Gene Editing therapy (also known as Gene Correction) has great market growth pot
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Gene Editing therapy (also known as Gene Correction) has great market growth potential even if it’s still an unproven therapy (eg. nothing beyond phase 2 in clinical trials for in-vivo).
This writing will primarily focus on “in-vivo” of Gene Editing therapy, and primarily on CRISPR/CAS as the underlying technology. The two core components of CRISPR/CAS system are the Cas protein (primarily Cas 9 family) and guide RNA (gRNA). This writing will deep-dive into the Cas protein component of the CRISPR/CAS system.
The goal of the assignment is to answer the following Critical Few questions as part of a strategy development for a hypothetical international biopharma company:
Understand current product / services available, the relevant unmet need in Gene Editing therapy (in-vivo), and identify potential sustainable advantages.
Describe What-a-winner-looks-like (WWLL) in Gene Editing services: What are the top criteria / capabilities needed to win over customers (biopharma / biotech) in Gene Editing therapy?
Translating the above into an offering / capability to create a “Winning Team” (eg. biotech/biopharma in Gene Editing are looking for suppliers who can also provide regulatory support, provide technical / problem solving support, etc).
Outline regulatory and manufacturing requirements from idea to large scale, commercial production.
Understand the scope of the delivery, the associated business model, and the size of the opportunity.
What is the scope of the delivery for Gene Editing and the associated business model that customers are looking for (eg. customers are looking for end-to-end CDMO including fill-and-finish?.
Compare and contrast two business model for “low volume – high mix” or “high volume – low mix.” Describe their advantages, disadvantages and which model would be best suited based on findings (as part of recommendations).
What is the overall size ($) of the opportunity for and the relevant segmentation? What is the current competitive landscape and the market share of relevant players for each segment? How does the size of the opportunity vary as the scopes of the delivery / business model vary in – eg. what is incremental value of fill-and-finish offering to customers?
Synthesize findings from the above into overall strategy for a hypothetical company to enter Gene Editing space – including both organic growth and inorganic growth strategy. What is the best strategy to fill the current gap? Eg. asset to buy, people to hire, IC investment, critical IP, etc.
Formating requirements: 30 pages (excluding references), single space, Times New Roman, 12 size font