What's New in Regulatory Science - Summer 2019

CDER continues with its Spotlight on CDER Science series featuring the Center’s noteworthy scientific and research-oriented activities. The latest spotlight articles include:

A Novel Mouse Model Offers Insights About Hypersensitivity to an HIV Drug A novel mouse model carrying a human gene variant is now able to show us how certain cells of the immune system play key roles in helping some patients tolerate the HIV drug abacavir while other patients experience hypersensitivity to it.

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IN PRESS

Generating Model Integrated Evidence for Generic Drug Development and Assessment Liang Zhao, Myong-Jin Kim, Lei Zhang, and Robert Lionberger

Quantitative methods and modeling (QMM) covers a spectrum of tools and many of them––particularly physiologically based models and quantitative clinical pharmacology ––are critical to generic drug development.  In this paper, the authors delve more deeply into the use of QMM in the modernization of generic drug development, bioequivalence assessment and regulatory decision making.

The US Food and Drug Administration's Model-informed Drug Development Paired Meeting Pilot Program: Early Experience and Impact Rajanikanth Madabushi, Jessica M. Benjamin, Renmeet Grewal, Michael A. Pacanowski, David G. Strauss, Yaning Wang, Hao Zhu, Issam Zineh

In this commentary, the authors describe the motivation for FDA’s Model-informed Drug Development Paired Meeting Pilot Program, review its progress in its first year, and discuss lessons learned.

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System Sai Rashmika Velugula-Yellela, David N. Powers, Phillip Angart, Anneliese Faustino, Talia Faison, Casey Kohnhorst, Erica J. Fratz-Berilla, Cyrus D. Agarabi

A detailed protocol for the purification monoclonal antibody therapeutics from cell culture fluid from microbioreactors and useful analytics to determine critical quality attributes are described.

Commentary on "Statistics at FDA: reflections on the past six years" Aloka G. Chakravarty

The Acting Director of CDER’s Office of Biostatistics provides an update on recently initiated efforts under the 21st Century Cures Act to advance complex innovative trial designs, including adaptive clinical trial designs; the use of real-world evidence in regulatory submissions; and some key milestones in guidance development.

RESOURCES

Regulatory Science Research and Education The public can access CDER’s Regulatory science and educational activities at FDA.gov.  These activities are aimed at speeding the development of new drugs while ensuring that they are safe and effective.

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UPCOMING EVENTS

The following are meetings, conferences, and workshops sponsored or co-sponsored by the Center for Drug Evaluation and Research (CDER): July 2019  Public Workshop: Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes, July 11 - 12, 2019. The Westin City Center, 1400 M St NW, Washington, DC  20005. Meeting Information FDA-ASCO Public Workshop: 2019 Clinical Outcome Assessments in Cancer Clinical Trials, July 12, 2019, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Meeting Information FDA Public Meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs, July 12, 2019, FDA White Oak Campus, 10993 New Hampshire Avenue, Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993.  Meeting Information FDA Public Meeting: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards, July 17, 2019, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Meeting Information August 2019 Public Workshop: Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients, August 8, 2019, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Meeting Information Public Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting Meeting Information, August 12, 2019, FDA White Oak Campus, 10903 New Hampshire Avenue, Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Meeting Information September 2019 Regulatory Education for Industry (RedI): 2019 Complex Generic Drug Product Development Workshop – September 25-26, 2019, The Hotel, 7777 Baltimore Ave, College Park, Maryland 20740. Meeting Information

CAREER OPPORTUNITIES

FDA has a new campaign to advance ongoing efforts to recruit and retain a world-class workforce dedicated to protecting and promoting the public health. Information on job vacancies, employment events, and hiring programs are available by following @FDAJobs on Twitter and by visiting the FDA’s LinkedIn page , the Jobs at CDER webpage and Career Opportunities at CDER webpage(videos). Help us spread the news through your social media networks!   For more information, please visit  the FDA In Brief webpage.  Scientific Internships and Fellowships / Trainees and Non-U.S. Citizens Whether you’re an undergraduate looking to pursue a career in science, a graduate science student seeking experience in regulatory science, a postgraduate looking for fellowship opportunities, or a senior scientist pursuing research experience in your field of expertise, FDA offers you many paths to learning about the exciting field of regulatory science. Click here for more information.