- ABOUT US
Who We Are
Altreos Research Partners is a Toronto-based scientific and regulatory consulting group focused on CNS-active drugs and nicotine products. The group helps sponsors design, execute, and defend abuse potential and clinical pharmacology programs from early development through marketing authorization.
The partners have deep experience across CNS drug classes, including opioids and abuse-deterrent formulations, stimulants, sedatives, cannabinoids, hallucinogens, dissociatives, and nicotine or tobacco products. Their work spans Phase 1 to 3, with a strong emphasis on human abuse potential studies, CNS clinical pharmacology, and substance use disorder programs.
- ABOUT US
Meet The Team
Naama Levy-Cooperman, Ph.D.
Dr. Levy-Cooperman has over 12 years experience in CNS drug development, behavioral and neurocognitive assessment, and evaluation of abuse liability, including involvement in the design and analysis of over 30 clinical studies. Dr. Levy-Cooperman has presented her research internationally and has a number of peer-reviewed research papers. Dr. Levy-Cooperman completed her Ph.D. in Neuroscience from the University Of Toronto Institute Of Medical Science. Dr. Levy-Cooperman’s previous research interests were in cognitive neurology and neuroimaging in neurodegenerative disorders. Dr. Levy-Cooperman then joined INC Research (formerly DecisionLine CRC and Kendle) in 2008 as a research scientist, was promoted to Scientific Business Development Liaison in 2010 and then Sr. Scientist in 2012. At INC Research, Dr. Levy-Cooperman was responsible for design and critical review of abuse liability and clinical studies, expert opinion in behavioral and neurocognitive assessment, and regulatory and legal scientific support.
Dr. Levy-Cooperman was also involved in the development and marketing of a novel brain network mapping technology for use in Phase I studies. As a founding partner of Altreos Research Partners, Dr. Levy-Cooperman continues her work in abuse liability by providing scientific and regulatory consulting, medical writing, and assessment of abuse potential of new molecular entities (NMEs) and abuse-deterrent formulation (ADFs).
Dr. Levy-Cooperman was also involved in the development and marketing of a novel brain network mapping technology for use in Phase I studies. As a founding partner of Altreos Research Partners, Dr. Levy-Cooperman continues her work in abuse liability by providing scientific and regulatory consulting, medical writing, and assessment of abuse potential of new molecular entities (NMEs) and abuse-deterrent formulation (ADFs).
Kerri A. Schoedel, Ph.D.
Dr. Schoedel has extensive experience in clinical pharmacology, CNS drug development, and the assessment of abuse liability in preclinical and clinical studies, including the design and analysis of over 50 human abuse potential studies. Dr. Schoedel has contributed to over 100 research and review articles, book chapters, and national/international scientific presentations, primarily in abuse liability and CNS drug development. Dr. Schoedel is also a member of the College on Problems of Drug Dependence, and regularly organizes and participates in meetings with regulatory agencies to advance abuse liability methodology. Dr. Schoedel completed her Ph.D. in Pharmacology at the University of Toronto, with a specialization in nicotine addiction. Dr. Schoedel joined INC Research (formerly Ventana/DecisionLine CRC and Kendle) in 2004 as a research scientist, was promoted to Scientific Director in 2008 and Sr. Director, Clinical Pharmacology in 2013.
At INC Research, Dr. Schoedel directed the Clinical Pharmacology group, lead strategic planning and was responsible for study design and support for scientific projects, including clinical studies (human abuse potential, safety/tolerability, pharmacokinetics, thorough ECG, and neurocognition). Dr. Schoedel has been involved in the preparation of numerous NDA and EMA drug abuse liability submissions, including those related to both NMEs and ADFs, and has interacted extensively with regulatory agencies.
At INC Research, Dr. Schoedel directed the Clinical Pharmacology group, lead strategic planning and was responsible for study design and support for scientific projects, including clinical studies (human abuse potential, safety/tolerability, pharmacokinetics, thorough ECG, and neurocognition). Dr. Schoedel has been involved in the preparation of numerous NDA and EMA drug abuse liability submissions, including those related to both NMEs and ADFs, and has interacted extensively with regulatory agencies.
Megan J. Shram, Ph.D.
Dr. Shram has 15 years of experience in addiction research, and extensive knowledge in clinical pharmacology and abuse liability assessment. Dr. Shram received her M.Sc. and Ph.D at the University of Toronto with specialization in Behavioral Pharmacology, during which she evaluated age and sex differences in response to various drugs of abuse. Her preclinical experience enables her to provide valuable input in the design and interpretation of animal abuse potential studies. Dr.
Shram joined INC Research in 2007 (formerly DecisionLine CRC and Kendle), as a Research Scientist and was promoted to Sr. Scientist. During that time, she was involved in the design, management and analysis of over 40 human abuse potential and other clinical studies, primarily within the CNS area. She has also assisted in developing comprehensive abuse liability programs for NMEs and ADFs. Dr. Shram’s combined preclinical and clinical experience facilitates preparation of regulatory documents, including NDA and EMA drug abuse liability submissions. Dr. Shram is also an adjunct professor of Pharmacology at the University of Toronto, has published numerous research articles in peer-reviewed journals and regularly presents at scientific meetings. At Altreos Research Partners, Dr. Shram continues to provide advice to pharmaceutical and biotech companies developing CNS products, with a particular focus on assessment of abuse liability and abuse deterrence.
Shram joined INC Research in 2007 (formerly DecisionLine CRC and Kendle), as a Research Scientist and was promoted to Sr. Scientist. During that time, she was involved in the design, management and analysis of over 40 human abuse potential and other clinical studies, primarily within the CNS area. She has also assisted in developing comprehensive abuse liability programs for NMEs and ADFs. Dr. Shram’s combined preclinical and clinical experience facilitates preparation of regulatory documents, including NDA and EMA drug abuse liability submissions. Dr. Shram is also an adjunct professor of Pharmacology at the University of Toronto, has published numerous research articles in peer-reviewed journals and regularly presents at scientific meetings. At Altreos Research Partners, Dr. Shram continues to provide advice to pharmaceutical and biotech companies developing CNS products, with a particular focus on assessment of abuse liability and abuse deterrence.
- ABOUT US
How We Work with Sponsors
Altreos works as an extension of internal clinical and regulatory teams, not as a large generalist CRO. Engagements are led and executed by senior PhD-level scientists who stay directly involved in the details of each program.
Support typically includes:
- Program-level consulting on CNS and abuse potential strategy
- Design, endpoint selection, and interpretation of human abuse potential and clinical pharmacology studies
- Structured review of existing data to identify risks, gaps, and opportunities
- Preparation of health authority briefing materials, meeting strategy, and written responses
- Authoring of protocols, clinical study reports, 8-factor analyses, and submission-ready summaries and overviews
Work is tailored to the questions, timelines, and constraints of each sponsor, with clear, evidence-based recommendations that reflect current regulatory expectations for CNS-active and abuse-liable products.