Timothy A. Anderson, MS, MBA, is a former FDA Review Chemist, with over 35 years of career experience in Pharmaceutical R&D, Quality Operations, and Regulatory Affairs. A uniquely interdisciplined individual, he melds comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.
As a consultant in his own pharmaceutical development advisory firm for over 23 years, Mr. Anderson has furnished clients with services ranging from providing regulatory application filing strategies specialized in Chemistry and Manufacturing Controls, to current Good Manufacturing Practice (cGMP), quality system regulation (QSR) audits for finished dosage, and active pharmaceutical ingredient (API) manufacturing, as well as for device, drug-device combination, and biologic products. Technical and regulatory compliance due diligence services are furnished to institutional investors.
Mr. Anderson has contributed to regulatory approvals for over 50 drug and drug / device applications, spanning generic (ANDA) and innovator NDA, BLA, 510(k), PMA, and 505(b)(2) applications, and has provided regulatory compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.
Clients have included Medtronic Ave., Allergan, Memorial Sloan-Kettering Cancer Center, Mass Biologics, MDS Pharma, US Pharmacopieia, Boehringer Ingelheim, BristolMyers Squibb, Genzyme, Intelliject/Sanofi, Church & Dwight, CR Bard/Davol, Ximedica, Fresenius-Kabi (Austria), KRS Biotechnology Ajanta, and many more
George Schiro is a DNA Technical Leader - Forensic Scientist. His duties include incorporating the DNA Advisory Board (DAB) standards, accountability for the technical operations of the lab, conducting DNA analysis using the 13 STR core loci and Y STR in casework, DNA research, forensic science training and crime scene investigation.
Mr. Schiro has worked over 3500 cases and has qualified as an expert over 175 times in 31 Louisiana parish courts, Arkansas, California, Florida, Mississippi, Missouri, Nevada, New York, Texas, West Virginia, federal court, U.S. court-martial, and two Louisiana city courts. Has also consulted on cases in 29 states.
Qualified as an Expert in the Following Areas:
Shrawan Kumar, is one of the top worldwide recognized experts in Biomechanics and Ergonomics. Dr. Kumar has been the Keynote or Plenary speaker on Biomechanics and Ergonomics at over 59 regional, national, and international scientific conferences in Canada, the US, the United Kingdom, Brazil, Germany, Sweden, India, Australia and New Zealand. He is the author of over 528 scientific peer-reviewed publications on Biomechanics and Ergonomics including 16 books and 27 book chapters.
Dr. Kumar was recognized for his lifetime achievements and contributions to Biomechanics and Ergonomics research by an award of ‘Officer of the Order of Canada’ from the Governor General in 2009. He has a Ph.D. in Human Biology and a Doctor of Science degree (D.Sc.) in Biological Sciences.
Dr. Kumar was most recently the Director the Physical Medicine and tenured Full Professor at the University of North Texas. Prior to this he served as a tenured Full Professor of Physical Therapy, Neuroscience, and Biomedical Engineering at the University of Alberta.
Consulting - Dr. provides injury prevention through ergonomic and product design improving productivity and work efficiency. He has worked with such companies as Western Airlines, Alberta Food Processing Company, Misericordia Hospital, and Price Waterhouse.
Areas of Expertise:
Ideal Innovations, Inc, (I3) is recognized as an industry leader for Biometric Examination Services, including expert fingerprint identification, latent print identification comparisons, data base system administration, information technologies, Automated Biometric Information System support and biometric data enrollment services.
I3 provides examination services to the Department of Defense (DoD) and the Department of Homeland Security (DHS). We have trained Federal, State, local, international, intelligence and industry professionals. Their instructors are key members of the Organization of Scientific Area Committee (OSAC) for Forensic Sciences, Facial Identification Scientific Working Group (FISWG), and the International Association.
Lora S. Sims, CTPE currently serves as the Director of the Facial Identification Training and a Biometrics SME. In this position, Ms. Sims coordinates all training classes as well as many other Face related activities within the company and also provides subject matter expertise on Biometrics for contracts and consulting/expert witness work.
Ms. Sims is an IAI Certified Tenprint Examiner and is the current chair of both the Facial Identification Scientific Working Group (FISWG) and the Facial Identification Subcommittee of the Organization of Scientific Area Committees (OSAC) for Forensic Sciences. She also sits on the IAI Facial Identification Subcommittee.
Ms. Sims joined Ideal Innovations, Inc. in 2008 as a Tenprint Examiner at the DoD DFBA, which transitioned into a Sr. Biometric Examiner comparing multiple biometrics (fingerprints, faces, and irises). In this position, she co-authored a training to competency program on facial identification & comparisons and is responsible for mentoring and training new employees through the tenprint and facial training program while integrating them into an operational environment
Steven Lee Johnson joined the I3 Advisory Board after 13 years of service to the company as Senior Vice President. Mr. Johnson is the current Chair of the Forensics Science Standards Board (FSSB) of the Organization of Scientific Area Committees (OSAC), a National Institute of Standards and Technology (NIST) entity dedicated to strengthening the nation’s use of forensic science by facilitating the development of technically sound forensic science standards and by promoting the adoption of those standards by the forensic science community.
Mr. Johnson served in the past as President and Chair of the IAI, secretary and chair of the IAI Forensic Art Certification Board, past chair of the IAI Science and Practices Committee, chair of the IAI Biometric Information Systems Committee and the chair of the IAI Facial Identification provisional sub-committee. In addition to his affiliation with the IAI, Mr. Johnson is an Associate Member of the International Association of Cranio-Facial Identifiers.
Mr. Johnson worked numerous forensic/biometric support contracts for the Department of Defense (DoD) and was actively involved in the development of DoD forensics and biometric standards. He is an International Association for Identification (IAI) Certified Latent Print Examiner (CLPE) and Forensic Artist. Prior to coming to I3, Steve served 20 years in the law enforcement community providing leadership and expertise in criminal investigation and forensic sciences at the municipal and state levels.
Dr. Ewen Todd is a Food Safety Expert with over 45 years of experience in the reporting and surveillance of Foodborne Disease, as well as development of analytical methods for identifying foodborne pathogens. As a result of his knowledge of foodborne disease and work researching different pathogens and toxins, Dr. Todd has influenced research programs and regulatory approaches taken by the Health Protection Branch of Health Canada. In the US, he held the position of Director of the National Food Safety and Toxicology Center and the Food Safety Policy Center at Michigan State University.
A leader in microbial research, foodborne disease surveillance, costing of outbreaks, food safety policy, seafood toxins, standard-setting, risk assessment, risk management and risk communication, his presentations and food safety programs have been influential in many countries including China, Cambodia, Japan, United Arab Emirates, Lebanon, Kuwait, Saudi Arabia, Europe, as well as Canada, and the USA. Dr. Todd has delivered over 400 presentations and posters at national and international meetings, with over 200 invitations to speak and teach workshops.
An acclaimed author in the field of Foodborne Illness, he has written 109 research papers, 16 reviews, 36 book chapters and booklets, 40 departmental publications, 37 conference proceedings, 9 laboratory methods, 56 investigational and editorial articles, 90 published abstracts, and 3 editings of proceedings or books. Dr. Todd has received 20 appointments and awards, including the Excellence in Science Award for 1998, the first to be awarded by Health Canada. He is a Fellow of the American Association for the Advancement of Science, the International Association for Food Protection and MSU University Outreach and Engagement as well as Editor in Chief for the Elsevier Encyclopaedia of Food Safety.
Dr. Todd's Consulting services are available to businesses and governments internationally. He responds to telephone calls, emails, and written requests for information on food and waterborne disease.
Consulting Services Include