Editors' Desk

71. Insiders' Guide To Winning In the Drug Delivery Device Market — Part 3: Quality Systems 2/9/2016

    I recently sat down with Christopher Eustace of Hospira, who has over 27 years of quality experience in both the pharmaceutical and medical device industries, to discuss how a combined QS program is necessary for life science companies striving to capture their piece of the delivery device market.

72. 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. 

73. 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.

74. Insiders' Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance 1/26/2016

    I recently sat down with David Amor, managing partner at MEDgineering, Inc., to discuss the challenges associated with bringing drug delivery devices to market, as well as emerging therapeutic areas and technologies. David’s background is in mechanical and biomedical engineering, with expertise in regulatory systems and compliance. 

75. 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. 

76. 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.

77. Insiders' Guide To Winning In the Drug Delivery Device Market — Part 1: Design 1/12/2016

    As challenges continue to mount in the med device industry, many companies are looking to drug delivery as a new revenue stream. Here, Neil Cammish, technical director, International Device Solutions, discusses the drug delivery technologies poised to have a market impact in 2016 and beyond.

78. 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.

79. How Important Is The Single-Use Supplier Relationship? 12/4/2015

    In a survey conducted by Pharma IQ for 2015, which captured the industry’s view on SUT and what challenges it faces, over 100 users were asked about their relationship with their SUT supplier. Of the most important factors identified when choosing a single-use supplier, 64 percent of respondents indicated that the relationship with the supplier ranks as the most important. How important is this as single-use technology adoption increases?

80. The California Drought's Impact On Pharma 10/22/2015

    Drought conditions are making it increasingly difficult for pharmaceutical manufacturers to secure the proper wastewater permits in The Golden State.