While most entrepreneurs know they need to have their venture ideas clearly presented in terms of what the idea is, how it was developed, and how protected it is, they may not know what specifically investors notice and value during the pitch that leads them to prefer some ventures over others. Investors proudly state they evaluate the market potential and the management team above anything else when considering whether or not to invest. But the evaluation of the pitch comes much earlier in the investment process and contributes to the investors’ assessment of whether or not the management team is one they would like to back. When asked, investors cannot state with certainty that there are no certain ‘rules’ or qualities that must be met when they watch entrepreneurs pitching.
The pitch remains a critical component of the investors’ decision to fund. Almost no investor would fund without watching the entrepreneur pitch his or her venture. The popularity of shows like Shark Tank and Dragon’s Den highlight our fascination with the entrepreneur pitch-investor interactions. And though the context is entrepreneurship, crafting effective pitches is a skill that can be applied by any manager across any category in business. In this session, learn what works and why when pitching to investors, and a chance to practice your pitch to make successful hits.
• Strategies for obtaining meaningful patent protection, from U.S. and EPO perspective
• How to claim an organism – patent eligible subject matter issues, tension between definiteness and breadth
• Establishing Freedom to Operate by defining your position, from search and analysis of competitor IP, to opinions of counsel and design-around options
You will receive an in-depth introduction to the user-friendly CosmosID cloud platform and explore published datasets of therapeutic relevance. The following concepts will be covered in detail: taxonomic profiling at strain level, comparative analysis across cohorts, comparison of alpha- and beta-diversity, and analysis of the community-resistome and virulence. Additionally, our tutors will guide you through the resolution of real-life research questions using published datasets. The data deep dive will explore the effect of an experimental oral drug on the antibiotic-mediated dysbiosis published by Connelly et al.1
Workshop Leaders: Nur Hasan, Ph.D., Chief Scientific Officer, Cosmos ID; Arne Materna, Ph.D., VP Product, Cosmos ID
A Targeted, Point of Care Solution for Microbiome Analysis
In order for the microbiome field to realize its promise to revolutionize health and wellness, we must translate both diagnostic and therapeutic discoveries out of the lab and into the clinic. Floragraph is advancing this promise in two ways: 1. Developing technology that make microbiome analysis simple, reproducible, rapid and accessible, and 2. Creating novel panels of rationally designed microbiomarkers, empirically validated for significance in disease. We will present preliminary results of biomarker validation in early detection and characterization of necrotizing enterocolitis (NEC) in stool samples from very low birthweight infants in the NICU.
Alicia Scheffer-Wong, Ph.D., Founder & CEO, Floragraph
The Skin is NOT the Gut: Optimizing DNA Extractions and Amplicon Sequencing for the Skin Microbiome
Most of the methods used in skin microbiome research have been borrowed from the gut field, often with little to no validation or optimization for skin microbes. I will discuss why this is problematic, with laboratory and clinical examples, as well as data-backed solutions for working with this distinctive community. Hint: I think we’ve been missing a lot!
Kelly N. Haas, Ph.D., Post Doctoral Scholar, Dermatology Department, University of California Davis
Type 1 Diabetes: Primary Prevention Therapeutic Programs and First Pre-Autoantibody Biomarker Based on Association Between Autoimmunity and Dynamics of Amyloid-Producing E. Coli
George Tetz, MD, Ph.D., Chief Executive Officer, Human Microbiology Institute
Developing Products to Unlock the Promise of the Microbiome in Health and Disease: A Novel Approach, Challenges and Common Opportunities
As the scientific knowledge of the microbiome grows and the tools to study it evolve so too does our understanding of the organ and its link to health and disease. Therapies directed at the microbiome organ are the next wave of medicines to be developed not only to treat diseases but also to maintain health and wellness. A number of different ways to target the microbiome are being developed, but there are also common learnings and knowledge that can inform the entire field as it continues to advance.In this presentation, Alison Lawton will discuss Kaleido’s unique chemistry-driven approach to leveraging the potential of the microbiome organ, and outline opportunities the field can address together to facilitate the development of safe and effective products aimed at targeting the microbiome.
Alison Lawton, Chief Executive Officer, Kaleido Biosciences
The Role of Pharmacokinetics: Integration of Microbiome Research in Drug Development
The microbiome, sometimes referred to as the twelfth organ system of the human body, can have a significant impact on pharmacokinetics, and sometimes even pharmacodynamics of certain drug therapies. As more and more diseases are found to have a component influenced by the status of the microbiome, and hence are impacted by dysbiosis, it is reasonable to start asking how the microbiome in turn impacts pharmacotherapies. One of the most researched - but still not well understood - fields is the interplay between the gut microbiome and the immune system influencing the effectiveness of oncology immunotherapies (e.g. PD-L1 inhibition). The challenge is our limited understanding of the specific factors contributing to inter-individual (as well as potentially intra-individual) differences over time: while certain dysbiotic manifestations can be clearly defined, most occurrences are based on longitudinal observations (i.e. connected to pharmacokinetics). Currently, the science is driven more by measuring a phenomenon and less by a fundamental mechanistic understanding. This is similar to the situation a decade plus ago when genomic research started to become an integral part of drug discovery and development. This presentation focuses on how the microbiome can be integrated in drug development and what - if any - regulatory considerations need to be evaluated.
Felix Frueh, Ph.D., Executive Partner, Opus Three, Partner, System 12, Former Associate Director, Genomics, FDA
Rapid Product Development: From Concept to Consumer Product
This talk will discuss BioCollective’s Approach to Rapid Probiotic/Prebiotic Prototyping using BioFlux™ Metabolic Modeling, existing extensive library of GRAS organisms/supply chain relationships, and small batch GMP production partners. Some of the most difficult challenges in formula development are:
• US Regulatory - GRAS status vs. new organisms (many organisms have similar functions - modeling can identify alternatives to deliver identical function with an already approved organism)
• Production - small batch photo-type product development, many vendors are already at maximum capacity and won’t do small production runs for prototyping-types
• Production - moving from small batch to scaled production
• Optimization - Organisms work as guilds, understanding the most synergistic combination can be simplified through metabolic modeling that closely mimics wet lab experiments
Martha Carlin, Chief Executive Officer, The BioCollective
The Human Microbiome: Towards Future Diagnostic and Clinical Solutions
The Human microbiome is a highly sophisticated system, much like the circulatory and immune systems, playing multiple roles within the human body. The most straightforward analysis of GI tract microbial compositions, “normal” and “deviated” (in case of various diseases) – is performed through sequencing of stool-derived DNA/RNA. The challenges associated with this approach include: stabilization of nucleic acids in the biological samples, minimization of bias upon DNA/RNA purification and sequencing, depletion of PCR inhibitors, process automation, and rapid “sample-to-answer”. All of these issues - and strategies around them - will be discussed in details. Ms. Jasti will overview the complete arsenal of tools enabling microbiota exploration, and highlight examples of workflow application towards studying effects of probiotics and diet on gastrointestinal tract bacterial populations, and rapid detection of pathogenic species.
Madhu Jasti, Scientist III R&D, Thermo Fisher Scientific
Enhancing the Power of the Microbiome Through Partnership
Partnership in any business is a crucial component to success. In the growing arena of microbiome therapeutics, partnerships between scientific, clinical, governmental and corporate teams lend credibility, flexibility and speed to the development of novel technologies. Join in the discussion about how partnerships can accelerate the microbiome field and push the boundaries of innovation to help a broader class of patients.
Panel Session Sponsored by Rebiotix. Panelists to be announced.
Microbial Signatures of Gut Wellness Through Multi-Study Integratlon of Human Stool Metagenomes
In this presentation, Dr. Sung will present results from a meta-analysis on an integrated, multi-cohort dataset of 4,347 publicly available stool metagenomes from healthy and non-healthy cohorts. Using probabilistic approaches that identifies frequent patterns across individual microbiome samples, I will show a set of microbial species and functions consistently observed within the healthy population, but not as frequent in disease. From these results, a gut microbiome health index, composed of multi-dimensional microbiome information, was developed to quantitatively assess the health status of a human gut.
Jaeyun Sung, Ph.D., Assistant Professor of Surgery, College of Medicine, Senior Associate Consultant I, Division of Surgery Research, Mayo Clinic
Microbial life at Scale: Applications, Analytics and Lessons Learned From the Food Supply Chain
This presentation will detail the work IBM Research has done with the Sequencing the Food Supply Chain Consortium to analyze food microbiomes to understand pathogens, community dynamics, and ingredient authentication using deep sequencing. We will also detail some of the challenges and solutions we've generated in applications, analytics, and reference data repositories to study microbial life at scale.
Kristen L. Beck, Ph.D., Research Staff Member, Sequencing the Food Supply Chain, Almaden Research Center, IBM
The First 1000 Days: Babies, Nutrition and Gut Health
Every time an infant is born marks the start of a new symbiosis between a human host and microbial communities that are essential for health. Microbial colonization patterns are partly determined by gestational age, delivery method, feeding practices, and many other, still poorly understood factors. There are numerous challenges in trying to deliver technology platforms to analyze the gut health and to optimize nutrition of preterm infants in the neonatal ICU and beyond. In this presentation, we will talk about the challenges in sample acquisition and processing, data analysis, and technical standards, both focused on our specific goals, as well as in the setting of current hopes and hypes of the microbiome field.
Elisabeth Bik, Ph.D., Director of Science, Astarte Medical
Biological, Chemical and Spatial Drivers of Microbiota Structure and Function: Therapeutic Implications
While fecal microbiota transplantation is highly effective for the treatment of recurrent Clostridium difficile infection, development of the next generation of therapeutics requires a deep mechanistic understanding of the dynamic host-microbiota relationship, as well as the inter- and intra-species relationships within the microbial community. We describe several basic research studies that are designed to elucidate the underlying biological, chemical, and spatial mechanisms that drive these relationships, the links to host physiology, and implications for microbial therapeutics.
Elliot Friedman, Ph.D., Senior Research Investigator, Division of Gastroenterology, Technical Director, Microbial Culture & Metabolomics Core, PennCHOP Microbiome Program, Perelman School of Medicine, University of Pennsylvania
New Modeling Tools to Predict Dynamics of Microbial Ecologies
This session will describe an ongoing collaboration between the Bucci Lab and Vedanta Biosciences to develop and experimentally validate new modeling tools to predict dynamics of microbial ecologies. The speakers will also present a specific application of the tools in the optimization of rationally designed bacterial consortia drugs.
Vanni Bucci, Ph.D., Assistant Professor, University of Massachusetts Dartmouth
Bernat Olle, Ph.D., Chief Executive Officer, Vedanta Biosciences
From Conceptualization to Launch: A Case Study of a GI Microbiome Modulator
Perhaps no other rapidly emerging space of innovation so confounds and comingles the disparate industries of nutrition and pharmaceuticals, as does the field of the microbiome. A collision of sorts is occurring now and will unfold over the coming years between the nutritional industry’s notions of the microbiome and the resultant emerging products with those of the pharmaceutical sector. Neither side seems fully prepared for the inevitable challenges and yet the prospects for breakthroughs and benefit are sufficiently high for strong optimism and commitment to the sector. The scientific insight and conceptualization of a potential therapy translated into a plan for scientific validation and regulatory compliance frequently runs in parallel with overcoming the hurdles of financing, and eventually, to product positioning, launch, marketing campaigns and consumer response. Such a life-cycle of any novel genre of product is usually tortuous and perhaps this has never been truer than with the emergent class of microbiome-derived products. The product life-cycle of one particular GI microbiome modulator will be reviewed in the context of these challenges from both the nutritional and pharmaceutical industry point of view.
Dale Pfost, Ph.D., Chief Executive Officer, MicroBiome Therapeutics, General Partner, Advent Life Sciences
Strategies for Approaching FDA for Your First Clinical Trial
This talk will address common questions and concerns related to FDA Pre-IND meetings, including what the process is for requesting a meeting, when to approach FDA, what types of content to include and how to frame questions, and what types of outcomes can be expected.
Nicole Rempel, MS, MBA, Director of Regulatory & Strategic Development, Clinipace
The Asian Gut Microbiome: A New Therapeutics Discovery Opportunity
Almost 90 percent of the current translational microbiome research is focused on the Western gut microbiome. AsiaBiome has created the first horizontally integrated microbiome discovery platform in Asia. The company is linking together a microbiota bank, clinical network, and R&D discovery platform to launch microbiome products for both the Asia and global markets. They have strategic partnerships with Hong Kong University and the Genome Institute of Singapore. In this presentation Jonathan will discuss the following:
• How is the Asian gut microbiome different than the Western gut microbiome
• How does fecal microbiota transplant yield new drug discovery opportunities
• How the Asian gut microbes work in global population
Jonathan Krive, Co-Founder, CEO, AsiaBiome
Statistical and Computational Tools for Functional Microbiome
Human microbiome research is quickly moving towards functional microbiomics in order to understand how microbes in the human gut affect host immunity and physiology, disease initiation and treatment outcome. Alterations in microbiome-associated metabolite levels and small molecules may explain such associations. In this presentation, I will describe several new machine learning methods for (1) predicting and quantifying metabolic potentials of a microbial community using shotgun metagenomics data, (2) understanding the complex network of interactions between the intestinal mucosal immune system and the microbiome by integrating CyTOF and shotgun data. I will demonstrate the insights we gain from applying these methods to study IBD, infant early growth dynamics and effects of diet on host metabolism.
Hongzhe Li, Ph.D., Professor of Biostatistics and Statistics, Chair, Graduate Program in Biostatistics, Director, Center for Statistics in Big Data, University of Pennsylvania