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.

Biologics, Drugs, and Inter-Center Review of Products and Processes

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

  • Serving as virtual chief scientific and regulatory affairs officers for early-stage start-ups developing cell and gene therapies.

  • Developing strategic risk-based product development and regulatory approaches for startups needing to meet inter-Center requirements (i.e., CVM, CBER, CDER, CDRH) for FDA, with emphasis on cells, tissues, and organs from non-human mammalian sources.

  • Developing scientific and regulatory strategies for cells, tissues, and organs to be used for xenotransplantation.

  • Developing food safety authorizations for animals with intentional genomic alterations intended for use as xenotransplantation sources to meet with consumer demand for food products derived from these animals  that do not cause alpha-gal syndrome

  • 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. 

  • Performing expert risk analyses of porcine endogenous retrovirus (PERV) presence in cells, tissues, and organs intended for xenotransplantation

    • Fishman J., L. Rudenko, and D. Sachs. Risk Assessment for Transmission of Porcine Endogenous Retrovirus in Clinical Xenotransplantation. MS in revision. 

  • Developing risk-based strategies for ensuring that animals to be used as sources of human biologics are free from endogenous and exogenous microbial risks (e.g., PCMV) 

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

  • 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 start-ups and established companies to develop risk-based APHIS import permits for biological materials to be used as research or development tools for producing animals with multiple genomic alterations

  • Working with foreign regulators to lawfully export biological materials or live animals from the US to other geopolitical units 

Products Regulated as Foods, Dietary Supplements, or Consumer Products

  • Providing expert scientific and regulatory advice to start-ups and established companies engaged in producing food products, food ingredients and ingredients for other consumer products via emerging biotechnologies

  • 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

  • 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  dossiers for 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

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

  • Preparation of dossiers for food ingredients and color additives to be used in the US

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

  • Interacting with C-Suite start-up officers and investors to develop scientific/regulatory due-diligence assessments for Seed, Series A ($20-40M) and B level (>$40 – 80M) raises

    • Worked with family funds, angel investors, specialized biotech-focused VC, and disease-specific foundations or philanthropies

    • Products include cell and gene therapy, rare disease therapies, cell-based combination devices, xenotransplantation

     

  • Our due diligence scope generally includes the following:

    • Scientific: underlying mechanism of action; sufficiency of proof of principle; safety profiles of vectors, cells, reagents; relevance of endpoints in preclinical trials

    • Technical: scale-up, dose-effects of administration vehicle/vectors; reagents/costs for cGMP manufacture; durability of drug product from manufacturing site to investigational site

    • Intellectual Property: extent of filed or granted patents; implications of expiration; augmentation of exclusivity; use of aspirational patents to expand intended use/indication

    • Competitor and market analysis: identification of similar products or products intended for similar uses/indications; adult v pediatric indications; first regulatory approval and extensions to similar indications with larger markets

    • Regulatory strategy: proof-of-principle, preclinical studies, utility of non-human primate studies; strategy for combing phases; use of FDA’s new guidance/policies for accelerated development/review/approval, especially for rare diseases; REMS, planning studies for expanded indications

    • Staff and facilities: analysis of science-advisory boards, company leadership; senior scientific/regulatory staff; adequacy of facilities; needs for /benefits of contracting out

    • Estimated funding: estimating funds likely needed for completion of various stages of development from preclinical through appropriate clinical trials to yield approvals; generating data-based valuations for different stages of development

       

  • Specific tasks addressed by BPS have included  

    • Evaluating relative scientific merits of potential start-ups in the context of existing markets, especially in relatively crowded fields

    • Providing information and judgments regarding technology sectors for potential investment in individual enterprises or BD considerations

    • As part of determining freedom to operate for novel products or products in crowded fields, issued and filed patents are assessed worldwide to develop novel product development strategies, including patent extension strategies and use of aspirational patents

    • Assessing “soft spots” in CMC strategies during product development to maximize progress through regulatory authorizations, especially when moving from proof of concept through pivotal trials

    • Developing strategies for regulatory compliance in the absence of the need for formal approval or authorization

    • Assessing various “accelerated” programs at FDA for purposes of speed to market (e.g., orphan/rare pediatric disease designation, regenerative medicine advanced therapy (RMAT), fast track)

    • 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.

    • 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

Methods Development and Implementation for Risk and Safety Assessments

Much of BPS’s work involves risk or safety assessment. The challenge when working with emerging biotechnologies, however, is how to adapt existing methods and regulatory frameworks to these new products, or how to implement new agency initiatives (e.g., NAMS, Reducing Animal Testing) in such assessments. In this context, BPS’s work has included

  • Developing risk-based product development and commercialization strategies for inventors and early-stage companies/start-ups, including timelines that considered regulatory hurdles

  • Estimating  timing and costs for both standard and new approach methodologies (NAMs) to be used to achieve regulatory authorization in the US as well as other jurisdictions

  • Identifying and qualifying vendors for outsourcing key analytical tools to aid in genome or proteome-based risk or safety assessments

  •  Implementing 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 range of safe exposure

  •  Evaluating in silico, molecular, cellular, and reduced whole animal testing approaches to account for differences in response among sensitive subpopulations within existing risk assessment methodologies as outlined in FDA’s 2026 Non-Clinical Testing Terminology Direct Final Rule and the draft General Considerations for the Use of New Approach Methodologies in Drug Development (2026)

  •  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 (human drugs and biologics, animal drugs, foods and dietary supplements, household chemicals, and pesticides)

Litigation Support

  • BPS founders have extensive experience in providing consulting support as well as 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, biologics, medical 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

  • We have worked with law firms to determine the relative merits of and strategies for potential litigation in products liability.

  • We have researched differences between current and historical regulatory requirements in the US, Canada, and the EU to support lawyers involved in litigation.

  • Dr. Plunkett has provided 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)

An important focus of BPS work protection of the intellectual property rights of individual inventors and companies developing new products, technologies, or methods of use. Not all intellectual property protection has to be accomplished by patents; BPS has relationships with experienced patent attorneys, and we focus on finding the fastest and most effective way to ensure the freedom to operate, including trade secrets, copywrite, and trademark. Part of this work includes strategic advice on when to file patents, as well as when to make public presentations, to publish, and when and how to collaborate with others. This work can be linked to due diligence assessments or to filing patent applications in the US or worldwide. Some examples include

  • 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

  • Extensive collaboration with foundations and philanthropies to evaluate aspects of and prepare reports on the bioeconomy, biosecurity, stimulating biomanufacturing, and regulatory reform.

  • Invited contributor: Workshop on Governance of Emerging Technologies: Framing Benefits and Risks of Biotech and Artificial Intelligence.  University of Tokyo, Japan.

  • Invited participant to and co-author of position papers from The Spirit of Asilomar 2025. 

    • Abbott, Z., Adelman, Z., Elani, Y., Freemont, P., Kiattisewee, C., Molla, K.A., Murray, R., & Rudenko, L. (2025). 4.3 Synthetic Cells for Environmental Release. Rice University. https://doi.org/10.25611/TRA2-AT67

    • Chemla, Y., Alexanian, T., Moronta Barrios, F., Demirer, G., Flores, A., Karthikeyan, S., Lindner, A., Mackelprang, B., Marken, J., Mitra, A., Molla, K. A., Rudenko, L., Syberg-Olsen, M. J., Wu, F., Silberg, J., & Voigt, C. A. (2025). 1.5 Identifying and Addressing the Risk of the Environmental Release of Organisms — Engineered or Natural. Rice University. https://doi.org/10.25611/RSQD-6V17

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

  • 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 engineered microbes for environmental release (EMERS) .  (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.

  •  Co-Chair on the OECD Expert Consultation of the safety assessment of foods derived from recombinant DNA animals

  •  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.