- Friday, September 23, 2022
5:00 PM – 7:00 PM ET
ACCP Registration Desk Open
5:00 PM – 7:00 PM ET
ACCP Registration Desk Open
Location:Grand Ballroom Foyer
6:00 PM – 10:00 PM ET
ACCP Executive Committee Meeting & Dinner (Invitation only)
6:00 PM – 10:00 PM ET
ACCP Executive Committee Meeting & Dinner (Invitation only)
Location:Great Falls
- Saturday, September 24, 2022
7:00 AM – 5:30 PM ET
ACCP Registration Desk Open
7:00 AM – 5:30 PM ET
ACCP Registration Desk Open
Location:Grand Ballroom Foyer
8:00 AM – 3:00 PM ET
ACCP Board of Regents Meeting (Invitation only)
8:00 AM – 3:00 PM ET
ACCP Board of Regents Meeting (Invitation only)
Location:Glen Echo
8:00 AM – 5:00 PM ET
2022 ACCP Trends in Drug Development Seminar Chair & Faculty: – US Food & Drug Administration
Faculty: – Pfizer Inc
Faculty: – US Food & Drug Administration
Faculty: – AbbVie Inc
Faculty: – Univ of Florida
Faculty: – Univ of Florida Coll of Pharmacy
Faculty: – Takeda Pharmaceuticals Intl Inc
Faculty: – Certara
Faculty: – US Food & Drug Administration
Faculty: – Shanghai Henlius Biotech
Faculty: – Bristol Myers Squibb
8:00 AM – 5:00 PM ET
2022 ACCP Trends in Drug Development Seminar Location:BrooksideChair & Faculty: – US Food & Drug Administration
Faculty: – Pfizer Inc
Faculty: – US Food & Drug Administration
Faculty: – AbbVie Inc
Faculty: – Univ of Florida
Faculty: – Univ of Florida Coll of Pharmacy
Faculty: – Takeda Pharmaceuticals Intl Inc
Faculty: – Certara
Faculty: – US Food & Drug Administration
Faculty: – Shanghai Henlius Biotech
Faculty: – Bristol Myers Squibb
Olanrewaju O. Okusanya, PharmD, MS – US Food & Drug Administration ### 1492816###Chair & Faculty###Deputy Division Director, Div of Cancer Pharmacology, Office of Clinical Pharmacology,###US Food & Drug Administration###Chair & Faculty: – US Food & Drug Administration
### @@@ Bharat Damle, PhD – Pfizer Inc ### 1615824###Faculty###Executive Director, Clinical Pharmacology, Global Product Development###Pfizer Inc###Faculty: – Pfizer Inc
### @@@ Kofi Kumi, PhD, RPh – US Food & Drug Administration ### 1615823###Faculty###Senior Reviewer, Clinical Pharmacology, Office of Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Patrick Marroum, PhD – AbbVie Inc ### 1615821###Faculty###Senior Director, Distringuished Research Fellow, Clinical Pharmacology & Pharmacometrics,###AbbVie Inc###Faculty: – AbbVie Inc
### @@@ Christopher McCurdy, PhD – Univ of Florida ### 1615826###Faculty###Professor & The Frank A. Duckworth Eminent Scholar Chair & Director of The UF Translational Drug Development Core,###Univ of Florida###Faculty: – Univ of Florida
### @@@ Abhisheak Sharma, MPharm, PhD – Univ of Florida Coll of Pharmacy ### 1615827###Faculty###Research Assistant Professor & Assistant Director, UF Translational Drug Development Core, Pharmaceutics###Univ of Florida Coll of Pharmacy###Faculty: – Univ of Florida Coll of Pharmacy
### @@@ Vikram Sinha, PhD – Takeda Pharmaceuticals Intl Inc ### 1615825###Faculty###Vice President, Quantitative Clinical Pharmacology###Takeda Pharmaceuticals Intl Inc###Faculty: – Takeda Pharmaceuticals Intl Inc
### @@@ Jaap Mandema, PhD – Certara ### 1678423###Faculty###Chief Innovation Officer###Certara###Faculty: – Certara
### @@@ Ankit Shah, PhD – US Food & Drug Administration ### 1678428###Faculty###Clinical Pharmacology Reviewer, Regulatory Toxicologist###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Haoheng (Sandy) Yan, MD, PhD – Shanghai Henlius Biotech ### 1682092###Faculty###Head of US Regulatory Affairs###Shanghai Henlius Biotech###Faculty: – Shanghai Henlius Biotech
### @@@ Lora Hamuro, MS, PhD – Bristol Myers Squibb ### 1752442###Faculty###Director, Clinical Pharmacology & Pharmacometrics###Bristol Myers Squibb###Faculty: – Bristol Myers Squibb
### 8:00 AM – 5:00 PM ET
PMWS: Quantitative Systems Pharmacology 101 Workshop: Concept & Applications in Clinical Drug DevelopmentCo-Chair & Faculty: – Daiichi Sankyo Co Inc
Co-Chair & Faculty: – Genentech Inc
Faculty: – US Food & Drug Administration
Faculty: – Daiichi Sankyo Inc
Faculty: – Univ of Florida Coll of Pharmacy
Faculty: – Metrum Research Group LLC
Clinical Investigations & Drug Development Track
8:00 AM – 5:00 PM ET
PMWS: Quantitative Systems Pharmacology 101 Workshop: Concept & Applications in Clinical Drug DevelopmentLocation:Grand Ballroom GCo-Chair & Faculty: – Daiichi Sankyo Co Inc
Co-Chair & Faculty: – Genentech Inc
Faculty: – US Food & Drug Administration
Faculty: – Daiichi Sankyo Inc
Faculty: – Univ of Florida Coll of Pharmacy
Faculty: – Metrum Research Group LLC
Clinical Investigations & Drug Development Track
Abhinav Kurumaddali, PhD – Daiichi Sankyo Co Inc ### 1492806###Co-Chair & Faculty###Manager, Pharmacometrics, Quantitative Clinical Pharmacology###Daiichi Sankyo Co Inc###Co-Chair & Faculty: – Daiichi Sankyo Co Inc
### @@@ Yi Ting (Kayla) Lien, PhD – Genentech Inc ### 1156611###Co-Chair & Faculty###Scientist###Genentech Inc###Co-Chair & Faculty: – Genentech Inc
### @@@ Jane Bai, PhD – US Food & Drug Administration ### 1598805###Faculty###Expert Regulatory Review Scientist (Systems Pharmacology), OCP, OTS###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Tarek Leil, PhD – Daiichi Sankyo Inc ### 1598806###Faculty###Head, Pharmacometrics, QSP & Specialty Medicine Clinical Pharmacology###Daiichi Sankyo Inc###Faculty: – Daiichi Sankyo Inc
### @@@ Stephan Schmidt, BPharm, PhD – Univ of Florida Coll of Pharmacy ### 480569###Faculty###Professor & Certara Endowed Director, Director of the Ctr for Pharmacometrics & Systems Pharmacology###Univ of Florida Coll of Pharmacy###Faculty: – Univ of Florida Coll of Pharmacy
### @@@ Matthew Riggs, PhD – Metrum Research Group LLC ### 1598804###Faculty###Chief Scientific Officer###Metrum Research Group LLC###Faculty: – Metrum Research Group LLC
### 3:30 PM – 4:30 PM ET
ACCP Publications Committee Meeting (Invitation Only)
3:30 PM – 4:30 PM ET
ACCP Publications Committee Meeting (Invitation Only)
Location:Linden Oak
7:00 PM – 9:00 PM ET
PharmaFete
7:00 PM – 9:00 PM ET
PharmaFete
Location:Grand Ballroom D
- Sunday, September 25, 2022
6:30 AM – 7:00 PM ET
ACCP Registration Desk Open
6:30 AM – 7:00 PM ET
ACCP Registration Desk Open
Location:Grand Ballroom Foyer
7:00 AM – 7:45 AM ET
New-member & First-time Attendee Welcome
7:00 AM – 7:45 AM ET
New-member & First-time Attendee Welcome
Location:Grand Ballroom A-C
7:00 AM – 7:45 AM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Welcome Breakfast
7:00 AM – 7:45 AM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Welcome Breakfast
Location:Grand Ballroom D
7:00 AM – 8:00 AM ET
Continental Breakfast
7:00 AM – 8:00 AM ET
Continental Breakfast
Location:Grand Ballroom E-H
7:00 AM – 7:00 PM ET
Exhibit Hall Open
7:00 AM – 7:00 PM ET
Exhibit Hall Open
Location:Grand Ballroom E-H
7:45 AM – 8:00 AM ET
Welcome & Opening Remarks by ACCP President
7:45 AM – 8:00 AM ET
Welcome & Opening Remarks by ACCP President
Location:Grand Ballroom A-C
8:00 AM – 9:30 AM ET
ACCP Open Plenary Session: Advancing Health Equity & Reducing Disparities in Drug DevelopmentChair & Faculty: – Aridhia Digital Research Environment
Faculty: – US Food & Drug Administration
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
8:00 AM – 9:30 AM ET
ACCP Open Plenary Session: Advancing Health Equity & Reducing Disparities in Drug DevelopmentLocation:Grand Ballroom A-CChair & Faculty: – Aridhia Digital Research Environment
Faculty: – US Food & Drug Administration
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
Jeff Barrett, PhD – Aridhia Digital Research Environment ### 1612544###Chair & Faculty###Chief Science Officer###Aridhia Digital Research Environment###Chair & Faculty: – Aridhia Digital Research Environment
### @@@ Richardae Araojo, PharmD – US Food & Drug Administration ### 1753556###Faculty###Associate Commissioner for Minority Health & Director of the OMHHE###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Namandje Bumpus, PhD – US Food & Drug Administration ### 1611350###Faculty###Chief Scientist###US Food & Drug Administration###Faculty: – US Food & Drug Administration
###
9:30 AM – 10:00 AM ET
Networking Break
9:30 AM – 10:00 AM ET
Coffee/Networking Break
Location:Grand Ballroom E-H
10:00 AM – 11:30 AM ET
SYM 2: Pharmacokinetic Interactions Between Uremic Toxins & Therapeutic AgentsChair & Faculty: – Univ of Alberta
Faculty: – Univ of Pittsburgh
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
10:00 AM – 11:30 AM ET
SYM 2: Pharmacokinetic Interactions Between Uremic Toxins & Therapeutic AgentsLocation:Grand Ballroom DChair & Faculty: – Univ of Alberta
Faculty: – Univ of Pittsburgh
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
Tony Kiang, PhD – Univ of Alberta ### 1357644###Chair & Faculty###Assistant Professor (Tenure-Track)###Univ of Alberta###Chair & Faculty: – Univ of Alberta
### @@@ Thomas D. Nolin, PharmD, PhD – Univ of Pittsburgh ### 1492777###Faculty###Associate Dean for Research & Sponsored Programs, Pharmacy & Therapeutics###Univ of Pittsburgh###Faculty: – Univ of Pittsburgh
### @@@ Kunyi Wu, PharmD – US Food & Drug Administration ### 1156409###Faculty###Clinical Pharmacologist, Office of Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 10:00 AM – 3:00 PM ET
SYM 1: Equity & Diversity in Clinical Research & Development: Addressing Disparities & Barriers to Improve Medication AccessCo-Chair & Faculty: – Fairleigh Dickinson Univ
Co-Chair & Faculty: – Children's National Hosp
Faculty: – The Hills Tandem LLC
Faculty: – US Food & Drug Administration
Faculty: – Genentech Inc
Faculty: – Clinical Research Group
Faculty: – Bristol Myers Squibb
Clinical Investigations & Drug Development Track
10:00 AM – 3:00 PM ET
SYM 1: Equity & Diversity in Clinical Research & Development: Addressing Disparities & Barriers to Improve Medication AccessLocation:Grand Ballroom A-CCo-Chair & Faculty: – Fairleigh Dickinson Univ
Co-Chair & Faculty: – Children's National Hosp
Faculty: – The Hills Tandem LLC
Faculty: – US Food & Drug Administration
Faculty: – Genentech Inc
Faculty: – Clinical Research Group
Faculty: – Bristol Myers Squibb
Clinical Investigations & Drug Development Track
Otito Iwuchukwu, PhD – Fairleigh Dickinson Univ ### 1492800###Co-Chair & Faculty###Associate Professor, Pharmaceutical Sciences###Fairleigh Dickinson Univ###Co-Chair & Faculty: – Fairleigh Dickinson Univ
### @@@ Natella Rakhmanina, MD, PhD – Children's National Hosp ### 1156376###Co-Chair & Faculty###Director, HIV Svcs & Special Immunology###Children's National Hosp###Co-Chair & Faculty: – Children's National Hosp
### @@@ Jennifer Fields, MPH – The Hills Tandem LLC ### 1492781###Faculty###President & Founder###The Hills Tandem LLC###Faculty: – The Hills Tandem LLC
### @@@ Anuradha Ramamoorthy, PhD – US Food & Drug Administration ### 480550###Faculty###Policy Lead of Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Ryan Owen, PhD – Genentech Inc ### 1492779###Faculty###Senior Director & Principal Scientist, Clinical Pharmacology###Genentech Inc###Faculty: – Genentech Inc
### @@@ Rodrigo Garcia, MD – Clinical Research Group ### 1761510###Faculty###Vice President, Sites and Patients Center of Excellence###Clinical Research Group###Faculty: – Clinical Research Group
### @@@ Jateh Major, PharmD – Bristol Myers Squibb ### 1769315###Faculty###Associate Director Oncology Global Regulatory Strategy, Diversity in Clinical Trials SME###Bristol Myers Squibb###Faculty: – Bristol Myers Squibb
### 11:30 AM – 1:30 PM ET
Lunch Buffet
11:30 AM – 1:30 PM ET
Lunch Buffet
Location:Grand Ballroom E-H
11:45 AM – 1:15 PM ET
Lunch & Awards
11:45 AM – 1:15 PM ET
Lunch & Awards
Location:Grand Ballroom A-D
1:30 PM – 3:00 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Panel Discussion & Career Guidance
1:30 PM – 3:00 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Panel Discussion & Career Guidance
Location:White Flint Amphitheater
1:30 PM – 3:00 PM ET
SYM 3: Is It Time to Rethink Assessing Renal Function in Drug Development & Beyond?Chair & Faculty: – Gilead Sciences Inc
Faculty: – US Food & Drug Administration
Faculty: – Boehringer Ingelheim Pharmaceuticals Inc
Faculty: – Univ of Pittsburgh
Clinical Investigations & Drug Development Track
1:30 PM – 3:00 PM ET
SYM 3: Is It Time to Rethink Assessing Renal Function in Drug Development & Beyond?Location:Grand Ballroom DChair & Faculty: – Gilead Sciences Inc
Faculty: – US Food & Drug Administration
Faculty: – Boehringer Ingelheim Pharmaceuticals Inc
Faculty: – Univ of Pittsburgh
Clinical Investigations & Drug Development Track
Islam Younis, PhD – Gilead Sciences Inc ### 1492821###Chair & Faculty###Senior Director, Clinical Pharmacology###Gilead Sciences Inc###Chair & Faculty: – Gilead Sciences Inc
### @@@ Martina Sahre, PhD – US Food & Drug Administration ### 1492828###Faculty###Policy Lead, Office of Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Ashish Sharma, PhD – Boehringer Ingelheim Pharmaceuticals Inc ### 1492827###Faculty###Site Head of Clinical Pharmacology###Boehringer Ingelheim Pharmaceuticals Inc###Faculty: – Boehringer Ingelheim Pharmaceuticals Inc
### @@@ Thomas D. Nolin, PharmD, PhD – Univ of Pittsburgh ### 1492777###Faculty###Associate Dean for Research & Sponsored Programs, Pharmacy & Therapeutics###Univ of Pittsburgh###Faculty: – Univ of Pittsburgh
### 3:00 PM – 3:30 PM ET
Coffee/Networking Break
3:00 PM – 3:30 PM ET
Coffee/Networking Break
Location:Grand Ballroom E-H
3:00 PM – 5:00 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Networking Reception
3:00 PM – 5:00 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Networking Reception
Location:Brookside
3:30 PM – 5:00 PM ET
SYM 4: Hot TopicsChair & Faculty: – Janssen Research & Development
Faculty: – Univ of the Sciences Philadelphia
Faculty: – US Food & Drug Administration
3:30 PM – 5:00 PM ET
SYM 4: Hot TopicsLocation:Grand Ballroom A-CChair & Faculty: – Janssen Research & Development
Faculty: – Univ of the Sciences Philadelphia
Faculty: – US Food & Drug Administration
Navin S. Goyal, PhD – Janssen Research & Development ### 637874###Chair & Faculty###Senior Director & Group Lead###Janssen Research & Development###Chair & Faculty: – Janssen Research & Development
### @@@ Amalia M. Issa, PhD, MPH – Univ of the Sciences Philadelphia ### 481878###Faculty###Professor & Founding Director###Univ of the Sciences Philadelphia###Faculty: – Univ of the Sciences Philadelphia
### @@@ Anuradha Ramamoorthy, PhD – US Food & Drug Administration ### 480550###Faculty###Policy Lead of Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 5:00 PM – 7:00 PM ET
Opening Reception, Exhibits & Poster Session 1
5:00 PM – 7:00 PM ET
Opening Reception, Exhibits & Poster Session 1
Location:Grand Ballroom E-H
6:00 PM – 6:45 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Podium Presentations
6:00 PM – 6:45 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Podium Presentations
Location:Industry Theater in the Exhibit Hall
- Monday, September 26, 2022
7:00 AM – 7:45 AM ET
ACCP IDE Committee Meeting (Invitation Only)
7:00 AM – 7:45 AM ET
ACCP IDE Committee Meeting (Invitation Only)
Location:Cabin John
7:00 AM – 7:45 AM ET
Meet the ACCP/ISoP Special Interest Group
7:00 AM – 7:45 AM ET
Meet the ACCP/ISoP Special Interest Group
Location:Grand Ballroom A-C
7:00 AM – 7:45 AM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Gathering
7:00 AM – 7:45 AM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Gathering
Location:Grand Ballroom D
7:00 AM – 8:00 AM ET
ACCP Education Committee Meeting (Invitation Only)
7:00 AM – 8:00 AM ET
ACCP Education Committee Meeting (Invitation Only)
Location:Middlebrook
7:00 AM – 8:00 AM ET
Continental Breakfast
7:00 AM – 8:00 AM ET
Continental Breakfast
Location:Grand Ballroom E-H
7:00 AM – 7:00 PM ET
ACCP Registration Desk Open
7:00 AM – 7:00 PM ET
ACCP Registration Desk Open
Location:Grand Ballroom Foyer
7:00 AM – 7:00 PM ET
Exhibit Hall Open
7:00 AM – 7:00 PM ET
Exhibit Hall Open
Location:Grand Ballroom E-H
8:00 AM – 9:30 AM ET
SYM 5: Assessing the Feasibility of Model-informed Precision Dosing: A Point-Counterpoint Debate, An ACCP/ISoP SIG Joint SymposiumCo-Chair & Faculty: – Projections Research Inc
Co-Chair & Faculty: – Boehringer Ingelheim Pharmaceuticals Inc
Faculty: – Stanford Univ School of Medicine
Faculty: – US Food & Drug Administration
Clinical Practice & Patient Care Track
8:00 AM – 9:30 AM ET
SYM 5: Assessing the Feasibility of Model-informed Precision Dosing: A Point-Counterpoint Debate, An ACCP/ISoP SIG Joint SymposiumLocation:Grand Ballroom A-CCo-Chair & Faculty: – Projections Research Inc
Co-Chair & Faculty: – Boehringer Ingelheim Pharmaceuticals Inc
Faculty: – Stanford Univ School of Medicine
Faculty: – US Food & Drug Administration
Clinical Practice & Patient Care Track
Diane R. Mould, PhD – Projections Research Inc ### 1492772###Co-Chair & Faculty###President###Projections Research Inc###Co-Chair & Faculty: – Projections Research Inc
### @@@ Nikolas Onufrak, PharmD – Boehringer Ingelheim Pharmaceuticals Inc ### 1492773###Co-Chair & Faculty###Associate Director, Pharmacometrics###Boehringer Ingelheim Pharmaceuticals Inc###Co-Chair & Faculty: – Boehringer Ingelheim Pharmaceuticals Inc
### @@@ Adam Frymoyer, MD – Stanford Univ School of Medicine ### 1492775###Faculty###Clinical Associate Professor, Pediatrics###Stanford Univ School of Medicine###Faculty: – Stanford Univ School of Medicine
### @@@ Yow-Ming Wang, PhD – US Food & Drug Administration ### 1492774###Faculty###Associate Director, Biosimilars & Therapeutic Biologics###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 8:00 AM – 9:30 AM ET
SYM 6: Clinical Pharmacology Considerations for Monoclonal Antibodies Developed to Combat COVID-19Chair & Faculty: – US Food & Drug Administration
Faculty: – Enhanced Pharmacodynamics LLC
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
8:00 AM – 9:30 AM ET
SYM 6: Clinical Pharmacology Considerations for Monoclonal Antibodies Developed to Combat COVID-19Location:Grand Ballroom DChair & Faculty: – US Food & Drug Administration
Faculty: – Enhanced Pharmacodynamics LLC
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
Sonia Pahwa, PhD – US Food & Drug Administration ### 1492791###Chair & Faculty###Senior Clinical Pharmacology Reviewer, Office of Clinical Pharmacology###US Food & Drug Administration###Chair & Faculty: – US Food & Drug Administration
### @@@ Scott Van Wart, PhD – Enhanced Pharmacodynamics LLC ### 1492792###Faculty###Vice President & Chief Scientific Officer, Pharmacometrics & Quantitative Systems Pharmacology###Enhanced Pharmacodynamics LLC###Faculty: – Enhanced Pharmacodynamics LLC
### @@@ Timothy Bensman, PharmD, PhD – US Food & Drug Administration ### 1657217###Faculty###Clinical Pharmacology Reviewer, Div of Infectious Disease Pharmacology, OCP, OTS, CDER###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 9:30 AM – 10:00 AM ET
Coffee/Networking Break
9:30 AM – 10:00 AM ET
Coffee/Networking Break
Location:Grand Ballroom E-H
10:00 AM – 11:30 AM ET
Invited Keynote Presentation: Advances in Our Understanding of the Effects of Drugs & AddictionChair & Faculty: – University of Florida
Faculty: – National Inst of Health
Clinical Practice & Patient Care Track
10:00 AM – 11:30 AM ET
Invited Keynote Presentation: Advances in Our Understanding of the Effects of Drugs & AddictionLocation:Grand Ballroom A-CChair & Faculty: – University of Florida
Faculty: – National Inst of Health
Clinical Practice & Patient Care Track
Oliver Grundmann, PhD – University of Florida ### 1156416###Chair & Faculty######University of Florida###Chair & Faculty: – University of Florida
### @@@ Nora D. Volkow, MD – National Inst of Health ### 1595499###Faculty###Director, National Inst on Drug Abuse,###National Inst of Health###Faculty: – National Inst of Health
### 11:30 AM – 1:30 PM ET
Lunch Buffet
11:30 AM – 1:30 PM ET
Lunch Buffet
Location:Grand Ballroom E-H
11:45 AM – 1:15 PM ET
Lunch & Awards
11:45 AM – 1:15 PM ET
Lunch & Awards
Location:Grand Ballroom A-D
1:30 PM – 3:00 PM ET
SYM 8: Impact of the COVID-19 Pandemic on Clinical Trials: Challenges & Opportunities From the Clinical Pharmacology PerspectiveChair & Faculty: – Astellas Pharma Inc
Faculty: – National Inst of Allergy & Infectious Diseases
Faculty: – AbbVie Inc
Faculty: – Gilead Sciences Inc
Clinical Investigations & Drug Development Track
1:30 PM – 3:00 PM ET
SYM 8: Impact of the COVID-19 Pandemic on Clinical Trials: Challenges & Opportunities From the Clinical Pharmacology PerspectiveLocation:Grand Ballroom DChair & Faculty: – Astellas Pharma Inc
Faculty: – National Inst of Allergy & Infectious Diseases
Faculty: – AbbVie Inc
Faculty: – Gilead Sciences Inc
Clinical Investigations & Drug Development Track
Tong Zhu, PhD – Astellas Pharma Inc ### 1492784###Chair & Faculty###Executive Director, Clinical Pharmacology & Exploratory Development###Astellas Pharma Inc###Chair & Faculty: – Astellas Pharma Inc
### @@@ John Beigel, MD – National Inst of Allergy & Infectious Diseases ### 1546658###Faculty###Associate Director for Clinical Research###National Inst of Allergy & Infectious Diseases###Faculty: – National Inst of Allergy & Infectious Diseases
### @@@ Mohamed-Eslam Mohamed, PhD – AbbVie Inc ### 1156374###Faculty###Director, Clinical Pharmacology & Pharmacometrics###AbbVie Inc###Faculty: – AbbVie Inc
### @@@ Rita Humeniuk, PhD – Gilead Sciences Inc ### 1546657###Faculty###Senior Clinical Pharmacologist, Clinical Pharmacology###Gilead Sciences Inc###Faculty: – Gilead Sciences Inc
### 1:30 PM – 5:00 PM ET
SYM 7: Model-informed Drug Development for Specific Populations: Current Status & Future Perspectives, An ACCP/ISSX Joint SymposiumCo-Chair & Faculty: – Genentech Inc
Co-Chair & Faculty: – Daiichi Sankyo, Inc
Faculty: – Aridhia Digital Research Environment
Faculty: – United Kingdom Medicines & Healthcare Products Regulatory Agency
Faculty: – US Food & Drug Administration
Faculty: – Amgen Inc
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
1:30 PM – 5:00 PM ET
SYM 7: Model-informed Drug Development for Specific Populations: Current Status & Future Perspectives, An ACCP/ISSX Joint SymposiumLocation:Grand Ballroom A-CCo-Chair & Faculty: – Genentech Inc
Co-Chair & Faculty: – Daiichi Sankyo, Inc
Faculty: – Aridhia Digital Research Environment
Faculty: – United Kingdom Medicines & Healthcare Products Regulatory Agency
Faculty: – US Food & Drug Administration
Faculty: – Amgen Inc
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
Yanke Yu, PhD – Genentech Inc ### 1492793###Co-Chair & Faculty###Principal Scientist, Clinical Pharmacology###Genentech Inc###Co-Chair & Faculty: – Genentech Inc
### @@@ Xinyuan Zhang, PhD – Daiichi Sankyo, Inc ### 1492797###Co-Chair & Faculty###Director, Quantitative Clinical Pharmacology###Daiichi Sankyo, Inc###Co-Chair & Faculty: – Daiichi Sankyo, Inc
### @@@ Jeff Barrett, PhD – Aridhia Digital Research Environment ### 1612544###Faculty###Chief Science Officer###Aridhia Digital Research Environment###Faculty: – Aridhia Digital Research Environment
### @@@ Susan M. Cole – United Kingdom Medicines & Healthcare Products Regulatory Agency ### 1523454###Faculty###Expert Clinical Pharmacology Accessor, Statistics & Clinical Pharmacology###United Kingdom Medicines & Healthcare Products Regulatory Agency###Faculty: – United Kingdom Medicines & Healthcare Products Regulatory Agency
### @@@ Rajanikanth Madabushi, PhD – US Food & Drug Administration ### 1044150###Faculty###Associate Director for Guidance & Scientific Policy, Office of Clinical Pharmacology###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Vijay V. Upreti, PhD – Amgen Inc ### 481864###Faculty###Director, Clinical Pharmacology Hematology/Oncology Therapeutic Area Leader###Amgen Inc###Faculty: – Amgen Inc
### @@@ Hao Zhu, PhD – US Food & Drug Administration ### 1523456###Faculty###Deputy Division Director###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 3:00 PM – 3:30 PM ET
Coffee/Networking Break
3:00 PM – 3:30 PM ET
Coffee/Networking Break
Location:Grand Ballroom E-H
3:30 PM – 5:00 PM ET
SYM 9: Resilience During Crisis from the Frontline, An ACCP/AAMC/CFAS Joint SymposiumCo-Chair & Faculty: – The George Washington Univ Medical Ctr
Co-Chair & Faculty: – Eastern Virginia Medical School
Faculty: – Eastern Virginia Medical School
Faculty: – Chesapeake Regional Healthcare
Clinical Practice & Patient Care Track
3:30 PM – 5:00 PM ET
SYM 9: Resilience During Crisis From the Frontline, An ACCP/AAMC/CFAS Joint SymposiumLocation:Grand Ballroom DCo-Chair & Faculty: – The George Washington Univ Medical Ctr
Co-Chair & Faculty: – Eastern Virginia Medical School
Faculty: – Eastern Virginia Medical School
Faculty: – Chesapeake Regional Healthcare
Clinical Practice & Patient Care Track
Claude Abdallah, MD, MS – The George Washington Univ Medical Ctr ### 1492812###Co-Chair & Faculty###Associate Professor of Anesthesiology & Pediatrics###The George Washington Univ Medical Ctr###Co-Chair & Faculty: – The George Washington Univ Medical Ctr
### @@@ Jennifer Wohl, DHSc, PA-C – Eastern Virginia Medical School ### 1492811###Co-Chair & Faculty###Associate Professor, MPA Program, Health Professions###Eastern Virginia Medical School###Co-Chair & Faculty: – Eastern Virginia Medical School
### @@@ Bruce Britton, MD – Eastern Virginia Medical School ### 1492813###Faculty###Professor, Family Medicine###Eastern Virginia Medical School###Faculty: – Eastern Virginia Medical School
### @@@ Traci Richards, PhD – Chesapeake Regional Healthcare ### 1492814###Faculty###Clinical Director, Behavioral Health Svcs###Chesapeake Regional Healthcare###Faculty: – Chesapeake Regional Healthcare
### 5:00 PM – 7:00 PM ET
Evening Reception, Exhibits & Poster Session 2
5:00 PM – 7:00 PM ET
Evening Reception, Exhibits & Poster Session 2
Location:Grand Ballroom E-H
6:00 PM – 6:45 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Podium Presentations
6:00 PM – 6:45 PM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Podium Presentations
Location:Industry Theater in the Exhibit Hall
7:00 PM – 9:00 PM ET
JCP & CPDD Editorial Board Dinner (Invitation only)
7:00 PM – 9:00 PM ET
JCP & CPDD Editorial Board Dinner (Invitation only)
Location:Brookside
- Tuesday, September 27, 2022
7:00 AM – 7:45 AM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Gathering
7:00 AM – 7:45 AM ET
Student, Trainee & Early-stage Professional (STEP & ESP) Gathering
Location:Grand Ballroom D
7:00 AM – 8:00 AM ET
ACCP Annual Meeting Program Committee Meeting (Invitation Only)
7:00 AM – 8:00 AM ET
ACCP Annual Meeting Program Committee Meeting (Invitation Only)
Location:Linden Oak
7:00 AM – 8:00 AM ET
Continental Breakfast
7:00 AM – 8:00 AM ET
Continental Breakfast
Location:Grand Ballroom Foyer
7:00 AM – 5:30 PM ET
ACCP Registration Desk Open
7:00 AM – 5:30 PM ET
ACCP Registration Desk Open
Location:Grand Ballroom Foyer
8:00 AM – 9:30 AM ET
SYM 10: Hot TopicsChair & Faculty: – Univ of Tennessee Health Science Ctr
Faculty: – Pfizer Inc
Faculty: – Pfizer Inc
8:00 AM – 9:30 AM ET
SYM 10: Hot TopicsLocation:Grand Ballroom A-CChair & Faculty: – Univ of Tennessee Health Science Ctr
Faculty: – Pfizer Inc
Faculty: – Pfizer Inc
Zaid Temrikar, PhD Candidate – Univ of Tennessee Health Science Ctr ### 1753664###Chair & Faculty######Univ of Tennessee Health Science Ctr###Chair & Faculty: – Univ of Tennessee Health Science Ctr
### @@@ Manoli Vourvahis, PharmD – Pfizer Inc ### 933625###Faculty###Senior Director, Clinical Pharmacology###Pfizer Inc###Faculty: – Pfizer Inc
### @@@ David A. Rodrigues, PhD – Pfizer Inc ### 1678472###Faculty###Senior Scientific Director###Pfizer Inc###Faculty: – Pfizer Inc
### 8:00 AM – 9:30 AM ET
SYM 11: Revisiting Oncology Dose Finding: Striking the Optimum Balance Between Efficiency & RobustnessCo-Chair & Faculty: – Pfizer Inc
Co-Chair & Faculty: – US Food & Drug Administration
Faculty: – Genentech Inc
Faculty: – US Food & Drug Administration
Faculty: – VA Ctr for Clinical Management & Research
Clinical Investigations & Drug Development Track
8:00 AM – 9:30 AM ET
SYM 11: Revisiting Oncology Dose Finding: Striking the Optimum Balance Between Efficiency & RobustnessLocation:Grand Ballroom DCo-Chair & Faculty: – Pfizer Inc
Co-Chair & Faculty: – US Food & Drug Administration
Faculty: – Genentech Inc
Faculty: – US Food & Drug Administration
Faculty: – VA Ctr for Clinical Management & Research
Clinical Investigations & Drug Development Track
Cen Guo, PhD – Pfizer Inc ### 1492815###Co-Chair & Faculty###Associate Director, Clinical Pharmacology###Pfizer Inc###Co-Chair & Faculty: – Pfizer Inc
### @@@ Olanrewaju O. Okusanya, PharmD, MS – US Food & Drug Administration ### 1492816###Co-Chair & Faculty###Deputy Division Director, Div of Cancer Pharmacology, Office of Clinical Pharmacology,###US Food & Drug Administration###Co-Chair & Faculty: – US Food & Drug Administration
### @@@ Nastya Kassir, PharmD, PhD – Genentech Inc ### 1557851###Faculty###Director & Principal Scientist###Genentech Inc###Faculty: – Genentech Inc
### @@@ Mirat Shah, MD – US Food & Drug Administration ### 1492820###Faculty###Clinical Reviewer, Office of Oncologic Diseases###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Garth W. Strohbehn, MD – VA Ctr for Clinical Management & Research ### 1557850###Faculty###Assistant Professor###VA Ctr for Clinical Management & Research###Faculty: – VA Ctr for Clinical Management & Research
### 9:30 AM – 10:00 AM ET
Coffee/Networking Break
9:30 AM – 10:00 AM ET
Coffee/Networking Break
Location:Grand Ballroom Foyer
10:00 AM – 11:30 AM ET
SYM 12: Utilizing Quantitative Clinical Pharmacology & Interventional Pharmacoeconomics to More Efficiently Optimize Dose RegimensChair & Faculty: – National Cancer Inst
Faculty: – The Univ of Texas MD Anderson Cancer Ctr
Faculty: – Emory Univ School of Medicine
Clinical Practice & Patient Care Track
10:00 AM – 11:30 AM ET
SYM 12: Utilizing Quantitative Clinical Pharmacology & Interventional Pharmacoeconomics to More Efficiently Optimize Dose RegimensLocation:Grand Ballroom A-CChair & Faculty: – National Cancer Inst
Faculty: – The Univ of Texas MD Anderson Cancer Ctr
Faculty: – Emory Univ School of Medicine
Clinical Practice & Patient Care Track
Cody J. Peer, PhD – National Cancer Inst ### 1357475###Chair & Faculty###Staff Scientist, Clinical Pharmacology Program###National Cancer Inst###Chair & Faculty: – National Cancer Inst
### @@@ Varsha Gandhi, PhD – The Univ of Texas MD Anderson Cancer Ctr ### 1492782###Faculty###Professor & Chair Ad Interim, Experimental Therapeutics###The Univ of Texas MD Anderson Cancer Ctr###Faculty: – The Univ of Texas MD Anderson Cancer Ctr
### @@@ R. Donald Harvey, III, PharmD – Emory Univ School of Medicine ### 1406546###Faculty###Professor, Hematology & Medical Oncology###Emory Univ School of Medicine###Faculty: – Emory Univ School of Medicine
### 10:00 AM – 11:30 AM ET
SYM 13: Drug-Drug Interactions in Those 65+: Are They Getting the Right Dose?Co-Chair & Faculty: – York Coll & Graduate Ctr, City Univ of New York
Co-Chair & Faculty: – US Food & Drug Administration
Faculty: – Certara UK
Faculty: – Virginia Commonwealth Univ
Clinical Investigations & Drug Development Track
10:00 AM – 11:30 AM ET
SYM 13: Drug-Drug Interactions in Those 65+: Are They Getting the Right Dose?Location:Grand Ballroom DCo-Chair & Faculty: – York Coll & Graduate Ctr, City Univ of New York
Co-Chair & Faculty: – US Food & Drug Administration
Faculty: – Certara UK
Faculty: – Virginia Commonwealth Univ
Clinical Investigations & Drug Development Track
Zhu Zhou, PhD – York Coll & Graduate Ctr, City Univ of New York ### 1492807###Co-Chair & Faculty###Assistant Professor, Chemistry,###York Coll & Graduate Ctr, City Univ of New York###Co-Chair & Faculty: – York Coll & Graduate Ctr, City Univ of New York
### @@@ Lei Zhang, PhD – US Food & Drug Administration ### 1492810###Co-Chair & Faculty###Deputy Director, Ctr for Drug Evaluation & Research###US Food & Drug Administration###Co-Chair & Faculty: – US Food & Drug Administration
### @@@ Alice Ke, PhD – Certara UK ### 1357727###Faculty###Senior Director, PBPK Consultancy###Certara UK###Faculty: – Certara UK
### @@@ Patricia W. Slattum, PharmD, PhD – Virginia Commonwealth Univ ### 1492808###Faculty###Professor, Virginia Ctr on Aging###Virginia Commonwealth Univ###Faculty: – Virginia Commonwealth Univ
### 11:30 AM – 1:30 PM ET
Lunch Buffet
11:30 AM – 1:30 PM ET
Lunch Buffet
Location:Grand Ballroom Foyer
11:45 AM – 1:15 PM ET
Lunch & Annual Business Meeting (open to all)
11:45 AM – 1:15 PM ET
Lunch & Annual Business Meeting (open to all)
Location:Grand Ballroom A-D
1:30 PM – 3:00 PM ET
SYM 14: Devil & Angel: The Global Therapeutic Benefits & Risks of Using Substances of AbuseCo-Chair & Faculty: – Bertino Consulting
Co-Chair & Faculty: – Univ of Connecticut
Faculty: – Auburn Univ, Harrison School of Pharmacy
Clinical Practice & Patient Care Track
1:30 PM – 3:00 PM ET
SYM 14: Devil & Angel: The Global Therapeutic Benefits & Risks of Using Substances of AbuseLocation:Grand Ballroom A-CCo-Chair & Faculty: – Bertino Consulting
Co-Chair & Faculty: – Univ of Connecticut
Faculty: – Auburn Univ, Harrison School of Pharmacy
Clinical Practice & Patient Care Track
Anne N. Nafziger, MD, PhD, MHS – Bertino Consulting ### 1044273###Co-Chair & Faculty###Clinical Pharmacology Consultant###Bertino Consulting###Co-Chair & Faculty: – Bertino Consulting
### @@@ C. Michael White, PharmD – Univ of Connecticut ### 1528049###Co-Chair & Faculty###Distinguished Professor & Chair, Pharmacy Practice###Univ of Connecticut###Co-Chair & Faculty: – Univ of Connecticut
### @@@ Scott R. Penzak, PharmD – Auburn Univ, Harrison School of Pharmacy ### 1528111###Faculty###Department Head & Professor, Pharmacy Practice###Auburn Univ, Harrison School of Pharmacy###Faculty: – Auburn Univ, Harrison School of Pharmacy
### 1:30 PM – 3:00 PM ET
SYM 15: Vaccine Development 101Co-Chair & Faculty: – Regeneron Pharmaceuticals Inc
Co-Chair & Faculty: – Gilead Sciences Inc
Faculty: – Astellas Pharma US Inc
Faculty: – UNC School of Medicine
Faculty: – Pfizer Inc
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
1:30 PM – 3:00 PM ET
SYM 15: Vaccine Development 101Location:Grand Ballroom DCo-Chair & Faculty: – Regeneron Pharmaceuticals Inc
Co-Chair & Faculty: – Gilead Sciences Inc
Faculty: – Astellas Pharma US Inc
Faculty: – UNC School of Medicine
Faculty: – Pfizer Inc
Faculty: – US Food & Drug Administration
Clinical Investigations & Drug Development Track
Hazem Hassan, PhD – Regeneron Pharmaceuticals Inc ### 1156585###Co-Chair & Faculty###Associate Director, Clinical Pharmacology###Regeneron Pharmaceuticals Inc###Co-Chair & Faculty: – Regeneron Pharmaceuticals Inc
### @@@ Islam Younis, PhD – Gilead Sciences Inc ### 1492821###Co-Chair & Faculty###Senior Director, Clinical Pharmacology###Gilead Sciences Inc###Co-Chair & Faculty: – Gilead Sciences Inc
### @@@ Gurunadh Chichili, PhD – Astellas Pharma US Inc ### 1492823###Faculty###Senior Director, Clinical Pharmacology Fellow###Astellas Pharma US Inc###Faculty: – Astellas Pharma US Inc
### @@@ Nilu Goonetilleke, PhD – UNC School of Medicine ### 1631678###Faculty###Associate Professor, Microbiology & Immunology###UNC School of Medicine###Faculty: – UNC School of Medicine
### @@@ Gianluca Nucci, PhD – Pfizer Inc ### 1492824###Faculty###Vice President###Pfizer Inc###Faculty: – Pfizer Inc
### @@@ Rebecca Reindel, MD – US Food & Drug Administration ### 1631679###Faculty###Medical Officer###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### 3:00 PM – 3:30 PM ET
Coffee/Networking Break
3:00 PM – 3:30 PM ET
Coffee/Networking Break
Location:Grand Ballroom Foyer
3:30 PM – 5:00 PM ET
SYM 16: Utilizing Past & Present Big Data in Decision Making for Drug Development & RegulationChair & Faculty: – Univ at Buffalo
Faculty: – US Food & Drug Administration
Faculty: – Pfizer Inc
Clinical Investigations & Drug Development Track
3:30 PM – 5:00 PM ET
SYM 16: Utilizing Past & Present Big Data in Decision Making for Drug Development & RegulationLocation:Grand Ballroom A-CChair & Faculty: – Univ at Buffalo
Faculty: – US Food & Drug Administration
Faculty: – Pfizer Inc
Clinical Investigations & Drug Development Track
Robert Bies, PharmD, PhD – Univ at Buffalo ### 1156417###Chair & Faculty###Professor, Pharmaceutical Sciences###Univ at Buffalo###Chair & Faculty: – Univ at Buffalo
### @@@ Kevin Feng, PhD – US Food & Drug Administration ### 1492803###Faculty###Staff Fellow###US Food & Drug Administration###Faculty: – US Food & Drug Administration
### @@@ Vaishali Sahasrabudhe – Pfizer Inc ### 1551605###Faculty###Executive Director, Clinical Pharmacology Internal Medicine Head###Pfizer Inc###Faculty: – Pfizer Inc
###