Name: Aditya Hongunti

NUID: 001529265
Course Name: The Biotechnology Enterprise
Course Name & Number: BIOT5219
Section Number: SEC 06 Fall 2022
Module Number/Assignment number: Module 2/ Assignment 2
Date: October 18th, 2022

1) Who is in charge of discovery and pre-clinical development?

Answer:
The research team within which the research are responsible for conducting the discovery and
the pre-clinical development of the drug the biotech company is producing. The research process
involves extensive research into the molecular biology of various compounds relevelant to the
disease the drug is supposed to cure or provide aid with. In addition to this, there are multiple
ways researchers discover new drugs as suggested by the FDA, which involve developing a drug
when new insights into the drug process are found. New technologies that help in targeting
specific sites within the body also are a way for researchers to test and discover new drugs (Step
1: Discovery and Development, 2018).
Once the discovery is done, there are multiple drugs that are found to be promising but only one
of them is taken for preclinical development. In the preclinical development process, the
researchers test the potential compound through experiments to understand how the compound
acts within the body and how the compound/drug reacts with other drugs, benefits vs side effects
and other experiments (Step 1: Discovery and Development, 2018).
References
Step 1: Discovery and Development. (2018, January 4). U.S. Food And Drug Administration.
https://www.fda.gov/patients/drug-development-process/step-1-discovery-and-development
2) What is the enterprise value of “Drug Trials Snapshot”? (meaning: why would a
company review Drug Trials Snapshot?)
Answer:
The drug trial snapshots are drug Q&A reports which answer multiple questions about the drug
on the FDA page so as to increase stakeholder visibility into the drug’s components and its
various nuances. Take the drg trials snapshot as a means to understand the components within
the drug, what are its benefits, what is the demographic data the drug is supposed to be used by
and benefits, the process of the trials the drug underwent, the fficancy and the various benefits vs
risks associated with the drug. The intent of the snapshots is to make the drug information more
readily available and transparent (Center for Drug Evaluation and Research, 2022)
References
Center for Drug Evaluation and Research. (2022, May 16). Drug Trials Snapshots. U.S. Food
And Drug Administration. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-
snapshots
3) Go back to the US FDA's “Drug Trials Snapshot” and select a drug of interest.  What
drug or biologic did you select, and why?
Answer:
The drug I chose is the CABENUVA, which is used for the treatment of human
immunodeficiency virus-1 (HIV-1) infection in adults who are virologically supressed and need
to replace their current HIV-1 medicines (Center for Drug Evaluation and Research, 2021).

HIV-1 is an infection which has still not been completely found to be curable and there are
millions of patients around the globe that are still suffering through this disease with the risk that
it is sexually transmissible. That makes it even more challenging for the healthcare professionals
and sometimes the patients to detect it on time before spreading it and the ill effects of this
disaease are significant and hence more research and development is needed in this field.
References
Center for Drug Evaluation and Research. (2021, February 17). Drug Trials Snapshot:
CABENUVA. U.S. Food And Drug Administration. https://www.fda.gov/drugs/drug-approvals-
and-databases/drug-trials-snapshot-cabenuva
4) What does your drug or biologic do for patients?
Answer:
The drug CABENUVA suppresses the HIV-1 viral load within a patient who is already on HIV-
1 medication. The drug comes as an injection within a co-packaged product  (cabotegravir and
rilpivirine) and are directly injected by healthcare providers into the muscle of each side of
buttocks once every month (Center for Drug Evaluation and Research, 2021). The suppressing of
the HIV-1 plays a key role in controlling the load of the virus and hence this drug benefits the
consumers in that way
References:
Center for Drug Evaluation and Research. (2021, February 17). Drug Trials Snapshot:
CABENUVA. U.S. Food And Drug Administration. https://www.fda.gov/drugs/drug-approvals-
and-databases/drug-trials-snapshot-cabenuva