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Sunday, November 17, 2024
7:00 AM – 8:00 AM
CT
CE Continental Breakfast
7:00 AM – 8:00 AM
CT
CE Continental Breakfast
Location: Lone Star Ballroom Foyer
7:00 AM – 8:00 AM
CT
New Member Mingle and VIP Breakfast
7:00 AM – 8:00 AM
CT
New Member Mingle and VIP Breakfast
Location: Room 303
7:00 AM – 6:00 PM
CT
Registration Open
7:00 AM – 6:00 PM
CT
Registration Open
Location: Lone Star Ballroom Foyer
8:00 AM – 11:30 AM
CT
Regulatory Toxicology Case Studies: An Interactive Session Involving Industry, CRO, Consultant and Regulatory Perspectives (CE1)
CE Course Chair:
Simon Authier, DVM, MBA, PhD, DSP
– Charles River Laboratories
CE Course Chair:
Katie B. Sokolowski, PhD, DABT
– Denali Therapeutics
CE Course Speaker:
Denis Roy, PhD
– SciLucent, Inc.
CE Course Speaker:
Armaghan Emami, PharmD, PhD
– US FDA
CE Course Speaker:
Paramita Mookherjee, PhD, DABT
– Regeneron
CE Course Speaker:
Wendy Haines, PhD, DABT, ERT
– PharmEng Technology
Advanced
Practical
8:00 AM – 11:30 AM
CT
Regulatory Toxicology Case Studies: An Interactive Session Involving Industry, CRO, Consultant and Regulatory Perspectives (CE1)
Location: Lone Star Ballroom F
CE Course Chair:
Simon Authier, DVM, MBA, PhD, DSP
– Charles River Laboratories
CE Course Chair:
Katie B. Sokolowski, PhD, DABT
– Denali Therapeutics
CE Course Speaker:
Denis Roy, PhD
– SciLucent, Inc.
CE Course Speaker:
Armaghan Emami, PharmD, PhD
– US FDA
CE Course Speaker:
Paramita Mookherjee, PhD, DABT
– Regeneron
CE Course Speaker:
Wendy Haines, PhD, DABT, ERT
– PharmEng Technology
Advanced
Practical
8:00 AM – 8:10 AM
CT
Introduction (CE1-1)
CE Course Speaker:
Katie B. Sokolowski, PhD, DABT
– Denali Therapeutics
8:10 AM – 8:50 AM
CT
Case Study Example #1: Advancing Gene Therapy: A Case Study on AAV Program Design for Central Nervous System Delivery in Orphan Indications (CE1-2)
CE Course Speaker:
Simon Authier, DVM, MBA, PhD, DSP
– Charles River Laboratories
8:50 AM – 9:30 AM
CT
Case Study Example #2: Leveraging the 505(b)(2) Pathway for an Investigational New Drug Formulation Using New Administration Modalities (CE1-3)
CE Course Speaker:
Denis Roy, PhD
– SciLucent, Inc.
9:30 AM – 10:00 AM
CT
Break (CE1-Break)
10:00 AM – 10:30 AM
CT
Case Study Example #3: Local Safety Margins for Intra-articular Products (CE1-4)
CE Course Speaker:
Armaghan Emami, PharmD, PhD
– US FDA
10:30 AM – 11:00 AM
CT
Case Study Example #4: Residual Solvent Toxicity in Products (CE1-5)
CE Course Speaker:
Wendy Haines, PhD, DABT, ERT
– PharmEng Technology
11:00 AM – 11:30 AM
CT
Case Study Example #5: Applying Nonclinical Data in Requesting Study Waivers for NMEs (CE1-6)
CE Course Speaker:
Paramita Mookherjee, PhD, DABT
– Regeneron
8:00 AM – 11:30 AM
CT
Fundamentals of Nonclinical Toxicology Study Pathology Reports, Peer Reviews, and Working Groups for Toxicologists and Regulators (CE2)
CE Course Chair:
Tom Steinbach, DVM, DACVP, DABT
– EPL, Inc.
CE Course Chair:
Daniel Patrick, DVM, DACVP, DABT
– Eli Lilly and Company, Inc.
CE Course Speaker:
Deb Tokarz, DVM, PhD, DACVP
– EPL, Inc.
CE Course Speaker:
Paul Snyder, DVM, DACVP, PhD
– EPL, Inc.
CE Course Speaker:
Ines Pagan, DVM, PhD
– US FDA
Foundational (Basic)
Practical
8:00 AM – 11:30 AM
CT
Fundamentals of Nonclinical Toxicology Study Pathology Reports, Peer Reviews, and Working Groups for Toxicologists and Regulators (CE2)
Location: Lone Star Ballroom C
CE Course Chair:
Tom Steinbach, DVM, DACVP, DABT
– EPL, Inc.
CE Course Chair:
Daniel Patrick, DVM, DACVP, DABT
– Eli Lilly and Company, Inc.
CE Course Speaker:
Deb Tokarz, DVM, PhD, DACVP
– EPL, Inc.
CE Course Speaker:
Paul Snyder, DVM, DACVP, PhD
– EPL, Inc.
CE Course Speaker:
Ines Pagan, DVM, PhD
– US FDA
Foundational (Basic)
Practical
8:00 AM – 8:05 AM
CT
Introduction (CE2-1)
CE Course Chair:
Tom Steinbach, DVM, DACVP, DABT
– EPL, Inc.
8:05 AM – 8:40 AM
CT
The Pathology Report (CE2-2)
CE Course Speaker:
Deb Tokarz, DVM, PhD, DACVP
– EPL, Inc.
8:40 AM – 9:15 AM
CT
Pathology Peer Review (CE2-3)
CE Course Speaker:
Daniel Patrick, DVM, DACVP, DABT
– Eli Lilly and Company, Inc.
9:15 AM – 9:30 AM
CT
Case Study and Panel Discussion: Part 1 (CE2-Panel1)
CE Course Speaker:
Tom Steinbach, DVM, DACVP, DABT
– EPL, Inc.
9:30 AM – 10:00 AM
CT
Break (CE2-Break)
10:00 AM – 10:35 AM
CT
Pathology Working Group (CE2-4)
CE Course Speaker:
Paul Snyder, DVM, DACVP, PhD
– EPL, Inc.
10:35 AM – 11:10 AM
CT
Reading a Pathology Report, Peer Review, or PWG Report from a Regulator’s Perspective (CE2-5)
CE Course Speaker:
Ines Pagan, DVM, PhD
– US FDA
11:10 AM – 11:30 AM
CT
Case Study and Panel Discussion: Part 2 (CE2-Panel2)
8:00 AM – 11:30 AM
CT
The Use of Novel Tools in Nonclinical Safety to Advance Drug Discovery and Early Development (CE3)
CE Course Chair:
Patricia Ryan, PhD
– AstraZeneca
CE Course Chair:
Julia Johansson, PhD
– AstraZeneca
CE Course Speaker:
Serah Kang, PhD
– Genentech, Inc.
CE Course Speaker:
Wen Sun, PhD
– Pfizer
CE Course Speaker:
Brian Vega, PhD
– Merck
CE Course Speaker:
Nakissa Sadrieh, PhD
– US FDA
Advanced
Emerging
8:00 AM – 11:30 AM
CT
The Use of Novel Tools in Nonclinical Safety to Advance Drug Discovery and Early Development (CE3)
Location: Lone Star Ballroom D
CE Course Chair:
Patricia Ryan, PhD
– AstraZeneca
CE Course Chair:
Julia Johansson, PhD
– AstraZeneca
CE Course Speaker:
Serah Kang, PhD
– Genentech, Inc.
CE Course Speaker:
Wen Sun, PhD
– Pfizer
CE Course Speaker:
Brian Vega, PhD
– Merck
CE Course Speaker:
Nakissa Sadrieh, PhD
– US FDA
Advanced
Emerging
8:00 AM – 8:30 AM
CT
Overview Strategy of How Novel Tools Are Used at AZ to Advance Drug Discovery and Development (CE3-1)
CE Course Speaker:
Julia Johansson, PhD
– AstraZeneca
8:30 AM – 9:00 AM
CT
Human Blood-Brain-Barrier Spheroids as an In Vitro Model of Drug Delivery to the Brain (CE3-2)
CE Course Speaker:
Serah Kang, PhD
– Genentech, Inc.
9:00 AM – 9:30 AM
CT
iScreen: The Next Frontier in Genotoxicity Testing (CE3-3)
CE Course Speaker:
Wen Sun, PhD
– Pfizer
9:30 AM – 10:00 AM
CT
Break (CE3-Break)
10:00 AM – 10:30 AM
CT
A Synergistic Approach with Combined In Silico, In Vitro, and In Vivo Models to Preclinically Derisk Peptide Mediated Pseudoanaphylaxis (CE3-4)
CE Course Speaker:
Brian Vega, PhD
– Merck
10:30 AM – 11:00 AM
CT
Implementation of NAMs at FDA/CDER (CE3-5)
CE Course Speaker:
Nakissa Sadrieh, PhD
– US FDA
11:00 AM – 11:30 AM
CT
Panel Discussion (CE3-Panel)
8:00 AM – 11:30 AM
CT
Safety Considerations for the Evaluation of Lipid-Based Nanoparticles (CE4)
CE Course Chair:
Elena Braithwaite, DABT
– US FDA
CE Course Chair:
Emily Place, PhD
– Aclairo Pharmaceutical Development Group, Inc.
CE Course Speaker:
David W. Hobson, PhD, DABT
– LoneStar PharmTox, LLC
CE Course Speaker:
Jonathan A. Phillips, PhD
– Intellia Therapeutics
CE Course Speaker:
Olen Stephens, PhD
– US FDA
CE Course Speaker:
Jessica Sutherland, PhD, DABT
– Alnylam Pharmaceuticals
Foundational (Basic)
Practical
8:00 AM – 11:30 AM
CT
Safety Considerations for the Evaluation of Lipid-Based Nanoparticles (CE4)
Location: Lone Star Ballroom E
CE Course Chair:
Elena Braithwaite, DABT
– US FDA
CE Course Chair:
Emily Place, PhD
– Aclairo Pharmaceutical Development Group, Inc.
CE Course Speaker:
David W. Hobson, PhD, DABT
– LoneStar PharmTox, LLC
CE Course Speaker:
Jonathan A. Phillips, PhD
– Intellia Therapeutics
CE Course Speaker:
Olen Stephens, PhD
– US FDA
CE Course Speaker:
Jessica Sutherland, PhD, DABT
– Alnylam Pharmaceuticals
Foundational (Basic)
Practical
8:00 AM – 8:10 AM
CT
Introduction (CE4-1)
CE Course Chair:
Elena Braithwaite, DABT
– US FDA
CE Course Chair:
Emily Place, PhD
– Aclairo Pharmaceutical Development Group, Inc.
8:10 AM – 8:45 AM
CT
Lipid-based Nanoparticles: What Have We Learned in the Past 60 Years? (CE4-2)
CE Course Speaker:
David W. Hobson, PhD, DABT
– LoneStar PharmTox, LLC
8:45 AM – 9:30 AM
CT
ADME Properties and Affects of Exposure to Lipid-Based Nanoparticles (CE4-3)
CE Course Speaker:
Jonathan A. Phillips, PhD
– Intellia Therapeutics
9:30 AM – 10:00 AM
CT
Break (CE4-Break)
10:00 AM – 10:45 AM
CT
FDA Evaluation of Drug Products Containing Lipid Nanoparticles (CE4-4)
CE Course Speaker:
Olen Stephens, PhD
– US FDA
10:45 AM – 11:30 AM
CT
The Nonclinical Safety Profile of ONPATTRO® (patisiran), a Lipid Nanoparticle-RNAi Therapeutic for the Treatment of Polyneuropathy of Hereditary Transthyretin-mediated Amyloidosis (hATTR amyloidosis) (CE4-5)
CE Course Speaker:
Jessica Sutherland, PhD, DABT
– Alnylam Pharmaceuticals
11:00 AM – 4:00 PM
CT
Speaker Ready Room Open
11:00 AM – 4:00 PM
CT
Speaker Ready Room Open
Location: Room 306
11:45 AM – 12:55 PM
CT
IJT Editorial Board Meeting
11:45 AM – 12:55 PM
CT
IJT Editorial Board Meeting
Location: Room 301
12:00 PM – 12:55 PM
CT
(EHP) Altasciences—Juvenile Nonhuman Primates for Gene Therapy Research: Use of Immunopathology Data to Adjust Testing Ages and the 3Rs
12:00 PM – 12:55 PM
CT
(EHP) Altasciences—Juvenile Nonhuman Primates for Gene Therapy Research: Use of Immunopathology Data to Adjust Testing Ages and the 3Rs
Location: Room 202
12:00 PM – 12:55 PM
CT
(EHP) Certara—Real-Time Nonclinical Study Data: Benefits, Logistics, and Data Analysis and Visualization
12:00 PM – 12:55 PM
CT
(EHP) Certara—Real-Time Nonclinical Study Data: Benefits, Logistics, and Data Analysis and Visualization
Location: Room 201
12:00 PM – 12:55 PM
CT
(EHP) Inotiv—Assessing the Genotoxic Potential of Lipid Nanoparticles (LNPs): Inotiv's In Vitro Study Experience
12:00 PM – 12:55 PM
CT
(EHP) Inotiv—Assessing the Genotoxic Potential of Lipid Nanoparticles (LNPs): Inotiv's In Vitro Study Experience
Location: Room 203
12:00 PM – 12:55 PM
CT
(EHP) Lovelace Biomedical Research Institute—Challenges and Opportunities in Nonclinical Intranasal Drug Delivery
12:00 PM – 12:55 PM
CT
(EHP) Lovelace Biomedical Research Institute—Challenges and Opportunities in Nonclinical Intranasal Drug Delivery
Location: Room 204
1:00 PM – 4:30 PM
CT
Translational Challenges from Nonclinical to Clinical Program: Case Study Examples (CE5)
CE Course Chair:
Deven Dandekar, PhD
– Eli Lilly and Company, Inc.
CE Course Chair:
August Wilke, PhD, DABT
– Eli Lilly and Company, Inc.
CE Course Speaker:
Deepa B. Rao, PhD, DABT, DACVP, FIATP
– Greenfield Pathology Services, Inc.
CE Course Speaker:
David B. Hawver
– Hawver Nonclinical Consulting, LLC
CE Course Speaker:
Bhanu Singh, DACVP, DABT, FIATP
– Gilead Sciences Inc.
Foundational (Basic)
Practical
1:00 PM – 4:30 PM
CT
Translational Challenges from Nonclinical to Clinical Program: Case Study Examples (CE5)
Location: Lone Star Ballroom F
CE Course Chair:
Deven Dandekar, PhD
– Eli Lilly and Company, Inc.
CE Course Chair:
August Wilke, PhD, DABT
– Eli Lilly and Company, Inc.
CE Course Speaker:
Deepa B. Rao, PhD, DABT, DACVP, FIATP
– Greenfield Pathology Services, Inc.
CE Course Speaker:
David B. Hawver
– Hawver Nonclinical Consulting, LLC
CE Course Speaker:
Bhanu Singh, DACVP, DABT, FIATP
– Gilead Sciences Inc.
Foundational (Basic)
Practical
1:00 PM – 1:30 PM
CT
Translating Monoclonal Antibody Nonclinical Findings Into Clinical Plans (CE5-1)
CE Course Speaker:
August Wilke, PhD, DABT
– Eli Lilly and Company, Inc.
1:30 PM – 2:00 PM
CT
Sensory Neurotoxicity: Getting Aligned to Translate Sensory Ganglion Findings from Nonclinical Studies to Clinical Trials (CE5-2)
CE Course Speaker:
Deepa B. Rao, PhD, DABT, DACVP, FIATP
– Greenfield Pathology Services, Inc.
2:00 PM – 2:30 PM
CT
Factors in Determining Safe Starting Doses and Safety Margins for First-in-Human Clinical Trials (CE5-3)
CE Course Speaker:
David B. Hawver
– Hawver Nonclinical Consulting, LLC
2:30 PM – 3:00 PM
CT
Break (CE5-Break)
3:00 PM – 3:30 PM
CT
Translational Challenges from Nonclinical Hepatic Findings to Clinical Path: Case Study (CE5-4)
CE Course Speaker:
Deven Dandekar, PhD
– Eli Lilly and Company, Inc.
3:30 PM – 4:00 PM
CT
Understanding the Impact of Local Tolerability of Long Acting Injectables in Nonclinical Species: Case Study (CE5-5)
CE Course Speaker:
Bhanu Singh, DACVP, DABT, FIATP
– Gilead Sciences Inc.
4:00 PM – 4:30 PM
CT
Panel Discussion (CE5-Panel)
1:00 PM – 4:30 PM
CT
Toxicologic Neuropathology of Novel Therapeutics (CE6)
CE Course Chair:
Dinesh S. Bangari, PhD, DACVP
– Sanofi
CE Course Chair:
Lisa Lanigan, DVM, PhD, DACVP
– Charles River Laboratories
CE Course Speaker:
Sarah Cramer, DVM, PhD, DACVP
– StageBio
CE Course Speaker:
Elizabeth Galbreath, DVM, PhD, DACVP
– Advanced Pathology Solutions
CE Course Speaker:
Jessica Grieves, DVM, PhD, ACVP
– Ionis Pharmaceuticals
CE Course Speaker:
René Meisner, DVM, DACVP, DABT
– TCG Labs Soleil
CE Course Speaker:
Arlin B. Rogers, DVM, PhD, DACVP
– Alnylam Pharmaceuticals
CE Course Speaker:
Brad Bolon, DVM, PhD
– GEMpath, Inc.
Advanced
Practical
1:00 PM – 4:30 PM
CT
Toxicologic Neuropathology of Novel Therapeutics (CE6)
Location: Lone Star Ballroom E
CE Course Chair:
Dinesh S. Bangari, PhD, DACVP
– Sanofi
CE Course Chair:
Lisa Lanigan, DVM, PhD, DACVP
– Charles River Laboratories
CE Course Speaker:
Sarah Cramer, DVM, PhD, DACVP
– StageBio
CE Course Speaker:
Elizabeth Galbreath, DVM, PhD, DACVP
– Advanced Pathology Solutions
CE Course Speaker:
Jessica Grieves, DVM, PhD, ACVP
– Ionis Pharmaceuticals
CE Course Speaker:
René Meisner, DVM, DACVP, DABT
– TCG Labs Soleil
CE Course Speaker:
Arlin B. Rogers, DVM, PhD, DACVP
– Alnylam Pharmaceuticals
CE Course Speaker:
Brad Bolon, DVM, PhD
– GEMpath, Inc.
Advanced
Practical
1:00 PM – 1:30 PM
CT
Vector-Based and Cell-Based Therapies (CE6-1)
CE Course Speaker:
Sarah Cramer, DVM, PhD, DACVP
– StageBio
1:30 PM – 2:00 PM
CT
Case Presentation: Routed by ROA—Effect of Route of Administration on AAV Neuropathology (CE6-2)
CE Course Speaker:
Elizabeth Galbreath, DVM, PhD, DACVP
– Advanced Pathology Solutions
2:00 PM – 2:30 PM
CT
Overview of Nucleic Acid-Based Therapies for Neurologic and Neuromuscular Diseases (CE6-3)
CE Course Speaker:
Jessica Grieves, DVM, PhD, ACVP
– Ionis Pharmaceuticals
2:30 PM – 3:00 PM
CT
Break (CE6-Break)
3:00 PM – 3:30 PM
CT
Engineered Large Molecules for CNS Delivery (CE6-4)
CE Course Speaker:
René Meisner, DVM, DACVP, DABT
– TCG Labs Soleil
3:30 PM – 4:00 PM
CT
RNAi Pharmacokinetics and Activity Assessment in CNS (CE6-5)
CE Course Speaker:
Arlin B. Rogers, DVM, PhD, DACVP
– Alnylam Pharmaceuticals
4:00 PM – 4:30 PM
CT
Concept Presentation: Grappling with Gliosis in Assessing Adversity (CE6-6)
CE Course Speaker:
Brad Bolon, DVM, PhD
– GEMpath, Inc.
1:00 PM – 4:30 PM
CT
Nonclinical Immunotoxicity Assessment: State of the Science and Future Directions (CE7)
CE Course Chair:
David McMillan, PhD, DABT
– US FDA
CE Course Chair:
Gary R. Burleson, PhD
– Burleson Research Technologies, Inc.
CE Course Speaker:
Gautham K. Rao, PhD, DABT
– Genentech, Inc.
CE Course Speaker:
Kristina Howard, DVM, PhD
– US FDA
CE Course Speaker:
Carmen Booker, PhD
– US FDA
CE Course Speaker:
Jamie DeWitt, PhD, DABT
– Oregon State University
Foundational (Basic)
Emerging
1:00 PM – 4:30 PM
CT
Nonclinical Immunotoxicity Assessment: State of the Science and Future Directions (CE7)
Location: Lone Star Ballroom D
CE Course Chair:
David McMillan, PhD, DABT
– US FDA
CE Course Chair:
Gary R. Burleson, PhD
– Burleson Research Technologies, Inc.
CE Course Speaker:
Gautham K. Rao, PhD, DABT
– Genentech, Inc.
CE Course Speaker:
Kristina Howard, DVM, PhD
– US FDA
CE Course Speaker:
Carmen Booker, PhD
– US FDA
CE Course Speaker:
Jamie DeWitt, PhD, DABT
– Oregon State University
Foundational (Basic)
Emerging
1:00 PM – 1:30 PM
CT
Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals: A Regulatory Perspective (CE7-1)
CE Course Speaker:
David McMillan, PhD, DABT
– US FDA
1:30 PM – 2:00 PM
CT
Strategies and Tools for Assessing Immunosuppression (CE7-2)
CE Course Speaker:
Gautham K. Rao, PhD, DABT
– Genentech, Inc.
2:00 PM – 2:30 PM
CT
Immunomodulation and Immunostimulation: Risk Identification and Assessment (CE7-3)
CE Course Speaker:
Kristina Howard, DVM, PhD
– US FDA
2:30 PM – 3:00 PM
CT
Break (CE7-Break)
3:00 PM – 3:30 PM
CT
Assessing Dermal Sensitization in a Topical Pharmaceutical (CE7-4)
CE Course Speaker:
Carmen Booker, PhD
– US FDA
3:30 PM – 4:00 PM
CT
Tools for Assessing Developmental Immunotoxicological Impacts (CE7-5)
CE Course Speaker:
Jamie DeWitt, PhD, DABT
– Oregon State University
4:00 PM – 4:30 PM
CT
Panel Discussion (CE7-Panel)
1:00 PM – 4:30 PM
CT
Toxicological Assessment of Pharmaceutical Impurities (CE8)
CE Course Chair:
Catrin Hasselgren, PhD
– Genentech
CE Course Chair:
Alessandro Brigo, PhD, ERT, DABT
– Roche Pharma Research & Early Development
CE Course Speaker:
Jessica Graham, PhD, DABT, ATS
– Genentech Inc
CE Course Speaker:
Michelle Kenyon, MA
– Pfizer Research and Development
CE Course Speaker:
Joel Bercu, PhD, MPH, DABT
– Gilead Sciences, Inc.
CE Course Speaker:
Jennifer Alleva, PhD
– Gilead Sciences, Inc.
Foundational (Basic)
Practical
1:00 PM – 4:30 PM
CT
Toxicological Assessment of Pharmaceutical Impurities (CE8)
Location: Lone Star Ballroom C
CE Course Chair:
Catrin Hasselgren, PhD
– Genentech
CE Course Chair:
Alessandro Brigo, PhD, ERT, DABT
– Roche Pharma Research & Early Development
CE Course Speaker:
Jessica Graham, PhD, DABT, ATS
– Genentech Inc
CE Course Speaker:
Michelle Kenyon, MA
– Pfizer Research and Development
CE Course Speaker:
Joel Bercu, PhD, MPH, DABT
– Gilead Sciences, Inc.
CE Course Speaker:
Jennifer Alleva, PhD
– Gilead Sciences, Inc.
Foundational (Basic)
Practical
1:00 PM – 1:20 PM
CT
Introduction and Framework for Impurity Management (CE8-1)
CE Course Speaker:
Catrin Hasselgren, PhD
– Genentech
1:20 PM – 2:00 PM
CT
Safety Assessment of Impurities in Biologic Therapeutics (CE8-2)
CE Course Speaker:
Jessica Graham, PhD, DABT, ATS
– Genentech Inc
2:00 PM – 2:30 PM
CT
Understanding Impurity Qualification (CE8-3)
CE Course Speaker:
Michelle Kenyon, MA
– Pfizer Research and Development
2:30 PM – 3:00 PM
CT
Break (CE8-Break)
3:00 PM – 3:30 PM
CT
ICH M7: Identification and Control of Mutagenic Impurities in Pharmaceuticals (CE8-4)
CE Course Speaker:
Joel Bercu, PhD, MPH, DABT
– Gilead Sciences, Inc.
3:30 PM – 4:00 PM
CT
Case Study: How to Assess and Control DNA Reactive (Mutagenic) Impurities in the Pharmaceutical Industry (CE8-5)
CE Course Speaker:
Alessandro Brigo, PhD, ERT, DABT
– Roche Pharma Research & Early Development
4:00 PM – 4:30 PM
CT
Leveraging Toxicology Data to Support Impurity Control Strategies in CMC Regulatory Submissions (CE8-6)
CE Course Speaker:
Jennifer Alleva, PhD
– Gilead Sciences, Inc.
2:00 PM – 6:30 PM
CT
Exhibition and Poster Setup
2:00 PM – 6:30 PM
CT
Exhibition and Poster Setup
Location: JW Grand Ballroom
4:45 PM – 6:30 PM
CT
Student Poster Competition
4:45 PM – 6:30 PM
CT
Student Poster Competition
Location: Room 404
7:00 PM – 8:30 PM
CT
Welcome Reception
7:00 PM – 8:30 PM
CT
Welcome Reception
Location: Griffin Hall