Mary Schaheen speaking at World Antimicrobial Resistance Congress

Mary Schaheen, President and Director, Prevail Partners 

 

What do you see as the biggest challenges facing the AMR space into 2022?

The biggest challenge in 2022 is that same as previous years: despite the growing need for new AMR drugs (estimated annual deaths will surpass cancer by 2050), high R&D research costs ($1.7B to post-approval) and low sales returns (usually < $500 annually) disfavors private investment in new research.  This is due to the restricted use of the product (short-term and only when absolutely necessary) and complexities in manufacturing.  Private funding in preclinical research is challenging due to the normal risk of failure in preclinical research compounded by the economic problems with antibiotics.  It is also a problem that pharma has at one point or another left or cut back in the space (e.g., Novartis, AstraZeneca, Sanofi, Allergan and The Medicines Company), thereby reducing the out-licensing opportunities of biotech companies in the space.    

 

If you could wave a magic wand, what would you like to see occur in the coming year to further combat AMR?

A solution would need to be multifaceted.  First, greater “Good Citizen” funding, such as the Antimicrobial Resistance Action Fund in which Pfizer committed $100M as well as the government supported Global Innovation Fund.  Second, further streamlining of the regulatory path for drugs intended to treat serious but rare infections, such as the LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) and Transferable Priority Review vouchers.  Third, commercial (”pull”) incentives, such as the REVAMP Act (providing transferable exclusivity vouchers for up to 12 months), Market Entry Awards ($1B or 2B award recommended by the O’Neill Review of Antimicrobial Resistance), and PASTEUR Act (government reimbursement based on drug’s value to public health instead of volume of drug sales).  Fourth, move from pay per pill to annual, reimbursable access licenses (like software).  

 

What would you like to highlight about your work/your organization for this coming year?

We will be looking for opportunities to support the AMR space both as a strategic investor in clinical stage companies and through the use of technologies to advance promising drug candidates in the clinic more cost effectively and with reduced operational risk.  While the AMR space is not a primary focus of ours due to challenges it poses to private investors, we remain active in the space due to the critical importance of this research.             

 

Do you have any predictions for the AMR space in 2022 and beyond? Any calls-to-action you’d like to highlight?

The COVID-19 pandemic will hopefully provide a wakeup call that investing now to address future disruptive healthcare events is good public policy.  It is therefore more likely than ever that commercial (“pull”) incentives will be adopted to encourage private investment in the AMR space such as the REVAMP and PASTEUR Acts.  This would be a welcome and long overdue catalyst for the AMR space  

 


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