Throughout the course we referenced a hypothetical pharmaceutical company called Getafix to illustrate several aspects of drug development.
Throughout the course we referenced a hypothetical pharmaceutical company called Getafix to illustrate several aspects of drug development. Getafix is a small start-up hoping to develop a drug for Alzheimer’s disease. After opening and maintaining an IND and conducting many of the nonclinical and clinical studies discussed in class, it is on the verge of NDA submission. However, after spending millions on research and development, it lacks the resources needed to take its product to the next step. Bringing it to the market will require a partnering or licensing agreement. Imagine that a larger hypothetical company, Megazyme, is interested in partnering with a company to commercialize a product for Alzheimer’s disease, and Getafix is on the list of possibilities. Senior management of both companies have been in contact for weeks discussing parameters of a partnering agreement. Perhaps Getafix lacks the resources necessary to submit an NDA, scale-up manufacturing activities, or create promotional material. In exchange for a share of the profits, Megazyme could help turn Getafix’s promising investigational drug into a blockbuster medication. Based on public information and company interactions, Megazyme is intrigued with the possibility of partnering with Getafix. However, the risks of doing business with another company can be great. Before finalizing a deal, Megazyme must perform due diligence. Due diligence is a risk evaluation process in which an investor vets a potential partner. Although due diligence efforts may lengthen the start-up time for a new business partner relationship, failing to do so may have negative financial and operational repercussions for companies seeking to partner. During due diligence, a potential partner (Getafix) may supply sensitive information to a secure electronic repository (e.g. ShareVault) available for a potential investor (Megazyme) to review. This virtual repository may contain hundreds of thousands of pages of information (e.g. IND submissions, health authority/ethics committee correspondence, research data, audit reports, SOPs, financial information). Employees from the potential investor scour this information, seek clarification as necessary, verify data, and follow-up on any red flags (e.g. unresolved concerns from FDA). After weeks, or perhaps months of extensive investigation into the files and partnering negotiations, a mutually beneficial partnering relationship may be formed.
Prompt: Getafix is preparing to upload files to ShareVault for your company to view. On behalf of your Regulatory group at Megazyme, construct a courteous and informative email to the CEO at Getafix, outlining your expectations for the kind of material you believe should be uploaded to ShareVault to allow for thorough and systematic investigation into the potential partner’s capabilities. Material may include but not be limited to Regulatory documents. Discuss the context and rationale behind the requested material, forecast potential requests for further information that may arise following your review, and discuss potential red flags that may arise
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