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2014 October Theme: Food Safety and Effectively Transform Organizations

10/9/14 (Thursday) Event Title: "FDA Food Safety Modernization Act (FSMA): The Vision and the Challenge of Improving Food Safety" 


10/23/14 (Thursday) Event Theme: "Transforming Organizations: Changing the Work Culture" 


To register our 10/23/14 evening event

 

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To provide your feedback to our Biomed/Biotech SIG Chair: Please email directly to .


 We celebrated our 100th SIG Discussion on 6/5/13.  


2014

11/6/14 (Thursday) Event Theme: "Diversity and Inclusion in the Private Sector" (TBA)

11/20/14 (Thursday) Event Theme: "ICH - The Science, Achievements, Impacts, and Challenges for Global Drug Development and Marketing Approval" (TBA)

12/4/14 (Thursday) Event Theme: "Neurological Drug Development and Review - Achievements and Challenges" (TBA)

12/11/14 (Thursday) Event Topic: Scientist-Entrepreneur Series III - "The SKM Citizen-Scientist Tool Set: A New Purely-Mathematical Language for Inspiring World-Class Scientific True-States Assessment Skills in American STEM Students" (TBA)


2015

1/8/15 (Thursday) Event Topic: "Detecting of Emerging and Novel Antimicrobial Resistance - How Whole Genome Sequencing Will Help." (TBA)

2/12/15 (Thursday) Event Theme: "Introduction to and Evolution of Clinical Trial Designs" (TBA)

2/26/15 (Thursday) Event Theme: "Medical Countermeasure and Animal Rules" (TBA)

3/12/15 (Thursday) Event Theme: "Research and Education on Infectious Diseases - Achievements and Challenges" (TBA)

3/26/15 (Thursday) Event Theme: "Running Quality Clinical Trials - A Trial Management perspective" (TBA)
 
4/9/15 (Thursday) Event Theme: "Regulatory Review for Generic Drug Applications - Achievements and Challenges" (TBA)

5/7/15 (Thursday) Event Theme: "Advancements and Challenges for Inhalation Therapeutics" (TBA)

 

 

Our Upcoming Meeting

“Transforming Organizations: 
   Changing the Work Culture” 

To be presented by

Stephen Sundlof, DVM, PhD, DABVT 
Senior Vice President for Regulatory Affairs
Kindred Biosciences, Inc.
Former Director, Center for Food Safety an Applied Nutrition, US FDA
Former Director, Center for Veterinary Medicine, US FDA

Thursday, October 23, 2014

6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:45 PM – Program 
8:45 – 9:00 PM – Door-prizes drawing; Networking
Online Registration site: https://asq509.org/ht/d/DoSurvey/i/35817

Open to Public – 
$5: non-ASQ members to cover pizza/drink cost; 
Free: ASQ members, veterans, senior citizens, past speakers, teachers, students, interns, residents, postdocs, FDA Commissioner’s Fellows, MJ-DC members, NTUAADC members, CAPA members, CKUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, Commissioned Corp officers, and current job-seekers. 

Location: Kelly’s Deli Conference Center, 7519 Standish Place, Rockville (Derwood, for GPS users), MD 20855
Registration Deadline: Please register by Thursday noon, October 23, 2014.  
Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; [email protected] or 240-793-8425 (cell).

Driving directions: By Cars: From I-270 (N or S bound): Take Exit 9A and exit from the FIRST right exit; turn left (east) onto Shady Grove Dr.; turn right (south) onto Rockville Pike (Route 355); turn left (east) onto East Gude Dr.; turn left (north) immediately onto Crabb’s Branch Dr.; turn left (west) immediately onto Standish Place. The first building on your right side is 7519 Standish Place; open parking). The venue is on the first floor of 7529 Building with its external entrance opposite to the left side of 7519 building main entrance. By Metro trains: Off from Red Line Shady Grove Station, and take RideOn Route 59 TOWARD ROCKVILLE and get off from “Calhoun Place” stop. Standish Place is next to the Bus stop. Our venue is within 2 min of walking distance from the stop.

Summary  
Research has shown that organizational performance and work culture are highly correlated.  Often, attempts to transform the workplace into a high performance organization (HPO) fail because the underlying culture remains static.  This is especially true for large, entrenched organizations like the FDA. 

Changing the work culture can be a daunting task for management.  Many, if not most, attempts are unsuccessful or even counterproductive.  Top down culture change initiatives are especially prone to failure because upper management cannot relate well to the lives of the front line workers, and the information flow is highly filtered as it travels upward in the organization.  Management tends to view the work culture as a monolithic entity when in fact there are multiple different cultures operating within the organization, some vibrant and engaged, others pulling the organization down.  Change initiatives should focus on reducing the toxic cultures without harming the healthy ones.

This presentation will examine certain organizational theories and suggest specific actions management can take to enhance the culture of their organization.


Speaker’s Bio: 
Dr. Stephen Sundlof is the Senior Vice President for Regulatory Affairs at Kindred Biosciences, Inc., a biopharmaceutical company dedicated to bringing the very best science and medicine to companion animals. From 2008 to 2010 he served as Director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) which is responsible for ensuring the composition, quality, safety, and labeling of foods, food and color additives, dietary supplements, and cosmetics.  In the 14 years preceding this appointment, Dr. Sundlof served as Director of FDA’s Center for Veterinary Medicine (CVM) which is responsible for ensuring the safety and effectiveness of animal drugs, and the safety of animal feed including pet food.  Prior to joining the FDA, he was a professor at the University of Florida, College of Veterinary Medicine. 

From 1994-2008 he served as chairman of the World Health Organization/Food and Agriculture Organization (WHO/FAO) of the United Nations Codex Alimentarius (Codex) Committee on Residues of Veterinary Drugs in Foods, and is past president of the American Academy of Veterinary Pharmacology and Therapeutics (AAVPT).  He received both his Doctorate in Veterinary Medicine and PhD in toxicology from the University of Illinois, and is a diplomate of the American Board of Veterinary Toxicology (ABVT).


This Biomed/Biotech SIG event is cosponsored by the Monte Jade Science and Technology Association of Greater Washington (www.MonteJadeDC.org) and NTU Alumni Association at DC (www.ntuaadc.org).

Our Past Events, Speakers, and Some Presentations:

Biomed/Biotech SIG was established in July 2008, and Our SIG events were launched since December 2008.  Up to now, we have discussed quality aspects for the following 137 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]
65. How are Candidate Food and Feed Ingredients and Animal Drugs Reviewed at FDA to Ensure Safety of Human Food? [Flyer] 
66. Information Security and Its New Challenges; [Flyer]
67. Nanotechnology and Its Application in Medical Countermeasure Development; [Flyer]
68. Radiation Toxicity and Syndrome; [Flyer]
69. Power Networking through Effective Communications; [Flyer]
70. Japan Fukushima Dai-Ichi Accident - One Year Later; [Flyer]
71. Overview of Healthcare Access within the Fairfax and Montgomery Counties; [Flyer]
72. Effective Communication through Accent Reduction and Modification; [Flyer]
73. Clinical Trials; [Flyer]
74. Getting Ahead: Break the Glass Ceiling; [Flyer]
75. Change Management - Driving Successful Changes and Creating a More Agile Organization; [Flyer]
76. Critical Research Supporting Regulatory Decisions and Actions; [Flyer]
77. Investigation of Curious Cloudiness in a Process Intermediate during Manufacturing of Meniningococcal Vaccine. [Flyer]
78. Melamine in Pet Food - How Poisoning Cats and Dogs Changed the FDA; [Flyer]
79. Development of Molecular Diagnostics - An FDA Perspective; [Flyer]
80. Making Smart Cuts; [Flyer]
81. Regulation of Genetically Engineered (GE) Animals at the US FDA; [Flyer]
82. Epidemiology Operations for National Food Safety; [Flyer]
83. Advances in Development of Pneumococcal Vaccines; [Flyer]
84. M&A in the LS Tools and Rx Space - Synergies, Pitfalls, and Learning; [Flyer]
85. Introduction to Nonprofit Organizations - How to Sustain Mission-Focused Operations; [Flyer]
86. Strategic Execution: Pick Projects that Pack a Bunch; [Flyer]
87. Design of Experiments: The Primary Tool in Quality-by-Design; [Flyer]
88. From Paycheck to Passion - Jumpstart Your Career; [Flyer]
89. Leadership and Mission for A High Performance Organization; [Flyer][Presentation]
90. Big Ears vs Large Antennae - When US and Japan Work Together; [Flyer]
91. FDA's Device Case for Quality; [Flyer]
92. Conversation on New Cancer Drugs - Development, Approval, and Access; [Flyer] 
93. SBA Contracting Programs and Federal Supports to Small Business Entrepreneurship; [Flyer] [Presentation]
94. FDA Regulatory Policy - How It Is Made and Who Makes It; [Flyer]
95. Evaluation of Benefit and Risk; [Flyer] [Presentation]
96. Building A Competitive Biologics Pipeline Portfolio through Novel Technologies; [Flyer]
97. The Evolution of Nuclear Safety; [Flyer] [Presentation]
98. Asian Community-Building - Vision, Experience, Challenge [Flyer][Presentation]
99. Career Opportunities at FDA - From A Regulatory Scientist Perspective; [Flyer][Presentation]
100. The Role of Clinical Pharmacology in Risk-Assessment for New Drugs; [Flyer][Presentation] 
101. Opportunities for Scientist-Entrepreneurs in Biotech Start-Ups; [Flyer]
102. "Hook Them at Hello" with Intentional Networking and Memorable Interview Skills; [Flyer]
103. US Export Controls; [Flyer]
104. What Are We Looking For; [Flyer]
105. From Start-Up to IPO; [Flyer]
106. Overview of FDA's Postmarket Drug Safety and Surveillance. [Flyer]
107. Driving Changes and Getting Results for Community Health in Challenging Time - From A Grassroots' Perspective; [Flyer] [Presentation]
108. Generic Drugs - Application and Regulatory Review. [Flyer] [Presentation]
109. Confession of a Lean Six Sigma Master Black Belt; [Flyer] [Presentation]
110. Systematic Pursuit of Performance Excellence; [Flyer] [Presentation]
111. Nonprofit Organizations - Tax-exempt Status, Good Governance, and More; [Flyer]
112. Pinpoint the Causes of Cancer Cluster - Challenges and Opportunities; [Flyer] [Presentation]
113. Overview of Asian American Health Initiative (AAHI), Montgomery County's Department Health and Human Services; [Flyer]
114. FDA's Question-Based Review: A Risk-Based Pharmaceutical Quality Assessment Tool; [Flyer] [Presentation]
115. Trademark Protection; [Flyer]
116. Making Effective Speeches - Tips for Toastmasters and Professionals; [Flyer]
117. Challenges and Opportunities in Developing Biologics and cGMP Operations Excellence in China; [Flyer]
118. How to Avoid Common CMC Deficiencies in INDs and NDAs; [Flyer] [Presentation]
119. How to Protect Intellectual Property against Economic Espionage [Flyer]
120. Dengue Disease: Old Disease, New Challenges; [Flyer]
121. The Road So Far - My Career in Toxicology; [Flyer]  
122. Enabling Programs and Leadership to Support FDA/CDER's Mission; [Flyer]
123. Particle Beam Therapy: A Complementary Radiotherapy of Photons - From X-Ray to Protons and Heavier Ions; [Flyer] [Presentation]
124. Copyrights. [Flyer]
125. A Dream within A Dream / The Salad Bowl; [Flyer]
126. Herbal Medicine and Plant-Derived Drugs - A Pharmacognosist's Persective; [Flyer]
127. Patent Overview and Patent Cooperation Treaty [PCT); [Flyer]
128. Effectively Applying Sequencing Technology for Translational Cancer Research; [Flyer]
129. HACCP - Its Practical Application and Global Implication; [Flyer]
130. Anthropogenic Global Warming - A Hoax or An Inconvenient Truth? [Flyer] 
131. Impact of Recent US Health Care Legislation on Patient Care and NIH Research Agenda for Substance Abuse Disorders. [Flyer] [Presentation Part 1][Presentation Part 2] 
132. Corporate Social Responsibility; [Flyer]
133. The Silent World. [Flyer]
134. Nanomedicine: Improving Current Cancer Therapies; [Flyer]
135. Hearing Loss Prevention and Modern Hearing Aids Technology; [Flyer] [Presentation]
136. FDA Food Safety Modernization Act: The Vision and Challenges of Improving Food Safety;[Flyer]
137. Transforming Organizations: Changing the Work Culture. [Flyer] [Presentation]

Our 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/groups within our local communities while promoting effective and efficient public health services and protect public health.

Our Topic Areas

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.

Our Leadership Biographies

Dr. C.J. George Chang (; 240-793-8425 (cell))

Dr. Chang is a native from Taiwan, the Republic of China (ROC), and is a veterinarian, veterinary pathologist, veterinary pharmacologist, and toxicologist by training, and a self-trained bioanalytical chemist.  

From 2008-2012, Dr. Chang served as a regulatory biologist (safety reviewer) at the Division of Animal Feeds, Office of Surveillance and Compliance, Center for Veterinary Medicine (CVM), US Food and Drug Administration (FDA).  He and his colleagues were responsible to regulate and review the safety of new animal-feed ingredients and assesses the health hazard of incidences of adulteration and/or misbranded animal feed products in the US.  In June 2012, he joined the oncology drug review team of the Center for Drug Evaluation and Research (CDER) of FDA as a senior pharmacologist assisting premarket, nonclinical safety/efficacy review for candidate cancer drugs. 

Before joining the Federal government in 2008, Dr. Chang had directed the development of biomedical products in biopharmaceutical industry, interacted with FDA and stakeholder organizations for IND submissions, and launched clinical trials; assisted in building a world-known toxicogenomics database in bioinformatic industry to predict candidate drug safety; and managed contract research projects/programs and directed non-clinical safety studies within contract research industry.  

Dr. Chang earned his veterinary medicine degree from the National Taiwan University (NTU, Taiwan, ROC), his first MS in veterinary pathology on pathogenesis and animal disease diagnosis from University of Minnesota (St. Paul, MN), and his second MS and his PhD degrees in veterinary physiology/pharmacology on reproductive endocrinology, chemical carcinogenesis, and chemotherapy and chemoprevention for human cancers from The Ohio State University (Columbus, OH).  He spent three years afterward conducting postdoctoral research with focus on molecular dosimetry of high impact carcinogens, quantified critical molecular biomarkers, and assessed chemo-preventive potential of candidate drugs for tobacco-specific nitrosamine-induced toxicities in animal models at a Wake Forest University/RJR Tobacco joined postdoc training program (Leon Goldberg Fellowship; Winston-Salem, NC).

Dr. Chang's career goals are to assess the efficacy/utility and safety of candidate biomedical products, to facilitate collaboration within scientific community, and to provide pertinent information protecting and promoting the health of general public.  He is board-certified as a general toxicologist (DABT), quality auditor (CQA), regulatory affairs specialist (RAC), and project management profession (PMP).