Christopher Carlson Email & Phone Number

Indianapolis, In, Us

New York, New York, United States

Responsible for identifying, evaluating, shaping, executing and managing innovative investment opportunities for ADDF's therapeutic pipeline through interactions with biotech and biopharma companies, academic institutions venture firms and other stakeholders from the life science industry ecosystem for potential investment opportunities. Responsible for conducting all scientific/technical due diligence to ensure in-depth understanding of the science behind each opportunity.

Pittsburgh, Pa

• Provided scientific guidance for the clinical development of iltamiocel, Autologous Muscle Derived Cells for female and male stress incontinence indications• Developed clinical study designs and facilitated transition of projects to clinical operations• Assisted in development of clinical report forms and eDC systems• Participated in preparation and development of phase 3 protocols, statistical analysis plans and data output formats (Tables Figures and Listings) and regulatory documents including leading the annual updates to Investigator Brochures and Developmental Safety Update for Regulatory• Supported Clinical Safety through medical review of adverse event MedDRA coding, laboratory data and WHO drug concomitant medication information. Generated and presented the yearly update for the Data Safety Monitoring Board.• Participated in preparation and review of all study-related documents, plans, training materials• Lead efforts in analysis, interpretation, presentation and reporting of clinical efficacy and safety data including development of clinical publication and communication strategies by authoring manuscripts and presentations at the American Urology Association and the International Continence Society meetings.• Provided training to both internal and field-based teams• Worked with cross-functional teams (regulatory, business units, etc.) to evaluate new clinical study strategies• Provided oversight of CRO (IQVIA) responsible for statistical analysis and outputs• Developed and maintained relationships with physician experts • Participated in medical education and scientific exchange to enhance product and disease state knowledge and track developments and trends in current treatment strategies• Assisted Cook MyoSite in receiving a FDA Regenerative Medicine and Advanced Therapeutics (RMAT) designation for the treatment of women who have recurrent or persistent symptoms following surgery for stress urinary incontinence

Indianapolis, In

• Provided medical input and support for development, implementation, monitoring, analysis, interpretation and reporting of global Phase III clinical safety and efficacy data from trials of solanezumab• Conducted Trial Level Safety Review, MedDRA Adverse Event Coding review, laboratory data and consultation on patient level medical issues. • Provided medical input for Protocols (Addendum and Amendments), Investigator Brochures, Informed Consent Documents, Clinical Study Reports, Patient Narratives, Clinical Report forms, Statistical Analysis Plans and other right to operate and regulatory documents.• Assisted in development of clinical report forms and eDC systems (Inform)• Prepared and presented materials for Investigator Meetings and Global Steering Committee updates• Responded to queries and requests from clinical sites and Institutional Review Boards/Committees • Consulted on adjudication of protocol deviations and other clinical trial subject issues• Developed and maintained relationships with key opinion leaders to enhance clinical development strategies• Provided oversight and partnering with CRO (Quintiles/IQVIA) and specialty vendors for imaging (Synarc/Bioclinica) and psychometric evaluations (UBC/Bracket) • Authored or co-authored 8 manuscripts, 10 abstracts and 5 poster and slide presentations and presented at international congresses (Alzheimer’s Association International Congress, Clinical Trials in Alzheimer’s Disease, American Academy of Neurology, International Conference on Alzheimer’s and Parkinson’s Diseases and American Academy of Neurology).

Indianapolis, In

• Authored manuscripts, abstracts, poster and slide presentations on global clinical trial data on exenatide (Byetta). Presented posters at American Diabetes Association.• Authored manuscripts, abstracts and poster and slide presentations on global clinical trial data on olanzapine (Zyprexa) for Schizophrenia and atomoxetine (Strattera) for Attention Deficit Hyperactivity Disorder. • Presented posters at congresses (American Psychiatric Association, Society of Biological Psychiatry, European Congress on Neuropsychiatry, World Psychiatric Association, World Congress of Psychiatry)• Aligned with Regulatory Writers to ensure consistency right to operate and regulatory documents.

Ph.D., Pharmacology

Ms, Pharmacology