LTPM CHINA

Rebiotix Leaders to Discuss Microbiome Product Development Challenges and Regulation at Microbiome Movement – Drug Development Summit 2019

publisher: BusinessWire
Time: 2019-06-27
Summary: Rebiotix Leaders to Discuss Microbiome Product Development Challenges and Regulation at Microbiome Movement – Drug Development Summit 2019

ROSEVILLE, Minn.–(BUSINESS WIRE)–#Cdiff–Rebiotix, Inc, a Ferring Pharmaceuticals company, announced today that two members of their senior leadership team, Dr. Ken Blount, Chief Scientific Officer and Dr. Edward Burd, Head of Regulatory Affairs, will engage in key panel discussions at the 2019 Microbiome Movement – Drug Development Summit. The fourth annual summit will take place on June 26-28 in Boston, MA.

An established figure in the microbiome field, Dr. Blount will speak at the Microbiome Industry Leaders panel, where he will highlight the ongoing scientific and product-development challenges within the category, including highlights from Rebiotix’s clinical and microbiome research under the company’s innovative, investigational MRT™ drug platform.

In addition to the panel, Dr. Blount will deliver a presentation about Rebiotix’s pioneering Microbiome Health Index™ (MHI). The talk will focus on the company’s advances in developing the algorithm as a means to assess restoration of a patient’s microbiome communities after treatment with one of the company’s investigational MRT formulations. Currently, there are two formulations in clinical development – the lead candidate, RBX2660, is a liquid suspension in Phase 3; RBX7455, an investigational, first-of-its-kind lyophilized, non-frozen, room-temperature stable oral capsule formulation. Both formulations are currently focused on reducing recurrent Clostridioides difficile (C. diff) infection in adults.

“It is exciting to take part in an event that showcases innovations that harness the power of the microbiome. I am honored to participate in the Microbiome Industry Leaders panel to engage with other authorities in the field,” said Dr. Blount. “It’s events like these that enable us to come together, share ideas and shape the future prospect of microbiome-based therapies.”

Beyond scientific and clinical innovation in the category, the regulatory landscape for microbiota-based therapies continues to evolve. Initially outlined by the U.S. Food and Drug Administration (FDA) in 2013, additional standards specific to fecal microbiota transplantation (FMT) are anticipated in the near future and continue to be a focal point of discussion. To highlight the most recent developments and impact on the field, Dr. Burd will chair the Building Clear Regulatory Guidelines for Microbiome-based Therapeutics panel during the summit. The panel will address the growing complexities within microbiome product development, including donor testing, product characterization, and the dynamic international regulatory landscape for this emerging class of products.

“It is critical that the players in this space focus on developing safe products and procedures for the patients we serve,” said Dr. Burd. “With representatives from key microbiome companies and regulatory bodies offering commentary on this important topic, we can continue to emphasize the need for regulatory oversight and careful clinical investigation when it comes to patient safety.”

Details for the panels and presentation are as follows:

Dr. Blount –

  • Title: Microbiome Industry Leaders Panel Discussion
  • Date and Time: Thursday, June 27, 2019 8:30 AM
  • Title: A Prototype Biomarker for Microbiome Rehabilitation in Patients with Clostridium Difficile Infections: Application to a Clinical Trial of a Lyophilized, Non-Frozen, Oral, Microbiota-Based Drug RBX7455
  • Date, Time and Location: Friday, June 28, 2019 12:30 PM; Track C

Dr. Burd –

  • Title: Building Clear Regulatory Guidelines for Microbiome-based Therapeutics
  • Date and Time: Thursday, June 27, 2019 6:15 PM

Previous: vTv Therapeutics Initiates Phase 2 Clinical Trial Evaluating Azeliragon in Patients with Mild Alzheimer’s Disease and Type 2 Diabetes

Next: Exicure Announces Preclinical Data Supporting Development of SNA Technology in the Central Nervous System