Articles by STEPHEN
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(a letter from the American Public Health Assoc)
(a letter from the American Public Health Assoc)
By STEPHEN SUN
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(Establishing a framework of new knowledge/information in an unfamiliar space)
(Establishing a framework of new knowledge/information in an unfamiliar space)
By STEPHEN SUN
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Interesting site for some out-of-box thinkers
Interesting site for some out-of-box thinkers
By STEPHEN SUN
Contributions
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Your R&D team is struggling to innovate. Can prototyping tools help?
Depends on type of R&D work. Biological? Chemical? Product manufacturing? Transport? This being said, prototyping can cost a wide range of resource allocation. So consider using an index fractional percentage, e.g. 1 to 5% (or whatever is sensible %) of the the full production budget to build a prototype and help envision its utility? What can you build with that type of allocation? Note: it's still R&D, maybe more than 1 will be needed.
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Your R&D team is struggling to innovate. Can prototyping tools help?
Prototyping is a brain crutch. Difficult to envision in the abstract, having a prototype helps to the next stage for collaborative discussion, think "draft" for a 2D version, less than a Version 1.0 for a software, proof of concept to play and envision.
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Your R&D team is struggling to innovate. Can prototyping tools help?
Consider prototyping in a few different dimensions: 2D (.ppt slides, images, back of napkin workflows), 3D (printed physical models, 3D digital images that can be rotated, Lego kit, touch and feel), 4D (proof of concept, wireframe, toy models with an environmental backdrop to simulate real-world conditions); whatever type of pre-production concept tools to stimulate the mind to get teams to envision the product in final real world conditions without the full time/resource investment.
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Your team is struggling to deliver a project on time. How can you keep them motivated and focused?
Define the public impact of reaching target objectives and the population benefit of each team member's contribution. As applicable, the outputs of research impacts so many others; people count on the R&D team to move the needle in science so it is worthwhile to invest the time to ensure they realize their individual and team importance for the broader objective. (sometimes, team members are so deep in the forest, they might not realize who or what months, years, other countries and governments, other innovations may benefit from the efforts of today)
Activity
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(Benefit-Risk Management / Pediatric Inflammatory Bowel Disease / NEW US FDA Draft Guidance) Conditions for developing IBD medications for adults and…
(Benefit-Risk Management / Pediatric Inflammatory Bowel Disease / NEW US FDA Draft Guidance) Conditions for developing IBD medications for adults and…
Shared by STEPHEN SUN
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(Benefit-Risk Management / Partial Onset Seizures / FINAL FDA Guidance) This is a fast/short guidance document that shares the current regulatory…
(Benefit-Risk Management / Partial Onset Seizures / FINAL FDA Guidance) This is a fast/short guidance document that shares the current regulatory…
Shared by STEPHEN SUN
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(Benefit-Risk Management / Drug Shortage / US FDA Extended Use Database) So today's highlight is pretty self-explanatory, if you have some…
(Benefit-Risk Management / Drug Shortage / US FDA Extended Use Database) So today's highlight is pretty self-explanatory, if you have some…
Shared by STEPHEN SUN
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(Benefit-Risk Management / Patients with Rare Diseases and Gene Therapy Access / 2 x US FDA Listening Meetings) Ok, listen up! The 1st of two FDA…
(Benefit-Risk Management / Patients with Rare Diseases and Gene Therapy Access / 2 x US FDA Listening Meetings) Ok, listen up! The 1st of two FDA…
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(Benefit-Risk Management / Opioid Use Disorder / Final FDA Guidance) How should I view this very special guidance? Particularly in the US where we…
(Benefit-Risk Management / Opioid Use Disorder / Final FDA Guidance) How should I view this very special guidance? Particularly in the US where we…
Shared by STEPHEN SUN
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Sharing my colleague's expertise for those who are looking to enter/explore/need assist with EU PV reporting requirements. Oppt to sample here for a…
Sharing my colleague's expertise for those who are looking to enter/explore/need assist with EU PV reporting requirements. Oppt to sample here for a…
Shared by STEPHEN SUN
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(Benefit-Risk Management / AI in Biopharma Development / US FDA + CTTI Workshop) So may want to invest your TUES, AUG 6 from 10AM to 530PM EST (more…
(Benefit-Risk Management / AI in Biopharma Development / US FDA + CTTI Workshop) So may want to invest your TUES, AUG 6 from 10AM to 530PM EST (more…
Shared by STEPHEN SUN
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(Risk Management / URRA / NEW Draft FDA Guidance) Super quick - what is a Use-Related Risk Analysis? URRA is a risk analysis tool used to identify…
(Risk Management / URRA / NEW Draft FDA Guidance) Super quick - what is a Use-Related Risk Analysis? URRA is a risk analysis tool used to identify…
Shared by STEPHEN SUN
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(Pharmacovigilance / Pharmacoepi RWD for Safety Assessment / New ICH FDA-Adopted Guidance) Lots of activities over the past few days. This first one…
(Pharmacovigilance / Pharmacoepi RWD for Safety Assessment / New ICH FDA-Adopted Guidance) Lots of activities over the past few days. This first one…
Shared by STEPHEN SUN
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(Benefit-Risk Management / Misinformation / NEW FDA Draft Guidance) In the era of misinformation awareness, FDA here taking a very directed Q&A…
(Benefit-Risk Management / Misinformation / NEW FDA Draft Guidance) In the era of misinformation awareness, FDA here taking a very directed Q&A…
Shared by STEPHEN SUN
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(Risk Management / URRA / NEW Draft FDA Guidance) Super quick - what is a Use-Related Risk Analysis? URRA is a risk analysis tool used to identify…
(Risk Management / URRA / NEW Draft FDA Guidance) Super quick - what is a Use-Related Risk Analysis? URRA is a risk analysis tool used to identify…
Shared by STEPHEN SUN
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(Risk Management / Food Safety / US FDA Webpage on Food Handling) We might think we know everything about eating outdoors during our July 4 wknd…
(Risk Management / Food Safety / US FDA Webpage on Food Handling) We might think we know everything about eating outdoors during our July 4 wknd…
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(Benefit-Risk Management / Social Media / US FDA Webpage) At some point, maybe not today or next month, but you might need to know if/what is the…
(Benefit-Risk Management / Social Media / US FDA Webpage) At some point, maybe not today or next month, but you might need to know if/what is the…
Shared by STEPHEN SUN
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(Benefit-Risk Management / FDA Labels / US FDA Tool Updated V2.9 Release) Today is a tool highlight - ever been in "FDALabel"? It's a tool that's…
(Benefit-Risk Management / FDA Labels / US FDA Tool Updated V2.9 Release) Today is a tool highlight - ever been in "FDALabel"? It's a tool that's…
Shared by STEPHEN SUN
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(Benefit-Risk Management / Drug-Device Combo and Delivery Devices / New DRAFT Guidance on "outputs" (think GMP)) This is likely to be a FDA guidance…
(Benefit-Risk Management / Drug-Device Combo and Delivery Devices / New DRAFT Guidance on "outputs" (think GMP)) This is likely to be a FDA guidance…
Shared by STEPHEN SUN
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