**All times in EDT**
Day Two
Thursday April 22
8:15 am Morning Networking
8:50 am Chair’s Opening Remarks
Advancing Clinical Superiority of Anti-Infectives to Drive Commercial Success
9:00 am Direct Lytic Agents (DLA): New Medical Modalities for Life- Threatening, Drug-Resistant Infections
Synopsis
- Harnessing the antimicrobial power of DLAs
- Translating the power of DLAs to clinical development
- Demonstrating the potential for superior outcomes for serious, life threatening, critically underserved infections
9:25 am Building a Pipeline of New Mechanism Antibiotics that Drives Commercial Sustainability through Clinical Superiority
Synopsis
- Targeted, new mechanism antibiotics
- Microbiome preserving for wider health and quality of life
- Differentiation through clinical superiority
9:50 am Q&A/Discussion
10:15 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 antiinfectives drug development space. Exchange digital business cards, catch-up with colleagues and strike long lasting connections using our unique speed networking feature
10:45 am Morning Break
Targeting Unmet Medical Need to Ensure Anti-Infective Economic Sustainability
11:15 am BV100 – a Novel Therapy for Antibiotic-Resistant Acinetobacter Infections
Synopsis
- BV100 displays potent in vitro and in vivo activity towards MDR Acinetobacter baumannii
- Bactericidal in vitro and demonstrates a low rate of resistance development
- Entered phase 1 development
11:40 am Ensuring Anti-Infective Economic Sustainability by Targeting the Unmet Medical Need
Synopsis
- Strategies to ensure success in bringing a novel agent to market to address an unmet need
- Next generation approaches to streamline anti-infective development to benefit patients with unmet need
- Developing a clinical development program that addresses the needs of all stakeholders to support regulatory and commercial success
12:05 pm Targeted Therapy for Rare Pathogens: Challenges & Opportunities
Synopsis
- Unique aspects of clinical trial design for targeted therapies
- Regulatory pathways for “rare” pathogens (to include contents of data package for regulatory review and approval and post approval requirements to support use)
- Partnering with clinicians to inform best practices for product usage
12:30 pm Q&A/Discussion
12:55 pm Lunch & Networking Break
Anti-Infectives of the Future: Discovery Superior Novel Agents to Combat AMR
2:00 pm Obstacles for Discovery & Development of Narrow Spectrum Antimicrobials
Synopsis
- Advantages of peptide and nucleotide based narrow spectrum antimicrobials
- Strategies and challenges to raise capitals for early stage antimicrobial developing companies
- Inform the scientific community around the RANT platform and progress Techulon has made in developing novel therapeutics
2:25 pm Novel Investigational Polymyxin MRX-8 with an Improved Safety & Efficacy against Key Gram-Negative Infections
Synopsis
- Multi-drug resistant gram-negative (GN) infections present a global health threat inadequately addressed by the current antibacterial drugs
- Polymyxins are potent anti-GN antibiotics limited by nephro- and neuro-toxicities, and relative lack of efficacy in pneumonia and urinary tract infections
- Conceptually novel drug candidate MRX-8 has demonstrated an attenuated renal and acute toxicity, along with a distinct potential for superior to polymyxin B efficacy in several preclinical models, supported by PKPD animal studies
- Update on initial US Phase 1 results for the new IND agent may also be presented