- Friday, September 8, 2023
6:00 PM – 10:00 PM PT
ACCP Executive Committee Meeting & Dinner (Invitation only)
6:00 PM – 10:00 PM PT
ACCP Executive Committee Meeting & Dinner (Invitation only)
Location:Birch
- Saturday, September 9, 2023
7:00 AM – 7:00 PM PT
ACCP Registration Desk Open
7:00 AM – 7:00 PM PT
ACCP Registration Desk Open
Location:Balsam Foyer
8:00 AM – 3:00 PM PT
ACCP Board of Regents Meeting (Invitation only)
8:00 AM – 3:00 PM PT
ACCP Board of Regents Meeting (Invitation only)
Location:Laurel
8:00 AM – 5:00 PM PT
PMWS: A Snapshot of Clinical Pharmacology Workflows With RCo-Chair & Faculty: – Takeda Pharmaceutical Co Ltd
Co-Chair & Faculty: – Pfizer Inc
Faculty: – Human Predictions LLC
Faculty: – US Food & Drug Administration
Faculty: – Univ of Southern California
Faculty: – Takeda Pharmaceutical Co Ltd
Clinical Drug Development & Investigations
8:00 AM – 5:00 PM PT
PMWS: A Snapshot of Clinical Pharmacology Workflows With RLocation:Cedar BallroomCo-Chair & Faculty: – Takeda Pharmaceutical Co Ltd
Co-Chair & Faculty: – Pfizer Inc
Faculty: – Human Predictions LLC
Faculty: – US Food & Drug Administration
Faculty: – Univ of Southern California
Faculty: – Takeda Pharmaceutical Co Ltd
Clinical Drug Development & Investigations
Tao Long, PhD – Takeda Pharmaceutical Co Ltd ### 1827459###Co-Chair & Faculty###Clinical Pharmacologist, Quantitative Clinical Pharmacology###Takeda Pharmaceutical Co Ltd###Co-Chair & Faculty: – Takeda Pharmaceutical Co Ltd
### @@@ Daisy Zhu, PharmD, PhD (she/her/hers) – Pfizer Inc ### 1827455###Co-Chair & Faculty###Clinical Pharmacology Lead, Immunology & Inflammation###Pfizer Inc###Co-Chair & Faculty: – Pfizer Inc
### she/her/hers @@@ William S. Denney, PhD (he/him/his) – Human Predictions LLC ### 1897024###Faculty###Chief Scientist###Human Predictions LLC###Faculty: – Human Predictions LLC
### he/him/his @@@ Eliford Kitabi, PhD – US Food & Drug Administration ### 1897022###Faculty###Pharmacometrician###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Michael Neely, MD – Univ of Southern California ### 1156398###Faculty###Professor of Pediatrics & Clinical Scholar, Keck School of Medicine, Pediatrics###Univ of Southern California###Faculty: – Univ of Southern California
### @@@ Wenping Wang, PhD – Takeda Pharmaceutical Co Ltd ### 1827458###Faculty###Senior Director, Pharmacometrics, Quantitative Clinical Pharmacology###Takeda Pharmaceutical Co Ltd###Faculty: – Takeda Pharmaceutical Co Ltd
### 3:30 PM – 4:30 PM PT
ACCP Publications Committee Meeting (Invitation only)
3:30 PM – 4:30 PM PT
ACCP Publications Committee Meeting (Invitation only)
Location:Cottonwood
7:00 PM – 10:00 PM PT
PharmaFete
7:00 PM – 10:00 PM PT
PharmaFete
Location:Grand Ballroom I-K
- Sunday, September 10, 2023
6:30 AM – 5:00 PM PT
ACCP Registration Desk Open
6:30 AM – 5:00 PM PT
ACCP Registration Desk Open
Location:Grand Ballroom East Foyer
7:00 AM – 7:45 AM PT
Continental Breakfast
7:00 AM – 7:45 AM PT
Continental Breakfast
Location:Grand Ballroom East Foyer
7:00 AM – 7:45 AM PT
New Member & First-time Attendee Welcome
7:00 AM – 7:45 AM PT
New Member & First-time Attendee Welcome
Location:Grand Ballroom E-H
7:00 AM – 7:45 AM PT
STEP & ESP Welcome
7:00 AM – 7:45 AM PT
STEP & ESP Welcome
Location:Grand Ballroom I-K
7:45 AM – 8:00 AM PT
Welcome & Opening Remarks by ACCP President
7:45 AM – 8:00 AM PT
Welcome & Opening Remarks by ACCP President
Location:Grand Ballroom E-K
8:00 AM – 9:30 AM PT
Plenary Session: Scientific, Regulatory & Operational Considerations for Working With Gene-based Medicines: Are You Ready to Conduct Gene Therapy Research?Chair & Faculty: – US Food & Drug Administration
Faculty: – WCG Clinical Svcs
Faculty: – Advarra
Clinical Drug Development & Investigations
8:00 AM – 9:30 AM PT
Plenary Session: Scientific, Regulatory & Operational Considerations for Working With Gene-based Medicines: Are You Ready to Conduct Gene Therapy Research?Location:Grand Ballroom E-KChair & Faculty: – US Food & Drug Administration
Faculty: – WCG Clinical Svcs
Faculty: – Advarra
Clinical Drug Development & Investigations
Myong-Jin Kim, PharmD – US Food & Drug Administration ### 1044120###Chair & Faculty###Division Director###US Food & Drug Administration###Chair & Faculty: – US Food & Drug Administration
### @@@ Christopher R. Doyle, PhD (he/him/his) – WCG Clinical Svcs ### 1872541###Faculty###Director, IBC Svcs###WCG Clinical Svcs###Faculty: – WCG Clinical Svcs
### he/him/his @@@ James Riddle, MCSE, CIP, CPIA, CRQM – Advarra ### 1872542###Faculty###VP Research Services & Strategic Consulting###Advarra###Faculty: – Advarra
### 9:30 AM – 10:00 AM PT
Coffee/Networking Break/Faculty in Focus
9:30 AM – 10:00 AM PT
Coffee/Networking Break/Faculty in Focus
Location:Grand Ballroom A-D
9:30 AM – 7:00 PM PT
Exhibit Hall Open
9:30 AM – 7:00 PM PT
Exhibit Hall Open
Location:Grand Ballroom A-D
10:00 AM – 11:30 AM PT
Symposium 1: Dose Individualization of Biologics to Improve Patient Outcome: A Joint ACCP/EACPT SymposiumCo-Chair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences
Co-Chair & Faculty: – Projections Research Inc
Faculty: – Princess Maxima Ctr for Pediatric Oncology
Faculty: – National Cancer Inst
Evidence-based Practice & Patient Care
10:00 AM – 11:30 AM PT
Symposium 1: Dose Individualization of Biologics to Improve Patient Outcome: A Joint ACCP/EACPT SymposiumLocation:Grand Ballroom E-HCo-Chair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences
Co-Chair & Faculty: – Projections Research Inc
Faculty: – Princess Maxima Ctr for Pediatric Oncology
Faculty: – National Cancer Inst
Evidence-based Practice & Patient Care
Donald E. Mager, PharmD, PhD – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences ### 1827460###Co-Chair & Faculty###Professor & Chair, Pharmaceutical Sciences###Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences###Co-Chair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences
### @@@ Diane R. Mould, PhD – Projections Research Inc ### 1492772###Co-Chair & Faculty###President###Projections Research Inc###Co-Chair & Faculty: – Projections Research Inc
### @@@ Rick Admiraal, MD, PhD – Princess Maxima Ctr for Pediatric Oncology ### 1827462###Faculty###Clinical Research Fellow###Princess Maxima Ctr for Pediatric Oncology###Faculty: – Princess Maxima Ctr for Pediatric Oncology
### @@@ Cody J. Peer, PhD – National Cancer Inst ### 1357475###Faculty###Deputy Head, Clinical Pharmacology Program###National Cancer Inst###Faculty: – National Cancer Inst
### 10:00 AM – 11:30 AM PT
Symposium 2: HIV Pre-exposure Prophylaxis: Evolving Clinical Practice & Product Development Guided by Clinical PharmacologyCo-Chair & Faculty: – Univ of Buffalo
Co-Chair & Faculty: – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Faculty: – US Food & Drug Administration
Faculty: – Johns Hopkins Univ School of Medicine
Clinical Drug Development & Investigations
10:00 AM – 11:30 AM PT
Symposium 2: HIV Pre-exposure Prophylaxis: Evolving Clinical Practice & Product Development Guided by Clinical PharmacologyLocation:Grand Ballroom I-KCo-Chair & Faculty: – Univ of Buffalo
Co-Chair & Faculty: – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Faculty: – US Food & Drug Administration
Faculty: – Johns Hopkins Univ School of Medicine
Clinical Drug Development & Investigations
Robert Bies, PharmD, PhD – Univ of Buffalo ### 1156417###Co-Chair & Faculty###Professor, Pharmaceutical Sciences###Univ of Buffalo###Co-Chair & Faculty: – Univ of Buffalo
### @@@ Craig W. Hendrix, MD, DABCP – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology ### 1827468###Co-Chair & Faculty###Professor of Medicine (Clinical Pharmacology)###Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology###Co-Chair & Faculty: – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
### @@@ Charu Mullick, MD – US Food & Drug Administration ### 1492790###Faculty###Medical Officer, Ctr for Drug Evaluation & Research###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Ethel Weld, MD, PhD – Johns Hopkins Univ School of Medicine ### 1827469###Faculty######Johns Hopkins Univ School of Medicine###Faculty: – Johns Hopkins Univ School of Medicine
### 11:30 AM – 1:30 PM PT
Lunch Buffet
11:30 AM – 1:30 PM PT
Lunch Buffet
Location:Grand Ballroom A-D
11:45 AM – 1:15 PM PT
Lunch & Awards
11:45 AM – 1:15 PM PT
Lunch & Awards
Location:Grand Ballroom E-H
1:30 PM – 3:00 PM PT
STEP & ESP Panel Discussion & Career Guidance
1:30 PM – 3:00 PM PT
STEP & ESP Panel Discussion & Career Guidance
Location:Auditorium
1:30 PM – 3:00 PM PT
Symposium 4: Hot Topics
1:30 PM – 2:30 PM PT
Symposium 4: Hot Topics
Location:Grand Ballroom I-K
Olanrewaju Okusanya, PharmD, MS – US Food & Drug Administration ### 895256###Chair & Faculty###Deputy Div Director, Office of Clinical Pharmacology, Ctr for Drug Evaluation & Research, Div of Cancer Pharmacology I###US Food & Drug Administration###Chair & Faculty: – US Food & Drug Administration
### @@@ Ankit Shah, PhD – US Food & Drug Administration ### 1678428###Faculty###Senior Clinical Pharmacology Reviewer###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 1:30 PM – 5:00 PM PT
Symposium 3: Novel Approaches for the Prediction of Drug Effects in ChildrenCo-Chair & Faculty: – Leiden Univ
Faculty: – Aridhia Digital Research Environment
Faculty: – Univ of Waterloo
Faculty: – Leiden Univ
Clinical Drug Development & Investigations
1:30 PM – 5:00 PM PT
Symposium 3: Novel Approaches for the Prediction of Drug Effects in ChildrenLocation:Grand Ballroom E-HCo-Chair & Faculty: – Leiden Univ
Faculty: – Aridhia Digital Research Environment
Faculty: – Univ of Waterloo
Faculty: – Leiden Univ
Clinical Drug Development & Investigations
Catherijne J. Knibbe, PharmD, PhD – Leiden Univ ### 1827453###Co-Chair & Faculty###Professor, Pharmacology###Leiden Univ###Co-Chair & Faculty: – Leiden Univ
### @@@ Jeffrey Barrett, PhD – Aridhia Digital Research Environment ### 1827454###Faculty###Chief Science Officer###Aridhia Digital Research Environment###Faculty: – Aridhia Digital Research Environment
### @@@ Andrea Edginton, PhD – Univ of Waterloo ### 1492795###Faculty###Professor & Hallman Director###Univ of Waterloo###Faculty: – Univ of Waterloo
### @@@ Elke Krekels, PhD – Leiden Univ ### 1357521###Faculty###Assistant Professor, Systems Biomedicine & Pharmacology###Leiden Univ###Faculty: – Leiden Univ
### 3:00 PM – 3:30 PM PT
Coffee/Networking Break
3:00 PM – 3:30 PM PT
Coffee/Networking Break
Location:Grand Ballroom A-D
3:00 PM – 5:00 PM PT
STEP & ESP Networking Reception
3:00 PM – 5:00 PM PT
STEP & ESP Networking Reception
Location:Larch
3:10 PM – 3:30 PM PT
Industry Theater Presentation: Presented by Certara
3:10 PM – 3:30 PM PT
Industry Theater Presentation: Antibody-Drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development Presented by CertaraLocation:Industry Theater in Exhibit HallSession Speaker: – Certara
Session Speaker: – Certara UK Ltd
Julie Bullock, PharmD – Certara ### 2003531###Session Speaker###Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine###Certara###Session Speaker: – Certara
### @@@ Ian E. Templeton, PhD – Certara UK Ltd ### 1044207###Session Speaker###Senior Director, PBPK Consultancy###Certara UK Ltd###Session Speaker: – Certara UK Ltd
### 5:00 PM – 5:30 PM PT
STEP & ESP Poster Walk
5:00 PM – 5:30 PM PT
STEP & ESP Poster Walk
Location:Grand Ballroom A-D
5:00 PM – 7:00 PM PT
Opening Reception, Exhibits & Poster Session 1
5:00 PM – 7:00 PM PT
Opening Reception, Exhibits & Poster Session 1
Location:Grand Ballroom A-D
6:00 PM – 6:45 PM PT
STEP & ESP Podium Presentations
6:00 PM – 6:45 PM PT
STEP & ESP Podium Presentations
Location:Industry Theater in Exhibit Hall
- Monday, September 11, 2023
7:00 AM – 7:45 AM PT
Meet the ACCP/ISoP Special Interest Group
7:00 AM – 7:45 AM PT
Meet the ACCP/ISoP Special Interest Group
Location:Grand Ballroom E-H
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 Annual Meeting Program Committee Meeting (Invitation only)
7:00 AM – 8:00 AM PT
ACCP Annual Meeting Program 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 A-D
7:00 AM – 5:00 PM PT
ACCP Registration Desk Open
7:00 AM – 5:00 PM PT
ACCP Registration Desk Open
Location:Grand Ballroom East Foyer
7:00 AM – 7:00 PM PT
Exhibit Hall Open
7:00 AM – 7:00 PM PT
Exhibit Hall Open
Location:Grand Ballroom A-D
8:00 AM – 9:30 AM PT
Symposium 5: Contemporary Issues Related to Pediatric Drug DevelopmentChair & Faculty: – US Food & Drug Administration
Faculty: – US Food & Drug Administration
Faculty: – Univ of California San Diego
Faculty: – F. Hoffmann-La Roche Ltd
Clinical Drug Development & Investigations
8:00 AM – 9:30 AM PT
Symposium 5: Contemporary Issues Related to Pediatric Drug DevelopmentLocation:Grand Ballroom E-HChair & Faculty: – US Food & Drug Administration
Faculty: – US Food & Drug Administration
Faculty: – Univ of California San Diego
Faculty: – F. Hoffmann-La Roche Ltd
Clinical Drug Development & Investigations
Martina Sahre, PhD – US Food & Drug Administration ### 1492828###Chair & Faculty###Policy Lead, Office of Clinical Pharmacology###US Food & Drug Administration###Chair & Faculty: – US Food & Drug Administration
### @@@ Vikram Arya, PhD – US Food & Drug Administration ### 637866###Faculty###Associate Director, Therapeutic Review, Div of Infectious Disease Pharmacology, Office of Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Jeremiah D. Momper, PharmD, PhD – Univ of California San Diego ### 1044394###Faculty###Professor###Univ of California San Diego###Faculty: – Univ of California San Diego
### @@@ Yumi Cleary, BSc, MSc – F. Hoffmann-La Roche Ltd ### 1044286###Faculty###Clinical Pharmacometrician, Principal Scientist, Roche Innovation Ctr Basel###F. Hoffmann-La Roche Ltd###Faculty: – F. Hoffmann-La Roche Ltd
### 8:00 AM – 9:30 AM PT
Symposium 6: The Tightrope of Substance Abuse Potential: The Preclinical & Clinical Factors that Make or Break the Scheduling of a Substance, Using Kratom (Mitragyna Speciosa) as an ExampleCo-Chair & Faculty: – Univ of Florida
Co-Chair & Faculty: – National Inst on Drug Abuse
Faculty: – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
Clinical Drug Development & Investigations
8:00 AM – 9:30 AM PT
Symposium 6: The Tightrope of Substance Abuse Potential: The Preclinical & Clinical Factors that Make or Break the Scheduling of a Substance, Using Kratom (Mitragyna Speciosa) as an ExampleLocation:Grand Ballroom I-KCo-Chair & Faculty: – Univ of Florida
Co-Chair & Faculty: – National Inst on Drug Abuse
Faculty: – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
Clinical Drug Development & Investigations
Oliver Grundmann, PhD (he/him/his) – Univ of Florida ### 1156416###Co-Chair & Faculty###Director & Clinical Professor, Medicinal Chemistry###Univ of Florida###Co-Chair & Faculty: – Univ of Florida
### he/him/his @@@ Kirsten E. Smith, PhD – National Inst on Drug Abuse ### 1827477###Co-Chair & Faculty###Postdoctoral Fellow, Real-World Assessment, Prediction & Treatment Unit###National Inst on Drug Abuse###Co-Chair & Faculty: – National Inst on Drug Abuse
### @@@ Jack Henningfield, PhD – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program ### 480554###Faculty###Vice President, Research, Health Policy & Abuse Liability, Pinney Associates Inc and Professor, Behavioral Biology###Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program###Faculty: – Johns Hopkins Univ School of Medicine Prediction & Treatment Unit, National Inst on Drug Abuse Intramural Research Program
### 9:30 AM – 10:30 AM PT
Coffee/Networking Break
9:30 AM – 10:30 AM PT
Coffee/Networking Break
Location:Grand Ballroom A-D
9:40 AM – 10:00 AM PT
Industry Theater Presentation: Roadmap to Starting a Successful Preclinical/Clinical Pharmacology Consultancy Presented by Patel Kwan Consultancy LLC
9:40 AM – 10:00 AM PT
Industry Theater Presentation: Roadmap to Starting a Successful Preclinical/Clinical Pharmacology Consultancy Presented by Patel Kwan Consultancy LLC
Location:Industry Theater in Exhibit Hall
10:30 AM – 11:30 AM PT
Invited Keynote: Benefit vs Risk: What's the Optimal Dose of Artificial Intelligence in Clinical Pharmacology?Chair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences
Faculty: – Pfizer Worldwide Research, Development & Medical Clinical Pharmacology & Bioanalytics
10:30 AM – 11:30 AM PT
Invited Keynote: Benefit vs Risk: What's the Optimal Dose of Artificial Intelligence in Clinical Pharmacology?Location:Grand Ballroom E-KChair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences
Faculty: – Pfizer Worldwide Research, Development & Medical Clinical Pharmacology & Bioanalytics
Donald E. Mager, PharmD, PhD – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences ### 1827460###Chair & Faculty###Professor & Chair, Pharmaceutical Sciences###Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences###Chair & Faculty: – Univ at Buffalo, SUNY School of Pharmacy & Pharmaceutical Sciences
### @@@ Cynthia J. (CJ) Musante, PhD – Pfizer Worldwide Research, Development & Medical Clinical Pharmacology & Bioanalytics ### 1947529###Faculty###Vice President, Scientific Research & Global Head of Quantitative Systems Pharmacology###Pfizer Worldwide Research, Development & Medical Clinical Pharmacology & Bioanalytics###Faculty: – Pfizer Worldwide Research, Development & Medical Clinical Pharmacology & Bioanalytics
### 11:30 AM – 1:30 PM PT
Lunch Buffet
11:30 AM – 1:30 PM PT
Lunch Buffet
Location:Grand Ballroom A-D
11:45 AM – 1:15 PM PT
Lunch & Awards
11:45 AM – 1:15 PM PT
Lunch & Awards
Location:Grand Ballroom E-K
1:30 PM – 5:00 PM PT
Symposium 7: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?Co-Chair & Faculty: – Amgen Inc
Co-Chair & Faculty: – Certara
Faculty: – US Food & Drug Administration
Faculty: – Applied BioMath LLC
Faculty: – US Food & Drug Administration
Faculty: – Bristol Myers Squibb
Faculty: – Genentech Inc
Faculty: – Certara
Clinical Drug Development & Investigations
1:30 PM – 5:00 PM PT
Symposium 7: Are Mechanistic Models Necessary or Nice-to-Have in the Development of Multispecific Antibodies?Location:Grand Ballroom E-HCo-Chair & Faculty: – Amgen Inc
Co-Chair & Faculty: – Certara
Faculty: – US Food & Drug Administration
Faculty: – Applied BioMath LLC
Faculty: – US Food & Drug Administration
Faculty: – Bristol Myers Squibb
Faculty: – Genentech Inc
Faculty: – Certara
Clinical Drug Development & Investigations
Khamir Mehta, PhD – Amgen Inc ### 1827463###Co-Chair & Faculty###Director, Clinical Pharmacology Modeling & Simulation###Amgen Inc###Co-Chair & Faculty: – Amgen Inc
### @@@ Piet van der Graaf, PhD, PharmD – Certara ### 1827464###Co-Chair & Faculty###Senior Vice President###Certara###Co-Chair & Faculty: – Certara
### @@@ Haleh Saber, PhD (she/her/hers) – US Food & Drug Administration ### 1827465###Faculty###Hematology Oncology Toxicology, Office of Oncologic Diseases, Ctr for Drug Evaluation & Research###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### she/her/hers @@@ Fei Hua, PhD – Applied BioMath LLC ### 2003047###Faculty###Vice President, Modeling & Simulation SVcs###Applied BioMath LLC###Faculty: – Applied BioMath LLC
### @@@ Xiling Jiang, PhD – US Food & Drug Administration ### 1357539###Faculty###Clinical Pharmacology Reviewer, Oncology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Alexander Ratushny, PhD – Bristol Myers Squibb ### 1827467###Faculty###Director, Quantitative Systems Pharmacology, Clinical Pharmacology, Pharmacometrics, Disposition & Bioanalysis###Bristol Myers Squibb###Faculty: – Bristol Myers Squibb
### @@@ Vincent Lemaire, PhD – Genentech Inc ### 1921729###Faculty###Distinguished Scientist###Genentech Inc###Faculty: – Genentech Inc
### @@@ Julie Bullock, PharmD – Certara ### 2003531###Faculty###Senior Vice President, Global Head of Clinical Pharmacology & Translational Medicine###Certara###Faculty: – Certara
### 1:30 PM – 5:00 PM PT
Symposium 8: Use of Real-time Simulation for Decision Making in Clinical PharmacologyCo-Chair & Faculty: – AbbVie Inc
Co-Chair & Faculty: – Univ of Florida
Faculty: – AbbVie Inc
Faculty: – AbbVie Inc
Clinical Drug Development & Investigations
1:30 PM – 5:00 PM PT
Symposium 8: Use of Real-time Simulation for Decision Making in Clinical PharmacologyLocation:Grand Ballroom I-KCo-Chair & Faculty: – AbbVie Inc
Co-Chair & Faculty: – Univ of Florida
Faculty: – AbbVie Inc
Faculty: – AbbVie Inc
Clinical Drug Development & Investigations
Matthew Rosebraugh, PhD – AbbVie Inc ### 1827448###Co-Chair & Faculty###Director, Clinical Pharmacology & Pharmacometrics###AbbVie Inc###Co-Chair & Faculty: – AbbVie Inc
### @@@ Stephan Schmidt, PhD – Univ of Florida ### 480569###Co-Chair & Faculty###Director/Professor###Univ of Florida###Co-Chair & Faculty: – Univ of Florida
### @@@ Mohamad Shebley, PhD – AbbVie Inc ### 1827449###Faculty###Head, Clinical Pharmacology Neuroscience, Clinical Pharmacology###AbbVie Inc###Faculty: – AbbVie Inc
### @@@ Sven Stodtmann, PhD (he/him/his) – AbbVie Inc ### 1754755###Faculty###Director, Pharmacometrics###AbbVie Inc###Faculty: – AbbVie Inc
### he/him/his3:00 PM – 3:30 PM PT
Coffee/Networking Break
3:00 PM – 3:30 PM PT
Coffee/Networking Break
Location:Grand Ballroom A-D
5:00 PM – 5:30 PM PT
STEP & ESP Poster Walk
5:00 PM – 5:30 PM PT
STEP & ESP Poster Walk
Location:Grand Ballroom A-D
5:00 PM – 7:00 PM PT
Evening Reception, Exhibits & Poster Session 2
5:00 PM – 7:00 PM PT
Evening Reception, Exhibits & Poster Session 2
Location:Grand Ballroom A-D
6:00 PM – 6:45 PM PT
STEP & ESP Podium Presentations
6:00 PM – 6:45 PM PT
STEP & ESP Podium Presentations
Location:Industry Theater in Exhibit Hall
7:00 PM – 9:00 PM PT
JCP & CPDD Editorial Board Dinner (Invitation only)
7:00 PM – 9:00 PM PT
JCP & CPDD Editorial Board Dinner (Invitation only)
Location:Larch
- 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 HospitalizedChair & Faculty: – US Food & Drug Administration
Faculty: – Rutgers Univ
Faculty: – Merck & Co
Clinical Drug Development & Investigations
8:00 AM – 9:30 AM PT
Symposium 9: Enteral Feeding & Soft Foods: Supporting Medication Dosing in Pediatrics & the HospitalizedLocation:Grand Ballroom I-KChair & Faculty: – US Food & Drug Administration
Faculty: – Rutgers Univ
Faculty: – Merck & Co
Clinical Drug Development & Investigations
Elimika Fletcher, PharmD, PhD – US Food & Drug Administration ### 1827480###Chair & Faculty###Policy Lead/Senior Clinical Pharmacologist, Office of Clinical Pharmacology###US Food & Drug Administration###Chair & Faculty: – US Food & Drug Administration
### @@@ Rachel Meyers, PharmD – Rutgers Univ ### 1922106###Faculty###Clinical Professor, Ernest Mario School of Pharmacy###Rutgers Univ###Faculty: – Rutgers Univ
### @@@ Karen Thompson, PhD – Merck & Co ### 1827481###Faculty###Senior Principal Scientist, Preclinical Development###Merck & Co###Faculty: – Merck & Co
### 8:00 AM – 11:30 AM PT
Symposium 10: First-in-Patient Dose Prediction for Adeno-associated Virus-mediated Gene TherapyClinical Drug Development & Investigations
8:00 AM – 11:30 AM PT
Symposium 10: First-in-Patient Dose Prediction for Adeno-associated, Virus-mediated Gene TherapyLocation:Grand Ballroom E-HClinical Drug Development & Investigations
Xiaofei Wang, PhD – US Food & Drug Administration ### 1156402###Co-Chair & Faculty###Clinical Pharmacologist, CBER/OTP/Office of Clinical Evaluation/Div of General Medicine###US Food & Drug Administration###Co-Chair & Faculty: – US Food & Drug Administration
### @@@ Peng Zou, PhD – Daiichi Sankyo Co Ltd ### 1827473###Co-Chair & Faculty###Director, Quantitative Clinical Pharmacology###Daiichi Sankyo Co Ltd###Co-Chair & Faculty: – Daiichi Sankyo Co Ltd
### @@@ Kefeng Sun, PhD – Takeda Pharmaceutical Co Ltd ### 1827475###Faculty###Clinical Pharmacology###Takeda Pharmaceutical Co Ltd###Faculty: – Takeda Pharmaceutical Co Ltd
### @@@ Tao Zhang, PhD (he/him/his) – Binghampton Univ ### 1827474###Faculty###Assistant Professor, Pharmaceutical Sciences###Binghampton Univ###Faculty: – Binghampton Univ
### he/him/his9:30 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 PharmacologyChair & Faculty: – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Faculty: – American Board of Clinical Pharmacology
10:00 AM – 11:00 AM PT
Symposium 11: Obtaining Board Certification & Training Program Credentialing With the American Board of Clinical PharmacologyLocation:Grand Ballroom I-KChair & Faculty: – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
Faculty: – American Board of Clinical Pharmacology
Craig W. Hendrix, MD, DABCP – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology ### 1827468###Chair & Faculty###Professor of Medicine (Clinical Pharmacology)###Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology###Chair & Faculty: – Johns Hopkins Univ School of Medicine and Chairman, American Board of Clinical Pharmacology
### @@@ Lionel D. Lewis, MA, MBBCh, MD – American Board of Clinical Pharmacology ### 1948972###Faculty###Professor of Medicine/Pharmacology & Toxicology, The Geisel School of Medicine at Dartmouth, Executive Director###American Board of Clinical Pharmacology###Faculty: – American Board of Clinical Pharmacology
### 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 SymposiumCo-Chair & Faculty: – Children's National Hosp
Co-Chair & Faculty: – Univ of Utah Coll of Pharmacy
Faculty: – US Food & Drug Administration
Evidence-based Practice & Patient Care
1:30 PM – 3:00 PM PT
Symposium 12: How Drug Shortages Impact the Healthcare System: History, Impact & the Future, A Joint ACCP/ASHP SymposiumLocation:Grand Ballroom I-KCo-Chair & Faculty: – Children's National Hosp
Co-Chair & Faculty: – Univ of Utah Coll of Pharmacy
Faculty: – US Food & Drug Administration
Evidence-based Practice & Patient Care
Claude Abdallah, MD, MS, FASA – Children's National Hosp ### 1827470###Co-Chair & Faculty###Associate Professor, Anesthesiology & Pediatrics, Anesthesiology###Children's National Hosp###Co-Chair & Faculty: – Children's National Hosp
### @@@ Erin Fox, PharmD, MHA, BCPS, FASHP (she/her/hers) – Univ of Utah Coll of Pharmacy ### 1044450###Co-Chair & Faculty###Univ of Utah Health & Pharmacotherapy###Univ of Utah Coll of Pharmacy###Co-Chair & Faculty: – Univ of Utah Coll of Pharmacy
### she/her/hers @@@ Valerie E. Jensen, RPh – US Food & Drug Administration ### 1909875###Faculty###Associate Director, Drug Shortage Staff###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 1:30 PM – 3:00 PM PT
Symposium 13: Clinical Pharmacology Challenges in Obesity & Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis: Mechanisms & TherapeuticsCo-Chair & Faculty: – Univ of North Carolina at Chapel Hill
Co-Chair & Faculty: – Leiden Univ
Faculty: – Mayo Clinic
Faculty: – US Food & Drug Administration
Faculty: – Gilead Sciences Inc
Clinical Drug Development & Investigations
1:30 PM – 3:00 PM PT
Symposium 13: Clinical Pharmacology Challenges in Obesity & Nonalcoholic Fatty Liver Disease/Nonalcoholic Steatohepatitis: Mechanisms & TherapeuticsLocation:Grand Ballroom E-HCo-Chair & Faculty: – Univ of North Carolina at Chapel Hill
Co-Chair & Faculty: – Leiden Univ
Faculty: – Mayo Clinic
Faculty: – US Food & Drug Administration
Faculty: – Gilead Sciences Inc
Clinical Drug Development & Investigations
Kim LR Brouwer, PharmD, PhD – Univ of North Carolina at Chapel Hill ### 1726477###Co-Chair & Faculty###WR Kenan Jr Distinguished Professor, Associate Dean, Research & Graduate Education###Univ of North Carolina at Chapel Hill###Co-Chair & Faculty: – Univ of North Carolina at Chapel Hill
### @@@ Catherijne J. Knibbe, PharmD, PhD – Leiden Univ ### 1827453###Co-Chair & Faculty###Professor, Pharmacology###Leiden Univ###Co-Chair & Faculty: – Leiden Univ
### @@@ Manal Abdelmalek, MD, MPH – Mayo Clinic ### 1920214###Faculty###Professor of Medicine, Director, Hepatobiliary Disease Interest Group, Div. of Gastroenterology & Hepatology###Mayo Clinic###Faculty: – Mayo Clinic
### @@@ Insook Kim, PhD – US Food & Drug Administration ### 1917349###Faculty###Team Lead, Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Yurong Lai, PhD – Gilead Sciences Inc ### 1917359###Faculty###Executive Director, Drug Metabolism###Gilead Sciences Inc###Faculty: – Gilead Sciences Inc
### 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 DrugsCo-Chair & Faculty: – Novartis Inst for Biomedical Research
Co-Chair & Faculty: – Daiichi Sankyo Inc
Faculty: – US Food & Drug Administration
Faculty: – Univ of Florida Coll of Pharmacy
Clinical Drug Development & Investigations
3:30 PM – 5:00 PM PT
Symposium 14: Recent Trends in Food Effect Assessment in Supporting Dosing Recommendations for Oral Oncology DrugsLocation:Grand Ballroom E-HCo-Chair & Faculty: – Novartis Inst for Biomedical Research
Co-Chair & Faculty: – Daiichi Sankyo Inc
Faculty: – US Food & Drug Administration
Faculty: – Univ of Florida Coll of Pharmacy
Clinical Drug Development & Investigations
Xiaoming Cui, PhD (she/her/hers) – Novartis Inst for Biomedical Research ### 1827451###Co-Chair & Faculty###Director, PK Sciences, Translational Medicine###Novartis Inst for Biomedical Research###Co-Chair & Faculty: – Novartis Inst for Biomedical Research
### she/her/hers @@@ Yvonne Lau, PhD – Daiichi Sankyo Inc ### 1827450###Co-Chair & Faculty###Executive Director, Oncology, Quantitative Clinical Pharmacology###Daiichi Sankyo Inc###Co-Chair & Faculty: – Daiichi Sankyo Inc
### @@@ Brian Booth, PhD – US Food & Drug Administration ### 1156385###Faculty###Director, Office of Clinical Pharmacology, CDER###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Lawrence Lesko, PhD – Univ of Florida Coll of Pharmacy ### 1827452###Faculty###Clinical Professor & Director, Ctr for Pharmacometrics & Systems Pharmacology###Univ of Florida Coll of Pharmacy###Faculty: – Univ of Florida Coll of Pharmacy
### 3:30 PM – 5:00 PM PT
Symposium 15: Hot TopicsCo-Chair & Faculty: – Children's National Hosp
Co-Chair & Faculty: – Biocryst Pharmaceuticals Inc.
Faculty:
Faculty:
Faculty:
Faculty: – Eastern Virginia Medical School
3:30 PM – 5:00 PM PT
Symposium 15: Hot TopicsLocation:Grand Ballroom I-KCo-Chair & Faculty: – Children's National Hosp
Co-Chair & Faculty: – Biocryst Pharmaceuticals Inc.
Faculty:
Faculty:
Faculty:
Faculty: – Eastern Virginia Medical School
Claude Abdallah, MD, MS, FASA – Children's National Hosp ### 1827470###Co-Chair & Faculty###Associate Professor, Anesthesiology & Pediatrics, Anesthesiology###Children's National Hosp###Co-Chair & Faculty: – Children's National Hosp
### @@@ Laurent Vernillet, PharmD, PhD – Biocryst Pharmaceuticals Inc. ### 1044176###Co-Chair & Faculty######Biocryst Pharmaceuticals Inc.###Co-Chair & Faculty: – Biocryst Pharmaceuticals Inc.
### @@@ Yulan Qi ### 1983185###Faculty#########Faculty:
### @@@ Phil Collis ### 2003116###Faculty#########Faculty:
### @@@ Heather Ferguson, PharmD, MS ### 2003118###Faculty#########Faculty:
### @@@ Jennifer Wohl, DHSc, PA-C – Eastern Virginia Medical School ### 1492811###Faculty###Associate Professor, MPA Program, Health Professions###Eastern Virginia Medical School###Faculty: – Eastern Virginia Medical School
###
