Speakers

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Our classrooms are exciting places!  You will get the chance to learn about a whole new field from outstanding experts in the field, who share their time and experience with you.  Opportunities for discussion and questions abound.  Check out our growing list of speakers.

The Regulatory Science Master’s program constantly strives to bring it’s students the insight and knowledge of outstanding speakers renowned in their specific fields. As you will see, we have certainly gathered some of the best speakers to address the material of interest to students of Regulatory Science. Here are just a handful of the speakers and advisors you will work with in this program:

Advisory Board

Kathy Allen, PhD
Professor of Clinical, USC Marshall School of Business

Dennis Atkinson, MSc
Research Advancement Director, USC Office of the Vice Provost

Mel Baron, PhD
Associate Professor of Clinical Pharmacy, USC School of Pharmacy

Catherine Beath, MBA
Vice President, Quality & Regulatory Affairs, Ethicon, Inc.

Dana Bell, PhD
Regulatory Affairs Consultant

John Bentivoglio, JD
Skadden, Arps, Slate, Meagher & Flom, LLP

Gilbert J. Burckart, PharmD
Associate Director for Regulatory Policy, CDER, U.S. FDA

Rosemarie Christopher, MS
Founder, MedExec International

Enrique Cadenas, PhD
Professor Ass0ciate Dean for Research Affairs, USC School of Pharmacy

Gary Charbonneau, MSRS
Global Regulatory Affairs & Safety Operations Department, Allergan, Inc.

Roger Clemens, DrPh, CNS, FACN
Adjunct Professor, USC School of Pharmacy, Regulatory Science Program

Karen Church, PhD, RAC
Vice President, Regulatory Affairs, OCERA Therapeutics, Inc.

MaryEllen Cosenza, PhD

Alonza Cruse, MS

Los Angeles District Director, FDA Office of Regulatory Affairs

Richard DeRisio MS
Vice President Regulatory Affairs, Abbott Medical Optics, Inc.

MaryAnn Foote, PhD
Freelance Writer, Editor & Teacher

Patricia Garvey, PhD
Regulatory Consultant

Mary Gordon
Conference Director, UBM Cannon LLC/Cannon Communications LLC

Michael Hamrell, PhD
President, Moriah Consultants

Sharon Higgins, MSc
Executive Director, Irish Medical Device Association, Dublin, Ireland

Lorry W. Huffman, RAC, MT
Sr. Director Regulatory Affairs, Volcano Corporation

Doug Hunt
Vice President, Global Regulatory Affairs, Baxter Pharmaceuticals

Michael Jamieson, DRSc
Associate Director, USC Regulatory Science Program; President, Insource Innovations Inc., Canada

Gerald Loeb, MD
USC Professor of Biomedical Engineering & Director Medical Device Development, Viterbi School of Engineering

Larry Lesko, PhD
Director, Office of Clinical Pharmacology, U.S. FDA

Michael McGuffin
President, American Herbal Products Association

Stephanie Mensh, MPA
Vice President Reimbursement Policy, StrokeSurvivor

Elaine Messa, BA
Director of Medical Device Quality Systems & Compliance Practice, Becker & Associates Consulting., Inc.

Michael Morton, MA
Vice President for Global Regulatory Affairs, Medtronic, Inc.

Virginia Perry, RAC, CQ
Founder & Partner, Perry-D’Amico & Associates

Susan Pignataro, MBA/MAS
Sr. Director, Customer Experience Solutions Group, Cisco Systems

Enid Rokaw, MS
Instructor, USC Regulatory Science Program; President EBR Consulting Group

Susan Rose, PhD
Executive Director, USC Office for Protection of Research Subjects

Judy Rosebloom
Founder & President, JR Associates

Javad Seyedzadeh, MS
Senior Vice President, Global QA & RA, GAMBRO

Nancy Singer, JD
President, Compliance-Alliance, LLC

Helene Spencer, BS
President, ClinReg Consulting Services

Stephen Ubl
President & CEO, AdvaMed

Course Speakers

Abernathy, R. Darrell
Contractor, Non-Government, FDA DHHS

Abraquez-Delacruz, Prosy
Regional Administrator, Food Safety Section-South, California Department of Health Services Food and Drug Branch

Adams, Gerrie Professor,
Department of Physical Sciences, Chapman University

Adkins, Gary Founder,
Executive Director, Diversity Solutions

Adomian, Susan
Clinical Manager, SANOFI, Serono

Ahmed, Ruhi,
PhD Manager, Regulatory Affairs, BioMarin Pharmaceutical Inc.

Albiani, Roy
Global Director, Brand Integrity, LifeScan, J&J Company

Alkana, Linda
Undergrad Advisor, History Dept., Dept of International Studies, CSULB

Allen, Kathy
Prof. of Clinical/Entrepreneurial Studies, USC Marshall School of Business

Alley-Zarakedes, Lisa
VP Food Technology, ET Horn

Anderson, John
Director, Corporate Strategic Planning, Beckman Coulter Inc.

Anderson, William
Associate Director, Biostatistics/Clinical Data Management, Edward Lifesciences LLC

Antonio, Duarte
IntraLase Corp.

Apfelberg, Andrew M, Esq.
Rutter Hobbs & Davidoff, Incorporated

Ardalan, Christopher
Ardalan and Associates

Asarch, Ken
VP, Clinical and Regulatory Affairs and Quality Systems, Careside Inc.

Bain, Susan
Consumer Safety Officer, FDA

Baker, Dennis
Deputy Commissioner for Regulatory Affairs, FDA

Baker, Don
VP II, Quality, Baxter Healthcare Corp.

Baron, Mel, PhD
Associate Professor of Clinical Pharmacy, Department of Pharmacy

Baron, Ross, PhD
Professor of Religion, Brigham Young University-Idaho

Beath, Catherine
WW VP QA/RA, Ethicon, Inc.

Beatty, Carol
Queen’s University, School of Business

Bell, Dana,
PhD Regulatory Affairs Consultant

Bentivoglio, John Skadden,
Arps, Slate, Meagher & Flom LLP

Berg, Jim
ET Horn Company

Bergan, John J.,
RAC Manager of Regulatory Affairs/QA, CMC Specialist, Amgen, Inc

Berger, Kenneth
VP, Quality Assurance & Regulatory Affairs, Irvine Pharmaceutical Services

Bernal, David, PharmD
Associate Director of RA, Genentech, Inc

Bernstein, David
Vice President, CATO Research, Ltd.
Bernstein, Ilisa
FDA DHHS

Besseling, Nicolaas C.
Principal, Medical Instrumentation, BesTech Consulting Services

Bhasin, Simon
Baxter Bioscience

Bidlack, Wayne, PhD
Dept. Human Nutrition & Food Service, CS polytechnic University, Pomona

Bills, Edwin
Principal Consultant, Bilanx Consulting LLC

Blasco, Michael
MS, RAC, Reg Affairs Manager, Gen-Probe Incorporated

Bobka, Marlene
VP, FOI Services, Inc.

Bolton, Sanford, PhD
Visiting Professor, University of Arizona.

Perkins, Bonnie
Senior Regulatory Affairs Specialist , Medtronic Vascular

Booth, Thomas, PhD
USC Viterbi School of Engineering

Borrelli, Joseph
Borrelli & Associates

Botero-Omary, Maria, PhD
Assistant Professor, Food Science & Human Nutrition, California State Polytechnic University

Bovenkamp, Diane
Director of Science Information & Programs, The Foundation Fighting Blindness

Bozeman, Mark H.
Attorney, Partner, Hogan & Hartson, LLP

Brandon, George
Partnership Development Leader, Morris, Plich & Purdy, LLP

Broad, John
NAMSA

Bruhn, Christine
Outcomes Liaison, Lilly

Buckley, Paul, B.S.
USC Alfred E. Mann Institute

Burckart, Gilbert
Assc. Director Reg Policy, Office Clinical Pharmacy, CDER, US FDA

Calicchia, Melissa
Technical Direct, Food Safety Solutions, Inc.

Campbell, Jeanette
PAI Air Quality Laboratory

Camps, Julio, MD
Amgen, Inc.

Castagnaro, Lee Carole
GCP Specialist, Drumbeat Dimensions

Carrier, Larry
Medtronic Vascular

Chacko, Jimmy
Regulatory Affairs Manager, Lenstec, Inc

Chamberlain, Mark
VP, Operations, BS, Bioness Inc.

Chan, Tony
Adjunct Instructor, USC Regulatory Science Program

Chang, Thomas
Seltzer Chemicals

Charbonneau, Gary
Global Reg Affairs and Safety, Operations Department Allergan, Inc.

Chignon, Thierry
Matignon Technologies

Chirnomas, Morton
Business Development & Licensing Assoc., USC Steven Institute for Innovation

Choy, Margaret
VP, Regulatory Affairs, Anchen Pharmaceuticals, Inc.

Christ, Oliver P.
General Manager Health Care, PROSYSTEM AG

Christopher, Rosemarie
Principal. MedExec International

Church, Karen K., PhD, RAC
V.P. Reg Affairs, Ocera Therapeutics, Inc.

Citron, Paul
VP, Medtronic, Inc.

Cleavenger, Becky
Senior Director, Global Advertising and Promotion Center of Excellence, Baxter Healthcare Corp.

Clemens, Roger A.
Director, Analytical Research & Services in Complementary Therapeutics, USC School of Pharmacy

Collins, Kenneth A.
Vice President, RA, QA & CA, Alsius Corporation

Cosenza, Mary Ellen, PhD
Executive Director of Reg Affairs, Amgen, Inc.

Coughlin, James R., PhD
President, Coughlin & Associates

Craft, Ginger
President, ISO Comp, Inc.

Jeffrey Craft, Esq.
Of Counsel, Arent Fox, Los Angeles; Directo fo IP, ABS Materials, Ohio

Cruse, Alonza
District Director, Los Angeles, FDA Office of Regulatory Affairs

Cruz, Martha L.
DVM, Dphil

Cullman, Louis “Chip”
K&L Gates, LLP

Cupo-Abbott, Jennifer
Asst. Professor of Clinical, Dept., University Hospital Pharmacy

Currey, Brain S.
O’Melveny & Myers LLP

Dahl, Rebecca
IRB, CHLA

Dahl, Russell, PhD
Burnham Institute for Medical Research

Dalpan, Gerald
Supervisory Medical, FDA DHHS/FDA/CDER/OSE

Daviels, AnnaMarie
VP of Clinical Research, Advanced Bionics

D’Argenio, David
Professor/Chairman, USC Biomedical Engineering

Das, Rupa
Director of Quality & Reg Compliance, BI Nutraceuticals

Davies, Audra
Manager, Nutrition Science & Services; Nutrition R&D Nutrilite

Davies, Daryl L., PhD
Associate Professor of Clinical Pharmacy, USC School of Pharmacy

DeBré, Kevin D., Esq.
Stubbs Alderton & Markiles, LLP

Delgra, Jr., Cecilio Galvez, M.D.
Associate Medical Director, Global Safety, Amgen, Inc.

DeRisio, Richard J.
Divisional VP Global Reg Affairs, Abbott Medical Optics, Inc.

Desai, Shetal, PharmD
Asst Prof., USC School of Pharmacyt, Norris Cancer Hospital

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.
Deputy Director of OCBQ, FDA CBER/OCBQ
Archer, Doug

Dzanis, David
Diplomate, American College of Veterinary Nutrition, Dzanis Consulting & Collaborations

Dziewanowska, Zofia
Ligand

Ed, Bills
Bilanx Consulting, LLC

Elisas, III, Chester G.
Sr. Manager, Global Reg Affairs & Safety, Amgen, Inc.

Elnatan, Andrew
Regulatory Affairs Dept., Amgen Inc

Enany, Ahmed. A.
Founder and President, Southern California Biomedical Council (SCBC/SoCalBio)

Epstein, Lilac
Senior Regulatory Associate

Ereshefsky, Larry, PharmD, FCCP, BCPP
California Clinical Trials, Exec VP, Chief Scientific Officer

Ertl, Farouz
Executive Vice President, Technical and Regulatory Affairs

Farin, Heinrich, MD
Chief Scientific Officer, Catalyst Pharmaceuticals

Fisher, Carlos, Esq.
Stout Uxa Buyan & Mullins, LLP

Fleitman, Jeff, PhD
Director, Pharmaceutical Analysis, Allergan

Flick, Jr., George J.
University Distinguished Professor, Food Science & Technology Dept., Virginia Tech (0418)

Foote, Mary Ann, PhD
Amgen Inc.

Frackiewicz, Edyta, PharmD
Senior Research Scientist

Fulle, Hans-Jurgen
Regulatory Affairs Manager, Central Corp RA/Development, RR1/RC Altana Pharma AG

Gaffaney, Bernard A.
Senior Counsel, Corporate, Pioneer North America, Inc.

Gallagher, Kesley
Senior Reg Affairs Specialist, Advanced Medical Optics, Inc.

Gareeb, Alexander
Attorney, Sedwick, Detert, Moran and Arnold LLP

Garg, Aditya
Director of TEL/DL, USC School of Pharmacy

Garvey, Patricia
VP, Regulatory

Gaynon, Paul
Professor, Pediatrics/Children’s Hospital, Keck School of Medicine

Geigert, John, PhD
President, BioPharmaceutical Quality Solutions

Gibson, Thomas
Hyman, Phelps, & McNamara, P.C.

Giese, Ferdinand
Manager, Global Marketing Information, Allergan, Inc.

Giffin, Suzana, PharmD
Exec. Dir. Medical Information, Amgen, Inc.

Glasscock, Brad, PharmD
Manager, Regulatory Affairs, Amgen, Inc.

Glucroft, Joel
Glucroft & Associates

Gokhale, Mamata, PhD
Associate Director, Asia and Latin America Clinical Development Operations, Amgen, Inc.

Gracon, Stephen
Senior Director, Global RA, Baxter Bioscience

Gregory, Paul
Pre-Clinical Research Manager, Boston Scientific

Grubs, Barry W.
Program Coordinator, USC HSC Institutional Board

Gryziewicz, Lewis
Director, Global Regulatory Affairs, Allergan

Gukasyan, Hovhannes, PhD
Worldwide Pharmaceutical Sciences, Research, Science and Technology, Formulations, Pfizer Global R&D, La Holla Laboratories

Gusev, Vlad
Amgen, Inc.

Haggerty, Kerry
Associate Director Global Safety – International Compliance, Amgen, Inc

Hamblet, Brian
Burke, Williams & Sorensen

Hammerle, Ron
Consultant, Advanced Educational Corporation

Hampton, Scott M.
CAN DO MEDICAL,Inc.

Hamrell, Michael, PhD
President, Moriah Consultants

Hans, Al
Allen Hans and Associates, Inc

Hardy, Mary, M.D.
Medical Director, Integrative Medicine, Cedars-Sinai Medical Center

Hartley, Linda
FDA

Harvey, Phillip W., PhD, FACN
Chief Science Officer, National Nutritional Foods Association

Harvey-Allchurch, Martin
Head of Executive Support, European Medicines Agency

Hatsis, Diana
R.N. Clinical Research Associate, Center for Clinical Research

Higgins, Sharon
Executive Director, Irish Medical Device Asso Confederation House

Hilferty, James
Manager, Regulatory Services Operations, Liquent Thomson Reuters

Himmel, Martin
FDA CDR, ORM, CDER

Hirata, Vivian
Medtronic , Inc.

Hoegi, Julie, M.D.
Manager, Drug Safety Dept., Watson Laboratories, Inc.

Hoffman, Tania
Regulatory Affairs Specialist, Glumetrics

Hori, Mas
California Department of Health

Huffman, Lorry W., RAC, MT(ASCP)
Sr.Director, Volcano Corp.

Hull, Richard Dr.
Dir Innovation Advancement & Bus. Development, USC Stevens Institute for Innovation

Hunt, Doug
VP Global Regulatory Affairs, Baxter Pharmceuticals

Hunter, Robert
Medical Info Manager, Amgen

Hurtado, Kathleen
President, CEO, Health Research Association, Inc., Keck School of Medicine

Hussain, Iqbal
Amgen, Inc.

Hutchinson, Ian
Professor of Pharmacy, USC Clinical Pharmacy & Econ & Policy

Isaacs, Jeanne, B.S.
Allergan, Inc.

Jacob, Mary, PhD, RD
Professor, Dept. of Family & Consumer Sciences, California State University, Long Beach

Jacobs, Pat
Advanced Personnel Profiles, Inc.

Jamieson, Michael
Managing Director, I-3 Insource Innovations, Inc.

Jancarik, Kent
Senior Regulatory Associate, BIOGEN – IDEC Pharmaceuticals

Jang, Graham, PhD
Amgen, Inc.

Jenkins, John K.
Director, Office of New Drug, FDA DHHS/FDA/CDER/OND

Jensen, Gerard M.
Director Development & Technical Services, Gilead Sciences

Jerian, Susan
OncoRD, Inc.

Jhee, Stanford, PharmD
Calfornia Clinical Trials, Glendale Adventist Medical Center

Johnson, Jerry D.
Consultant to the Pharmaceutical Industry

Johnson, Kathleen, PhD, PharmD
Associate Professor of Clinical Pharmacy, School of Pharmacy, USC

Jones, Andrew
Regulatory Affairs Librarian, Genzyme

Jope, Theodore
Jope & Associates

Jordan-Marsh, MaryAlice, PhD, RN, Faan
Assistant Professor, Chair Health Concentration, Nurse Social Work, Practitioner, USC School of Social Work

Joseph, Joy
VP, Quality, Technical Operations & Product Development PHARMAVITE Corp

Kadow, James Asst
VP – Corporate Quality Assurance, KADOW ASSOCIATES Ltd.

Kalowes, Peggy
Instructor of Clinical Nursing

Kamal, Fred
Associate Director and Department Head, Chemistry, Amgen, Inc

Kaplan, Hilton
Medical Advisor, Allergan Medical

Kaplon, Marsha
Wyeth, Inc.

Kaplowitz Haley J., PhD
Senior Director, Risk Mgmt & Epidemiology, Allergan, Inc.

Kazeminy, Assad
Founder & CEO, Irvine Pharmaceutical Services

Keats, Tony, Esq.
Lkeats McFarland & Wilson

Kennel, Natalie
Director, Quality, Clinical & Regulatory, PLUS Orthopedics USA, Inc

Kessler Larry G., ScD
Dir: Off of Science & Engineering, CDRH, FDA

Keville, Elizabeth
Laboratory Director, U.S. FDA, Pacific Regional Laboratory/South West

Khodavirdi, Ani
Medical Communications, Oncology, Amgen, Inc.

Kiser, Dan
Senior Director, Quality Assurance, Alphatec Spine

Kistner, Kristi
President, Pacific Otterworks, Inc.

Kitzmiller, Cindy
Executive VP, Seltzer Chemicals

Klassen, Dan G.
Director, RA and QA, Klassen Consulting, LLC

Kleiser, Annette, PhD
Sr. Business Development & Licensing Assoc., USC Stevens Institute for Innovation

Ko, Richard
Research Scientist (Food & Drug), CA Dept. Health Services, Food & Drug Branch

Koller, Ron
Investigator, US FDA

Kontnik, Lew
Brand Protection, Amgen, Inc.

Korbin, Gus, RAC
CQA Medical Device Consultant, Strategic Regulatory Solutions

Krieger, Robert, PhD
Dept. Entomology, UC Riverside

Krueger, Carol
FDA

Kubic, Tom
PSI

Kulkarni, Ashutosh, PhD
Scientist-Pharmacokinetics & Drug Metabolism, Allergan, Inc.

Kunas, Gretchen
Project Manager, KEMA Quality B.V., KEMA Medical

Kuo, Benson, PhD
Manager, Consulting Center, USC Regulatory Science Program

LaCorte, Laura
Executive Director Office of Compliance, Audit and Compliance

Lai, Johan
Chief Operations Officer, Accelerated Approval, Inc.

Lam, Nancy
Amgen, Inc.

Landolph, Joseph
USC Keck School of Medicine, Dept of Molecular Microbiology & Immunology

Lassiter, Jim
Principal, THE LASSITER GROUP

Laufer, Jaap L., PharmD
Managing Director – Europe, Propel Biomedical Consulting

Lauro, Stephen, Esq.
Attorney, President, ColorMaker

Lawrence, C. Stephen
Partner, Hogan & Hartson, LLP

Lesko, Larry
Director, Office of Clinical Pharmacology & Biopharmaceuticals, FDA Center for Drug Evaluation & Research

Lewis, Doug, PhD
Department Chair, Food Science & Human Nutrition, California State Polytechnic University

Lieskovan, Ed, Dr.
President & CEO, Performance Research Labs, Inc

Lieu, Cynthia
Asst Professor of Clinical Pharmacy, USC School of Pharmacy

Lisager, Terry, EdD
Assistant Professor, California State University, Northridge, Department of Family and Consumer Sciences

Liu, Marie E.
Attorney, Associate, K & R Law Group, LLP

Lloyd-Smith, Malcolm
SVP Regulatory Affairs & QA, Cadence Pharmaceuticals, Inc.

Loeb, Gerald, MD
Director, Medical Device Development Facility, Alfred E. Mann Institute

Loh, Evangeline
VP, Regulatory Affairs, EMERGO GROUP

Lou, Mimi
Project Manager & Biostatistician, USC School of Pharmacy

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

Graham-Lyons, Katie
Senior Consultant, Opus Regulatory

Ma, Kimberly P.
Medtronic, Inc.

Macdonald, Douglas, PhD
Director of Drug Discovery, CHDI Management, Inc.

MacKay, Andrew
Assistant Professor of Pharmacology & Pharmaceutical Sciences, USC School of Pharmacy, Dept of Pharmacology & Pharrmaceutical Sciences

Maderazo, Alan, PhD, RAC
Senior Manager, Regulatory Affairs, Gen-Probe

Maffuid, Paul
Sr. Vice President, Operations, Irvine Pharmaceutical Sciences

Maguire, Stacey
Attorney, Sedgwick, Detert, Moran & Arnold

Maletta, Mathew
Allergan, Inc.

Malloy, John
Malloy and Associates

Margolis, Benjamin Robert
Attorney at Law

Marler, William
Attorney, Marler Clark

Mauzey, Duane
Scientist, Pharmaceutical Analysis, Allergan Inc.

McDonald, Janet
FDA San Francisco

McGuffin, Michael
President, American Herbal Products Association

McKay, Brandi
Attorney, Sedwick, Detert, Moran and Arnold

McKinney, Eula
Manager, Comprehensive Spine Center, UCLA

McKonic, Marc
CEO, Biocell Laboratories, Inc.

McNabb, Matt
Training & Development, Allergan, Inc.

Meissel, Richard
Propel Biomedical Consulting

Mendivil, Steven
Amgen, Inc.

Mensh, Stephanie
VP, Reimbursement Policy Stroke Survivor.com

Mercurio, Ken, MS
President, Label Compliance

Messa, Elaine
Director of Medical Device Quality Systems, Becker & Associates Consulting, Inc.

Meyers, Elizabeth
Associate Manager, Corp. Quality Compliance, Amgen, Inc

Miller, Jay
Associate Director, Clinical Operations – Japan Representative Office, Global Development, Amgen

Mire-Sluis, Anthony
Amgen, Inc

Mishra, Lakshmi
Adjunct Professor, SoCal University of Health Sciences

Molzon, Justina
Sr. Program Management, FDA DHHS

Montecalvo, Joe, PhD
Professor, Food Science and Human Nutrition, California Polytechnic University

Moore, Kellie Ann
Attorney, Sedgwick, Detert, Moran and Arnold

Moran, Matthew
Director of Global CMC Regulatory Affairs, Allergan, Inc.

Morel, Keith, PhD
Senior Project Manager, KEMA Quality

Morton, Michael
Sr. Director Global Regulatory Affairs, Medtronic, Inc.

Mounho, Barbara, PhD
Amgen, Inc.

Nancy, Singer
Compliance-Alliance, LLC

Newburry, Keith Andrew, Esq.
Edwards Lifesciences, LLC

Newman, Joseph B.
Project Configuration Manager, QA, Diagnostic Products Corporation

Ngau, Grace
USC School Pharmacy

Nickell, Robert
President & CEO, Homelink National Pharmacy

Niksch, Barbara
Vice President, Regulatory, Quality & Clinical Affairs, Visiogen, Inc.

Nilsen, Jon, PhD
Biomedical Writer, Amgen, Inc.

Nimmer, Thomas
Amgen, Inc

Niu, Helen, MD
Two-World Bio-Pharma Consultancy, Beijing, China

Novak, Kathleen
Manager of Medical and Scientific Affairs, Nutrition Division, Nestle

O’Brien, Patrick
Attorney, Johnson & Johnson Law Department

O’Meara, Regina J., RAC
Director, Global Legislative & Government Affairs, Beckman Coulter, Inc., Retired

Ortiz Akhondzadeh, Korina
Regulatory Specialists

Pacifici, Eunjoo, PharmD, PhD
Clinical Research Specialist

Pacifici, Robert
Chief Scientific Officer, CHDI Foundation

Pandey, Ajit
Amgen, Inc.

Patel, Leena, PhD
Allergan, Inc.

Patterson, Nancy
Venture Analyst & Consultant, MedFocus Fund

Patterson, Hal
Director of Quality Assurance, ISTA Pharmaceuticals

Perdon, Elisa
Quality Assurance Manager for Contract Manufacturing, Chattem, Inc.

Perkins, Daya
USC Postdoctoral Fellow, Global Pharmaceutical Sciences, Allergan Inc.

Perkowski, Peter, Esq.
Winston & Strawn, LLP, Los Angeles

Perry, Virginia
Founder and Partner, Perry-D’Amico and Associates

Petrime, Matt
VP, GM of Speciality Division, Applied Medical

Pham, Chris
Attorney, Sayegh & Pham

Phillips, Howard
FOI Services, Advanced Compliance Alliance

Phillips, Richard, PhD
Sr. Vice President, Chief Regulatory Officer, Regulatory Affairs and Quality Assurance, Cougar Biotechnology, Inc.

Piazza-Hepp, Toni
Associate Director for RA, Supervisory Pharmacist, FDA DHHS/FDA/CDER/OSE/RMS

Pierce, Gary
Reg. F&D Director, SW Region HFR-SW1 FDA

Pih, Will, PharmD
President & CEO, BioSys Labs, Inc.

Pilcher, Garrett
Regulatory Affairs Specialist, Medtronic

Pitts, Peter
Porter Novelli

Pollmeier, Vincent
Attorney, Quinn Emanuel et al LLP

Potter, Geoffrey
Patterson Kelnap Webb & Tyler, LLP

Posin, Christine
Consultant in Regulatory and Quality Assurance

Prakash, Anu, PhD
Associate Professor, Department of Physical Sciences, Chapman University

Pulicharam, Riya
Medical Director of Clinical Research, Health Care Partners

Purcell, Meredith
Associate Director, Regulatory Affairs Publishing, Allergan, Inc.

Qian, Victoria, PharmD, PhD
Allergan, Inc.

Quattrone, Alfredo, PhD
DABT, Staff Toxicologist, FDA CA-DHHS

Quinn, David, MD
Associate Professor of Clinical Medicine Oncology, Keck School of Medicine

Rastein, Daniel N.
FDA GLP Compliance Officer, Cedars-Sinai Medical Center

Raumbaugh, Trudi
VP Regulatory Affairs, Baxter Healthcare Corp.

Raval, Ruchika
Ruchika Raval & Associates

Reck, Ross
Ross Reck & Associates

Resch, Gerda, RAC
Manager of Regulatory Affairs, Alfred Mann Foundation

Reznik, Phil
Attorney at Law, BRG&S, LLP

Richmond, Frances, PhD
Director, Clinical & Regulatory Science, AMI Research Professor of Molecular Pharmacology and Toxicology, AMI-USC School of Pharmacy

Ripley, Ann-Marie
Alfred E. Mann Foundation

Robb, Melissa A.
Sr. Program Manager, FDA DHHS/FDA/OC/OCS/OCPP

Robertson, Jan
Manager, Labeling and Advertising Baxter Healthcare Corp

Robinson, Robert
Attorney, Bowman and Brooke LLP

Rodriguez, Dana RNP, RAC
Quality Consultant, Medical Device Industry

Rokaw, Enid
EBR Consulting

Roper, Doug
Director of Laboratory/Quality Assurance, BOTANICALS INTERNATIONAL

Rosales, Tita
Amgen, Inc.

Rose, Susan L.
Executive Director, Office for the Protection for Research Subjects, USC

Rosenbloom, Judy
Founder & President, JR Associates

Rosencrans, Heather
FDA CDRH/ODE

Rostami, Reza
Manager, Clinical Data Services, Duke Clinical Research Institute

Rumbaugh, Trudy
VP, Global Regulatory Affairs, Biologics & Biopharmaceuticals, Baxter Healthcare Corp

Rush, Gary
Senior Food & Drug Investigator, California Department of Health Services

Salter, Anne Dupont, M.Eng, PhD
Instructor, USC Regulatory Science Program, & Queen’s Univeristy School of Rehabilitation Therapy

Sattler, Fred R., M.D.
Prof. Medicine & Biokinesiology, USC GCRC Keck School of Medicine

Sawyer, Tom
Retired, FDA/ORA

Scanlon, Kevin J., 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
Consultant, Searchlight International

Scognamillo, Christian
Attorney, Cooley Godward LLP

Serrano, David
Consumer Safety Officer, FDA Dept. of Health/Human Services

Seyedzadeh, Javad
Sr. VP, Global QA/RA, Gambro Renal Products, Inc.

Shaddle, Bill
Director of Internet Strategy, Metagenics

Shaham, Cigal
Clinical Research Coordinator, Children’s Hospital of Los Angeles

Shapiro, Daniel K.
Asst. Director, Office of Compliance/General Counsel, USC Office of Compliance

Shapiro, Michael
Dorothy W. Nelson Professor of Law, USC School of Law

Sharma, Avyaya
Clinical/Quality Engineer, Clinical Research and Clinical Trials Management, Medtronic Vascular

Shen, James.C.
Compliance Officer, US FDA

Sherman, Neil
Watson-Retired

Simmons, John
Supervisory Chemist, OPS, CDER

Slomoff, Robert Joel
Special Consultant Food and Drug Law, Fulbright & Jaworski, LLP

Smerkanich, Nancy
Global Affairs Regulatory, Octagon Research Solutions

Smith, Russell, MLS
Educational Support Librarian, USC Norris Medical Library

Son, Michael C., PhD, RAC
Director, PanGenomics, Inc.

Spencer, Helene
Spencer Instrumentation/ VP, Regulatory Affairs and Quality Assurance, GluMetrics, Inc.

Sperber, Stephanie
O’Melveny & Myers, LLP

Spicer, Darcy
Professor, Head of IRB, Clinical Medicine at USC

Spink, Peter, PhD, CPP
Asso.Dir & Asst Prof, Michigan State University

Stagg, Del
Senior Director, Allergan, Inc.

Stahl, Ann
Federal Trade Commission

Standish, Gail, Esq.
Winston & Strawn, LLP, Los Angeles

Stark, Fumi
Program Director, GNH Unit I USC

Stark, Charles
Reg Med Rsch Spec, Pfizer, Inc.

Stearns, Denis, Esq.
Marler Clark LLP PS

Steiner, Randy
Associate Director, Regulatory Affairs, Amgen, Inc.

Storm, Neal
Regulatory Affairs, Amgen, Inc.

Swain, Chris
Director, USC Games Institute, USC School of Cinamtic Arts

Swaroop, Sheila Neha, Esq.
Knobbe Martens, et al, LLP

Swit, Michael A.
The Weinberg Group, Inc./ Heller, Ehrman, White & McAuliffe LLP

Taddonio, Laurie
President, LMT Consulting, LLC

Tadjalli, Virginia
American Art & Technology

Tai, Phyllis, PharmD, M.S., Post-Doctoral Fellow
Regulatory Strategy & Risk Management, Global Regulatory Affairs, Allergan, Inc.

Taylor, Julie
Tec Solutions

Thatcher, Dave
Amgen, Inc.

Thenell, Scott
J. S. Thenell Company

Thompson, Barry
Partner, Crosby, Heafey, Roach & May (Los Angeles)

Thompson, Monica
Prosecutor, Immigration and Naturalization Services

Tonetta, Sharon
Vice President, Clinical Research and Development, Baxter Healthcare Corp

Topham, Debra K.W., MS, RD
Director, Knowledge Bank

Tsai, Yali, PhD, RPh
VP Product Development, Latitude Pharmaceuticals, Inc.

Tucker, Mark, PhD
Compliance Officer, FDA

Ubl, Stephen
President & CEO, AdvaMed

Van Antwerp, Bill
VP, Chief Scientific Officer, Medtronic Minimed

Van Etten, Aaron
Manager, Medical Writing, Amgen, Inc

Vidor, Arlene
Vice President, Regulatory Affairs, North America, Retired from Baxter

Vivirito, Michele
Principal Medical Writer, Medical Affairs Department, Amgen Inc

Volner, William
Manager, Global Trade Compliance Department , Allergan

Walsh, Michael, Esq.
Attorney, Sedgwick, Detert, Moran and Arnold

Wang, Sue-Jane
Associate Director for Adaptive Design and Pharm, Office of Biostatistics, OTS/CDER/FDA

Weber, Jeffrey, M.D.
PhD USC Norris Cancer Center

Weir, Andrea
Charles River Laboratories, Navigators

Weisbuch, Holly
Assistant Director & Quality Assurance Supervisor, Clinical Investigations Support Office

Weismann, Fred
Associate Dean, Academic & Clinical Affairs, USC School of Pharmacy

Were, Lillian, PhD,
Assistant Professor, Department of Physical Sciences, Chapman University

Williams-Hill, Donna M., PhD
Microbiologist, Food Pathogen Specialist, FDA, Department of Health & Human Services

Wilson, Rick
Allergan, Inc.

Winckler, Susan
President & CEO, Food & Drug Law Institute

Witherly, Steve, PhD
President & CEO, Technical Products Inc.. Nutraceutical consulting firm.

Wolfe, Allan, MD
UV Partners

Woodward, Karen
Attorney, Sedgwick, Detert, Moran & Arnold LLP

Wu, Weicheng, PhD
Regulatory Associate III, Watson Laboratories, Inc.

Yedigarova, Larisa, MD, PhD
Vis Assistant Professor of Research, Obstetrics & Gynecology at USC

Yen, Richard
Cofounder & CEO, Agile Pharmaceuticals, Inc.

York, Peter B.
Analyst, Pharmaceutical Security Institute

Yoshida, Hideo
Director, Regulatory Affairs, Japan, Amgen, Inc.

You, Thomas J.
Crosby, Heafey, Roach & May

Zagari, Martin
Amgen, Inc.

Zineh, Issam, PharmD, MPH
Associate Director of Genomics, Office of Clinical Pharm, Office of Translational Sciences, CDER, U.S. FDA

Zink, Donald
CIFSAN – FDA

Zoric, Joe
Director of Regulatory Affairs, Cougar Biotechnology, Los Angeles