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Sunday, November 4, 2018
7:00 AM - 8:00 PM

Registration Hours
7:00 AM - 8:00 PM

Registration Hours
Location: Salon GHI, WEWCC

Favorite
8:00 AM - 5:00 PM

Executive Lounge (by invitation only)
8:00 AM - 5:00 PM

Executive Lounge (by invitation only)
Location: 144 AB, WEWCC

Favorite
8:00 AM - 5:00 PM

Exhibitor Move-In
8:00 AM - 5:00 PM

Exhibitor Move-In
Location: Exhibit Hall A/B, WEWCC

Favorite
8:00 AM - 7:30 PM

Coat Check
8:00 AM - 7:30 PM

Coat Check
Location: Salon GHI, WEWCC

Favorite
9:00 AM - 1:00 PM

Short Course: (DAY 2) Development of Fixed Dose Combination Products: Considerations of GI Physiology and Overall Development Strategy
Workshop Organizer: Bart Hens, PhD, PharmD – KU Leuven
Workshop Organizer: Alexis Aceituno – Instituto de Salud Publica de Chile
9:00 AM - 9:50 AM

SC2 - Considering the Biopharmaceutical/Physicochemical Aspects of FDC
Location: 207 B, WEWCCAmitava Mitra, PhD – Sandoz, USA
Clinical Pharmacology

Workshop and Short Course

Favorite

Amitava Mitra, PhD – Sandoz, USA ### 465957###Workshop Presenter
9:00 AM - 1:00 PM

SC2 - Short Course: (DAY 2) Development of Fixed Dose Combination Products: Considerations of GI Physiology and Overall Development Strategy

Location: 207 B, WEWCCBart Hens, PhD, PharmD – KU Leuven; Alexis Aceituno – Instituto de Salud Publica de Chile
Clinical Pharmacology

Workshop and Short Course

Favorite

Bart Hens, PhD, PharmD – KU Leuven ### 567422###Workshop Organizer @@@ Alexis Aceituno – Instituto de Salud Publica de Chile ### 572020###Workshop Organizer
9:50 AM - 10:45 AM

SC2 - Current Regulatory Requirements to Assess Bioequivalence of FDC Products Worldwide (EU/USA/ Latin America/Japan)
Location: 207 B, WEWCCAlexis Aceituno – Instituto de Salud Publica de Chile
Clinical Pharmacology

Workshop and Short Course

Favorite

Alexis Aceituno – Instituto de Salud Publica de Chile ### 572020###Workshop Presenter
11:00 AM - 12:00 PM

SC2 - Formulation Design, Challenges, and Development Considerations for Fixed Dose Combination (FDC) of Oral Solid Dosage Forms
Location: 207 B, WEWCCDivyakant Desai – Bristol-Myers Squibb Company
Clinical Pharmacology

Workshop and Short Course

Favorite

Divyakant Desai – Bristol-Myers Squibb Company ### 593602###Workshop Presenter
12:00 PM - 1:00 PM

SC2 - Clinical Pharmacology Aspects of Fixed-Dose Combination Drug Development
Location: 207 B, WEWCCDakshina Murthy Chilukuri, PhD – Office of Clinical Pharmacology, OTS, CDER, FDA
Clinical Pharmacology

Workshop and Short Course

Favorite

Dakshina Murthy Chilukuri, PhD – Office of Clinical Pharmacology, OTS, CDER, FDA ### 593603###Workshop Presenter
9:00 AM - 1:00 PM

Short Course: (DAY 2) Surfactants and Biopharmaceuticals – A Love-Hate Relationship
Workshop Organizer: Satish K. Singh, PhD, FAAPS – Lonza AG
Workshop Organizer: Atanas Koulov, PhD – Lonza AG
9:00 AM - 9:30 AM

SC1 - Analytical Toolbox for Characterization and Control of Surfactants in Biopharmaceuticals
Location: 207 A, WEWCCMichael Jahn, PhD – Lonza DPS
Formulation and Quality

Workshop and Short Course

Favorite

Michael Jahn, PhD – Lonza DPS ### 593595###Workshop Presenter
9:00 AM - 1:00 PM

SC1 - Short Course: (DAY 2) Surfactants and Biopharmaceuticals – A Love-Hate Relationship

Location: 207 A, WEWCCSatish K. Singh, PhD, FAAPS – Lonza AG; Atanas Koulov, PhD – Lonza AG
Formulation and Quality

Workshop and Short Course

Favorite

Satish K. Singh, PhD, FAAPS – Lonza AG ### 572029###Workshop Organizer @@@ Atanas Koulov, PhD – Lonza AG ### 572028###Workshop Organizer
9:30 AM - 10:00 AM

SC1 - Surfactant Analytics in Biopharmaceutical Development – Case Studies
Location: 207 A, WEWCCZhihua Liu, PhD – Bristol Myers Squibb
Formulation and Quality

Workshop and Short Course

Favorite

Zhihua Liu, PhD – Bristol Myers Squibb ### 595832###Workshop Presenter
10:00 AM - 10:45 AM

SC1 - Regulatory Perspective on Surfactant Monitoring and Control
Location: 207 A, WEWCCAshutosh Rao – FDA
Formulation and Quality

Workshop and Short Course

Favorite

Ashutosh Rao – FDA ### 572027###Workshop Presenter
11:00 AM - 11:30 AM

SC1 - Surfactant Control Strategy (1)
Location: 207 A, WEWCCAtanas Koulov, PhD – Lonza AG
Formulation and Quality

Workshop and Short Course

Favorite

Atanas Koulov, PhD – Lonza AG ### 572028###Workshop Presenter
11:30 AM - 12:00 PM

SC1 - Surfactant Control Strategy (2)
Location: 207 A, WEWCCRobert Kopf, Dipl Ing Chem (FH) – Hoffmann - La Roche AG
Formulation and Quality

Workshop and Short Course

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Robert Kopf, Dipl Ing Chem (FH) – Hoffmann - La Roche AG ### 627295###Workshop Presenter
12:00 PM - 1:00 PM

SC1 - Control Strategy Panel Discussion
Location: 207 A, WEWCC
Formulation and Quality

Workshop and Short Course

Favorite
9:00 AM - 1:00 PM

Short Course: Immunogenicity Data Evaluations and Clinical Interpretation
Workshop Organizer: Viswanath Devanarayan, PhD, FAAPS – Charles River Laboratories
9:00 AM - 9:15 AM

SC7 - Immunogenicity Testing Strategy and Regulatory Expectations on Method Validation

Location: 146 A, WEWCCHaoheng Yan, MD, Ph.D – FDA
Bioanalytics

Workshop and Short Course

Favorite

Haoheng Yan, MD, Ph.D – FDA ### 584184###Workshop Presenter
9:00 AM - 1:00 PM

SC7 - Short Course: Immunogenicity Data Evaluations and Clinical Interpretation

Location: 146 A, WEWCCViswanath Devanarayan, PhD, FAAPS – Charles River Laboratories
Bioanalytics

Workshop and Short Course

Favorite

Viswanath Devanarayan, PhD, FAAPS – Charles River Laboratories ### 466008###Workshop Organizer
9:15 AM - 10:05 AM

SC7 - Recommendations for Different Cut Point Evaluations and In-Study Extensions

Location: 146 A, WEWCCRonald R. Bowsher, AAPS Fellow – B2S Life Sciences
Bioanalytics

Workshop and Short Course

Favorite

Ronald R. Bowsher, AAPS Fellow – B2S Life Sciences ### 572030###Workshop Presenter
10:05 AM - 10:45 AM

SC7 - Case Study Illustrations of Some Practical Challenges and Resolutions

Location: 146 A, WEWCCRobert Nelson, PhD – Novimmune SA
Bioanalytics

Workshop and Short Course

Favorite

Robert Nelson, PhD – Novimmune SA ### 584204###Workshop Presenter
11:00 AM - 12:00 PM

SC7 - Regulatory Experience with Immunogenicity Data Reviews, and Case Studies

Location: 146 A, WEWCCBrian Janelsins, PhD – FDA; Haoheng Yan, MD, Ph.D – FDA
Bioanalytics

Workshop and Short Course

Favorite

Brian Janelsins, PhD – FDA ### 584203###Workshop Presenter @@@ Haoheng Yan, MD, Ph.D – FDA ### 584184###Workshop Presenter
12:00 PM - 1:00 PM

SC7 - Some Solutions to Frequently Encountered Challenges with Immunogenicity Data Evaluations

Location: 146 A, WEWCCViswanath Devanarayan, PhD, FAAPS – Charles River Laboratories
Bioanalytics

Workshop and Short Course

Favorite

Viswanath Devanarayan, PhD, FAAPS – Charles River Laboratories ### 466008###Workshop Presenter
9:00 AM - 1:00 PM

Short Course: Quantitative-System-Pharmacology: Why, How and When in Drug Discovery and Development
Workshop Organizer: Nidhi Sharda, PhD – Bristol Myers Squibb
Workshop Organizer: Anjaneya Chimalakonda, PhD – Bristol Myers Squibb
9:00 AM - 9:10 AM

SC6 - Brief Introduction on Session, Learning Objective and Speaker's Panel

Location: 146 B, WEWCC
Preclinical Development

Workshop and Short Course

Favorite
9:00 AM - 1:00 PM

SC6 - Short Course: Quantitative-System-Pharmacology: Why, How and When in Drug Discovery and Development

Location: 146 B, WEWCCNidhi Sharda, PhD – Bristol Myers Squibb; Anjaneya Chimalakonda, PhD – Bristol Myers Squibb
Preclinical Development

Workshop and Short Course

Favorite

Nidhi Sharda, PhD – Bristol Myers Squibb ### 572009###Workshop Organizer @@@ Anjaneya Chimalakonda, PhD – Bristol Myers Squibb ### 572008###Workshop Organizer
9:10 AM - 9:45 AM

SC6 - General scope in drug discovery and development

Location: 146 B, WEWCCTarek Leil, MS, PhD – Bristol-Myers Squibb
Preclinical Development

Workshop and Short Course

Favorite

Tarek Leil, MS, PhD – Bristol-Myers Squibb ### 584324###Workshop Presenter
9:45 AM - 10:15 AM

SC6 - QSP in drug discovery: Target Identification and lead candidate selection/optimization

Location: 146 B, WEWCCJoshua F. Apgar, Ph.D. – Applied BioMath
Preclinical Development

Workshop and Short Course

Favorite

Joshua F. Apgar, Ph.D. – Applied BioMath ### 584325###Workshop Presenter
10:15 AM - 10:45 AM

SC6 - Current Landscape of QSP in Pharmaceutical Industry

Location: 146 B, WEWCCMaria Nijsen, PhD – Abbvie
Preclinical Development

Workshop and Short Course

Favorite

Maria Nijsen, PhD – Abbvie ### 593522###Workshop Presenter
11:00 AM - 11:40 AM

SC6 - QSP in early clinical development and translational research (case studies where QSP was used for FIH dose selection and translating PK-PD-efficacy from nonclinical species to human)

Location: 146 B, WEWCCMary Spilker, Senior Principal Scientist – Pfizer Inc.
Preclinical Development

Workshop and Short Course

Favorite

Mary Spilker, Senior Principal Scientist – Pfizer Inc. ### 593454###Workshop Presenter
11:40 AM - 12:15 PM

SC6 - QSP in full clinical development: Application in design of Phase II and Phase III studies

Location: 146 B, WEWCCKonstantinos (Kostas) Biliouris, PhD – Novartis
Preclinical Development

Workshop and Short Course

Favorite

Konstantinos (Kostas) Biliouris, PhD – Novartis ### 584327###Workshop Presenter
12:15 PM - 12:50 PM

SC6 - Regulatory perspective on application of QSP in drug development

Location: 146 B, WEWCCYaning Wang, PhD – FDA
Preclinical Development

Workshop and Short Course

Favorite

Yaning Wang, PhD – FDA ### 567451###Workshop Presenter
12:50 PM - 1:00 PM

SC6 - Concluding Remarks

Location: 146 B, WEWCCAnjaneya Chimalakonda, PhD – Bristol Myers Squibb
Preclinical Development

Workshop and Short Course

Favorite

Anjaneya Chimalakonda, PhD – Bristol Myers Squibb ### 572008###Speaker
9:00 AM - 1:00 PM

Workshop: Bioanalytical Method Validation: The Finalized Guidance
Workshop Organizer: Brian Booth, Ph.D.
9:00 AM - 9:35 AM

WS2 - Highlights of the BMV Guidance

Location: 146 C, WEWCCBrian Booth, Ph.D.
Bioanalytics

Workshop and Short Course

Favorite

Brian Booth, Ph.D. ### 576429###Workshop Presenter
9:00 AM - 1:00 PM

WS2 - Workshop: Bioanalytical Method Validation: The Finalized Guidance

Location: 146 C, WEWCCBrian Booth, Ph.D.
Bioanalytics

Workshop and Short Course

Favorite

Brian Booth, Ph.D. ### 576429###Workshop Organizer
9:35 AM - 10:05 AM

WS2 - Bioanalytical Method Validation of LC/MS assays-what the clinical reviewer looks for

Location: 146 C, WEWCCSriram Subramaniam
Bioanalytics

Workshop and Short Course

Favorite

Sriram Subramaniam ### 594383###Workshop Presenter
10:05 AM - 10:45 AM

WS2 - Bioanalytical Method Validation of LBAs—what the clinical reviewer looks for

Location: 146 C, WEWCCTheingi Thway, PhD – FDA
Bioanalytics

Workshop and Short Course

Favorite

Theingi Thway, PhD – FDA ### 567599###Workshop Presenter
11:00 AM - 11:30 AM

WS2 - Bioanalytical Method Validation of ANDAs-what the reviewer looks for

Location: 146 C, WEWCCNilufer Tampal
Bioanalytics

Workshop and Short Course

Favorite

Nilufer Tampal ### 594386###Workshop Presenter
11:30 AM - 12:00 PM

WS2 - Bioanalytical Method Validation-OSIS inspections

Location: 146 C, WEWCCSean Kassim, PhD – FDA/CDER/OTS/OSIS
Bioanalytics

Workshop and Short Course

Favorite

Sean Kassim, PhD – FDA/CDER/OTS/OSIS ### 594387###Workshop Presenter
9:00 AM - 5:00 PM

Short Course: Science and Risk Based Stability Strategies: Applications of Predictive Tools
Workshop Organizer: Yan Wu, PhD – Merck Sharp & Dohme
Workshop Organizer: Megan McMahon, MS – Pfizer
Workshop Organizer: Brian Regler, PhD – Merck
9:00 AM - 9:20 AM

SC5 - Introduction and Objectives
Location: 206, WEWCC
Formulation and Quality

Workshop and Short Course

Favorite
9:00 AM - 5:00 PM

SC5 - Short Course: Science and Risk Based Stability Strategies: Applications of Predictive Tools

Location: 206, WEWCCYan Wu, PhD – Merck Sharp & Dohme; Megan McMahon, MS – Pfizer; Brian Regler, PhD – Merck
Formulation and Quality

Workshop and Short Course

Favorite

Yan Wu, PhD – Merck Sharp & Dohme ### 572022###Workshop Organizer @@@ Megan McMahon, MS – Pfizer ### 572024###Workshop Organizer @@@ Brian Regler, PhD – Merck ### 572023###Workshop Organizer
9:20 AM - 10:45 AM

SC5 - Accelerated Stability Modeling Overview
Location: 206, WEWCCDonald J. Clancy, B.S., M.S., ChemE – GlaxoSmithKline
Formulation and Quality

Workshop and Short Course

Favorite

Donald J. Clancy, B.S., M.S., ChemE – GlaxoSmithKline ### 584229###Workshop Presenter
11:00 AM - 11:30 AM

SC5 - Applications of Accelerated Stability Models in Product Development
Location: 206, WEWCCBrian Regler, PhD – Merck
Formulation and Quality

Workshop and Short Course

Favorite

Brian Regler, PhD – Merck ### 572023###Workshop Presenter
11:30 AM - 12:00 PM

SC5 - Stability Risk Assessments - What, When and How
Location: 206, WEWCCRobert Timpano – Pfizer Inc
Formulation and Quality

Workshop and Short Course

Favorite

Robert Timpano – Pfizer Inc ### 584230###Workshop Presenter
12:00 PM - 1:00 PM

SC5 - Defining Meaningful Stability Parameters: Timepoints, Storage Conditions, & Tests
Location: 206, WEWCCAnthony Rainosek, BS – Baxter Healthcare; Cherokee S. Hoaglund-Hyzer, PhD – Eli Lilly & Company
Formulation and Quality

Workshop and Short Course

Favorite

Anthony Rainosek, BS – Baxter Healthcare ### 596448###Workshop Presenter @@@ Cherokee S. Hoaglund-Hyzer, PhD – Eli Lilly & Company ### 584232###Workshop Presenter
2:00 PM - 3:00 PM

SC5 - Application of Accelerated Stability Modeling Tools in Regulatory Filings
Location: 206, WEWCCYan Wu, PhD – Merck Sharp & Dohme; Dennis Stephens, PhD – Abbvie
Formulation and Quality

Workshop and Short Course

Favorite

Yan Wu, PhD – Merck Sharp & Dohme ### 572022###Workshop Presenter @@@ Dennis Stephens, PhD – Abbvie ### 584233###Workshop Presenter
3:15 PM - 4:15 PM

SC5 - Applying Science and Risk Based Stability Strategies Globally
Location: 206, WEWCCMegan McMahon, MS – Pfizer; Donnie Pulliam, MBA – Biogen
Formulation and Quality

Workshop and Short Course

Favorite

Megan McMahon, MS – Pfizer ### 572024###Workshop Presenter @@@ Donnie Pulliam, MBA – Biogen ### 584234###Workshop Presenter
4:15 PM - 5:00 PM

SC5 - Panel Discussion/Q&A
Location: 206, WEWCCKim HuynhBa
Formulation and Quality

Workshop and Short Course

Favorite

Kim HuynhBa ### 636579###Moderator
10:00 AM - 12:00 PM

Journal of Pharmaceutical Innovations Advisory Board
10:00 AM - 12:00 PM

Journal of Pharmaceutical Innovations Advisory Board
Location: Scarlet Oak, Marriott Marquis, Mezzanine Level
Affiliate Event

Favorite
2:00 PM - 4:30 PM

Student Chapter Leaders Forum
2:00 PM - 4:30 PM

Student Chapter Leaders Forum
Location: Georgetown, Marriott Marquis

Favorite
2:00 PM - 4:30 PM

Executive Track: Protecting and Enhancing IP while Navigating M&A Part 1 (By Invitation Only)
2:00 PM - 4:30 PM

Executive Track: Protecting and Enhancing IP while Navigating M&A Part 1 (By Invitation Only)
Location: 143 ABC, WEWCCEyal Barash, MS, JD – Barash Law, LLC; Justin Shuman, MBA – Dorsata; Stephanie A. Pasas-Farmer, Phd – BioData Solutions, LLC; jim datin, mba – BioAgilytix; Derek Bowen; Chad Briscoe, PhD – PRA - Lenexa, KS
Executive-Invite Only

Executive Track

Favorite

Eyal Barash, MS, JD – Barash Law, LLC ### 609439###Executive Education Speakers @@@ Justin Shuman, MBA – Dorsata ### 609440###Executive Education Speakers @@@ Stephanie A. Pasas-Farmer, Phd – BioData Solutions, LLC ### 590019###Executive Track Moderator @@@ jim datin, mba – BioAgilytix ### 627439###Executive Education Speakers @@@ Derek Bowen ### 628987###Executive Education Speakers @@@ Chad Briscoe, PhD – PRA - Lenexa, KS ### 605822###Executive Education Speakers
5:00 PM - 6:30 PM

Opening Plenary & Awards Celebration
5:00 PM - 5:15 PM

Awards Celebration
Location: Ballroom ABC, WEWCC
Opening Plenary Session

Favorite
5:00 PM - 6:30 PM

Opening Plenary & Awards Celebration
Location: Ballroom ABC, WEWCC
Opening Plenary Session

Favorite
5:50 PM - 6:30 PM

A Conversation with J. Craig Venter
Location: Ballroom ABC, WEWCCJ. Craig Venter, PhD – J. Craig Venter Institute
Opening Plenary Session

Favorite

J. Craig Venter, PhD – J. Craig Venter Institute ### 581278###Plenary Speaker
6:30 PM - 8:00 PM

First-Time Attendee Event
6:30 PM - 8:00 PM

First-Time Attendee Event

Location: Marquis Ballroom, Marriott Marquis
Reception

Favorite
6:30 PM - 8:00 PM

Welcome Reception
6:30 PM - 8:00 PM

Welcome Reception

Location: Marquis Ballroom, Marriott Marquis
Reception

Favorite
8:00 PM - 9:00 PM

American Society of Iranian Pharmaceutical Scientists (ASIPS) Meeting
8:00 PM - 9:00 PM

American Society of Iranian Pharmaceutical Scientists (ASIPS) Meeting

Location: Georgetown, Marriott Marquis
Affiliate Event

Favorite