This is the fourth and final entry of a series of posts in which I’ve presented an expanded version of a presentation I made in May 2022 at the AIChE 5th Commercializing Industrial Biotechnology conference in San Diego, discussing strategies for planning and implementing regulatory submissions for industrial biotechnology projects involving a partnership with another party. In the first entry, I summarized the different types of relationships that might govern industrial biotechnology commercialization efforts, and presented a summary of the types of information typically needed in biotechnology regulatory submissions. In the second post, I discussed the issues and challenges that might be faced in preparing regulatory dossiers for these different types of commercial partnerships. The third post addressed issues that might arise when the commercial project will take place in a foreign country, under the jurisdiction of a possibly unfamiliar regulatory agency. Today’s post will complete the series with some recommendations for approaching regulatory submissions for projects involving commercial partners.
Recommendations
Although these various scenarios offer differing challenges, they nevertheless share enough similarities so that I can offer some general recommendations for planning regulatory submissions for such collaborative projects.
First is the advice I give to any company contemplating the need for regulatory approvals, which is to plan ahead. It is wise to begin internal planning at least 9-12 months before intended start date, where possible, perhaps longer if the collaboration will be international. Most biotechnology regulations specify agency review periods of at least 90 days, although some can be quite a bit longer, and this of course varies from country to country. This advice applies not only to internal planning but also to your communications with the partner regarding the likely regulatory roadmap. It is necessary to involve your third party partners as early as possible in the process, and to set clear expectations from the outset.
Along these lines, it is important to clearly establish the responsibilities of the respective parties in developing the information and data needed in the regulatory process. In some cases this can be addressed in the partnership agreement between the parties, in which the roles and responsibilities of the partners will often be specified. But you need to make clear to the partner as early as possible what your expectations or needs may be for the information and other assistance you’ll need from them,
Communications can be difficult where the third party is a customer or licensee: be sure the third party understands the need and value of the regulatory process. Some partners for industrial biotech projects may operate in industries or countries where there is little or no regulation, or in most cases the partners will not be familiar with the way biotechnology processes are regulated. You should be sure they understand and accept the necessity and the legitimacy of the regulatory process, and are committed to helping you achieve success. Finally, as mentioned above, it will often be necessary to explain agency policies towards company confidential information, to ensure your partner that their information will be protected.
This is the final installment in this 4-post report. To obtain a PDF copy of the entire report, in the form of a white paper, please contact David Glass at dglass@dglassassociates.com.
D. Glass Associates, Inc. is a consulting company specializing in government and regulatory affairs support for renewable fuels and industrial biotechnology. David Glass, Ph.D. is a veteran of over thirty-five years in the biotechnology industry, with expertise in industrial biotechnology regulatory affairs, U.S. and international renewable fuels regulation, patents, technology licensing, and market and technology assessments. In addition to his work as a consultant assisting industrial biotechnology companies prepare for and comply with government regulations, he has served as Director of Regulatory Affairs for Joule Unlimited Technologies and Vice President of Government and Regulatory Affairs for BioTechnica International. Dr. Glass has extensive experience with the biotechnology regulations of the U.S. EPA and other agencies, and has coordinated or assisted in the preparation and submission of 18 successful Microbial Commercial Activity Notices and several other biotechnology submissions in the U.S. and other countries. Dr. Glass holds a B.S. in Biological Sciences from Cornell University and a Ph.D. in Biochemical Sciences from Princeton University.
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