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.

This webinar will discuss the concepts related to determining who should be listed as an author on a scholarly manuscript.

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...

Our target audience is pharmaceutical or biotech professionals who are already in the industry. These people can include business development professionals,...

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.

Expert speakers will discuss the challenges and strategies regarding immunogenicity risk assessment, bioanalysis, and Integrated Summary of Immunogenicity and...

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...

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...

Intranasal drug delivery continue to grow in prevalence throughout all classes of compounds. Research continues for targeted nose to brain delivery, local targets and...

Overview of pharma outsourcing services provided by contract research, development, and manufacturing (CRO-CDMO) organizations for small molecules and biologics...

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...

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...

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...

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...

In this session, we will discuss how the mapping of small molecule biomarkers in blood delivers complementary information relative to traditional DNA and protein...

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....

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...

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...

Molecular testing platforms, such as qPCR, ddPCR and NGS enable discovery and development of cell and gene therapy products. While these technologies are...

Is a dermatological formulation or transdermal patch the best choice to deliver a drug into or across the skin? Scientific, pragmatic and regulatory considerations...

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...

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...

This webinar will describe a framework for establishing patient-centric specifications based on correlative analysis linking product attributes with clinical outcomes,...

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...

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...

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...

Discussion of reliable Dissolution Rate comparable to traditional methods, readily measured from unprocessed powder samples below 100 µg using the image-based single...

Evaluating the QT prolongation potential of new molecular entities early is an integral component of drug development programs. In this webinar, experts from industry...

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...

​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...

Several sartan, ranitidine and metformin-based drug products were recalled due to the nitrosamine contamination in the respective drugs products and drug substances in...

In this webinar, presenters will discuss common clinical trial and data related challenges during drug development in non-cirrhotic NASH population, including...

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...

Professor Brouwer will provide an overview of transporter regulation mechanisms, and discuss examples of disease-mediated alterations in hepatic transporters and...

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...

This webinar describes in detail recent and proposed updates related to dissolution testing in both compendial and regulatory forums. Specific topics to be discussed...

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...

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...

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...

Next Generation Sequencing has significantly decreased costs and time in obtaining sequence information and analyzing individual genomes. This is crucial for...

​In this session, USP will be presenting key findings from the nitrosamine survey conducted recently to understand current challenges faced by our stakeholders in...

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...

​In this session, we will discuss a next-generation mass spectrometry-based platform that enables rapid population-level discovery of circulating biomarkers. We will...

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...

This talk will cover applications of multiparameter flow cytometry in drug development and how this technology can provide useful and important information in support...

Traditional hybridoma and phage display methods have shown limited success in delivering therapeutic antibodies against difficult targets like most GPCRs and ion...

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...

Traditional hybridoma and phage display methods have shown limited success in delivering therapeutic antibodies against difficult targets like most GPCRs and ion...

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...

The generation of pure API nanoparticles, whether alone or in combination with other methodologies, can offer new drug delivery opportunities towards the generation of...

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...

Our IFF expert will discuss managing key excipient parameters, which are often specific to your drug substance and its properties.

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...

In this presentation, formulation experts will share the latest strategies for ionizable lipids screening and the characterizations of mRNA-LNPs with the introduction...

This presentation focuses on the bioanalytical challenges and considerations for RNA-based drugs, bispecific antibodies and multi-domain protein therapeutics,...

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...

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...

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...

This presentation provides an overview of the increasingly prevalent cybersecurity threat, ransomware, and increases awareness of the risk for corporate leadership and...

In this webinar, two API characterization techniques, (intrinsic and apparent dissolution) will be described in detail, sharing some clear case studies.

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...

Oral liquid dosage forms are becoming increasingly popular, in particular among pediatric and geriatric patients. Developing the proper suspension formulation comes...

In this eChalk talk, Dr. Camille Dumont, Formulation Scientist, will present an evidence-based approach to develop and optimize lipid-based nanocarriers to improve...

​In this presentation, we discuss SEC method development, with an emphasis on method transfer and sustainability. U/HPLC system configurations, differences in SEC...

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...

In this webinar, a framework for parameter inference and virtual population generation in the context of quantitative systems pharmacology model development will be...

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....

This DEI Webinar will discuss the systematic analysis conducted by (SJAR) Task Force, which was formed to dismantle biasness through education, evaluation, and...

In vitro and clinical CYP450 and transporters-mediated drug-drug interaction studies and FDA guidances

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...

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...

In this eChalk Talk, Donovan Werke, a Guatemalan generic drug manufacturer, will discuss manufacturing processes to reduce impurity presence as far as possible, as...

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...

In this webinar, our experienced industry panelists will provide practical advice on how to identify industrial job opportunities, principles of winning job...

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...

This chalk talk will offer an overview of Hydroxyl Radical Protein Footprinting, focusing on explaining the fundamentals of the technique and applications relevant to...

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....

The FDA comparability guidance (1996) recognized the need for manufacturers to improve manufacturing processes and analytical methods without performing additional...

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...

USP <922> water activity general chapter is now official. This webinar highlights the technical justification to add water activity measurements to the stability...

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...

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.

In this eChalk Talk, we will look at how a French CRO successfully implemented new technologies to improve analytical development services for their customers.

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...

This eChalk Talk will give participants a better understanding of the analytical assays associated with pre-clinical gene therapy studies

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...

Demand for the formulation development and manufacturing of nanomedicines is surging like never seen before. The nanomedicine landscape provides a large variety of...

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...

An IQ Working Group developed and conducted a survey across multiple biopharmaceutical companies in early 2020 in order to gain information about design options...

This webinar will be focused on highlighting formulation, process and manufacturing challenges for vaccine development and present case studies to illustrate the...

This webinar will cover the utility, promises, and challenges in using biomarkers of nephrotoxicity.

This presentation will compare pharmacokinetic advantages of nasal powder formulations to aqueous formulations. Formulation and invitro performance attributes for...

Phase 0 approaches — which include microdosing — evaluate subtherapeutic exposures of new drugs in first-in-human studies known as exploratory clinical trials. Recent...

​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...

The objective of this webinar is to illustrate various elements considered in regulatory assessment with respect to BE demonstration of additional strengths for which...

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...

Identification and Quantitation of Oligonucleotides and their Impurities using High-resolution Accurate-mass LC-MS

LBA/LC-MS/MS hybrid workflow is more sensitive and consistent than traditional methods, which is critical in efficacy and safety testing

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...

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...

This presentation will explore how to receive feedback non-defensively. Receiving critical feedback can result in normal emotional reactions such as: surprise,...

With regulatory requirements, validation protocol, and data integrity all being in the forefront, it is important to equip the laboratory with more than just...

Mass Spectrometers typically lend themselves to achieve higher throughputs but are being slowed by upfront chromatography or sample preparation.

The unprecedented vaccine and therapeutic development efforts in response to the COVID-19 pandemic have created an urgent need for rapid, accurate, and sensitive...

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...

In this webinar, PRA scientists will summarize some recent developments in the way the bioanalytical community feels about measurement of biomarker samples.

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...

When producing a quality vaccine, all manufacturers must confirm the purity as well as the stability of their formulation and final product

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...

Gene expression biomarkers are now available for application in the identification of genotoxic hazards. The TGx-DDI transcriptomic biomarker can accurately...

This webinar will provide the overall development process of selecting biomarkers, which will potentially replace the current 2-year study requirement for...

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...

Preclinical evaluation of cell and gene therapy (CGT) products in vitro and in vivo contributes significantly to characterization of the product benefit versus risk...

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. ...

Dissolution is one of the first methods applied in formulation development to gain information on the expected in-vivo performance of the pharmaceuticals. Nanoparticle...

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...

Join four experts who are part of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) working group intricately involved in the...

This presentation will focus on 1) the biopharmaceutics and clinical pharmacology studies needed to support the approval of repurposed drug products administered...

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...

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...

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...

In this webinar, the presenter will review a few case studies around lipid degradation, size distribution measurements, and filtration unit operations largely made...

This webinar provides a review of microencapsulation technologies that could be used in producing sustained-release microparticles for liquid suspensions, including...

. 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:...

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...

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...

For a half-century clearance concepts have been utilized in pharmacokinetics to understand the relationship between the dose administered and the time-course of...

In this webinar, the presenter will introduce the new IVIVE approach and compared its prediction performance with five literature in vitro prediction approaches.

During these unprecedented times, it’s important to keep your drug development program moving toward approval. This session will highlight strategic actions to take...

This presentation will discuss the fundamental formulation and processing considerations for obtaining a high-performing and physically- and chemically stable...

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...

In this webinar, the presenter will discuss strategic planning and selection of a high-quality bioanalytical lab that has experience and technological capabilities to...

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...

This webinar will focus on the promise of this therapy, process development and scale up approaches, challenges in analytics, and cryopreservation formulation...

The U.S. Food and Drug Administration approved labels for all drug and biologic products include extensive information on patient populations, disease indications and...

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...

In this webinar, we will describe the most commonly used statistical approaches, using examples to highlight their applicability in different comparability scenarios....

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?)

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...

​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...

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...

This webinar will discuss how Microfluidic Modulation Spectroscopy (MMS) can be used to understand the secondary structures of proteins, specifically monoclonal...

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...

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...

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. ...

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...

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...

Due to the increasing complexity of biopharmaceuticals, development of a drug product can be a major challenge. Issues include chemical and physical degradation that...

In this webinar, translational strategies for prediction of human linear PK of mAbs, including use of typical human popPK parameters and allometric exponents from...

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

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...

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.

The immunomodulatory biologics are designed to engage immune cells to support the effective killing of targeted cancer cells. In this lecture, the speaker will...

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...

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...

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,...

In this webinar, explore TKC with pharmaceutical polymers in ASD formulations and see how they create new opportunities for differentiated drug products.

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...

Join us for this exciting webinar as the experts from Death by PowerPoint share strategies on how to create informative, visually intriguing PowerPoint presentations...

Review the process for viral inactivation of clarified harvest using the detergent Octyl-D-glucopyranoside (ODG).

This webinar will provide the regulatory pathways for genomics and targeted therapies.

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...

An introductory session to provide a basic understanding of Pharmacogenetics.

2017, the next five years, and beyond.

Regulatory requirements with regard to extractables and leachables.

This webinar will provide an overview of a recent research project.

Learn the primary mechanisms of aerosol generation used in nebulization, namely, air jet, ultrasonic, and vibrating mesh nebulization.

A panel of industry, regulator, and academic experts to discuss lessons learned from the previous cases and steps to consider when developing QSP models.

The 5th live event in the Personalized Medicine series.

Siscuss and debate such aspects from industrial and regulatory perspective and would help to exchange of ideas to move the field further.

The 4th live event in the Personalized Medicine series.

The 3rd live event in the Personalized Medicine series.

Why can’t I have drug disposition just like Mom and Dad? Understanding the impact of transporter and enzyme ontogeny in pediatrics.

The 2nd live event in the Personalized Medicine series.

How microsampling is being used to in the quantitation of drugs, metabolites, and biomarkers in preclinical and clinical development.

Monitoring manufacturing and laboratory processes under continued process verification.

The 1st live event in the Personalized Medicine series.

Introduce formulation scientists, device engineers, and other pharmaceutical professionals to the core technical considerations of respiratory drug delivery.

Progress drug discovery candidates from any pharmaceutical organization to development with low risk that provide a balance of speed and quality.

A fresh perspective on networking for introverts and extroverts alike. Get the most out of your networking opportunities!

A discussion among leading experts who have successfully applied these advanced novel analytical technologies in pharmaceutical impurities analysis.

Prepare yourself to participate in the public arena where science is often met with skepticism.

What does one do when spray-drying and melt-extrusion fail to meet the drug product needs for their compound? Join us!

Get the basics here and then a deeper, hands-on experience at the 2017 Annual Meeting!

Explore the regulatory path-way for the approval of combination products and the unique challenges.

Address the current gap in the field of impact assessment of clinically relevant immunogenicity as it relates to impact on safety.

An exploratory assessment of the topic.

Learn how to focus on the needs of a live audience, not an imagined reader, when preparing and delivering a scientific presentation.

Current methods and state-of-the-art approaches.

Discuss current issues related to the use of surfactants in parenteral formulations.

Experts discuss these draft guidelines and highlight their similarities, differences, and major issues.

Understand and discuss protein formulation and analytical development.

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.

Review the state-of-the art nature of this field; pros and cons of different approaches and how these systems will have consequences.

Highlight the three winning research articles from the PPB Student Committee implemented a Best Student/Postdoc Manuscript Contest.

Can you See what I See? As modeling becomes more and more powerful and should be seen as the future for oral drug development.

Discuss the new FDA guidance and interact with scientists to discuss the consequences to industry.

The do’s and don’t’s from effective job search to durable career development.

Everything you need to know about Japan's new drug application-specific bracketing strategies.

Understand the principles and applications of primary 3D micro-imaging technology.

Come discuss six LBA methods validated either in house or at a CRO to support bioanalysis for GLP toxicokinetic or clinical pharmacokinetic studies.

Hear the arguments for each side of this debate and decide who wins your vote!

Exploring the pre-clinical and translational development of therapeutic antibodies.

How to Utilize Current Technology in Designing Successful Characterization and Control Strategies.

New methodologies in intrinsic clearance measurement, reaction phenotyping, and metabolite identification for low clearance compounds.

Monitor particulate matter in parenteral drug products.

A discussion on emerging trends in antibacterial drug research.

Demise of the heavy metals approach and implementation of ICH Q3D and USP <232> and <233>: considerations and challenges.

Transporter changes in the setting of liver disease can lead to clinically significant changes in drug disposition.

Faster and better evaluation and prediction of formulation properties and the improvement of biopharmaceutical development.

Discuss the challenges encountered with multiplex LBAs, the underlying causes, and explore tangible solutions.

How to design and execute manipulation and extraction studies.

Recommendations from the AAPS Biosimilars Committee and reflections on regulatory feedback.

A discussion of the recent FDA guidance with a focus on safety.