Robert Dann Email & Phone Number

Medical writing• Designed two phase 1 protocols for a start-up company for the detection (using PET imaging with a novel radiopharmaceutical) and treatment of pancreatic cancer • Wrote multiple SOPs for two drug companiesWrote Clinical Study Report for Phase 1 studyWrote Clinical Protocol for Phase 2 studyWrote Investigator's Brochure for Phase 2 studyWrote Radiopharmacy Manual for Phase 2 studyClinical trial monitoring• Monitored a phase 1 pharmacokinetic trial evaluating a novel treatment for myeloproliferative neoplasms and a phase 3 trial evaluating a new treatment for rare neuroendocrine tumors – one of my sites underwent an FDA inspection that resulted in no 483 and no negative findings• Monitored two phase 3 trials for a new treatment of lymphoma and leukemia• Conducted multiple qualification visits in the US and Canada for multiple indications

Wilmington, Nc, Us

• Principal CRA on two Phase III multicenter studies evaluating the efficacy and safety of a new treatment for treatment-naïve HIV patients• Unblinded monitor of a central clinical laboratory for two pharmacokinetic trials

Bedford, Massachusetts, Us

• Director-level position managing PET (positron emission tomography) imaging trials• Developed clinical site database of over 2700 sites offering PET myocardial perfusion imaging • Primary responsibility for coordination of 100 clinical sites and 25 radiopharmacies in the U.S., Canada, Brazil, and Finland • Reviewed and approved all final documents (study manuals, protocols, procedures, training manuals)

• Selected an independent safety monitor (ISM) and wrote ISM charter for Company• Developed business plan and SOPs for provincial (Alberta, Canada) Phase 1 oncology unit• Audited English- and French-speaking clinical sites participating in the Phase 3 trial of a CT contrast agent and wrote clinical study reports and SOPs for several companies

Bedford, Nh, Us

• Managed and monitored clinical trials of three radiopharmaceuticals for radioimmunotherapy in lung cancer, non-Hodgkin’s lymphoma and multiple myeloma; radiopharmaceuticals for cardiovascular and oncologic diagnoses; cardiovascular therapeutic drug; and contrast agent for ultrasound-enhanced characterization of liver lesions

• Responsible for the clinical development of five radiopharmaceuticals, covering both diagnostic imaging and therapeutic applications (DVT, Pulmonary embolism, Non-small-cell lung cancer, Bone pain palliation, and Coagulation disorders)

• Supervised two large-scale sepsis trials, as well as advised and guided a biotechnology company through its first clinical trial

• Managed the writing of the PLA for ReoPro, as primary author of the safety sections of the integrated summary and individual study reports, and as supervisor of the senior CRAs who authored other study reports - approved for marketing by FDA• Wrote the Phase 3 study report and the Integrated Summary of Safety of the PLA for ReoPro, a drug subsequently approved to prevent post-angioplasty re-stenosis• Wrote large portions of the protocols for the Phase 3 DVT imaging trials, analyzed the data, and wrote the final study report • Analyzed data, wrote reports, and presented findings for ovarian cancer imaging trial to senior management

Philadelphia, Pa, Us

• Constructed a computerized atlas of the human brain and designed the structure of a software package to elastically match the atlas with tomographic images of the brain (PET, CT, MRI, SPECT) • Managed the clinical operation of the Positron Emission Tomography (PET) Center, taught statistics and research methodology to radiologists and nuclear physicians, and wrote grant applications and clinical manuscripts• Performed many of the earliest PET human studies and detected a previously unsuspected chemical impurity in the major PET radiopharmaceutical through inference from the data• Analyzed data, wrote manuscripts, and presented study results at national and international meetings

• Helped develop innovative surgical techniques, including hypothermia and cardiac transplantation and took call as a circulating nurse in the hyperbaric operating room

Bachelor Of Science - Bs, Humanities And Chemistry

Neuroanatomy

Comparative Literature

Licentiate Degree, Comparative Literature