Author Archives: ToxStrategies

EpidStrategies opens new post for Epidemiologist

EpidStrategies, a division of ToxStrategies Inc., is founded on rigorous scientific principles that guide our research on complex health conditions. We are scientists who provide consulting services to public and private sectors worldwide. With a focus on pharmaceuticals, medical devices, nutrition, and environmental chemicals, our scientists aid clients in the conduct, evaluation, and interpretation of epidemiologic studies. We are seeking an epidemiologist to join our team of epidemiologists and statisticians conducting systematic literature reviews and statistical analyses, and preparing manuscripts.  EpidStrategies offers a challenging and dynamic work environment, professional development opportunities, and competitive compensation and benefits.

 

Specific job responsibilities include:

  • Perform systematic literature reviews following establishing guidelines such as PRISMA
  • Conduct statistical analyses using SAS, STATA, or R
  • Write project proposals and other technical documents
  • Draft conference abstracts and manuscripts
  • Develop new and maintain existing client relationships
  • Project management including oversight of multiple project timelines, deliverables, and budgets

 

Ideal candidate will have:

  • MPH, MS, or PhD in a relevant field such as epidemiology
  • Approximately 3-5 years of work experience
  • Strong writing and communication skills
  • Experience conducting literature reviews
  • Proficiency in at least one statistical computing package
  • Familiarity with attending and presenting at professional conferences
  • Existing authorization to work in the United States

 

Interested candidates should send a cover letter and CV to hr@toxstrategies.com.

New paper shows acceptable radiation exposure from beneficial use of alumina waste

ToxStrategies scientist Dr. Bill Rish is a co-author of a new article that demonstrates acceptably low doses of naturally occurring radiation (NORM) when using the waste from alumina production (APR, or alumina production residue) in producing and using cement. Putting APR to this beneficial use, instead of storing it indefinitely, has raised concerns about workers involved in cement production or use, or members of the public, being exposed to radiation. The findings of Dr. Rish and colleagues, however, demonstrate that workers or the public being exposed to radiation over the life cycle of APR reuse will not receive doses in excess of any current risk-based standards. The article is published in the Journal of Air & Waste Management Association.

Publication on lack of aspartame carcinogenicity

A recently published article by ToxStrategies scientists, with Dr. Daniele Wikoff as lead author, presents the systematic identification, appraisal, and integration of mechanistic data in an assessment of potential carcinogenicity of the non-nutritive sweetener aspartame. Based on the evaluation of over 1300 measurements/assay endpoints related to one or more key characteristics of carcinogens (KCC) reported in the literature and via high-throughput screening data, the authors found a lack of evidence for activity across the mechanistic database. These results align with the overall lack of tumor response to aspartame in rodent cancer bioassays, corroborating previous reports of a lack of carcinogenicity related to aspartame exposure. The open access article can be found here: https://www.sciencedirect.com/science/article/pii/S0278691519306568

ToxStrategies scientists focus on cannabidiol (CBD) safety

Following implementation of the Hemp Farming Act, part of the Agricultural Improvement Act of 2018 (aka, “2018 Farm Bill”), interest in hemp-derived products, especially cannabidiol (CBD), has outpaced the development of a legal pathway for their use. As the industry advocates for the US FDA to issue a regulation for lawful marketing of CBD in food and/or dietary supplements, ToxStrategies has been assisting clients in conducting systematic safety evaluations, including those to support future regulatory submissions. Specific experience includes assessment of CBD manufacturing conditions and toxicological safety that could support future Generally Recognized as Safe (GRAS) and New Dietary Ingredient (NDI) submissions, as well as the safety profile of naturally occurring CBD in hemp food products. ToxStrategies continues to monitor regulatory developments in the area of hemp-derived products and participates in relevant trade associations, such as the Council for Responsible Nutrition (CRN), where Dr. Rayetta Henderson (ToxStrategies Managing Scientist) is a member of the CBD Task Force.

ToxStrategies at BSTP/AIT 2016 – Alderley Edge, Cheshire, UK

ToxStrategies will be represented at the upcoming 31st annual meeting of the British Society of Toxicologic Pathology (BSTP) held jointly with the Association of Inhalation Toxicologists (AIT) in Alderley Edge, Cheshire, UK (November 10-11, 2016) by Dr. Marcie Wood. Dr. Wood will be presenting a US regulatory perspective on determination of adversity in inhalation toxicology studies.

Dr. Wood is a Senior Scientist in ToxStrategies’ Biopharmaceutical/Pharmaceutical Practice and has expertise assisting clients with issues related to nonclinical safety assessment of small molecule and biologic products, including general toxicology and inhalation toxicology. ToxStrategies’ scientists have worked at the FDA, as well as in the biopharmaceutical and pharmaceutical industries, and are uniquely suited to assist clients with complicated scientific, regulatory, and strategic challenges that arise during the nonclinical development of drug candidates.

Please contact Dr. Wood (mwood@toxstrategies.com) if you would like to arrange to meet with her at BSTP/AIT.

ToxStrategies at SETAC 2016 – Orlando, FL (Booth #706)

Dr. Kirby Tyndall and Ms. Camarie Perry will be attending and exhibiting at the upcoming Society of Environmental Toxicology and Chemistry (SETAC) meeting in Orlando, Florida (November 6-10, 2016). This year marks the 7th SETAC World Congress meeting, and the 37th Annual SETAC North America meeting.

Dr. Tyndall and Ms. Perry are Senior Scientists at ToxStrategies.  They have extensive expertise assisting clients with a wide array of issues related to toxicology, complex environmental and human health risk assessments, and development of risk-based cleanup levels. ToxStrategies’ scientists have experience working at various regulatory agencies (state and federal), within industry, and consulting.  As a result, our scientists are uniquely suited to assist clients with complicated scientific, regulatory, and strategic challenges.

Dr. Tyndall and Ms. Perry are looking forward to seeing some familiar faces and meeting new people while in Orlando.  Please stop by and visit them at booth #706!

ToxStrategies at ACT 2016 – Baltimore, MD

ToxStrategies will be represented at the upcoming American College of Toxicology (ACT) meeting in Baltimore, Maryland (November 6-9, 2016) by Dr. Andrea Weir and Dr. Gary Chellman.

Dr. Weir and Dr. Chellman are Senior Scientists in ToxStrategies’ Biopharmaceutical/Pharmaceutical Practice and have extensive expertise assisting clients with a wide array of issues related to nonclinical safety assessments for novel small molecule and biological products, including general toxicology and reproductive toxicology.  ToxStrategies’ scientists have worked at the FDA, as well as in the biopharmaceutical and pharmaceutical industries, and are uniquely suited to assist clients with complicated scientific, regulatory, and strategic challenges that arise during the nonclinical development of drug candidates.

Please contact Dr. Weir (aweir@toxstrategies.com) or Dr. Chellman (gchellman@toxstrategies.com) if you would like to arrange to meet with them at ACT.

FSMA Compliance Deadline for Large Companies Has Arrived

The first major compliance deadline for larger businesses (>500 employees) to comply with the Food Safety Modernization Act (FSMA) Preventive Control rules for human and animal foods has arrived.  FSMA was “a call for a new, prevention-oriented safety system.”  This new focus on prevention requires food facilities to have written food safety plans encompassing both Good Manufacturing Practices and applicable Hazard Analysis and Preventive Controls.

As of September 19, businesses involved in the production of human foods must comply with both the Hazard Analysis and Preventive Controls regulations as well as adhere to the current Good Manufacturing Practices published in 21 CFR Part 117 Subpart B.  Animal food businesses are only required to comply with current Good Manufacturing Practices described in 21 CFR Part 507 Subpart B.   This is a new era for food safety regulation and is being met with some expected angst and trepidation.  However, FDA has communicated that while the expectation is for businesses to be in compliance, the focus of FDA will continue to be on education and training to assist businesses in compliance.  Joann Givens, co-chair of the FSMA Operations Team Steering Committee and director of FDA’s Food and Feed Program in the Office of Regulatory Affairs, states, “We want to see people doing the best they can. It’s a marathon, not a sprint. They’re learning; we’re learning. We are very committed to educating while we regulate to align understanding and expectations.”  FDA’s goal is to continue to publish guidance documents to assist businesses understand expectations and will continue to engage industries.  A culture of food safety is being built, with emphasis on practices and procedures recognized to minimize the risk of safety issues.  However, FDA is quick to point out if safety issues are observed, they will take swift action.

Compliance with FSMA will be an evolving process.  Our Foods & Consumer Goods Practice staff at ToxStrategies is very knowledgeable regarding the requirements of FSMA and are available to provide assistance.  Ms. Jodi Miller, a Senior Scientist on our staff, is a recognized Preventive Control Qualified Individual Lead Instructor for both human and animal foods.  Ms. Miller is available to provide personalized PCQI training as well as a fundamentals of FSMA course.  If you need assistance implementing or complying with FSMA, or would like more information on FSMA training, please contact Jodi Miller, Senior Scientist at (937) 681-9476 or Candace Doepker, Ph.D., Food and Consumer Products Practice Leader at (513) 206-9929.   For additional information on FSMA compliance, click here.