BIOGRAPHICAL INFORMATION

John C. Kapeghian, Ph.D., D.A.B.T.
President, Preclinical Safety Associates
Reno, NV

John Kapeghian is an independent consultant (President, Preclinical Safety Associates; Reno, NV, USA) specializing in preclinical drug development and issues impacting drug safety.  He was formerly head of Charles River’s Navigator Scientific and Regulatory Consulting group, and prior to that, John held several senior management positions at Sierra Biomedical, Inc, an independent contract research organization subsequently acquired by Charles River Laboratories, Inc.  Dr. Kapeghian previously worked for Ciba Pharmaceuticals (now Novartis), heading up regulatory toxicology units, representing preclinical safety on international project teams, and directing their U.S. Experimental Toxicology program.

He received his Ph.D. in pharmacology/toxicology from the University of Mississippi (Oxford campus) and has been board-certified in general toxicology by the American Board of Toxicology since 1985.  John is a member of the American College of Toxicology (ACT), Society of Toxicology (SOT), and International Society for the Study of Xenobiotics (ISSX).  John formerly chaired the Pharmaceuticals Manufacturing Association’s DRUSAFE committee on In Vitro Toxicology.  He currently serves as an Associate Editor for the International Journal of Toxicology.  

John has extensive experience in both small molecule and biologics drug development, biochemical and genetic toxicology, and mechanisms of drug-induced hepatotoxicity.  He has worked on both U.S., Canadian, and European drug regulatory applications, has over 20 years of experience in preclinical safety, and has numerous publications and scientific presentations in the field.

Douglas J. Kornbrust, Ph.D., D.A.B.T.
President, Preclinsight
7245 Lingfield Drive, Reno, NV  89502
Phone: 775-857-4113; Email: preclinsight@charter.net

Doug Kornbrust is currently an independent consultant (President, Preclinsight) living in Reno, NV.  He received a Ph.D. degree in Toxicology from the University of Rochester in 1979, and continued his training as a postdoctoral fellow at the Chemical Industry Institute of Toxicology.  In 1981, he accepted a position at Research Triangle Institute in North Carolina, and later moved to the National Institute of Environmental Health Sciences as a Senior Staff Fellow.

Dr. Kornbrust's career in the pharmaceutical industry began in 1984 with a senior scientist position in the Safety Assessment Group of Merck Research Labs.  While there, he advanced through positions of increasing responsibility and, in 1988, moved to Rhone-Poulenc Rorer (now Aventis-Sanofi) as an Associate Director in the Drug Safety Group. In 1991, Dr. Kornbrust accepted a position as Director of Toxicology for Alliance Pharmaceutical Corp. in San Diego, and then moved to Isis Pharmaceuticals in 1992 as the Director of Toxicology and the Pharmacokinetics & Metabolism Departments.  He joined Sierra Biomedical in late 1994 and served as Senior Vice President and Scientific Director for 9 years.

At present, Doug serves as a consultant for numerous companies in the area of non-clinical product development, with specific expertise in oligonucleotide-based therapeutics, biotherapeutics, and anticancer products.

Laura Andrews, Ph.D.
Vice President of Pharmacology and Toxicology, Genzyme

Laura Andrews is Vice President of Pharmacology and Toxicology at Genzyme where she directs the development programs for therapeutics in Genzyme’s pipeline. She is responsible for the preclinical development programs for therapeutic biologics, gene therapy products, and cell based therapies. Laura oversees the design, implementation and interpretation of the in vivo GLP studies and the in vitro assays to support product development. Laura has authored the pharmacology and toxicology section for several Genzyme INDs and marketing applications in several different territories.

Dr. Andrews received a BS (1983) in Biology and Chemistry from Dickinson College, and a Ph.D. (1987) in Pathology and Cell Biology from Thomas Jefferson University and Medical College in Philadelphia, PA. She holds memberships in the Society of Toxicology (SOT), Society for Toxicologic Pathology and the American College for Toxicology. Laura is on the Board of Directors of the American Board of Toxicology. She was Board Certified in General Toxicology in 1998.

Mark T. Butt, DVM
Diplomate, American College of Veterinary Pathologists
President, Tox Path Specialists, LLC
293 Kenwood Place, Walkersville, MD  21793
Phone: 301-845-0719; Email: mbutt@toxpath.net

Dr. Mark Butt is a 1984 graduate of the veterinary college at Cornell University. After several years of clinical practice, Dr. Butt returned to Cornell in 1988 to complete a residency in anatomic pathology, training under, among other notables, neurologist Alexander deLahunta, neuropathologist Brian Summers and gross pathologist John King. Dr. Butt received his anatomic pathology board certification in 1991 and began work for Ciba-Geigy Pharmaceuticals.

In 1994, Dr. Butt joined Pathology Associates International, where he specialized in the pathology of neuroactive compounds with emphasis on studies involving drugs delivered directly to the central nervous system. In 2001, coincident with the acquisition of Pathology Associates by Charles River Laboratories, he was named General Manager, with complete scientific and financial responsibility for an organization of more than 40 veterinary pathologists and 200 support personnel. During that time, Dr. Butt continued to function as a neuropathologist for many studies in a variety of laboratory species. He has evaluated over 200 studies involving the development of neuroactive compounds in a variety of laboratory species.

In July, 2007, Dr. Butt left Pathology Associates to start Tox Path Specialists, a firm specializing in providing neuropathology and more general pathology support to preclinical studies and other investigational endeavors. He has spoken at many national and international meetings on topics related to the development and safety assessment of neuroactive compounds.

In addition to neuropathology, Dr. Butt is a well known local newspaper and magazine columnist, writing about life and marriage in suburban America. The proceeds from his columns and book have established and continue to support The Mark and Susan Butt Saturday Morning’s Fund, a charitable foundation helping local children in need.

Glenn S. Elliott, DVM, M.S., Ph.D., D.A.C.V.P.
Principal Director, Clinical Pathology
Charles River Laboratories, Nevada

Glenn has specialty training and advanced degrees in small animal oncology (MS, 1984) and clinical pathology (Ph.D., 1989).  Since specialty training, Glenn was Assistant Professor of Clinical Pathology at Kansas State University (2 years) and Staff Clinical Pathologist at DuPont, Haskell Laboratory for Toxicology and Industrial Medicine (8 years).   He joined Sierra Biomedical (a preclinical CRO specializing in primate studies, now part of Charles River Laboratories) in 1998 as Clinical Pathologist and as Director of Pathology.  He has over 15 years experience in the field of clinical pathology; has authored or co-authored more than 20 publications; and chaired a symposium on clinical pathology at the annual meeting of the Society of Toxicologic Pathology.  Glenn regularly consults in matters pertaining to hematology, clinical chemistry, and coagulation for preclinical toxicity assessment.

Gerald R. Galluppi, Ph.D.
Director, Pharmacokinetics, Metabolism, and Pharmacodynamics
Biogen Idec, La Jolla

Dr. Galluppi received BS degrees in Chemistry and Biochemistry at Penn State University, a Ph.D. in Biochemistry at Indiana University, and postdoctoral training in Molecular Biology at the University of Wisconsin. In 1980, he joined the Monsanto Company and helped establish the newly emerging biotechnology program that transformed Monsanto from a chemical company into a biotechnology powerhouse. He led a program in Protein Biochemistry, serving as Senior Research Director. As part of Monsanto’s strategic move into pharmaceuticals, Dr. Galluppi’s department transferred to subsidiary GD Searle Discovery Research and provided capabilities for discovering and developing protein therapeutics in what had been a classical small molecule drug research unit.

In 1996, Dr. Galluppi spent one year on sabbatical leave with the Center for Drug Development Science at Georgetown University, and returned to Searle Preclinical Research to lead a group in Pharmacokinetics and Metabolism as an interface between Discovery and Preclinical Research to identify and develop both small and large molecule drug candidates. Dr. Galluppi has served in a number of leadership roles, including the Searle Research and Development Executive Committee, Corporate Liaison for the Monsanto/Washington University Biomedical Research Agreement, The Steering Committee for a joint venture between Monsanto and Chiron, and he helped redesign the R&D process at Searle and Pharmacia from one of functional separation to a more streamlined, functionally integrated process.

After 23 years in big pharma, Dr. Galluppi consulted for three years with dozens of companies in the biotechnology industry before joining Biogen Idec. In his current position, Dr. Galluppi works in clinical pharmacology on the design, execution, interpretation, and reporting of results from all phases of clinical trials.

Melanie T. Hartsough, Ph.D.
Senior Consultant
Biologics Consulting Group, Inc.

Melanie Hartsough is a Senior Consultant at Biologics Consulting Group, Inc. She utilizes her expertise in the strategy and development of biotechnology-derived products to assist clients with preclinical development of biologics.

Melanie graduated with a B.S. degree in chemistry from Juniata College, Huntingdon, PA in 1991 and received her Ph.D. in Pharmacology from the Pennsylvania State University in 1997.

Immediately upon receiving her Ph.D., Melanie joined the National Cancer Institute, NIH, as a cancer research fellow. Her research focused on identifying protein-mediated signaling mechanisms associated with a metastasis-suppressor protein in breast cancer.

In 2001, she left the laboratory and joined the FDA’s Center for Biologic Evaluation and Research (CBER), Division of Therapeutic Proteins, as a full-time product reviewer. During this time, she performed chemistry, manufacturing and controls (CMC) reviews for biologics/biotechnology-derived products. In 2004, Melanie transferred to the Division of Therapeutic Biological Oncology Products (now Division of Biologic Oncology Products), Center for Drug Evaluation and Research (CDER), as a pharmacology/toxicology reviewer. She was responsible for reviewing the preclinical pharmacology and toxicology data submitted by sponsors to support the safety of clinical trials and, ultimately, the approval of new biological therapeutics.

In 2006, she left the FDA and joined Aclairo Pharmaceutical Development Group, Inc as a consultant, where she aided drug sponsors with small molecule and biologic products with IND submissions (pharmacology/toxicology sections), provided product (CMC) review for biologic products and assisted in the design and interpretation of toxicology studies. In 2007, Melanie left Aclairo and joined the Biologics Consulting Group, Inc.

Jeff Hazelette, Ph.D.
Executive Director and Global Head of Planning and Contracting
Preclinical Safety for Novartis Pharmaceuticals Corporation
East Hanover, New Jersey

Jeff Hazelette is Executive Director and Global Head of Planning and Contracting in Preclinical Safety for Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. In this position, he is responsible for coordinating internal resource allocation and study/project planning, scheduling and tracking to insure optimal resource utilization. In addition, he administers all outsourcing and contract-related activities for Preclinical Safety globally. Beginning in 1983 at Novartis, Jeff worked as a Study Director as outlined in the GLPs for general toxicity studies performed to determine relative safety of either pharmaceutical or agrochemical compounds. Subsequently, Jeff held jobs of increasing managerial responsibility in the toxicology department at Novartis and also for about 2 years for the DuPont Merck Pharmaceutical Company in Newark, Delaware.

Kirk Huber, M.S.
Senior Director, Operations and Process Quality, and Global Head of Compliance
Preclinical Development at Johnson & Johnson Pharmaceutical Research and Development
Raritan, New Jersey

Kirk Huber is currently Senior Director, Operations and Process Quality, and Global Head of Compliance, for Preclinical Development at Johnson & Johnson Pharmaceutical Research and Development in Raritan, New Jersey. His current position encompasses responsibility for preclinical computer systems validation, document and submissions processing, operational/business functions and regulatory compliance, including archives and SOP management.

Prior to joining Johnson & Johnson in 2005, Kirk was Global Head of Exploratory Development GLP Quality Assurance for Novartis Pharmaceuticals Corporation, East Hanover, New Jersey. In this position, he was responsible for the QA GLP operations in the US, Switzerland, France and Japan. Kirk’s career at Novartis started with the former Ciba-Geigy Company in 1982 as an animal technician in Preclinical Safety. Subsequently, Kirk held jobs of increasing responsibility in the Preclinical Safety department at Novartis including 8 years as a preclinical Study Director. He was appointed head of Novartis’ US GLP Quality Assurance in 1995 and global head of GLP QA in 1999.

Kirk received a BS degree in Biology from Muhlenberg College and a MS in biology from Fairleigh Dickinson University.

Kirk is an active member of PhRMA, a former member of the PhRMA Bioresearch Monitoring Steering Committee (BRMC) and DruSafe liaison, current member of the GLP Working Group and chair of BRMC annual workshop.

Debra L. Kirchner, Ph.D., D.A.B.T.
Senior Program Manager
Covance Laboratories, Inc., Madison, WI

Debra is a member of the Program Management Group at Covance Laboratories. This group consists of senior scientific staff and project managers who provide integrated development services to pharmaceutical/biotech companies. This Group complements sales, client services and the technical staff by providing tactical, logistical and scientific support to these development programs across Covance sites. The role of the Program Management Group is to coordinate the scientific, regulatory and logistical expertise of our staff to help clients design, execute and compile the IND submission, which will allow Phase I first in human dosing at Covance, followed by Phase IIa “Proof-of-Concept” clinical development in a timely manner.

Overall, Debra has over 18 years of experience in the pharmaceutical industry. She previously worked for Wyeth Research both as a Study Director conducting general toxicology, carcinogenicity, and developmental and reproductive toxicology (DART) nonclinical studies and as a Drug Safety Metabolism representative to global development teams. While at Wyeth, Debra worked on numerous regulatory documents for the U.S. (including IND applications and carcinogenicity study protocol submissions to the carcinogenicity assessment committee), Canada, and Europe. Prior to Wyeth, Dr. Kirchner was at Toxicology Research Laboratory as a Study Director primarily conducting DART nonclinical studies; and at Ciba Pharmaceuticals (now Novartis) as a Study Director conducting DART and general toxicology nonclinical safety studies.

Debra received her Ph.D. in anatomy/embryology from The Ohio State University (College of Medicine, Columbus, OH) and completed a post-doctoral course of training in the field of teratology at the Stein Research Center, Jefferson Medical College of Thomas Jefferson University in Philadelphia, PA. Dr. Kirchner has been board-certified in general toxicology by the American Board of Toxicology since 1994; is a member of the Teratology Society, the Middle Atlantic Reproduction and Teratology Association (MARTA), and Society of Toxicology (SOT).

Fred Kirchner, Ph.D., D.A.B.T.
Director, Toxicology and Pathology Scientific Services
Covance Laboratories, Inc., Madison, WI

Fred Kirchner currently is the Director of Toxicology and Pathology services at Covance Laboratories in Madison, WI, USA. He has management responsibility for over 140 people including 35 study directors and 15 anatomic and clinical pathologists. He was formerly the Director of Toxicology for Wyeth pharmaceuticals, Smith Kline Beecham pharmaceuticals, and Manager of study directors for Ciba Geigy (now Novartis) pharmaceuticals. He also worked as study director for Colgate-Palmolive Co., and conducted risk assessments while working for Argonne National Laboratory's Environmental Assessment Division, in Lemont, IL. Mr. Kirchner serves on the Executive Committee of the Board of Directors for the American Board of Toxicology.

He received his Ph.D. in Radiation Biology from the University of Iowa in 1978 and has been board certified in general toxicology by the American Board of Toxicology since 1990. He is a full member of the Society of Toxicology.

Fred has extensive experience in both small molecule and biopharmaceutical drug development, and in inhalation toxicology. He has overseen the training and development of Study Directors in three major pharmaceutical companies and is now Director of over 35 study directors in a major contract research organization. He has over 24 years of experience in preclinical safety, and has worked on US, Canadian, Japanese, and European drug regulatory applications.

Michael J. Schlosser, Ph.D., D.A.B.T.
President and Founder, Midwest BioResearch

Michael J. Schlosser, Ph.D., D.A.B.T., is the President and Founder of Midwest BioResearch, a specialty contract research and consulting organization focused on drug disposition and toxicology. Mike has more than 20 years of experience as a pharmaceutical manager and director, overseeing up to 100 professional and technical specialists devoted to discovery, development, and registration of novel drugs. Prior to founding Midwest BioResearch in 2003, Mike served as Senior Director in Safety Sciences at Pfizer, with Site Head responsibility for nonclinical safety activities at the Skokie R&D site, formerly Pharmacia/Searle. Prior to that, he served as Director of Experimental Toxicology and Pathology at Fisons/Astra (now AstraZeneca) and Head of Experimental Toxicology at Ciba-Geigy (now Novartis). Mike did a two-year postdoctoral fellowship at Thomas Jefferson University. He earned his Ph.D. in toxicology/pharmacology from the University of Mississippi in 1987. Mike has been a member of the Society of Toxicology (SOT) since 1983 and is past President of the Midwest Regional Chapter of SOT. He also is a member of the American College of Toxicology (ACT), where he served on their Animals in Research Committee, and is a member of the Environmental Mutagen Society. Mike has over 50 full research publications/scientific abstracts and has been responsible for over 800 technical reports and regulatory documents during the past 20 years in the pharmaceutical and CRO industries.

Steven (Steve) Snyder, M.S.
President, Outsourcing Support Services, Inc.
www.outsource-support.com
Phone: 317-408-0286; Email: info@outsource-support.com

Mr. Steven Snyder is the President of Outsourcing Support Services, Inc., a consulting company that provides preclinical study monitoring and CRO assessments for pharmaceutical and biotechnology companies.  Much of his career consists of job experiences in the toxicology divisions at Wyeth, Johnson & Johnson, and at Eli Lilly where he managed the in-life general toxicology department.  He later learned the inner workings of the preclinical CRO industry at Charles River Laboratories through roles in marketing and project management.  With 30 years of industry experience, Mr. Snyder is regarded as an industry expert in toxicology operations, study management, and preclinical outsourcing.  He is familiar with the management, facilities, and capabilities at most of the leading preclinical CROs.  He is a regular contributor to the trade publication, Contract Pharma, where his articles on preclinical outsourcing appear each month and he is a highly regarded advisor to the investment community on the preclinical outsourcing industry.

Mark Walker, D.V.M.
Senior Director, Scientific and Laboratory Operations
Program Director, Continuous Infusion

Mark joined Charles River in 2001 and is currently the Senior Director of Scientific and Laboratory Operations. In addition, he is the Program Director for Continuous Infusion. He is responsible for the senior scientific and managerial support of Laboratory Sciences, Formulations, and Scientific Resources. Mark’s management responsibilities include supervising multiple scientists and interrelated departments at Charles River Laboratories-Nevada, guiding the training of scientific staff and supporting professional development programs, determining and maintaining appropriate staffing, contributing to strategic planning and business development, and implementing cross-departmental process improvement initiatives. He has over 17 years of experience in preclinical toxicology, has published reference materials for primate toxicology and intravenous infusion, and has made numerous scientific presentations related to regulatory toxicology issues.

Prior to joining Charles River Laboratories, Mark was a Senior Principal Scientist at Covance Laboratories, where he developed the multispecies Continuous Infusion Program at their laboratory in Vienna, Virginia. He also managed the toxicologists within the Department of Toxicology. After a brief period in private veterinary practice, he completed a residency and postdoctoral fellowship in Primate Medicine and Surgery, with an emphasis in Comparative Pathobiology and Laboratory Animal Medicine, at the Bowman Gray School of Medicine. Mark received his B.S. and D.V.M. degrees from Texas A&M University in 1985.

Darren L. Warren, Ph.D.
Director of Preclinical Support, SNBL USA Ltd

Darren is currently the Director of Preclinical Support for SNBL USA Ltd, a contract research organization in Everett Washington. He received a Ph.D. degree in Pharmacology and Toxicology from the University of California at Davis in 1986, and continued his training as a postdoctoral fellow at Oregon State University. In 1989 he joined Mobay (currently Bayer) Corporation as a toxicologist and study director, and conducted both basic research as well as a variety of toxicology studies for the agrochemical, veterinary, and human health sectors. After accepting positions of increasing responsibility for toxicological evaluations, he transitioned to a pharmaceutical project management position within Bayer Healthcare in 1997. As a project manager he led projects focusing on anticancer drug development. Returning to toxicology after a corporate downsizing in 2002, he joined CRL-Sierra Division early in 2003 as a Director of Research, and then joined SNBL USA late in 2005. At present he assists with execution of non-clinical research and safety studies by coordinating with research staff and providing senior toxicologic input to study designs and reports.