Home  >  ASQ Washington, DC &...  >  Special Interest Groups  >  BioMed/BioTech SIG     Printable Version Tell a friend

2018 October Theme: US Biosimilars and Interchangeable Products

10/11/18 (Thursday) Event topic: 

Overview of the Regulatory Framework and FDA's Guidance for the Development and Approval of Biosimilars and Interchangeable Products in the US

To Register Our 10/11/18 SIG Event

 

November: Real World Data for Clinical Evidence Generation

Q4:

The Opioid Crisis - Challenges and Solutions (Interagency Collaboration)

Regulatory Project Management

Gene-Based Solutions - Entrepreneurs' Perspective


YOUR FEEDBACKS are important to help with the continuous improvement efforts to our SIG operation, topics, speakers, and events.

If you wish to be on our SIG-event-announcement distribution list: Please email your request to C.J. George Chang at gchang2008@yahoo.com or send text to 240-793-8425.

To provide your feedback to our Section Chairs: Please email directly to chair@asq509.org and chair-elect@asq.org.

To provide your feedback to our Biomed/Biotech SIG Chair: Please email directly to biomedtechsig@asq509.org.


We celebrated:

Our 200th SIG event on 11/30/17, 

Our 175th SIG event on 7/7/16, 

Our 150th SIG event and the 7th anniversary of our SIG on 6/18/15; and 

Our 100th SIG event on 6/5/13 

(Cake contributor: Mr. Arvinder Singh; photo contributor: Ms. Xiting Yang).

 

Our Upcoming Meeting

“Overview of the Regulatory Framework and 
FDA’s Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US”
                          To be presented by

Sue Lim, MD, MS
Director 
Scientific Review Staff 
with Therapeutic Biologics and Biosimilars Staff
Office of New Drugs (OND)
Center for Drug Evaluation and Research (CDER), US FDA
       Thursday, October 11, 2018

Venue: 9366 Gaither Rd. “1st Floor Music Room”, Gaithersburg, MD 20877 (CCACC)
6:00 – 6:20 PM – Networking; Pizza/drink 
6:20 – 8:50 PM – Program 
8:50 – 9:00 PM – Door-prizes drawing; Networking


Open to Public – 
$5: non-ASQ members to cover pizza/drink cost; 
Free: ASQ members, current job-seekers, CCACC volunteers/employees/members, veterans, senior citizens, past speakers, US PHS Commissioned Corp officers, teachers, students, interns, residents, postdocs, FDA Commissioner’s Fellows, MJ-DC members, NTUAADC members, CAPA members, NTMUADC members, CKUAADC members, NTHUAADC members, NJTUAADC members, FAPAC members, CBA members, AAGEN members, NCARSQA members, OCA-DC members, AAMB members, ACAP members, DC Leaders Club members, BioTrain volunteers, and all Tai-Chi classes students in the Metropolitan Washington DC.

Registration Deadline: Please register by Thursday noon, October 11, 2018.  
Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; gchang2008@yahoo.com or 240-793-8425 (cell).

Driving directions: By Cars: From I-270 (N or S bound): Take Exit 8 onto Shady Grove Dr. Drive toward east and turn left onto Gaither Rd. The building is on your left after passing a stop sign. By Metro rail: Exit at the Red Line Shady Grove Station. 

Summary 
The Biologics Price Competition and Innovation Act of 2009 created an abbreviated licensure pathway for biosimilar and interchangeable products to be approved in the US.  This presentation describes the regulatory framework and key scientific concepts which support the approval of these products.

Speaker 
Dr. Sue Lim is the Director of the Scientific Review Staff with the Therapeutic Biologics and Biosimilars Staff at FDA.  In this role, she provides scientific oversight and advice on the development and approval of therapeutic biologics and biosimilar products and is also involved in policy development and implementation as it pertains to biosimilar products.  

Dr. Lim was previously a Medical Officer with the FDA’s Division of Anti-Infective Products.  Prior to the FDA, Dr. Lim served as an Infectious Diseases physician and Associate Hospital Epidemiologist at the University Health Network in Toronto, Canada.  She received her M.D. from the University of Toronto where she also completed her residency in Internal Medicine and subspecialty training in Infectious Diseases and served as a Lecturer in the Faculty of Medicine. She has a Master of Science degree in Health Policy, Management and Evaluation from the University of Toronto.

This event is cosponsored by Chinese Culture and Community Service Center, Inc. (CCACC, www.ccacc-dc.org), NTU Alumni Association DC Chapter (www.ntuaadc.org), and Chinese American Professionals Association of Metropolitan Washington, DC (www.capadc.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 215 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][Presentation
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][Presentation]
13. Melamine in Food; [Flyer][Presentation]
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][Presentation]
17. Working with the FDA to Test A New Vaccine Regulatory Science 101 for Basic Researchers. [Flyer][Presentation]
18. Medicine Errors. Oops! [Flyer]
19. Steps to a Quality CBER Submission; [Flyer][Presentation]
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][Presentation]
32. Dangerous Documents: Avoiding Land Mines in Your FDA Record and Emails; [Flyer]
33. Liver Cancer-Free National Program; [Flyer]
34. CDCs Disease Detectives Epidemic Intelligence Services; [Flyer]
35. Why Quality by Design A Case Study; [Flyer]
36. Piron Diseases and FDAs 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][Presentation]
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] [Presentation]
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][Presentation]
60. USP Verification Program - A unique 3rd Party Certification Program; [Flyer][Presentation]
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][Presentation]
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] [Presentation]
79. Development of Molecular Diagnostics - An FDA Perspective; [Flyer][Presentation]
80. Making Smart Cuts; [Flyer][Presentation]
81. Regulation of Genetically Engineered (GE) Animals at the US FDA; [Flyer][Presentation]
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][Presentation]
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][Presentation]
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][Presentation]
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][Presentation]
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][Presentation]
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] [Presentation]
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]
138. Adaptive Leaders - Trait for Success and D&I (Diversity and Inclusion); [Flyer] [Presentation]
139. Overview of Parkinson's Disease and Neurology Drug Development; [Flyer]
140. New View of US Science and Medical Innovation Potential - From the STEM Students' Perspective; [Flyer] [Presentation][Handout]
141. Overview of NARMS Program and Detection of Emerging/Novel Antimicrobial Resistance;[Flyer][Presentation]
142. Regulations and Specific Clinical Trial Designs; [Flyer] [Presentation]
143. ICH - Its History, Evolution, Achievements, and Challenges; [Flyer][Presentation]
144. Incorporating Quality Oversight in Clinical Trial Management; [Flyer]
145. Conducting Clinical Trials in China - Opportunities and Challenges; [Flyer][Presentation]
146. Scientific Considerations for Establishing Bioequivalence of Generic Drug Products; [Flyer][Presentation]
147. FDA/CDER Regulatory Affairs and Project Management; [Flyer]
148. Winning Clinical Trials - Some Statistic Review Perspectives; [Flyer]
149. FDA Drug Manufacturing Facility Inspections and Current Good Manufacturing Practices;[Flyer][Presentation]
150. Human Resources Impact on You and the Organization; [Flyer][Presentation]
151. Securing and Sharing the Worldwide Public Health Mission - Serving in the First US FDA Office in India; [Flyer][Presentation]
152. Food cGMP Workshop; [Flyer][Presentation]
153. Food HACCP Workshop; [Flyer][Presentation]
154. Building Diversity/Inclusion/Equality Organizations - Achievements and Challenges. [Flyer][Presentation]
155. Challenges in Nonclinical Development of Inhalation Drug Products; [Flyer][Presentation]
156. How Physical Therapy Impacts Everyone; [Flyer]
157. Experience in Entrepreneurship and Impact Scholarship; [Flyer]
158. Preclinical Product Development for Drugs, Biologics, and Medical Devices - A Veterinary Pathologist's Perspective; [Flyer]
159. Be the Leaders You Already Are; [Flyer][Presentation]
160. Merger and Acquisition - The Best Global Practices on IP-Related Transactions; [Flyer]
161. Mobile Health - Opportunities, Achievements, Challenges and Impacts; [Flyer][Presentation]
162. US Postmarket Safety Surveillance - Medical Device Perspective; [Flyer]
163. Introduction to Regulatory Hematology and Oncology; [Flyer][Presentation]
164. Helping Fight Ebola in the Recent Epidemic at West Africa [Flyer][Presentation]
165. Bone Marrow Mesenchymal Stem Cells - Characterization and Therapies [Flyer][Presentation]
166. Role of Clinical Pharmacology in Biologic Drug Development [Flyer][Presentation]
167. Care for the Seriously Ill: Role of Palliative Medicine and Partnership with Primary Care; [Flyer][Presentation]
168. Development of New Technology and Scientific Capability to Rapid/Sensitive Detection of Microbial Agents in Human Grafts and HCT/Ps. [Flyer][Presentation]
169. Global Market Access and Business Development - An MBDA/White House Initiative Perspective [Flyer][Presentation]
170. US National Antimicrobial Resistance Monitoring System - Achievements and Challenges [Flyer][Presentation]
171. A Rx for Sustainable Agile Culture Transformation for a Global Healthcare Corporation. 

Our Past Events, Speakers, and Some Presentations: continued

172. The Romantic Disease: Tuberculosis and Launching Clinical Trials in China [Flyer][Presentation];
173. Follow the Money [Flyer][Presentation];
174. Colorful Leadership - Pave the Way for An Authentic, Fulfilling Career [Flyer];
175. Making of A Socially Conscientious Engineer [Flyer][Presentation];
176. An Examination of the Physical-Mental Association - Results from A Representative Sample of the US General Population [Flyer];
177. The HHS Entrepreneurs-In-Residence Program - Where Superheros Gather in Government [Flyer];
178. Overview of FDA's Expedited Programs with A Case Study of immunotherapy for Renal Cell Cancer [Fyer];
180. Rethink the Science of Cancer - An Integrated 21st Century Cancer Research Conversation [Flyer][Presentation 1][Presentation 2];
181. Development of Companion Diagnostics - An FDA Perspective [Flyer][Presentation]
182. Public Health Strategy to Cope with an Aging Society - Taiwan's Experience on a 10-Year Long-Term-Care Plan [Flyer][Presentation]
183. Mystery Event [Presentation][Presentation]
184. Introduction to Good Laboratory Practice [Flyer][Presentation]
185. Current Good Manufacturing Practice and Drug Manufacturing Quality [Flyer][Presentation]
186. Navigating Through Unconscious Biases - In Your Community and Workplace [Flyer][Presentation]
187. FDA's Case for Quality and Product Quality Metrics - Medical Device Perspective [Flyer][Presentation][Handout]
188. How the Cancer Moonshot Task Force Is Unleashing the Power of Data to End Cancers [Flyer][Presentation]
189. Functional Imaging with Positron Emission Tomography (PET) [Flyer][Presentation]
190. The Cancer Genomic Atlas (TCGA) Project and Precision Medicine [Flyer]
191. How Do Biological Neural Network Encode, Memorize, Recall, and Generalize as A Learning Machine [Flyer][Presentation]
192. 2016 ICH E6(R2) Amendment - Impact on Quality and Clinical CRO Operation [Flyer][Presentation]
193. Surviving Leaving a Federal Job - My Journey of Becoming a Consultant [Flyer][Presentation]
194. Evolving Regulatory Sciences in Generic Drugs [Flyer][Presentation]
195. How Human Body Is Perceived and Health Preserved by Chinese Medicine [Flyer][Presentation]
196. A Pharmaceutical Industry Scientist's Journey to GXP and Quality Assurance World [Flyer][Presentation]
197. Chinese Medicine and Medical Practice, Advantages, and Mechanisms [Flyer]
198. Current Changes and Hope for Mental Health - Focusing on Depression Disorders, Substance-Use Disorders, and Violence [Flyer][Presentation]
199. The Evolving Landscape of Drug Products Containing Nanomaterials [Flyer][Presentation]
200. Entrepreneurship, Corporate Finance, and Related Best Practices [Flyer][Presentation]
201. Clinical Endpoint Bioequivalence Study Review of ANDA Submission [Flyer][Presentation]
202. Regulatory Approval of Gene-Based Cancer Immunotherapies - A Product Perspective [Flyer][Presentation]
203. Good Clinical Practice in the US [Flyer][Presentation]
204. The Role of Bioinformatics - From Bench to Regulatory [Flyer]
205. Community Mental Health Solutions [Flyer]
a. Feeling Good - Mental Health Beyond Medication [Presentation]
b. Moving Beyond Depression - By Faith, Hope, and Love [Presentation]
206. What FDA Expects in A Pharmaceutical Trial [Flyer][Presentation]
207. Regulatory Perspective of Animal Rule [Flyer]
208. NGS in Oncology - FDA's Perspective [Flyer][Presentation]
209. Comparison of US-China Regulatory Systems [Flyer][Presentation]
210. A Commotion in the Blood: What You Should Know About Leukemia [Flyer]
211. Emotional Intelligence, Performance Improvement, and Change Management of A Successful Health Care Service [Flyer][Presentation]
212. State of Global AIDS Epidemic and Gates Foundation's HIV Strategy [Flyer][Presentation]
213. National Environmental Policy Act (NEPA) and the Environmental Impacts of Tobacco Products [Flyer
214. Big Data Analytics for Healthcare Quality - Perspectives of Data Science [Flyer][Presentation]
215. Overview of Regulatory Framework and FDA's Guidance for the Development and Approval of Biosimilar and Interchangeable Products in the US. [Flyer][Presentation]

Our Mission and Event Themes

Our Mission:

This Biomed/Biotech SIG was established in the second half in 2008, when global financial crisis with stock market crash occurred, leading to massive unemployment within our local communities at the Metropolitan DC. 

We have wished to use this open learning/discussion platform to connect critical talents and timely local opportunities while ensured folks can continuously receive interesting but low-threshold education programs through this open forum where academia, industry, and government professionals and administrators meet, greet, network, and inspire for better practices and quality understanding.

1. To provide an open and transparent discussion and networking platform among regulatory, industry, and academic communities.

2. To facilitate truthful and honest, informed quality understanding and practices of biomedical and biotechnological research, operation, services, products, policies, and regulations.  

Our Event Themes:

1. Topics on quality principles and practices to facilitate professional advancement, intellectual development, performance excellency, and organizational and personal growth.

2. For our members and interested individuals/groups within our local communities.

3. To promote effective and efficient public health services to protect public health, human and other animals alike.

Our Focus and Passion

1. To promote true understanding and practices in Quality Control, Quality Assurance, Continuous Improvement, Performance Excellence, and Sustainable Growth.

2. To facilitate inter-generation, inter-sector, inter-disciplinary, inter-cultural networking and collaboration while building focused quality teams to prepare for current and upcoming Local and Global Challenges.

3. To continue improving toward model practices for all aspects of SIG operations for our Local and Global Communities.

Our Leadership Biographies

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

 

Career Development for Life!

Becoming Winning Team-Players and Leaders in Biomed/Biotech Sectors!

Why and How We Have Successfully Built A Biomed/Biotech SIG?