Welcome to the IQ Annual Report

Pierre Boulas (Biogen)
IQ Consortium Chair

After launching in 2010, IQ grew steadily and now ranks among the most influential scientific- and regulatory-focused consortia in the life sciences industry. We are a vibrant and dynamic group that continues to grow. We look forward to maintaining—even accelerating—our momentum.

The following annual report was created in response to an opportunity identified by IQ’s Board of Directors to communicate how IQ is impacting our industry and the value it generates for its member companies. IQ’s achievements would not be possible without the passion, hard work, and commitment of all IQ participants and our government and academic partners. Together, we are advancing innovation and quality in pharmaceutical development in truly inspiring ways.

We rely on member engagement to drive IQ’s success. Recently, we completed a comprehensive Participant Engagement Survey. The overall input was significant and the survey results are already informing constructive changes across IQ. Over the past few years, the Board’s careful attention to membership feedback led to the creation of a Biologics CMC Leadership Group, a unified Quality Leadership Group, an enhanced database agreement, and affiliated groups focused on drug-induced liver injury (DILI) and microphysiological systems (MPS). IQ will continue to adapt and change to meet the new challenges presented by evolving science, regulations, and our members’ needs.

It is also important to share our work with the rest of the pharmaceutical community. We are establishing ties with the American Association of Pharmaceutical Scientists (AAPS), the International Society for Pharmaceutical Engineering (ISPE), the Pharmaceutical Research and Manufacturers of America (PhRMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the American Society for Clinical Pharmacology and Therapeutics (ASCPT), and other like-minded organizations to raise awareness of our achievements and objectives.

To remain a strong and vital organization, we must continue to identify and empower emerging leaders within the IQ community. The recent elevation of Carl McMillian (Eli Lilly) and the election of Margaret Faul (Amgen) as our next chair and vice chair, respectively, bode well for our ability to attract innovative and dynamic thinkers to lead our organization. In addition, our commitment to attracting a broader range of our colleagues to engage in IQ activities, including the annual IQ Symposium, ensures that the impact and value of IQ will be sustained.

In reading this report, you’ll find that IQ proudly offers a compelling value proposition and remains dedicated to identifying and adapting to our membership’s needs. There is no greater prerequisite for the effectiveness of our consortium. As we approach a second decade of IQ activities, I want to take this opportunity to thank you for your past support and your commitment to what is sure to be a bright and exciting future.

Vision

The vision of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium or IQ) is to be the leading science-based organization advancing innovative solutions to biomedical problems and enabling pharmaceutical companies to bring quality medicines to patients.

Mission

As a technically focused organization of pharmaceutical and biotechnology companies, IQ advances science and technology to augment the capability of member companies to bring transformational solutions that benefit patients, regulators, and the broader research and development (R&D) community.

Strategic Objectives

Collaborate across IQ member companies to create cross-functional data sets, scientific positions, and conclusions with greater scope and impact than possible by any member company alone.

Advance relationships with global professional organizations, other consortia, academics, and government research institutes to ensure scientific excellence and harmonization.

Proactively engage global regulators on issues and opportunities to advance science-based regulations in pharmaceutical development.

Share the results of IQ’s initiatives with international scientific and regulatory communities.

Ensure the continued value of IQ through committed leadership, focused and clear priority setting, productive cross-disciplinary collaborations, and active engagement by a diverse talent pool to plan for leadership succession.

1,411 Participants

In 2018, the IQ Participant Engagement Survey was conducted to understand the value that member companies and individuals derive from involvement in IQ. Here we present the percentage of survey respondents who strongly agreed or agreed with the following statements.

100%
IQ provides valuable opportunities to address important scientific and regulatory challenges with colleagues in the industry
98%
Benchmarking exercises conducted through IQ help me to stay current on industry practices and trends
96%
IQ gives me valuable opportunities to learn about emerging scientific and regulatory issues
86%
IQ provides me with the opportunity to advance innovative ideas
97%
IQ helps me to meet new people and build my professional network
92%
Data-sharing activities have helped us to expand our knowledge of specific topics
88%
IQ provides an effective platform for engaging regulatory authorities on important regulatory science issues
89%
IQ provides valuable professional development opportunities for our scientist

Data Sourced from 2018 IQ Participant Engagement Survey

The Power of Collaboration

With more than 40 members—including some of the world’s leading pharmaceutical and biotechnology companies—and 80 scientifically driven working groups, IQ provides a science-focused venue to facilitate drug research and development. Our collaborative structure and culture foster powerful benefits.

Shared Technical Expertise

Members draw on the intellectual capital of more than 1,400 scientists in a pre-competitive space. Member company representatives engage collaboratively in a range of initiatives addressing timely and critical drug-development issues. 

Shared Research

IQ members leverage a unique database and data-sharing framework. Voluntarily contributed data is categorized and analyzed in formulating scientific positions, conclusions, and recommendations. Survey results, white papers, conference proceedings, and other materials are shared Consortium-wide.

Benchmarking & Analytics

IQ employs careful analysis of R&D data to assess performance, examine industry trends, answer critical business questions, establish best practices, and identify opportunities for innovation and scientific development. 

Managed Risk

Two or more members frequently sponsor cooperative research projects. This approach, even when it does not result in discovery, often provides data and insights that inform better decisions and further mitigate risk.

Cost Efficiencies

The 40+ members of the IQ Consortium enjoy substantial economies of scale. Annual fees are reasonable, administrative costs are well controlled, resource redundancy is minimized, and costly “dead ends” are often avoided.

External Partnerships 

IQ focuses on constructive scientific exchange through publications, conferences, workshops, and roundtables. Our 80 working groups frequently include representatives from government and academia, eliciting immediate and ongoing feedback from key opinion influencers and thought leaders.

Regulatory Engagement 

Consortium members enjoy a valuable platform from which they can engage with the FDA and with European, Latin American, and Asian regulatory bodies.

Professional Development

Members enter into pilots and other work streams that might not be available to them through their individual companies. Industry leaders can harness the potential of IQ to build professional networks and hone “softer” team-building, emotional intelligence, and communications skills.

Legal & Administrative Resources

The Consortium’s Secretariat provides legal, compliance, and technical support for IQ’s activities, fostering compliance with antitrust laws and assisting with the combination of data sets across companies for use in defined research projects. The Secretariat also handles various administrative tasks, allowing IQ participants to maintain a scientific focus.

Affiliated Groups 

As the market and our clients’ interests warrant, IQ creates affiliated groups to explore distinct pharmaceutical and biotechnological issues, reducing redundancies and generating potential cost savings. Currently, scientists representing a cross-section of companies are focused on drug-induced liver injury (DILI) and microphysiological systems (MPS).

IQ Events

IQ provides a pre-competitive, science-focused venue to facilitate drug research and development. As part of this mission, IQ hosts educational events to facilitate technical expertise, research, and best-practice sharing; encourage networking opportunities; and engage with regulators. 

IQ Symposium

To date, IQ has held seven members-only full-day symposia focused on a cutting-edge theme, emerging trend, or industry challenge. Each year, these pivotal events are attended by hundreds of representatives of IQ member companies actively engaged on the IQ Board of Directors, Leadership Groups, and Working Groups. IQ Symposium themes have focused on innovation through pre-competitive collaboration, new horizons in drug development, industry approaches to medical challenges in an aging population, and the development of new therapies for underserved populations. Each IQ Symposium features gifted thought leaders and renowned speakers from the biopharmaceutical industry, international regulatory bodies, and patient populations. Attendees cultivate crucial connections through a combination of interactive speaker presentations, team-building exercises, and breakout sessions. Participants return to their organizations with enlightened perspectives and fresh ideas for addressing industry challenges, and they bring value-added best practices that benefit not only their companies but also the broader R&D community.

IQ CMC Summit

The IQ Chemistry, Manufacturing, and Controls (CMC) Summit is an annual event that brings together subject-matter experts from the IQ CMC Leadership Groups and Working Groups for a full day of inspired presentations, in-depth discussions, and a holistic review of the Consortium’s CMC portfolio. The CMC Summit features plenary talks on contemporary topics and fosters an environment where members can explore collaborative topics, coordinate existing efforts, and launch new initiatives across Leadership Groups. Members emerge from the CMC Summit with operational plans and strengthened connections; many new Working Groups and joint efforts have originated from CMC Summit discussions. This venue generates continuous collaborative dialogue and helps fulfill IQ’s mission of advancing innovative solutions through pharmaceutical development.

IQ’s Impact on Professional, Scientific, and Regulatory Communities in 2018

With more than 40 members—including some of the world’s leading pharmaceutical and biotechnology companies—and 80 scientifically driven working groups, IQ provides a science-focused venue to facilitate drug research and development. Our collaborative structure and culture foster powerful benefits.

Publications

Akseli, I., Hilden, J., Katz, J. M., Kelly, R. C., Kramer, T. T., Mao, C., ... & Strong, J. C. (2018). Reproducibility of the measurement of bulk/tapped density of pharmaceutical powders between pharmaceutical laboratories. Journal of Pharmaceutical Sciences. Drug Product LG  

Birkebak, J., Buckley, L.A., Dambach, D., Musvasva, E., Price, K., Ralston, S., & Sacaan, A.  (in press). Pharmaceutical industry perspective on combination toxicity studies: Results from an intra-industry survey conducted by IQ DruSafe Leadership Group. Regulatory Toxicology and Pharmacology. DruSafe LG

Chattoraj, S., Daugherity, P., McDermott, T., Olsofsky, A., Roth, W. J., & Tobyn, M. (2018). Sticking and picking in pharmaceutical tablet compression: An IQ Consortium review. Journal of Pharmaceutical Sciences, 107(9), 2267-2282. ● Drug Product LG

Gong, H.H., Ihle, N., Jones, M.T. et al. (2018). Control strategy for small molecule impurities in antibody-drug conjugates. AAPS PharmSciTech 19(3): 971-977. ● Active Pharmaceutical Ingredient LG

IQ CRO Outreach Working Group (2018). IQ 3Rs CRO Assessment Tool: A Risk-Based Approach to Assessments of Contracted Programs for Animal Studies.  Retrieved from https://iqconsortium.org. ● 3Rs Translational and Predictive Sciences LG

IQ Dissolution Working Group (in press). First-Principles and Empirical Approaches to Predicting In Vitro Dissolution for Pharmaceutical Formulation & Process Development and for Product Release Testing. The AAPS Journal. Analytical LG

Kenny, J. R., Ramsden, D., Buckley, D.B., Dallas, S., Fung, C., Mohutsky, M., ... Hariparsad, N. (2018). Considerations from the Innovation and Quality Induction Working Group in Response to Drug-Drug Interaction Guidances from Regulatory Agencies: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance. Drug Metabolism and Disposition, 46(9):1285-1303. ● Translational and ADME Sciences LG

Kothare, P. A., Jadhav, P., Gupta, P., Croft Harrelson, J., & Dickmann, L. (2018). Harnessing the Potential of Emerging Digital Health and Biological Sampling Technologies for Clinical Drug Development: Promise to Reality. Clinical Pharmacology & Therapeutics, 104(6):1125-1135. ● Clinical Pharmacology LG

McWilliams, J. C., Allian, A. D., Opalka, S. M., May, S. A., Journet, M., & Braden, T. M. (2018). The Evolving State of Continuous Processing in Pharmaceutical API Manufacturing: A Survey of Pharmaceutical Companies and Contract Manufacturing Organizations. Organic Process Research & Development, 22(9), 1143-1166. ● Active Pharmaceutical Ingredient LG

Popkin, M. E., Borman, P. J., Omer, B. A., Seibert, K. D., Srivastava, S., Lepore, J. V., ... & Tymonko, S. (2018). The Delivery of Flexibility from the Application of QbD to API Development. Journal of Pharmaceutical Innovation, 13(4), 367-372. ● Active Pharmaceutical Ingredient LG

Popkin, M.E., Borman, P.J., Omar, B.A. et al. (2018). Enhanced Approaches to the Identification, Evaluation and Control of Impurities. Journal of Pharmaceutical Innovation. Retrieved from https://doi.org/10.1007/s12247-018-9363-8. ● Active Pharmaceutical Ingredient LG

Popkin, M.E., Omer, B.A., Seibert, K.D. et al. (2018). Enhanced Approaches to the Development of the Control Strategy and the Implementation in the Manufacturing Process Description. Journal of Pharmaceutical Innovation. Retrieved from https://doi.org/10.1007/s12247-018-9340-2. ● Active Pharmaceutical Ingredient LG

Regev, A., Palmer, M., Avigan, M.I., Dimick-Santos, L., Treem, W.R., Marcinak, J.F., … Chalasani, N. (in press). Best Practices for Detection, Assessment and Management of Suspected Acute Drug Induced Liver Injury During Clinical Trials in Patients with NASH. Alimentary Pharmacology & Therapeutics. ● IQ-DILI

Roschangar, F., Zhou, Y., Constable, D. J., Colberg, J., Dickson, D. P., Dunn, P. J., ... & Kopach, M. E. (2018). Inspiring process innovation via an improved green manufacturing metric: iGAL. Green Chemistry, 20(10), 2206-2211. ● Active Pharmaceutical Ingredient LG

Stephens, D., Williams, H., McMahon, M., Qiu, F., Hoaglund Hyzer, C., Debie, E., … Wang, J. (2018). Risk-Based Predictive Stability for Pharmaceutical Development–A Proposed Regulatory Template. Pharmaceutical Technology 42(8): 42-47. ● Analytical LG

Valentin, J. P., Guillon, J. M., Jenkinson, S., Kadambi, V., Ravikumar, P., Roberts, S., ... & Armstrong, D. (2018). In vitro secondary pharmacological profiling: An IQ-DruSafe industry survey on current practices. Journal of Pharmacological and Toxicological Methods, 93, 7-14. ● DruSafe LG

Comments on Regulatory Guidances and Standards

IQ 3Rs Leadership Group (2018, February 12). IQ Consortium Comments in Response to “Request for Information on Identifying Regulatory Reform Initiatives” [Docket No. USDA-201-0002].
Retrieved from https://www.regulations.gov/
document?D=USDA-2017-0002-0312
.

IQ Clinical Pharmacology Leadership Group (2018, December 13). IQ Consortium Comments on [FDA Docket No. FDA-2018-D-3292] Draft Guidance for Industry “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-D-3292-0011

IQ Clinical Pharmacology Leadership Group, Drug Metabolism Leadership Group (2018, January 23). IQ Consortium Comments on Draft Guidance for Industry “In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies Guidance for Industry.” Retrieved from https://www.regulations.gov/
document?D=FDA-2017-D-5961-0009
.

IQ Clinical Pharmacology Leadership Group, Drug Metabolism Leadership Group (2018, July 25). IQ Consortium Comments on [FDA Docket No. FDA-2018-N-1820] “Framework for Assessing pH-Dependent Drug-Drug Interactions.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-N-1820-0009
.

IQ Clinical Pharmacology Leadership Group, Drug Metabolism Leadership Group (2018, July 11). IQ Consortium Comments to [FDA Docket No. FDA-2018-N-1415] “Framework for Assessment of Drug-Drug Interactions for Therapeutic Proteins.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-N-1415-0010
.

IQ Clinical Pharmacology Leadership Group, Drug Metabolism Leadership Group (2018, July 9). IQ Consortium Comments to FDA Docket No. FDA-2018-N-0791: “Exposure-Response Analysis in Drug Development and Regulatory Decision Making.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-N-0791-0018

IQ Clinical Pharmacology Leadership Group, Drug Metabolism Leadership Group (2018, January 23). IQ Consortium Comments on [Docket No. FDA-2017-D-5961] Draft Guidance for Industry “Clinical Drug Interaction Studies —Study Design, Data Analysis, and Clinical Implications.” Retrieved from https://www.regulations.gov/
document?D=FDA-2017-D-5961-0008


IQ Clinical Pharmacology Leadership Group (2018, April 19). Submission of Comments on [Docket No.  FDA-2018-D-0178-0003] FDA Draft Guidance, “Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-D-0178-0003

IQ Clinical Pharmacology Leadership Group (2018, October 9). IQ Consortium Comments on [Docket No. FDA-2018-D-2777] “Draft 1 – Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-D-2777-0007

IQ DruSafe Leadership Group, Drug Metabolism Leadership Group (2018, July 6). IQ Consortium Comments on FDA-2018-D-1328 Draft Guidance for Industry “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-D-1328-0004
.

IQ DruSafe Leadership Group (2018, August 28). IQ Consortium Comments on Docket No. FDA-2018-D-1772-0002 Draft Guidance for Industry: “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations.” Retrieved from https://www.regulations.gov/
document?D=FDA-2018-D-1772-0003
.

IQ DruSafe Leadership Group (2018, February 13). IQ Consortium Comments on FDA-2017-D-5138: “Draft Guidance for Industry - ICH S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals.” Retrieved from https://www.regulations.gov/
document?D=FDA-2017-D-5138-0006

IQ Extemporaneous Formulations Working Group (2018). IQ Comments on USP <795> “Pharmaceutical Compounding – Nonsterile Preparations.”

IQ Extemporaneous Formulations Working Group (2018). IQ Consortium Comments on USP General Chapter <797> “Pharmaceutical Compounding – Sterile Preparations.”

IQ ICH Q3D Implementation Working Group (2018). Comments on USP General Chapter <661.1> “Plastic Materials of Construction.” 

IQ ICH Q3D Implementation Working Group (2018). Comments on “Technical Guidance for the Preparation and Analysis of Pharmaceutical Materials for Compliance with USP <232>.” 

IQ Quality Leadership Group (2018). Submission of comments on [EMA/CHMP/ICH/804273/2017] “ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.”

IQ Statistics Leadership Group (2018, July 25). IQ Consortium Comments on USP-PF 44(1) Stimuli Article “Measurement Uncertainty for the Pharmaceutical Industry.”

Presentations, Posters, and Webinars

IQ 3RLeadership Group (2018, March). The 3Rs in North America. Presentation at the PRIM&R 2018 Institutional Animal Care and Use Committee Conference, Columbus, OH. 

IQ 3RLeadership Group (2018, October). Innovation and Quality Initiatives for Reproducibility of Studies. Presentation at the American Association for Laboratory Animal Science Conference, Baltimore, MD. 

IQ Analytical Quality by Design Working Group (2018, September). Co-promotion of USP Workshop “Analytical Method Lifecycle,” and Analytical Method Lifecycle for Impurity Methodology: Some Strategies and Examples [Presentation]. USP Workshop on Analytical Method Lifecycle, Rockville, MD.

IQ Antibody Drug Conjugates Working Group (2018, October). Antibody Drug Conjugates Working Group Progress update post-roundtable discussion at the 2017 IQ/OCP Oct meeting. Presentation at IQ/U.S. Food and Drug Administration Office of Clinical Pharmacology Meeting, Silver Spring, MD. 

IQ Clinical Pharmacology Leadership Group, Drug Metabolism Leadership Group (2018, October). Transformative Potential of Emerging Technologies for Clinical Drug Development. Presentation at IQ/U.S. Food and Drug Administration Emerging Technologies Roundtable, Silver Spring, MD. 

IQ CPLG Pediatric Working Group (2018, October). Relevance of PK (PK/PD) in Pediatric Drug Development [Webinar].  Retrieved from https://attendee.gotowebinar.com/
recording/8234004380289558791
.

IQ CRO Outreach Working Group (2018, March). Safety Assessment: Pharmaceutical-Drug Development I. Presentation at Society of Toxicology Conference, San Antonio, TX.

IQ CRO Outreach Working Group (2018, October). The 3Rs: Considerations for Contracted Research [Webinar].  Retrieved from https://attendee.gotowebinar.com/
recording/6784819468020848904
.

IQ DPLG Pediatric Working Group (2018, April).   What Is the EuPFI and What Can We Do for You? [Webinar].  Retrieved from https://attendee.gotowebinar.com/
recording/995384967963531777
.

IQ DPLG Pediatric Working Group (2018, March).  CMC Considerations for Pediatric Drug Development [Webinar].  Retrieved from https://attendee.gotowebinar.com/
register/7888703843965859331

IQ DPLG Pediatric Working Group (2018, May).  Container Closure and Device Systems for Pediatric Combination Products [Webinar]. 

IQ DPLG Pediatric Working Group (2018, May). IQ Drug Product Pediatric Working Group – FDA Collaborative Meeting. Presentation at U.S. Food and Drug Administration Collaborative Meeting, Silver Spring, MD.  

IQ DPLG Pediatric Working Group (2018, September). Partnership:  EuPFI – IQ Drug Product Pediatric Working Group. Poster presented at 10th Annual European Paediatric Formulation Initiative Conference, London, UK.

IQ DPLG Pediatric Working Group (2018, September). Uncovering the Current Practices of Pediatric CMC Development Proposal from PIP/PSP: A Survey of IQ-EuPFI Member Companies. Presentation at the 10th Annual European Paediatric Formulation Initiative Conference, London, UK.

IQ Drug Substance Continuous Manufacturing Working Group (2018, June). Current State of Continuous Processing in Pharmaceutical Companies and Contract Manufacturing Organizations. Presentation at International Society for Pharmaceutical Engineering Continuous Manufacturing Workshop, Arlington, VA.

IQ DruSafe Leadership Group (2018). Presentation at PharmTox Reviewer Training. 

IQ DruSafe Leadership Group (2018, May). Presentation at Annual FDA/DruSafe/BioSafe Meeting, Silver Spring, MD. 

IQ DruSafe Leadership Group (2018, November). The IQ Consortium Nonclinical to Clinical Translational Database and Predictive Value. Presentation at American College of Toxicology’s 39th Annual Meeting, West Palm Beach, FL. 

IQ DruSafe Leadership Group (2018, October).  Current Nonclinical in vivo Safety Pharmacology Testing enables Safe Entry to First-In-Human Clinical Trials: The IQ Consortium Nonclinical to Clinical Translational Database. Poster at the Safety Pharmacology Society Annual Meeting, Washington, D.C. 

IQ DruSafe Leadership Group (2018, October).  Current Nonclinical in vivo Safety Pharmacology Testing enables Safe Entry to First-In-Human Clinical Trials: The IQ Consortium Nonclinical to Clinical Translational Database. Presentation the Safety Pharmacology Society Annual Meeting, Washington, D.C. 

IQ DruSafe Leadership Group (2018, October). Are the Principles of ICH M3 Appropriate for the Development of Drugs Treating Rare Diseases? Presentation to Chinese Society of Toxicology, Chongqing, China. 

IQ Green Chemistry Working Group (2018, March).  Innovative Green Chemistry – The Key to a Sustainable Future [Webinar].  Retrieved from https://attendee.gotowebinar.
com/recording/
696189162370117899
.

IQ ICH Q3D Working Group (2018, March).  ICH Q3D Compliance Strategy: Elemental Impurities Risk Assessment Documentation. Presentation to PharmaEd Resources. 

IQ Induction Working Group (2018, December).  Considerations from the IQ Induction Working Group: Focus on CYP3A4 mRNA In Vitro Response Thresholds, Variability, and Clinical Relevance [Webinar].  Retrieved from https://attendee.gotowebinar.
com/recording/
8234004380289558791
.

IQ Induction Working Group (2018, July). In Vitro Induction Data Fitting and Interpretation. Short Course Presentation at the 12th International Society for the Study of Xenobiotics Meeting, Portland, OR. 

IQ Induction Working Group (2018, November).  Considerations from the IQ Induction Working Group: Focus on Downregulation, CYP2C Induction, and CYP2B6 Positive Control [Webinar].  Retrieved from https://attendee.gotowebinar.
com/recording/
29903812856403975
.

IQ Lean Stability Working Group (2018, November). Defining Meaningful Stability Parameters. Workshop at American Association of Pharmaceutical Scientists PharmSci 360, Washington, D.C.  

IQ Lean Stability Working Group (2018, October). IQ Update: Lean Stability Perspectives Across Industry and Current Regulatory Feedback. Presentation at the Science of Stability Conference, Boston, MA. 

IQ MABEL Working Group (2018, October). IQ Consortium survey on FIH dosing: How well has MABEL dosing worked? Presentation to European Drug Metabolism Discussion Group.

IQ Plasma Protein Binding Working Group (2018, October). Plasma Protein Binding of Highly Bound Compounds. Presentation at IQ/U.S. Food and Drug Administration Drug-Drug Interaction Roundtable, Silver Spring, MD. 

IQ Quantitative Systems Pharmacology Working Group (2018, October). Presentation at IQ/U.S. Food and Drug Administration Quantitative Systems Pharmacology Roundtable, Silver Spring, MD. 

IQ Risk Based Predictive Stability Working Group (2018, November). Accelerated Stability Overview and Risks. Workshop at American Association of Pharmaceutical Scientists PharmSci 360, Washington, D.C.

IQ Risk Based Predictive Stability Working Group (2018, October). Regulatory Updates: IQ Risk-Based Predictive Stability Regulatory Sub-Team. Presentation at the Science of Stability Conference, Boston, MA. 

IQ Risk Based Predictive Stability Working Group (2018, October). Risk-Based Predictive Stability: Feedback from IQ Working Group Regulatory Sub-Team. Presentation to the Medicines and Healthcare Products Regulatory Agency, London, UK.

IQ Stable Label Working Group (2018, June). Stable Label Active Pharmaceutical Ingredients: A Science-Based Proposal for Synthesis, Analysis, and Control. Part 1: Framing the Problem. Presentation at the 13th International Symposium on the Synthesis and Applications of Isotopes and Isotopically Labelled Compounds, Prague, Czech Republic.

IQ’s Impact on Professional, Scientific, and Regulatory Communities in 2018

IQ participants share perspectives on their engagement in the consortium

“We’re a global organization. All of our companies are multinational. We’re working with regulatory agencies not only here in North America but also in Europe and Asia.”

Akintunde Bello
Bristol-Myers Squibb

“IQ allows us to share data in a pre-competitive manner so we can advance the science in a way that we wouldn’t be able to do easily within our own companies.”

Nancy Agrawal
Merck & Co.

“IQ has an excellent structure that manages all of the working and leadership groups, as well as a website that contains relevant, timely information.”

 Jing-Tao Wu
Alnylam

“Often we don’t have a large enough data set to make a breakthrough or try to improve upon a process or science, and IQ gives all members a way to bring that data together
to look at it across companies.”

Jack Cook
Pfizer

“IQ creates a common pre-competitive space in biomedical research that facilitates intelligent, effective, and safe innovation for all.”

Tracy Williams
Eli Lilly

“It’s a one-stop shop where, whether you’re involved in late-stage drug development or very early in discovery, you can work in a pre-competitive space with colleagues to solve some really challenging problems.”

Leon Carayannopoulos
Celgene

“IQ has it all: It’s a pre-competitive space where the scientific and technical developers can share data and ideas; access relevant, timely information; work with colleagues to solve challenging problems; and open and maintain a dynamic dialogue with the FDA, EMA, and other regulatory agencies. Done and done!”

Mark Rogge
Takeda

IQ Membership

AbbVie
Agios
Alnylam
Amgen
AstellasPharma 
AstraZeneca/MedImmune
Baxter 
Bayer
Biogen
Blueprint
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Daiichi Sankyo
Eisai
Eli Lilly
EMD Serono 
Genentech
Gilead
GlaxoSmithKline
Incyte 
Ironwood 
Johnson & Johnson/Janssen
Merck
Mitsubishi Tanabe
Novartis
Otsuka 
Pfizer
Pierre Fabre Laboratories
Roche
Sanofi
Sarepta
Seattle Genetics
Shire
Sunovion
Takeda/Millennium
Teva
Theravance Biopharma
UCB Pharma
Vertex

IQ Board of Directors

Chair: Pierre Boulas   ●   Biogen
Vice Chair: Carl McMillian   ●   Eli Lilly
Vice Chair Elect: Margaret Faul   ●   Amgen
Hafez Abdel-Kader   ●   Sanofi
Leslie Anthony   ●   Eli Lilly
Phil Bonasia   ●   Sunovion
Francois Brackman   ●   Pierre Fabre
Alexander Bryant   ●   Ironwood
John Burkhardt   ●   Pfizer
Leigh Ann Burns   ●   Gilead
Anne Chester   ●   Gilead
Patrick Cullinan   ●   Takeda
Donna Dambach   ●   Genentech
Kelly Davis   ●   Baxter
Myrtle Davis   ●   Bristol-Myers Squibb
Olympe Depelchin   ●   UCB Pharma
Paul Deutsch   ●   UCB Pharma
Craig Dunbar   ●   Ironwood
Joseph Dybowski   ●   Alnylam
Philip Floyd   ●   GlaxoSmithKline
Michael Garvin   ●   AstraZeneca
Theresa Goletz   ●   EMD Serono
Peggy Guzzie-Peck   ●   Johnson & Johnson/Janssen
Takayuki Hara   ●   Mitsubishi Tanabe
Timothy Hart   ●   GlaxoSmithKline
Ling He   ●   Daiichi Sankyo
Marcel Hop   ●   Genentech
Keith Horspool   ●   Boehringer Ingelheim
Elisabeth Husar   ●   Roche
Vivek Kadambi   ●   Blueprint Medicines
Douglas Keller   ●   Sanofi
Belinda King   ●   Eisai
Steve King   ●   AbbVie
Brent Kleintop   ●   Bristol-Myers Squib
Gondi Kumar   ●   Celgene
Sanjeev Kumar   ●   Vertex
Hue Kwon   ●   Roche
Daniel Lapadula   ●   Novartis
Qun Lu   ●   Celgene
Suresh Mallikaarjun   ●   Otsuka
Jim McShane   ●   Eisai
Mark Milton   ●   Novartis
Thomas Monticello   ●   Amgen
Dale Morris   ●   Biogen
Mark Mowery   ●   Merck
Brad Mueller   ●   Incyte
Dennis O’Connor   ●   Boehringer Ingelheim
Palani Palaniappan   ●   Sarepta
Alexandre Passioukov   ●   Pierre Fabre
Lakshminarasimhan Pranatharthiharan   ●   Sunovion
Arash Raoufinia   ●   Otsuka
Mark Rogge   ●   Takeda
Wendy Saffell-Clemmer   ●   Baxter
Marlowe Schneidkraut   ●   Astellas
Anita Shah   ●   Bayer
Dana Shuey   ●   Incyte
Lee Silverman   ●   Agios
Wataru Takasaki   ●   Daiichi Sankyo
Srini Tenjarla   ●   Shire
Kimberly Treinen   ●   Sunovion
Yoshifumi Uno   ●   Mitsubishi Tanabe
Csanad Varga   ●   Blueprint
Thomas Visalli   ●   Eisai
Timothy Watson   ●   Pfizer
Markus Weigandt   ●   EMD Serono
Devin Welty   ●   Shire
Philip Worboys   ●   Theravance
Danlin Wu   ●   Vertex
Jing-Tao Wu   ●   Alnylam
Paul Wu   ●   Bayer
W. Peter Wuelfing   ●   Merck
Mehran Yazdanian   ●   Teva
Gorm Yoder   ●   Johnson & Johnson/Janssen
Tong Zhu   ●   Astellas

Leadership Group Leads

CMC

Analytical LG
Mark Argentine   ●   Eli Lilly
Brian Regler   ●   Merck
Dennis Stephens  ●   AbbVie
Active Pharmaceutical Ingredient LG
Timothy Curran   ●   Vertex
John Traverse   ●   Celgene
Kevin Seibert   ●   Eli Lilly
Drug Product LG
Qun Lu   ●   Celgene
Ahmad Almaya   ●   Eli Lilly
Robert Ternik   ●   Eli Lilly
Biologics CMC LG
Saroj Ramdas   ●   GlaxoSmithKline
Barbara Rellahan  ●   Amgen

Quality

Quality LG
Dennis O’Connor   ●   Boehringer Ingelheim
Chris Turner   ●   Celgene
K. Scott Dunham   ●   Merck
Jeff Beebie   ●   Pfizer
Mark Butchko   ●   Eli Lilly
Chris Grosso   ●   Merck

Statistics

Statistics LG
J. David Christopher   ●   Merck

Life Sciences

Clinical Pharmacology LG
Sandhya Girish   ●   Genentech
Vikram Sinha   ●   Merck
Tong Zhu   ●   Astellas
Akintunde Bello   ●   Bristol-Myers Squibb
Translational and ADME Sciences LG
Nancy Agrawal   ●   Merck
Jens Sydor   ●   AbbVie
DruSafe LG
Donna Dambach   ●   Genentech
Thomas Monticello   ●   Amgen
Mazin Derzi   ●   Pfizer
Timothy Hart   ●   GlaxoSmithKline
3Rs Translational and Predictive Sciences LG
Szczepan Baran   ●   Novartis
Natalie Bratcher   ●   AbbVie
Sean McGuire   ●   GlaxoSmithKline
Norman Peterson   ●   MedImmune

Secretariat Support

The law firm of Drinker Biddle & Reath LLP serves as Secretariat and Legal Counsel to the IQ Consortium.  Comprising attorneys, scientists, and project managers, Drinker Biddle’s Consortium Management Team executes central legal and administrative tasks. Team support includes:

Facilitating member company decision-making processes to develop consensus positions on strategic initiatives and projects

Ensuring antitrust compliance by providing training, oversight, and ad hoc legal counsel

Providing broad scientific, project management, legal, and administrative support

Providing the Board of Directors with robust strategic, operational, and planning support

Supporting the exploration and scoping of various data-sharing initiatives

Implementing and executing data-sharing projects through custom-designed databases and surveys

Reviewing manuscripts under development to ensure antitrust compliance

Facilitating external engagements with key stakeholders

Managing internal and external communications

Managing the public website and internal collaboration portal

Providing venue and logistical support for in-person meetings

For more information about IQ membership and its benefits, please contact Mary Devlin Capizzi or Maureen Cruz  at the IQ Secretariat.

Mary Devlin Capizzi, Esq.
+1 202-230-5101 (office)
Maureen Cruz, Ph.D., MPH
+1 202-230-5365 (office)