Speakers/Advisors
Thanks to all of our speakers, instructors, and members of our advisory committee for their valuable contributions toward our program.
| Abarquez-Delacruz, Prosy | Regional Administrator, Food Safety Section-South, California Department of Health Services |
| Adams, Gerrie | Professor, Department of Physical Sciences, Chapman University |
| Adomian, Susan | Clinical Manager, SANOFI |
| Ahmed, Ruhi, PhD | Regulatory Affairs Associate, BAXTER |
| Asarch, Ken | VP, Clinical and Regulatory Affairs and Quality Systems, Careside Inc. |
| Bain, Susan | Consumer Safety Officer, FDA |
| Baker, Dennis | Associate Commissioner for Regulatory Affairs, FDA |
| Baron, Mel, PhD | Associate Professor of Clinical Pharmacy |
| Bell, Dana, PhD | Baxter Healthcare Corp |
| Bergan, John, RAC | Manager of Regulatory Affairs/QA, CMC Specialist, Amgen, Inc |
| Bernal, David, PharmD | Associate Director of RA, Genentech, Inc |
| Bernstein, David | CATO Consulting |
| Besseling, Nicolaas C. | BesTech Consulting Services |
| Botero-Omary, Maria, PhD | Assistant Professor, Food Science & Human Nutrition, California State Polytechnic University |
| Bozeman, Mark | Partner, Hogan & Hartson, LLP |
| Broad, John | NAMSA |
| Buckley, Paul, B.S. | USC Alfred E. Mann Institute |
| Burckart, Gilbert | Department Chair and Professor, USC Department of Pharmacy |
| Castagnaro, Lee Carole | GCP Specialist, Drumbeat Dimensions |
| Chacko, Jimmy | Regulatory Affairs Manager, Lenstec, Inc |
| Chamberlain, Mark | |
| Chan, Tony | Advanced Global Scientific Management, Inc. |
| Choy, Margaret | VP, Regulatory Affairs, Anchen Pharmaceuticals, Inc. |
| Church, Karen | Global Therapeutic Area Leader, PFIZER |
| Clemens, Roger, DrPH, CNS, FACN | Program Director for Analytical Research & Services in Complementary Therapeutics Research, USC |
| Coughlin, James R., PhD | President, Coughlin & Associates |
| Craft, Ginger | President, ISO Comp, Inc. |
| Craft, Jeffrey | Nordman Cormany Hair & Compton |
| D'Argenio, David | Professor/Chairman, USC Biomedical Engineering |
| Davies, Audra | Manager, Nutrition Science & Services; Nutrition R&D Nutrilite |
| Devos, Ann | GCP Manager, Innogenetics N.V. |
| Dhuwalia, Jack | President, JD Consulting |
| Dishon, Michelle | Watson Pharmaceuticals |
| Doan, Chau, PharmD | Manager, Drug Safety Dept., Watson Pharmaceuticals |
| Donato, Brian, Esq. | Hyman, Phelps, & McNamara, P.C. |
| Donlon, Jerome, M.D., Ph.D. | FDA CBER/OCBQ |
| Dzanis, David | DVM, Dzanis Consulting & Collaboration |
| Enany, Ahmed. A. | Founder and President, Southern California Biomedical Council (SCBC) |
| Epstein, Lilac | Senior Regulatory Associate |
| Fleitman, Jeff, PhD | Director, Pharmaceutical Analysis, Allergan |
| Foote, Mary Ann, PhD | Amgen Inc. |
| Frackiewicz, Edyta, PharmD | Senior Research Scientist |
| Gareeb, Alexander | Associate, Sedgwick, Detert, Moran and Arnold |
| Garg, Aditya | Computer Consultant Specialist, USC school of pharmacy |
| Gaynon, Paul | Professor, Keck School of Medicine |
| Glucroft, Joel | Glucroft & Associates |
| Gracon, Stephen | Senior Director, Global RA, Baxter Bioscience |
| Gregory, Paul | Pre-Clinical Research Manager, Boston Scientific |
| Grubs, Barry | Program Coordinator, USC HSC Institutional Board |
| Gryziewicz, Lewis | Director, Global Regulatory Affairs, Allergan |
| Haggerty, Kerri | Associate Director (International Compliance), Amgen, Inc |
| Hampton, Scott | CAN DO MEDICAL,Inc. |
| Hamrell, Michael, PhD | President, Moriah Consultants |
| Hans, Al | Allen Hans and Associates, Inc |
| Hardy, Mary, M.D. | |
| Hatsis, Diana | R.N. Clinical Research Associate, Center for Clinical Research |
| Hoegi, Julie, M.D. | Manager, Drug Safety Dept., Watson Pharmaceuticals |
| Hoffman, Tania | Regulatory Affairs Specialist, Allergan |
| Hunt, Doug | Amgen, Inc |
| Hurtado, Kathleen | |
| Isaacs, Jeanne, B.S. | Advanced Medical Optics |
| Jamieson, Mike | Managing Director, Pharmacon Research, Inc. |
| Jancarik, Kent | Senior Regulatory Associate, BIOGEN - IDEC |
| Johnson, Kathleen, PhD, PharmD | Associate Professor of Clinical Pharmacy, School of Pharmacy, USC |
| Jones, Andrew | Regulatory Affairs Librarian, Genzyme |
| Jordan-Marsh, MaryAlice | Assistant Chair, Department of Nursing, USC |
| Joseph, Joy | VP, Quality, Technical Operations & Product Development PHARMAVITE Corp |
| Kadow, James | KADOW ASSOCIATES Ltd. |
| Kamal, Fred | Amgen, Inc |
| Kaplan, Hilton | Medical Advisor, Dermogenesis, USA |
| Kaplon, Marsha | Wyeth |
| Kennel, Natalie | Director, Quality, Clinical & Regulatory, PLUS Orthopedics USA, Inc |
| Keville, Elizabeth | Laboratory Director, U.S. FDA, Pacific Regional Laboratory/South West |
| Kiser, Dan | Director of Quality Systems, Johnson & Johnson |
| Kistner, Kristi | President, Pacific Otterworks, Inc. |
| Klassen, Dan | Director, RA and QA, Allecure |
| Koller, Ron | Investigator, US FDA |
| Korbin, Gus, RAC CQA, | Medical Device Consultant, Strategic Regulatory Solutions |
| Kuo, Benson | |
| Lassiter, Jim | THE LASSITER GROUP |
| Laufer, Jaap | President, European Medical Device |
| Lauro, Stephen, Esq. | President, ColorMaker |
| Lawrence, Steve | Partner, Hogan & Hartson, LLP |
| Lewis, Doug, PhD | Department Chair, Food Science & Human Nutrition, California State Polytechnic University |
| Lieskovan, Ed, Dr. | Performance Research Labs, Inc |
| Liu, Marie | Associate, K & R Law Group |
| Loeb, Gerald, MD | Director, Medical Device Development Facility, Alfred E. Mann Institute |
| Louie, Stan | Associate Professor of Clinical Pharmacy, USC Department of Pharmacy |
| Lowe, Lester | Supervising Food and Drug Investigator, California Department of Health Services, Food and Drug Branch |
| Macdonald, Doug, PhD | Director of Drug Discovery, CHDI, Inc. |
| Maguire, Stacey | Associate, Sedgwick, Detert, Moran and Arnold |
| Mauzey, Duane | Scientist, CMC Regulatory Affairs, Allergan |
| McKay, Brandi | Associate, Sedgwick, Detert, Moran and Arnold |
| Meyers, Elizabeth | Amgen, Inc |
| Mire-Sluis, Anthony | Amgen, Inc |
| Montecalvo, Joe, PhD | Professor, Food Science and Human Nutrition, California Polytechnic University |
| Moore, Kellie | Associate, Sedgwick, Detert, Moran and Arnold |
| Ngau, Grace | USC Pharmacy |
| Nickell, Robert | President & CEO, Homelink National Pharmacy |
| Niksch, Barbara | Director, RA, QA and Clinical Affairs, Glaukos |
| Nimmer, Thomas | Amgen, Inc |
| O'Brien, Patrick | Senior Counsel, Office of General Counsel, Johnson & Johnson |
| Ortiz Akhondzadeh, Korina | Regulatory Specialists |
| Pacifici, Eunjoo, PharmD, PhD | Clinical Research Specialist |
| Pacifici, Robert | CHDI Inc |
| Pandey, Ajit | Amgen Inc. |
| Perdon, Elisa | Quality Assurance Manager for Contract Manufacturing, Chattem, Inc. |
| Petrime, Matt | VP, GM of Speciality Division, Applied Medical |
| Petterson, Hal | Director of Quality Assurance, ISTA Pharmaceuticals |
| Pham, Chris | Associate, Sedgwick, Detert, Moran and Arnold |
| Pierce, Gary, | Reg. F&D Director, SW Region FDA |
| Pollmeier, Vincent | Associate, Quinnemanuel Urquhart Oliver & Hedges |
| Posin, Christine | Consultant in Regulatory and Quality Assurance |
| Prakash, Anu, PhD | Associate Professor, Department of Physical Sciences, Chapman University |
| Purcell, Meredith | Associate Director, Publishing Group, Allergan |
| Purificacion, Kimberly | Research Protocol Manager, USC University Hospital & Norris Cancer Hospital |
| Quattrone, Alfredo, PhD | FDA |
| Raval, Ruchika | Ruchika Raval & Associates |
| Resch, Gerda, RAC | Manager of Regulatory Affairs, Alfred Mann Foundation |
| Richmond, Frances | Director, Clinical & Regulatory Science, AMI Research Professor of Molecular Pharmacology and Toxicology |
| Robertson, Jan | Manager, Labeling and Advertising Baxter Healthcare Corp |
| Rodriguez, Dana | RNP, RAC Quality Consultant, Medical Device Industry |
| Rokaw, Enid | EBR Consulting |
| Roper, Doug | Director of Laboratory/Quality Assurance, BOTANICALS INTERNATIONAL |
| Rose, Susan | Executive Director, Office for the Protection for Research Subjects |
| Rosencrans, Heather | FDA CDRH/ODE |
| Rostami, Reza | Manager, Clinical Data Services, Duke Clinical Research Institute |
| Rush, Gary | Senior Food and Drug Investigator, California Department of Health Services, Food and Drug Branch |
| Salter, Anne Dupont, PhD | |
| Scanlon, Kevin, PhD, | Founder and CEO, International BioScience |
| Schakenraad, Jeff | Manager, Kema Medical |
| Schneider, Carol | Irell & Manella, LLP |
| Schultz, Dan, M.D. | FDA CDRH/ODE |
| Schwartz, Nancy | Searchlight International |
| Scognamillo, Christian | Associate, Reed Smith, LLP |
| Serrano, David | Consumer Safety Officer, FDA |
| Shaddle, Bill | Metagenics |
| Shaham, Cigal | Clinical Research Coordinator, Children's Hospital of Los Angeles |
| Sharma, Avyaya | Clinical/Quality Engineer, Medtronic |
| Shen, James.C. | Compliance Officer, US FDA |
| Spencer, Helene | VP, Regulatory Affairs and Quality Assurance, GluMetrics, Inc. |
| Spicer, Darcy | Professor, Head of IRB, Clinical Medicine at USC |
| Stagg, Del | Senior Director, Allergan |
| Stark, Fumi | Program Director, USC |
| Steiner, Randy | Associate Director, Regulatory Affairs, AMGEN |
| Swit, Michael | Heller, Ehrman, White & McAuliffe LLP |
| Taddonio, Laurie | Bioresearch Program Director, Quintiles Consulting |
| Thompson, Barry | Crosby, Heafey, Roach & May |
| Thompson, Monica | JD |
| Topham, Debra, MS, RD | Director, Knowledge Bank |
| Tucker, Mark, PhD | Compliance Officer, FDA |
| Van Antwerp, Bill | VP, Chief Scientific Officer, Medtronic Minimed |
| Van Etten, Aaron | Manager, Medical Writing, Amgen, Inc |
| Vivirito, Michele | Principal Medical Writer, Medical Affairs Department, Amgen Inc |
| Volner, William | Manager, Globaltrade Compliance Department , Allergan |
| Walsh, Michael, Esq. | Associate, Sedgwick, Detert, Moran and Arnold |
| Weber, Jeffrey, M.D. PhD | USC Norris Cancer Center |
| Weisman, Fred | USC School of Pharmacy |
| Were, Lillian, PhD, | Assistant Professor, Department of Physical Sciences, Chapman University |
| Williams-Hill, Donna, PhD | Food Pathogen Specialist, FDA |
| Witherly, Steve, PhD | President & CEO, Technical Products Inc.. Nutraceutical consulting firm. |
| Wu, Weicheng, PhD | |
| Yedigarova, Larisa, MD, PhD | Assistant Professor of Research, Obstetrics & Gynecology at USC |
| You, Thomas J. | Crosby, Heafey, Roach & May |
Advisory Board
| Anderson, John | Director, corporate strategic planning,Beckman Coulter Inc. |
| Asarch, Ken | VP, Clinical and Regulatory Affairs and Quality Systems, Careside Inc |
| Christopher, Rosemarie | MedExec International |
| Fairchild-Dzanis, Melanie | Director, Regulatory Issues, Nestle; Special Nutritionals |
| Foote, MaryAnn | Director, Amgen |
| Garvey, Pat | VP, Regulatory Affairs, Edwards Life Sciences |
| Jamieson, Mike | Managing Director, Pharmacon Research Inc. |
| Kitzmiller, Cindy | Executive VP, Seltzer Chemicals |
| Lassiter, Jim | The Lassiter Group |
| Livingston, John | VP Technology, Minimed Corp |
| Malloy, John | Malloy and Associates |
| McGuffin, Michael | American Herbal Products Association |
| McKonic, Marc | CEO, Biocell Laboratories Inc. |
| Sawyer, Tom | Director,FDA Los Angeles District, Compliance Branch |
| Stagg, Del | Senior Director, Allergan |
