Assignment: 'Bench to Bedside'
IPhO Chapter Team Finishes 3rd in National Competition for Bringing Theoretical Drug through Development, Approval Process
April — A team of UH College of Pharmacy Pharm.D. students finished third among more than 40 other chapter submissions in the national 2019-20 Industry Pharmacists Organization (IPhO) Value in Pharmacists (VIP) Case Competition.
The competition involves student teams covering drug development from many perspectives, including clinical sciences, regulatory affairs, commercial/marketing, and medical affairs, in which pharmacists most frequently contribute to the "bench-to-market" development of a drug. According to the IPhO, "each phase of the drug's development lifecycle presents a unique challenge that encourages students to think strategically and apply both their clinical and pharmaceutical industry knowledge."
The "Clinical Sciences" component, for example, would be expected to perform clinical trials to show the efficacy and safety of the drug, while the "Regulatory Affairs" component would be responsible for ensuring compliance with the stringent regulations that are applied to the drug development process.
Each participating school is given the same case and drug, which for the 2019-20 competition was a treatment for triple-negative breast cancer patients. The new molecular entity, loraparib, is a poly ADP-ribose polymerase inhibitor aimed at triple-negative breast cancer with germline mutations in BRCA 1/2. Preclinical studies conducted in rodents and non-rodents demonstrated preclinical safety that is comparable with similar medications currently on the market, so the teams were tasked with developing the human clinical study protocol and file an investigation new drug application with the U.S. Food and Drug Administration.
"One of the ideas that really made us stand out was that we proposed our drug also has prophylaxis abilities at a certain dose," said Pharm.D. student Joseph Nguyen, who served as competition coordinator for the UHCOP team. "In addition to treating TNBC, our drug seems to be able to prevent it as well. This is something that is not usually seen in the pharmaceutical industry. One of the creative strengths was that we are located here in Houston down the street from the Texas Medical Center giving us access to many patients who have TNBC."
In addition to Nguyen, the UHCOP team also comprised IPhO members Lina To, Jason Le, Ban Vu, Karishma Thakkar, Azzam Yazji and Sally Wang, clinical development; Jennifer Nguyen, Jennifer Lim, Vu Do, Uyen Tran, and Grace Prathusha Bethala, medical affairs; Theresa Nguyen, Jenny Chang, Lauren Eichinger, Gagan Deep Singh, Kathy Vo and Judy Chen, regulatory affairs; and Joshua Wu, Izuh Ikpeama, Hafeez Ayomide Adewusi, Kelvin Obimah and Andre Obimah, marketing.
Among the competition's goals are to demonstrate the value of industry pharmacists; create a cohesive drug development plan, engaging several of the key functions where pharmacists most frequently contribute; provide diverse exposure to student pharmacists and allow them to explore new areas, think critically, and expand their network; and provide student chapters with the opportunity to network and liaise with a current industry fellows.
"We also included a SWOT (Strengths, Weaknesses, Oppportunities and Threats) analysis of our company and product to ensure that we were able to justify the cost of our drug," Nguyen said. " Overall, we were able to incorporate the things we have learned inside the classroom and apply it to the drug development process."
Due to the in-depth requirements of the project, the students were able to apply the work done on it for elective credit in their Pharm.D. curriculum.