July 2015 Semi-Annual Update
IQ Semi-Annual Updates are issued once each summer and winter, and feature updates for the Consortium at large. The IQ website has complete information about upcoming events, specific Leadership Groups and Working Groups, and IQ publications.
In This Newsletter
- 2015 IQ Symposium
- Formation of Biologics Leadership Group
- IQ Database Development Moves Forward
- Participant Orientation Program Launched
- Working Group Highlights
- Resource FYI: Publications Directory
2015 Symposium: Past, Present, Future
This October 21st, we invite you to celebrate IQ's 5th anniversary with us as we explore the Consortium's Past, Present and Future. This event is taking place at the Westfields Marriott Washington Dulles just outside of Washington, DC. Our speakers include:
- Lawrence Yu, Director of Pharmaceutical Quality, FDA
- Susanne Keitel, Director of the European Directorate of the Quality of Medicines and HealthCare (EDQM)
- Regina Holliday, Patient Rights Activist, Artist, Author, Founder of the Walking Gallery
- Dan Fletcher, Associate Professor at UC Berkley, Founder of CellScope
Formation of Biologics Leadership Group
At its June meeting, the IQ Board of Directors endorsed formation of a CMC Biologics Leadership Group. The IQ Planning Committee is selecting leaders for this group, and the group’s first objective will be to develop a clear mission and project plan. The Biologics LG collaborate closely with existing CMC LGs; additionally, before sanctioning new projects, this LG will scan the landscape and coordinate with other organizations to foster synergy and avoid redundant efforts.
IQ Database Development Moves Forward
IQ is developing a database framework to support data-sharing projects by IQ working groups. This effort was initiated in mid-2014 to make the initiation and execution of data-sharing projects more streamlined and user-friendly. IQ has adopted a database framework agreement which is being executed by member companies, as well as a process for Working Groups to propose new projects.
Participant Orientation Program Launched
This spring, IQ launched a brief online orientation for IQ Board, Leadership Group, and Working Group members to familiarize themselves with IQ. All new and legacy participants are encouraged to complete the orientation to learn about IQ’s IQ's vision, mission, objectives and structure; area-specific Leadership and Working Groups; opportunities for involvement and guidelines for participation; available resources; and staying connected.
Participants can take the orientation at: http://www.atschoolorientation.net/iqconsortium.
Working Group Highlights
Final Installment in API Starting Material Manuscript Series Published
The API Starting Material Working Group has published the third installment of its three-part series on selection and justification of starting materials in Organic Process Research and Development. The three manuscripts are:
- Part 1: A Review and Perspective of the Regulatory Guidance to Support Designation and Justification of API Starting Material
- Part 2: Designation and Justification of API Starting Materials: Current Practices across Member Companies of the IQ Consortium
- Part 3: Designation and Justification of API Starting Materials: Proposed Framework for Alignment from an Industry Perspective
All manuscripts are listed in the IQ publications directory.
Itraconazole DDI WG Published in Journal of Clinical Pharmacology
IQ’s Clinical Pharmacology Leadership Group (CPLG) has published a review article presenting rationale for the use of itraconazole as a replacement for ketoconazole in clinical DDI studies, “Best practices for the use of itraconazole as a replacement for ketoconazole in drug–drug interaction studies.”
Global 3Rs Award Program Launched
IQ has formally launched its Global 3Rs Award Program. This program, run in partnership with the Association for the Assessment and Accreditation of Laboratory Animal Care, International (AAALAC), will recognize 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. The deadline for nominations was July 1. Awards will be presented in November 2015.
The IQ 3Rs Leadership Group also edited a special topics journal for the Journal of the American Association for Laboratory Animal Science (JAALAS) in March 2015.
Recent and Upcoming Events
2015 CMC Summit – June 10
IQ's Chemistry, Manufacturing, and Control (CMC) Leadership Groups hold annual summer meetings that address joint initiatives. A major outcome of this year’s Summit was the recommendation to form a Biologics Leadership Group (addressed above).
Meeting between DruSafe, FDA, and BioSafe – June 26
On 26 June 2015, IQ DruSafe had a one-day face-to-face meeting with the FDA pharm/tox supervisors and representatives from BioSafe. Discussion topics included (i) experiences and challenges with new technologies such as platforms for off-target reactivity, in vitro prediction of immunogenicity, in vivo imaging, as well as human-on-a-chip model for DMPK and toxicology applications; (ii) models and assays for immunoactivators and combination products; and (iii) weight-of-evidence and alternative approaches to carcinogenicity risk assessment for biotherapeutics. The meeting was well-received by the industry and the FDA attendees. Following the meeting the FDA expressed interest in co-organizing two follow-up workshops with DruSafe and BioSafe: one on new technologies, and the other one on the implementation of Standard for Exchange of Nonclinical Data (SEND).
Improving Productivity in Pharmaceutical Research and Development – July 28
The Center for Health Policy at Brookings in collaboration with the International Consortium for Innovation & Quality in Pharmaceutical Development and the U.S. Food and Drug Administration (FDA) hosted a public event to explore how emerging science could be better leveraged to improve the efficiency of drug development programs and better optimize treatments.
PBPK Webinar – September 18
The application of physiologically based pharmacokinetic modeling (PBPK) has developed rapidly within the pharmaceutical industry and is becoming an integral part of drug discovery and development. PBPK models can provide a quantitative mechanistic framework for prediction of systemic and tissue exposures, and when combined with pharmacodynamic models can be used to estimate the time course of drug response for diverse dosing regimens in different species, populations, and disease states. An IQ-sponsored whitepaper was published by scientists within pharmaceutical industry highlighting various strategies, challenges/future opportunities, case examples and views on regulatory interactions for using PBPK modeling in drug discovery and development. These areas will be covered in detail during the webinar. (Jones, H. M., et al. "Physiologically based pharmacokinetic modeling in drug discovery and development: a pharmaceutical industry perspective." Clinical Pharmacology & Therapeutics 97.3 (2015): 247-262.) Registration will open in August
2015 Symposium – October 21
As described above, our 5th anniversary Symposium will explore the Consortium's Past, Present and Future. Register now
Resource FYI: Publications Directory
IQ maintains a publications directory with publications, comments, and presentations that we encourage you to explore. If your IQ group has recently published but your publication is not listed in our directory, please contact us. We strive to maintain a complete directory.