BioPolicy Solutions, LLC was founded when Laura Plunkett of Integrative Biostrategies, (LLC) and Larisa Rudenko of LXR Solutions joined forces to provide expert advice on technical, business, or policy issues stemming from novel or complex biological technologies and their applications.

Our boutique consultancy works at the interface of biological sciences, policy development, and business decisions to provide solutions to issues rooted in science, but with major financial and policy implications. BPS focuses on emerging biotechnologies that produce novel products or conventional products via novel processes that impact the bioeconomy, including ensuring adequate protection for intellectual property. We have extensive experience in regulatory requirements for US and multiple international markets related to products that include human therapeutics (drugs, biologics, and devices), articles regulated as veterinary drugs including animals with intentional genomic alterations, products regulated as foods and food additives, and cosmetic products. We also provide scientific, technical, regulatory, and intellectual due diligence for funders and investment seekers. We work with the private sector, philanthropies, and foundations as they seek to resolve some of the key issues associated with policy within the US government, and as they harmonize with regulatory agencies in other geopolitical units.

BPS is not our first joint venture: early in our professional careers we worked together at a large consultancy, were Managing Directors at Integrative Biostrategies prior to Dr. Rudenko’s government service and have resumed our partnership as Co-Founders of BPS.

Dr. Laura Plunkett is trained as a pharmacologist and has worked with clients throughout her career in developing safety programs for private clients. In addition to her training and skills in pharmacology and toxicology she is a Registered Patent Agent who has successfully worked with start-ups to protect their intellectual property; she also holds an Adjunct Faculty position at Baylor University and is a Board-Certified Toxicologist (DABT).  Dr. Larisa Rudenko received her training in molecular and cell biology. In the immediate past, she was a Senior Advisor for Biotechnology at FDA for 15 years on issues related to emerging technologies; she holds a research affiliate position at MIT at the Program on Emerging Technologies and is a Visitor at the  Linde Center for Science, Society, and Policy (LCSSP) at Caltech. They are joined by Dr. Austin Mircheff, a retired professor from the University of Southern California’s Keck School of Medicine, providing expertise in physiology, immunology, and receptor-mediated gene transcription.

BPS has grown to accommodate our clients’ needs, but we keep the number of our direct employees low. This ensures that we have maximum ability to reach out to our colleagues in independent practices for specialized expertise, while maintaining low overheads so that we provide expert and cost-effective assistance to the public and private sectors. More routine tasks such as literature search and retrieval, database creation and management are assigned to BPS’s professional support staff, again to ensure cost-effective service. 

Some of our key close collaborators with independent practices include the following:

  • Lucy Gillespie, PhD. Specializes in public and administrative data analysis and manipulation. With a background in public policy analysis, government, and process improvement, she helps organizations turn complex datasets into clear, actionable insights. Her work spans data acquisition, cleaning, analysis, visualization, and the development of efficient solutions to systemic problems. She brings a practical perspective to using data to understand complex systems and support evidence-based decision-making.

  • Julie Hagan, MS, who has been involved with or in the C-suite of multiple human therapeutic start-ups in the cell and gene therapy space, RNA/LNP therapy, and has played a key role in the early regulatory filings for xenotransplantation, cell and gene therapy, and other biologics.  She has demonstrated expertise in orphan indications, rare diseases, the use of AAV vectors, genome editors, fast track and orphan drug designations, as well as RMAT applications.  She is an expert in developing and reviewing GLP, cGMP, and Good Clinical Practices as part of human therapeutic development and approvals.

  • Doug Kern, DVM, MS a Board-Certified veterinarian with prior senior-level experience working in most of the biotechnology companies involved in developing animals with intentional genomic alterations for use as source materials for human therapeutics or food. He has over 35 years of experience spanning swine and bovine health, diagnostics, vaccines, gene therapy, and genome-edited animal models. He has held senior roles in both startups and global companies, helping pioneer the first gene therapy approval for food animals without slaughter restrictions.  His career blends veterinary practice, industry leadership, and regulatory expertise at the intersection of animal health and human medicine.  His most recent professional endeavors are focused on supporting CMC production processes, regulatory strategy, and adventitious agent risk management programs for swine-based xenotransplantation.

  • Robert Merker, PhD, former supervisor in the Office of Food Additives at the Center for Food Safety and Nutrition (CFSAN) at FDA frequently joins us on an ad hoc basis. At FDA, Dr. Merker was responsible for implementing the consultation process for food from genetically engineered plants. Dr. Merker was trained in microbiology and maintains his currency in that field.

On an as-needed basis, BPS has close working relationships with other individuals with expertise in areas such as government database information retrieval and analysis, biosecurity, and US food and drug law.

BPS’ co-founders maintain academic affiliations because we realize the education is key to maintaining excellence in the scientific and policy workforces: we are involved in teaching and mentoring students, particularly young women interested in STEM fields who come from less-advantaged environments.

All work performed by BPS is held confidential in perpetuity, including the names of our clients.

Our Approach

Co-Founders

Laura M. Plunkett, PhD, DABT

Laura Plunkett is co-founder of BioPolicy Solutions. She has a doctorate in pharmacology, is board-certified in toxicology, is a registered patent agent (USPTO Registration No. 45,015) and holds an adjunct professor position at Baylor university (Department of Environmental Sciences). Over her career she has worked in government and academic research, has taught undergraduate, graduate and law students, worked with inventors to move their ideas from the laboratory bench to the marketplace, and advised clients on regulatory strategies for all types of products in the global marketplace. She has worked on novel approaches to risk and safety assessment for substances and/or products where non-standard approaches may not be warranted. Over the years of her consulting career, Dr. Plunkett has assisted clients marketing products of all types that are regulated by agencies such as the U.S. Food and Drug Administration (FDA) and the U.S Environmental Protection Agency (EPA). She has assisted clients in preparing pre-market submissions that might be required by regulatory authorities, in designing product safety testing, in responding to post-market stewardship concerns, and in design of regulatory strategies for new products. She has served as an expert in courtrooms describing the relationship between exposure to chemicals or products and the risks they pose to human health as well as the regulatory paradigms that relate to development and marketing of products of all types (e.g., drugs, medical devices, foods, cosmetics, pesticides and industrial chemicals). Her work with the private sector also has included due diligence reviews for investors and companies seeking capital, focusing on developing regulatory strategies for products. 

Laura Plunkett is based in Aurora, Colorado.

Larisa Rudenko, PhD

Larisa Rudenko has spent her career evaluating emerging biotechnologies in the private (consultancies) and public sectors (US FDA).  Dr. Rudenko moved from the bench to more policy-oriented pursuits by developing novel methods for the risk/safety assessment of substances with non-traditional characteristics, including the products of biotechnology.  In her policy-oriented work, Dr. Rudenko has provided advice and comments to White House level bureaus on regulatory roadblocks and reforms. She has  worked with foundations, philanthropies, academicians, and professional organizations to help identify solutions to long-standing issues that limit the ability of the bioeconomy to flourish, including issues rooted in regulatory inefficiencies.  At BioPolicy Solutions, LLC, she and Co-Founder Dr. Laura Plunkett continue their work in emerging biotechnologies, including developing regulatory strategies for new products or new methods of manufacture for more traditional products; providing due diligence reviews for investors or companies seeking funding; post-market vigilance; and participating in advisory groups to governmental agencies and philanthropies interested in policy issues associated with the bioeconomy, regulatory reform, and developing efficient, science-based approaches for the products of emerging biotechnologies their responsible implementation. Following her early work in the private sector, including venture capital, she was recruited by the US FDA to serve as the senior advisor for biotechnology and inaugural Director of the Animal Biotechnology Interdisciplinary Group at the Center for Veterinary Medicine. There she was the primary author of seminal risk/safety novel approaches adopted by the US and that have functioned as the basis of similar approaches in other countries. She served as a subject matter expert to the US Trade Representative in negotiations with the EU, participated in key roles representing the US in Codex Alimentarius Writing/Working groups, expert consultations at the OECD, and as an expert in briefings to various Ministries and governmental regulatory agencies. She serves on several grant review committees in the US and Canada.. She has a PhD in Cellular and Molecular Pharmacology.

Larisa Rudenko is based in Ventura, California.