Final Workshop and Report


A panel of experts on the Biomanufacturing field presented their findings from study tours of top European and Asian labs in a workshop held at the Holiday Inn Ballston on November 5, 2014 from 8:30 am to 4:00 pm.


For the final report click here

For the webcast archive click here.

For the final workshop agenda click here


Introduction


The non-profit WTEC, and its subsidiary ITRI, Inc., have conducted over 70 international assessments of R&D under sponsorship of most of the Federal research agencies. These assessments have been used to help guide U.S. funding of research to help maintain the Nation's leadership of science and technology.

The purpose of this paper is to propose a concept for an international assessment of research on biomanufacturing capabilities worldwide. The study would be conducted by a team of the leading U.S. researchers in the field. The goals include bringing back to the US some of the most promising research results, best practices in handling intellectual property (IP), and most effective technology transfer and commercialization processes. Re-invigorating U.S. manufacturing capabilities has become a high priority of the Administration, and several large scale initiatives and agency programs have been created to coordinate national resources in this area. Expert knowledge is needed about the technologies and economic sectors that are most ripe for development of biomanufacturing capabilities; the business, commercialization, and workforce development models employed in other countries; and the potential areas of competition developing internationally.

 

Plan for WTEC Study


The concept for the study proposed here is that the national efforts outlined above can be informed by an expert review of the research programs, technology areas, commercialization models and organizations, and infrastructure supporting biomanufacturing that currently exists, or is being developed, in other countries such as Germany, Korea, Japan, Taiwan, and China. Each of these countries has developed its own models for facilitating manufacturing, and they are focused on rapid creation of these capabilities for economic growth. Understanding the technological and commercial underpinnings of their efforts will not only be advantageous in informing our own efforts, but also in understanding the potential for future economic competition to the U.S. in these areas.

This concept paper presents a brief plan by which WTEC offers to conduct an international assessment of the current status and trends in research and commercialization models. To make this study more feasible, it will be focused on the rapidly growing opportunities in the biomanufacturing sector. (Other WTEC studies may focus on manufacturing of physical products like automobiles, information technology products, and other primarily mechanical items.) The objectives of this assessment would be to:

Guide and justify U. S. research investments;
Look for new commercialization and IP models (technology transfer);
Look for opportunities for cooperation and collaboration
Compare U.S. R&D programs and commercialization models with those abroad.
Look for efforts and models for workforce development.

A panel of U.S. experts, nominated by sponsoring agencies and recruited by WTEC, would conduct the study, using the WTEC methodology to carry out peer reviews of research abroad, visiting the sites of the research institutions and researchers who are noted for the most recent work in Europe and/or Asia. The results will be presented in a (webcast) public workshop soon after the panel returns from abroad. An academic-quality final report would serve to disseminate the results widely.

 

Purpose and Scope


The purpose of this study is to identify gaps, grand challenges and future direction of the field, focusing on the use of technology to generate biologically-relevant products and devices wherein biological components and/or processes are included. The aims of this study are to identify the needs and barriers in global biomanufacturing including:

Molecular approaches and building blocks that advance mapping and engineering of the brain, cellular reprogramming for cell-based therapy, and cellular rewiring for generating useful components and useful pathways towards new monomers for building polymers or for functionalizing devices or systems
Cellular approaches, assemblies and polymers that advance synthetic and computational biology, neuroprosthetics, and neurorobots
Biosensing manufacturing and innovation for brain mapping, disease diagnosis, prevention and management
Tissue/organ approaches that advance 3D printing or assembly of tissues/organs and understanding and replication of brain circuits for developing more intelligent systems
Systems integration that bring together the biological building blocks, polymers, organism assemblies or tissues/organs into functional devices and systems such as neuroprosthetics
Regulatory issues regarding advanced biomanufacturing such as methodologies for characterization of the cell-based products and manufacturing processes, and standards for GMP production of cell-based therapeutics and agents, etc.

 

The actual composition of the study will be determined by discussions with the sponsors and panel members. Finally, beyond the above technical issues, the study may also address the following non-technical issues in the field:

Mechanisms for enhancing cooperation among advanced biomanufacturing professional disciplines, and among sectors: academe, government, businesses (large, medium and small), and end users;
Opportunities for shortening the lead time for deployment of new advanced biomanufacturing technologies (products and processes) emerging from the laboratory; and
Long range research, educational, and infrastructure issues that need to be addressed to promote better progress in the field of advanced biomanufacturing; and
High level advanced biomanufacturing research funding initiatives and agencies abroad.

Tasks


(1) The contractor, in consultation with study sponsors, shall select a panel of six (6) U.S. experts (including a chair) in the field who are familiar with the technology elements listed above for R&D on advanced manufacturing capabilities and who are also current in international activities in the field. The panel chair shall have sufficient stature in this field to command respect in recruitment of panelists, and make presentations of results to his or her peers. The chair also will have the necessary skills at leading a panel to efficiently conduct the study. The contractor will conclude standard consulting contracts with these panelists for their work, including bonuses for timely delivery of their reports.
(2) The panel shall be organized at a kick-off meeting to be held in the Washington, DC area.  The chair will define the scope of the study (with guidance from all of the agency sponsors) and assign each panelist a section of the final report based on his or her area of expertise within the field. A schedule for the study will be established, including dates for the workshop and completion of the final report. During the preliminary study, the contractor shall assist the panelists by conducting electronic literature searches and by acquiring, extracting, and reproducing relevant literature. Passworded and public web sites will be established and maintained by the contractor during the course of the study as needed to facilitate the work of the panel.

(3) It has been proven in previous R&D assessments that visits to foreign laboratories greatly improve the amount, accuracy, and timeliness of the information available to the panelists. Thus, the contractor shall organize a fact-finding trip for the panel to visit centers of excellence in advanced manufacturing R&D at selected sites abroad.  We have has found that professional advance work for these trips is highly beneficial, thus allowances for advance work to be performed by proven performers are included in the recommended budget.  This budget assumes that the panel will travel to Asia or Western Europe; other regions may also be considered if the budget permits.

(4) The contractor shall organize a workshop in the Washington, DC area for the presentation of the results. Approximately 30 key participants from government and the private sector would be expected to attend a one-day presentation and discussion of the results. Each panelist will make a 30-minute presentation with visual aids of his or her findings, and the chair will make an overall summary.

The workshop will also be webcast, allowing live remote viewing of the workshop. The webcast will also be archived, permitting viewing of the workshop for years following the conclusion of the study.>/ 

(5) The contractor shall produce a final written report detailing the findings and distribute it to study participants, hosts, and sponsors.  The contractor may also find appropriate professional society or commercial publishers suitable for optimal distribution to the research community and the public.  The study shall be completed within eighteen (18) months after project initiation (API).

(6) The contractor shall convert the complete final written report into Adobe Acrobat (pdf) format and make it available free on the WTEC Web server and on CD-ROM.

 

Schedule, Milestones, and Deliverables


The schedule for the study will be determined at the kickoff meeting by mutual agreement of the sponsors, the WTEC staff, and the panel members.  However, a typical schedule and associated deliverables is shown below.  The term “or” means the latter of two events.  The schedule presented below is a plan for finishing the study in 12 months, although 18 months is allowed under paragraph 4.5 above to allow time for dissemination activities that may extend for some months after the report is complete.

Kickoff meeting -- November 2013
Foreign site visits completed -- May 2014
Draft site reports from the site visits - June 2014
Final workshop -- June 27, 2014 (hard copies of presentation material delivered and posted on Web shortly thereafter)
Final report -- approximately November 2014 (printed version, 75 copies total, simultaneously placed in PDF form on a CD and a public Web site -- the primary means of dissemination).

 

Partnerships


There are many offices that might contribute to this proposed study. The NSF Division of Chemical, Bioengineering, Environmental, and Transport Systems (CBET) is expected to take a lead role. Other potential participants include the NSF Industrial Innovation and Partnerships Division (IIP), DOE, DOE, NIBIB, and NIST.

 

Geographic Scope


The most important sites to visit will be identified by the expert panelists, assisted by bibliometric data provided by WTEC. Some preliminary possibilities include several of the Fraunhofer institutes in Germany as listed in Table 1. There are also several Fraunhofer institutes in the US, including one on manufacturing innovation in Massachusetts, and one on molecular biotechnology in Delaware. Another possibility is Taiwan’s Industrial Technology Research Institute, which is best known for information technologies, but it also has a substantial program on biotechnology. China and India are emerging as leaders in biopharmaceutical manufacturing with the support of local research institutes.

 

Table 1 Fraunhofer Institutes Related to Biomanufacturing

Biomedical Engineering

Sankt Ingbert

Biomedical Engineering-Branch Potsdam

Cell Therapy and Immunology

Leipzig

Marine Biotechnology

Lubeck

Interfacial Engineering and Biotechnology

Stuttgart

 

For More Information:


Frank Huband, WTEC, Frank@Huband.org, 202-290-5230
Duane Shelton, WTEC, shelton@wtec.org, 717-299-7130

 

 

 

References:

WTEC Report on Bioprocess Engineering in Japan, Daniel Wang (ed.) Baltimore: WTEC, 1992.
WTEC Report on Rapid Vaccines Manufacturing, Joe Bielitzki (ed.) Baltimore: WTEC 2010.
http://www.wtec.org/vaccine2/RpdVaccMfg-Asia-final07.12.11.pdf‎

    Study Chair


       
    Stephen Drew

    Drew Solutions
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