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Explore Events

  • Live Events
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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

Live Web Event Icon
February 8, 2023
Wed 11:15 AM EST
Web

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....

  • Duration 0H 30M
  • Seats Available
  • Single event
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February 8, 2023
Wed 1:15 PM EST
Web

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...

  • Duration 0H 30M
  • Seats Available
  • Single event
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February 9, 2023
Thu 12:30 PM EST
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A Practical Approach to Navigating Assessment Tools to Benefit your Career and Workplace

This session will provide insights into the range of available individual and 360-degree assessment tools and what attributes they measure with respect to relevance to...

  • Duration 1H 30M
  • Seats Available
  • Single event
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February 15, 2023
Wed 11:15 AM EST
Web

eChalk Talk: Subvisible Particles in Injectables: Routine Analytical Process Today and Tomorrow

This presentation aims to aims to provide inside information on light obscuration, its downsides, puts it into context of an traditional analytical workstream, and...

  • Duration 0H 30M
  • Seats Available
  • Single event
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February 22, 2023
Wed 1:15 PM EST
Web

eChalk Talk: Particles for Injectables: Regulatory Requirements

This presentation aims to introduce the audience into the world of pharmacopeial requirements related to particulates.

  • Duration 0H 30M
  • Seats Available
  • Single event
February 23, 2023
Thu 11:00 AM EST
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Part 1: Technologies to Facilitate High-Dose SC Administration

  • Duration 2H 0M
  • Seats Available
  • Part of Roadmapping the Clinical...
February 23, 2023
Thu 3:00 PM EST
Web

Part 2: Trial Designs and Regulatory Considerations for SC Development Paths

  • Duration 2H 0M
  • Seats Available
  • Part of Roadmapping the Clinical...
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February 28, 2023
Tue 12:30 PM EST
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Understanding the 'Dreaded' Manuscript Review Process

How to review papers and understanding reviewer comments

  • Duration 1H 0M
  • Seats Available
  • Single event
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March 2, 2023
Thu 11:30 AM EST
Web

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...

  • Duration 1H 30M
  • Seats Available
  • Single event
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March 7, 2023
Tue 12:30 PM EST
Web

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.

  • Duration 1H 30M
  • Seats Available
  • Single event
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March 15, 2023
Wed 11:15 AM EDT
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eChalk Talk: Enzyme Inhibition Studies: Elements of Design and Important Considerations in Data Analysis

We will address frequently asked questions from sponsors seeking inhibition studies and elaborate on some recommendations to achieve successful regulatory submission....

  • Duration 0H 30M
  • Seats Available
  • Single event
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March 21, 2023
Tue 12:00 PM EDT
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Critical Overview of the Biological Effects of Excipients - Part I

  • Duration 1H 0M
  • Seats Available
  • Single event
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March 23, 2023
Thu 12:00 PM EDT
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A Critical Overview of the Biological Effects of Excipients - Part II

  • Duration 1H 0M
  • Seats Available
  • Single event
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May 23, 2023
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Seats Available
  • Single event

Past Live Events

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January 25, 2023
Wed 1:15 PM EST
Web

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.

  • Duration 0H 30M
  • Closed
  • Single event
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January 12, 2023
Thu 12:30 PM EST
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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.

  • Duration 1H 30M
  • Closed
  • Single event
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January 11, 2023
Wed 11:15 AM EST
Web

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...

  • Duration 0H 30M
  • Closed
  • Single event
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December 14, 2022
Wed 1:15 PM EST
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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,...

  • Duration 0H 30M
  • Closed
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December 7, 2022
Wed 11:15 AM EST
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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.

  • Duration 0H 30M
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December 6, 2022
Tue 12:30 PM EST
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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...

  • Duration 1H 30M
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November 30, 2022
Wed 11:15 AM EST
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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...

  • Duration 0H 30M
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November 10, 2022
Thu 12:30 PM EST
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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...

  • Duration 1H 30M
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  • Single event
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November 2, 2022
Wed 1:15 PM EDT
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eChalk Talk: ELISpot Assay Assessments and Method Validation for Next Generation Therapeutics

  • Duration 0H 30M
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October 27, 2022
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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October 12, 2022
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
  • Closed
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October 11, 2022
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
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September 29, 2022
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
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September 28, 2022
Wed 1:15 PM EDT
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eChalk Talk: Avoid getting "lost in translation" - Increase confidence in translational research using biosimulation

  • Duration 0H 30M
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  • Single event
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September 28, 2022
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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September 27, 2022
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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September 22, 2022
Thu 12:30 PM EDT
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General Formulation Considerations in Bioequivalence Assessment for Generic Drug Approval

  • Duration 1H 30M
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September 21, 2022
Wed 1:15 PM EDT
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eChalk Talk: Increasing the Productivity of Oligonucleotide Purification through Column Scaling and Method Optimization

  • Duration 0H 30M
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September 20, 2022
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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September 15, 2022
Thu 12:30 PM EDT
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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....

  • Duration 1H 30M
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September 7, 2022
Wed 1:15 PM EDT
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eChalk Talk: New Software Tools for Impurity Analysis of Synthetic Oligonucleotides

  • Duration 0H 30M
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August 30, 2022
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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August 16, 2022
Tue 1:30 PM EDT
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Dissolution Best Practices

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August 16, 2022
Tue 10:00 AM EDT
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Dissolution in Pharmacopeias

  • Duration 2H 30M
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  • Part of Dissolution Best Practic...
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July 27, 2022
Wed 1:15 PM EDT
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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...

  • Duration 0H 30M
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July 27, 2022
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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July 26, 2022
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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July 21, 2022
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
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July 19, 2022
Tue 12:00 PM EDT
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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...

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June 15, 2022
Wed 1:15 PM EDT
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eChalk Talk: Monkeypox: What is it, What therapies exist, and What Research Tools Exist to Study and Evaluate Interventions

  • Duration 0H 30M
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June 14, 2022
Tue 12:30 PM EDT
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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,...

  • Duration 1H 30M
  • Closed
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May 25, 2022
Wed 10:00 AM EDT
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Part II: Clinical Strategies

  • Duration 3H 0M
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  • Part of Measurement and Understa...
May 24, 2022
Tue 10:00 AM EDT
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Part I: Assessing the Risk

  • Duration 3H 0M
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  • Part of Measurement and Understa...
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May 18, 2022
Wed 1:15 PM EDT
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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...

  • Duration 0H 30M
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May 5, 2022
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
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May 4, 2022
Wed 1:15 PM EDT
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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...

  • Duration 0H 30M
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May 4, 2022
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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April 28, 2022
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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April 27, 2022
Wed 1:15 PM EDT
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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...

  • Duration 0H 30M
  • Closed
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April 27, 2022
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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April 20, 2022
Wed 1:15 PM EDT
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eChalk Talk: Application of Expert System with Augmented Intelligence in Regulated Bioanalysis

  • Duration 0H 30M
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April 20, 2022
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
  • Seats Available
  • Single event
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April 19, 2022
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
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April 14, 2022
Thu 10:00 AM EDT
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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...

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April 13, 2022
Wed 2:00 PM EDT
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Part 6: Hot Topics and Closing Keynote

  • Duration 2H 0M
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  • Part of Drug Transporters in ADM...
April 13, 2022
Wed 10:00 AM EDT
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Part 5: Transporter IVIVE

  • Duration 2H 30M
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  • Part of Drug Transporters in ADM...
April 12, 2022
Tue 2:00 PM EDT
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Part 4: Regulatory Considerations

  • Duration 2H 30M
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  • Part of Drug Transporters in ADM...
April 12, 2022
Tue 10:00 AM EDT
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Part 3: Transporter Regulation and Altered Expression

  • Duration 2H 30M
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  • Part of Drug Transporters in ADM...
April 11, 2022
Mon 2:00 PM EDT
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Part 2: Transport in Non-Traditional Tissues

  • Duration 2H 30M
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  • Part of Drug Transporters in ADM...
April 11, 2022
Mon 10:00 AM EDT
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Part 1: Opening Keynote and Hot Topics

  • Duration 2H 30M
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  • Part of Drug Transporters in ADM...
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April 7, 2022
Thu 12:00 PM EDT
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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...

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March 30, 2022
Wed 1:15 PM EDT
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Unlock the Full Potential of Your Lab: CrossLab Asset Monitoring

  • Duration 0H 30M
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March 22, 2022
Tue 12:30 PM EDT
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Smaller, Faster & More Effective: Clinical Trial Enrichment Using Circulating Biomarkers

  • Duration 1H 30M
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March 17, 2022
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
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March 15, 2022
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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March 10, 2022
Thu 2:00 PM EST
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Part 4: Final Panel Discussion

  • Duration 2H 0M
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March 10, 2022
Thu 10:00 AM EST
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Part 3: Developmental Journeys

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March 9, 2022
Wed 2:00 PM EST
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Part 2: Regulatory Perspectives and Role of Modeling in LAI Drug Development

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March 9, 2022
Wed 10:00 AM EST
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Part 1: Current Landscape of Long-Acting Injectable Drug Product Development

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March 3, 2022
Thu 12:30 PM EST
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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...

  • Duration 1H 30M
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March 2, 2022
Wed 11:15 AM EST
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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...

  • Duration 0H 30M
  • Seats Available
  • Single event
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February 24, 2022
Thu 12:30 PM EST
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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...

  • Duration 1H 30M
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February 22, 2022
Tue 12:30 PM EST
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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...

  • Duration 1H 30M
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February 9, 2022
Wed 11:15 AM EST
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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...

  • Duration 0H 30M
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January 27, 2022
Thu 12:30 PM EST
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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...

  • Duration 1H 30M
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December 15, 2021
Wed 1:15 PM EST
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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...

  • Duration 0H 30M
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December 15, 2021
Wed 11:15 AM EST
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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...

  • Duration 0H 30M
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December 8, 2021
Wed 1:15 PM EST
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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...

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December 8, 2021
Wed 11:15 AM EST
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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...

  • Duration 0H 30M
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December 2, 2021
Thu 12:30 PM EST
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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...

  • Duration 1H 30M
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December 1, 2021
Wed 11:15 AM EST
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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...

  • Duration 0H 30M
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November 30, 2021
Tue 12:30 PM EST
Web

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...

  • Duration 1H 30M
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November 16, 2021
Tue 12:30 PM EST
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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...

  • Duration 1H 30M
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November 10, 2021
Wed 1:15 PM EST
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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...

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November 10, 2021
Wed 11:15 AM EST
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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.

  • Duration 0H 30M
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November 9, 2021
Tue 12:30 PM EST
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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...

  • Duration 1H 30M
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November 3, 2021
Wed 1:15 PM EDT
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eChalk Talk: Leveraging Compaction Simulator Technology to Predict Tablet Performance in High-Speed Production

  • Duration 0H 30M
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November 3, 2021
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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November 2, 2021
Tue 12:30 PM EDT
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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,...

  • Duration 1H 30M
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October 27, 2021
Wed 1:15 PM EDT
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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...

  • Duration 0H 30M
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October 27, 2021
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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October 7, 2021
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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October 6, 2021
Wed 11:15 AM EDT
Web

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...

  • Duration 0H 30M
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September 30, 2021
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
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  • Single event
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September 14, 2021
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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September 9, 2021
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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September 8, 2021
Wed 11:15 AM EDT
Web

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...

  • Duration 0H 30M
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September 7, 2021
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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August 31, 2021
Tue 12:30 PM EDT
Web

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...

  • Duration 1H 30M
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August 26, 2021
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
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August 25, 2021
Wed 11:15 AM EDT
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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....

  • Duration 0H 30M
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August 24, 2021
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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August 19, 2021
Thu 1:00 PM EDT
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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

  • Duration 1H 30M
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August 17, 2021
Tue 12:30 PM EDT
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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...

  • Duration 1H 30M
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August 4, 2021
Wed 1:15 PM EDT
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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...

  • Duration 0H 30M
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July 21, 2021
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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July 20, 2021
Tue 2:00 PM EDT
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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...

  • Duration 1H 0M
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July 8, 2021
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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June 30, 2021
Wed 11:15 AM EDT
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eChalk Talk: Solution Towards a Vendor-Neutral Secure Data Transfer Process between LIMS/eLN and instruments for Bioanalysis (June 30)

  • Duration 0H 30M
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June 24, 2021
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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June 23, 2021
Wed 11:15 AM EDT
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eChalk Talk: Solution towards a vendor-neutral secure data transfer process between LIMS/eLN and instruments for Bioanalysis (June 23)

  • Duration 0H 30M
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June 22, 2021
Tue 12:00 PM EDT
Web

WTO’s Intellectual Property Waiver—What Is It, and What Could It Mean to YOU If Passed?

  • Duration 1H 30M
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June 17, 2021
Thu 1:15 PM EDT
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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...

  • Duration 0H 30M
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June 17, 2021
Thu 11:15 AM EDT
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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....

  • Duration 0H 30M
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June 16, 2021
Wed 10:30 AM EDT
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Harmonization of qPCR: Part 2

  • Duration 1H 30M
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  • Part of Harmonization of qPCR
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June 15, 2021
Tue 10:30 AM EDT
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Harmonization of qPCR: Part 1

  • Duration 1H 30M
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  • Part of Harmonization of qPCR
June 10, 2021
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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June 9, 2021
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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June 3, 2021
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
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June 2, 2021
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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May 27, 2021
Thu 10:00 AM EDT
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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.

  • Duration 1H 30M
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May 12, 2021
Wed 11:15 AM EDT
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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.

  • Duration 0H 30M
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May 11, 2021
Tue 11:15 AM EDT
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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...

  • Duration 0H 30M
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May 5, 2021
Wed 11:15 AM EDT
Web

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

  • Duration 0H 30M
  • Seats Available
  • Single event
May 4, 2021
Tue 1:00 PM EDT
Web

Ask The Experts: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential

  • Duration 1H 30M
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April 28, 2021
Wed 1:00 PM EDT
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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...

  • Duration 1H 30M
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April 22, 2021
Thu 12:30 PM EDT
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Consideration for Program Design in Nonclinical Development of Gene Therapy

  • Duration 1H 30M
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April 21, 2021
Wed 11:15 AM EDT
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eChalk Talk: Unique Challenges of Implementing an ELISPot Assay in a Regulated Environment: A Case Study on SARS-CoV-2 Vaccine Development

  • Duration 0H 30M
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April 20, 2021
Tue 12:30 PM EDT
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Implementation of Process Analytical Technology Systems in Innovative Pharmaceutical Production Processes

  • Duration 1H 30M
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April 14, 2021
Wed 11:15 AM EDT
Web

eChalk Talk: Pharmacokinetic assay – Ligand Binding assays for Large Molecules - Method Development and Validation

  • Duration 0H 30M
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April 13, 2021
Tue 10:00 AM EDT
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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...

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April 8, 2021
Thu 12:30 PM EDT
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The Role of Cognitive Biases on Drug Development Decisions

  • Duration 1H 30M
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April 7, 2021
Wed 11:15 AM EDT
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Best Practices to Ensure Rapid Resolution when your Ligand Binding Assay Goes into Investigation

  • Duration 0H 15M
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April 1, 2021
Thu 12:30 PM EDT
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Optimizing Extraction Recovery for Volumetric Absorptive Microsampling (VAMS)

  • Duration 1H 30M
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March 25, 2021
Thu 2:00 PM EDT
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Part 4

  • Duration 2H 0M
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  • Part of Vaccine Stability Consid...
March 25, 2021
Thu 10:30 AM EDT
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Part 3

  • Duration 1H 30M
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  • Part of Vaccine Stability Consid...
March 24, 2021
Wed 2:00 PM EDT
Web

Part 2

  • Duration 2H 0M
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  • Part of Vaccine Stability Consid...
March 24, 2021
Wed 10:30 AM EDT
Web

Part 1

  • Duration 1H 30M
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  • Part of Vaccine Stability Consid...
March 23, 2021
Tue 12:00 PM EDT
Web

Attribute Based Control Strategies for Raw Materials Used to Manufacture Pharmaceuticals

  • Duration 1H 30M
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March 18, 2021
Thu 10:00 AM EDT
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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...

  • Duration 1H 0M
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March 8, 2021
Mon 12:00 PM EST
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Still Work to Do: Addressing Sexism with Agency and Allyship

  • Duration 2H 0M
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February 25, 2021
Thu 10:30 AM EST
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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...

  • Duration 1H 30M
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February 18, 2021
Thu 12:30 PM EST
Web

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...

  • Duration 1H 30M
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February 17, 2021
Wed 11:15 AM EST
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Emergency Use Authorizations of Coronavirus Vaccines – Similarities and Differences between an EUA and Approval and Legal Ramifications of Potential Vaccine Injury

  • Duration 0H 30M
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February 11, 2021
Thu 12:30 PM EST
Web

Journey of Biomarker from Discovery to Qualification

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

  • Duration 1H 30M
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February 10, 2021
Wed 11:15 AM EST
Web

eChalk Talk: Intranasal Drug Delivery

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

  • Duration 0H 15M
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February 4, 2021
Thu 9:30 AM EST
Web

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...

  • Duration 1H 30M
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January 26, 2021
Tue 12:30 PM EST
Web

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...

  • Duration 1H 30M
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January 21, 2021
Thu 12:30 PM EST
Web

Session 2: Immunogenicity Considerations for Therapeutic Proteins in COVID Patients

  • Duration 2H 15M
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  • Part of COVID-19 - Immunogenicit...
January 20, 2021
Wed 12:30 PM EST
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Session 1: Overview of the Immune Response to SARS-CoV-2, Hyperinflammation and Cytokines

  • Duration 2H 15M
  • Closed
  • Part of COVID-19 - Immunogenicit...
December 10, 2020
Thu 12:30 PM EST
Web

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...

  • Duration 1H 30M
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December 1, 2020
Tue 12:30 PM EST
Web

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...

  • Duration 1H 30M
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November 19, 2020
Thu 12:30 PM EST
Web

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

  • Duration 1H 30M
  • Closed
  • Single event
November 18, 2020
Wed 12:30 PM EST
Web

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

  • Duration 1H 30M
  • Closed
  • Single event
November 17, 2020
Tue 12:30 PM EST
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
November 16, 2020
Mon 12:30 PM EST
Web

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...

  • Duration 1H 30M
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November 13, 2020
Fri 12:30 PM EST
Web

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,...

  • Duration 1H 30M
  • Closed
  • Single event
November 12, 2020
Thu 12:30 PM EST
Web

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...

  • Duration 1H 30M
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November 11, 2020
Wed 1:00 PM EST
Web

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.

  • Duration 1H 30M
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November 11, 2020
Wed 10:00 AM EST
Web

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...

  • Duration 1H 30M
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  • Single event
November 10, 2020
Tue 12:30 PM EST
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
November 9, 2020
Mon 12:30 PM EST
Web

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.

  • Duration 1H 30M
  • Seats Available
  • Single event
October 22, 2020
Thu 9:00 AM EDT
Web

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...

  • Duration 2H 0M
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October 21, 2020
Wed 12:30 PM EDT
Web

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

  • Duration 1H 30M
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  • Single event
October 20, 2020
Tue 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
October 15, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
October 8, 2020
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
  • Single event
September 30, 2020
Wed 11:00 AM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 29, 2020
Tue 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 23, 2020
Wed 11:15 AM EDT
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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. ...

  • Duration 1H 0M
  • Closed
  • Single event
September 16, 2020
Wed 11:15 AM EDT
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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...

  • Duration 1H 0M
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September 15, 2020
Tue 1:00 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 3, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 2H 0M
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July 15, 2020
Wed 11:15 AM EDT
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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...

  • Duration 0H 30M
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  • Single event
July 9, 2020
Thu 12:30 PM EDT
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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...

  • Duration 1H 30M
  • Closed
  • Single event
July 8, 2020
Wed 11:15 AM EDT
Web

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...

  • Duration 0H 30M
  • Seats Available
  • Single event
July 1, 2020
Wed 11:15 AM EDT
Web

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...

  • Duration 0H 30M
  • Seats Available
  • Single event
June 25, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
June 4, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
June 3, 2020
Wed 11:15 AM EDT
Web

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:...

  • Duration 0H 30M
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  • Single event
June 1, 2020
Mon 3:00 PM EDT
Web

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...

  • Duration 1H 0M
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  • Part of AAPS Career Planning Wor...
May 21, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
May 14, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
May 7, 2020
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
April 29, 2020
Wed 11:15 AM EDT
Web

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...

  • Duration 0H 30M
  • Closed
  • Single event
April 16, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
March 26, 2020
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
March 10, 2020
Tue 9:00 AM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
February 27, 2020
Thu 12:30 PM EST
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
December 12, 2019
Thu 12:30 PM EST
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
October 24, 2019
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
October 15, 2019
Tue 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
October 10, 2019
Thu 12:30 PM EDT
Web

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....

  • Duration 1H 30M
  • Closed
  • Part of 10/10/19 -Synolostats we...
October 4, 2019
Fri 12:30 PM EDT
Web

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?)

  • Duration 1H 30M
  • Closed
  • Single event
October 2, 2019
Wed 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 26, 2019
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 23, 2019
Mon 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 17, 2019
Tue 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 12, 2019
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Part of 09/12/19-Synolostats web...
August 15, 2019
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Part of 08/15/19-Synolostats web...
July 31, 2019
Wed 11:00 AM EDT
Web

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. ...

  • Duration 1H 30M
  • Closed
  • Single event
July 18, 2019
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Part of 07/18/2019- Synolostats ...
June 28, 2019
Fri 12:30 PM EDT
Web

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...

  • Duration 2H 0M
  • Closed
  • Part of 06/28/19 Synolostats web...
June 25, 2019
Tue 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
May 30, 2019
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
May 9, 2019
Thu 12:30 PM EDT
Web

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

  • Duration 1H 30M
  • Closed
  • Single event
April 30, 2019
Tue 10:30 AM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
April 4, 2019
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
March 6, 2019
Wed 12:30 PM EST
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
January 30, 2019
Wed 12:30 PM EST
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
January 24, 2019
Thu 12:30 PM EST
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
October 25, 2018
Thu 12:30 PM EDT
Web

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,...

  • Duration 1H 30M
  • Closed
  • Single event
October 18, 2018
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
October 4, 2018
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 21, 2018
Fri 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
September 20, 2018
Thu 12:30 PM EDT
Web

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).

  • Duration 1H 30M
  • Closed
  • Single event
September 6, 2018
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
August 30, 2018
Thu 12:30 PM EDT
Web

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...

  • Duration 1H 30M
  • Closed
  • Single event
August 9, 2018
Thu 12:30 PM EDT
Web

The Role of Biomarkers in Supporting Personalized Medicine Efforts

An introductory session to provide a basic understanding of Pharmacogenetics.

  • Duration 1H 30M
  • Closed
  • Single event
June 28, 2018
Thu 12:30 PM EDT
Web

Diagnostic Strategies for Cancer Immune Therapies

2017, the next five years, and beyond.

  • Duration 1H 30M
  • Closed
  • Single event
June 14, 2018
Thu 12:30 PM EDT
Web

Extractables and Leachables: Regulatory Expectations to Laboratory Assessment

Regulatory requirements with regard to extractables and leachables.

  • Duration 1H 30M
  • Closed
  • Single event
May 24, 2018
Thu 12:30 PM EDT
Web

Nasally Administered Drug Products: Clinically Relevant In-vitro Tests

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

  • Duration 1H 30M
  • Closed
  • Single event
May 17, 2018
Thu 12:30 PM EDT
Web

Nebulization: Back to Basics

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

  • Duration 1H 30M
  • Closed
  • Single event
April 19, 2018
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
April 12, 2018
Thu 12:30 PM EDT
Web

Systems Pharmacology Approach for Personalized Treatment of Pain

The 5th live event in the Personalized Medicine series.

  • Duration 1H 30M
  • Closed
  • Single event
April 5, 2018
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
March 29, 2018
Thu 12:30 PM EDT
Web

Matching Cancer Drugs with Mechanism

The 4th live event in the Personalized Medicine series.

  • Duration 1H 30M
  • Closed
  • Single event
March 15, 2018
Thu 12:30 PM EDT
Web

Personalized Medicine in Neurological diseases

The 3rd live event in the Personalized Medicine series.

  • Duration 1H 30M
  • Closed
  • Single event
March 8, 2018
Thu 12:30 PM EST
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
February 15, 2018
Thu 12:30 PM EST
Web

Technology in Pharmacogenetic Decision Making: FDA lead consortium efforts

The 2nd live event in the Personalized Medicine series.

  • Duration 1H 30M
  • Closed
  • Single event
February 1, 2018
Thu 12:30 PM EST
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
January 25, 2018
Thu 12:30 PM EST
Web

Optimizing the Performance of Statistical Process Control Charts

Monitoring manufacturing and laboratory processes under continued process verification.

  • Duration 1H 30M
  • Closed
  • Single event
January 24, 2018
Wed 12:30 PM EST
Web

Emerging Pharmacogenetics Practices and its Application

The 1st live event in the Personalized Medicine series.

  • Duration 1H 30M
  • Closed
  • Single event
January 18, 2018
Thu 12:30 PM EST
Web

Metered Dose Inhalers 101

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

  • Duration 1H 30M
  • Closed
  • Single event
November 9, 2017
Thu 12:30 PM EST
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
November 3, 2017
Fri 12:30 PM EDT
Web

OPEN ACCESS: Network Like an Introvert

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

  • Duration 1H 0M
  • Closed
  • Single event
November 2, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
October 19, 2017
Thu 12:00 PM EDT
Web

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.

  • Duration 1H 0M
  • Closed
  • Single event
October 18, 2017
Wed 12:30 PM EDT
Web

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!

  • Duration 1H 30M
  • Closed
  • Single event
October 13, 2017
Fri 12:00 PM EDT
Web

OPEN ACCESS: Resume Writing 101

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

  • Duration 1H 0M
  • Closed
  • Single event
October 12, 2017
Thu 12:30 PM EDT
Web

Bioequivalence Evaluation of Generic Drug-Device Combination Products: “Implants”

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

  • Duration 1H 30M
  • Closed
  • Single event
October 5, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
September 28, 2017
Thu 12:30 PM EDT
Web

Subcutaneous Extended Release Delivery of New Modalities

An exploratory assessment of the topic.

  • Duration 1H 30M
  • Closed
  • Single event
September 25, 2017
Mon 12:30 PM EDT
Web

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.

  • Duration 1H 0M
  • Closed
  • Single event
September 21, 2017
Thu 12:30 PM EDT
Web

Solubility Prediction and Computational Co-crystal Screening

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

  • Duration 1H 30M
  • Closed
  • Single event
September 20, 2017
Wed 12:30 PM EDT
Web

OPEN ACCESS: Surfactants: the Good, the Bad, the Ugly

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

  • Duration 1H 30M
  • Closed
  • Single event
September 14, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
August 3, 2017
Thu 12:30 PM EDT
Web

Formulation Strategies to Prevent Protein Degradation

Understand and discuss protein formulation and analytical development.

  • Duration 1H 30M
  • Closed
  • Single event
July 27, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
July 20, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
July 13, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
June 15, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
June 8, 2017
Thu 12:30 PM EDT
Web

FDA Guidance: Interchangeability for Biosimilars

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

  • Duration 1H 0M
  • Closed
  • Single event
May 18, 2017
Thu 12:30 PM EDT
Web

Open Sesame to the Biopharmaceutical Industry

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

  • Duration 1H 30M
  • Closed
  • Single event
May 11, 2017
Thu 12:30 PM EDT
Web

Japan CTD: Bracketing Strategies for the Manufacturing Process

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

  • Duration 1H 30M
  • Closed
  • Single event
May 4, 2017
Thu 12:30 PM EDT
Web

3D Micro-imaging for Drug and Delivery System Characterization

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

  • Duration 1H 30M
  • Closed
  • Single event
April 20, 2017
Thu 12:30 PM EDT
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
April 13, 2017
Thu 12:30 PM EDT
Web

Debate: Clearance (CL) vs. Elimination Rate Constant (ke)

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

  • Duration 1H 30M
  • Closed
  • Single event
April 6, 2017
Thu 12:30 PM EDT
Web

Advances in Mechanistic TMDD and Platform PBPK Models

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

  • Duration 1H 30M
  • Closed
  • Single event
April 5, 2017
Wed 12:30 PM EDT
Web

OPEN ACCESS: Sub-Visible and Sub-Micrometer Particles in Biopharmaceutical Development

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

  • Duration 1H 30M
  • Closed
  • Single event
March 30, 2017
Thu 12:30 PM EDT
Web

Addressing the Challenges of Low Clearance in Drug Discovery

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

  • Duration 1H 30M
  • Closed
  • Single event
March 29, 2017
Wed 12:30 PM EDT
Web

Phase Appropriate Selection of Analytical Methodology

Monitor particulate matter in parenteral drug products.

  • Duration 1H 30M
  • Closed
  • Single event
March 23, 2017
Thu 12:30 PM EDT
Web

Monoclonal Antibodies as an Alternative to Antibiotics?

A discussion on emerging trends in antibacterial drug research.

  • Duration 1H 30M
  • Closed
  • Single event
March 9, 2017
Thu 12:30 PM EST
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
February 23, 2017
Thu 12:30 PM EST
Web

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.

  • Duration 1H 30M
  • Closed
  • Single event
February 8, 2017
Wed 12:30 PM EST
Web

High Throughput Screening of Formulations for Large Molecules

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

  • Duration 1H 30M
  • Closed
  • Single event
February 2, 2017
Thu 12:30 PM EST
Web

Biomarker Multiplex Ligand Binding Assays in Drug Development

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

  • Duration 1H 30M
  • Closed
  • Single event
January 26, 2017
Thu 12:30 PM EST
Web

Demonstrate Abuse-Deterrent Properties in Opioid Formulations

How to design and execute manipulation and extraction studies.

  • Duration 1H 30M
  • Closed
  • Single event
January 19, 2017
Thu 12:30 PM EST
Web

OPEN ACCESS: Bioanalytical Methods in Support of Biosimilar Drug Development

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

  • Duration 1H 30M
  • Closed
  • Single event
January 12, 2017
Thu 12:30 PM EST
Web

Human Factors/Usability Engineering in the Medical Product Cycle

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

  • Duration 1H 30M
  • Closed
  • Single event

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