Our Work

The following is a selected set examples of the expert advice BPS has provided for both the public and private sectors. Because of the strict nature of the confidentiality agreements that we have in place with our clients, the descriptions have been redacted to preserve client confidentiality.

Regulatory and Product Development Strategies for Emerging Biotechnologies

  • Providing expert scientific and regulatory advice to start-ups and established companies engaged in producing food products and ingredients for a variety of products via emerging biotechnologies.

  • Serving as virtual chief scientific and regulatory affairs officers for seed-level and early stage start-ups.

  • Developing strategic risk-based product development and regulatory approaches for startups needing to meet inter-Center requirements for FDA.

  • Participating in an expert panel for a start-up engaged in developing xenotransplantation products.

    • Groenendaal, H., et al.  Expert opinion on the identification, risk assessment, and mitigation of microorganisms and parasites relevant to xenotransplantation products from pigs.  2023.  Xenotransplantation. 30:(5) D12815 https://doi.org/10.1111/xen.12815.

  • Engaging in frequent face to face interactions with regulators in multiple jurisdiction on developing novel science-based approaches to the regulation of bioactive ingredients  using  relevant molecular and pharmacokinetic measures.

  • Developing successful regulatory strategies for the commercialization of products of precision fermentation and cultured cell food in multiple regulatory agencies.

  • Developing strategies for estimating dietary exposures and population-specific risks for foods and food ingredients produced via emerging biotechnologies for all age groups.

  • Deploying novel exposure scenarios for products that do not fit neatly into established food categories by adaptation of US and other national data bases on food intakes.

  • Developing comprehensive international regulatory and analytical strategies for the importation and food use authorization of conventional protein sources and complex foods produced by precision fermentation or cell culture.

  • Advising domestic and international companies that develop novel products for human biomedical applications, especially combination, multi-agency, or dual-center review.

  • Working with clients on product development strategies that comport with existing US regulations as well as strategies for integrating US requirements with those of other major regulatory authorities (EU, Canada, FSANZ, Japan, Singapore).

  • Working with business units in companies to identify minimum viable products and/or sequences of market entry to maximize ROI.

  • Acting as adjunct to in-house regulatory staff on compliance with regulations related to labeling and promotion for ingredients of consumer products produced by biotechnology.

  • Developing a successful strategy for use of a semi-synthetic pyrethroid pesticide for world-wide licensing.

Scientific/Regulatory Due-Diligence for Investors/Start-ups

  • Interacting with C-Suite start-up officers and investors to develop scientific/regulatory due-diligence.

  • Researching issued and filed worldwide patents to develop novel product development strategies that ensure freedom to operate for start-ups in crowded fields.

  • Evaluating scientific merits of potential start-ups in the context of existing markets.

  • Developing investment estimates for scale-up from pilot to commercial scales including costs associated with regulatory inspections and oversight.

  • Developing strategies for upgrading manufacturing facilities from food to pharma grade.

  • Providing information and judgments regarding technology sectors and individual enterprises to venture capital, large investment groups, and angel investors to inform investment decisions from seed capital to Series B raises.

  • Preparing in-house investor and investor-oriented pitches and post hoc reviews for seed-through Series B funding.

  • Reporting to investors on data/information from conferences, individual sessions with start-ups.

  • Providing strategic advice to Corporate Boards of international companies on IP protection, coordinated regulatory strategies, and public perception.

Risk and Safety Assessments Including Methods Development

  • Serving as virtual chief scientific and regulatory affairs officers for seed-level and early stage start-ups.

  • Identifying additional sources of private, public, and philanthropic capital to complement existing early stage raises.

  • Developing commercialization strategies for inventors and early-stage companies/start-ups, including timelines that considered regulatory hurdles and estimates on costs for the types of testing that might be required to achieve a regulatory authorization in the US as well as other countries around the world.

  • Proposing novel approaches for assessing human health risks for substances essential to both normal cell growth and development but have also been recognized to have a limited ranges of safe exposure.

  • Evaluating molecular, cellular, and whole animal testing approaches to account for differences in response among sensitive subpopulations within existing risk assessment methodologies.

  • Developing safety and analytical testing strategies for novel substances or new uses of existing substances in human nutrition or biomedical applications.

  • Providing staff training within companies that lack regulatory and toxicological expertise. Training has included revised or current requirements of US regulatory authorities (e.g., USFDA and USEPA) as well as international regulatory authorities (e.g., EFSA, FSANZ, SFA) for a variety of consumer products (foods and dietary supplements, human and animal drugs, cosmetics, household chemicals and pesticides).

Litigation Support

  • Providing consulting support and expert testimony on civil litigation cases in state and federal courts in the US to support arguments in the following disciplines and knowledge sets:

    • Pharmacology

    • Toxicology

    • Regulations that govern the marketing of various consumer products in the US and other countries (drugs, devices, foods, dietary supplements, cosmetics, household chemicals, pesticides).

    • Industry standards applicable to product development.

    • Safety assessment paradigms that are relevant for different types of products.

  • Working with law firms to determine the relative merits of and strategies for potential litigation for products liability.

  • Researching differences between current and historical regulatory requirements in the US, Canada, and the EU.

  • Providing consulting support and expert testimony in both civil and criminal litigation cases involving impairment related to use of different substances either alone or in combination such as:

    • Legal drug use (prescription and OTC drugs)

    • Illegal drug use (marijuana and other cannabinoids; cocaine; PCP; methamphetamine; heroin)

    • Ethanol

    • Novel illicit psychoactive compounds

Intellectual Property (IP) 

  • Researching worldwide issued and filed patents/applications to develop novel product development strategies that ensure freedom to operate for start-ups in crowded fields.

  • Working with inventors to move ideas from the laboratory bench to the marketplace by drafting patent applications and responding to official actions from the USPTO on behalf of inventors or their counsel.

  • Working with business units in companies to identify minimum viable products and/or sequences of market entry to maximize IP and ROI.

  • Interfacing with foreign patent agents and authorities on international strategies for protection of IP.

Policy

  • Working with foundations and philanthropies to prepare reports on the bioeconomy, including stimulating biomanufacturing and regulatory reform.

  • Serving as a member of Schmidt Future Task Force on the US Bioeconomy resulting in a key report:

“The U.S. Bioeconomy: Charting a Course for a Resilient and Competitive Future ,” outlines what it would take for the U.S. and for people worldwide to maximize the benefits of the bioeconomy – from creating jobs to fighting climate change to reducing dependence on fossil fuels. https://www.schmidtfutures.org/wp-content/uploads/2023/05/Bioeconomy-Task-Force-Strategy-4.14.22-4.pdf.

  • Providing input to National Academies on Science, Engineering, and Technology on protecting the bioeconomy of the United States in several presentations, and an invited response in Issues in Science and Technology.

  • Engaging in small expert group sponsored by CalTech to evaluate whether there is need for regulatory policy changes associated with microbial products of synthetic biology.  (manuscripts in preparation).

  • Developing, chairing, and participating in a program session held at a national scientific meeting focusing on women’s health issues around common themes. These underscore the importance of community organization, outreach to communities with limited participation and access to justice, in the context of sound science, responsive regulatory policies in order to prioritize women’s health and achieve powerful and equitable health outcomes that impact quality of life.

  • Providing comments to regulatory agencies as part of Notice and Comment activities associated with draft Rules and Guidance for Industry on behalf of individual companies, academicians, and 501c3 and other non-industry groups on various subject areas (e.g., medical devices, regulation of microbes, plants, and animals developed by modern biotechnology, gene drives, labeling cell cultured meats) as well as larger issues such as regulatory reform, the implications of the CHPS Act, Executive Order 14081.

  • Participating (by invitation) in Regulatory Roundtables sponsored by the Singapore Food Agency (2022).

  • Authoring (as senior or co-author) a series of policy papers on the governance of gene drives.

    • Adelman, A. et al., Rules of the road for insect gene drive research and testing.  2017.  Nature Biotechnology  35: 716-718.

    • Rudenko, L. , M. Palmer, and K. Oye. 2018.  Considerations for the governance of gene drive organisms .  Pathogens and Global Health 112L 2018.

    • Long, K. C. et al.  2020  Core commitments for field trials of gene drive organisms.  Science 370 (6523) 1417-1419.

    • Taitingfong et al.,  2023.  Exploring the value of a global gene drive project registry.  Nature Biotechnology.  41: 9-13. 

  • Authoring (as primary authors) a key reference on the ethics and regulation of biotech animals.

    • Rudenko, L., L. M. Plunkett, et al. Overview of the regulation of genetically altered animals in research.  2024.  In Biotech Animals in Research: Ethical and Regulatory Aspects.  Ed. Gjerris, Kornum, Rocklinsberg, and Sorensen.  CRC Press.

  • Serving on closed session Expert Panels to the National Academies of Science, Engineering, and Technology on regulatory roadblocks for emerging products of biotechnology.

  • Presenting comments to the President’s Commission on Science and Technology on potential pathways to regulatory reform.

  • Participating in initiatives driven by scientific societies and other interested parties to affect changes in law and/or regulations that impact products marketed to consumers.