Lucia LaBoy-Apseloff

Clinical Research Consultant, Ohio Clinical Trials Associates LLC

EDUCATION Central CT State University – BA in Biology and concentration in Chemistry - 1989 PROFESSIONAL SUMMARY Clinical Trials Management Budget Negotiation and Management Development of timelines to Meet Corporate Milestones Strategic and Operational Planning QA Due-diligence Audits Monitoring of Clinical Trials SOP Development Planning, Implementation and Execution of Clinical Studies – All Phases Supervision, evaluations and training Serious Adverse Event Reporting More than seventeen years of industry experience in all clinical phases with 8+ years in Phase 1. Therapeutic areas of experience include phase 1 (PK, PD), infectious diseases, endocrinology, gastroenterology, urology, rheumatology, women's health, neuropsychiatry, pediatrics, oncology/immunology, cardiovascular medicine, pulmonary medicine, pain and methodology. EMPLOYMENT HISTORY Quintiles Inc., Overland Park, KS September 2007 – October 2008 Clinical Study Manager Assisting in the management of clinical trials, including oversight of personnel, report preparation, and coordination and resolution of key clinical issues. Interdisciplinary management Facilitating discussions of project issues across and within research and development departments as well as with sponsors. Assess project needs, such as resource allocation, time and event planning for clinical development, and interaction between non-clinical and clinical research. Prologue Research International February 2007 – September 2007 Manager, Site Operations In charge of a team of 5 people responsible for regulatory files compilation, completion, review, maintenance, archiving Ohio Clinical Trials Associates, LLC, Columbus, OH September 2001 – February 2007 Sole Owner and Independent Consultant Clients: Novo Nordisk, Inc, Prologue International, MedImmune Vaccines, AlgoRx Pharmaceuticals, Boehringer-Ingelheim, Purdue Pharma LP, and Pfizer Inc. Contracts: Clinical study monitoring Overseeing all phases of clinical research studies in multiple therapeutic areas. Monitoring activities include site selection visits, initiation, interim monitoring visits, and site close-out visits. Clinical project management Assisting in the management of clinical trials, including oversight of personnel, report preparation, and coordination and resolution of key clinical issues. Multidisciplinary project management Facilitating discussions of project issues across and within research and development departments. Assess project needs, such as resource allocation, time and event planning for clinical development, and interaction between nonclinical and clinical research. Pfizer Global Research and Development, Groton, CT March 1992 – September 2001 CRA I, CRA II and Sr. CRA (Phases 1, 2, 3 and 4) Planned, coordinated and managed studies in all phases Audited for due-diligence in product licensing Developed, reviewed and wrote protocols Conducted project team meetings Reviewed budgets, cost estimates and specifications Conducted site selections Planned and conducted investigators’ meetings Prepared and conducted presentations Managed study sites and CROs Developed informed consent form templates Reviewed regulatory documentation Provided national and international sites with study resources Managed sites to achieve recruitment goals Personnel training and troubleshooting Ensured regulatory document compliance Familiarized sites/CROs' staff with protocols and data collection Designed and CRFs Co-monitored with domestic and international CROs Developed and maintained study tracking tools Reviewed labs and safety data for significant patterns Completed serious adverse event reports Conducted and reported on site monitoring visits Managed study files National Medical Research Corporation – Hartford, CT October 1991 – March 1992 Clinical Research Associate (Phases 3 and 4) Monitored clinical trials Assisted in the preparation of study documents to conduct and implement clinical trials Provided technical and scientific guidance to study site personnel Acted as liaison with sponsors’ representatives to implement and maintain clinical trials as per SOPs Directed the tracking of enrollment rates Received and reviewed completed CRFs and grant documentation Prepared monitoring trip reports and draft status reports for sponsors Determined the needs and adequacy of all clinical trial supplies Maintained drug accountability American Distilling and Manufacturing, Inc. – East Hampton, CT January 1990 – October 1991 Assistant Laboratory Director COMPUTER LITERACY: Microsoft Excel, Microsoft Word, PowerPoint AUXILLIARY SKILLS: Fluent in Spanish (native language) AFFILIATIONS: Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP PUBLICATIONS: Apseloff G, Foulds G, LaBoy-Goral L, Kraut E, Vincent J. Severe neutropenia caused by recommended prophylactic doses of rifabutin. Lancet 1996;348:685. Apseloff G, Foulds G, LaBoy-Goral L, Vincent J. Severe neutropenia and prophylactic doses of rifabutin. Invited reply to a letter. Lancet 1996:348:1593. Apseloff G, Foulds G, LaBoy-Goral L, Willavize S, Vincent J. Comparison of azithromycin and clarithromycin in their interactions with rifabutin in healthy volunteers. J Clin Pharmacol 1998;38:830-5. Foulds G, LaBoy-Goral L, Wei GC, Apseloff G. The effect of azithromycin on the pharmacokinetics of indinavir. J Clin Pharmacol 1999;39:842-6. Apseloff G, Bao X, LaBoy-Goral L, Friedman H, Shah A. Practical considerations regarding the influence of the menstrual cycle on leukocyte parameters in clinical trials. Am J Ther 2000;7:297-302. Shah AK, LaBoy-Goral L, Scott N, Morse T, Apseloff G. Pharmacokinetics and safety of oral eletriptan during different phases of the menstrual cycle in healthy volunteers. J Clin Pharmacol 2001;41:1339-44. Wilner K, LaBoy L, LeBel M. The effects of cimetidine and antacid on the pharmacokinetic profile of sildenafil citrate in healthy male volunteers. Br J Clin Pharmacol 2002;53 Suppl 1:31S-6S ABSTRACTS Vincent J, Foulds G, Apseloff G, LaBoy-Goral L, Gerber N. Interaction of rifabutin (RIF) with the macrolides azithromycin (AZM) and clarithromycin (CLA). 36th ICAAC, 1996. Vincent J, Agin M, LaBoy-Goral L, Hunt T, Carlson J, Apseloff G, Kuye O. The effect of dosing with food and bedtime dosing on the incidence of dizziness with trovafloxacin in young, healthy, female subjects. 38th ICAAC, 1998. Shah AK, Friedman DL, Morse TM, LaBoy-Goral L, Hinkel CA, Silber M, Apseloff G, Friedman HL. Evaluation of methods for rapid screening of CYP2D6 status using dextromethorphan as a probe in normal, healthy subjects. aaps PharmSci Suppl, 1(1):S-32, 1998. Foulds G, LaBoy-Goral L, Hunt T. Pharmacokinetic interaction between azithromycin (AZM), and fluconazole (FL). Fourth International Conference on Macrolides, Azalides, Streptogramins and Ketolides, Barcelona, Spain, January 21-23, 1998. No. 5.05: 53. Foulds G, LaBoy-Goral L, Wei G, Apseloff G. Effect of azithromycin (AZM) on the pharmacokinetics of indinavir (IND). Fourth International Conference on Macrolides, Azalides, Streptogramins and Ketolides, Barcelona, Spain, January 21-23, 1998. No. 5.04: 53.