October: Development of Synthetic Biotic Medicines
October: Cosmetic Regulation
Microbiome Business Development: Forging a New Empire>
Presentation by Kenda Rigdon, Founder/Owner, Right in the Gut Nutrition>
In an era when microbiome research is disrupting old dogmas of medical science, this is a call to “come together” and forge a new “empire” focused on products that bring healing to the gut microbiome and disease.
Consumer Communications and Community Building>
Presentation by Alana and Lisa Macfarlane, The Gut Stuff>
Gut Check: Protecting IP relating to the microbiome>
Presentation by Mark FitzGerald, Partner, Nixon Peabody LLP>
In this presentation, Mark FitzGerald discusses the state of patent protection for microbiome therapeutics. Dr. FitzGerald discusses some of the specific challenges faced in obtaining patent protection for microbiome technology, and ways to overcome them. He also looks at the types and scope of patent claims being allowed in this arena, and discusses recent challenges to the validity of issued microbiome patents and the guidance such challenges can provide.
Microbiome Covid-19 Therapy>
Presentation by Susan Finston, President, Finston Consultancy>
This presentation highlights the potential value of microbiome peptides as COVID-19 therapeutics, focusing on modified, truncated peptides of MPT-63, a protein of mBovis with demonstrated anti-viral activity. Over the past decade Susan K. Finston worked closely with microbiome and biotech pioneer Ananda Chakrabarty (z”l), and together they founded Amrita Therapeutics Ltd. to study microbial peptides with anti-viral, anti-cancer, anti-inflammatory activity. This new initiative reflects Dr. Chakrabarty’s often stated view that bacterial proteins (and related peptides) are highly intelligently designed by microbial biofilms with 3 billion years of evolutionary wisdom to combat invaders of the human body.
Clinical trials, actual clinical practice and marketing the product>
Presentation by Milana Shternberg, CEO, ClearSkin Medical>
In this talk, Milana shares the challenges and experiences of developing and presenting to the market their product MiBiome, which has been commercial for two and a half years. Clinical aspects and marketing challenges are described in this talk.
Patenting Microbiome Innovation>
Presentation by Ross Cummings, Patent Attorney, GJE>
The special requirements for obtaining patent protection for innovations in biotechnology, in particular in the microbiome space. Considering where patenting restrictions bite and what you need to do before filing your patent application with real examples.
What Launching a Citizen Science Project Taught Me About Science Communication>
Presentation by Holly Ganz, CSO, Animalbiome
Holly Ganz discusses key insights into how to convey scientific content to pet owners that she gathered after launching the KittyBiome citizen science project. Most people don't care about the names of microbes or what they do, they just want their pet to be healthy. Because medical professionals are busy and hard to access, most people consult regularly with Dr. Google. You can reach them with thoughtful, detailed blog posts. Effective communication of science and health related content takes a lot of work but it’s important.
The Power Of Your Skin Microbiome>
Presentation by Bernhard Paetzold, Founder, S-Biomedic
In this presentation, Bernhard discusses the history of the microbiome and its impact on aging, before introducing the viewer to the abundance of Cutibacterium Acnes during aging and its molecular interaction points.
BoobyBiome: Our Journey and Learnings>
Presentation by Lydia Mapstone, CEO, BoobyBiome
Meet Boobybiome, the company which aims to improve infant health by harnessing the power of microbes in breast milk. CEO and Co-founder Lydia Mapstone provides an introduction to how BoobyBiome was founded and their lessons from the last year.
Intellectual Property Strategy for the Microbiome & Probiotic Company>
Presentation by MATT BRESNAHAN, Wilson Sonsini Goodrich & Rosati
Patent strategy for microbiome companies, including portfolio development and freedom to operate.
Formulating probiotic products to deliver health benefit>
Presentation by VANDANA SHARMA, Ph.D. Principal Nutrition Scientist, Pharmavite LLC
This presentation discusses key steps involved in probiotic product formulation, right from strain selection to a product on the shelf. It lays out key considerations for strain identification, dose selection, delivery forms, excipient choice, stability studies, benefit claims, product packaging and labeling.>
Development of Synthetic Biotic Medicines for Metabolic Diseases>
Presentation by Caroline Kurtz, Synlogic
This presentation describes the development of two engineered bacterial strains using Synlogic’s proprietary platform to design, build and test synthetic biotics medicines for the treatment of metabolic and immunologic diseases. In my talk I will focus on two programs in our metabolic pipeline. One program in PKU is in Phase 2 clinical development for the treatment of phenylketonuria, a rare inborn error of metabolism disorder. We have designed a synthetic biotic medicine as an oral therapy to consume phenylalanine from the GI tract. The second program is for the treatment of enteric hyperoxaluria, an acquired condition leading to formation of kidney stones and kidney disease. We have designed an oral synthetic biotic medicine to lower absorption of oxalate from the GI tract to prevent formation of kidney stones. This program is in IND enabling studies. These programs demonstrate the concept that living synthetic biotic medicines can metabolize toxic substrates while operating from the GI tract to treat metabolic diseases.>
Cosmetics Regulatory and Manufacturing Considerations>
Presentation by Maria Cho, Phi Therapeutics
A drug for the skin or a cosmetic for the skin? What are the differences and what you need to know before you start commercialising your skincare product.
Patenting the Microbiome>
Presentation by Anthony Sabatelli, Wiggin & Dana
In this presentation, patent attorney Anthony Sabatelli examines the background of patents in the microbiome space, including the technology, investment and IP trends, before examining the challenges that you may encounter when patenting your product. He then goes on to discuss practical ways in which you can meet those challenges and be prepared for what's to come.
Speaker Q&A - October
Maria Cho, COO, Phi Therapeutics
Anthony Sabatelli, Patent Counsel, Wiggan and Dana
Caroline Kurtz, Senior Vice President and Head of Metabolic Programs
Vandana Sharma, Principal Nutrition Scientist, Pharmavite
REPLAY COMING SOON
Matthew Bresnahan, Partner, Wilson Sonsini Goodrich & Rosati Lydia Mapstone, CEO, BoobyBiome Bernhard Paetzold, Chief Scientific Officer, S-Biomedic Holly Ganz, Chief Science Officer, AnimalBiome>
All rights reserved - L2OD - Copyright 2020>
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