**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
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
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
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
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
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