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January 2012 SIG Theme: Food Safety

Food Safety Modernization Act (FSMA) amending Federal Food, Drug, and Cosmetic Act (FFDCA) was signed into law on 1/4/11.  At this 1st year anniversary of FSMA, theme of our Biomed/Biotech SIG events in January 2012 will be on Food Safety.

We have invited scientific experts from local academia and Federal regulatory agency to present and lead our disucssion on our past and current challenges in food safety and how we assess risks scientifically regarding food safety for both human and animals in US. 

1/26/12 Evening: "How Are Candidate Ingredients Reviewed at FDA for Use in Human Food, Animal Feed, or New Animal Drugs?"

Registration: BioMed/BioTech SIG Meeting, January 26, 2012

Upcoming Meetings

“How Are Candidate Ingredients Reviewed at FDA for Use in Human Food, Ani
mal Feed, or New Animal Drugs?”

To be presented by

Karen Ekelman, PhD, MPM
Director, Division of Human Food Safety
Office of New Animal Drug and Evaluation 
Center for Veterinary Medicine, US FDA

Thursday, January 26, 2012

6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:30 PM – Program 
8:30 – 8:45 PM – Door-prizes drawing; Networking


Open to Public - $5 for non-ASQ members to cover pizza/drink cost; 
Free to ASQ Members, students, local interns, postdocs, FDA Commissioner’s Fellows, and current job-seekers 
Location: Kelly’s Deli Conference Center, 7519 Standish Place, Rockville, MD 20855
Registration Deadline: Please register by Thursday noon, January 26, 2012.  
Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; gchang2008@yahoo.com or 240-793-8425 (cell).

Presentation Summary:  
“How Are Candidate Ingredients Reviewed at FDA for Use in Human Food, Animal Feed, or New Animal Drugs?” 

Dr. Ekelman will discuss the various ways in which chemicals that are, or may be, human carcinogens are reviewed - and sometimes approved - as food additives, animal feed ingredients, and new animal drugs at the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM) of US FDA.  She will provide examples and describe some of the current unresolved policy issues associated with such substances.  

Presenter’ Bio:  Karen Ekelman, PhD, MPM 

Dr. Karen Ekelman has a PhD in developmental biology from the Ohio State University, where she studied mechanisms of human chemical carcinogenesis with Dr. George Milo.  After graduation, Karen conducted research in this area for several more years at the Argonne National Research Laboratory and at the University of Chicago School of Medicine.  After moving to Maryland, Karen earned a MPM (Masters of Public Management) degree at the University of Maryland – College Park and spent several years as an IEEE Science Fellow at the USEPA and as a Fellow at the National Academy of Engineering, National Academy of Sciences, working and writing in the areas of environmental and human health risk assessment policy and practice.  

In 1987, Karen joined FDA’s Center for Food Safety and Applied Nutrition (CFSAN) as a toxicologist in the Office of Food Additive Review (OFAR).  During her 14 years with CFSAN, she was recognized as an expert in the review of carcinogenic food additives, break-down products, and constituents, and served as Executive Secretary of CFSAN’s Cancer Assessment Committee.  In 2001 Karen joined Center for Veterinary Medicine (CVM) as Leader of the Feed Safety Team in the Division of Animal Feeds/Office of Surveillance and Compliance (OSC), and in 2008 she became Director of the Division of Human Food Safety in CVM’s Office of New Animal Drug Evaluation (ONADE).

SIG Mission

The mission of our Biomed/Biotech SIG of ASQ509  is to provide an open discussion and networking platform among regulatory, industry, and academic communities to facilitate truthful and honest, informed quality understanding and practices of biomedical and biotechnological research, operation, services, products, policies, and regulations.  Our SIG event topics have been focused on quality principles and practices to facilitate professional advancement, intellectual development, performance excellency, and organizational and personal growth for our members and interested individuals and groups with our local communities while promoting effective and efficient public health services.

BioMed/BioTech Special Interest Group (SIG)

Biomed/Biotech SIG was established in July 2008 and SIG events were launched since December 2008. Up to now, we have discussed quality aspects for the following 64 Biomed/Biotech Topics within the Metropolitan DC communities: 

1. Regulations of Genetically Engineered Animals; [Flyer]
2. Challenges in Our Healthcare Systems & Use of Quality Data to Drive Improvements in Patient Care; [Flyer]
3. Shanghai Clinical Research Center – Progress, Challenges, and Its Quality Specimen-Procurement Program; [Flyer]
4. Quality by Design in Pharmaceutical Industry; [Flyer]
5. Nano-particles as Drug Delivery Carriers; [Flyer] 
6. Nano-medicine – Clinical Applications and Challenges; [Flyer]
7. Regulatory Challenges in Utilizing Biofuel Co-Products As An Animal Feed Ingredient; [Flyer]
8. Technical Challenges in Converting Biomass to Biofuel; [Flyer]
9. Animal Feed Safety System; [Flyer]
10. Food Safety Considerations of Antimicrobial Drugs for use in Food Animals: Two Different Microbiological Approaches; [Flyer]
11. DNA-barcoding – Its Science, Development, and Regulatory Applications at FDA; [Flyer]
12. How Aquatic Research Is Helping to Solve Questions about Melamine Toxicity; [Flyer]
13. Melamine in Food; [Flyer]
14. Bioinformatics, System Biology, and Translational Medicine; [Flyer]
15. A Systemic Framework of Genome Screening Seeking a Predictive Genomic Composite Biomarker for Potential Treatment Individualization; [Flyer]
16. Oncology Biopharmaceuticals and Preclinical Development; [Flyer]
17. Working with the FDA to Test A New Vaccine – Regulatory Science 101 for Basic Researchers. [Flyer]
18. Medicine Errors. Oops! [Flyer]
19. Steps to a Quality CBER Submission; [Flyer]
20. Communicate and Motivate for Quality; [Flyer]
21. Take Charge of Your Career Growth and Development; [Flyer]
22. Gene Therapy – Dog Models for Humans; [Flyer]
23. Generic Drugs – Myths and Truths; [Flyer]
24. Biomedical/Biotechnology Opportunities and Challenges in Taiwan and China; [Flyer]
25. Research and Development of a Hepatitis E Vaccine – China Biomed/Biotech Progress Update I; [Flyer]
26. World Intellectual Property War and its Impact on Pharmaceutical Industry in Taiwan and China – China Biomed/Biotech Progress Update II; [Flyer]
27. Changing Regulatory Environment in India for Global Clinical Trials, Etc; [Flyer]
28. FDA/CVM Regulation of Bioengineered Feed; [Flyer]
29. Technology Entrepreneurship; [Flyer]
30. Good Clinical Practice (GCP) Concepts for Quality Clinical Trials; [Flyer]
31. Disaster Recovery and the Role of QA; [Flyer]
32. Dangerous Documents: Avoiding Land Mines in Your FDA Record and Emails; [Flyer]
33. Liver Cancer-Free National Program; [Flyer]
34. CDC’s Disease Detectives – Epidemic Intelligence Services; [Flyer]
35. Why Quality by Design – A Case Study; [Flyer]
36. Piron Diseases and FDA’s Animal Feed Regulations to Prevent the Spread of BSE in the US Cattle Population; [Flyer]
37. Inspection, Compliance, and Quality Implementation of A New BSE Rule; [Flyer]
38. The New NCI NExT Program – A Quality Initiative; [Flyer]
39. Retrovirology – AIDS and Other Human Diseases – Quality Research, Sciences, and Challenges; [Flyer]
40. Nanoparticles as Drug Delivery Vehicles for Molecular Imaging and Chemotherapy applications – Science, utility, and Challenges; [Flyer]
41. Three Case Studies of Remediation of Hazardous Waste Contaminated Sites; [Flyer]  
42. China Biopharma R&D Experience – 2003 to 2010 – Achievements and Challenges; [Flyer]
43. Regulatory Sciences; [Flyer]
44. Medical Device Development – Underpinning by Quality System; [Flyer]
45. Incorporating Risk Management into Quality System – A Key Operation in the American Red Cross; [Flyer]
46. FDA Import Operations and Challenges; [Flyer]
47. Salmonella in Animal Feed – FDA Policy and Regulation; [Flyer]
48. Development of Ciprofloxacin Tablets – Using the Concept of Quality by Design (QbD); [Flyer]
49. Quality Automation and Controls in Pharmaceutical Manufacturing Facilities; [Flyer]
50. A County in Transition and Its Impact on Health and Human Services; [Flyer]
51. Improving Health Access and health for Vulnerable Montgomery County Residents; [Flyer]
52. Codex Alimentarius and Veterinary Drugs - Ractopamine HCl as An Example; [Flyer]
53. Montgomery County Leadership Network and Bioscience Strategy and Master Plan; [Flyer]
54. How Do We Know That Food Additives Are Safe - Two Case Studies: Aspartame and Melamine; [Flyer]
55. GLP Modernization - An Update; [Flyer]
56. Design, Construction, and Operation of Multi-drug cGMP Facilities; [Flyer]
57. Overview of Biologics Drug Inspections; [Flyer] 
58. European Food Safety Authority (EFSA) - Risk Assessment for Decision-Making and Challenges for EU and US; [Flyer]
59. Path to Senior Executive Services (SES); [Flyer]
60. USP Verification Program - A unique 3rd Party Certification Program; [Flyer]
61. USP Reference Standards Evaluation - From Material to Reference Standard; [Flyer]
62. Savvy Social Security Planning - What Baby Boomers Need to Know to Maximize Retirement Income; [Flyer]
63. Medicare 101; [Flyer]
64. Mutifaceted Food Safety Challenges - What's Next? [Flyer]


Quality Topic Areas of Discussion

To provide an open platform to discuss critically the quality principles and practices in conducting scientific research, applying biotechnology, developing biomedical products or services to ensure community sustainability while promote the health of the general public, human and other animals alike.

To promote true understanding and practices in Quality Control, Quality Assurance, Continuous Improvement, Performance Excellency, and growth sustainability.

To facilitate inter-generation, inter-sector, inter-disciplinary, inter-cultural networking and collaboration while building quality operational teams to prepare for any upcoming global challenges.

To model best practices in all aspects of SIG operations for community.


Leadership Biographies

Dr. C.J. George Chang (gchang2008@yahoo.com)

Dr. Chang is a native from Taiwan, Republic of China (ROC), and is a veterinarian, pathologist, pharmacologist, and toxicologist by training and a self-trained bioanalytical chemist.  He is board-certified for general toxicology (DABT), auditor (CQA), regulatory affairs specialist (RAC), and project management profession (PMP).  Currently, Dr. Chang serves as a regulatory toxicologist at the Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine, US Food and Drug Administration.  He and his colleagues are responsible to regulate and review safety of the use of new animal-feed ingredients and assess the health hazard of incidences of adulteration and/or misbranding of animal feed products in the US.

Before joined the Federal government in 2008, Dr. Chang had been directing development of biomedical products in biopharmaceutical industry, interacting with FDA, and launching clinical trials; assisting in building toxicogenomics database in bioinformatic industry for predicting safety of candidate new chemical entities; and managing contract research projects/programs and directing non-clinical safety studies within contract research industry.  Dr. Chang earned his veterinary medicine degree from National Taiwan University (NTU, Taiwan, ROC), his first MS degree in veterinary pathology studied pathogenesis and pathology diagnostics from University of Minnesota (St. Paul, MN), and his second MS and PhD degrees in veterinary physiology/pharmacology on reproductive endocrinology, chemical carcinogenesis, and chemotherapy and chemoprevention from The Ohio State University (Columbus, OH).  He spent three years afterward conducting postdoctoral research on molecular dosimetry of high impact carcinogens, quantifying criitical molecular markers, and assessed chemoprevention potential of candidate drugs for toxicity of tobacco-specific nitrosamines in animal models at a Wake Forest University/RJR Tobacco joint training program (Winston-Salem, NC).

Dr. Chang's career goals are to assess the efficacy/utility and safety of candidate biomedical products, facilitate collaboration within scientific community, and provide pertinent information and protect and promote the health of general public, human and other animals alike.