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
Wed 11:15 AM EDT
eChalk Talk: The Strategies and Methods for in vitro ADME Characterization of ADCs
Tue 12:30 PM EDT
Advanced Oxidation Processes in Pharmaceutical Formulations: Complex Reaction Mechanisms Triggered by API, Excipients, and Impurities
Pharmaceutical formulations are exposed to a variety of stresses during manufacturing, shipment, storage and administration. These stresses may cause chemical and...
Thu 12:30 PM EDT
Pharmacokinetics and Toxicity of Oral and Inhaled Cannabinoids
Lovelace Biomedical performed research in rats on the pharmacokinetics and toxicity of CBD and its major metabolites after single and repeat dose oral and inhalation...
Tue 12:30 PM EDT
Transporter Based Drug‐Drug Interactions: Combining the Power of Endogenous Biomarkers and PBPK Modeling
Wed 11:15 AM EDT
eChalk Talk: Orthogonal and Complementary Techniques for Subvisible Particle Characterization in Biotherapeutics
Wed 1:15 PM EDT
eChalk Talk: Ultrasensitive Bioanalysis and Machine Learning - Case Studies
While significant advances have been made in terms of ultra-sensitive technology platforms for measurement of biologics and biomarkers, most platforms requires high...
Thu 12:30 PM EDT
Cold Chain and Transport Validation of Complex Biologic Modalities
This webinar will provide practical insights to integrate your stability data into your cold chain transportation validation design for complex biologics. The use of...
Tue 12:30 PM EDT
How to Successfully Transition Your Career: Industry and Academia
In this session, we will discuss the challenges, opportunities and practical approaches required for the successful transition from academics to industry and vice versa.
Thu 12:30 PM EDT
Winning Grants Faster - How You Can Learn from an Expert
Dr. Ekins will explain what you need to do before you write a grant, describe why its important to have a good idea. Deciding whether you should do a grant solo or...
Tue 12:30 PM EDT
Considerations for First-in-Human Clinical Studies: Strategies to Minimize Risk for Small Molecule Drug Candidates
The advancement of a drug candidate from preclinical studies to first in human studies are a key milestone in translational science to transform scientific discoveries...
Thu 12:30 PM EDT
Moving the Needle in Veterinary Pharmacology and Comparative Medicine Using Adult Stem Cells Derived Canine Organoids
Organoids are a relatively new biomedical model first described in 2009, which are 3-dimensional (3D) structures formed by stem cells which offer a variety of...
Past Live Events
Tue 12:30 PM EDT
Career Transition in Industry: Why, When and How?
In this webinar, the PPDM community would like to invite two seasoned scientists from industry who have had some very successful career transitions and also have...
Thu 1:00 PM EDT
SESSION IV: Effective Tools for Managing Conflict
A fundamental dilemma in all organizations is how to foster cognitive diversity of thought and ideas that improves decision quality while simultaneously minimizing...
Thu 10:30 AM EDT
SESSION III: Sponsors at Home and Mentors Away - Establishing and Making the Most of Support Relationships for Career Success
Mentors and sponsors can play multifaceted roles in personal development and career advancement. Mentors support growth and development throughout your career....
Wed 1:00 PM EDT
SESSION II: Effective Feedback as a Manager: How to Deliver It and How to Receive It
Wed 10:30 AM EDT
SESSION I: Creating a More Inclusive Science Workplace - Action Steps for Organizations, Managers and Individuals
In this perfect storm of the #MeToo, #BlackLivesMatter and COVID's #GreatResignation movements, the need for organizations to finally genuinely address the inclusivity...
Thu 12:30 PM EDT
Application of Quantitative Modelling in the Optimization of Dosing Regimen for Oncology Drug Development
The traditional paradigm of oncology drug development by taking one maximum tolerated dose into late phase testing put many challenges on evidence generation. To...
Wed 1:15 PM EDT
eChalk Talk: Timing is Everything: Biomarkers for Early Detection of Preclinical Toxicology Events
This presentation will explore the use of next-generation mass spectrometry for small molecule biomarker discovery (“metabolomics”) to enable the early detection of...
Tue 12:30 PM EDT
Development and Regulatory Landscape of Cell-based and CAR-T Therapies
This webinar will discuss the principles behind the design, development and manufacturing of emerging CAR-T therapies. Topics will include design challenges and...
Thu 12:30 PM EDT
Mechanisms for Protein Aggregation and Stabilization in Solution, During Freezing and Drying, and at Interfaces
To assure the quality, safety and efficacy of protein drug products it is absolutely essential that levels of protein aggregation and particles be measured properly...
Thu 12:30 PM EDT
Colonic Drug Absorption- Part 3: Predicting Colonic Absorption
Mechanistic absorption models are increasingly used to predict drugs potential for colonic absorption and guide development of modified-release products. Predictive...
Thu 12:30 PM EDT
Colonic Drug Absorption- Part 2: Developing Colon-targeting Formulations
Colon targeting formulations have gained a great attention for two major reasons: 1) to create extended-release formulations for rapidly absorbed immediate-release...
Wed 1:15 PM EDT
eChalk Talk: Inhalation and Intranasal Delivery for Gene Therapy and Biologics
This e-chalk talk will detail the methodology for aerosol and intranasal delivery that is unique for gene therapy and biologics. The e-chalk will specifically...
Wed 11:15 AM EDT
eChalk Talk: Navigating the Landscape of Service Providers for Critical Laboratory Assets Like LCMS
Maintaining the performance, uptime, managing costs and overall sustainability of a busy LCMS lab today requires a well thought out plan and team of service providers....
Tue 12:30 PM EDT
Retractions Are On The Rise, But Not Enough
In 2000, there were about 40 retractions from the scientific literature. In 2022, there were nearly 5,000. That is a dramatic increase, even accounting for the growing...
Tue 12:30 PM EDT
Measuring the Opalescence of mAb Solutions with Microscale Nephelometry
The visual opacity of protein solutions, known as opalescence, is a phenomenon arising from molecular self-association that is quantified via turbidimetry....
Thu 12:30 PM EDT
New USP Dissolution Performance Verification Standard: What, Where, and When
The USP announced the release of a new PVT calibration standard called the Dissolution Performance Verification Standard – Prednisone. The new calibrator is expected...
Tue 2:30 PM EDT
What You Need to Know to Nominate a Fellow
Tue 12:30 PM EDT
Colonic Drug Absorption- Part 1: Colon Physiology and its Environment for Drug Absorption
Understanding factors responsible for drugs’ potential for colonic absorption has been of interest for pharmaceutical scientists for absorption extending purposes, or...
Thu 12:00 PM EDT
A Critical Overview of the Biological Effects of Excipients - Part II
Tue 12:00 PM EDT
Critical Overview of the Biological Effects of Excipients - Part I
Tue 12:30 PM EST
Publish or Perish: Writing for Impact in the Pharmaceutical Sciences
How to write a high-quality paper and how to keep proper data and legitimate notebooks.
Thu 11:30 AM EST
DMPK Challenges and Strategies for Developing Oligonucleotide Drugs
This presentation will share our strategies to tackle these DMPK challenges and accelerate oligonucleotide drug development, particularly breaking the challenges into...
Tue 12:30 PM EST
Understanding the 'Dreaded' Manuscript Review Process
How to review papers and understanding reviewer comments
Thu 3:00 PM EST
Part 2: Trial Designs and Regulatory Considerations for SC Development Paths
Thu 11:00 AM EST
Part 1: Technologies to Facilitate High-Dose SC Administration
Wed 1:15 PM EST
eChalk Talk: Particles for Injectables: Regulatory Requirements
This presentation aims to introduce the audience into the world of pharmacopeial requirements related to particulates.
Wed 1:15 PM EST
eChalk Talk: Subvisible Particles in Therapeutic Protein Products
In this session, we will discuss that the brand of commercially used tubing greatly affected particle formation during the pumping of a model protein and during...
Wed 11:15 AM EST
eChalk Talk: Analysis of Oligonucleotide Therapeutic Candidates by Antisense Capture with High-Resolution Mass Spectrometry
Therapies based on oligonucleotides (OGN) often require multiple bioanalytical assay formats to measure the active pharmaceutical ingredient in tissues and fluids....
Wed 1:15 PM EST
eChalk Talk: The Clinical Trial Conundrum: Identifying Responders vs. Non-Responders
This presentation will explore the use of small molecule biomarkers to improve patient selection and to enrich for responders as part of a clinical trial strategy.
Thu 12:30 PM EST
Demystifying Who Is and Is Not an Author
This webinar will discuss the concepts related to determining who should be listed as an author on a scholarly manuscript.
Wed 11:15 AM EST
eCT: Updating Regulated Assays in Anticipation of ICH M10.
The adoption of ICH M10 will introduce several operational changes in the regulated bioanalytical laboratory. While most of these changes are minor, depending upon the...
Wed 1:15 PM EST
eCT: Updating Regulated Assays in Anticipation of ICH M10
Our target audience is pharmaceutical or biotech professionals who are already in the industry. These people can include business development professionals,...
Wed 11:15 AM EST
eChalk Talk: Bioanalytical fit-for-purpose solutions for preclinical and clinical development
Biomarkers and PK/PD-studies play key roles in the drug development process with the potential to improve success rate and reduce uncertainty in regulatory decisions.
Tue 12:30 PM EST
Immunogenicity Risk Assessment and Integrated Summary of Immunogenicity
Expert speakers will discuss the challenges and strategies regarding immunogenicity risk assessment, bioanalysis, and Integrated Summary of Immunogenicity and...
Wed 11:15 AM EST
eChalk Talk: Plasma Derived Drug Products and Hemostatic Risk
In this webinar, we will explore a quantitative analytical method that measures Factor Xla like activity as a function of thrombin generation. This method is a...
Thu 12:30 PM EST
Gene Therapy for Neurodegenerative Disease: Translating the October 2022 Guidance into Practice for Preclinical Pharm/Tox
On November 10, 2022 Dr. Jake McDonald and colleagues will provide a synopsis of the FDA guidance and examples of how this guidance has and is put into practice. This...
Wed 1:15 PM EDT
eChalk Talk: ELISpot Assay Assessments and Method Validation for Next Generation Therapeutics
Thu 12:30 PM EDT
Considerations for intranasal drug delivery in formulation, pharmacology and toxicology
Intranasal drug delivery continue to grow in prevalence throughout all classes of compounds. Research continues for targeted nose to brain delivery, local targets and...
Wed 11:15 AM EDT
eChalk Talk: Overview of pharma outsourcing for CRO/CDMO
Overview of pharma outsourcing services provided by contract research, development, and manufacturing (CRO-CDMO) organizations for small molecules and biologics...
Tue 12:30 PM EDT
Novel Ionizable Lipid Library for Enabling Non-Viral Delivery
The success of the mRNA-LNP COVID-19 vaccines have clinically proven the modality of lipid-based nanoparticles for genomic medicines with ionizable amino lipids being...
Thu 12:30 PM EDT
2022 Draft ICH Drug Interaction Studies Global Guideline: In Vitro Highlights and Comparison
Hear Drug-Drug Interaction (DDI) expert, Dr. Brian Ogilvie, discuss the important takeaways from the in vitro sections of the draft ICH M12 global guideline as well as...
Wed 1:15 PM EDT
eChalk Talk: Avoid getting "lost in translation" - Increase confidence in translational research using biosimulation
Wed 11:15 AM EDT
eChalk Talk: Cytokine Analysis in Non-Clinical Studies: Thoughts on ability to relate cytokine findings to adverse toxicology findings
This chalk talk will explore the possibilities and challenges in the analysis and interpretation of multiplex cytokine data in the context of non-clinical safety...
Tue 12:30 PM EDT
Enabling Patient-Centric Nanoparticle Drug Discovery and Design through Sparse-Data AI
The power of nanoparticle engineering, guided by sparse-data AI, promises to unlock a range of benefits for patients. This presentation will examine a variety of solid...
Thu 12:30 PM EDT
General Formulation Considerations in Bioequivalence Assessment for Generic Drug Approval
Wed 1:15 PM EDT
eChalk Talk: Increasing the Productivity of Oligonucleotide Purification through Column Scaling and Method Optimization
Tue 12:30 PM EDT
What's Next in Precision Medicine? Small Molecule Biomarkers to Personalize Disease Prediction, Diagnostics and Therapies
In this session, we will discuss how the mapping of small molecule biomarkers in blood delivers complementary information relative to traditional DNA and protein...
Thu 12:30 PM EDT
Implement or Expand Water Activity testing using USP<922>
During the last 12-months, pharmaceutical firms have been implementing and expanding the use of water activity testing as defined in the USP<922> general chapter....
Wed 1:15 PM EDT
eChalk Talk: New Software Tools for Impurity Analysis of Synthetic Oligonucleotides
Tue 12:30 PM EDT
Implementation of Process Analytical Technology Systems for Real Time Release Testing of Biopharmaceutical Products
In this webinar, we present a pilot initiative using RTRT elements for a control strategy applied to a biotech product. Concepts, implementation strategy and suitable...
Tue 1:30 PM EDT
Dissolution Best Practices
Tue 10:00 AM EDT
Dissolution in Pharmacopeias
Wed 1:15 PM EDT
eChalk Talk: Mapping the Missing Link- Bridging the Gap Between Human Genetics and Disease Biology Through Small Molecule Biomarker Discovery
In this session, we will discuss approaches for the comprehensive assay of small molecule biomarkers on a population-scale and application of these biomarkers to...
Wed 11:15 AM EDT
eChalk Talk: Answering Frequently Asked Questions Around Challenges When Using qPCR, ddPCR and NGS in Regulated Studies for Cell and Gene Therapy Products
Molecular testing platforms, such as qPCR, ddPCR and NGS enable discovery and development of cell and gene therapy products. While these technologies are...
Tue 12:30 PM EDT
Multifaceted considerations to pick the right technology to get your drug under my skin!
Is a dermatological formulation or transdermal patch the best choice to deliver a drug into or across the skin? Scientific, pragmatic and regulatory considerations...
Thu 12:30 PM EDT
Scientific and Regulatory Considerations of Applying Morphologically Directed Raman Spectroscopy in Bioequivalence Assessment for Generic Orally Inhaled Nasal Drug Products
This presentation will provide an overview of application of MDRS technology as it relates to demonstrating BE of the generic orally inhaled nasal drug products...
Tue 12:00 PM EDT
Towards a Real World Data - Informed Drug Development and Disease Control Programs
The primary goal of this webinar is to highlight the importance of real world evidence in drug development and disease control. In this webinar, presenters will...
Wed 1:15 PM EDT
eChalk Talk: Monkeypox: What is it, What therapies exist, and What Research Tools Exist to Study and Evaluate Interventions
Tue 12:30 PM EDT
Developing Patient-centric Specifications for Autologous Chimeric Antigen Receptor T Cell Therapies
This webinar will describe a framework for establishing patient-centric specifications based on correlative analysis linking product attributes with clinical outcomes,...
Wed 10:00 AM EDT
Part II: Clinical Strategies
Tue 10:00 AM EDT
Part I: Assessing the Risk
Wed 1:15 PM EDT
On the Mark: Identifying Non-Invasive Biomarkers of Target Engagement
In this eChalk Talk we will learn why assessment of target engagement is a critical step to inform ‘go / no-go’ decisions in a drug development program and explore the...
Thu 12:30 PM EDT
Impurities in mRNA Vaccines - Unwanted Immune System Activation
This webinar will be focused on development of mRNA tools and technology. During the COVID-19 pandemic haunting us the past three years, we have realized how brilliant...
Wed 1:15 PM EDT
eChalk Talk: Novel Hepatocyte Suspension-Based Assay Formats for BSEP and MDR3
Drug-induced liver injury (DILI) accounts for >50% acute liver failures, and is the leading cause of drug development failure, and boxed warning and market withdrawal...
Wed 11:15 AM EDT
eChalk Talk : API Sparing Dissolution Rate Determinations for Discovery
Discussion of reliable Dissolution Rate comparable to traditional methods, readily measured from unprocessed powder samples below 100 µg using the image-based single...
Thu 12:30 PM EDT
New Initiatives to Evaluate Cardiac Safety in Drug Development
Evaluating the QT prolongation potential of new molecular entities early is an integral component of drug development programs. In this webinar, experts from industry...
Wed 1:15 PM EDT
eChalk Talk: Meeting Compliance Requirements with UV-VIS Systems
In this talk, we will discuss a basic overview of meeting compliance requirements for operating a UV-VIS spectrometer and how the vendor’s software package for the...
Wed 11:15 AM EDT
eChalk Talk: How Oncology Drug Developers Can Prepare for FDA’s Project Optimus
During this eChalk talk, Certara’s Dr. Julie Bullock will address: ~How Project Optimus may impact development in the oncology space ~How developers can prepare for...
Wed 1:15 PM EDT
eChalk Talk: Application of Expert System with Augmented Intelligence in Regulated Bioanalysis
Wed 11:15 AM EDT
eChalk Talk: Accurate Determination of Mutagenic Azido, NDSRI and Nitrosamine Impurities in Drug Substances and Products Using LC-MS/MS
Several sartan, ranitidine and metformin-based drug products were recalled due to the nitrosamine contamination in the respective drugs products and drug substances in...
Tue 12:30 PM EDT
Addressing Data Challenges in Noncirrhotic Nonalcoholic Steatohepatitis (NASH) Drug Development
In this webinar, presenters will discuss common clinical trial and data related challenges during drug development in non-cirrhotic NASH population, including...
Thu 10:00 AM EDT
Rethinking Drug Solubility Enhancement? How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery
In this webinar we present this new manufacturing technology and support services for particle-engineered free-flowing ASDs for oral drug delivery. Our speakers will...
Wed 2:00 PM EDT
Part 6: Hot Topics and Closing Keynote
Wed 10:00 AM EDT
Part 5: Transporter IVIVE
Tue 2:00 PM EDT
Part 4: Regulatory Considerations
Tue 10:00 AM EDT
Part 3: Transporter Regulation and Altered Expression
Mon 2:00 PM EDT
Part 2: Transport in Non-Traditional Tissues
Mon 10:00 AM EDT
Part 1: Opening Keynote and Hot Topics
Thu 12:00 PM EDT
Disease- and Drug-Mediated Alterations in Transporters: Mechanisms and Model Systems
Professor Brouwer will provide an overview of transporter regulation mechanisms, and discuss examples of disease-mediated alterations in hepatic transporters and...
Wed 1:15 PM EDT
Unlock the Full Potential of Your Lab: CrossLab Asset Monitoring
Tue 12:30 PM EDT
Smaller, Faster & More Effective: Clinical Trial Enrichment Using Circulating Biomarkers
Thu 12:30 PM EDT
Covid-19 Variants: Science, Pharmacology and Challenges
The COVID-19 Pandemic has forged a world-wide concerted scientific endeavor to understand, control and mitigate the outcomes of a runaway viral disease. The US has...
Tue 12:30 PM EDT
Important Regulatory and Compendial Updates for Dissolution Testing
This webinar describes in detail recent and proposed updates related to dissolution testing in both compendial and regulatory forums. Specific topics to be discussed...
Thu 2:00 PM EST
Part 4: Final Panel Discussion
Thu 10:00 AM EST
Part 3: Developmental Journeys
Wed 2:00 PM EST
Part 2: Regulatory Perspectives and Role of Modeling in LAI Drug Development
Wed 10:00 AM EST
Part 1: Current Landscape of Long-Acting Injectable Drug Product Development
Thu 12:30 PM EST
Theragnostic Application of an Antioxidant from Mushrooms for Alzheimer’s Disease
This program focuses on discussing how to develop a PET radioisotope derived from an antioxidant for imaging Alzheimer’s disease (AD). The program will also cover the...
Wed 11:15 AM EST
eChalk Talk: Bioanalytical Considerations for Adeno-Associated Virus (AAV) Gene Therapy Drugs
In this eChalk Talk, we will discuss considerations for AAV-based gene therapy programs, and best approaches and strategies for development and validation of assays to...
Thu 12:30 PM EST
Meeting Regulatory Requirements for Your High-Resolution Mass Spec Data
Meeting regulatory requirements such as US FDA 21 CFR Part 11 and EU Annex 11 in a biopharmaceutical laboratory can be challenging, particularly as laboratories adopt...
Tue 12:30 PM EST
How Next Generation Sequencing Can Help Accelerate Cell and Gene Therapy Development
Next Generation Sequencing has significantly decreased costs and time in obtaining sequence information and analyzing individual genomes. This is crucial for...
Wed 11:15 AM EST
eChalk Talk: Overview of Nitrosamine Survey Findings and Nitrosamine Exchange
In this session, USP will be presenting key findings from the nitrosamine survey conducted recently to understand current challenges faced by our stakeholders in...
Thu 12:30 PM EST
Are In Vitro Metabolism and DDI Studies Critical for an IND?
Drug metabolism and drug-drug interaction studies often take a back seat to toxicity studies when preparing for an IND. However, benefits to drug development...
Wed 1:15 PM EST
eChalk Talk: Large-Scale Mass Spectrometry Profiling: Accelerated Biomarker Discovery Drives Drug Development
In this session, we will discuss a next-generation mass spectrometry-based platform that enables rapid population-level discovery of circulating biomarkers. We will...
Wed 11:15 AM EST
eChalk Talk: Digital Droplet PCR in the Regulated Bioanalytical Laboratory
Although ddPCR has been used extensively in basic research and discovery sciences for the last decade, ddPCR is transitioning to support GLP nonclinical studies and...
Wed 1:15 PM EST
eChalk Talk: Utilizing Multiparameter Flow Cytometry in Clinical Trials
This talk will cover applications of multiparameter flow cytometry in drug development and how this technology can provide useful and important information in support...
Wed 11:15 AM EST
eChalk Talk: Advanced Screening Technologies for Antibody Discovery
Traditional hybridoma and phage display methods have shown limited success in delivering therapeutic antibodies against difficult targets like most GPCRs and ion...
Thu 12:30 PM EST
Reporting Immunogenicity Raw Data for Nonclinical and Clinical Databases
How does immunogenicity data get from the laboratory into integrated analyses in the context of all clinical data? Learn about the November 2021 update to the...
Wed 11:15 AM EST
eChalk Talk: Advanced Immunization Strategies for Antibody Discovery
Traditional hybridoma and phage display methods have shown limited success in delivering therapeutic antibodies against difficult targets like most GPCRs and ion...
Tue 12:30 PM EST
Role of Model-Informed Drug Development (MIDD) in Designing Complex Clinical Trials
This webinar will focus on applications of Model Informed Drug Development (MIDD) in design and success of clinical trials. MIDD can streamline and accelerate the...
Tue 12:30 PM EST
Tailored API Nanoparticles: How Powerful Can Small Be?
The generation of pure API nanoparticles, whether alone or in combination with other methodologies, can offer new drug delivery opportunities towards the generation of...
Wed 1:15 PM EST
eChalk Talk: Facilitating Rapid, Large Volume Subcutaneous Administration of Biologics Using Enhanze Drug Delivery Technology
An introduction to the issues with large volume subcutaneous injections and the role that rHuPH20 may play in overcoming these issues. This will include a review of...
Wed 11:15 AM EST
eChalk Talk: How to Overcome Formulation Challenges with Customized Excipient Properties
Our IFF expert will discuss managing key excipient parameters, which are often specific to your drug substance and its properties.
Tue 12:30 PM EST
Improve Ion Exchange Methods with Faster Method Development and Lower Dispersion
New advances in UHPLC technology resulted in bio specific LC systems for the analysis of large molecules and these systems are made in all varieties, including binary...
Wed 1:15 PM EDT
eChalk Talk: Leveraging Compaction Simulator Technology to Predict Tablet Performance in High-Speed Production
Wed 11:15 AM EDT
eChalk Talk: Discovery of Lipid NanoParticle (LNP) and its Key Material Ionizable Lipid for mRNA Delivery
In this presentation, formulation experts will share the latest strategies for ionizable lipids screening and the characterizations of mRNA-LNPs with the introduction...
Tue 12:30 PM EDT
The Unique Bioanalytical Needs of New Modalities
This presentation focuses on the bioanalytical challenges and considerations for RNA-based drugs, bispecific antibodies and multi-domain protein therapeutics,...
Wed 1:15 PM EDT
eChalk Talk: Using single cell data to characterize combinatorial drug perturbations in two non-small cell lung cancer (NSCLC) cell lines
This webinar will discuss how HTS on two non-small cell lung cancer (NSCLC) cell lines using Chromium Single Cell Gene Expression assays can better characterize the...
Wed 11:15 AM EDT
eChalk Talk: How to Ensure Pharmaceutical Product Success through Excipient QbD Efforts
Two technical experts from IFF (the makers of pharmaceutical excipients) will give a sneak peek on QbD (Quality by Design) efforts that can best support pharmaceutical...
Thu 12:30 PM EDT
Facilitating Rapid, Large Volume Subcutaneous Administration of Biologics Using Enhanze Drug Delivery Technology
An introduction to the issues with large volume subcutaneous injections and the role that rHuPH20 may play in overcoming these issues. This will include a review of...
Wed 11:15 AM EDT
eChalk Talk: Today’s Challenge in Cyber Security – Defending Against Ransomware
This presentation provides an overview of the increasingly prevalent cybersecurity threat, ransomware, and increases awareness of the risk for corporate leadership and...
Thu 12:30 PM EDT
Application of Dissolution Testing for API Quality Characterization
In this webinar, two API characterization techniques, (intrinsic and apparent dissolution) will be described in detail, sharing some clear case studies.
Tue 12:30 PM EDT
Where the Rubber Meets the Road: From Digital Dreams to Real Efficiency Gains
A lot of attention in the pharmaceutical industry focuses on data integrity. Achieving data integrity and compliance comes very often at the price of a process...
Thu 12:30 PM EDT
The Top 3 Excipients (and How to Choose) for Optimal Pharmaceutical Suspensions
Oral liquid dosage forms are becoming increasingly popular, in particular among pediatric and geriatric patients. Developing the proper suspension formulation comes...
Wed 11:15 AM EDT
eChalk Talk: Lipid-based Nanocarriers for Oral Peptide Delivery
In this eChalk talk, Dr. Camille Dumont, Formulation Scientist, will present an evidence-based approach to develop and optimize lipid-based nanocarriers to improve...
Tue 12:30 PM EDT
Method Robustness and Transferability for Modern Size Exclusion Methods
In this presentation, we discuss SEC method development, with an emphasis on method transfer and sustainability. U/HPLC system configurations, differences in SEC...
Tue 12:30 PM EDT
Implementation of Process Analytical Technology Systems in Innovative Pharmaceutical Production Process
This webinar will provide an overview of the current landscape of determining API concentration in low-dosed formulations, as well as highlight some of the promising...
Thu 12:30 PM EDT
QSP Model Parameterization and Developing Virtual Populations
In this webinar, a framework for parameter inference and virtual population generation in the context of quantitative systems pharmacology model development will be...
Wed 11:15 AM EDT
eChalk Talk: Best Practices for the Development and Validation of qPCR and ddPCR Assays
The emergence and evolution of cell and gene therapy has led many bioanalytical laboratories to implement qPCR and/or ddPCR to support preclinical and clinical assays....
Tue 12:30 PM EDT
Understanding the Dimensions of Biasness
This DEI Webinar will discuss the systematic analysis conducted by (SJAR) Task Force, which was formed to dismantle biasness through education, evaluation, and...
Thu 1:00 PM EDT
Updates to the Final In Vitro and Clinical FDA DDI Guidance – Underlying Thoughts and Remaining Challenges
In vitro and clinical CYP450 and transporters-mediated drug-drug interaction studies and FDA guidances
Tue 12:30 PM EDT
Three Strategies for Confidently Connecting with an Unseen Audience
David P. Otey has been helping AAPS members give more successful presentations since 2016. Join him on August 17 for a 75-minute webinar titled “Three Strategies for...
Wed 1:15 PM EDT
eChalk Talk: Simplify Residual Solvents Analysis through Technology
In this presentation, we will present the relevant GC/FID and GC/FID/MS based analytical strategies to confidently detect and quantify Class 1, 2, and 3 as well as...
Wed 11:15 AM EDT
eChalk Talk: Nitrosamine Analysis (NDMA & NDEA) in Raw Materials/Excipients and Finished Product by UPLC-QDa
In this eChalk Talk, Donovan Werke, a Guatemalan generic drug manufacturer, will discuss manufacturing processes to reduce impurity presence as far as possible, as...
Tue 2:00 PM EDT
Interview Strategies for Women in Pharmaceutical Sciences
Spend an hour with an experienced pharmaceutical recruiter. This session will take you inside the hiring process and offer a strategy to create successful interviews...
Thu 12:30 PM EDT
Navigating Today’s Industry Landscape : A Guide for Students and Professionals
In this webinar, our experienced industry panelists will provide practical advice on how to identify industrial job opportunities, principles of winning job...
Wed 11:15 AM EDT
eChalk Talk: Solution Towards a Vendor-Neutral Secure Data Transfer Process between LIMS/eLN and instruments for Bioanalysis (June 30)
Thu 12:30 PM EDT
Amorphous Formulations Using Proteins as Excipients - A New Platform to Solve Solubility Issues of Poorly Soluble Drugs
This webinar has a focus on solid oral dosage form development for poorly soluble drugs and will highlight key technologies that can help address solubility issues as...
Wed 11:15 AM EDT
eChalk Talk: Solution towards a vendor-neutral secure data transfer process between LIMS/eLN and instruments for Bioanalysis (June 23)
Tue 12:00 PM EDT
WTO’s Intellectual Property Waiver—What Is It, and What Could It Mean to YOU If Passed?
Thu 1:15 PM EDT
Revolutionizing Protein Higher Order Structural Analysis with Flash Oxidation (Fox) Protein Footprinting
This chalk talk will offer an overview of Hydroxyl Radical Protein Footprinting, focusing on explaining the fundamentals of the technique and applications relevant to...
Thu 11:15 AM EDT
eChalk Talk: Clinical Pharmacology in Rare and Neglected Disease Drug Development: Applications to Global Health
Learn about the role of clinical pharmacology and model-informed drug development in aiding the development and approval of drugs for rare and neglected diseases....
Wed 10:30 AM EDT
Harmonization of qPCR: Part 2
Tue 10:30 AM EDT
Harmonization of qPCR: Part 1
Thu 12:30 PM EDT
Statistical Methods for CMC Comparability Studies
The FDA comparability guidance (1996) recognized the need for manufacturers to improve manufacturing processes and analytical methods without performing additional...
Wed 11:15 AM EDT
eChalk Talk: Risk Assessment and Test Method Development for Nitrosamines based on the Latest Regulatory Trends
In this eChalk Talk, Shionogi Pharma, a Japanese CDMO, will discuss how they selected and then incorporated new systems to offer total support for nitrosamine...
Thu 12:30 PM EDT
USP <922> Chapter for Water Activity Measurements
USP <922> water activity general chapter is now official. This webinar highlights the technical justification to add water activity measurements to the stability...
Wed 11:15 AM EDT
NEW DATE: eChalk Talk - Balance Study Design for Anti-Drug Antibody Cut Point Analysis
The goal for this e-Chalk Talk is to walk through a general overview of what a balance design is and why it is truly needed to successfully set a cut point for ADA...
Thu 10:00 AM EDT
Dr. Hartmut Derendorf Memorial Symposium: Celebrating the Life of a Dedicated Pharmacokineticist, Educator and Mentor
Celebrate the life of one of the greatest scientists of the AAPS organization. Join and learn about his massive contributions to the field of pharmacokinetics.
Wed 11:15 AM EDT
eChalk Talk: Routine Accurate Mass Detection for Forced Degradation Studies
In this eChalk Talk, we will look at how a French CRO successfully implemented new technologies to improve analytical development services for their customers.
Tue 11:15 AM EDT
eChalk Talk - Confidently Detect and Quantify Trace Nitrosamine (NDMA) Impurities in Drug Products
In this presentation, we will cover the USFDA regulations for the detection of nitrosamines. We will also review the LC/TQ based analytical method for the...
Wed 11:15 AM EDT
eChalk Talk: Assays Supporting Gene Therapy: Biodistribition and Immunology
This eChalk Talk will give participants a better understanding of the analytical assays associated with pre-clinical gene therapy studies
Tue 1:00 PM EDT
Ask The Experts: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential
Wed 1:00 PM EDT
Outsourcing Best Practices Panel
Pharmaceutical outsourcing has been integral to our industry since decades. Various models exist, each with their own risks and benefits. There are a number of...
Thu 12:30 PM EDT
Consideration for Program Design in Nonclinical Development of Gene Therapy
Wed 11:15 AM EDT
eChalk Talk: Unique Challenges of Implementing an ELISPot Assay in a Regulated Environment: A Case Study on SARS-CoV-2 Vaccine Development
Tue 12:30 PM EDT
Implementation of Process Analytical Technology Systems in Innovative Pharmaceutical Production Processes
Wed 11:15 AM EDT
eChalk Talk: Pharmacokinetic assay – Ligand Binding assays for Large Molecules - Method Development and Validation
Tue 10:00 AM EDT
Nanomedicines: Overcoming Delivery Challenges with Lipid and Polymeric Platform Technologies
Demand for the formulation development and manufacturing of nanomedicines is surging like never seen before. The nanomedicine landscape provides a large variety of...
Thu 12:30 PM EDT
The Role of Cognitive Biases on Drug Development Decisions
Wed 11:15 AM EDT
Best Practices to Ensure Rapid Resolution when your Ligand Binding Assay Goes into Investigation
Thu 12:30 PM EDT
Optimizing Extraction Recovery for Volumetric Absorptive Microsampling (VAMS)
Thu 2:00 PM EDT
Part 4
Thu 10:30 AM EDT
Part 3
Wed 2:00 PM EDT
Part 2
Wed 10:30 AM EDT
Part 1
Tue 12:00 PM EDT
Attribute Based Control Strategies for Raw Materials Used to Manufacture Pharmaceuticals
Thu 10:00 AM EDT
New Approaches to Oral Drug Delivery from Immediate Release Through Precise Colonic Targeting
From the buccal cavity, through the gastrointestinal tract and into the colon, the human body offers opportunities and challenges for oral drug delivery of small and...
Mon 12:00 PM EST
Still Work to Do: Addressing Sexism with Agency and Allyship
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.