Written By: James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics

More than 40 students from the MS in Regulatory Science and Doctor of Pharmacy (PharmD) programs at the School of Pharmacy visited the U.S. Food and Drug Administration (FDA) in White Oak, Md., on April 17 and met with top scientists in the Division of Psychiatry Products. The two major topics of conversation for the trip included how new drug applications (NDAs) are composed and reviewed, as well as what roles and responsibilities various scientists and health care professionals play at the FDA.

Meeting the Experts

The event was organized by Keith Kiedrow, PharmD, MS, RAC, team leader for project management staff in the Division of Psychiatry Products at the FDA.

The Division of Psychiatry Products regulates and reviews investigational new drug (IND) applications and marketing applications for products used to treat psychiatric diseases and conditions, including bipolar disorder, schizophrenia, major depressive disorder, and attention deficit hyperactivity disorder.

Additional panel members from the division included:

  • Mitchell Mathis, MD, Director
  • Marc Stone, MD, Deputy Director for Safety
  • Javier Muniz, MD, Clinical Team Leader
  • Juliette Toure, PharmD, MBA, RAC, Senior Policy Advisor
  • Jia Yao, PhD, RAC, DPP Pharmacology/Toxicology Reviewer
  • Hao Zhu, PhD, Team Leader, Office of Clinical Pharmacology
  • Peiling Yang, PhD, Team Leader, Office of Biostatistics
  • Andrei Ponta, PhD, Reviewer, Office of Product Quality
  • Kimberly Updegraff, RPh, MS, RAC, Associate Director for Labeling
  • Paul David, RPh, Chief, Project Management Staff
  • Steven Hardeman, RPh, Chief, Project Management Staff
  • Ermias Zerislassie, PharmD, MBA, MS, Safety Regulatory Project Manager

Gaining New Insights

Panel members spent two hours engaged in discussion with students, including an in-depth Q&A session. One student asked about a label update for Invega Sustenna®, a sustained-release injectable suspension of paliperidone palmitate to treat schizophrenia. The label update addressed a recent study that examined long-term comparative monotherapy treatment of paliperidone palmitate versus oral antipsychotic therapy.

Interestingly, the findings from that study were based on real-world data and included patients from homeless shelters, soup kitchens, and jail-release or diversion programs. Panel members noted that the results indicated a longer time to first treatment failure for paliperidone palmitate compared with oral antipsychotic medications. In addition, they explained that the time to first arrest and/or incarceration or psychiatric hospitalization was also longer for paliperidone palmitate compared to the oral antipsychotic group.

Being able to organize events such as this trip that provide our students with a firsthand glimpse into the field of regulatory science is one of my favorite parts of serving as the director of the MS in Regulatory Science program, which is offered exclusively online. Through their participation in this experience, students in the MS in Regulatory Science program not only had the chance to meet their classmates in-person – a rare opportunity for students enrolled in an online program – but also to learn how the concepts and tools they are learning in the curriculum can be applied in the real world. In addition, our student pharmacists had an opportunity to learn more about the importance of the regulatory science field as well as explore new career opportunities for individuals with PharmD degrees who might not necessarily be interested in working in the traditional community or health system pharmacy.

To learn more about the Division of Psychiatry Products, please visit its website. For more information about the MS in Regulatory Science program at the School of Pharmacy, visit the program’s website.

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