**All times in EDT**

Day One

Wednesday April 21

7:45 am Registration & ‘Coffee Room’ Networking

8:20 am Chair’s Opening Remarks

8:30 am Keynote Presentation: A Review of the Antibacterial Development Pipeline

  • Peter Beyer Senior Advisor and Team Lead, World Health Organization - WHO

Synopsis

The presentation will present the preclinical and clinical antibacterial drug development pipeline, including small molecule antibiotics as well as non-traditional products and provide some outlook for future developments. WHO is publishing annual assessments of the antibacterial treatments in clinical development and runs a database on preclinical drug development projects that includes non-traditional products as well as vaccines.

Re-imagining Anti-Infective Drug Development to Ensure Economic Sustainability

9:00 am AMR Action Fund: Strengthening & Accelerating Antibiotic Development

  • Silas Holland Head of External Affairs (Interim) & Director of Global Public Policy, The AMR Action Fund & Merck

Synopsis

  • Due to a broken market, many promising antibiotics in the early-stage pipeline may never reach patients because of a lack of investors in clinical development
  • More than 20 pharmaceutical companies have launched the US$1B AMR Action Fund that will make investments in biotechs to bring 2-4 new antibiotics to patients by 2030
  • Urgent policy action is needed to implement market-based reforms to enable sustainable investment into antibiotic R&D

9:25 am Surviving FDA Approval of your Antibiotic

  • Kevin Outterson Executive Director & Professor of Law, CARB-X & Boston University

Synopsis

  • What can we learn from the past decade of FDA antibiotic approvals?
  • Niche markets where your drug can differentiate from generics
  • Non-dilutive funding: CARB-X, BARDA, HERA
  • Exit: AMR Action Fund, PASTEUR

9:50 am Trends in the Development & Approval of New Anti-infectives: Cycle Times, Success Rates & Expedited Regulatory Pathways

Synopsis

  • Clinical and approval phase times for new anti-infectives relative to those for other therapeutic classes
  • Cycle times and success rates for neglected anti-infective diseases
  • The impact on development and approval times of expedited regulatory pathways for anti-infectives

10:15 am Q&A/Discussion

  • Silas Holland Head of External Affairs (Interim) & Director of Global Public Policy, The AMR Action Fund & Merck
  • Kevin Outterson Executive Director & Professor of Law, CARB-X & Boston University
  • Joseph DiMasi Director of Economic Analysis, Tufts CSDD

10:40 am Virtual Speed Networking

Synopsis

Grab a cup of coffee and a bite to eat from the comfort of your own kitchen or office and virtually connect with new contacts in the anti-infectives drug development space. Exchange digital business cards, catch-up with colleagues and strike long lasting connections using our unique speed networking feature

11:10 am Morning Break

11:40 am Expedited Regulatory Pathways for Development & Licensure of Novel Anti-Infectives

Synopsis

  • Discuss pathways for licensure of innovative anti-infective therapies and vaccines
  • Key strategic considerations for expedited development and licensure
  • Special regulatory designations for these investigational products
  • Key challenges and opportunities for sponsors, HAs and industry

12:05 pm Differentiated Approach to Harnessing Novel Biologics & Overcome AMR

Synopsis

  • Peptilogics’ leading peptide design platform capable of unlocking new drug design space that has remained inaccessible
  • Overcoming systemic efficacy and toxicity concerns through designed, synthetic peptide sequences
  • Differentiated anti-infectives & orthopaedics strategy & product offering with focus on superiority trial design, first-in-class clinical safety & best-in-class efficacy

12:30 pm Q&A/Discussion

12:50 pm Lunch & Networking Break

Exploring Non-Traditional Approaches to Combat Multi-Drug Resistance

1:50 pm Clinical Experience with crPhage in Urinary Tract Infections

Synopsis

  • Reviewing the clinical experience with CRISPR-engineered bacteriophage
  • Discussing the design, results, and sensitivity observed from our phase 0
  • Discussing the design and top line results from our phase 1

2:15 pm Fighting Fire with Fire: Live Biotherapeutics for Pulmonary Infections

Synopsis

  • SciBac has a first-in-class approach of delivering beneficial bacteria directly into the lungs to fight chronic bacterial infections in cystic
    fibrosis & beyond
  • SciBac’s MERGE platform allows strains to be patented yet still non- GMO with faster development and a low cost of goods
  • SciBac’s multiple mechanisms (anti-bacterials, mucolytic action, biofilm removal, anti-inflammatory) increase efficacy and decrease pathogen resistance

2:40 pm Q&A/Discussion

3:00 pm Virtual Networking

3:30 pm Afternoon Break

4:00 pm Pseudomonas Elastase (LasB) as a Therapeutic Target

Synopsis

  • The pseudomonas aeruginosa LasB elastase (elastase B, pseudolysin) is a major secreted protease which hydrolyses a vast array of host proteins, causing tissue damage, disrupting immune responses and promoting inflammation
  • LasB is a virulence factor in experimental p.aeruginosa lung infections and has been proposed as an attractive target for development of a novel anti-virulence therapy
  • This presentation summarises the activities and biological roles of LasB and focusses on efforts to identify and develop specific LasB inhibitor drugs as a novel anti-virulence therapy for p.aeruginosa infections

4:25 pm A De-Risked Small Molecule Anti-Toxin for the Treatment of C.difficile Infections

  • Marc Navre Chief Executive Officer & Chief Scientific Officer, Facile Therapeutics

Synopsis

  • Preventing recurrence is the unmet need – anti-toxins are validated for prevention of recurrence
  • Ebselen is a small molecule anti-toxin that protects intestine in mouse model of CDI
  • Ebselen de-risked for safety: 20 years of late-stage clinical trials for indications unrelated to infectious disease
  • Facile’s goal: human proof of concept in CARB-X sponsored program

4:50 pm Q&A/Discussion

  • Martin Everett Chief Scientific Officer, AntaBio
  • Marc Navre Chief Executive Officer & Chief Scientific Officer, Facile Therapeutics

5:10 pm Close of Conference Day One