Goals: At the end of this activity, you will: • Experience working on tasks for a biotechnology regulatory affair position • Deal with a real-life case faced by biotechnology-related companies ⚫ Gain experience navigating through the FDA website • Gain experience researching FDA regulations • Learn how to refer to FDA regulation sections • • Gain experience building action plans to comply with FDA regulations Discover how the FDA inspects and audits compliance • Get exposed to the consequences of failing to comply with FDA regulations Liveyon Labs Inc, located in California USA, manufactures cellular products derived from human umbilical cord blood. Liveyon LLC (https://www.linkedin.com/company/liveyon/about/)distributes these products internationally as a regenerative medicine. "This product contains cells, stem cells and growth factors which may serve as a therapy for various [orthopedic] degenerative [conditions]." In May 2019, the FDA conducted an inspection on the two firms and investigated their compliance. After this inspection, a warning letter was issued, on December 2019, to the President/Chief Executive Officer of Liveyon Labs Inc. You can view the letter here. https://www.fda.gov/inspections-compliance- enforcement-and-criminal-investigations/warning-letters/liveyon-labs-inc-588399-12052019 In this assignment, Liveyon Labs hired you, as a Biotechnology Regulatory Affairs Specialist, to review the warning letter, identify the issues at Liveyon Labs, and suggest an action plan that targets these issues. You will need to complete the following: 1. List the regulations in the warning letter that were failed to be met. The regulation listed should include the regulation title, collection, part, and section (e.g. 123 ABC 456.789 title 123, collection ABC, part 456, section 789). 2. Under each regulation listed, clarify (in up to 30 words per issue) why this regulation was not met, as per the warning letter. 3. Under the clarification of the regulations listed only from points 1, 2, 6, 7, and 9 in the warning letter (numbered in bold), suggest an action plan to be implemented at Liveyon Labs such that compliance with FDA can be met. You will be able to extract an action plan from the regulation documents posted by FDA. Tip: If you search for the regulation using an online search engine, you can use www.govinfo.gov as a tool to direct you to the specific "Document in Context" from the complete Code of Federal Regulations.

Phase II drug trials are conducted on animals, while Phase III drug trials are conducted on healthy volunteers. Both are required for FDA approval. True False

Objective: Explore how external environmental factors, in general, affect healthcare organizations. Senario: The merger between Aetna and Humana is blocked while the merger between Aetna and CVS is recently approved. What do you think about these two cases? Why is one merger blocked and the other is approved? What would be the potential impact of these two mergers on consumers, competitors, and the healthcare industry?

Outline the general steps from initial drug discovery to IND filing. Add as much detail as you need and feel free to use flow charts, graphics, visuals, as long as is made by you alone and not directly copied-pasted from another source. If an IND is cleared to proceed by the US-FDA, what is the single most important goal of a first-in-human (FIH) clinical trial?