Periodic Reporting for period 1 - ABD (A bioengineered, naturally-derived, sustainable biocide for breaking down organic biofilms formed by drug-resistant bacteria.)
Periodo di rendicontazione: 2016-12-01 al 2017-04-30
The enemy is the bacterial BIOFILM. A biofilm is an extracellular structure that most bacterial colonies generate which allows them to adhere to surfaces and most importantly, to resist external attack. The film is made up of proteins and biopolymer-like substances which, after decades of evolution due to over-prescription and overuse of antibiotics in human and veterinary medicine, grows thicker and is virtually impenetrable to modern antimicrobials and antibiotics. Biofilm is irreversibly associated with a surface, meaning it cannot simply be washed off with conventional rinsing or sterilization methods. Biofilms are the leading component of all antimicrobial resistance (AMR) in bacterial infections, especially multidrug resistant strains, which caused a staggering 700,000 deaths in 2016.
Aequor has developed the derivatives from this primary natural molecule; all present biofilm dispersing, antibiotic and/or biocidal properties. Such a significant development leads to a number of direct impacts which are summarised as follows. They all
- remove existing biofilm;
- control bacterial and fungal contamination, infection, and fouling in a new way;
- promise to overcome the great challenges currently presented by drug-resistant; bacteria and fungal strains and biocide-resistant fouling;
- prevent the ability of bacteria to colonize by inhibiting their ability to form biofilm.
ABD and the four backup molecules chosen for this development are small molecules with antibiofilm and antimicrobial properties. The ABD new drug product development plan (PDP) is intended to scale up production of ABD and take it from its current TRL of 6 through pre-clinical trials. This would represent advancement to TRL8, where the ABD will be ready to enter clinical trials and begin the process of achieving REACH regulatory approval. Following certification of ABD as an approved new active pharmaceutical ingredient (API), the commercialisation plan is focused on the establishment of a joint venture or licensing agreement with a drug manufacturer certified for Good Manufacturing Practice (GMP) to produce ABD at industrial scale and integrate it into commercial products for marketing and sale to end users. This will lead to achieving TRL9.
Aequor has developed the derivatives from this primary natural molecule; all present biofilm dispersing, antibiotic and/or biocidal properties. Such a significant development leads to a number of direct impacts which are summarised as follows. They all
- remove existing biofilm;
- control bacterial and fungal contamination, infection, and fouling in a new way;
- promise to overcome the great challenges currently presented by drug-resistant; bacteria and fungal strains and biocide-resistant fouling;
- prevent the ability of bacteria to colonize by inhibiting their ability to form biofilm.
ABD and the four backup molecules chosen for this development are small molecules with antibiofilm and antimicrobial properties. The ABD new drug product development plan (PDP) is intended to scale up production of ABD and take it from its current TRL of 6 through pre-clinical trials. This would represent advancement to TRL8, where the ABD will be ready to enter clinical trials and begin the process of achieving REACH regulatory approval. Following certification of ABD as an approved new active pharmaceutical ingredient (API), the commercialisation plan is focused on the establishment of a joint venture or licensing agreement with a drug manufacturer certified for Good Manufacturing Practice (GMP) to produce ABD at industrial scale and integrate it into commercial products for marketing and sale to end users. This will lead to achieving TRL9.
Decide on the product to be developed and needs to be met: Use market needs to provide context for product specification and development (see below). ABD for first commercialisation to be identified.
Plan product development by assessing the path to TRL9: Devise the needs of the pre-clinical trial and engage with service providers.
Establish a feasible regulatory and industrialization plan (large scale production process) and elaborate the business full operations in the therapeutic or medical device field: All the following issues to be addressed - Required certifications/authorizations: in particular the plan for obtaining REACH approval; medicinal application approval; marketing approval; and specific opportunities to shorten the paths involved.1 ABD value chain evaluated and elaborated. Relevant stakeholders contacted and interest secured.
Risk assessment and contingency plan: The main risks identified and proper counteractions planned.
Size the reachable customers and a reliable market share: qualitative and quantitative results shown from comprehensive analysis of customers and entry barriers.
Commercial viability check (establish a sound go-to-market strategy) and development of a suitable marketing and communication strategy: establishing market needs and confirming problems with customers and end-users, development of a marketing and communications strategy.
Accomplish 4-years financial projections:
Establish an effective IP management strategy: Intellectual property rights strategy prepared including patenting and trademark strategy
Plan product development by assessing the path to TRL9: Devise the needs of the pre-clinical trial and engage with service providers.
Establish a feasible regulatory and industrialization plan (large scale production process) and elaborate the business full operations in the therapeutic or medical device field: All the following issues to be addressed - Required certifications/authorizations: in particular the plan for obtaining REACH approval; medicinal application approval; marketing approval; and specific opportunities to shorten the paths involved.1 ABD value chain evaluated and elaborated. Relevant stakeholders contacted and interest secured.
Risk assessment and contingency plan: The main risks identified and proper counteractions planned.
Size the reachable customers and a reliable market share: qualitative and quantitative results shown from comprehensive analysis of customers and entry barriers.
Commercial viability check (establish a sound go-to-market strategy) and development of a suitable marketing and communication strategy: establishing market needs and confirming problems with customers and end-users, development of a marketing and communications strategy.
Accomplish 4-years financial projections:
Establish an effective IP management strategy: Intellectual property rights strategy prepared including patenting and trademark strategy
The Aequor Biofilm Dispersant (ABD) family includes 35 novel derivatives (‘backup molecules’) of a specific active molecule produced naturally by a tropical aquatic microbe. This was discovered by Aequor’s Founder, Dr Cynthia K. Burzell.
Aequor has developed the derivatives from this primary natural molecule; all present biofilm dispersing, antibiotic and/or biocidal properties. Such a significant development leads to a number of direct impacts which are summarised as follows. They all
- remove existing biofilm;
- control bacterial and fungal contamination, infection, and fouling in a new way;
- promise to overcome the great challenges currently presented by drug-resistant; bacteria and fungal strains and biocide-resistant fouling;
- prevent the ability of bacteria to colonize by inhibiting their ability to form biofilm.
Aequor has developed the derivatives from this primary natural molecule; all present biofilm dispersing, antibiotic and/or biocidal properties. Such a significant development leads to a number of direct impacts which are summarised as follows. They all
- remove existing biofilm;
- control bacterial and fungal contamination, infection, and fouling in a new way;
- promise to overcome the great challenges currently presented by drug-resistant; bacteria and fungal strains and biocide-resistant fouling;
- prevent the ability of bacteria to colonize by inhibiting their ability to form biofilm.