Longmont LifeScience Thursday July 20, 2006; Guest Panel to Discuss “A Road Map”: Taking Drugs from IND Stage Through Phase III Clinical Trials
The Longmont Area Economic Council sponsors the Colorado BioScience Association's (CBSA) (www.cobioscience.com) Longmont LifeScience Thursday on July 20, 2006 from 3:30 p.m. until 6:00 p.m. at the Radisson Conference Center in Longmont, at 1900 Ken Pratt Blvd. The event will feature four experts who will present A Road Map: Taking drugs from the IND stage through phase III clinical trials.
Longmont, CO (PRWEB) July 12, 2006 -- The Longmont Area Economic Council (www.longmont.org) is proud to sponsor the Colorado BioScience Association's (CBSA) (www.cobioscience.com) Longmont LifeScience Thursday on July 20, 2006 from 3:30 p.m. until 6:00 p.m. at the Radisson Conference Center in Longmont, at 1900 Ken Pratt Blvd. The event will feature four experts who will present A Road Map: Taking drugs from the IND stage through phase III clinical trials.
Presenters will include Brenda Fielding, president and head of regulatory affairs at Regulus Pharmaceutical Consulting, Dr. David Apelian, vice president of clinical development and regulatory affairs and chief medical officer at GlobeImmune, Dr. Ali Said Faqi, director of development and reproductive toxicology at MPI Research and Dr. Dorothy Colagiovanni, toxicologist at Replidyne.
The estimated cost of new drug development is between $900 million and $1 billion per drug. Candidate compounds that fail in clinical trials due to drug toxicity or lack of clinical efficacy are the main reasons for high cost failures. Recently, the U.S. has had to withdraw marketed drugs due to unexpected drug toxicity not found during nonclinical and clinical safety trials. It is widely known that most candidate compounds fail during drug development either because they exhibit unacceptable drug toxicity or because they lack efficacy in human use. This process of taking drugs from the investigational new drug (IND) stage through phase III clinical trials is the topic of the symposium. The guest panel will present a “road map” on regulatory requirements, clinical protocol development, IRB review, data analysis, supportive toxicology and pharmacology studies, and potential pitfalls.
Registration begins at 3:30 p.m., the program starts at 4:00 p.m., and a cash bar reception and networking starts at 5:00 p.m. CBSA members may attend at no cost. Non-member admission is $50, and a student discount is available. To register, visit www.cobioscience.com, and click on "CBSA Events."
Longmont LifeScience Thursday, held each quarter, began in 2003, and is designed to provide information and networking opportunities for those interested in the life science industry, including those involved or interested in biotechnology, medical devices, ag biotech, pharmaceuticals, research institutions and life science industries. The Longmont Area Economic Council is a founding sponsor of the event and John Cody, LAEC President, serves on the CBSA Program Committee. Denise Brown, Executive Director of CBSA, has been instrumental in developing new programs for the Association and raising its profile in Colorado.
This program is also sponsored by Cooley Godward LLP.
Guest Panel Bios
Brenda Fielding, President and Head of Regulatory Affairs, Regulus Pharmaceutical Consulting
Fielding has more than 20 years experience in the pharmaceutical and biotechnology industry, primarily in the area of drug regulatory affairs. She is a graduate of the University of London, UK, and has held management positions with a number of pharmaceutical companies. See www.reguluspharma.com.
David Apeliean, Vice President Clinical Development and Regulatory Affairs and Chief Medical Officer, GlobeImmume
Dr. Apelian’s therapeutic area experience includes inflammatory bowel disease, hepatitis C and hepatitis B. Dr Apelian came to GlobeImmune from Bristol-Myers Squibb where he was a clinical director in its infectious diseases group and served as the medical lead for clinical development for the entecavir NDA filing for chronic hepatitis B. Previously, he served as clinical director in the department of Hepatology/ Gastroenterology, at Schering Plough where he was medical lead on the pediatric sNDA for Rebetron for chronic HCV. Dr. Apeliean received his doctorate in biochemistry from Rutgers University, his doctorate of medicine from the University of Medicine and Dentistry of New Jersey and Masters of Business Administration from Quinnipiac University. He completed his residency in pediatrics at New York Hospital, Cornell Medical Center and is a board certified Pediatrician. See www.globeimmune.com.
Ali Said Faqi, Director of Development and Reproductive Toxicology, MPI Research
Dr. Ali Said Faqi is the Director of Development and Reproductive Toxicology at MPI Research in Kalamazoo, Michigan. Prior to joining MPI Research he was a senior scientist at IITRI in Chicago, Illinois and Allergan Pharmaceuticals in Irvine, California. Dr. Faqi is also an adjunct professor at the University Palermo, Italy. Dr. Faqi received his Doctorate of Veterinary Medicine from the Somali National University in Mogadishu, Somalia and diploma of specialization in experimental pharmacology at the University of Milan in Italy. He received his doctorate from the University of Leipzig in Germany. He worked as t a postdoctoral fellow/research scientist at the Free University of Berlin, in Germany, Thomas Jefferson University in Philadelphia and Morehouse School of Medicine in Atlanta. See www.mpiresearch.com.
Dorothy Colagiovanni, Toxicologist, Replidyne
Dr. Colagiovanni is a toxicologist at Replidyne, Inc., in Louisville, Colorado, working in novel antibiotic development. Before working at Replidyne, Dr. Colagiovanni was a research investigator at OSI Pharmaceuticals where she was involved in development of targeted cancer therapeutics and managed the toxicology group, which conducted GLP compliant studies for regulatory submissions. Previous to OSI, Dr. Colagiovanni worked for Amgen in the area of immunotoxicology assessment of novel proteins and at Gilead Sciences in the anti-infectives division. Dr. Colagiovanni received her bachelor’s of science degree in medical technology from the University of Vermont. She received her doctorate in molecular toxicology from the University of Colorado Health Sciences Center, and she is board certified as a diplomat of the American Board of Toxicology. Dr. Colagiovanni has written numerous toxicology articles to support IND submissions and investigator’s brochures. See www.replidyne.com.
About the Colorado BioScience Assocation
The Colorado BioScience Association is a not-for-profit corporation providing services and support for Colorado’s growing biosciences industry. Colorado is embarking on an aggressive plan to grow the state’s bioscience industry into one of the country’s premier bioscience clusters. CBSA enjoys the support of over 200 member organizations representing a range of bioscience companies dedicated to solving problems and developing products as well as companies providing key services to the bioscience industry and research institutions. CBSA works closely with the state and local policy makers to represent the interests of the bioscience industry. A critical component for Colorado to become one of the country’s top bioscience clusters is a supportive legislative and regulatory environment. The Colorado BioScience Association actively works to achieve these results. For more information, call (303) 592-4073, email CBSAInfo@cobioscience.com, or visit www.cobioscience.com.
About the Longmont Area Economic Council
The Longmont Area Economic Council, which is celebrating its 25th year, exists for the sole purpose of keeping the Longmont area economy strong. This is accomplished specifically by "actively supporting the creation and preservation of quality primary jobs." Primary employers are those who sell the majority of their goods and services outside the region. LAEC is a public/private partnership, governed by a Board of Directors made up of representatives from primary employers, the City of Longmont, and the business community at large. For more information, call (303) 651-0128, email laec@longmont.org, or visit www.longmont.org.
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