AAPS (American Association of Pharmaceutical Scientists)

PRESENTATIONS (ALL TIMES EST): 

Keynote: From Preclinical to Clinical Drug Product Development- A Path for Smooth Transition
Presented by: VP, Regulatory Affairs, Sandra Suarez-Sharp
Date: Tuesday, October 18th, 2022
Time: 1:30 PM – 2:30 pm
Location: 254 A

Rapid Fire Session: Model Informed Drug Development (MIDD): Role in Dose Selection, Vulnerable Populations, and Biowaivers (CE)
Application of Modeling and Simulation in Long-Acting Injectable Product Development
Speaker: Chief Scientific Officer, Viera Lukacova
Date: Tuesday, October 18th, 2022
Time: 3:15 PM – 3:30 pm
Location: 151 AB

POSTERS (ALL TIMES EST): : 

Title: Physiologically Based Pharmacokinetic (PBPK) Modeling of Rifampicin and Its Application for Drug-Drug Interaction with Midazolam in Adults
Presented by: Scientist II, Suvarchala Avvari
Description: The purpose was to develop a mechanistic PBPK model for RIF which accounts for all the relevant mechanisms after IV and PO administration in healthy and tuberculosis (TB) subjects. This model was validated by predicting effect of RIF administration on midazolam (MDZ) PK.
Poster #: W0930-05-26
Date/Time: Wednesday, October 19th at 9:30 am, Forum #5, Monitor#26

Title: Establishment of preclinical mechanistic in vitro-in vivo correlations for long-acting injectable suspensions
Presented by: Scientist I, Daniela Silva
Description: The purpose of this study was to use different modeling approaches to mechanistically understand the in vivo performance of different long-acting injectable suspensions (reference listed drug of medroxyprogesterone acetate and formulation variants) in preclinical species and to establish an in vitro – in vivo correlation.
Poster #: M1030-02-07
Date/Time: Monday, October 17th at 10:30 am, Forum # 2, Monitor #07.

Title: ILDsym successfully simulates SSc-ILD pathophysiology and inter-patient variability
Presented by: Principal Scientist, Zackary Kenz
Description: The purpose of this work was to develop a mechanistic QSP model for systemic sclerosis (SSc)-associated interstitial lung disease (ILD) pathophysiology validated with clinical data and capable of representing responses to existing and novel treatments.
Poster #: M1330-11-62
Date/Time: Monday, October 17^th at 1:30 pm, Forum #11, Monitor #62.

Title: Use of Quantitative Systems Toxicology (QST) to Identify Potential Intrinsic Mechanisms of Toxicity
Presented by: Principal Scientist, Christina Battista
Description: The purpose of this study was to investigate whether a QST model could account for liver chemistry abnormalities observed during BAY1128688 treatment and provide insight into mechanisms driving hepatotoxicity and bilirubin elevations.
Poster #: M1530-11-64
Date: Monday, October 17th at 3:30 pm, Forum #11, Monitor #64.

Title: Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Gatifloxacin Solution Case Study
Presented by: Scientist II, Farah Al Qaraghuli
Description: Development and validation of gatifloxacin administration as an ophthalmic solution in rabbits as well as predicting its clinical exposure in humans.
Poster #: W1230-02-1
Date/Time: Wednesday, October 19^th at 12:30 pm, Forum #02, Monitor #10.

MENTORING BREAKFAST
Panelists: Jill Fiedler-Kelly
Date/Time: Tuesday, October 18th from 7:00 – 8:30 am EST
Location: Harbor 1&2, Westin Boston Seaport District Hotel

CAREER DEVELOPMENT 
The Skills You Need to be a Pharmaceutical Consultant 
Panelists: Jill Fiedler-Kelly and Al Berg
Date/Time: Tuesday, October 17th at 9:00 am EST
Location: 360 Stage #3

LinkedIn Profile Critiques and Resume Reviews
Reviewer: Sandra Suarez-Sharp and Arlene Padron  
Dates/Times: Tuesday, October 17th from 2:30 – 3:30 pm EST
Wednesday, October 18th from 10:30 – 11:30 am &2:30 – 3:30 pm EST
Location: Exhibit Hall A&B

Visit us at Booth #1219.

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18th Annual Simulations Plus Forum

Hit a Homerun with Our Team!

We are excited to be back in person, and all of us are looking forward to
an evening of food, cocktails, fun, and prizes!

There will be brief presentations from our MIDD experts on the following topics:

• The advancement of M&S and Simulations Plus
• Oral and non-oral PBBM models for regulatory submissions
• The latest work in the areas of NAFLD/NASH, pulmonary fibrosis, and DILI
• … and more!

Tuesday, October 18th | 6:00 PM to 9:00 PM EST
Tickets and conference badges are required for entry.

Email arlene.padron@simulations-plus.com to RSVP. 

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CRO Partner Event:

Crystal Pharmatech, in booth 320 at 3pm on Monday, October 17th, will host a Beer & Wine Happy Hour discussion to share their newest capabilities and engage with industry innovators who encounter these challenges.  Learn more here.