Articles by Louis Garguilo
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Drug Serialization Reaching Consumers
2/8/2016
Three years into a U.S. initiative for drug “serialization,” companies are: (a) working with the FDA; (b) taking their own steps to traceability; and/or (c) hoping the day of reckoning fades further into the future. But the future is here with serialization reaching into the consumer’s home.
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Is Marketing Manipulating Your CMO Selection?
2/2/2016
A report on biologics API outsourcing provides insights on how marketing and reputation influences BioPharma's selection of CMOs. Both sides need to line up actual CMO performance and capabilities with market perceptions. But sponsors beware: Under a marketing spell, it appears the best strategy to select CMOs is to find those perceived as most expensive.
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More Biotech Mixology For Successful Outsourcing
1/25/2016
Last we left off, M. (Ken) Kengatharan, PhD, MBA, serial start-up entrepreneur and scientist – or biotech mixologist – was mixing examples of outsourcing that included falsely inflated balloons and Super Hero deliveries of API. Here Kengatharan draws some final lessons and insights into successful outsourcing.
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Outsourcing Lessons From A Biotech Mixologist
1/19/2016
M. (Ken) Kengatharan is an accomplished mixologist. What he mixes professionally is biotech business models, drug researchers and developers, private and venture capital, entrepreneurs and investors … with a large shot of strategic outsourcing. Through his experiences at the five biotechs he’s put together, we can learn how to improve sponsor and service-provider dynamics.
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Pharmaceutical Outsourcing: What Are You Thinking?
12/17/2015
In this final editorial of 2015, we look into the collective mind of the outsourcing industry, and select a leader of the year. The biopharma industry is now second to none in global consciousness and importance, and the significance of outsourcing within that heightened position grows in equal measure. Prepare well for 2016.
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Innovators In The Pharmaceutical Packaging Industry
12/11/2015
As biologics and global injectable-drug markets grow, BioPharma needs advancements ensuring the highest quality in the integration of new delivery systems and packaging technologies that can be administered outside of clinical settings. Service providers are responding.
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Leadership At “The Best CMO In The World”
7/8/2015
An Exclusive Interview on Leadership with Samsung BioLogics President & CEO Tae Han Kim.
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The Drums Of BIO 2015: Dollars, Nano and Data
7/2/2015
Among the drumbeat of discussions at BIO 2015, three sounds reverberated above all: the first came from the bass drum of money; next was the razor-sharp tones of the nanotech snare drum; and hitting the cymbals for exclamation was “the whole digital field interacting with pharma and bio."
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An All-Outsourcing Model For Orphan Drugs
6/15/2015
Nils U. Olsson, VP of Chemistry, Manufacturing and Controls at Retrophin Inc., says his company’s business model targeting new drugs for orphan diseases allows for a perfect application of an all-outsourcing strategy.
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Super Quality Accidental Collisions at BIO 2015
6/8/2015
At first blush, the BIO 2015 theme of “Super” doesn’t sound all that, well, super. But after meeting a super hero of the industry who warns of the need to prepare for super quality accidental collisions, the theme comes into full focus.