Kristian Fried, Ph.D., Dr. rer. nat., DABT, ERT

Regulatory Safety for Ultraviolet Filters in Sunscreens under FDA, Washington, DC — Leading consortia support team regarding FDA requirements for existing sunscreen active ingredients. Overseeing new formulation development, literature review and in silico and in vitro determination of metabolism, and in vitro dermal permeation tests. Activities include reviewing existing clinical safety data and identifying new testing needs, as well as supporting nonclinical work team for FDA submission.

Evaluation of Emerging Ingredient Vulnerabilities for Consumer Products, Confidential Location — Reviewed key ingredient groups for four risk factors:  human and environmental safety endpoints of interest, current regulatory activities, current business climate among customers and competitors, and reputational vulnerability due to negative attention from opinion leaders, activists, academics, and consumers. Developed recommendations and strategies for ingredient defenses.

Development of Product Stewardship Guidance Regarding Laser-Generated Airborne Contaminants, Confidential Location — Performed an assessment and toxicological evaluation of emissions from at-home laser devices. Reviewed material-specific emissions data regarding consumer health. Developed safety guideline based on modeled concentrations in indoor air.

Product Stewardship Guidance for Regulatory Compliance, Confidential Location — Advising an internationally operating manufacturer on compliance strategies with applicable European and U.S. regulations and potential applications for corporate sustainability goals.

Human Safety Assessments for Consumer Products Ingredients, Confidential Location — Leading a team of risk assessors in drafting comprehensive safety reviews for raw materials. Efforts include the identification of suitable read-across compounds, compilation of hazard data, identification of key endpoints and key studies, dose–response assessments as well as consumer exposure calculations and the determination of margins of safety.

Independent Scientific Review of Safety Assessments, Confidential Location — Determining scientific comprehensiveness and logic, toxicological soundness and adequacy, as well as factual correctness and supportability of third-party safety assessments. Supporting client compliance with internal quality standards and, subsequently, global regulatory compliance.

Environmental Safety Screening of Consumer Products Ingredients, Confidential Location — Grouped raw materials into structurally similar chemical categories for efficient screening of toxicological properties. The key physical-chemical properties identified were used to assess biodegradation and aquatic toxicity.

Identification and Justification of Read-across to Address Gaps in Toxicological Data Sets, Confidential Location — Determining key moieties in parent compounds and identifying structural analogs to expand the supporting toxicological database. Deriving probable metabolic pathways and resulting products to support the read-across justification. Anchoring toxicological data of surrogates to specific endpoints of the parent compound for confirmation of validity.

Comments on Human Health Hazards for Two Chemicals Assessed by USEPA in Accordance with the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Washington, DC — Provided scientific reviews to a client seeking to submit comments to EPA’s draft risk evaluations of two halogenated chemicals. Proposed comments for consideration by the Science Advisory Committee on Chemicals.

Safety Monitoring after a Commercial Lithium Battery Fire, New York — During a post-emergency response, developed sampling plan and testing strategy including identification of key analytes relevant for human health and subsequent assessment of drinking water and soil samples.

Leader of the Oral Care Global Product Safety Group for a Large Consumer Goods Company, U.S./Global — Supported all globally developed oral care products and devices in the therapeutic and cosmetic sectors as well as professional dental and oral health applications. Developed and implemented strategies for submission to FDA (pre-investigational new drug, investigational new drug, and medical device applications) and European authorities. Worked with client consumer affairs and corporate communications to develop responses to media inquiries for product or ingredient safety issues. Served on crisis management teams, advised the pharmacovigilance group on assessments of safety relevant to the post-marketing surveillance of adverse events, and worked closely with corporate legal counsel to provide support on safety labeling, claims, and product liability.

Leader of the Home Care, Flavors and Fragrances Global Product Safety Group for a Large Consumer Goods Company U.S./Global — Supported global research and development teams across a multitude of product types and product forms including laundry detergents and fabric conditioners, surface cleaners, dish detergents and industrial/commercial cleaning products, and degreasing agents. Worked with client consumer affairs, corporate communications, and global legal to develop responses to product or ingredient safety issues.

Consortium Toxicology Lead Regarding the European Commission’s Scientific Committee on Consumer Safety (SCCS) Opinion on Water-Soluble Zinc Salts Used in Oral Hygiene Products, Brussels, Belgium — Developed submission strategy and coauthored age-specific safety assessments, including exposure assessments, according to the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, and customization thereof for pediatric uses.

Consortium Toxicology Team Member and Later Lead Regarding the European Commission’s SCCS Review of a Biocide, Brussels, Belgium — Codeveloped scientific defense and coauthored safety assessments, including a deterministic exposure assessment, according to the SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation, and a probabilistic exposure assessment based on market data.

Corporate Toxicology Assessor for California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65), California — Conducted literature-based as well as experimental exposure assessments to determine consumers’ exposure to chemicals Listed or with the Intent to List on Prop 65. Derived safe harbor levels if not published, and identified potential labeling requirements or absence thereof.

Response to a Notice of Intended Change of a Threshold Limit Value, Time-Weighted Average by the American Conference of Governmental Industrial Hygienists (ACGIH®), Cincinnati, Ohio — Collaborated with consortium leadership and drafted a response to proposed changes of the safe occupational exposure level of a respirable mineral. Provided a comprehensive scientific review of the referenced literature and other, publicly available information to consortium members for submission to ACGIH.

Automotive Specialty Additives Safety, Detroit, Michigan — Reviewed adverse events from occupational exposures and provided guidance on usage habits, personal protective equipment, and safer alternatives.

Environmental Safety Justification, FDA, Washington, DC — Performed quantitative evaluation of potential environmental risks for a new drug application. Identified different read-across compounds based on the new drug’s novel mode of action. Discussed identified safety thresholds and potential for combined effects as well as expected environmental concentrations with FDA.

Environmental Risk Evaluation, Swiss Agency for Therapeutic Products, Bern, Switzerland — Provided quantitative determination of aquatic risks from increased market volumes of a drug product. Compared highest projected discharges from use to predicted no-effect concentrations in the context of fate and occurrence in Swiss waterways.

Pharmaceutical Safety Dossiers for Pre-investigational New Drug, Investigational New Drug, and New Drug Application Submissions to FDA, Washington, DC — Leading the compilation of existing nonclinical and clinical safety data into dossier format for novel anticaries and antiperiodontitis agents.

Safety Dossier for a 510(k) Medical Device Submission to FDA, Washington, DC — Prepared a safety dossier for consideration of biocompatibility testing under the International Organization for Standardization (ISO) Standard 10993-1, irritation and sensitization testing under ISO 10993-10, and cytotoxicity testing under ISO 10993-5.

Safety Dossiers on Fluoride for Regulatory Submissions to Drug and Medicine Agencies, U.S., Europe, and Latin America, Global — Prepared safety dossiers in support of the safe use of high-fluoride dentifrices for children and adults in prescription and over-the-counter applications.

Safety Certification for Extractables and Leachables in a European Drug Manufacturing Process, Basel, Switzerland — Reviewed analytical data and assessed detected contaminants on the basis of hazards, dose response, and patient exposure.

Assessment of Allowable Carryover Contamination with Pharmaceuticals in Batch Manufacturing for Submission to the European Medicines Agency, Amsterdam, Netherlands — Applied the principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M7 guideline to calculate compound-specific acceptable intakes. ICH M7 outlines the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk.

Development of a Drug Lead, Munich, Germany; Kansas City, Kansas, U.S.; Nottingham, U.K. — Collaborated internationally on the development of a novel pharmaceutical based on a known pharmacophore. Conducted research visits at academic and government facilities in the U.S., U.K., and Germany.

Binding Studies on Pharmaceutical Target Receptors, Munich, Germany; Nottingham, U.K. — Developed and implemented in silico and in vitro study strategies to assess binding affinity and efficacy of a novel pharmaceutical to a molecular target.

Nonclinical Safety and Efficacy Studies, Kansas City, Kansas — Translated molecular mechanisms of action into biological effects in three different animal models by identifying and quantifying two hematological biomarkers.

Assessment of the Safety of Fluoride in Drinking Water, Kenya — Provided safety support for a nonprofit nongovernmental organization regarding elevated fluoride levels in newly drilled drinking water wells in Kenya.

Biodegradation of Petrochemicals, U.S. and U.K. — Project chair and technical leader to develop guideline-compliant modified biodegradation protocols, accounting for the unique physical-chemical properties of test materials.

Environmental Mobility of Water Soluble Polymers, Confidential Location — Reviewed existing scientific literature regarding the migration of this class of polymers between environmental compartments including wastewater and assessment of in silico models and test methods to predict real-world environmental behavior.

Regulatory Toxicology Evaluations for PFAS, U.S. — Examined the scientific basis of proposed rulemakings for a variety of per- and polyfluoroalkyl substances (PFAS) at the state and federal levels, as well as internationally, and assessed the extent to which they are founded on sound scientific principles.

Geospatial PFAS Presence and Chemistry Assessment, Confidential Location — Conducted location-based reviews for potential PFAS contamination based on past land use, including identification of expected congeners.

Forensics PFAS Chemistry, Confidential Location — Reviewed PFAS congener distributions in groundwater and assessed the plausibility of links to parent compounds potentially deposited in a historical industrial landfill.

Chemistry of PFAS Food Contact Substances, Confidential Location — Evaluated environmentally occurring compounds regarding historical use in food contact paper packaging applications that had been authorized under the FDA’s Food Contact Notification process.

PFAS in Chemical Manufacturing, Confidential Location — Reviewed historical industrial chemical production processes for potential uses or preparation of PFAS.

PFAS Resin Stability Assessment, Confidential Location — Assessed the potential for a PFAS resin to release environmentally relevant degradation products under landfill conditions.

Monitoring of Regionally Relevant PFAS Communications, California, Pennsylvania, New Jersey — Attended town hall meetings and followed locally relevant podcasts with emphasis on toxico-chemical discussions and risk communication regarding PFAS.

Integral’s Monthly PFAS Updates, Portland, Maine — Leads team of scientists conducting continuous literature reviews and summarizing scientific publications regarding PFAS occurrences, fate and transport, remediation and treatment, and toxicology, as well as environmental and human safety.  The subscription-based newsletter also includes updates regarding PFAS policy decisions and current developments in the global regulatory landscape.

Personal Injury Litigation Support Regarding Pesticides, Minnesota — Authored expert report regarding toxicokinetics; exposure time and onset of alleged adverse health effects; toxicological hazards and risks; as well as ingredient properties.

Air Emissions from Wood-Based Combustion Processes, Texas — Authored declarations and expert report regarding modeled emission concentrations at a facility’s fence line, characterized the risk and importance of time and toxicokinetics, and assessed individual emission components including, but not limited to, hazardous air pollutants, volatile organic compounds, and particulate matter. Commented on other expert reports.

Litigation Support Regarding PCBs, Multiple Locations U.S. — Providing technical support for biomonitoring data analysis, performing human health risk assessments, and providing toxicological guidance to counsel for multiple litigation projects related to PCBs in the environment. Primary focus of the human health risk assessments is exposure to PCBs in ambient air, surface water, and sediment and from consumption of seafood. This project is ongoing.