Microbiome Industry Outlook

European funding strategies for impact and societal benefit

Dr Dirk Hadrich, Policy and Programme officer, European Commission, Belgium
Healthy Lives, Personalised Medicine, Human Microbiome

Abstract
EU has already funded more than 200 projects for more than € 500 M to promote Microbiome research and to advance our knowledge on microbes. MetaHIT as one of the first projects had a catalysing effect with its produced catalogue of gut microbes and functionalities. Many more projects followed but today mechanisms and causalities are still not fully understood so that latest trends aim to gather all kind of data to complement patient information for holistic pictures of health and diseases. Three new projects start in 2019 to deliver applications and to enhance knowledge on the microbiome, host metabolism, nutrition, immune responses, lifestyle and other interplaying confounders. They focus on cancer, liver failure and autism. By end 2020, a coordinative and support action should be funded to enhance international collaboration on methods, standards, procedures and references.

  • The trend is to combine microbiome data with all kinds of other health data for better understanding diseases.
  • New microbiome projects should deliver concrete tools predicting health and disease states.

The potential of microbiome research is increasing with agreed methods, data comparability and international collaboration.

 


 

Mapping the Biotech Landscape: Research programs, therapeutic approaches and disease targets in Microbiome Drug Development

Luis Gosalbez, Managing Director, Sandwalk BioVentures

Abstract
Microbiome science has traditionally been applied to functional foods. However, the field has recently captured the attention from pharmaceutical companies which see the microbiome as a therapeutic target or strategy to develop new drugs. This is why a number of biotechnology companies, mostly startups, have launched microbiome-centric research programs to discover medicines. We scanned the landscape of these pharmabiotics companies and found a total of 200 entities, collectively working on over 600 research programs. We will present the key findings of our scientific, clinical, regulatory and financial analysis to provide a comprehensive picture of where the industry is, and will discuss where the sector is headed.

 


The Vedanta Opposition: A Healthy Sign of a Maturing Industry

Craig Thomson, Partner, HGF Limited & Jennifer Bailey,  Life Sciences Patent Director, HGF Limited

Abstract
As we move towards marketing approval for microbiome therapeutics, the “value” of the microbiome industry is increasing exponentially. This will inevitably result in disputes between the leading competitors seeking to protect their key intellectual property (IP) rights, including patent monopoly rights.  Whilst some may regret the ramping up of competitive behaviours, this should be seen as part of the healthy development of an increasingly commercially relevant industry.  

The most significant challenge to patent rights in the therapeutic microbiome field to-date is the “Vedanta Opposition”. The patent (European Patent No. 2575835) was granted to the University of Tokyo (UoT) in October 2016.  

Within the 9-months after grant, the European Patent Office (EPO) received six Oppositions from Seres Therapeutics, Nestec and four anonymous parties. The Opposition hearing lasted three days and almost 130 documents were considered.  Ultimately, the patent was maintained by the EPO’s Opposition Division (OD) but in an amended form, with a narrower claim scope; this decision has been appealed and it will likely be at least 2 years until the Appeal is heard.  

Monitoring further developments as this case moves through the EPO’s Appeal procedures, and any national court litigation, is likely to reveal more insight into what the future holds for patent protection in the therapeutic Microbiome field.

 


 

Panel Discussion: The Business of the Microbiome

Luis Gosalbez, Managing Director, Sandwalk BioVentures

Craig Thomson, Partner, HGF Limited

Michel de Baar, BD&L, MSD

Aurelie Grienenberger, CBO, Eligo Bioscience 

Discussion Points

  • Microbiome opportunities in drug candidates as well as drug targets and diagnostics 
  • Will the microbiome be a disruptive force in the pharma world? Promising areas of microbiome research / health applications.
  • Effective strategies to drug the microbiome i.e. FMT, defined consortia, single-strain LBP, postbiotics, small molecules, phages, GMO.
  • What data/results will help convince traditional pharma?
  • Challenges in bringing science to market / building a microbiome drug company:
    • IP – what are the implications for generic rights when considering Live Bacteria?
    • Regulatory
    • Manufacturing
    • Human resources
    • Quality of science 

 

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