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.

ToxStrategies at TCEQ Trade Fair in Austin, TX (Booth #527)

Dr. Kirby Tyndall, Mrs. Camarie Perry, and Ms. Alea Goodmanson will be at the annual TCEQ Environmental Trade Fair & Conference next week in Austin, TX.  They’re looking forward to seeing some familiar faces and meeting new people. Stop by and visit them at booth #527!

ToxStrategies Presenting and Exhibiting at SOT 2016 (Booth #948)

ToxStrategies’ scientists continue to develop innovative solutions to address some of the most challenging scientific issues that face our clients buy xenical.  Several recent examples of such projects will be presented at the Society of Toxicology 55th Annual Meeting. The SOT 2016 conference will be in New Orleans the week of March 13-27, 2016. To see a schedule of our presentations, click here.  If you will be present in New Orleans, come by and visit with us at our presentations.  If you will not be in attendance, but would like to receive a copy of a particular presentation, reply to this email with your request and we will send you a copy of the presentation at the conclusion of the meeting. Additionally, ToxStrategies will be exhibiting at the ToxExpo. Visit us at Booth #948 to learn more about our services and meet members of our staff.

ToxStrategies at IPPE 2016 – Atlanta, GA (Booth #3010)

ToxStrategies will be attending and exhibiting at the International Production & Processing Expo (IPPE) in Atlanta, GA from January 26 to January 28, 2016.

IPPE is one of the largest annual trade shows for the poultry, meat and feed industry. It is a collaboration of three shows: the International Poultry Expo, the International Meat Expo, and the International Feed Expo. IPPE focuses on:

  • Innovation – presenting the latest technology of product and services
  • Education – providing seminars on topics that cross industry interests from production to regulation
  • Global Reach – more than 7,000 international visitors representing over 100 countries will attend
  • Networking – provides opportunities to collaborate with leaders from various aspects of protein processing and production

ToxStrategies scientists, Alea T xenical diet pills. Goodmanson and Jodi Miller, are looking forward to meeting new people and seeing a few familiar faces. Stop by and visit them at booth #3010!

For more information on the education program, the trade show, or other meeting details, please click here.

Dr. Daniele Wikoff invited to speak at EPA’s Advancing Systematic Review Workshop (December 2015)

ToxStrategies’ Health Sciences Practice Leader, Dr. Daniele Wikoff was an invited speaker at EPA’s ‘Advancing Systematic Review for Chemical Risk Assessment’ workshop held in Arlington, VA on December 16-17, 2015.  Dr. Wikoff presented ‘Lessons learned in protocol development and implementation of multi-endpoint systematic reviews’ and participated in a panel discussion on the integration of mechanistic data in a systematic review.

 

The goal of this workshop, was to facilitate discussion on both advances and applications of methods for the identification of relevant epidemiological, toxicological, and mechanistic scientific data to be relied upon in chemical assessments. Sessions involved a number of scientific experts and were part of a three-part workshop series supporting implementation of a systematic review process within the EPA’s IRIS program.

 

Dr. Wikoff has extensive expertise in the area of systematic reviews, particularly with regards to the assessment of adverse effects potentially associated with consumption of caffeine.  Dr. Wikoff has also registered several systematic review protocols, which can be viewed here.