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Tuesday, September 12, 2023
7:00 AM - 7:45 AM
PT
STEP & ESP Gathering
7:00 AM - 7:45 AM
PT
STEP & ESP Gathering
Location: Grand Ballroom I-K
7:00 AM - 8:00 AM
PT
ACCP Education Committee Meeting (Invitation only)
7:00 AM - 8:00 AM
PT
ACCP Education Committee Meeting (Invitation only)
Location: Laurel
7:00 AM - 8:00 AM
PT
Continental Breakfast
7:00 AM - 8:00 AM
PT
Continental Breakfast
Location: Grand Ballroom East Foyer
7:00 AM - 5:30 PM
PT
ACCP Registration Desk Open
7:00 AM - 3:30 PM
PT
ACCP Registration Desk Open
Location: Grand Ballroom East Foyer
8:00 AM - 9:30 AM
PT
Symposium 9: Enteral Feeding & Soft Foods: Supporting Medication Dosing in Pediatrics & the Hospitalized
Chair & Faculty:
Elimika Fletcher, PharmD, PhD
– US Food & Drug Administration
Faculty:
Rachel Meyers, PharmD
– Rutgers Univ
Faculty:
Karen Thompson, PhD
– Merck & Co
Clinical Drug Development & Investigations
CE: 1.5
8:00 AM - 9:30 AM
PT
Symposium 9: Enteral Feeding & Soft Foods: Supporting Medication Dosing in Pediatrics & the Hospitalized
Location: Grand Ballroom I-K
Chair & Faculty:
Elimika Fletcher, PharmD, PhD
– US Food & Drug Administration
Faculty:
Rachel Meyers, PharmD
– Rutgers Univ
Faculty:
Karen Thompson, PhD
– Merck & Co
Clinical Drug Development & Investigations
CE: 1.5
8:00 AM - 9:30 AM
PT
1 - It’s a Jungle Out There: Administering Medications With Enteral Feeding & Soft Foods to Pediatric Patients in the Real World
Faculty:
Rachel Meyers, PharmD
– Rutgers Univ
Clinical Drug Development & Investigations
8:00 AM - 9:30 AM
PT
2 - Clinical Pharmacology Perspective on Supporting Dosing of Drugs via Feeding Tubes & With Soft Foods
Chair & Faculty:
Elimika Fletcher, PharmD, PhD
– US Food & Drug Administration
Clinical Drug Development & Investigations
8:00 AM - 9:30 AM
PT
3 - Formulation Considerations to Support Dosing of Drugs via Feeding Tubes & With Soft Foods
Faculty:
Karen Thompson, PhD
– Merck & Co
Clinical Drug Development & Investigations
8:00 AM - 9:30 AM
PT
4 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
8:00 AM - 11:30 AM
PT
Symposium 10: First-in-Patient Dose Prediction for Adeno-associated Virus-mediated Gene Therapy
Co-Chair & Faculty:
Xiaofei Wang, PhD
– US Food & Drug Administration
Co-Chair & Faculty:
Peng Zou, PhD
– Daiichi Sankyo Co Ltd
Faculty:
Kefeng Sun, PhD
– Takeda Pharmaceutical Co Ltd
Faculty:
Tao Zhang, PhD (he/him/his)
– Binghampton Univ
Clinical Drug Development & Investigations
CE: 3.0
8:00 AM - 11:30 AM
PT
Symposium 10: First-in-Patient Dose Prediction for Adeno-associated, Virus-mediated Gene Therapy
Location: Grand Ballroom E-H
Co-Chair & Faculty:
Xiaofei Wang, PhD
– US Food & Drug Administration
Co-Chair & Faculty:
Peng Zou, PhD
– Daiichi Sankyo Co Ltd
Faculty:
Kefeng Sun, PhD
– Takeda Pharmaceutical Co Ltd
Faculty:
Tao Zhang, PhD (he/him/his)
– Binghampton Univ
Clinical Drug Development & Investigations
CE: 3.0
8:00 AM - 11:30 AM
PT
1 - Clinical Pharmacology Considerations for Adeno-associated, Virus-mediated Gene Therapy: A Regulatory Perspective
Co-Chair & Faculty:
Xiaofei Wang, PhD
– US Food & Drug Administration
Clinical Drug Development & Investigations
8:00 AM - 11:30 AM
PT
2 - First-in-Patient Dose Prediction for Adeno-associated, Virus-mediated Gene Therapy
Co-Chair & Faculty:
Peng Zou, PhD
– Daiichi Sankyo Co Ltd
Clinical Drug Development & Investigations
8:00 AM - 11:30 AM
PT
3 - Interspecies Scaling of Transgene Products for Intramuscular & Intravesical Gene Therapies
Faculty:
Tao Zhang, PhD (he/him/his)
– Binghampton Univ
Clinical Drug Development & Investigations
8:00 AM - 11:30 AM
PT
4 - Clinical Pharmacology Considerations for Recombinant Adeno-associated, Virus-based Gene Therapy: Focus on Biodistribution, Immune Response & Durability
Faculty:
Kefeng Sun, PhD
– Takeda Pharmaceutical Co Ltd
Clinical Drug Development & Investigations
8:00 AM - 11:30 AM
PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
9:30 AM - 10:00 AM
PT
Coffee/Networking Break
9:30 AM - 10:00 AM
PT
Coffee/Networking Break
Location: Grand Ballroom East Foyer
10:00 AM - 11:00 AM
PT
Symposium 11: Obtaining Board Certification & Training Program Credentialing With the American Board of Clinical Pharmacology
Chair & Faculty:
Craig W. Hendrix, MD, DABCP
– Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Faculty:
Lionel D. Lewis, MA, MBBCh, MD
– American Board of Clinical Pharmacology
CE: 1.0
10:00 AM - 11:00 AM
PT
Symposium 11: Obtaining Board Certification & Training Program Credentialing With the American Board of Clinical Pharmacology
Location: Grand Ballroom I-K
Chair & Faculty:
Craig W. Hendrix, MD, DABCP
– Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Faculty:
Lionel D. Lewis, MA, MBBCh, MD
– American Board of Clinical Pharmacology
CE: 1.0
10:00 AM - 11:00 AM
PT
1 - Why an American Board of Clinical Pharmacology?
Faculty:
Lionel D. Lewis, MA, MBBCh, MD
– American Board of Clinical Pharmacology
10:00 AM - 11:00 AM
PT
2 - How Does a Clinical Pharmacology Training Program Earn Accreditation?
Faculty:
Craig W. Hendrix, MD, DABCP
– Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
10:00 AM - 11:00 AM
PT
3 - Why & How Does a Clinical Pharmacologist Achieve Board Certification?
Faculty:
Lionel D. Lewis, MA, MBBCh, MD
– American Board of Clinical Pharmacology
10:00 AM - 11:00 AM
PT
4 - What is the New Collaboration With ACCP All About?
Faculty:
Craig W. Hendrix, MD, DABCP
– Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
10:00 AM - 11:00 AM
PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
11:30 AM - 1:30 PM
PT
Lunch Buffet
11:30 AM - 1:30 PM
PT
Lunch Buffet
Location: Grand Ballroom East Foyer
11:45 AM - 1:15 PM
PT
Lunch & Annual Business Meeting (open to all)
11:45 AM - 1:15 PM
PT
Lunch & Annual Business Meeting (open to all)
Location: Grand Ballroom E-H
1:30 PM - 3:00 PM
PT
Symposium 12: How Drug Shortages Impact the Healthcare System: History, Impact & the Future, A Joint ACCP/ASHP Symposium
Co-Chair & Faculty:
Claude Abdallah, MD, MS, FASA
– Children's National Hosp
Co-Chair & Faculty:
Erin Fox, PharmD, MHA, BCPS, FASHP (she/her/hers)
– Univ of Utah Coll of Pharmacy
Faculty:
Valerie E. Jensen, RPh
– US Food & Drug Administration
Evidence-based Practice & Patient Care
CE: 1.5
1:30 PM - 3:00 PM
PT
Symposium 12: How Drug Shortages Impact the Healthcare System: History, Impact & the Future, A Joint ACCP/ASHP Symposium
Location: Grand Ballroom I-K
Co-Chair & Faculty:
Claude Abdallah, MD, MS, FASA
– Children's National Hosp
Co-Chair & Faculty:
Erin Fox, PharmD, MHA, BCPS, FASHP (she/her/hers)
– Univ of Utah Coll of Pharmacy
Faculty:
Valerie E. Jensen, RPh
– US Food & Drug Administration
Evidence-based Practice & Patient Care
CE: 1.5
1:30 PM - 3:00 PM
PT
1 - Clinical Impact of Medication Shortages
Co-Chair & Faculty:
Claude Abdallah, MD, MS, FASA
– Children's National Hosp
Evidence-based Practice & Patient Care
1:30 PM - 3:00 PM
PT
2 - Drug Shortages: Current Updates
Co-Chair & Faculty:
Erin Fox, PharmD, MHA, BCPS, FASHP (she/her/hers)
– Univ of Utah Coll of Pharmacy
Evidence-based Practice & Patient Care
1:30 PM - 3:00 PM
PT
3 - The US Food & Drug Administration’s Drug Shortage
Faculty:
Valerie E. Jensen, RPh
– US Food & Drug Administration
Evidence-based Practice & Patient Care
1:30 PM - 3:00 PM
PT
4 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Evidence-based Practice & Patient Care
1:30 PM - 3:00 PM
PT
Symposium 13: Clinical Pharmacology Challenges in Obesity & Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis: Mechanisms & Therapeutics
Co-Chair & Faculty:
Kim LR Brouwer, PharmD, PhD
– Univ of North Carolina at Chapel Hill
Co-Chair & Faculty:
Catherijne J. Knibbe, PharmD, PhD
– Leiden Univ
Faculty:
Manal Abdelmalek, MD, MPH
– Mayo Clinic
Faculty:
Insook Kim, PhD
– US Food & Drug Administration
Faculty:
Yurong Lai, PhD
– Gilead Sciences Inc
Clinical Drug Development & Investigations
CE: 1.5
1:30 PM - 3:00 PM
PT
Symposium 13: Clinical Pharmacology Challenges in Obesity & Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis: Mechanisms & Therapeutics
Location: Grand Ballroom E-H
Co-Chair & Faculty:
Kim LR Brouwer, PharmD, PhD
– Univ of North Carolina at Chapel Hill
Co-Chair & Faculty:
Catherijne J. Knibbe, PharmD, PhD
– Leiden Univ
Faculty:
Manal Abdelmalek, MD, MPH
– Mayo Clinic
Faculty:
Insook Kim, PhD
– US Food & Drug Administration
Faculty:
Yurong Lai, PhD
– Gilead Sciences Inc
Clinical Drug Development & Investigations
CE: 1.5
1:30 PM - 3:00 PM
PT
1 - The Obesity Epidemic: Consequences for Dosing in Adults & Children
Co-Chair & Faculty:
Catherijne J. Knibbe, PharmD, PhD
– Leiden Univ
Clinical Drug Development & Investigations
1:30 PM - 3:00 PM
PT
2 - Pathophysiologic Changes, Staging, Diagnosis & Trial Endpoints for NAFLD/NASH
Faculty:
Manal Abdelmalek, MD, MPH
– Mayo Clinic
Clinical Drug Development & Investigations
1:30 PM - 3:00 PM
PT
3 - Mechanistic Understanding of Physiological Changes in NASH that Impact Drug Disposition
Co-Chair & Faculty:
Kim LR Brouwer, PharmD, PhD
– Univ of North Carolina at Chapel Hill
Clinical Drug Development & Investigations
1:30 PM - 3:00 PM
PT
4 - Challenges & Current Regulatory Issues in Drug Development for Obesity & NAFLD/NASH
Faculty:
Insook Kim, PhD
– US Food & Drug Administration
Clinical Drug Development & Investigations
1:30 PM - 3:00 PM
PT
5 - Use of Physiologically-based Pharmacokinetic Modeling to Advance Clinical Trials in Obesity & NAFLD/NASH
Faculty:
Yurong Lai, PhD
– Gilead Sciences Inc
Clinical Drug Development & Investigations
1:30 PM - 3:00 PM
PT
6 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
3:00 PM - 3:30 PM
PT
Coffee/Networking Break
3:00 PM - 3:30 PM
PT
Coffee/Networking Break
Location: Grand Ballroom East Foyer
3:30 PM - 5:00 PM
PT
Symposium 14: Recent Trends in Food Effect Assessment in Supporting Dosing Recommendations for Oral Oncology Drugs
Co-Chair & Faculty:
Xiaoming Cui, PhD (she/her/hers)
– Novartis Inst for Biomedical Research
Co-Chair & Faculty:
Yvonne Lau, PhD
– Daiichi Sankyo Inc
Faculty:
Brian Booth, PhD
– US Food & Drug Administration
Faculty:
Lawrence Lesko, PhD
– Univ of Florida Coll of Pharmacy
Clinical Drug Development & Investigations
CE: 1.5
3:30 PM - 5:00 PM
PT
Symposium 14: Recent Trends in Food Effect Assessment in Supporting Dosing Recommendations for Oral Oncology Drugs
Location: Grand Ballroom E-H
Co-Chair & Faculty:
Xiaoming Cui, PhD (she/her/hers)
– Novartis Inst for Biomedical Research
Co-Chair & Faculty:
Yvonne Lau, PhD
– Daiichi Sankyo Inc
Faculty:
Brian Booth, PhD
– US Food & Drug Administration
Faculty:
Lawrence Lesko, PhD
– Univ of Florida Coll of Pharmacy
Clinical Drug Development & Investigations
CE: 1.5
3:30 PM - 5:00 PM
PT
1 - Dose & Prandial Condition Optimization from Phase 1 to Post-marketing
Co-Chair & Faculty:
Yvonne Lau, PhD
– Daiichi Sankyo Inc
Clinical Drug Development & Investigations
3:30 PM - 5:00 PM
PT
2 - Can “Given With Food” Be a Default Food Condition?
Co-Chair & Faculty:
Xiaoming Cui, PhD (she/her/hers)
– Novartis Inst for Biomedical Research
Clinical Drug Development & Investigations
3:30 PM - 5:00 PM
PT
3 - Food: Leveraging the Clinical Pharmacology of Your Oncology Drug
Faculty:
Brian Booth, PhD
– US Food & Drug Administration
Clinical Drug Development & Investigations
3:30 PM - 5:00 PM
PT
4 - Why Are FDA-approved Drug Labels Pertaining to Food-Drug Interactions Essential to the Advancement of Therapeutic Optimization of Oral Cancer Drugs?
Faculty:
Lawrence Lesko, PhD
– Univ of Florida Coll of Pharmacy
Clinical Drug Development & Investigations
3:30 PM - 5:00 PM
PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation
Clinical Drug Development & Investigations
3:30 PM - 5:00 PM
PT
Symposium 15: Hot Topics
Co-Chair & Faculty:
Claude Abdallah, MD, MS, FASA
– Children's National Hosp
Co-Chair & Faculty:
Laurent Vernillet, PharmD, PhD
– Biocryst Pharmaceuticals Inc.
Faculty:
Yulan Qi
Faculty:
Phil Collis
Faculty:
Heather Ferguson, PharmD, MS
Faculty:
Jennifer Wohl, DHSc, PA-C
– Eastern Virginia Medical School
CE: 1.5
3:30 PM - 5:00 PM
PT
Symposium 15: Hot Topics
Location: Grand Ballroom I-K
Co-Chair & Faculty:
Claude Abdallah, MD, MS, FASA
– Children's National Hosp
Co-Chair & Faculty:
Laurent Vernillet, PharmD, PhD
– Biocryst Pharmaceuticals Inc.
Faculty:
Yulan Qi
Faculty:
Phil Collis
Faculty:
Heather Ferguson, PharmD, MS
Faculty:
Jennifer Wohl, DHSc, PA-C
– Eastern Virginia Medical School
CE: 1.5
3:30 PM - 5:00 PM
PT
1 - Clinical Pharmacology Evaluation & Dose Optimization of Vosoritide, a Therapy for Children With Achondroplasia
Faculty:
Yulan Qi
3:30 PM - 5:00 PM
PT
2 - Opportunities for Accelerating the Drug Development Process in Rare Diseases
Faculty:
Phil Collis
3:30 PM - 5:00 PM
PT
3 - Uncovering Drug Diversion in the Clinical Setting
Faculty:
Heather Ferguson, PharmD, MS
3:30 PM - 5:00 PM
PT
4 - Drug Diversion During the COVID-19 Pandemic
Faculty:
Jennifer Wohl, DHSc, PA-C
– Eastern Virginia Medical School
3:30 PM - 5:00 PM
PT
5 - Faculty Panel Discussion, Questions & Answers, Learner Feedback & Evaluation