Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Plenary Session: The Microbiome, 2016 MassBio Annual Meeting  03/31/2016 8:00 AM – 04/01/2016 3:00 PM Royal Sonesta Hotel, Cambridge, MA

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

covers in REAL TIME

2016 MassBio Annual Meeting  03/31/2016 8:00 AM – 04/01/2016 3:00 PM Royal Sonesta Hotel, Cambridge, MA

 In Attendance, steaming LIVE using Social Media

Aviva Lev-Ari, PhD, RN

Editor-in-Chief

http://pharmaceuticalintelligence.com

Director & Founder

Leaders in Pharmaceutical Business Intelligence (LPBI) Group, Boston

https://www.massbio.org/events/2016-massbio-annual-meeting-1120

2016 MassBio Annual Meeting  03/31/2016 8:00 AM – 04/01/2016 3:00 PM Royal Sonesta, Cambridge MA

http://pharmaceuticalintelligence.com/2016/03/02/2016-massbio-annual-meeting-03312016-800-am-04012016-300-pm-royal-sonesta-cambridge-ma/

Plenary Session: The Microbiome – NEW Therapeutic Class as a Platform

• Jose-Carlos Gutierrez-Ramos, CEO, Synlogic

Probiotic is safe. c-Diff has positive response, rules of colonization, PKPD – What does it say? Rare orphan Diseases, pharmacological definition,  Blood products are different, Epo is $10K per treatment. Measurement in vitro and in vivo – done genes – synthetic biology, enzyme catalytical, Best time to go to FDA with new therapeutic platforms, shift from small molecule to Biologics, Now shift to Therapeutics PLATFORMS that are new, are welcome. Immune system is dealing with micro trasslocation, immune system systemic and the microbiome, nerve ending in the Gut 25 feet of gut, Sesotonin in the gut, Mutations are drifts, bacteria is changing, manufacturing will control better microbiome than we are able to control mutations. Induction of certain genes, optimal product not known

• Alan Moss

microbial based therapy, patients prefer that vs immunotherapy. Patient undergo Transplantation, patient consent  as investigational. CROHN’s didease and EC, phenotype – in remission engraft the microbiome samples frozen. For Crohn, submission of microbiome FDA requested only Safety. Gut is an immune system. FMT success, improvement in short term, Antigenic response: Fever

• Gideon Gil, Panel Chair

Demonstrate the safety, FDA approval, probiotics needs evidence like FDA Approval CHallenge to persuade consumers. What are the Unknowns: Cancer and Bacteria

• Kareem Reda

Value of FDA is important, MicroBiome is Not regulated, convience the FDA, straints approved by FDA brings better results, Treat Microbiome as Drug, drug development where pricing and manufacturing is different. Tumor is low biomass vs GI large biomass, Bacteria-Host interaction, immunotherapy PD1 – Checkpoints, Microbes at the Tumor site, bacteria has role in immunology, antibiotics, Microbiome –>> Immune disease –>> Cancer, genetic drift,

• Bernat Olle

Average person understand microbe existence. Organisms are safe. Lactobascillas – dairy products, Stool transplant as carrier of microbe, Fecal Transplantation – works for c-Diff. Drug discovery: Consortia of bacteria growers, mixture of anaaerobes – this expertise is lost in Pharma, Microbiology is the Hype. C-Diff, Infectious diseases in the intestine, immune system, Metabolism, diet is very important. Cell bank to minimize drift and NSG will be used, Developing World has a big problem with microbiome,

Question from the Floor:

• FDA Representative: Should FDA regulate Microbiome,
• Longer term outcome from respondents to microbiome
• IP Protection: Living Organism Class of Drugs: Spread how to protect IP