IQ Consortium News
Drug Substance – Small Molecule Impurities Working Group Public Call Response Deadline - 11 February
January 5, 2022
IQ Drug Substance Small Molecule Impurities Working Group Issues Public Call for Invited Guest
IQ Explorative Clinical Trials Group Publishes Paper in Clinical and Translational Science Journal
December 1, 2021
The IQ Explorative Clinical Trials Working Group recently published a paper entitled "To blind or not to blind in human and exploratory clinical trials: Acceleration of development vs. risk of bias"
AI/ML in Pediatric Research: Medical & Pharmaceutical Perspectives
November 2, 2021
Inaugural Artificial Intelligence and Machine Learning in Pediatric Research Symposium
IQ Consortium and AAALAC International announce Global 3Rs Award Program Winners
November 2, 2021
Congratulations to IQ/AAALAC International Global 3Rs Award Recipients!
2021 IQ Consortium Recognition Awards
October 27, 2021
IQ Consortium announces recipients of 2021 Recognition Awards!
IQ Patient Centric Sampling Working Group Co-sponsoring Symposium at 2021 AACP Virtual Meeting
September 8, 2021
Remember to register for the September 17 "Patient-centric Sampling Opportunities & Challenges for Implementation in Drug Development Programs" Symposium
Registration open for IQ PDM RTRT virtual workshop
September 7, 2021
IQ Consortium invites you to register for the Predictive Dissolution Models for Real-time Release Testing: Development and Implementation Virtual Workshop taking place 11-12 November 2021.
IQ DruSafe publishes paper in Regulatory Toxicology and Pharmacology Journal
August 27, 2021
The IQ DruSafe Leadership Group and EFPIA publish the results from their collaborative survey on photosafety evaluation of pharmaceuticals after implementation of ICH S10.
DruSafe Impurities Safety Working Group publishes paper in Regulatory Toxicology and Pharmacology
August 19, 2021
The Impurities Safety Working Group recently published a paper in Regulatory Toxicology and Pharmacology on calculating non-mutagenic impurity levels.
IQ DSLG Green Chemistry Working Group publishes paper in ACS Sustainable Chemistry & Engineering
August 11, 2021
The Green Chemistry Working Group published a paper on "Improved iGAL 2.0 Metric Empowers Pharmaceutical Scientists to Make Meaningful Contributions to United Nations Sustainable Development Goal 12."
IQ Nitrosamine Working Group publishes manuscript in Organic Process Research & Development
July 22, 2021
IQ DSLG Nitrosamine Working Group has recently published a new manuscript in Organic Process Research & Development entitled "Nitrosamine Reactivity: A Survey of Reactions and Purge Processes"
IQ Regulatory Advisory Committee (RAC) publishes white paper on collaboration in the age of COVID-19
July 2, 2021
Reports from nine IQ groups spanning the pharma development lifecycle provide an important framework for the industry to support future pandemic or unmet medical needs for the patients we serve.
IQ DILI Affiliate launches trial membership to pharma and biotech companies
May 21, 2021
The IQ Drug Induced Liver Injury (IQ-DILI) Initiative invites pharma and bio tech companies to join the affiliate for 1-year trial basis.
IQ Celebrates! A look back on the IQ Consortium’s first decade with a Viewpoint in Pharm Tech
April 28, 2021
The IQ Consortium will continue to refine the attributes that brought success in its first decade into the next with technical depth, key capabilities, and its influential presence.
IQ commemorates 10th anniversary with five articles published in Pharmaceutical Technology
April 28, 2021
IQ publishes five case studies in Pharm Tech Regulatory Sourcebook, promoting collaboration and technical groups in response to current challenges and trends in pharmaceutical industry.
IQ Statistics Leadership Group, Biostatistics/CMC Forum Webinar Pt. 3 - 30 July
April 16, 2021
Join the the IQ Statistics Leadership Group, Biostatistics/CMC Forum for Pt. 3: 30 July IQ Webinar
IQ Statistics Leadership Group, Biostatistics/CMC Forum Webinar Pt. 2 - 23 July
April 16, 2021
Join the the IQ Statistics Leadership Group, Biostatistics/CMC Forum for Pt. 2: 23 July IQ Webinar
IQ Statistics Leadership Group, Biostatistics/CMC Forum Webinar Pt. 1 - 16 July
April 16, 2021
Join the the IQ Statistics Leadership Group, Biostatistics/CMC Forum for Pt. 1: 16 July IQ Webinar
Control Strategy Global Harmonization Webinar - 20 May
April 8, 2021
Join the the IQ QLG Control Strategy Global Harmonization Working Group for the 20 May IQ Webinar
A Multi-company Assessment of Submicron Particle Levels in Biotechnology-derived Protein Products
March 22, 2021
Registration opens for 15 April IQ Webinar: A Multi-company Assessment of Submicron Particle Levels in Biotechnology-derived Protein Products
Biodistribution and bioanalytical considerations for AAV based Gene Therapies Webinar - 26 March
February 23, 2021
Join the the IQ TALG Cell and Gene Therapy Working Group for the 26 March IQ Webinar: Biodistribution, PK/PD and related bioanalytical considerations for AAV based Gene Therapies
Announcing Global 3Rs Award Program Winners and Launching 2021 Nominations
February 22, 2021
Congratulations to 2020 3Rs Award Winners!
Dates Announced for 2021 IQ Pediatric Working Group Webinar Series
February 22, 2021
IQ Drug Product Leadership Group's Pediatric Working Group Opens Registration for Five New Webinars in 2021
Registration open for IQ Closed Systems Transfer Devices Webinar
February 17, 2021
Join us for "Challenges of Using Closed System Transfer Devices (CSTDs) with Biological Products" a public webinar presented by IQ Closed Systems Transfer Devices (CSTD) Working Group
Registration open for IQ/AAPS Blinding in Early Clinical Development Trials Webinar
February 11, 2021
Join IQ and AAPS on 25 February for Blinding in Early Clinical Development Trials Webinar
Registration opens for IQ Induction Working Group two-part webinar series in February 2021
January 27, 2021
Join the The IQ Translational and ADME Sciences Leadership Group (TALG) Induction Working Group (IWG) in a public webinar series based on its two recent publications in Drug Metabolism and Disposition
IQ Consortium 2020 Recognition Awards
January 1, 2021
IQ Consortium announces recipients of 2020 Recognition Awards
IQ Consortium Biologics CMC Subvisible Particles Working Group Case Study
September 11, 2020
IQ BioCMC LG Subvisible Particles Working Group Case Study presents a Multi-company Assessment of Submicron Particle Levels in Biotechnology-derived Protein Products
Registration Open for IQ Webinar on Recent Advances in Coprocessed APIs
June 5, 2020
IQ DSLG Coprocessed API Working Group presents webinar on recent perspective paper - Recent Advances in Coprocessed APIs & Proposals for Enabling Commercialization of These Transformative Technologies
Knock, Knock! It’s FDA! GLP Inspections
June 4, 2020
Registration Opens for an IQ Quality Leadership Group webinar to help prepare for the next US FDA inspection.
IQ DPLG Pediatric Working Group Announces 2020 Webinars
May 4, 2020
IQ Drug Product Leadership Group's Pediatric Working Group Opens Registration for Five New Webinars
IQ Consortium Clinical Pharmacology Pediatric WG Extrapolation Case Study
April 24, 2020
IQ CPLG Pediatrics Working Group Case Study - Extrapolation: A New Tool Making Pediatric Drug Development More Feasible
IQ DILI Collaborates with DILI Experts to Develop Guidelines Featured in AP&T
December 6, 2019
IQ DILI is pleased to announce their latest publication in AP&T on detection, assessment and management best practices for suspected DILI in clinical trials for adults with cholestatic liver disease.
IQ MPS Affiliate
November 8, 2019
The IQ MPS Affiliate has launched its new website. Open this story to learn more about the Affiliate and its activities.
2019 Global 3Rs Awards Winners
October 23, 2019
Congratulations to the 2019 Global 3Rs Award Winners!
2019 IQ CPLG and TALG FDA Meeting
October 15, 2019
IQ Clinical Pharmacology, and Translational and ADME Sciences Leadership Groups participate in significant scientific exchange at US FDA OCP.
2019 IQ Recognition Award Recipients Announced
October 7, 2019
Join IQ as it celebrates the tremendous efforts of the 2019 IQ Recognition Award recipients.
2019 IQ CPLG Meeting at Astellas Japan
September 30, 2019
IQ Consortium Clinical Pharmacology Leadership Group Meets with the Japan Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceuticals and Medical Devices Agency (PDMA)
IQ DILI Collaborates with Biorepository, DILI Experts, and US FDA to Publish in CPT
August 9, 2019
IQ DILI collaborated with Biorepository, nationwide DILI experts in industry, academia, and US FDA to develop comprehensive guidelines addressing best practices for bio specimen collection.
IQ Consortium Webinar Series from Analytical Leadership Group’s Dissolution Working Group
April 15, 2019
IQ Consortium Analytical Leadership Group's Dissolution Working Group Starts Public Webinar Series
New IQ Case Studies Highlight High Impact Initiatives
February 27, 2019
IQ has released a series of case studies on high-impact initiatives led by IQ working groups.
IQ Releases Animal Care and Use Program Assessment Tools
January 24, 2019
The assessment tools for partner research organization animal care and use programs were developed with IQ member company and CRO input.
Joint IQ ALG/USP USP Workshop on Enhanced Approaches for Analytical Procedure Lifecycle
January 24, 2019
IQ was involved in a recent USP Workshop, Enhanced Approaches for Analytical Procedure Lifecycle.
2019 IQ Symposium and Related Events Registration Now Open
December 13, 2018
Registration is Now Open for the 2019 IQ Symposium and Related Events
IQ Consortium Lean Stability and Risk-Based Predictive Stability Working Groups join forces at 2018
November 4, 2018
IQ Consortium Lean Stability and Risk-Based Predictive Stability Working Groups join forces at 2018 PharmSci 360
IQ Co-Sponsoring USP Workshop
July 30, 2018
IQ is co-sponsoring USP's upcoming workshop "Enhanced Approaches for Analytical Procedure Lifecycle: An Alternative to Traditional Validation."
IQ Tool Featured on Cover of Green Chemistry Journal
June 1, 2018
The iGAL developed by the IQ Green Chemistry Working Group has been featured on the cover of the May Issue of Green Chemistry.
Sucesso de IQ na ANVISA!
May 21, 2018
IQ DruSafe presents on ICH multidisciplinary safety guidelines at ANVISA Workshop in Brasilia
IQ CPLG Pediatrics Working Group Publishes in CPT on Key Area for Pediatrics Product Development
February 9, 2018
IQ CPLG Pediatrics Working Group publishes important publication on pediatric medicines development and alternate/novel approaches for clinical trials
IQ API LG Small Molecules Impurities Working Group Publishes White Paper in AAPS PharmSciTech
January 31, 2018
The IQ API LG Small Molecules Impurities Working Group publishes, "Control Strategy for Small Molecule Impurities in Antibody-Drug Conjugates," in AAPS PharmSciTech.
IQ PAT Working Group hosts session at IFPAC
January 22, 2018
IQ PAT Working Group Hosts "Emerging Tools and Techniques and Their Impact Supporting Process Understanding" session at IFPAC
IQ Drug Metabolism QSP Working Group publishes in CPT Pharmacometrics & Systems Pharmacology
January 22, 2018
IQ Drug Metabolism QSP Working Group publishes in CPT Pharmacometrics & Systems Pharmacology
2017 IQ Symposium Report Now Available!
December 18, 2017
Download the 2017 IQ Consortium's Symposium Report to read about this year's speakers' talks and IQ's continued initiatives to bring innovation and quality to pharmaceutical development.
IQ 3Rs Leadership Group continues effort to modernize animal studies for improved clinical translata
December 1, 2017
IQ 3Rs Leadership Group continues effort to modernize animal studies for improved clinical translatability
The ALG Dissolution Working Group publishes in AAPS Journal.
November 30, 2017
The ALG Dissolution Working Group publishes article entitled "Approaches for Establishing Clinically Relevant Dissolution Specifications for Immediate Release Solid Oral Dosage Forms" in AAPS Journal.
2017 Global 3Rs Award Winners
November 13, 2017
IQ Consortium congratulates the 2017 winners of the Global 3Rs Award, a collaboration between IQ and AAALAC International.
2018 ASCPT/IQ Symposium & Workshop Announced!
October 24, 2017
Register now for the joint ASCPT/IQ Half-day Symposium and Workshop on Pediatric Drug Development: Challenges and Opportunities in Extrapolation - 21 March 2018 at the Annual ASCPT Meeting in Orlando
Allotrope Framework Released for Commercial Use
July 24, 2017
The first phase of the Allotrope Framework has been released for commercial use.
AQbD Working Group Publishes in PharmTech
April 3, 2017
The article presents the results of a survey on implementation of analytical quality by design concepts by small- and large- molecule companies.
2017 IQ Consortium Leadership Transition
December 13, 2016
IQ Says Thank You to Outgoing Chair 2014-2016, and Welcomes New Chair and Vice-Chair 2017-2019
A Deeper Shade of Green: Inspiring Sustainable Drug Manufacturing
November 23, 2016
The IQ Green Chemistry Working Group has published a new artice in Green Chemistry in collabortion with the ACS Green Chemistry Institute Pharmaceutical Roundtable.
2016 Global 3Rs Award Winners
November 21, 2016
View a summary here of the 2016 IQ/AAALAC Global 3Rs Award Winners
IQ Launches Drug Induced Liver Injury (DILI) Initiative
September 27, 2016
A new collaborative initiative was recently formed within the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) to tackle this challenge.
Now Available - IQ Change Management in Development White Paper
August 9, 2016
IQ's Change Management Working Group has produced a white paper on how to implement a change management system in the clinical development phase of a product’s lifecycle.
IQ Forms New CMC Biologics Leadership Group
August 5, 2016
The IQ Consortium has formed an 11th Leadership Group to address CMC aspects of biologic development.
IQ Pediatric Workshop A Success
August 1, 2016
Leaders of the IQ Consortium Pediatric Working Group worked with the University of Maryland, FDA, EuPFI, and PDCO to organize a pediatric formulations workshop on June 8th and 9th.
Training Resource: Animal Welfare and the 3Rs (Replacement, Reduction, Refinement)- Sponsor and CRO
May 11, 2016
Access the 3Rs CRO Outreach Working Group Training Program
IQ and AAALAC Launch 2nd Annual Global 3Rs Award
April 11, 2016
The Global 3Rs Award recognizes significant innovative contributions toward the 3Rs of animal research to advance ethical science, by any researcher in academia or industry in any area of biology.
February 2016 Semi-Annual Update
February 5, 2016
Our February 2016 Semi-Annual Update is now available.
IQ and Osthus Announce Launch of IQ Database Framework
February 5, 2016
The Framework will accelerate data sharing activities that support the Consortium’s mission.
Q&A for ICH E14 Guideline Revised with Input from IQ
January 5, 2016
Q&A for "The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential For Non-Antiarrhythmic Drugs" revised.
Fall 2015 IQ Working Group Report Released
December 22, 2015
IQ's first Working Group Directory is now available.
2015 IQ Symposium Report Available
December 16, 2015
The 2015 IQ Symposium Report, presentations, and a recording of the Chairs' reflection session are now available.
Concert Pharmaceuticals Joins IQ
September 8, 2015
Concert Pharmaceuticals has become the newest member of the IQ Consortium.
IQ Consortium Welcomes Pierre Fabre Laboratories
September 3, 2015
Pierre Fabre Laboratories is the newest member of the IQ Consortium.
Seattle Genetics Joins IQ
July 15, 2015
Seattle Genetics has joined IQ, bringing the number of companies in the Consortium to 38.
Final Installment in API Starting Material Manuscript Series Published
June 22, 2015
The API Starting Material Working Group has published its third publication on starting material selection and justification.
IQ Announces Formation of Biologics Leadership Group
June 12, 2015
At its June meeting, the IQ Board of Directors endorsed formation of a CMC Biologics Leadership Group.
IQ Consortium and AAALAC International 2015 Global 3Rs Awards Program
May 21, 2015
The IQ Consortium has partnered with the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) to create a Global 3Rs Award Program.
New Orientation Program Launched
May 20, 2015
IQ has launched an online orientation program for participants.
Training Resource: Animal Welfare and the 3Rs (Replacement, Reduction, Refinement)- Sponsor and CRO
April 30, 2015
The CRO Outreach WG, an effort within the 3Rs LG, has developed a brief training program on managing and understanding the animal welfare and research implications of study design/timeline changes.
Presentation: IQ Consortium Initiatives with Respect to AQbD/Analytical Method Lifecycle Management
April 6, 2015
Mark Argentine presented IQ Consortium Initiatives with Respect to AQbD/Analytical Method Lifecycle Management as part of the morning workshop on “Recent Initiatives by FDA and Compendia" at Pittcon.
3Rs Special Topics Journal
March 30, 2015
A JAALAS Special Topics Journal on the 3Rs, edited by the IQ 3Rs Leadership Group, was published in March.
It’s Easy Being Green
March 25, 2015
The IQ Green Chemistry Working Group has been published in the March 2015 issue (#52) of Innovations in Pharmaceutical Technology.
Meet IQ’s 2015-6 Chair
March 16, 2015
We are proud to introduce IQ's new Chair for 2015-6, Dr. Steve King. Watch Dr. King's participant profile to hear more about him and how IQ has helped the pharmaceutical industry.
IQ Participant Profile Videos
March 15, 2015
In celebration of IQ's fifth year, we are releasing IQ Participant Profile videos throughout the year that share real interviews with IQ leaders about how IQ has impacted their job and their industry.
IQ QTc Working Group Completion
January 27, 2015
IQ QTc Working Group has completed their prospective study of QTc prolongation in early phase 1!
A Chair’s Reflection on 2014
January 16, 2015
Lewis Kinter, IQ's Past Chair for 2013-2014, has offered his reflections on IQ’s accomplishment and growth in 2014.
Recipients of Third Quarter IQ Member Recognition Award Announced!
December 24, 2014
Drs. Nick Thomson, John Orr, Letty Medina, and Scott Obach Received the Third Quarter IQ Member Recognition Award!
2014 IQ Consortium Annual Symposium Report and Presentations
October 17, 2014
Click to view the nine 2014 IQ Symposium Speaker Presentations given on October 9th, 2014.
IQ DruSafe members met jointly with BioSafe leadership and FDA Pharm Tox
September 5, 2014
Members discussed Adversity and the NOAEL in toxicology studies, Starting Dose for Ph1 Clinical studies, Emerging New Science, Non clinical requirements to support orphan drug development, etc.
NIH Announces SBIR Contract Solicitation for Enabling Technologies
August 28, 2014
The NIH has announced SBIR Contract Solicitations, including two for the development of enabling technologies.
IQ Semi-Annual Member Newsletter Vol. 1, Issue 1 (June 25, 2014)
June 27, 2014
We are pleased to present the IQ Consortium’s first newsletter update. This newsletter includes the latest exclusives on the accomplishments of the IQ Consortium.
New Initiatives at the IQ CMC Summit
June 25, 2014
On Wednesday, June 4, 2014, the IQ Consortium’s Chemistry, Manufacturing, and Control (CMC) Leadership Groups held its annual Summit in Philadelphia, PA.
PAT Article Selected As Editor’s Choice Article
June 19, 2014
A PAT Working Group article published in Organic Process Research & Development Industry Perspectives, has been selected as an ACS Editors' Choice article.
Recipients of First Quarterly IQ Member Recognition Award Announced!
June 13, 2014
Drs. Dale Martin and Margaret Faul Received the First Quarterly IQ Member Recognition Award!
IQ Webinar Covered in ACS Nexus Blog
May 21, 2014
The ACS Nexus Blog has published a story covering the April 25th Green Chemistry Webinar.