IQ Consortium

Organization of pharmaceutical and biotechnology companies with a mission of advancing science and technology.

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*** SAVE THE DATE – Friday, March 13, 2026 *** Bioanalysis of Antibody-Drug Conjugates Workshop

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Bioanalysis of Antibody-Drug Conjugates (ADCs) Workshop
March 13, 2026

Spring House Innovation Park, PA
An IQ In-person Workshop

BACKGROUND

Bioanalysis of ADCs is uniquely challenging, requiring multiple assays (e.g., total antibody, conjugated antibody, free payload, metabolites, immunogenicity) across preclinical and clinical phases. Current industry practice often “measures everything,” resulting in high costs, excessive time demands, and large sample volumes. The IQ Consortium’s Drug Conjugates Working Group, co-chaired by Faye Vazvaei-Smith (Merck & Co. Inc.) and Wenkui Li (Novartis) is driving consensus on best practices to make ADC bioanalysis more efficient and fit-for-purpose.

 

PURPOSE OF WORKSHOP

Save the date to join us for a full-day IQ Consortium workshop focused on harmonizing and streamlining bioanalytical practices for Antibody-Drug Conjugates (ADCs), reducing unnecessary complexity and resource use while maintaining scientific rigor and patient safety.

 

GOAL OF WORKSHOP

Develop clear consensus recommendations on which ADC constituent(s) should be measured—and when—enabling efficient fit-for-purpose bioanalysis across the stages of drug development. This includes alignment on:

  • Which analyte(s)/assessment (e.g., total antibody, conjugated antibody, free payload, conjugated payload/metabolites/immunogenicity) are essential at each phase (preclinical, Phase I, pivotal studies, post-approval).
  • When there is scientifical justification to start or stop measuring specific constituents.
  • How to balance regulatory expectations with operational efficiency.

 

HIGHLIGHTS

  • Plenary: The impact of bioanalysis on ADC development
  • IQ Survey results: Current practices and opportunities for streamlining
  • FDA participation (invited): Regulatory experience
  • Breakout sessions: Practical guidance for “what to measure, when”
  • Consensus-building: Drafting the IQ playbook for ADC bioanalysis

Who Should Attend?

    • Bioanalytical, PK, and modeling scientists
    • Clinical pharmacology professionals
    • Regulatory affairs professionals
    • Program strategists and operational leads

Why Attend?

    • Shape industry best practices for ADC bioanalysis
    • Collaborate with leading experts from IQ TALG, CPLG, Statistics LGs, and regulatory agencies (FDA invited)
    • Contribute to a decision framework that reduces unnecessary complexity and resource use
    • Engage in breakout sessions on assay strategy, PK/ER modeling, immunogenicity, and operational streamlining

 

DATE/TIME

Friday, March 13, 2026
Approx. 9 AM – 5 PM ET

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IN-PERSON EVENT

This Workshop will be in-person only.

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WORKSHOP MATERIALS   

​Download our Workshop 1-pager and share with your interested colleagues.
​A draft program will be available here (to be available late January 2026).

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REGISTRATION AND FEES

Registration to open in late January 2026.
Note: A nominal fee will be charged to cover event expenses.

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WORKSHOP LOCATION AND LOGISTICS

Spring House Innovation Park
727 Norristown Rd., Building 1
Lower Gwynedd Township, PA 19002

​More information on logistics and accommodations will be available shortly.

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QUESTIONS

​​Contact the IQ Secretariat:
✉ [email protected] | 📞 +1 (202) 230-5607

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Best Industry Practices for the Qualification of Food Vehicles in Drug Administration

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Presented by the Pediatric Working Group
Sponsored by the Drug Product Leadership Group

Speakers: Anna Externbrink, MSD and and Yemin Liu, AbbVie
Moderator: Elizabeth Galella, Bristol Myers Squibb

The use of soft foods and liquids as vehicles for drug administration can significantly enhance palatability and acceptability in pediatric patients, thereby improving therapeutic outcomes. In vitro assessments are employed to identify and qualify food vehicles for drug product labeling; however, interpreting and applying regulatory guidance in this area can be challenging.

This webinar aims to provide pharmaceutical R&D professionals and regulators with a scientific framework for justifying food vehicles in drug administration while facilitating the development of clear and meaningful label instructions. Attendees will gain insights into best industry practices, supported by case studies and practical examples.

This is a public webinar. Membership in the IQ Consortium is not required to attend.

Predictive Dissolution Models for Surrogate Release: An Industry Position

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Thursday, 11 September 2025  |  11:00 AM-12:15 PM ET  |  Attendance is limited. Register today

Presented by: IQ Dissolution Working Group
Sponsored by: IQ Drug Product Leadership Group

In vitro dissolution testing is commonly performed to ensure that oral solid dosage medicines are of high quality and will achieve their targeted in vivo performance. However, this testing is time and material-consuming. Therefore, pharmaceutical companies have been developing predictive dissolution models (PDMs) for drug product release based on fast at- and/or on-line measurements. Recently, PDMs have seen acceptance by major regulatory bodies as release tests for the dissolution critical quality attribute.

This webinar will describe several methodologies to develop and validate a fit-for-purpose model, then implement it as a surrogate release test for dissolution. These approaches will be exemplified by real-life case studies, which demonstrate that PDMs for release are not only viable but also more sustainable than in vitro dissolution testing and can significantly accelerate drug product release. The rise of continuous manufacturing within the pharmaceutical industry further favors the implementation of real-time release testing. Therefore, a steep uptake of PDMs for release is expected once this methodology is globally accepted. To that end, it is advantageous for global regulators and pharmaceutical innovators to coalesce around a harmonized set of expectations for the development, validation, implementation, and lifecycle of PDMs as part of drug product release testing.

SPEAKERS/MODERATORS

  • Tessa Carducci, PhD, Merck & Co., Inc.
  • Melanie Dumarey, PhD, AstraZeneca
  • Himanshu Gandhi, Bristol-Myers Squibb
  • Sarah Nielsen, PhD, Johnson & Johnson
  • Yanmei Lan, PhD, Takeda
  • Ana Filipa Tavares da Silva, PhD, Janssen Pharmaceutica NV
  • Nikolay Zaborenko, PhD, Eli Lilly & Co.

The webinar organizers encourage you to read the paper on which the content is based, Dissolution of Oral Solid Dosage Formulations: Surrogate Models and Real-time Release, before joining us in September.

  • Dumarey, M., Carducci, T.M., Walworth, M.J., Smith, C.J., García-Muñoz, S., Nielsen, S., Jacquart, S., Tavares da Silva, A., Altan, S., Otava, M., Lan, Y., Zaborenko, N., AAPS J 27, 115 (2025). https://doi.org/10.1208/s12248-025-01102-0

Membership in the IQ Consortium is not required to attend this public webinar.

Making Bitter Medicines Better for Everyone

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* New Date*

Presented by the Pediatric Working Group
Sponsored by the Drug Product Leadership Group

People vary widely in how bitter they perceive medicines to be, which can impact how easily they take them. A global study from the Monell Chemical Senses Center found that genetic ancestry influences how bitter certain medicines taste and how well sweeteners or other modifiers reduce bitterness. For example, a common sweetener worked better for some groups than others, which has important implications for making medicines more palatable for children and adults alike. By understanding these differences, pharmaceutical companies can develop better formulations that improve medication adherence, particularly in pediatric and global health settings where taking every dose is critical.

PBBM Report Template: Considerations for Improved Quality in View of Regulatory Submissions

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Sponsored by the Regulatory Advisory Committee

Pharmaceutical innovators and generic companies employ Physiologically Based Biopharmaceutics Models (PBBMs) to inform drug product development and may be able to waive clinical pharmacokinetic studies for changes occurring both before and after product approval. The 2023 M-CERSI workshop titled “PBBM Best Practices for Drug Product Quality: Regulatory and Industry Perspectives” recognized that a standardized PBBM report template could benefit both industry stakeholders and regulatory bodies. This webinar will discuss the PBBM report template, which summarizes a set of expectations and proposes a structure for presenting input data, modeling plan, context of the model, model parameters, and clinical data on which the model was developed and validated to minimize the number of PBBM rejections in the future. Efforts have been made to align the framework presented in the PBBM report template with the overarching ICH M15 Guideline on Model Informed Drug Development (MIDD).

For further information about the PBBM report template, please refer to the publication Arora et al. Development of a Physiologically Based Biopharmaceutics Model (PBBM) Report Template: Considerations for Improved Quality in View of Regulatory Submissions. Molecular Pharmaceutics (submission in progress)