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Conference Agenda
Saturday, June 21
7:00 am - 12:00 pm
Registration
8:00 am - 6:00 pm (with coffee at 7:30 am)
Ligand Binding Assay Training Course
ACPE #: 073-999-08-301-L04P
Room 714A
An additional fee is required to attend this training course
Sunday, June 22
7:00 am - 5:00 pm
Registration
7:00 am - 5:00 pm
Speaker Ready Room
Room 709
8:00 am - 5:00 pm
Press Room
Room 707
8:00 am - 6:00 pm (with coffee at 7:30 am)
Ligand Binding Assay Training Course (continued)
ACPE #: 073-999-08-301-L04P
Room 714A
An additional fee is required to attend the training course
8:30 am - 5:00 pm
BIOTEC Open Forum: Protein Aggregation - Therapeutic and Pharmaceutical Viewpoints
Room 701A
An additional fee is required to attend this open forum
Satish K. Singh, Ph.D.
Pfizer Inc.
Maria Lambros
Caltech & Western University of Health Sciences
1:30 pm - 5:00 pm
RS Open Forum: ComparabilityProtocols for Biologics - How Can They Be Leveraged to Obtain Regulatory Relief?
Room 716A
Funded by Grants from
An additional fee is required to attend this open forum
Monday, June 23
7:00 am - 5:30 pm
Registration
7:00 am - 5:00 pm
Speaker Ready Room
Room 709
8:00 am - 5:00 pm
Press Room
Room 707
8:30 am - 11:30 am
Plenary Session: Pharmaceutical Biotechnology - The Next Steps
Exhibit Hall G
Funded by a Grant from
8:30 am
Welcome
John Lisack, CAE
AAPS Executive Director
8:45 am
Welcome and Presentation of Chair’s Plaques
Karen Habucky, Ph.D.
2008 AAPS President
9:15 am
Opening Remarks
Giovanni M. Pauletti, Ph.D.
University of Cincinnati
2008 National Biotechnology Conference Chair
Moderators
Giovanni M. Pauletti, Ph.D.
University of Cincinnati
Andrew M. Vick, Ph.D.
Millipore Bioscience Division
9:30 am
Transgenic Oilbody Technology: New Opportunities for Pharmaceutical Biotechnology
Maurice Moloney, Ph.D.
SemBioSys
10:10 am
RNAi: An Opprotunity for a New Class of Therapeutics
Akshay K. Vaishnaw, M.D., Ph.D.
Alnylam Pharmaceuticals, Inc.
10:50 am
How to Produce Therapeutic Vaccines in Plants
Louis P. Vézina, Ph.D.
Medicago
10:30 am - 6:30 pm
AAPS Exposition
Exhibit Hall D
10:30 am - 6:30 pm
Exhibit Hall D
Funded by Grants from
10:30 am - 6:30 pm
Contributed Papers Poster Session
Exhibit Hall D
Authors will be present from
5:00 pm - 6:00 pm to answer questions.
Poster Numbers: M1001 - M1092
11:30 am - 1:30 pm
Cash and Carry Lunch
Exhibit Hall D
1:00 pm - 3:30 pm
Plant-based Biologicals: Developmental and Regulatory Aspects
SYMPOSIUM
Room 716
Moderators
Raja B. Velagapudi, Ph.D.
Barr Laboratories, Inc.
Satish K. Singh, Ph.D.
Pfizer Inc.
1:00 pm
PRODUCTION AND CHARACTERIZATION OF PLANT-BASED HUMAN INSULIN
Maurice Moloney, Ph.D.
SemBioSys
1:30 pm
THE LEX SYSTEM
Glen Williams
Biolex, Inc.
2:00 pm
REGULATORY CONSIDERATIONS IN THE DEVELOPMENT OF PLANT-BASED BIOLOGICS
Chana Fuchs, Ph.D.
U.S. Food and Drug Administration
2:30 pm
PRODUCTION AND CHARACTERIZATION OF PLANT-BASED VACCINES AND THERAPEUTIC ANTIBODIES
Irene Clement, Ph.D.
Medicago
3:00 pm
PANEL DISCUSSION
1:00 pm - 3:30 pm
Smuggler’s Junction: Getting Drugs Past the Respiratory Epithelium Into the Systemic Circulation
SYMPOSIUM
Room 714
Moderators
1:00 pm
DNA NANOPARTICLES FOR GENE TRANSFER TO THE AIRWAY EPITHELIUM
Pamela B. Davis
Case Western Reserve University
1:30 pm
ADVANCES IN NASAL DRUG DELIVERY THROUGH TIGHT JUNCTION TECHNOLOGY
Henry R. Costantino
Nastech Pharmaceutical Company Inc.
2:00 pm
NUCLEOLIPOPLEXES: A NEW PARADIGM FOR PHOSPHOLIPID BILAYER-NUCLEIC ACID INTERACTIONS
Debora Berti
Universiti di Firenza
2:30 pm
PANEL DISCUSSION
1:00 pm - 3:30 pm
Spurious Drugs
SYMPOSIUM
Room 701B
Moderator
John P. Jasper
Nature’s Fingerprint/MIT LLC
1:00 pm
THREAT OF COUNTERFEIT MEDICINES IN THE THIRD WORLD
Dipika R. Chauhan, Ph.D.
Indian Food and Drugs Control Administration
1:30 pm
SPURIOUS MEDICINES AND QUALITY REGARDING
Dipika R. Chauhan, Ph.D.
Indian Food and Drugs Control Administration
2:00 pm
COUNTERFEIT DETECTION AND QUANTITY ASSURANCE OF BIOPHARMACEUTICALS
Lucinda Buhse, Ph.D.
U.S. Food and Drugs Control Administration
2:30 pm
MITIGATING PHARMACEUTICAL COUNTERFEITING AND PROCESS PATENT INFRINGEMENT
John Jasper
Nature’s Fingerprint/MIT LLC
1:00 pm - 3:30 pm
Quality by Design
SYMPOSIUM
Room 701A
Moderator
Clarice Hutchens
Pfizer Inc.
1:00 pm
AN INDUSTRY PERSPECTIVE ON QUALITY BY DESIGN IN BIOLOGICS DEVELOPMENT
Clarice Hutchens
Pfizer Inc.
1:30 pm
REGULATORY CHALLENGES IN QUALITY BYDESIGN IMPLEMENTATION FOR BIOPHARMACEUTICALS
Sandeep Kumar, Ph.D.
Amgen Inc.
2:00 pm
FDA PERSPECTIVE ON QUALITY BY DESIGN FOR BIOLOGICS
Barry Cherney, Ph.D.
U.S. Food and Drug Administration
2:30 pm
HEALTH CANADA PERSPECTIVE ON QUALITY BY DESIGN FOR BIOLOGICS
Anthony Ridgway, Ph.D.
Health Canada
3:00 pm
PANEL DISCUSSION
3:00 pm - 4:00 pm
Coffee Break
Exhibit Hall D
3:30 pm - 5:00 pm
Current Progress and Considerations for Registration of Follow-on Protein Products
ROUNDTABLE
Room 713
Moderators
Raja B. Velagapudi, Ph.D.
Barr Laboratories, Inc.
Mei-Ling Chen, Ph.D.
U.S. Food and Drug Administration
CURRENT STATUS ON REGULATORY CONSIDERATIONS FOR FOLLOW-ON BIOLOGIES
Barry Cherney, Ph.D.
U.S. Food and Dr
UNITED STATES PHARMACOPEIA UPDATE ON BIOLOGIC STAND
Tina Morris, Ph.D., M.S.
U.S. Pharmacopeia
CHARACTERIZATION OF BIOLOGICALS
Zachary Shriver
Momenta Pharmaceuticals, Inc.
ug Administration
3:30 pm - 5:00 pm
Oral Delivery for Macromolecules: Where Are We and Where Do We Go from Here?
ROUNDTABLE
Room 715
Moderators
Rahul S. Rajan, Ph.D.
Amgen Inc.
Balvinder S. Vig, Ph.D.
Bristol-Myers Squibb Company
ORAL PEPTIDES AND PROTEINS: AN OVERVIEW
Shoufeng Li, Ph.D.
Novartis Pharmaceutical Corp.
THE FUTURE OF SMART CARRIERS IN ORAL PROTEIN DELIVERY
Anthony Lowman, Ph.D.
Drexel University
3:30 pm - 5:00 pm
Molecular Pharming: Therapeutic Antibodies from Plants and Animals
ROUNDTABLE
Room 717
Moderators
S. Russ Lehrman
Lehrman Biopharma
Satish K. Singh, Ph.D.
Pfizer Inc.
TOWARDS A CANADIAN REGULATORY FRAMEWORK FOR DRUGS MADE FROM PLANT MOLECULAR FARMING
Kwasi A. Nyarko, Ph.D.
Health Canada
PRODUCTION OF RECOMBINANT PROTEINS IN THE MILK OF TRANSGENIC ANIMALS
Yann Echelard, Ph.D.
GTC Biotherapeutics
PLANT BASED BIOLOGICS
Ajaz S. Hussain, Ph.D.
Philip Morris International
3:30 pm - 5:00 pm
Ligand Binding and Immunogenicity Assays: the Dilemma of One-Off Platforms
HOT TOPIC
Exhibit Hall D
Moderator
Julia Z. Qiu, Ph.D.
Genentech Inc.
THE END OF BIOVERIS - TRANSFERRING PK BIOANALYTICAL METHODS TO NEW IMMUNOASSAYS PLATFORMS
Jennifer Yohrling, Ph.D.
Centocor R&D
PHARMACOKINETIC METHOD COMPARISON - ELISA AND ECL
Mark H. Ma, Ph.D.
Amgen Inc.
5:00 pm - 6:30 pm
AAPS Contributed Papers Reception
Exhibit Hall D
Funded by Grants from
Tuesday, June 24
7:00 am - 5:00 pm
Registration
7:00 am - 5:00 pm
Speaker Ready Room
Room 709
7:30 am - 8:30 am
AAPS Mentoring Breakfast
Room 801B
Funded by a Grant from
7:30 am - 8:30 am
2008/2009 NBC Screeners Meeting
Room 706
Tuesday Sunrise Sessions are Funded by a Grant from
7:30 am - 8:30 am
Protein Aggregation and Immunogenicity
SUNRISE SESSION
Room 713
Moderators
Hanns-Christian Mahler, Ph.D.
F. Hoffmann-LaRoche Ltd.
Mary Cromwell, Ph.D.
Genentech Inc.
IMMUNOGENICITY CONSIDERATIONS FOR BIOPHARMACEUTICALS
Harald Kropshofer, Ph.D.
F. Hoffman-LaRoche LTD
AGGREGATION IN BIOPHARMACEUTICALFORMULATIONS AND STATE-OF-THE-ART ANALYTICAL METHODS USED
Tapan K. Das, Ph.D.
Pfizer Inc.
7:30 am - 8:30 am
Multi-factorial Statistical Design and Data Assessment in Method Development of Ligand Binding Assay
SUNRISE SESSION
Room 717
Moderator
Jean W. Lee, Ph.D.
Amgen Inc.
OVERVIEW OF MULTI-FACTORIAL OPTIMIZATION (DOE) AND THE IMPORTANCE OF ENDPOINT SELECTION
Devanarayan Viswanath, Ph.D.
Abbott Laboratories
IDENTIFICATION OF MULTIPLE FACTORS AND USE OF DOE AND ROBOTICS TO SELECT THE RIGHT CONDITIONS FOR THE VARIABLES FOR LBA METHOD VALIDATION – CASE STUDIES
Chad A. Ray, Ph.D.
Amgen Inc.
DOE FOR MICRO ARRAY AND LIGAND BINDING ASSAYS IN THE HTS DISCOVERY
G. Sitta Sittampalam, Ph.D.
The University of Kansas Medical Center
7:30 am - 8:30 am
Use of Mechanistic PK/PD Modeling to Assist Design of 2nd Generation Biologics
SUNRISE SESSION
Room 715
Moderators
Steven W. Martin, Ph.D.
Pfizer Inc.
Mark C. Peterson, Ph.D.
Amgen Inc.
CLINICAL DEVELOPMENT OF 2ND GENERATION ANTI-IGE (HAE1) MONOCLONAL ANTIBODYCASE STUDY
Jing Li, Ph.D.
Genentech Inc.
THE EVOLUTION OF ESA DRUGS AND OTHER INTERACTIVE LESSONS
Sameer Doshi, Ph.D.
Amgen Inc.
8:00 am - 5:00 pm
Press Room
Room 707
9:00 am - 10:30 am
Development and Utilization of Disease Progression Models
ROUNDTABLE
Room 713
Moderators
Mark C. Peterson, Ph.D.
Amgen Inc.
Steven W. Martin, Ph.D.
Pfizer Inc.
LITERATURE-BASED DISEASE PROGRESSION MODELS TO SUPPORT KNOWLEDGE MANAGEMENT AND DECISION-MAKING IN CLINICAL DRUG DEVELOPMENT
Farkad Ezzet, Ph.D.
Pharsight Corporation
DEVELOPMENT OF A MECHANISTIC MODEL OF BONE HOMEOSTASIS
Matthew M. Riggs, Ph.D.
Metrum Research Group LLC
9:00 am - 10:30 am
Personalized Medicine: Opportunities, Challenges and Current Status
ROUNDTABLE
Room 717
Moderators
Manohar Katakam, Ph.D.
Wyeth Pharmaceuticals
Tony Calandra, M.S.
Biogen Idec
GENETICS AND GENOMICS IN CLINICAL MEDICINE
Raju Kucherlapati, Ph.D.
Harvard Medical School
IMPLEMENTATION OF PREDICTIVE BIOMARKERS IN THE DEVELOPMENT PORTFOLIO
Mark E. Curran, Ph.D.
Bristol-Myers Squibb Company
9:00 am - 10:30 am
Oligonucleotide Bioanalysis in Biological Fluids and Tissue Samples - Points to Consider
ROUNDTABLE
Room 715
Moderator
Richard Geary, Ph.D.
ISIS Pharmaceuticals Inc.
QUANTITATIVE BIOANALYSIS OF OLIGONUCLEOTIDES IN BIOLOGICAL FLUIDS AND TISSUES
Sandra Carriero, Ph.D.
Charles River Laboratories (PCS-MTL)
BIOANALYSIS OF APTAMER MOLECULE IN APTAMER THERAPEUTICS
Renta Hutabarat, Ph.D.
Archemix Corporation
IMMUNOGENICITY ASSESSMENT FOR OLIGONUCLEOTIDES AND RELATED BIOTHERAPEUTICS
Deborah Finco-Kent, Ph.D.
Pfizer Inc.
9:00 am - 10:30 am
Requirements for the Registration of U.S.-Approved Therapeutic Biological Products in Canada
ROUNDTABLE
Room 801A
Moderator
Raja B. Velagapudi, Ph.D.
Barr Laboratories, Inc.
ANALYTICAL TECHNIQUES FOR THE EVALUATION OF SUBSEQUENT ENTRY BIOLOGICS
Michel Girard, Ph.D.
Health Canada
BIOSIMILAR REGISTRATIONS IN CANADA - INDUSTRY PERSPECTIVE
Ingrid Schwarzenberger
Sandoz
REQUIREMENTS FOR THE REGISTRATION OF U.S.-APPROVED THERAPEUTIC BIOLOGICAL PRODUCTS IN CANADA
Jian Wang, M.D., Ph.D.
Health Canada
Tuesday Morning
Symposia are
Funded by a Grant From
9:00 am - 11:30 am
Glycoprotein and Glycan Analysis of Biopharmaceutical Products
SYMPOSIUM
Room 716
Moderators
Chris Jones, Ph.D.
NIBSC
Tina S. Morris, Ph.D., M.S.
U.S. Pharmacopeia
9:00 am
DEVELOPMENT OF COMPENDIAL GUIDANCE AND REFERENCE STANDARDS FOR GLYCOPROTEIN AND GLYCAN ANALYSIS
Tina S. Morris, Ph.D., M.S.
.S. Pharmacopeia
Chris Jones, Ph.D.
NIBSC
9:30 am
EVALUATION OF CARBOHYDRATE COMPONENTS IN VACCINES
John P. Hennessey, Jr., Ph.D.
Merck Research Laboratories
10:00 am
ACADEMIC PERSPECTIVE ON COMPLEX CARBOHYDRATE ANALYSIS
Parastoo Azadi, Ph.D.
University of Georgia
10:30 am
APPLICATION OF GLYCAN ANALYSIS IN DEVELOPMENT, MANUFACTURING AND RELEASE
Joseph Siemiatkoski
Biogen Idec
11:00 am
PANEL DISCUSSION
9:00 am - 11:30 am
Advances in the Development of Virus Entry/Fusion Inhibitors
SYMPOSIUM
Room 701B
Moderators
Panayiotis P. Constantinides, Ph.D.
Biopharmaceutical & Drug Delivery
Consulting, LLC
Richard A. Houghten, Ph.D.
Torrey Pines Institute for Molecular Studies
9:00 am
NEW CHALLENGES AND OPPORTUNITIES IN MICROBICIDE DEVELOPMENT
Liza Solomon, Ph.D.
Alliance for Microbicide Development
9:30 am
PRECLINICAL AND CLINICAL DATA WITH NAPHTHALENE-2-SULFONATE POLYMER COMPOSITION
Albert T. Profy, Ph.D.
Indevus Pharmaceutical
10:00 am
PRECLINICAL STUDIES WITH MICROBICIDAL LAYERED PHYLLOSILICATES
Jerald W. Darlington, M.S.
AMCOL International
10:30 am
PANEL DISCUSSION
9:00 am - 11:30 am
Process Modeling, Controls and Monitoring for Biopharmaceutical Manufacturing
SYMPOSIUM
718A
Moderators
Manpreet-Vick S. Wadhwa, Ph.D.
Amgen Inc.
Sharmista Chatterjee, Ph.D.
U.S. Food and Drug Administration
THE ROLE OF SIMULATION AND SCHEDULING TOOLS IN BIOPROCESS DEVELOPMENT,
TECHNOLOGY TRANSFER AND MANUFACTURING OF BIOPHARMACEUTICALS
Demetri Petrides, Ph.D.
Intelligen, Inc.
9:30 am
RATIONAL DEVELOPMENT OF OPERATIONAL AND PERFORMANCE CONTROLS FOR EFFECTIVE PROCESS MONITORING
Xiangyang Wang, Ph.D.
Amgen Inc.
10:00 am
REGULATORY INSIGHTS ON SUCCESSFUL BIOPHARMACEUTICAL PAT APPLICATIONS IN GMP MANUFACTURING
Chris Watts, Ph.D.
U.S. Food and Drug Administration
10:30 am
PANEL DISCUSSION
9:00 am - 11:30 am
Protein Aggregation and Immunogenicity – Current Science and Regulations
SYMPOSIUM
701A
Moderators
Mary Cromwell, Ph.D.
Genentech Inc.
Michelle R. Frazier-Jessen, Ph.D.
MedImmune
9:00 am
PROTEIN AGGREGATION: LESSONS FROM THE DARK SIDE
Michelle R. Frazier-Jessen, Ph.D.
MedImmune
9:30 am
MEASURING PROTEIN AGGREGATES
Mary Cromwell, Ph.D.
Genentech Inc.
10:00 am
PRESENTATION TITLE TO BE DETERMINED
Ilona Reischl, Ph.D.
10:30 am
PANEL DISCUSSION - ALL SPEAKERS
10:30 am - 11:30 am
Coffee Break
Exhibit Hall D
10:30 am - 6:30 pm
AAPS Exposition
Exhibit Hall D
10:30 am - 6:30 pm
Exhibit Hall D
Funded by Grants from
10:30 am - 6:30 pm
Contributed Papers Poster Session
Exhibit Hall D
Poster Numbers: T2001 - T2093
Authors will be present from
5:00 pm - 6:00 pm to answer questions.
12:00 pm - 1:00 pm
BioTalk - Connect with Speakers
Exhibit Hall D
Topics available for discussion include
Bioanalytics Protein Characterization and Modeling Drug Discovery Formulations, Primary Packaging, Stability, Devices Immunogenicity Novel Therapeutics Drug Delivery PK/PD Patent Topics Protein Engineering Vaccines
12:00 pm - 1:00 pm
Protein Aggregation and Immunogenicity Focus Group Membership Meeting
Room 713
1:00 pm - 3:30 pm
Strategic Approaches for Immunogenicity Assessment
SYMPOSIUM
Room 701A
Moderators
Patrick M. Liu, M.D., Ph.D.
Genentech Inc.
Valerie E. Quarmby, Ph.D.
Genentech Inc.
1:00 pm
ASSESSING IMMUNOGENICITY IN NONCLINICAL STUDIES: WHAT’S THE PURPOSE AND HOW TO DEFINE A MEANINGFUL BIOANALYTICAL STRATEGY (CASE STUDY)
Bonita Rup, Ph.D.
Wyeth Research
1:30 pm
DETECTION LIMIT REQUIREMENTS FOR IMMUNOGENICITY ASSAYS
Lorin K. Roskos, Ph.D., R.Ph.
AstraZeneca Pharmaceuticals
2:00 pm
NEUTRALIZING ANTIBODY ASSESSMENTS FOR BIOLOGICALS DURING CLINICAL DEVELOPMENT
Shalini Gupta, Ph.D.
Amgen Inc.
2:30 pm
ASSESSING IMMUNOGENICITY IN CLINICAL PROGRAMS - DESIGNING AN INFORMATIVE
BIOANALYTICAL STRATEGY
Valerie E. Quarmby, Ph.D.
Genentech Inc.
3:00 pm
SURROGATE MARKERS FOR VACCINES – A REGULATORY PERSPECTIVE
Elwyn Griffiths, Ph.D.
Health Canada
1:00 pm - 3:30 pm
State of the Art in Prediction of Protein Stability by Computational Methods and Their Utilization in Protein Design and Formulation Development
SYMPOSIUM
Room 701B
Moderators
Satish K. Singh, Ph.D.
Pfizer Inc.
Tapan K. Das, Ph.D.
Pfizer Inc.
1:00 pm
MOLECULAR SIMULATIONS FOR THERAPEUTIC ANTIBODY DESIGN AND FORMULATION
Bernhardt L. Trout, Ph.D.
Massachusetts Institute of Technology
1:30 pm
ENGINEERING DEVELOPABILITY IN BIOPHARMACEUTICALS BY TARGETING POLYPEPTIDE AGGREGATION AND STABILITY
Jesús Zurdo, Ph.D.
Lonza Biologics PLC, UK
2:00 pm
SIMULATIONS OF “SIMPLE” MODEL PROTEINS WITH APPLICATIONS IN BIOTECHNOLOGY AND BIOMEDICINE
Troy Cellmer, Ph.D.
National Institutes of Health
2:30 pm
THE ROAD NOT TAKEN: MOLECULAR DYNAMICS SIMULATIONS OF AMYLOID BETA PEPTIDE GLOBULOMER AND ITS RELATIONSHIP WITH AMYLOID BETA-PEPTIDE AGGREGATION
Buyong Ma, Ph.D.
National Cancer Institute
3:00 pm
PANEL DISCUSSION
1:00 pm - 3:30 pm
Defining Biomarkers and Advancing Biomarkers from Discovery to Diagnostics
SYMPOSIUM
Room 716
Moderators
Brian R. Moyer, M.S., CNMT
Contractor, Health and Human Services/BARDA
BRMoyer & Associates, LLC
William Kramp, Ph.D.
Contractor, Health and Human Services/BARDA
1:00 pm
IMAGING BIOMARKERS - AN INNOVATIVE DRUG DISCOVERY TOOL
Brian R. Moyer, M.S., CNMT
Contractor, Health and Human Services/BARDA
BRMoyer & Associates, LLC
1:25 pm
VACCINE BIOMARKERS - STATE OF THE TECHNOLOGY
William Kramp, Ph.D.
Contractor, Health and Human Services/BARDA
1:50 pm
PRECLINICAL DEVELOPMENT OF A NOVEL VASCULAR DISRUPTING AGENT, BIOMARKERS OF EFFICACY
Kevin Foley, Ph.D.
Synta Pharmaceuticals
2:15 pm
FDA PERSPECTIVES ON DEVELOPMENT AND QUALIFICATION OF COMPANION DIAGNOSTICS
Courtney C. Harper, Ph.D.
U.S. Food and Drug Administration
2:40 pm
SURROGATE MARKERS FOR VACCINES – A REGULATORY PERSPECTIVE
Elwyn Griffiths, Ph.D.
Biologics and Genetic Therapies Directorate, Health Canada
3:10 pm
PANEL DISCUSSION
1:00 pm - 3:30 pm
Analytical and In Vivo Assessment of Comparability for Biologics Prior to Approval
SYMPOSIUM
Room 718A
Moderators
Saileta Prabhu, Ph.D., M.Pharm.
Genentech Inc.
Wendy Putnam, Ph.D.
Genentech Inc.
1:00 pm
COMPARABILITY DURING CLINICAL DEVELOPMENT OF mAbs: EXAMPLES OF PROCESS AND PRODUCT CHANGES
Kathleen Francissen, Ph.D.
Genentech Inc.
1:30 pm
TECHNICAL & ANALYTICAL CHALLENGES IN BIOLOGICAL CHARACTERIZATION OF BIOTHERAPEUTICS
Meena Subramanyam, Ph.D.
Biogen Idec, Inc.
2:00 pm
RISK-BASED PK/PD COMPARABILITY ASSESSMENTS IN DRUG DEVELOPMENT
Yow-Ming C. Wang, Ph.D.
Amgen Inc.
2:30 pm
A RISK ASSESSMENT OF PRE-LICENSURE MANUFACTURING CHANGES
Patrick G. Swann, Ph.D.
U.S. Food and Drug Administration
3:00 pm
PANEL DISCUSSION
3:00 pm - 4:00 pm
Coffee Break
Exhibit Hall D
3:30 pm - 5:00 pm
Preparative Separation Science and Biotechnology
ROUNDTABLE
Room 717
Moderator
Satinder Ahuja, Ph.D., M.Pharm.
Ahuja Consulting
OVERVIEW OF PREPARATORY SEPARATION SCIENCE AND BIOTECHNOLOGY
Satinder Ahuja, Ph.D., M.Pharm.
Ahuja Consulting
CAPILLARY ELECTROPHORESIS: A PRACTICAL TOOL TO SUPPORT PROCESS DEVELOPMENT
Oscar Salas-Solano, Ph.D.
Genentech, Inc.
REGULATORY ISSUES AND CHALLENGES FOR DRUG CANDIDATES THAT EMPLOY PREPARATIVE SEPARATIONS
Christine Seymour, Ph.D.
Pfizer Global Research & Development
3:30 pm - 5:00 pm
Data Analysis for Anti-product Antibody Assessment
ROUNDTABLE
Room 713
Moderator
Boris M. Gorovits, Ph.D.
Wyeth
IMMUNOGENICITY ASSAY VALIDATION CRITERIA - PRACTICAL POINT OF VIEW
Boris M. Gorovits, Ph.D.
Wyeth
3:30 pm - 5:00 pm
Strategic Integration of Quantitative Pharmacology Throughout Antibody Drug Development
ROUNDTABLE
Room 715
Moderator
Mohammad A. Tabrizi, Ph.D., R.Ph.
AstraZeneca Pharmaceuticals
APPLICATION OF MODELING & SIMULATION IN SUPPORT OF ANTIBODY DEVELOPMENT FROM BENCH TO BEDSIDE
Lorin K. Roskos, Ph.D., R.Ph.
AstraZeneca Pharmaceuticals
MODEL-BASED DRUG DEVELOPMENT: ANTIBODIES IN ONCOLOGY
Yu-Nien (Tom) Sun, Ph.D.
Amgen Inc.
MODEL-BASED DRUG DEVELOPMENT: ANTIBODIES IN INFLAMMATORY DISEASES
Amita S. Joshi, Ph.D.
Genentech Inc.
3:30 pm - 5:00 pm
“Total” or “Free” PK/PD Assays - What Should Be Measured In A Ligand Binding Assay
HOT TOPIC
Exhibit Hall D
Moderator
Jean Lee, Ph.D.
Amgen Inc.
ADD SPEAKERS
5:00 pm - 6:30 pm
AAPS Conributed Papers Reception
Exhibit Hall D
5:30 pm - 7:30 pm
BIOTEC Section Membership Meeting and Reception
Room 718A
Wednesday, June 25
7:00 am - 5:00 pm
Registration
7:00 am - 5:00 pm
Speaker Ready Room
Room 709
7:30 am - 8:30 am
2008/2009 NBC Program Committee Meeting
Room 706
7:30 am - 8:30 am
siRNA as Therapeutic Agents - Promises and Challenges
SUNRISE SESSION
Room 715
Moderators
K. Sandy Pang, Ph.D.
University of Toronto
Jerome Hochman, Ph.D.
Merck and Company
RNAi MECHANISMS AND APPLICATION
John J. Rossi, Ph.D.
Beckman Research Institute of City of Hope
Speaker to be announced
siRNA AS A NEW CLASS OF THERAPEUTIC AGENTS: DMPK PERSPECTIVES
Jerome Hochman, Ph.D.
Merck and Company
7:30 am - 8:30 am
High Concentration Protein Formulations
SUNRISE SESSION
Room 717
Moderator
Hanns-Christian Mahler, Ph.D.
F. Hoffmann-La Roche Ltd.
FORMULATION CHALLENGES OF HIGHCONCENTRATION ANTIBODY DOSAGE FORMS
Wolfgang Friess, Ph.D.
University of Munich
ANALYTICAL CHALLENGES FOR HIGHCONCENTRATION ANTIBODY FORMULATIONS
Jun Liu, Ph.D.
Genentech, Inc.
7:30 am - 8:30 am
A Primer on Enzyme Replacement Therapies
SUNRISE SESSION
Room 713
Moderator
Alison McVie-Wylie, Ph.D.
Genzyme Corp.
PHARMACOKINETICS-PHARMACODYNAMICS OF ERTs
Kerry Culm-Merdek, Ph.D.
Genzyme Corp.
CLINICAL ASPECTS OF ERTs
Celeste Decker, M.D.
BioMarin Pharmaceutical Inc.
8:00 am - 11:30 am
Press Room
Room 707
9:00 am - 10:30 am
Drug-Drug Interactions for Biologics and Small Molecule Combinations
ROUNDTABLE
Room 713
Moderators
Frank-Peter Theil, Ph.D., Pharm.D.
Genentech Inc.
Sandhya Ramanathan-Girish, Ph.D., M.S., M.Pharm.
Genentech Inc.
CURRENT KNOWLEDGE ON CLEARANCE MECHANISMS: DRUG-DRUG INTERACTION POTENTIAL FOR MONOCLONAL ANTIBODIES WITH OTHER PROTEIN BIOTHERAPEUTICS AND SMALL MOLECULE DRUGS
Frank-Peter Theil, Ph.D., Pharm.D.
Genentech Inc.
HOW TO ADDRESS POTENTIAL DRUG-DRUG INTERACTIONS OF PROTEIN BIOTHERAPEUTICS INCLUDING mAb AND OTHER BIOLOGICALS IN CLINICAL DEVELOPMENT?
Barbara J. Brennan, Pharm.D.
F. Hoffmann-LaRoche Ltd.
REGULATORY PERSPECTIVE ON DRUG-DRUG INTERACTION STRATEGY FOR PROTEIN BIOTHERAPEUTICS
Jang-Ik Lee, Ph.D., Pharm.D.
U.S. Food and Drug Administration
9:00 am - 10:30 am
Lab-On-A-Chip Systems in Biotechnology
ROUNDTABLE
Room 717
Moderators
Susan M. Lunte, Ph.D.
University of Kansas
Nathan A. Lacher, Ph.D.
Pfizer Global Biologics
COMMERCIAL MICROFLUIDIC SYSTEMS FOR PROTEOMICS AND CELLULAR ASSAYS
Susan M. Lunte, Ph.D.
University of Kansas
MICROFLUIDIC SYSTEMS FOR\ CELL-BASED ASSAYS
Aaron Wheeler
University of Toronto
MICROFLUIDIC SYSTEMS FOR PHARMACEUTICAL ANALYSIS
Sabeth Verpoorte
University of Groningen
9:00 am - 10:30 am
Storage and Shipping of Biologics
ROUNDTABLE
Room 715
Moderators
Satish K. Singh, Ph.D.
Pfizer Inc.
Hanns-Christian Mahler, Ph.D.
F. Hoffmann-LaRoche Ltd.
IMPLEMENTATION OF A STRATEGY TOOPTIMIZE STORAGE AND SHIPPING OF BIOPHARMACEUTICAL BULK DRUG SUBSTANCES
Thomas M. Spitznagel, Ph.D.
Human Genome Sciences
FREEZING AND THAWING OF BIOLOGICS
Michael Pikal, Ph.D.
University of Connecticut
CURRENT TRENDS IN DEVELOPING EXPERIMENTAL MODELS FOR STORAGE AND SHIPPING OF BIOPHARMACEUTICALS
Sriram Vemuri, Ph.D.
SIPCO LLC
9:00 am - 10:30 am
Successful Nonclinical Development of High Risk Biotherapeutics
HOT TOPIC
Room 801A
Moderators
Jennifer E. Visich, Ph.D.
Genentech Inc.
Victor Wroblewski, Ph.D.
Eli Lilly and Company
PHARMACOKINETIC STRATEGIES FOR ESTIMATING EXPOSURE-BASED, SCIENCEDRIVEN SAFETY MARGINS FOR HIGH RISK THERAPEUTICS
Eric Stefanich
Genentech Inc.
WHEN “ONE SIZE” DOES NOT FIT ALL: CHALLENGES AND OPPORTUNITIES IN THE
DESIGN OF NONCLINICAL SAFETY PROGRAMS FOR HIGH RISK BIOTHERAPEUTICS
Laura Andrews, Ph.D., D.A.B.T.
Genzyme Corporation
9:00 am - 11:30 am
Alternative Scaffolds – Beyond Antibody Based Biologics
SYMPOSIUM
Room 701B
Moderators
Andrew M. Vick, Ph.D.
Millipore Bioscience Division
Wolfgang Glaesner, Ph.D.
Eli Lilly and Company
9:00 am
THE RISE OF NON-ANTIBODY PROTEIN SCAFFOLDS FOR MOLECULAR RECOGNITION IN
MEDICAL THERAPY AND BIOTECHNOLOGY
Arne Skerra, Ph.D.
Technische Universitaet Muenchen
9:30 am
ADNECTINS, A NOVEL, PROPRIETARY CLASS OF TARGETED BIOLOGICS
Eric Furfine, Ph.D.
Adnexus
10:00 am
ANTICALIN, A NOVEL CLASS OF BINDING PROTEINS AND THEIR USE AS THERAPEUTICS
Andreas M. Hohlbaum, Ph.D.
Pieris AG
10:30 am
MONO AND DUAL TARGETING USING DOMAIN ANTIBODIES
Laurent S. Jespers, Ph.D.
Domantis
11:00 am
TITLE TO BE DETERMINED
Hans de Haard, Ph.D.
Ablynx NV
9:00 am - 11:30 am
Biomarkers and Decision Making During Drug Development
SYMPOSIUM
Room 701A
Moderator
Paul Fielder, Ph.D.
Genentech Inc.
9:00 am
USING PD BIOMARKERS TO ADDRESS CHALLENGES IN DRUG DEVELOPMENT
William C. Manning, Ph.D.
Genentech Inc.
9:30 am
PROTEOMIC PROFILING OF ASCITES TO IDENTIFY PUTATIVE BIOMARKERS FOR OVARIAN CANCER
Thomas Kislinger, Ph.D.
University of Toronto
10:00 am
TRANSLATION OF PRE-CLINICAL PHARMACODYNAMIC BIOMARKERS TO THE CLINIC FOR THE DEVELOPMENT OFLARGE MOLECULE DRUGS IN AUTOIMMUNE DISEASES
Heleen Scheerens, Ph.D.
Genentech Inc.
10:30 am
THE USE OF HEALTHY VOLUNTEER MODELS OF DISEASE STATES TO ACCELERATE EARLY CLINICAL DEVELOPMENT
John Connell, Ph.D.
Icon Development Solutions
11:00 am
PANEL DISCUSSION
9:00 am - 11:30 am
Immunogenicity of Therapeutic Proteins - From Assay Methodology to Clinical Impact
SYMPOSIUM
Room 718B
Moderators
Hong Zhao, Ph.D.
U.S. Food and Drug Administration
Amita S. Joshi, Ph.D.
Genentech Inc.
9:00 am
IMMUNOGENICITY OF THERAPEUTIC PROTEINS: A REGULATORY PERSPECTIVE ON CHALLENGES
Susan L. Kirshner, Ph.D.
U.S. Food and Drug Administration
9:30 am
IMMUNOGENICITY TESTING OF BIOLOGICAL PRODUCTS IN ANIMAL STUDIES - THE VALUE AND THE CHALLENGES
Lynne LeSauteur, Ph.D.
Charles River Laboratories
10:00 am
IMPACT OF IMMUNOGENICITY ON PHARMACOKINETICS, EFFICACY AND SAFETY OF MONOCLONAL ANTIBODIES – INDUSTRY EXPERIENCE
Amita S. Joshi, Ph.D.
Genentech Inc.
10:30 am
IMPACT OF IMMUNOGENICITY ON PHARMACOKINETICS, EFFICACY AND SAFETY OF THERAPEUTIC PROTEINS -FDA EXPERIENCE
Hong Zhao, Ph.D.
U.S. Food and Drug Administration
11:00 am
PANEL DISCUSSION
9:00 am - 11:30 am
Effective Targeted Delivery of RNAi Diagnostics and Therapy
SYMPOSIUM
Room 718A
Moderators
Ram I. Mahato, Ph.D.
University of Tennessee
Maria Lambros, Ph.D.
Caltech & Western University of Health Sciences
9:00 am
USING siRNA IN PROPHYLACTIC AND THERAPEUTIC REGIMENS AGAINST SARS CORONAVIRUS
Patrick Y. Lu, Ph.D.
siRNAomics, Inc.
9:30 am
EFFECTIVE DELIVERY OF siRNAS FOR DEVELOPMENT OF RNAi BASED THERAPEUTICS
Shaguna Seth, Ph.D.
Nastech Pharmaceutical Company, Inc.
10:00 am
SILENCING OFF MULTIPLE PRO-APOPTOTIC GENES FOR IMPROVING HUMAN ISLET
TRANSPLANTATION
Ram I. Mahato, Ph.D.
University of Tennessee
10:30 am
PATHWAYS OF FUNCTIONAL siRNA DELIVERY MEDIATED BY CATIONIC LIPIDS
Jianzhu Chen
Massachusetts Institute of Technology
11:00 am
PANEL DISCUSSION
11:30 am - 1:00 pm
Graduate Student Symposium Luncheon
Funded by a Grant from
Room 801B
Graduate students whose research has been competitively judged as outstanding will present the findings of their research efforts.
Moderators:
Victor Wroblewski, Ph.D.
Eli Lilly and Company
Andrew M. Vick, Ph.D.
Millipore Bioscience Division
Su-Eon Jin
Seoul National University
Poster M1027
Dilip Damodarrao Devineni
Mercer University
Poster M1015
Christian Grimstein
College of Pharmacy, University of Florida
Poster M1042
Payal Agarwal
Saint Johns University-NY
Poster M1049
1:00 pm - 3:30 pm
Stabilization, Characterization and Formulation Considerations of Biologics in Primary Containers
SYMPOSIUM
Rom 701A
Moderator
Neelima V. Phadnis, Ph.D.
Consultant
1:00 pm
REGULATORY PERSPECTIVE ON EXTRACTABLE AND LEACHABLE SUBSTANCES IN PRIMARY CONTAINERS
Ingrid Markovic, Ph.D.
U.S. Food and Drug Administration
1:30 pm
FORMULATION CONSIDERATIONS OF BIOLOGICS IN PRIMARY CONTAINERS
Manisha M. Dali, Ph.D.
Bristol-Myers Squibb Company
2:00 pm
CHALLENGES IN UNDERSTANDING PARTICLE FORMATION IN PRIMARY CONTAINERS FOR MONOCLONAL ANTIBODY FORMULATIONS
Rahul S. Rajan, Ph.D.
Amgen Inc.
2:30 pm
BIOLOGICS IN SOLUTION AND INTERACTION WITH CONTAINER CLOSURE SYSTEMS
Satish K. Singh, Ph.D.
Pfizer Inc.
3:00 pm
SUMMARY AND PANEL DISCUSSION
Neelima V. Phadnis, Ph.D.
Consultant
1:00 pm - 3:30 pm
Product Development and Regulatory Perspectives on Gene Therapy
SYMPOSIUM
Room 718B
Moderator
Alain P. Rolland, Ph.D.
Vical Incorporated
1:00 pm
PRODUCT DEVELOPMENT FOR PLASMID BASED GENE THERAPY
Alain P. Rolland, Ph.D.
Vical Incorporated
1:30 pm
HIF-BE/VPIG GENE TRANSFER FOR THERAPEUTIC ANGIOGENESIS
Geoff Akita, Ph.D., D.V.M.
Genzyme Corporation
2:00 pm
AAV IN PARKINSON’S DISEASE
Jeffrey M. Ostrove, Ph.D.
Ceregene Inc.
2:30 pm
REGULATORY CHALLENGES
Joyce L. Frey-Vacconcells, Ph.D.
PharmNet Consulting
3:00 pm
PANEL DISCUSSION
1:00 pm - 3:30 pm
Immune Tolerance Induction for Protein Therapeutics
SYMPOSIUM
Room 718A
Moderator
Amy S. Rosenberg, M.D.
U.S. Food and Drug Administration
1:00 pm
MECHANISMS OF TOLERANCE INDUCTION
Terry B. Strom, Ph.D.
Beth Israel Deaconess Medical Center/
Harvard Medical School
1:30 pm
TOLERANCE INDUCTION IN NON-HUMAN AND HUMAN PRIMATES-POTENTIAL MECHANISMS OF THE HYPORESPONSIVE STATE
Lou Vaickus, M.D.
Tolerx, Inc.
2:00 pm
TOLERANCE INDUCTION TO ENZYME REPLACEMENT THERAPY: ROLE OF MANNOSE-6-PHOSPHATE RESIDUES
Emil D. Kakkis, M.D., Ph.D.
BioMarin Pharmaceutical Inc.
2:30 pm
ERT IN POMPE’S DISEASE: NECESSITY FOR TOLERANCE INDUCTION
Richard Moscicki, M.D.
Genzyme Corporation
3:00 pm
PANEL DISCUSSION
1:00 pm - 3:30 pm
Site-specific Delivery of Nucleic Acids for Treating Fibrosis
SYMPOSIUM
Room 701B
Moderators
Ram I. Mahato, Ph.D.
University of Tennessee
Maria Lambros, Ph.D.
California Institute of Technology
1:00 pm
NEW INSIGHTS INTO FIBROSIS AND EXTRACELLULAR MATRIX
Scott L. Friedman, M.D.
Mount Sinai School of Medicine
1:30 pm
SITE-SPECIFIC DELIVERY OF OLIGONUCLEOTIDES AND siRNA FOR TREATMENT OF LIVER FIBROSIS
Ram I. Mahato, Ph.D.
University of Tennessee
2:00 pm
MICRORNAS, TGF-BETA 1, ANGIOTENSIN RECEPTORS, AND PULMONARY FIBROSIS -
ARE THEY ALL INTER-RELATED
Terry S. Elton, Ph.D.
The Ohio State University
2:30 pm
ADV-SHRNA FOR GENE SILENCING
Chae-OK Yun, Ph.D.
Yonsei University College of Medicine
South Korea
3:00 pm
SYSTEMIC DELIVERY OF siRNA VIA TARGETED NANOPARTICLES
Mark E. Davis, Ph.D.
California Institutes of Technology
3:30 pm - 5:00 pm
Designing Immunogenicity of Biopharmaceuticals Through Glycoengineering
ROUNDTABLE
Room 713
Moderator
Uwe Marx, M.D.
ProBioGen AG
PHARMACEUTICAL GLYCODESIGN - IMPACT ON HUMAN IMMUNOGENICITY
Werner Reutter, M.D.
Institute of Biochemistry and Molecular Biology
Charité Berlin
CHALLENGES AND HURDLES OF MODERN IMMUNOGENICITY TESTING
Huub Schellekens, M.D., Ph.D.
Utrecht University
NEW APPROACHES IN IMMUNOGENICITY TESTING IN VITRO
Christopher Giese, Ph.D., R.Ph.
ProBioGen AG
3:30 pm - 5:00 pm
Challenges and Opportunities in siRNA Delivery
ROUNDTABLE
Room 715
Moderator
Panayiotis P. Constantinides, Ph.D.
Biopharmaceutical & Drug Delivery
Consulting, LLC
OPPORTUNITIES AND CHALLENGES OF siRNA-BASED THERAPIES
William Kohlbrenner, Ph.D.
Abbott Laboratories
LIPIDIC NANOPARTICLES AND TRANSFECTION AGENTS FOR siRNA DELIVERY
Devin Leake, Ph.D.
Thermo Fisher Scientific
NANOPARTICLE-MEDIATED siRNA DELIVERY FOR MULTI-TARGETED RNAi THERAPEUTICS
Patrick Y. Lu, Ph.D.
Sirnaomics, Inc.
3:30 pm - 5:00 pm
Update and Impact of Legislation and Regulations for Biosimilars
ROUNDTABLE
Room 717
Moderator
Eyal H. Barash, J.D., M.S.
Aptuit Consulting
A BIOSIMILAR PREQUEL: KEY PROVISIONS OF THE HATCH-WAXMAN ACT FOR SMALL MOLECULES
Eyal H. Barash, J.D., M.S.
Aptuit Consulting
LEGISLATING AND REGULATING BIOSIMILARS - WHERE WE ARE TODAY
Arie Michelsohn, J.D., Ph.D.
Milbank, Tweed, Hadley & McCloy, LLP
3:30 pm - 5:00 pm
New EMEA Guidance on Immunogenicity for Biologicals
HOT TOPIC
Room 801A
Moderator
Valerie E. Quarmby, Ph.D.
Genentech Inc.
NEW EMEA GUIDANCE ON IMMUNOGENICITY - EMEA PERSPECTIVE
Robin Thorpe, Ph.D.
National Institute for Biological Standards
and Control
NEW EMEA GUIDANCE ON IMMUNOGENICITY - U.S. PERSPECTIVE
An Song, Ph.D.
Genentech Inc.
Thursday, June 26
7:30 am - 5:00 pm
Short Course Registration
700 Level
8:30 am - 5:00 pm
Short Course 1: Binding to the Target Ligand: Monoclonal Antibody PK/PD First Principles (Berkeley Madonna Hands-On)
ACPE #: 073-999-08-302-L04P
Room 715A
Please be sure to bring your own laptop
An additional fee is required to attend this course.
Short Course #2: Overview of Monoclonal Antibody Immunoconjugates in Cancer Therapy
Thursday, June 26, 2008
8:30 am - 5:00 pm
Room 715B
ACPE Number: #073-999-08-303-L04P
An additional fee is required to attend this course.
Several approaches have been used in the treatment of cancer, including radiation therapy, cytotoxics and cytokines. Treatment should be aggressively as possible to destroy the tumor but in doing so often leads to severe side effects and therefore many promising therapeutics cannot be administered systemically. Similarly many cytokines function physiologically in a para- or autocrine fashion at high concentration to have effects. One approach that is currently being investigated to concentrate the effects of these various agents at the tumor site is via conjugation to tumor specific antibodies. This short course will outline analytical issues in the measurement of these molecules in serum as well as preclinical and clinical development issues for antibody-drug conjugates and fusion proteins. Immunocongates will cover the following types of molecules; antibody-drug conjugates; immunotoxins; antibody-directed enzyme prodrugs; antibody cytokine fusion proteins; and bispecific double antibodies.
Moderators
Steven W. Martin, Ph.D.
Pfizer Inc.
Mark C. Peterson, Ph.D.
Amgen Inc.
7:30 am – 8:30 am
Coffee Service
8:45 am - 9:15 am
Welcome and Introduction
Steven W. Martin, Ph.D.
Pfizer Inc.
9:15 am - 10:15 am
Bioanalytical Considerations for Antibody-drug Conjugates
Surinder Kaur, Ph.D.
Genentech, Inc.
10:15 am – 10:30 am
Coffee Break
10:30 am – 11:30 am
Preclinical Development Issues for Immunoconjugates
Jay Tibbitts, Ph.D., D.V.M.
Genentech Inc.
11:30 am – 12:30 pm
Clinical Development Issues for mAB -Cytokines
Michael Derby, Ph.D.
Roche Palo Alto LLC
12:30 pm – 1:30 pm
Lunch
713AB
Lunch is complimentary to all short course attendees.
1:30 pm -2:30 pm
Antibody-directed Enzyme Prodrug Therapy: Preclinical and Clinical Development with an Engineered Fusion Protein
Richard H. Begent, Ph.D., M.D.
Royal Free and University College Medical School
2: 30 pm – 3: 30 pm
Antibody-maytansinoid Conjugates as Anticancer Therapeutics: Proving their Benefit
Hans Erickson, Ph.D.
Immunogen, Inc.
3:30 pm – 4:00 pm
Coffee Break
4:00pm – 5:00 pm
Recent Advances in AntibodyImmunoconjugates -focusing on cytotoxins and cytokines
Steven C. Alley, Ph.D.
Seattle Genetics, Inc.
5:00 pm – 5:15 pm
Final Discussion and Closing Remarks
5:15 pm
Adjournment
8:30 am - 5:00 pm
Short Course 3: Unwanted Immunogenicity of Protein Therapeutics
ACPE #: 073-999-08-304-L04P
Room 714A
An additional fee is required to attend this course.
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