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Translating Phage-Based Applications Into Clinically and Commercially SPEAKERS TO INCLUDE: Steffanie Strathdee Carl Merril Scott Stibitz & Tom Patterson CSO and Founder Microbiologist, Center for University of Adaptive Phage Biologics Evaluation and California San Diego Therapeutics Research FDA 29-30TH JANUARY 2019 | WASHINGTON D.C, USA Translating phage-based applications into clinically and commercially viable therapeutics Martha Clokie Biswajit Biswas Joe Campbell Professor of Chief, Division of Research Resources Microbiology Bacteriophage Science, Project Officer University of Biological Defense NIH (NIAID) Regulatory guidance to achieve clinical data from Cara Fiore, FDA Leicester Research Directorate US Naval Medical Research Center Strategies to access the market via the veterinary, personalized medicine and traditional pharmaceutical routes INSTITUTIONS PRESENT INCLUDE: Insights into investment drivers for phage therapy from NIH and Merck Facts on how to manufacture GMP phage Applications to overcome multi-drug resistance with combined approaches such as phage therapy and antibiotics www.phage-futures.com | +44 (0)20 3696 2920 | [email protected] WELCOME The Phage Futures Congress has the potential to act as a catalyst to further With antimicrobial resistance an ongoing worldwide issue, there is now a renewed interest cooperative and collaborative efforts in phage therapy as an alternative to antibiotics. There has been uncertainty as to whether to develop alternate Phage based approaches to phage therapy can be a commercially viable and FDA/EMA approved product. However, the the antibiotic crisis. highly positive results of compassionate use cases since 2016 and knowledge gained recently from microbiome research have been key catalysts to progress the field within western “ medicine. Successful phase II clinical trials are on the horizon! In addition, the location in the Washington DC area will facilitate an opportunity for Government The Phage Futures Congress will bring together peers from biotech companies and academia, along with experts from regulatory bodies, pharmaceutical companies and government Agencies, responsible for public health, such as institutions, to discuss how to actively progress clinical science and viable phage application the NIH, FDA, USDA and DOD to participate routes to market. The conference will cover key industry trends including: and interact with educational research groups and biotechnology companies developing phage Regulatory guidance to achieve Opportunities within the personalized clinical data and market approval medicine model and veterinary market therapies and initiating clinical testing. Combined therapy approach of phage Use of phage in chronic indications Carl Merril, such as IBD and antibiotics to alleviate MDR Adaptive Phage Therapeutics How to manufacture GMP Investment drivers compliant phage ” EVENT PARTNERS www.phage-futures.com | +44 (0)20 3696 2920 | [email protected] THE ROADMAP TO COMMERCIAL DELIVERY PHAGE THERAPY MEDICINE Antibiotics have a broad spectrum, how can phages compete? Kevin Yehl, MIT – presenting the importance of SCIENCE engineered phage and next-generation scaffolds to What does the sequencing efficiently broaden host range and suppress MDR of the microbiome mean for phage therapy? Nick Conley, Locus Biosciences – offering insights into utilising APPLICATION bacteriophages to deliver precision Route to market in phage microbiome engineering to eradicate involves many parameters bacterial targets. including disease, host and phage source selections. IMPLEMENTATION Biswajit Biswas, Naval Medical Translational skills are crucial Research Center - discussing a route for progressing phage in to market, personalised medicine human health. model and the importance of phage Magda Barbu, C3J Therapeutics synergy for maximum efficacy. – Sharing how to transfer drug development knowledge to phage therapy clinical studies. COLLABORATION REGULATION Infectious disease groups with pharma What are the phage therapy regulatory are watching the phage field. considerations for clinical studies Joe Campbell, NIH – presenting the importance Cara Fiore, FDA – on the required regulatory input for phage, of collaboration and investment in phage therapy to INDs and compassionate case long term validity. facilitate successful bacteriophage efficacy trials. www.phage-futures.com | +44 (0)20 3696 2920 | [email protected] ANSWERING THE CRITICAL QUESTIONS TO BUILD A PHAGE FUTURE TALK TO OUR SPEAKERS ABOUT... Addressing future antimicrobial resistance Benefits of expanded access cases versus a with phage evolution full clinical trial Key translational skills How microbiome related applications are opening up the field The applications of phage therapy How to target an appropriate host range How to produce GMP compliant phage Why phage therapy is important for industry The key considerations for designing & where they see it going clinical trials Commercial pathways for phage therapies MEDIA PARTNERS www.phage-futures.com | +44 (0)20 3696 2920 | [email protected] SPEAKERS Dr Steffanie Strathdee Professor Thomas Patterson Dr Carl Merril Scott Stibitz Professor Martha Clokie Cara Fiore Dr Biswajit Biswas Associate Dean of Global University of California CSO and founder Microbiologist Professor of Microbiology Microbiologist Chief, Division of Bacteriophage Science, Health Sciences San Diego School of Medicine Adaptive Phage Therapeutics Center for Biologics Evaluation University of Leicester Center for Biologics Biological Defense Research Directorate, University of California San Diego and Research FDA Evaluation and Research FDA US Naval Medical Research Center Dr Joe Campbell Dr Magda Barbu Dr Shawna McCallin Xavier Duportet Dr Brian Varnum Dr David Harper Dr Tobi Nagel Research Resources Senior Director, Synthetic Biology Project Leader CEO Chief Development Officer CEO and CSO Founder & President Project Officer C3J therapeutics PhageForward Eligo Bioscience C3J therapeutics Evolution Biotechnologies Phages for Global Health NIH (NIAID) Greg Merril Dr Betty Kutter Dr Breck Duerkop Dr Catherine Loc-Carrillo Dr Derek Holman Dr Nick Conley Dr Benjamin Chan CEO and founder Head of Bacteriophage Lab Assistant Professor of Internal Medicine - Research Stanford University Principal Scientist Yale University Adaptive Phage Therapeutics Evergreen State College Immunology & Microbiology Assistant Professor Locus Biosciences University of Colorado School University of Utah of Medicine Dr Jarek Dastych, Dr Mark Engel, Dr Carl Balibar Dr Chandrabali Ghose Dr Taylor Wallace Dr Kevin Yehl Dr Carrie-Lynn Langlais Furr Dr Laurent Bretaudeau CEO CEO Principal Scientist Founder and CEO George Mason Lead Phage VP of Regulatory Affairs Head of R&D Proteon Phagelux Merck Bioharmony Therapeutics University Researcher AmpliPhi Biosciences Clean Cells Pharmaceuticals MIT www.phage-futures.com | +44 (0)20 3696 2920 | [email protected] AGENDA DAY 1 8:00 am REGISTRATION OPENS 10:30 am KEYNOTE: Regulatory and manufacturing compliance of phage therapy products PLENARY SESSION: CURRENT OUTLOOK • From a pharmaceutical classification point of view, phages fall in the categories of anti- infectious products and of biological products, given the intended use and their live nature. 8:50am Chairperson’s opening remarks At the production steps, the compliance to the Good Manufacturing Practices (GMP) is a requirement for any medicinal product, with the objective to ensure the quality, safety 9:00 am KEYNOTE: The success of phage therapy in the US: A patient’s view of and efficacy of both investigational and approved drugs. receiving phage therapy • The EU-funded PhagoBurn’s project was conducted with the objective to set the • Hear the sequence of events which saved Tom Patterson’s life from a multi-drug standards from the regulatory and manufacturing points of view. This experience and resistant bacterial infection other projects with natural and genetically modified phages open the way for future • Gain a patient’s perspective on receiving phage therapy developments of phage therapy Professor Thomas Patterson, University of California San Diego Dr Laurent Bretaudeau, Head of R&D, Clean Cells Dr Steffanie Strathdee, Associate Dean of Global Health Sciences, 11:00am NETWORKING BREAK University of California San Diego DEVELOPING PHAGE THERAPIES TO MINIMIZE 9:30 am KEYNOTE: The evolutionary necessity for the development and uses of ANTIMICROBIAL RESISTANCE phage libraries for the individualized therapy of bacterial infections • Explore how bacteria, phage and humans evolve and how their subsequent 11:30 am Combining bacteriophages and antibiotics for wound infections interactions affect the potential use of phage as a therapeutic antibacterial agent • Assess the feasibility and efficacy of locally delivering a phage and antibiotic • Address the need for ever expanding clinically relevant and safe phage libraries, combination (PAC) therapy to treat polymicrobial wound infections touching upon methods to rapidly screen such libraries for effective phage based • Present case studies detailing how to develop reproducible infected rat therapeutic applications models to test the efficacy of antimicrobials, which rely on non-invasive Dr Carl Merril, CSO and Founder, Adaptive Phage Therapeutics monitoring techniques to allow the infection to be tracked in ‘real-time’ • Determine if a combination of phage and antibiotic is more effective at 10:00 am KEYNOTE: Rational analysis of why phase II clinical trials have been failing reducing the bacterial
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