AAPS Webinars bring insights and research from across the pharmaceutical sciences to you. Live AAPS Webinars are free and open to the public. AAPS members have FREE access to archived AAPS Webinars. Not an AAPS member? Join now!
Upcoming Live Events
Mon 12:00 PM EST
Still Work to Do: Addressing Sexism with Agency and Allyship
Tue 11:15 AM EDT
Achieving Virtual Bioequivalence (VBE) with PBPK
Thu 10:00 AM EDT
New Approaches to Oral Drug Delivery from Immediate Release Through Precise Colonic Targeting
Tue 12:00 PM EDT
Attribute Based Control Strategies for Raw Materials Used to Manufacture Pharmaceuticals
Wed 10:30 AM EDT
Part 1
Wed 2:00 PM EDT
Part 2
Thu 10:30 AM EDT
Part 3
Thu 2:00 PM EDT
Part 4
Wed 11:15 AM EDT
Balance Study Design for Anti-Drug Antibody Cut Point Analysis
Thu 12:30 PM EDT
Optimizing Extraction Recovery for Volumetric Adsorptive Microsampling (VAMS)
Past Live Events
Thu 10:30 AM EST
Blinding in Early Clinical Development Trials
An IQ Working Group developed and conducted a survey across multiple biopharmaceutical companies in early 2020 in order to gain information about design options...
Thu 12:30 PM EST
Vaccine Drug Product Development – Opportunity and Challenges
This webinar will be focused on highlighting formulation, process and manufacturing challenges for vaccine development and present case studies to illustrate the...
Wed 11:15 AM EST
Emergency Use Authorizations of Coronavirus Vaccines – Similarities and Differences between an EUA and Approval and Legal Ramifications of Potential Vaccine Injury
Thu 12:30 PM EST
Journey of Biomarker from Discovery to Qualification
This webinar will cover the utility, promises, and challenges in using biomarkers of nephrotoxicity.
Wed 11:15 AM EST
eChalk Talk: Intranasal Drug Delivery
This presentation will compare pharmacokinetic advantages of nasal powder formulations to aqueous formulations. Formulation and invitro performance attributes for...
Thu 9:30 AM EST
Phase 0/Microdosing Approaches: Time for Mainstream Application in Drug Development
Phase 0 approaches — which include microdosing — evaluate subtherapeutic exposures of new drugs in first-in-human studies known as exploratory clinical trials. Recent...
Tue 12:30 PM EST
Application of Pharmacometrics Methods in Pediatric Drug Development
The objective of this webinar is to give an overview of the methodological basis of population PK and PBPK and how it relates to pediatric drug development. A few...
Thu 12:30 PM EST
Session 2: Immunogenicity Considerations for Therapeutic Proteins in COVID Patients
Wed 12:30 PM EST
Session 1: Overview of the Immune Response to SARS-CoV-2, Hyperinflammation and Cytokines
Thu 12:30 PM EST
Generic Oral Modified Release Drug Products: Establishing Bioequivalence for “Additional Strengths”
The objective of this webinar is to illustrate various elements considered in regulatory assessment with respect to BE demonstration of additional strengths for which...
Tue 12:30 PM EST
Oral Pediatric Biopharmaceutics: Issues in Designing in vitro and in Silico Models and Evaluating Drug Product Performance in Infants Based on Adults Data
This webinar is being submitted as part of a series of three webinars “Pediatric Biopharmaceutics." Each of the three webinars will have two sections, for a total of...
Thu 12:30 PM EST
Identification and Quantitation of Oligonucleotides and their Impurities using High-resolution Accurate-mass LC-MS and Bespoke Processing Software
Identification and Quantitation of Oligonucleotides and their Impurities using High-resolution Accurate-mass LC-MS
Wed 12:30 PM EST
Chromatographic Optimization for Hybrid LBA LC-MS/MS for Pharmacokinetic Profiling of Large Molecules
LBA/LC-MS/MS hybrid workflow is more sensitive and consistent than traditional methods, which is critical in efficacy and safety testing
Tue 12:30 PM EST
Pediatric Biopharmaceutics – Part 2: Predicting Performance in Pediatric Populations with PBBM and Virtual Bioequivalence Studies for Pediatric Biopharmaceutics: How Far from Reality?
This webinar is being submitted as part of a series of three webinars “Pediatric Biopharmaceutics." Each of the three webinars will have two sections, for a total of...
Mon 12:30 PM EST
Amorphous Content: Quantification in Drug Substance and Drug Product
During this webinar, we will discuss a number of these techniques, such as XRPD, DSC, DVS, and isothermal and solution calorimetry, and highlight their respective...
Fri 12:30 PM EST
Receiving Feedback with Aplomb, Part 2
This presentation will explore how to receive feedback non-defensively. Receiving critical feedback can result in normal emotional reactions such as: surprise,...
Thu 12:30 PM EST
Simplifying Compliance with USP <232> and USP <233> ICH Q3D
With regulatory requirements, validation protocol, and data integrity all being in the forefront, it is important to equip the laboratory with more than just...
Wed 1:00 PM EST
A Complete Approach to High-Throughput Mass Spectrometry
Mass Spectrometers typically lend themselves to achieve higher throughputs but are being slowed by upfront chromatography or sample preparation.
Wed 10:00 AM EST
Advancing SARS-CoV-2 Vaccine and Therapeutic Development: Rapid and High Throughput Bioanalytical Tool for Immunogenicity and Titer Analysis
The unprecedented vaccine and therapeutic development efforts in response to the COVID-19 pandemic have created an urgent need for rapid, accurate, and sensitive...
Tue 12:30 PM EST
Pediatric Biopharmaceutics – Part 1: “Drug Product Development” and “GI Luminal Water Volumes”
This webinar will introduce the overall webinar series and cover high-level objectives of product design for pediatric therapies, with a focus on clinical and patient...
Mon 12:30 PM EST
Recent Developments in Analytical Support of Biomarkers
In this webinar, PRA scientists will summarize some recent developments in the way the bioanalytical community feels about measurement of biomarker samples.
Thu 9:00 AM EDT
Choosing the Right CDMO for Your HPAPI Development, Manufacturing & Packaging
With the complexities involved in the safe handling of potent molecules and increasing regulatory requirements, it is imperative to choose the right partner for the...
Wed 12:30 PM EDT
Accelerating Vaccine Development Using a Next Generation Microfluidic CE Platform
When producing a quality vaccine, all manufacturers must confirm the purity as well as the stability of their formulation and final product
Tue 12:30 PM EDT
Nanosuspensions Downstream Processing - Strategies and Key Facts for Oral Dosage Forms
Nanotechnologies have a significant impact on the quality of life of millions of patients since the introduction of the first commercial product, Ambisome™ & Doxil™ in...
Thu 12:30 PM EDT
Development and Regulatory approval for toxicogenomics(TGX) biomarker to detect DNA damage-inducing agents
Gene expression biomarkers are now available for application in the identification of genotoxic hazards. The TGx-DDI transcriptomic biomarker can accurately...
Thu 12:30 PM EDT
Aligning Regulatory Agencies and the Pharmaceutical Industry toward Reducing Toxicity Associated Drug Development Costs, Timelines and Attrition: 2 yr Rodent Carcinogenicity Testing
This webinar will provide the overall development process of selecting biomarkers, which will potentially replace the current 2-year study requirement for...
Wed 11:00 AM EDT
Data Integrity and Analytical Instrumentation
We will discuss the overall trends relating to Data Integrity, independent of instrument type or potential solution. Our goal is to create a platform for a high-level...
Tue 12:30 PM EDT
Preclinical Considerations in Cell and Gene Therapy Product Development
Preclinical evaluation of cell and gene therapy (CGT) products in vitro and in vivo contributes significantly to characterization of the product benefit versus risk...
Wed 11:15 AM EDT
Pulmonary delivery of test articles by intratracheal nebulization or liquid instillation in small animal models -implications for COVID19 therapeutic testing
COVID19 has increased global interest in methods to deliver test articles (TAs) (e.g. AAVs, siRNAs, proteins, small molecules, etc.) locally to the lung parenchyma. ...
Wed 11:15 AM EDT
Predictive Dissolution of Nanoparticle Formulations
Dissolution is one of the first methods applied in formulation development to gain information on the expected in-vivo performance of the pharmaceuticals. Nanoparticle...
Tue 1:00 PM EDT
Cancer Drug Development: Open Opportunities
This will be a scientific seminar presented by Dr. Vinay Prasad. It will provide keen insights on cancer drug development, pitfalls in current clinical trial designs...
Thu 12:30 PM EDT
ICH M9: Harmonization of Biopharmaceutics Classification System (BCS)-Based Biowaivers
Join four experts who are part of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) working group intricately involved in the...
Wed 11:15 AM EDT
Accelerating the Development of Re-purposed Drug Products Including COVID-19 Therapy: The Role of Physiologically Based Biopharmaceutics Modeling (PBBM/PBPK)
This presentation will focus on 1) the biopharmaceutics and clinical pharmacology studies needed to support the approval of repurposed drug products administered...
Thu 12:30 PM EDT
The Use of Mean Kinetic Temperature to Aid Evaluation of Temperature Excursions: Proper and Improper Application
The extent of physicochemical degradation of drug products depends on factors such as product stability, how a product is stored, and how it is packaged. During the...
Wed 11:15 AM EDT
Picosecond Infrared Laser (PIRL) Scalpel: Achieving Fundamental (Single Cell) Limits to Minimally Invasive Surgery and Biodiagnostics
The first atomic movie of strongly driven phase transitions revealed the means to limit nucleation growth and associated shock wave damage. This insight has led to the...
Wed 11:15 AM EDT
The Contribution of SIFT-MS to Breath Analysis and Drug Research
As a direct mass spectrometry, Selected Ion Flow Tube Mass Spectrometry (SIFT-MS) is a novel tool to breath analysis and early-stage drug research. With SIFT-MS, the...
Thu 12:30 PM EDT
Lipid NanoParticles (LNPs): Product Development for Optimal Delivery of RNA molecules
In this webinar, the presenter will review a few case studies around lipid degradation, size distribution measurements, and filtration unit operations largely made...
Thu 12:30 PM EDT
Oral sustained release liquid suspensions: Towards patient-centered pharmaceutical development in pediatric and geriatric patients
This webinar provides a review of microencapsulation technologies that could be used in producing sustained-release microparticles for liquid suspensions, including...
Wed 11:15 AM EDT
Pivoting from Manufacturing Therapeutics to Commercializing the AntiCoV-ID™ IgG ELISA Assay
. This Chalk Talk will focus on a therapeutic company’s pivot from an internal focus on a clinical development pipeline to serving a need for the global community:...
Mon 3:00 PM EDT
LinkedIn Profile Advice
LinkedIn is the most popular social media platform among AAPS members. Arlene Padron of Simulations-Plus reviews a few actual LinkedIn profiles to help you revise your...
Thu 12:30 PM EDT
Biomarker Driven Lipidomics in Pharma R&D
This webinar is intended to provide the audience with an introductory knowledge of the promise of lipidomics and its inherent challenges as well as providing resources...
Thu 12:30 PM EDT
Clearance is driven by exposure and is always model dependent
For a half-century clearance concepts have been utilized in pharmacokinetics to understand the relationship between the dose administered and the time-course of...
Thu 12:30 PM EDT
Predicting human milk/plasma (M/P) concentration ratios of small-molecule drugs and therapeutic antibody
In this webinar, the presenter will introduce the new IVIVE approach and compared its prediction performance with five literature in vitro prediction approaches.
Wed 11:15 AM EDT
COVID-19: Three Strategies to Keep Your Program in Motion
During these unprecedented times, it’s important to keep your drug development program moving toward approval. This session will highlight strategic actions to take...
Thu 12:30 PM EDT
Advances in bioavailability enhancing technologies for poorly soluble molecules: In vitro and In vivo case studies
This presentation will discuss the fundamental formulation and processing considerations for obtaining a high-performing and physically- and chemically stable...
Thu 12:30 PM EDT
Rapid, Low Volume Subvisible Particle Analysis with HORIZON
The Horizon® system from Halo Labs is the industry’s first analytical system to address the need for rapid, comprehensive subvisible particle analysis even when...
Tue 9:00 AM EDT
Challenges and best practices in supporting clinical bioanalysis in China
In this webinar, the presenter will discuss strategic planning and selection of a high-quality bioanalytical lab that has experience and technological capabilities to...
Thu 12:30 PM EST
The voice of influence: How to speak more confidently and move your big ideas forward
In this webinar, you will practice simple exercises to develop a more clear, confident, and engaging voice; master 3 easy steps to engage a complete stranger in a...
Thu 12:30 PM EST
Chimeric Antigen Receptor T- Cell therapy (CART): Process, analytical and cryopreservation challenges
This webinar will focus on the promise of this therapy, process development and scale up approaches, challenges in analytics, and cryopreservation formulation...
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 Sciences
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 difference: Connection is the key to information transfer
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 Antibody-Antigen Binding Kinetics
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 Structural Analysis of Protein Biopharmaceuticals
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 Lifecycle
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, Formulations and Methods
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 product design and development
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 Prediction of Linear Pharmacokinetics of Monoclonal Antibodies in Humans using Cynomolgus Monkey and hFcRn Tg32 Mice
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 (by Chemspeed Technologies)
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 – Interplay between Formulation and Dosage Form Microstructure
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 Regimens: Risk Assessment for Immunogenicity and Bioanalytical Considerations
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 Quality Control
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 Technology
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 Inactivation and Analytical Quantitation of Residual Detergent
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 Maximizing the Impact of Individualized Therapy
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 Precision Cancer Treatment
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 Efforts
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 Laboratory Assessment
Regulatory requirements with regard to extractables and leachables.
Thu 12:30 PM EDT
Nasally Administered Drug Products: Clinically Relevant In-vitro Tests
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 Models
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 consortium efforts
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 Analysis
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 Conversation at a Time
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 & Enable Bioavailability
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 Products: “Implants”
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 Safety
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 Sides of the Pond
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 Recent Trends
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 Ex-In vivo System
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 Research Presentations
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 Biopharmaceutical Development
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 Drug Development
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.