Michael L. Corrado, MD - Chief Executive Officer
Over the last twenty years, Dr. Michael Corrado has established himself as an infectious disease expert in the pharmaceutical industry. After spending eight years with Merck and eight years with Johnson & Johnson, Dr. Corrado partnered with Howard Solomon to found Advanced Biologics in 1995. He has been intricately involved in the complete development of numerous infectious disease compounds, from pre-clinical work through to marketing application submission. Dr. Corrado has served as Primary Medical Author of six NDAs, five sNDAs, and several expert reports submitted to European regulatory bodies. Included in the impressive list of infectious disease compounds he has worked on are norfloxacin, ofloxacin, levofloxacin, chibroxin, Mefoxin®, Primaxin®, Pneumovax®, Renova®, Ultram®, and an AIDS test kit. Dr. Corrado has numerous publications and presentations to his credit and is a member of the IDSA - FDA Anti-infective Guidelines Committee. He is also a reviewer of anti-microbial agents and chemotherapy for the Archives of Internal Medicine.
Howard F. Solomon, PhD - Chief Operating Officer
Dr. Howard Solomon has nearly 20 years of experience in the pharmaceutical industry. He spent eight years on the faculty at Loyola College in Baltimore, before moving on to Merck and Johnson & Johnson. During his eight years at Merck, Dr. Solomon was involved in the development of Mevacor® (cholesterol lowering), Fosomax® (osteoporosis), Proscar® (benign prostatic hyperplasia), Propecia® (hair growth), and MK-801 for stroke. He also established a first-of-its-kind pharmaceutical Research Imaging Department at Merck. Dr. Solomon went on to spend five years as Assistant Director of Research Imaging at the R.W. Johnson Pharmaceutical Research Institute where he was involved in radiodiagnostic, CNS, cardiovascular, and immunomodulator research. In 1995, he co-founded Advanced Biologics with Dr. Michael Corrado. He has published over 100 articles and abstracts in the areas of immunology, nuclear medicine, drug delivery, infectious disease and gastroenterology.
Michael J. Napoliello, MD, MBA - Senior Medical Monitor, CNS Operations
Dr. Michael Napoliello has studied and worked in the pharmaceutical industry for over 25 years. Dr. Napoliello is currently Senior Medical Monitor, CNS Operations at Advanced Biologics and has been working closely with Advanced Biologics over the past year in developing specific clinical CNS strategies. Dr. Napoliello’s experience includes executive leadership in Clinical Research and Worldwide Medical Affairs with Yamanouchi, USA and Bristol-Myers Squibb. In the early 1990s, he held responsibility for all CNS Medical Planning for BMS and prior to that was Scientific Director of CNS Products and Director of CNS Clinical Investigation. Dr. Napoliello’s extensive background and knowledge in CNS drug development provides invaluable awareness and direction to our clinical CNS team.
Louis Boccumini, MS - Executive Director, Clinical Operations
Lou Boccumini began his work in pre-clinical pharmaceutical development in 1981. He has been focused in clinical research over the past ten years, initially in Proof of Principle studies across several therapeutic areas, bridging pre-clinical and clinical development for new chemical entities (NCEs). Lou joined Advanced Biologics in 1996 and is currently Executive Director of Clinical Operations, specializing in the clinical development of anti-infective drugs in numerous indications. Lou’s leadership and organizational skills were further refined during a 21-year career as an officer in the Army Reserve. Lou continues to deliver an extremely focused and educated clinical team with the ability to conduct professional and accurate clinical trials.
Kimberly Cheshire-Kinney - Director, Clinical Operations
Kimberly Cheshire-Kinney has held a wide range of clinical operations positions during her 13 years in the pharmaceutical industry. Kim joined Advanced Biologics in 2001 as a Project Manager, was promoted to Associate Director in 2001 and subsequently promoted to Director of Clinical Operations in 2003. In her current role as Director, Kim heads up Advanced Biologics’ Clinical Operations group specializing in CNS, oncology, cardiovascular diseases, women’s health, and vaccines. Kim began her career in oncology discovery as a biologist where she had the rare opportunity of taking a compound from mouse to man. Early in her career, she was a CRA for programs in infectious diseases, oncology, and sepsis. Later, her career involved a management position with a global pharmaceutical company as a CRO liaison. Kim also spent time developing web-based clinical capabilities designed specifically for CROs. Her breadth of experience, dedication, and process management skills are a key asset to Advanced Biologics where she is responsible for the leadership and supervision of a dynamic team of clinical researchers.
Susan McLaughlin, MS - Director, Data Services
Sue McLaughlin became Director of Data Services for Advanced Biologics in 2007. In this role, she oversees all aspects of Data Administration, Data Management, Application Development, and Clinical Programming. She has a Masters Degree in Quality Assurance and Regulatory Affairs from Temple University and is a member of ACRP (Association of Clinical Research Professionals) and ASTD (American Association of Training and Development). Prior to coming to Advanced Biologics, Sue was the Director of Worldwide Education and Training for DIA (the Drug Information Association). Before her position at the DIA, she worked for the Johnson and Johnson family of companies, progressing from Technical Data Processor to the Manager of Data Processing, at first McNeil Pharmaceutical, and then as the Manager of International Data Management, Biostatistics & Research Data Services at the R.W. Johnson Pharmaceutical Research Institute (PRD). Her last assignment at J&J was in the Central Safety & Surveillance group as the Senior Manager. Sue’s extensive experience both as a manager of large groups and with hands on data processing is a tremendous asset to Advanced Biologics.
Patricia A. Rudolph - Assistant Director, Clinical Programming
Patricia Rudolph joined Advanced Biologics in 1998 as a Lead Clinical Programmer. She currently oversees a staff of twelve Clinical (SAS) Programmers. Pat has worked in programming for such companies as American Cyanamid, Colgate-Palmolive, Wallace Laboratories, and most recently, the RWJ Pharmaceutical Research Institute, where she was Manager of Scientific Programming. She did her undergraduate work in biology at Trenton State College and has numerous post-graduate credits in such areas as statistics and computer science. Pat’s areas of therapeutic expertise are cardiology, CNS, and infectious disease.
Kem Phillips, PhD - Technical Consultant, Biostatistics
Kem Phillips has provided his statistical expertise to the pharmaceutical community for over 20 years. He spent two years with the FDA as a Statistician in the Division of Biometrics before moving on to spend ten years with Pfizer, Inc. as Senior Associate Director of Biometrics. He then began consulting to provide statistical services to various companies in the industry, one of which was Advanced Biologics. Kem joined Advanced Biologics full-time in 1999 as the Director of Biostatistics, and today he continues to assist pharmaceutical and biotech companies in the clinical development of various compounds in many therapeutic areas via his role as Technical Consultant. Kem has proven his ability to manage key aspects of a trial including planning, analysis and reporting of data. His areas of expertise include pharmacokinetics, CNS, and infectious disease, and he has been author or co-author of a number of publications. Kem’s understanding of Biostatistics in the clinical process is an essential element to providing quality clinical research.
Annie Frimm - Senior Director, Regulatory Affairs
Annie Frimm brings 25 plus years of pharmaceutical experience to her position as head of regulatory affairs at Advanced Biologics. Annie has held positions at several major pharmaceutical companies, including 20 years at Merck Co., as well as at ALZA and Syntex/Roche. Annie has particular expertise in regulatory compliance and global submissions. She is responsible for all regulatory activities within Advanced Biologics, including regulatory documentation collection for all clinical studies conducted by Advanced Biologics. Her areas of therapeutic expertise include anti-rheumatics, anti-infectives, genitourinary, gastrointestinal, cardiovascular and women’s health products. Annie’s strong managerial and leadership skills complement her ability to develop effective client relationships that have ensured customer satisfaction for all activities conducted within her functional area.
Phoebe Strome, MS - Associate Manager, Medical Writing
Phoebe Strome joined Advanced Biologics mid-2004. She has a strong 6-year track record for writing clear and concise clinical documents, including clinical study reports (Phase I-Phase IV), appropriate sections of INDs and NDAs, other summary documents, and annual updates. Her responsibilities also include contributing to statistical analysis plans concerning organization and table layout and reviewing summary tables and data listings for document preparation. Her therapeutic areas of expertise include CNS, Infectious Disease, Dermatology, Oncology, Immunology, and Women’s Health. Her experience prior to clinical writing includes pre-clinical writing for submissions, pharmaceutical industry pre-clinical R&D, and academic research. She holds degrees from Gettysburg College (BA) and the University of Massachusetts (MS). Phoebe is a member of AAAS and the Middle Atlantic Society of Toxicologists.
