I am the President and CEO of Aztec Nutraceuticals Inc, a home business that I founded in 2014 to advance the commercial interests of my patents for a new nutritional treatment for unipolar depression. I obtained a European Union patent in 2014 and am currently pursuing the U.S. patent for this novel approach, which is based on a successful clinical study I performed while an Assistant Professor of Psychiatry at the Harvard Medical School.With 20 years of experience in clinical development and neuroscience research, both in academia and industry, I have directed and designed clinical studies in multiple indications, ranging from Phase I to Phase IV, and have gained extensive regulatory experience. I have also collaborated with key opinion leaders, vendors, and multidisciplinary teams in various neuroscience projects. My mission is to bring innovative and effective solutions to people who suffer from psychiatric and neurological illnesses.
Aztec Nutraceuticals Inc: Home Business
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President And CeoAztec Nutraceuticals Inc: Home BusinessBedford, Ma, Us
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President & CeoAztec Nutraceuticals Inc: Home Business Apr 2014 - Present• Obtained European Union patent 2014 for a new treatment for unipolar depression. • Pursuing U.S. patent.• Pursued activities to advance the commercial interests of my patents.• Currently, designing preclinical, pharmacokinetic and/or biomarker studies as follow-up to the positive open clinical study in unipolar depression I performed at Harvard.• Home business activities will not interfere with a full-time position.
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Medical DirectorForum Pharmaceuticals Inc. Aug 2013 - Apr 2014Director, Clinical Development• Directed two pivotal Phase III studies in Cognitive Impairment Associated with Schizophrenia (CIAS) within multidisciplinary teams, working in close collaboration with Pharmacokinetics, Statistics, Safety, Regulatory, Clinical Operations, KOLs and vendors. • Directly involved in recruitment and management of Investigators for the large global Phase III studies. • Directly involved in improvement of study subject recruitment, selection and management. • Chief Medical Monitor overseeing CRO Medical Monitors for the global Phase III studies. • Developed multiple blinded study data metrics to monitor quality of the Phase III data. • Direct involvement in Phase I study design and protocol development, as well as necessary Investigator and KOL consultations. • Primary author in development of a novel Phase IIa Proof-of-Concept (POC) study for schizophrenia indication. • Primary author in development of a Phase IIb study for difficult to study schizophrenia indication. • Constructed clinical development plans with specific GO-NO GO criteria for compounds in CNS indications. • Key role in selecting new indications for existing compounds in development, in collaboration with preclinical scientists, others in Clinical Development, Commercial and Regulatory. • Direct involvement in generating initial submissions and responses to queries for regulatory authorities in the U.S. and worldwide. • Provided education for study Investigators at Investigator Meetings and for Site Monitors at in-house seminars.
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Director, Clinical DevelopmentForest Research Institute Aug 2011 - Aug 2013Jersey City, Nj, Us• Participated in the design, and wrote and directed Phase IIb and Phase III clinical studies for multiple indications in psychiatry (schizophrenia, bipolar, depression, anxiety) within multidisciplinary teams, working in close collaboration with Pharmacokinetics, Statistics, Safety, Regulatory, Clinical Operations, KOLs and vendors. • Developed multiple blinded study data metrics to monitor quality of the Phase IIb data, and determined minimal clinically meaningful improvement necessary for positive study by in-depth analyses of all public competitor studies. • Was the supervising Medical Monitor overseeing in-house and CRO Medical Monitors for the global Phase IIb and Phase III studies. • Directly involved in improvement of study subject recruitment, selection and management. • Direct involvement in generating initial submissions and responses to queries for regulatory authorities in the U.S. and worldwide. • Central role in determining that proposed new psychiatric diagnosis should not be pursued as a new indication for existing product, in collaboration with preclinical scientists, others in Clinical Development, Commercial and Regulatory. Provided education for study Investigators at Investigator Meetings and for Site Monitors at in-house seminars. -
Associate Director, NeurosciencePfizer, Inc Apr 2008 - Jul 2011New York, New York, Us• Worked closely within multidisciplinary teams of preclinical scientists, Clinical Medicine, Pharmacokinetics, Statistics, Safety, Regulatory, Commercial and Clinical Operations, as well as KOLs and vendors, for Phase I and Phase IIa studies for compounds developed for CNS indications, such as Alzheimer’s Disease (symptomatic and disease-modifying compounds), autism, bipolar disorder, CIAS, depression and schizophrenia.• In Translational Medicine, was responsible for developing plans for Proof-of-Mechanism for an average of 10 compounds at a time, and designed, wrote and directed many preclinical and Phase 1 healthy volunteer studies to establish Proof-of-Mechanism via biomarkers. Responsible for designing, writing and performing Methods studies for biomarkers new to the company.• In Clinical Medicine, participated in the designs, and wrote and directed Phase I First-in-Human single and multiple dose, Phase I First-in-Patient, and Phase IIa POC studies. • Prepared clinical development plans for compounds across multiple CNS indications. • Collaborated in evaluation of in-licensing opportunities.• Was Medical Monitor for multiple clinical studies across multiple CNS indications.• Managed collaborations with Investigators, KOLs, academic institutions and foundations. -
Director Of Affective Disorders ResearchCambridge Health Alliance Jul 2005 - Apr 2008Assistant Professor at the Harvard Medical School.Wrote and directed Phase 2, 3 and 4 psychopharmacological studies for affective disorder patients, as well as collaborated in studies in schizophrenia and anxiety disorders. Developed a new treatment for unipolar depression utilizing nutritional supplements, (U.S. patent filed and European patent approved). Sought IRB approval for studies under my direction, and served as IRB member. Provided evaluation and ongoing treatment of outpatients suffering from psychiatric disorders, specializing in the evaluation and care of bipolar disorder patients. Taught psychiatry residents, including yearlong lecture series on psychopharmacology and yearlong lecture series psychiatric research methods.
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Medical Director, Cahill 3 Inpatient UnitCambridge Health Alliance Jan 2002 - Jul 2005Assistant Professor at the Harvard Medical School.Supervised a 17 bed locked inpatient psychiatry unit in a public hospital caring for the seriously mentally ill. Reduced average length of stay from 28 days to 12 days with no increase in readmission rates and no increase in post-discharge suicide attempt rates. Evaluated and cared for psychiatric inpatients. Taught and supervised psychiatry residents, Harvard Medical School students and social work interns in patient care, case conferences and psychopharmacology lectures.
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Chief Of PsychiatryQuincy Medical Center Dec 2000 - Dec 2001UsAssociate Professor, Boston University School of Medicine.Supervised a 20 bed locked inpatient geriatric psychiatry unit, outpatient geriatric partial program, and outpatient geriatric psychiatric care. Initiated programs for evaluating and improving quality of care. Initiated programs for psychiatry resident and medical student rotations in psychiatry. Taught psychiatry residents, including lecture series on psychopharmacology. -
Acting Chief Of PsychiatryBoston Veterans Affairs Medical Center Feb 2000 - Dec 2000Associate Professor, Boston University School of MedicineSupervised two 28 bed locked inpatient psychiatry units and numerous outpatient psychiatry clinics. Contributed significantly to regional VA hospital strategic planning. Initiated successful programs to reduce assaults committed on inpatient units. Taught psychiatry residents, including lecture series on psychopharmacology.
Robert Dunn Skills
Robert Dunn Education Details
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The University Of Chicago Pritzker School Of MedicineMedicine; Pharmacology & Physiology -
Boston UniversityBiology And Psychology
Frequently Asked Questions about Robert Dunn
What company does Robert Dunn work for?
Robert Dunn works for Aztec Nutraceuticals Inc: Home Business
What is Robert Dunn's role at the current company?
Robert Dunn's current role is President and CEO.
What schools did Robert Dunn attend?
Robert Dunn attended The University Of Chicago Pritzker School Of Medicine, Boston University.
What skills is Robert Dunn known for?
Robert Dunn has skills like Psychiatry, Medicine, Psychopharmacology, Neuropharmacology, Phase I Iv Clinical Trials, Translational Medicine, Pre Clinical Studies, Clinical Trials, Cro, Clinical Development, Drug Discovery, Life Sciences.
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