What is a Toxicology Consultant?
The services a Toxicology Consultant provides are diverse and vary from one individual consultant to another based on the Toxicology Consultant’s expertise and experience.
- Designing, monitoring and interpreting nonclinical safety studies
- Knowledge of GLPs and technical auditing
- Serving on Expert Panels and Scientific Advisory Boards
- Reviewing scientific literature
- Writing Expert Reports, White Papers, Study Report, product labels, Material Safety Data Sheets, Investigator’s Brochures, etc.
- Soliciting bids, evaluating and selecting Contract Research Organizations (CRO)
- Acting as liaison between sponsors and global regulatory authorities (FDA, EMA, EPA, Health Canada, etc.)
- Gap analysis and needs assessment
- Preparation of global regulatory submissions (IND/CTA, NDA/BLA, etc.)
- Responding and helping resolve US and international regulatory issues
- Assisting in new product development and existing product defense
- Provision of subject matter expertise during due-diligence activities
- Project Team subject matter expertise and leadership
- International and domestic pharmaceutical and medical device development
- Selection of clinical starting dose based on nonclinical safety data
- Registration and regulation of imported drugs and chemicals
Government/ Other Industry
- Occupational exposure and effects of exposure
- Chemical causation of cancer, birth defects, and other disease states
- Cosmetics and consumer product development
- Food additive petitions, GRAS evaluations, food contact notifications
- Dietary supplement 75-day notice development
- Pesticide exposure claims
- Environmental pollutants in soil, water and air
- Superfund and toxic waste site risk assessment
- Indoor air pollutants and sick building syndrome
- Safety assessment of military and police agents
- Registration and regulation of imported chemicals
- Litigation support
- Expert witness
- Communication of exposure risks to juries, the press and the public.
- Toxicological effects of alcohol and drugs of abuse
- Worker’s compensation litigation
The Origin of the Roundtable of Toxicology Consultants
Dr. Richard Parent founded the Roundtable of Toxicology Consultants (RTC) in 1986 following ongoing discussions with active toxicology consultants at Society of Toxicology meetings dating from 1984. Since that time the RTC has become the oldest and largest organization of independent consulting toxicologists in the world. Over the years he has actively and graciously helped many toxicologists make a successful transition from industry, government or academic careers in toxicology to success as independent consulting toxicologists who each day make significant contributions toward advancing the practice of toxicology in many unsung practical ways.
Not surprisingly, the early history of the RTC, from 1984 through 1988 was a formative time.
Late in 1984 and in early 1985, Richard Parent, Frank Dost, and Fred Oehme, the President of SOT, discussed the possibility of convening a group of consultants concerned with litigation support. An initial meeting for the group, with 32 people in attendance, occurred during the SOT meeting in San Diego, CA, during March of 1985. Various topics of discussion included the possibility of becoming a Specialty Section within SOT, qualification for membership, liability insurance, and a Code of Ethics. Following a meeting of Richard Parent with Emil Pfitzer, SOT President, in July of 1985, a symposium for the 1986 SOT meeting in New Orleans was proposed.
Initial organization of RTC occurred in early 1986. Early committees and chairs included: Frank Dost, Ethics; Steven Lamm, Roster; Norbert Page, Education; Ted Farber, Goals and Activities; and Andrew Reeves, Symposia. Richard Parent, as ad-hoc leader of this group, appointed Anne Wolven to chair the Organizing Committee, Carl Hake to chair the Nominating Committee, and C Schulz to chair the Operations and Bylaws Committee. During the 1986 SOT meeting, with 21 participants in attendance, R Parent was voted in as Chairman, A Wolven as Vice-Chairman, and N Page as Treasurer. Initial operating expenses were funded by passing the hat at the meeting; a whopping $125 was collected. By the end of 1986, Gordon Edwards began organization of a referral service for the 46 RTC members.
In early 1987, SOT President John Doull granted the RTC meeting space and a listing in the SOT activities brochure at the upcoming 1987 SOT meeting in Washington, DC. Minutes from that meeting revealed discussion of a RTC Constitution and by-laws (F Dost), and an update from various committee chairs: Finance (N Page), Education (Arthur Furst), RTC Referral Service (G Edwards), Organizing (F Dost), Symposia (Fred Homburger), Newsletter (Rudy VonBurg), Insurance (Dave Eaton), and Ethics (F Dost). And last but not least, the Nominating committee’s (led by C Hake) suggestions of R Parent (President), F Dost (Vice President), N Page (Treasurer), and R von Burg (Secretary) were unanimously accepted.
In August of 1987, the first RTC newsletter was issued, thanks to Rudy vonBurg and John Wedig, and contained requests for submissions, a listing of services, unique cases, RDX exposure, Market Place, an update on the RTC Referral Service, Q&A, Ideas, upcoming meetings, and address changes. Subsequent to newsletter receipt, a letter from Jerry Hook, SOT President, to R Parent congratulated the RTC for an apparently successful initiation.
By February of 1988, the organization registered 41 members, with 25 in attendance at the SOT meeting in Dallas, TX. Discussion topics included the constitution, advertising option, and a treasury report ($800). Various committees made their reports, and an Ethics committee (Walter Decker, Ralph Fogleman, Richard Parent, Vince Piccirillo, and Tom Shellenberger) was founded. Arthur Furst and Walter Decker were elected as Vice Preident and Secretary, respectively, by unanimous vote. Prior to the close of the meeting, President Richard Parent turned the Presidency over to Frank Dost.