Shawn Lee has over 15 years of experience in the bio-pharmaceutical industries as in-house counsel and as an expert consultant and witness. He has worked for companies such as Teresa & Shawn International Corp, Johnson & Johnson, and CSSC Inc, where he specialized in areas like computer validations, SOP protocols, analytical method validations, and in-process validations. He holds a Certificate in Accounting, Taxation and Legal Programs from New York University, an MS in Bioinformatics from New Jersey Institute of Technology, an MS in Chemical Engineering from Ohio University, and a BS in Chemical Engineering from Tamkang University.
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct biocompatibility testing. Biocompatibility testing is used to determine the “potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body”. The FDA relies heavily on ISO 10993 as the guiding force for biocompatibility testing in medical devices. This ISO standard is rooted in a risk-based approach to testing that the FDA views as the gold standard to ensure that medical devices do not cause adverse local or systemic effects due to contact with human tissue...
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...OECD Environment
Humans and the environment are exposed every day to chemicals. How do we make sure that these chemicals are safe?
Industry is required to test these chemicals to understand how they may affect people and the environment. In the past, these tests were most commonly carried out on animals. As scientific methods and tools progress, the use of animals to test a product designed for humans are becoming obsolete, in addition to being unethical. With new methods being developed, it is possible to perform these tests on human and animal cell cultures with equally rigorous and robust results. Because the OECD is committed to chemical safety and animal welfare, a new ground-breaking Guideline on Defined Approaches for Skin Sensitisation (OECD GL 497: https://doi.org/10.1787/b92879a4-en) was released on 14 June 2021. It is the first ever Guideline that uses non-animal methods to predict whether a chemical can cause skin allergies. The OECD organised a webinar on 18 October 2021 at 14:00 to discuss the implementation of the Defined Approaches on Skin Sensitisation for chemical safety in member countries. This webinar paved the way for companies and authorities to determine the environmental toxicity of chemicals without having to resort to animal testing.
Speakers:
- Nicole Kleinestreuer: NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) - Silvia Casati: European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
- Anna Lowit: U.S. Environmental Protection's Office of Pesticide Programs (US EPA OPP)
- Paul Brown: U.S. Food and Drug Administration (US FDA)
- Laura Rossi: European Chemicals Agency (ECHA)
- Andre Muller: National Institute for Public Health and the Environment (RIVM)
Access the video replay and more information about our work at: https://oe.cd/testing-assessment-webinars
Researchers at EPA’s National Center for Computational Toxicology integrate advances in biology, chemistry, and computer science to examine the toxicity of chemicals and help prioritize chemicals for further research based on potential human health risks. The goal of this research program is to quickly evaluate thousands of chemicals, but at a much reduced cost and shorter time frame relative to traditional approaches. The data generated by the Center includes characterization of thousands of chemicals across hundreds of high-throughput screening assays, consumer use and production information, pharmacokinetic properties, literature data, physical-chemical properties as well as the predictive computational modeling of toxicity and exposure. We have developed a number of databases and applications to deliver the data to the public, academic community, industry stakeholders, and regulators. This presentation will provide an overview of our work to develop an architecture that integrates diverse large-scale data from the chemical and biological domains, our approaches to disseminate these data, and the delivery of models supporting predictive computational toxicology. In particular, this presentation will review our new publicly-accessible CompTox Dashboard as the first application built on our newly developed architecture. This abstract does not reflect U.S. EPA policy.
If your medical device has contact with human tissue, it is a safe bet that you will be required to conduct biocompatibility testing. Biocompatibility testing is used to determine the “potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body”. The FDA relies heavily on ISO 10993 as the guiding force for biocompatibility testing in medical devices. This ISO standard is rooted in a risk-based approach to testing that the FDA views as the gold standard to ensure that medical devices do not cause adverse local or systemic effects due to contact with human tissue...
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...OECD Environment
Humans and the environment are exposed every day to chemicals. How do we make sure that these chemicals are safe?
Industry is required to test these chemicals to understand how they may affect people and the environment. In the past, these tests were most commonly carried out on animals. As scientific methods and tools progress, the use of animals to test a product designed for humans are becoming obsolete, in addition to being unethical. With new methods being developed, it is possible to perform these tests on human and animal cell cultures with equally rigorous and robust results. Because the OECD is committed to chemical safety and animal welfare, a new ground-breaking Guideline on Defined Approaches for Skin Sensitisation (OECD GL 497: https://doi.org/10.1787/b92879a4-en) was released on 14 June 2021. It is the first ever Guideline that uses non-animal methods to predict whether a chemical can cause skin allergies. The OECD organised a webinar on 18 October 2021 at 14:00 to discuss the implementation of the Defined Approaches on Skin Sensitisation for chemical safety in member countries. This webinar paved the way for companies and authorities to determine the environmental toxicity of chemicals without having to resort to animal testing.
Speakers:
- Nicole Kleinestreuer: NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) - Silvia Casati: European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
- Anna Lowit: U.S. Environmental Protection's Office of Pesticide Programs (US EPA OPP)
- Paul Brown: U.S. Food and Drug Administration (US FDA)
- Laura Rossi: European Chemicals Agency (ECHA)
- Andre Muller: National Institute for Public Health and the Environment (RIVM)
Access the video replay and more information about our work at: https://oe.cd/testing-assessment-webinars
Researchers at EPA’s National Center for Computational Toxicology integrate advances in biology, chemistry, and computer science to examine the toxicity of chemicals and help prioritize chemicals for further research based on potential human health risks. The goal of this research program is to quickly evaluate thousands of chemicals, but at a much reduced cost and shorter time frame relative to traditional approaches. The data generated by the Center includes characterization of thousands of chemicals across hundreds of high-throughput screening assays, consumer use and production information, pharmacokinetic properties, literature data, physical-chemical properties as well as the predictive computational modeling of toxicity and exposure. We have developed a number of databases and applications to deliver the data to the public, academic community, industry stakeholders, and regulators. This presentation will provide an overview of our work to develop an architecture that integrates diverse large-scale data from the chemical and biological domains, our approaches to disseminate these data, and the delivery of models supporting predictive computational toxicology. In particular, this presentation will review our new publicly-accessible CompTox Dashboard as the first application built on our newly developed architecture. This abstract does not reflect U.S. EPA policy.
6 3-2016 regulatory affairs entry level resume bum kimBum Kim
I find it very difficult to get my first step in the door for my Regulatory Affairs Career, but I am sure that I will be a very successful Regulatory Affairs Professional once I can get started with my first job!!! Knocking on the opportunities right now!!!
6 3-2016 regulatory affairs entry level resume bum kimBum Kim
I find it very difficult to get my first step in the door for my Regulatory Affairs Career, but I am sure that I will be a very successful Regulatory Affairs Professional once I can get started with my first job!!! Knocking on the opportunities right now!!!
Leveraging Data to Develop, Execute and Exceed the Expectations of Your Regu...April Bright
Scientific data, homegrown or from published literature, is essential to your regulatory strategy…be it establishing substantial equivalence in FDA 510(k) applications, qualifying a device as a legitimate predecessor in the context of a Technical File for CE Mark, predicting the performance of a device in development, judging a new device in verification and validation testing and, with proper planning, expanding indications for use and identifying new marketable claims of performance (or mitigation of risk and liability). In this session, participants will be exposed to various vital data sources and obtain practical examples for putting them to meaningful use.
Anthony Presentation at DIA Chicago Oct 2008AKTaylor
The requirements of the clinical trial databases provision in the FDA
Amendments Act apply to academic and independent investigators
as well as to industry conducted clinical trials. This session will
highlight the challenges faced by academic and independent investigators
and best practices in registering clinical trials and establishing
procedures for reporting study results to ClinicalTrials.gov.
Anthony Presentation DIA Florida Ctd Nov2007AKTaylor
Creating a business process that is accurate, predictable, and capable of
meeting the changing needs for disclosing information about clinical trials
in multiple study registries and results databases is difficult. Companies
need to leverage their current clinical trial process, determine if the disclosure
steps will be centralized or decentralized, determine how much to
leverage technology, and decide whether, and how, to use outside
resources. During this session, we will hear how a large pharma, a small
biopharmaceutical company, and a device company developed their clinical
trial disclosure business process.
Multiplex Assays in Translational Medicine: Technologies, Applications, and F...ReportLinker.com
The development and growth of assay technologies has pushed translational medicine into a category unto itself. In a broad perspective on this field, this new report:Defines translational medicine by giving some historical background as well as providing personal definitions from experts in the field Discusses the evolution of assay technologies Reviews currently available assay technologies that apply directly to translational medicine Describes and evaluates current applications of these technologies Provides case studies of clinicians currently using this technology in their research Discusses future directions of assay technologies for translational medicine Gives input from the FDA on translation medicine and assay technologies Provides interviews from experts in the field of both translational medicine and specific assay technologies Profiles premier companies active in the field Assay technologies have been evolving since scientists first discovered they could measure glucose, insulin, and several hormones in the blood to help them diagnose disease. Early instruments such as the Ames Reflectance Meter, used for detecting glucose levels, have morphed into such sophisticated systems as flow cytometers. The Human Genome Project provided the basics for researchers to launch into the field of human genomics and they needed the tools to accomplish this. DNA microarrays allowed for massively parallel gene expression analyses. Scientists soon discovered that while the genomewide assays were extremely valuable, there were genes of interest that they had difficulty measuring when they got hundreds of data points from a microarray. Low- to mid-density assays have allowed scientists to pinpoint the genetic code for a variety of uses, from genetic heredity studies to drug metabolism and patient stratification.
1. Shawn Lee
www.teresashawncorp.com
Experience
teresa&shawn int’l corp January 2007 – Present NY, CT, NJ
In-house counsel in bio-pharmaceutical industries in related to computer validations and SOP
protocols consulting. In year of 2002, I was assigned as expert consultant for four months in
Puerto Rico at Schering Plough Pharmaceuticals sites, and Schering Plough is merged with
Merck now.
Expert witness in scientific discovery for forensic accounting and relevant evident in court
A Johnson & Johnson Company January 2003 – August 2003
Research Scientist Warren, New Jersey
Develop HPLC assay, Elution testing for USP apparatus 4 method on multi-APIs components
with anti-biotic medicines, steroids, and hormones.
Apply Polymer coating techniques in formulating APIs and vehicles in compliance with c-
GMPregulation.
CSSC Inc. January 2002 – June 2002
Sr. Validation Scientist Morristown, New Jersey
•Conduct in-process validation in automated monitoring systems
•Conduct analytical method validation related to FDA compliance
•Conduct 21 CFR Part 11 related to data integrity, automatic audit trails documentum
Education
New York University (2008 ~ 2011)
Certificate in Accounting, Taxation and Legal Programs,
CFE
New Jersey Institute of Technology
MS. in Bioinformatics (2008– 2010)
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2. Ohio University, Athens, Ohio (1982-1984)
M.S. in Chemical Engineering
Tamkang University.Taiwan (1975-1979)
B.S. in Chemical Engineering
MEMBERSHIP
American Bar Association, ABA section of Business Law (2003 ~ 2011)
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