The Biobased and Renewable Products Advocacy Group (BRAG) helps members develop and bring to market their innovative biobased and renewable chemical products through insightful policy and regulatory advocacy. BRAG is managed by B&C® Consortia Management, L.L.C., an affiliate of Bergeson & Campbell, P.C.


 

By Lynn L. Bergeson

Two food-producing companies have jointly launched an initiative to drive the adoption of products and services on-farm at scale to increase sustainability on Earth. The initiative invites companies and entrepreneurs with new and emerging on-farm sustainability products and services, focused on greenhouse gases (GHG) reduction, to submit solutions to the leading companies’ experts. In August 2019, participants will be selected to present their solutions to an audience and panel of industry experts for consideration. The most promising opportunities presented will be given a special pitch event where participants will receive input, coaching, and advice from dairy and agricultural technical leaders to help bring their products and services to market scale. Additionally, up to $200,000 in funding will support the implementation of one of the selected solutions.

Tags: Research

 

By Lynn L. Bergeson

On May 13, 2019, the U.S. Food and Drug Administration (FDA) issued in final guidance designed to assist sponsors in demonstrating that a proposed biological product is interchangeable with a reference product for the purposes of submitting a marketing application or supplement. This would mean that an abbreviated licensure pathway would be created, where biological products shown to be biosimilar to or interchangeable with an FDA-licensed biological reference product may be submitted without intervention. The guidance focuses on therapeutic protein products, providing an overview of scientific considerations in showing interchangeability of a proposed therapeutic protein product with a reference product. It pertains to a series of guidance documents FDA is developing to implement the Biologics Price Competition and Innovation Act of 2009. This final guidance provides sponsors with more certainty on the development of these proposed interchangeable products. Its scope includes scientific considerations of:

  • The data and information needed to support a demonstration of interchangeability;
     
  • The design and analysis of a switching study or studies to support a demonstration of interchangeability;
     
  • The comparator product in a switching study or studies; and
     
  • The development of presentations, container closure systems, and delivery device constituent parts for proposed interchangeable products.

 

 

By Lynn L. Bergeson

From July 23-24, 2019, the Food and Drug Law Institute (FDLI) will be hosting the Introduction to Drug, Biologics, and Biosimilars Law and Regulation conference in Boston, MA. The conference will cover an overview of administrative agencies that impact these industries and how they interact with the U.S. Food and Drug Administration (FDA). It will also include sessions on the development of drug and biological products, FDA’s review and approval of marketing applications, biosimilars and generic drugs, manufacturing issues, and case studies, among other topics.

Tags: FDA, Biobased

 

 

 

 

 

By Lynn L. Bergeson

On April 4, 2019, DOE EERE’s Bioenergy Technologies Office (BETO) announced the appearance of 23 journal articles from some of the nation’s leading biomass experts in the journal Frontiers in Energy Research. The collection of articles, titled Advancements in Biomass Feedstock Preprocessing: Conversion Ready Feedstocks, focuses on the many years of research and development into biomass preprocessing that has been largely supported by DOE EERE’s BETO. According to the announcement, researchers from Idaho National Laboratory, National Renewable Energy Laboratory, Oak Ridge National Laboratory, and Lawrence Berkeley National Laboratory were part of more than 100 authors representing more than 30 research institutions, universities, and private companies who contributed to the special issue containing these 23 articles.


 
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