Whitepaper: Human microbiome therapeutics - research, investment and regulatory landscape
We are looking for a subject matter expert to write a -2000 word whitepaper on the global growth of research and investment in human microbiome therapeutics development. Additionally we are looking for -1000 words on the current regulatory landscape of microbiome therapeutics that should work as a standalone piece as well as fit alongside the longer research and investment piece.
It should be written for an audience of microbiome therapeutic industry professionals and those interested in growing in the microbiome sector.
The whitepaper should be an overview of where research and investment in the industry is now and where it is going in the future. It could include (though is not limited to) the following:
- Essential: Table with key stats on the biggest investors in the industry
- Essential: Table of where along the pipeline the most advanced companies are with their products
- Where is research (and therefore investment) being focused at the moment? Where is going to be in the future?
- Major investments, mergers and acquisitions in the last year and upcoming
- Business models - differences between Big Pharma and smaller microbiome specific companies
- Partnership models and case studies of specific industry partnerships
- Changing landscape of funding models - VCs vs Pharma
The shorter regulations piece should give an overview of the current and evolving regulatory landscape for human microbiome therapeutics in Europe and the US. It could include (though is not limited to) the following:
- What are the regulatory requirements to license a microbiome drug in Europe and USA?
- Expectations for different microbiome treatment modalities
- Considerations for clinical trials, CMC, quality, GMP production
- Key regulatory agency programs to expedite development
- Differences between EU and USA requirements
- Potential future regulatory changes
This is to be used as part of the marketing for the KNect365 Microbiome Therapeutics conference series. Exploring the agendas for the Europe event and US event will give you the best idea of the topics we cover and the areas we'd like covered in this whitepaper.
Timelines:
- First draft for internal edits: 1 week after commission
- Edits returned to writer: 2 days after draft provided
- Final version deadline: 2 days after edited draft returned
About the recuiterMember since May 20, 2018 Altaf Ansari
from Tabasco, Mexico