Gaithersburg, Maryland, United States
Contact Info
3K followers
500+ connections
Gaithersburg, Maryland, United States
Contact Info
3K followers
500+ connections
About
Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded…
Activity
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Just finishing my vacation in the United States. It strikes me every time what a remarkable country it is. The good and the bad, but the highlight…
Just finishing my vacation in the United States. It strikes me every time what a remarkable country it is. The good and the bad, but the highlight…
Liked by Andrew Chang
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Great day of learning about the possibilities of AI in quality systems at the 22nd PIA Regulatory Meeting. Special thanks to my Lilly colleagues on…
Great day of learning about the possibilities of AI in quality systems at the 22nd PIA Regulatory Meeting. Special thanks to my Lilly colleagues on…
Liked by Andrew Chang
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ONE YEAR LATER ... About 1 year ago, I left my position at Sanofi under pre-retirement conditions and indicated that I will first take a 4-month…
ONE YEAR LATER ... About 1 year ago, I left my position at Sanofi under pre-retirement conditions and indicated that I will first take a 4-month…
Liked by Andrew Chang
Experience & Education
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Novo Nordisk
View Andrew’s full experience
See their title, tenure and more.
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Volunteer Experience
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Chair, PDA Biopharmaceutical Advisory Board (BioAB)
PDA - Parenteral Drug Association
- Present 2 years 2 months
Science and Technology
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Member Board Of Directors
CASSS – Sharing Science Solutions
- Present 2 years 8 months
Science and Technology
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Honors & Awards
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The FDA Commissioner's Special Citation
FDA
for successfully completing FDA’s initiative on product quality regulation
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FDA Center Director's Distinguished Service Group Award
FDA
for Outstanding Efforts and Results in Reaching FY07 MDUFMA Goals in FY03
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FDA Group Recognition Award
FDA
as a member of the Team Biologics Evaluation Workgroup for Diligence
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FDA Group Recognition Award
FDA
for Outstanding Effort and Performance in the Preparation of International Potency Standards for Blood Coagulation Factors
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CBER’s Public Health Achievement Award
FDA
for Outstanding Regulatory Review Performance that Resulted in Averting a Crisis in Product Availability
Languages
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Chinese
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English
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More activity by Andrew
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Excited to be leading this CoP with true experts in the field - Eric Staib and Nick Armstrong - and of course our great ISPE Director, Tim…
Excited to be leading this CoP with true experts in the field - Eric Staib and Nick Armstrong - and of course our great ISPE Director, Tim…
Liked by Andrew Chang
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I’m looking forward to attending and presenting again at the upcoming ISPE Annual Meeting in October. Please join us for an informative…
I’m looking forward to attending and presenting again at the upcoming ISPE Annual Meeting in October. Please join us for an informative…
Liked by Andrew Chang
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I look forward to this town hall meeting from the FDA. #CGT #CellTherapy #CGTAnalytics
I look forward to this town hall meeting from the FDA. #CGT #CellTherapy #CGTAnalytics
Liked by Andrew Chang
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Can’t wait for PDA Week 2025! This will be the next amazing edition of PDA Week and I look forward to the great science and networking events…
Can’t wait for PDA Week 2025! This will be the next amazing edition of PDA Week and I look forward to the great science and networking events…
Liked by Andrew Chang
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Authors from FDA CDER have proposed a framework for taxonomy and controlled vocabulary for quality attributes of therapeutic proteins. An important…
Authors from FDA CDER have proposed a framework for taxonomy and controlled vocabulary for quality attributes of therapeutic proteins. An important…
Liked by Andrew Chang
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I’m delighted to be re-invited back onto PDA’s Biopharmaceutical Advisory Board. The PDA BioAB is composed of a diverse group of experts drawn from…
I’m delighted to be re-invited back onto PDA’s Biopharmaceutical Advisory Board. The PDA BioAB is composed of a diverse group of experts drawn from…
Liked by Andrew Chang
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It is an esteemed privilege to be appointed as a member of the ad hoc planning committee convened by The National Academies of Sciences, Engineering,…
It is an esteemed privilege to be appointed as a member of the ad hoc planning committee convened by The National Academies of Sciences, Engineering,…
Liked by Andrew Chang
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I feel so honored that FDA highlights our AI/ML review work in the CDER Science Spotlight. This was the first time that the US Food and Drug…
I feel so honored that FDA highlights our AI/ML review work in the CDER Science Spotlight. This was the first time that the US Food and Drug…
Liked by Andrew Chang
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Ever wondered why closely related nitrosamine analogues can have different carcinogenicity? Read our latest publication which reveals the reasons why…
Ever wondered why closely related nitrosamine analogues can have different carcinogenicity? Read our latest publication which reveals the reasons why…
Liked by Andrew Chang
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The executive summary of the Inaugural Quality Business Leadership (QBL) Summit in Dublin is attached here. Former FDA acting commissioner janet…
The executive summary of the Inaugural Quality Business Leadership (QBL) Summit in Dublin is attached here. Former FDA acting commissioner janet…
Liked by Andrew Chang
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Second meeting on #API #manufacturing in #Nigeria hosted by National Agency for Food and Drug Administration and Control (NAFDAC). #regulatory…
Second meeting on #API #manufacturing in #Nigeria hosted by National Agency for Food and Drug Administration and Control (NAFDAC). #regulatory…
Liked by Andrew Chang
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Panel discussions are always impactful because of the variety of thoughts and ideas that spring up! Come & contribute to the amalgamation in…
Panel discussions are always impactful because of the variety of thoughts and ideas that spring up! Come & contribute to the amalgamation in…
Liked by Andrew Chang
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The U.S. Pharmacopeia (USP) announced today that it has voted to adopt a new standard to make it easier for biomedical companies to use synthetic…
The U.S. Pharmacopeia (USP) announced today that it has voted to adopt a new standard to make it easier for biomedical companies to use synthetic…
Liked by Andrew Chang
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We are incredibly lucky at Takeda to have the industry-leading pathogen safety expertise of Thomas Kreil and his team. I’m especially proud of the…
We are incredibly lucky at Takeda to have the industry-leading pathogen safety expertise of Thomas Kreil and his team. I’m especially proud of the…
Liked by Andrew Chang
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Really fantastic to see this news from the Swedish Medical Products Agency and open letter from the Competent Authorities for Medical Devices (#CAMD)…
Really fantastic to see this news from the Swedish Medical Products Agency and open letter from the Competent Authorities for Medical Devices (#CAMD)…
Liked by Andrew Chang
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Control strategies for drug-linkers used in Antibody-Drug Conjugates (ADCs) are underpinned by the intricate chemical nature of ADCs. Assessing…
Control strategies for drug-linkers used in Antibody-Drug Conjugates (ADCs) are underpinned by the intricate chemical nature of ADCs. Assessing…
Liked by Andrew Chang
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