Past Live Events
Thu 12:30 PM EDT
Navigating and Understanding FDA Review Documents
The U.S. Food and Drug Administration approved labels for all drug and biologic products include extensive information on patient populations, disease indications and...
Tue 12:30 PM EDT
Using Hard Capsules for Moisture Sensitive and Hygroscopic APIs
During this webinar, we will address the reasons for API instability including heat, oxidation, pH, light, and moisture; what methods may be used to impact the...
Thu 12:30 PM EDT
Statistical Methods for Evaluations of Comparability
In this webinar, we will describe the most commonly used statistical approaches, using examples to highlight their applicability in different comparability scenarios....
Fri 12:30 PM EDT
What Comes After “Hello”: Networking for Introverts
Attend this webinar and learn the one tool that will help you more than any “elevator pitch” or “30-second commercial.” (Because, really, who has time for those?)
Wed 12:30 PM EDT
Rapid Fire Presentations from the Journal of Pharmaceutical...
This will be a series of rapid fire presentations similar to the format used in PharmSci 360. A 10 minute presentation with a 3 minute Q&A. The topics were selected...
Thu 12:30 PM EDT
PharmSci 360 Speaker Training- Make your data make a...
Information doesn’t sell itself. That is the presenter’s job. In this webinar, he will draw upon some of the principles explained in his forthcoming book, The...
Mon 12:30 PM EDT
A Modeling and Experimental Investigation of Avidity Driven...
In this webinar, Dr. John J. Rhoden will discuss a conceptual and mathematical model of multivalent antibody binding to cell surface antigens. This model predicts that...
Tue 12:30 PM EDT
An Automated, Higher Performance Infrared (IR) Technology For...
This webinar will discuss how Microfluidic Modulation Spectroscopy (MMS) can be used to understand the secondary structures of proteins, specifically monoclonal...
Thu 12:30 PM EDT
Fit-for-Purpose Statistics for Stability Studies
In this webinar we will begin with a refresher of linear regression as applied to stability study data, and from there take a deeper dive into the meaning of...
Thu 12:30 PM EDT
Statistics for Optimization of Analytical Methods Across the...
This webinar will discuss the AQbD roadmap and the timing and categories of statistical methods to apply. This is the third lecture in a series of webinars brought to...
Wed 11:00 AM EDT
Better Together: Building More Effective Cross Functional Teams
Pharma companies are under intense pressure to get products to market faster than ever in order to drive profits and deliver value to their customers. ...
Thu 12:30 PM EDT
Improve Problem Solving Using Exploratory Data Analysis
In this webinar, the powerful, yet relatively simple, statistical tools and approach of exploratory data analysis (EDA) are introduced. This is the second lecture in...
Fri 12:30 PM EDT
Fundamentals of DOE for Design of Pharmaceutical Processes,...
This webinar will provide an overview of the basic principles of DOE, demonstrate the many scientific and business benefits of DOE, and dispel some common myths...
Tue 12:30 PM EDT
Fast to Clinic Strategies: Options and relevance for drug...
Due to the increasing complexity of biopharmaceuticals, development of a drug product can be a major challenge. Issues include chemical and physical degradation that...
Thu 12:30 PM EDT
A Translational Population Pharmacokinetic Model for the...
In this webinar, translational strategies for prediction of human linear PK of mAbs, including use of typical human popPK parameters and allometric exponents from...
Thu 12:30 PM EDT
Gene therapy: Bioanalytical support and strategies
This is LECTURE 2 in the Emerging Modalities series. To register for Lecture 1 in the series visit https://www.pathlms.com/aaps/webinars/4920
Tue 10:30 AM EDT
Automated Capabilities for Solid Handling within Pharma R&D...
This webinar is brought to you by Chemspeed Technologies. Discover innovative examples of how complex workflows in the pharmaceutical R&D industry can be optimized...
Thu 12:30 PM EDT
Right, First Time for Tablet Disintegration and Dissolution –...
This webinar will present the key properties of a drug product that influences disintegration behavior and discusses how these are related to the dissolution performance.
Wed 12:30 PM EST
Considerations for Development of Biologics in Combination...
The immunomodulatory biologics are designed to engage immune cells to support the effective killing of targeted cancer cells. In this lecture, the speaker will...
Wed 12:30 PM EST
Executive Anxiety: Moving From Stress to Strength
Join Martin Daunbey as he takes a deep dive into various belief systems regarding stress, how these beliefs develop, and how to adjust beliefs to support a winning...
Thu 12:30 PM EST
Conversations about Science: A Deeper Dive
In his presentation, David gave attendees three tools to help them have a more productive conversation about the value of their work. Anyone who struggles to convey...
Thu 12:30 PM EDT
Embracing Digital Technology and Database Updates within...
Discover the ways your Quality Control Department can embrace opportunities to use digital technology as a way to implement process changes to make workloads easier,...
Thu 12:30 PM EDT
KinetiSol®: Increasing the Value of Amorphous Dispersion...
In this webinar, explore TKC with pharmaceutical polymers in ASD formulations and see how they create new opportunities for differentiated drug products.
Thu 12:30 PM EDT
Moderator Best Practices
Many scientific presenters are so enamored of their data that they forget they are there to serve their audience members! As a moderator, your role is to help the...
Fri 12:30 PM EDT
How to Avoid Death by PowerPoint
Join us for this exciting webinar as the experts from Death by PowerPoint share strategies on how to create informative, visually intriguing PowerPoint presentations...
Thu 12:30 PM EDT
How to Rescue a pH Sensitive Protein: Detergent Viral...
Review the process for viral inactivation of clarified harvest using the detergent Octyl-D-glucopyranoside (ODG).
Thu 12:30 PM EDT
The Role of CDER Genomics and Targeted Therapy Group in...
This webinar will provide the regulatory pathways for genomics and targeted therapies.
Thu 12:30 PM EDT
PharmSci 360 Preview: Tumoroids-on-a-Chip Platform for...
The primary goal of this webinar is to review the state-of-the-art developments in the nanomedicine, discuss the pros and cons of different approaches, and examine...
Thu 12:30 PM EDT
The Role of Biomarkers in Supporting Personalized Medicine...
An introductory session to provide a basic understanding of Pharmacogenetics.
Thu 12:30 PM EDT
Diagnostic Strategies for Cancer Immune Therapies
2017, the next five years, and beyond.
Thu 12:30 PM EDT
Extractables and Leachables: Regulatory Expectations to...
Regulatory requirements with regard to extractables and leachables.
Thu 12:30 PM EDT
Nasally Administered Drug Products: Clinically Relevant...
This webinar will provide an overview of a recent research project.
Thu 12:30 PM EDT
Nebulization: Back to Basics
Learn the primary mechanisms of aerosol generation used in nebulization, namely, air jet, ultrasonic, and vibrating mesh nebulization.
Thu 12:30 PM EDT
A Strategy for Enhancing Regulatory Acceptance of your QSP...
A panel of industry, regulator, and academic experts to discuss lessons learned from the previous cases and steps to consider when developing QSP models.
Thu 12:30 PM EDT
Systems Pharmacology Approach for Personalized Treatment of Pain
The 5th live event in the Personalized Medicine series.
Thu 12:30 PM EDT
IVIVC: Current Perspectives on Models and Practices
Siscuss and debate such aspects from industrial and regulatory perspective and would help to exchange of ideas to move the field further.
Thu 12:30 PM EDT
Matching Cancer Drugs with Mechanism
The 4th live event in the Personalized Medicine series.
Thu 12:30 PM EDT
Personalized Medicine in Neurological diseases
The 3rd live event in the Personalized Medicine series.
Thu 12:30 PM EST
Transporter and Enzyme Ontogeny in Pediatric Populations
Why can’t I have drug disposition just like Mom and Dad? Understanding the impact of transporter and enzyme ontogeny in pediatrics.
Thu 12:30 PM EST
Technology in Pharmacogenetic Decision Making: FDA lead...
The 2nd live event in the Personalized Medicine series.
Thu 12:30 PM EST
Microsampling—How it Can Influence Drug Development
How microsampling is being used to in the quantitation of drugs, metabolites, and biomarkers in preclinical and clinical development.
Thu 12:30 PM EST
Optimizing the Performance of Statistical Process Control Charts
Monitoring manufacturing and laboratory processes under continued process verification.
Wed 12:30 PM EST
Emerging Pharmacogenetics Practices and its Application
The 1st live event in the Personalized Medicine series.
Thu 12:30 PM EST
Metered Dose Inhalers 101
Introduce formulation scientists, device engineers, and other pharmaceutical professionals to the core technical considerations of respiratory drug delivery.
Thu 12:30 PM EST
Successful Candidates in a Biotech Start-up or Virtual Company
Progress drug discovery candidates from any pharmaceutical organization to development with low risk that provide a balance of speed and quality.
Fri 12:30 PM EDT
OPEN ACCESS: Network Like an Introvert
A fresh perspective on networking for introverts and extroverts alike. Get the most out of your networking opportunities!
Thu 12:30 PM EDT
Advanced Analytical Technologies for Pharmaceutical Impurity...
A discussion among leading experts who have successfully applied these advanced novel analytical technologies in pharmaceutical impurities analysis.
Thu 12:00 PM EDT
OPEN ACCESS: Your Science Can Change the World; One...
Prepare yourself to participate in the public arena where science is often met with skepticism.
Wed 12:30 PM EDT
OPEN ACCESS: Front-Line Solutions to Enhance Solubility &...
What does one do when spray-drying and melt-extrusion fail to meet the drug product needs for their compound? Join us!
Fri 12:00 PM EDT
OPEN ACCESS: Resume Writing 101
Get the basics here and then a deeper, hands-on experience at the 2017 Annual Meeting!
Thu 12:30 PM EDT
Bioequivalence Evaluation of Generic Drug-Device Combination...
Explore the regulatory path-way for the approval of combination products and the unique challenges.
Thu 12:30 PM EDT
Clinically Relevant Immunogenicity: Strategies for Impact on...
Address the current gap in the field of impact assessment of clinically relevant immunogenicity as it relates to impact on safety.
Thu 12:30 PM EDT
Subcutaneous Extended Release Delivery of New Modalities
An exploratory assessment of the topic.
Mon 12:30 PM EDT
The Art and Science of Connecting: Are you being heard?
Learn how to focus on the needs of a live audience, not an imagined reader, when preparing and delivering a scientific presentation.
Thu 12:30 PM EDT
Solubility Prediction and Computational Co-crystal Screening
Current methods and state-of-the-art approaches.
Wed 12:30 PM EDT
OPEN ACCESS: Surfactants: the Good, the Bad, the Ugly
Discuss current issues related to the use of surfactants in parenteral formulations.
Thu 12:30 PM EDT
First-In-Class Regulatory PBPK Modeling Guidelines from both...
Experts discuss these draft guidelines and highlight their similarities, differences, and major issues.
Thu 12:30 PM EDT
Formulation Strategies to Prevent Protein Degradation
Understand and discuss protein formulation and analytical development.
Thu 12:30 PM EDT
Selection of Regulatory Starting Materials: New Guidelines and...
The focus of this event will be to share in more detail specifics of each ICH Q&A and an update on the status of the guideline.
Thu 12:30 PM EDT
Microfluidics based Four Dimensional Tumoroids Platform as...
Review the state-of-the art nature of this field; pros and cons of different approaches and how these systems will have consequences.
Thu 12:30 PM EDT
2016 PPB Student/Postdoc Best Manuscript Contest Winner...
Highlight the three winning research articles from the PPB Student Committee implemented a Best Student/Postdoc Manuscript Contest.
Thu 12:30 PM EDT
Modeling Gastrointestinal Luminal Drug Precipitation
Can you See what I See? As modeling becomes more and more powerful and should be seen as the future for oral drug development.
Thu 12:30 PM EDT
FDA Guidance: Interchangeability for Biosimilars
Discuss the new FDA guidance and interact with scientists to discuss the consequences to industry.
Thu 12:30 PM EDT
Open Sesame to the Biopharmaceutical Industry
The do’s and don’t’s from effective job search to durable career development.
Thu 12:30 PM EDT
Japan CTD: Bracketing Strategies for the Manufacturing Process
Everything you need to know about Japan's new drug application-specific bracketing strategies.
Thu 12:30 PM EDT
3D Micro-imaging for Drug and Delivery System Characterization
Understand the principles and applications of primary 3D micro-imaging technology.
Thu 12:30 PM EDT
Accelerating Bioanalysis for Biotherapeutics using Gyrolab™ xP
Come discuss six LBA methods validated either in house or at a CRO to support bioanalysis for GLP toxicokinetic or clinical pharmacokinetic studies.
Thu 12:30 PM EDT
Debate: Clearance (CL) vs. Elimination Rate Constant (ke)
Hear the arguments for each side of this debate and decide who wins your vote!
Thu 12:30 PM EDT
Advances in Mechanistic TMDD and Platform PBPK Models
Exploring the pre-clinical and translational development of therapeutic antibodies.
Wed 12:30 PM EDT
OPEN ACCESS: Sub-Visible and Sub-Micrometer Particles in...
How to Utilize Current Technology in Designing Successful Characterization and Control Strategies.
Thu 12:30 PM EDT
Addressing the Challenges of Low Clearance in Drug Discovery
New methodologies in intrinsic clearance measurement, reaction phenotyping, and metabolite identification for low clearance compounds.
Wed 12:30 PM EDT
Phase Appropriate Selection of Analytical Methodology
Monitor particulate matter in parenteral drug products.
Thu 12:30 PM EDT
Monoclonal Antibodies as an Alternative to Antibiotics?
A discussion on emerging trends in antibacterial drug research.
Thu 12:30 PM EST
ICH Guidelines and USP Chapters for Measuring Elemental Impurity
Demise of the heavy metals approach and implementation of ICH Q3D and USP <232> and <233>: considerations and challenges.
Thu 12:30 PM EST
How Disease can Modulate Drug Transport Mechanisms in the Liver
Transporter changes in the setting of liver disease can lead to clinically significant changes in drug disposition.
Wed 12:30 PM EST
High Throughput Screening of Formulations for Large Molecules
Faster and better evaluation and prediction of formulation properties and the improvement of biopharmaceutical development.
Thu 12:30 PM EST
Biomarker Multiplex Ligand Binding Assays in Drug Development
Discuss the challenges encountered with multiplex LBAs, the underlying causes, and explore tangible solutions.
Thu 12:30 PM EST
Demonstrate Abuse-Deterrent Properties in Opioid Formulations
How to design and execute manipulation and extraction studies.
Thu 12:30 PM EST
OPEN ACCESS: Bioanalytical Methods in Support of Biosimilar...
Recommendations from the AAPS Biosimilars Committee and reflections on regulatory feedback.
Thu 12:30 PM EST
Human Factors/Usability Engineering in the Medical Product Cycle
A discussion of the recent FDA guidance with a focus on safety.
Thu 12:30 PM EST
Bi-Specific Monoclonal Antibodies: A New Paradigm in Development
Focus on the CMC considerations for the development, manufacture, and characterization of Bi-specific Abs.
Thu 12:30 PM EDT
Stat Approaches to Assess Biosimilarity from Analytical Data
Explore statistical evaluation of critical quality attributes (CQAs), which define the purity, potency and safety of a protein therapeutic, for the purpose of...
Thu 12:30 PM EDT
Endogenous Biomarkers for OATP Inhibition
Paradigm-shifting innovations to assess OATP DDI liabilities.
Wed 12:30 PM EDT
OPEN ACCESS: Container Closure Integrity
Regulatory Requirements, Testing Concepts and a Holistic Approach to Designing a High-Quality Container Closure System.
Thu 12:30 PM EDT
Immunocapture-LC/MS for Anti-drug Antibodies (ADA) Analysis
Disscuss recent innovative applications of LC/MS for ADA measurement in drug discovery and development and case studies to provide some insight of this new technology.
Thu 12:30 PM EDT
Development of Extemporaneous Formulations for NCEs
Preformulation considerations for development of extemporaneous on-site compounded (OSC) drug in bottle (DIB) formulations.
Thu 12:30 PM EDT
Introduction Question Based Review and Submission Challenges
Drug Application Webinar Series: Type II Drug Master Files – API Submissions
Fri 12:00 PM EDT
OPEN ACCESS: Creating and Presenting Captivating Posters
Join us and learn the art of selling your science!
Thu 12:30 PM EDT
OPEN ACCESS: BioRAM–based Decisions
A hands on experience with the BioRAM tool and Q&A with the experts.