susan shelby

Clinical Affairs and Regulatory consultant for the bio-pharmaceutical industry. Deep experience in clinical R&D, synthesizing non-clinical results to design FIH-phase II POC clinical research programs, and mitigating risks. Adept at design/execution/oversight/analysis of phase III-approval stage development. Experienced at writing, executing, and defending protocols, clinical investigative plan, IBs, CSRs, PSURs, and other CTD documents. Responds to emergent program issues. Response to FDA drug audits, clinical holds, FDA/EMA compliance, submissions planning, clinical, and/or regulatory questions. Can identify capable vendors and manage CROs to expected outcomes. Handles and resolves complex issues by applying drug development expertise, deep clinical research and operations knowledge, and submissions and approval experience.

Design, plan, and execute clinical research trials in therapeutic areas of analgesia, and antiinflammatory/CNS. Lead multidisciplinary team from pre-IND through design of clinical trials and early phase III. Research and development liaison with Medical Affairs: publications, investigator-initiated studies, phase IIIB/phase IV.

Head of Clinical Research for oncology and HIV projects. Design and develop clinical research (protocols, IND submissions, other regulatory submissions), and oversee clinical operations work with CROs. Identify and organize advisory board meetings with clinical experts, and communicate clinical results with senior management and FDA.

As Senior Medical Director, Head of the Pain/CNS Business Unit for Medical Affairs at Jazz Pharmaceuticals, Dr. Shelby continued her medical research interests in developing opioid alternatives for patients with severe chronic pain. Leadership of medical science liaison professionals group. Overall strategic lifecycle planning and execution for phase IV studies, CME, investigator-initiated studies, publications, and advisory boards related to products.

Write clinical regulatory submissions documents for end of phase II meeting packets, and for Common Technical Documents (CTDs) and New Drug Applications (NDA). Infectious disease and backup in oncology.

* Project manager, project leader, and clinical research director for a morphine sulfate drug and synthetic corticosteroid compound. * ·Chairperson of the development team for assigned compounds (two), writing strategic development plan, study designs, and clinical budget. * ·Facilitated design of clinical studies (phase IIIB trials, post approval obligations; phase IV; phase I) for AVINZA® to explore unique study populations, to gather data on differentiating features of AVINZA®, and to fulfill safety obligations. Including budgets, resourcing, CRO selection, etc. * ·Developed AVINZA®’s sNDA program for a new indication (sleep disorder). * ·Key member of the publication team. Planned and co-wrote, within Ligand 5 manuscripts which were available for product launch. Analyzed clinical results, wrote up study results for trade meetings. * ·Designed clinical development program with clinician for NME in rheumatoid arthritis and won internal approval of IND program.

Responsible for managing the San Diego office of PPD. Supervised 6 direct reports (from Sr. CRA to Project Manager to other Associate Directors of Clinical Operations) and 25 clinical research professionals. ·Responsible for finalizing the clinical portion of an NDA for oncology agent (SnET2-a photodynamic therapy agent) for a client company (worked with and directed staff of 6 for 4 months at client company). ·Responsible for an international $10.7 million phase IIIb glaucoma study with 23 sites. This study exceeded enrollment objectives and finished early and within budget. ·Directly managed Phase IIIb program (2 protocols) for a burn device, with a total of 14 sites. Co-monitored sites in California, and developed investigator relationships. ·Envisioned, wrote business plan for and started up office of 90 clinical ops staff in San Francisco.

Biomedical Systems is a premier global provider of centralized diagnostic services. Founded in 1975, Biomedical Systems is a leading clinical trial provider to pharmaceutical, medical device, biotech, and contract research organizations (CROs). Our comprehensive clinical trial solutions include cardiac safety, pulmonary function, imaging, electronic clinical outcome assessment (eCOA), and scientific affairs. Biomedical Systems' corporate headquarters is located in St. Louis, Missouri. Our European headquarters is located in Brussels, Belgium with supporting offices in Japan, China and India. Please send inquiries to info@biomedsys.com or call +1.800.877.6334 or +32.2.661.2070.

Activities and Societies: Leading 2 week backpacking trips for incoming freshmen in the Sierra Nevadas.

Crystallographic and biochemical analysis of enzyme mutations resulting in Amyotrophic Lateral Schlerosis (Lou Gehrig's Disease). Understanding the molecular basis of medicine. Activities and Societies: Phi Beta Kappa, House of Germany, Society of Fellows

Activities and Societies: Work with local high school teacher to create video of how vision works. Society of Fellows. Toastmaster's Public Speaking Club - 15 speeches.