |
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| Years | Employer | Title | Department |
| Years: 2019 to 2020 | Employer: Drexel College of Medicine | Title: Assistant Professor | Department: Psychiatry |
Responsibilities:Worked as a staff psychiatrist in an outpatient psychiatry clinic |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2020 to 2019 | Agency: FDA | Role: Medical Officer Division of Psychiatry | Description: - Conducted independent assessments of emergent adverse reactions and proposed labelling changes - Served as a subject matter expert for psychiatry for external divisions conducting epidemiologic safety studies - Frequently consulted by other divisions within the agency to assess emergent behavioral adverse reactions of nonpsychiatric compounds - Managed over 20 INDs of different psychiatric compounds by reviewing their protocols, DSURs, PSURs and trial data for emergent safety concerns - Completed a full NDA review, including independent analysis and review of all TEAEs, SAEs, AESI, laboratory analytes, and EKG assessments |
Career Accomplishments
| Associations / Societies |
|---|
| Member, International Society for CNS Clinical Trials and Methodology Member, American Society of Clinical Psychopharmacology Member, American Psychiatric Association |
| Licenses / Certifications |
|---|
| Board Certified in Psychiatry, American Board of Psychiatry and Neurology 2019- present Active Medical Licenses in Maryland, Pennsylvania, Texas, Tennessee, Georgia, Utah, Louisiana, Colorado, and New Mexico Buprenorphine Waiver Training Certificate, American Academy of Addiction Psychiatry 2019 |
| Professional Appointments |
|---|
| Assistant Professor 2019-2020 (Drexel College of Medicine) Medical Advisory Board, Benzodiazepine Information Coalition |
| Awards / Recognition |
|---|
| Gold Humanism Honor Society |
| Publications and Patents Summary |
|---|
| 3 publications 6 presentations |
Additional Experience
| Expert Witness Experience |
|---|
| Have written forensic reports and been deposed on issues concerning adverse reactions to psychiatric medications |