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 Strategies for Products of Emerging Biotechnologies

  • Scientific and regulatory advice to start-ups and established companies engaged in producing food products and ingredients via emerging biotechnologies.

  • Strategies to demonstrate the safety of foods and food ingredients produced via emerging biotechnologies for all age groups.

  • 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.

  • Advisors to domestic and international companies developing novel products for human biomedical applications, especially combination, multi-agency, or dual-center review.

  • Worked with clients to develop 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)

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

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

  • Frequent resource to venture capital, large investment groups, and angel investors to provide general and company-specific information to inform investment decisions from seed capital to Series B raises.

  • Advisors to start-ups seeking capital by assisting in preparation of in-house investor pitches, post-hoc reviews.

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

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

Human Health Risk Assessment

  • Proposed a novel approach for assessing human health risks for a compound that is both essential to normal cell growth and development but is recognized to have a limited range of safe exposure

  • Developed safety and analytical testing strategies for novel compounds to be used in human nutrition or biomedical applications

  • Evaluated testing and approaches to account for differences in response among sensitive subpopulations within current risk assessment methodologies

  • Provided training to staff within companies lacking regulatory and toxicological expertise on the current requirements of the USFDA and the USEPA for a variety of consumer products (foods and dietary supplements, cosmetics, household chemical and pesticides)

Litigation Support

  • Provided consulting support and expert testimony on civil litigation cases in state and federal courts in the US in the areas of pharmacology, toxicology, and regulation of various products (drugs, devices, foods, dietary supplements, cosmetics)

  • Provided consulting support and expert testimony in both civil and criminal litigation cases involving impairment related to both legal and illegal drugs, as well as ethanol intoxication

Intellectual Property (IP) 

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

  • Developed commercialization strategies for inventors including timelines that considered regulatory hurdles and estimates on costs for the types of testing that might be required to achieve a regulatory authorization

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

Policy

  • Worked with Foundations and Philanthropies to prepare reports on the bioeconomy, including stimulating biomanufacturing and regulatory reform.

  • Addressed the National Academies on Science, Engineering, and Technology on protecting the bioeconomy of the United States.

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

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