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 and Ligia Duarte Botelho, M.A.

First published last week, on November 25, 2019, the article titled “Consolidated Production of Coniferol and Other High-Value Aromatic Alcohols Directly from Lignocellulosic Biomass” has gained media attention across the globe. Given the finite geological oil reserves, the competition to identify alternative biobased and biorefinery processes continues to grow. According to the article, the aim in identifying such products is not only to find alternatives, but most importantly to “overcome significant costs and productivity barriers.” In the aforementioned article, published in the Green Chemistry Journal, scientists write about a novel technique using the biocatalytic production of coniferol (a versatile chemical block) directly from lignocellulosic biomass. The process to do so involves a biocatalytic treatment of lignocellulose, which releases and converts ferulic acid with feruloyl esterase (XynZ), carboxylic acid reductase (CAR), and aldo-keto reductase (AKR). This catalytic reaction achieves the equivalent release of ferulic acid from lignocellulose compared to alkaline hydrolysis, also displaying efficient conversion of ferulic acid to coniferol. Consolidating a biodegradation-biotransformation strategy for the production of high value fine chemicals from waste plant biomass, this novel process offers a potential to minimize environmental waste and add value to agro-industrial residues. A number of grants, including from the São Paulo Research Foundation and David Phillips Fellowship, supported the study outlined in the journal article. Grants of these types continue to arise as the need to address resource efficiency and, therefore, biobased chemical production has become the focus of various government agencies in many countries. The U.S. Department of Energy (DOE) for example, often provides scientist from all backgrounds similar opportunities.


 

By Lynn L. Bergeson

On November 15, 2019, Sarah Yim, M.D., acting director of the Food and Drug Administration (FDA) Office of Therapeutic Biologics and Biosimilars in FDA’s Center for Drug Evaluation and Research, released a statement on FDA’s continued progress facilitating competition in the biologic marketplace with approval of its 25th biosimilar project. In her statement, Dr. Yim highlights FDA’s approval of one of nine new biosimilar products approved in 2019. Bringing the overall total of biosimilar approvals to 25, Dr. Yim states: “I’m pleased to see this progress and am confident that the market for these therapies will continue to grow.” Approved under FDA’s Biosimilar Product Development Program, the 25th biosimilar announced is one of 38 products that have been enrolled in the program. The program’s goal is to discuss development of proposed biosimilar products or interchangeable products, laying the foundation for ongoing competition in the marketplace.

Typically more complex than other drugs and developed through advanced science, biological products, commonly referred to as biologics, are generally made from natural or living sources, such as animal and plant cells, and microorganisms such as bacteria or yeast. Biologics and biosimilar products are highly similar to, and have no clinically meaningful differences from, existing FDA-approved biologic products called reference products. As part of FDA’s efforts to support these products, Dr. Yim also highlighted FDA’s work under the Biosimilars Action Plan. The work under this plan includes efforts to develop and implement new biosimilar-specific review templates and progress toward the development and validation of pharmacodynamic biomarkers tailored to biosimilar development. Part of these efforts involves FDA’s provision of scientific and regulatory clarity for the biosimilar development community, combined with communication and outreach education. Dr. Yim concludes: “The promise of biosimilar and interchangeable biological products in providing increased access to important therapies is great, and the FDA will continue to do all that we can to facilitate competition in this area.”


 

By Lynn L. Bergeson

On October 30, 2019, the U.S. Department of Energy (DOE) Office of Energy Efficiency and Renewable Energy (EERE) announced open meetings of the Biomass Research and Development (R&D) Technical Advisory Committee. The first meeting is scheduled for November 19, 2019, from 8:00 a.m. to 5:00 p.m. (EST), and the second meeting will take place on November 20, 2019, from 8:00 a.m. to 1:30 p.m. (EST) in Washington, D.C. The purpose of the committee is to advise the Secretaries of Energy and Agriculture with respect to the Biomass Initiative. The committee also evaluates and makes recommendations in writing to the Biomass R&D Board. The meetings will address the advice and guidance the committee will promote for R&D leading to the production of biobased fuels and biobased products. The meetings’ tentative agenda includes updates on the U.S. Department of Agriculture (USDA) Biomass R&D activities, presentations from government and industry that provide insights on the intersection of forest health and bioenergy growth, and updates on DOE Biomass R&D activities. Written and oral statements will be accepted. The meeting summary will be available for public review here.

Tags: DOE, EERE, Biomass

 

By Lynn L. Bergeson

On October 25, 2019, Iowa State University’s (ISU) Vice President for Research, Dan Kirkpatrick, announced that Sundeep Vani, Ph.D., has joined the team as the Chief Technology Officer (CTO) for Biobased Products, a newly created role. Announced in an ISU press release, Dr. Vani’s role will be to serve as a conduit between research and industry. Dr. Vani will work closely with the Biobased Product platform leader, Brent Shanks, his team, and the Iowa Innovation Corporation (IIC) CEO. Identifying promising emerging technologies and facilitating their development into market scale will also be at the top of Dr. Vani’s list of priorities. Dr. Vani stated that he is “excited to join Iowa State in this mission to grow Iowa’s economy through the state’s overall Biosciences initiative.” His addition to the team is partially attributed to Iowa’s legislature in July 2019 granting the university $825,000 in fiscal year 2020.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On October 23, 2019, the Alliance to End Plastic Waste (AEPW) announced a partnership with innovation platform Plug and Play to develop an accelerator program focused on the plastics value chain to identify start-ups with innovative ideas addressing plastic waste. Named the End Plastic Waste Innovation Platform (EPWIP), this initiative will focus on solutions to lower the impact of plastic waste in the environment. Focus areas include but are not limited to collecting, managing, and sorting plastic waste; recycling and processing technologies; and creating value from post-recycled plastics. Two programs will be run throughout the calendar year in Silicon Valley, Paris, and Singapore. Plug and Play will source specific start-ups working on solutions in selected focus areas. Running for 12 weeks, the programs will accept ten start-ups each, under which Plug and Play will invest in 20 selected start-ups per year. Engaging start-ups to AEPW members throughout the entire plastics value chain on infrastructure, education and engagement, innovation, and cleanup efforts, the programs will serve as a bridge between start-ups and access to new markets through AEPW members. Applications are now open for the first program, which will run from February through May 2020.


 

By Lynn L. Bergeson and Ligia Duarte Botelho, M.A.

On October 16, 2019, the University of Surrey, United Kingdom, announced that its researchers have partnered with colleagues from France, Germany, and Spain to start working on a new technique to tackle plastic waste. According to the university’s article, this novel technique may revolutionize the recycling industry. The plan is to create engineered microbial communities that will digest two types of plastic polymers -- polyethylene terephthalate (PET) and polyurethane (PU) -- and transform them into molecules that can be used to develop a more environmentally friendly material called Bio-PU. This more environmentally friendly material is often used as a construction and insulation material.

According to the University of Surrey, current physical or chemical methods to degrade PET and PU are inefficient. Impurities in PET polymers and high energy costs associated with the high temperatures required to break down the material make its degradation very difficult. Similarly, degradation of PU is limited due to the difficulty in breaking down urethane bonds in the material. Given these challenges, University of Surrey Senior Lecturer in synthetic biology Dr. Jose Jimenez highlights that “[m]oving away from the reliance on single use plastics is a positive step; however, the problem of how we deal with current plastic waste still needs to be addressed.” Hence, the project will investigate the ability of microorganisms to digest plastic waste and turn it into a more environmentally friendly material that can be recycled.


 

By Lynn L. Bergeson

On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical procedures such as chromatographic assays (CC) and ligand-binding assays (LBA) that quantitatively determine the levels of drugs and their metabolites and therapeutic proteins in biological matrices such as blood, serum, plasma, urine, and tissue such as skin.  The templates in this guidance can be used for new drug applications (NDA), biologics license applications (BLA), and supplements to these applications to provide information regarding bioanalytical methods for pharmacokinetic assessments.

Tags: FDA

 

By Lynn L. Bergeson

The U.S. Food and Drug Administration (FDA), on September 30, 2019, announced the availability of a draft guidance for industry (GFI) #171 titled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The draft GFI describes how EPA intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media. EPA is accepting comments on the draft GFI until November 29, 2019, before it starts working on the final version of it.

Tags: FDA

 

 

On September 11, 2019, from 12:00 p.m. to 1:30 p.m. (EDT), the Environmental Law Institute (ELI) will host a webinar titled “Genetic Engineering: The Good, The Bad, and The Necessary.” The webinar is designed to cover the vast possibilities offered by genetic engineering in a world where regulatory officials face increasing pressure to guarantee global food security. Along with the many possibilities associated with genetic engineering, however, there are great concerns about the environmental, health, and ethical implications of it. Webinar panelists will discuss many of these possibilities and concerns.

Tags: ELI, GE

 
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