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About Lifetree - Who We Are Our Philosophy Executive Management Team: Alice A. Jackson, R.N. Lynn R. Webster, MD, FACPM, FASAM Matthew Iverson Sean Kotrady, CCRC, CCRP Neuroscience Research Team: Miroslav "Misha" Bačkonja, MD Mark A. Johnston, MD N. Lee Smith, MD Daniel B. Vine, MD Mary Jane Norman, MD Dennis Thoen, MD Debra F. Hobbins, DNP, APRN, LSAC, CARN-AP
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Industry Thought Leaders in Human Abuse Liability (HAL)

Lifetree Clinical Research® is a global leader in abuse liability research, pioneering new methodologies, study designs, and following through with precise execution, made possible by years of experience with this subject population. As thought leaders, we are committed to understanding the evolving regulatory environment and have regular interaction with the US FDA regarding the abuse liability of drugs in the marketplace and research strategies that may help us to understand the relative risk of abuse before a drug comes to market. We attend the relevant Advisory Panel Meetings and strive to make certain that client programs are aligned with the most current guidance documentation available for consideration in human abuse liability study design and execution, as well as current regulatory thinking on risk management.

One of our studies was a key component in a milestone 2008 NDA submission (EMBEDA™ (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules for oral use - CII ). A landmark approval was granted in August 2009 of this first drug product to contain labeling information regarding abuse liability.

Dr. Lynn Webster, the Medical Director of Lifetree, is uniquely qualified to address problems of abuse and addiction with pain medicine: Dr. Webster is Board Certified in Pain Medicine and certified in Addiction Medicine. His daily clinical practice and research interests are at the crossroads where abuse liability, and the shadow it casts on medical practice, is having the greatest impact on patient care. Dr. Webster is recognized as an expert by his peers in this emerging field and has many publications and presentations to his credit. He has also met with the FDA on behalf of clients and in thought-leader forums.

Dr. Debra Hobbins serves as the Executive Research Scientist for Lifetree Center for Neuroscience Research. Dr. Hobbins received her Doctor of Nursing from the University of Utah and is a seasoned nurse practitioner of over 25 years. She is board certified as an Addictions Nurse Practitioner and is a Licensed Substance Abuse Counselor (LSAC). She has been working in the field of addiction for over 10 years and is an expert in the management of medication-assisted treatment utilizing methadone and Suboxone and opioid withdrawal. Dr. Hobbins serves on several local and state committees and has received many awards for excellence in clinical practice.

Lifetree provides complete consulting services for your product candidate, grounded on the most recent FDA recommendations, including:

  • Protocol design
  • Selection of abuse liability assessment tools to fit pharmacologic class
  • Optimizing design for best use of subjects and effective evaluation of endpoints
  • Selection of comparator drugs
  • Determining methods of dosage form “manipulation” if necessary (crushing, grinding, dissolving)
  • Selection of and rationale for primary and secondary endpoints
  • Determination of sample sizes
  • Recruitment and enrichment strategies to ensure best target population

Abuse Liability data is now considered a critical piece of information during the NDA review process for most CNS drugs and having clinical data is a significant positive. Any sponsor working in these fields is strongly encouraged to understand the full impact of recent regulatory decisions, including those from Advisory Committees, FDA guidance documents, relevant IMPACT-X publications, etc., and take those factors into careful consideration as early as possible in designing a full clinical development program. Lifetree’s experience in the field and our commitment to maintaining a leadership position means you get the best, the most recent, and the RIGHT thinking. Lifetree has the people, the knowledge and the drive to deliver what you need, when you need it.