Articles By Ed Miseta

81. Engage With Patients, Not Paper 4/12/2013

    Technology has come a long way, and continues to evolve in ways that many of us could not have imagined 20 years ago. Consider the iPhone 5. This device has a user friendly interface, PassPort (an app that keeps all your gift cards, coupons, boarding passes, and tickets organized, and which are ready for you when you need them), enables cloud computing, and of course has Siri, which remembers where you are, reminds you of appointments, and gives you directions. Just 10 years ago, I could not have imagined doing all of that from the palm of my hand.

     

    Michael Smyth, general manager of TransPerfect Life Sciences Solutions, thinks of this technology every time he walks into a clinical investigative site and sees row after row of shelves piled high with binders full of paper. “When a new technology comes out, like the iPhone 5, most people can’t wait to embrace it,” he says.  “It makes our lives better and easier in so many ways, it is almost counter-productive to NOT embrace it. I know many people in the life science industry who have this device. Yet when it comes to documenting the results of clinical trials, many sites continue to use the same methods that were used 100 years ago, even though far more efficient and time-saving technologies are now available. I believe it is time for the life sciences industry to embrace these technologies as well.”

82. Economics And Safety Make The Case For Continuous Flow Processing 4/8/2013

    Is continuous flow processing the next wave in small molecule API manufacturing? James Bruno, managing director of Chemical and Pharmaceutical Solutions, Inc., makes the case for it. Bruno examines the improved economics, waste reduction, safer operations, and applications in making the case for continuous flow processes.

83. Outsourcing Perceptions From The CEO Of An Early Stage Start-Up 4/1/2013

    Leslie Williams is President, CEO, and founder of ImmusanT, Inc., an early stage company focused on peptide treatments for auto-immune diseases. Williams has over 20 years of industry experience in healthcare, management, commercial product development and marketing. Williams took time out from her managerial duties to share her perceptions on outsourcing and working with CROs.

84. Outsourcing Insights From The Executive Director Of Medical Research Operations For Purdue Pharma 4/1/2013

    Dr. Mitchell Katz, Ph.D. is the executive director of medical research operations responsible for leading activities across all clinical programs for Purdue Pharma. He has 26 years’ experience in the pharmaceutical and biotech industries, including preclinical research, pharmaceutical operations, and regulatory affairs. Katz, a key opinion leader within the clinical trial space, often speaking at key industry events such as Partnerships in Clinical Trials, and DIA. He recently shared his insights regarding outsourcing in the clinical universe.

85. Growing To Meet The Needs Of Big Pharma: Acquisitions Help BioClinica Increase Profits by 20% 3/26/2013

    Recent acquisitions have convinced Mark Weinstein, CEO of BioClinica, that his company is ready to work with the largest of pharmaceutical companies, be they CRO or drug sponsor. Bio-Imaging, which officially became BioClinica in 2009 following a major merger, is currently running over 400 imaging studies with over 200 clients. Weinstein notes a series of well-planned steps were required to get them to this position.

86. Candid Insight On Working With CROs From Sangart VP Of Clinical Operations 3/18/2013

    Mary Rose Keller is the VP of Clinical Operations for Sangart, Inc. and is responsible for the execution of all clinical programs, including sickle cell, trauma and future treatments at Sangart. Keller has over 25 years of experience in clinical research and clinical trial execution and has been involved with numerous, successful regulatory submissions for companies such as Agouron, Pfizer and Shire Pharmaceuticals. Keller provides her candid insight on working with CROs.

87. Former Acorda Chief Medical Officer Discusses Benefits And Pitfalls Of Outsourcing 3/18/2013

    Dr. Thomas C. Wessel, former chief medical officer for Acorda Therapeutics, recently shares his expertise acquired from working with the clinical development and operations, regulatory affairs, biostatistics, data management and drug safety functions.

88. Drug Delivery Insights From A 30-Year Veteran At 3M 2/21/2013

    James Ingebrand, president and general manager for 3M (NYSE: MMM) Drug Delivery Systems, joined 3M back in 1984. Having worked across a number of 3M’s divisions in the United States and the United Kingdom, both on the branded and OEM sides of the business, Ingebrand has rich insight into industry trends as well as 3M’s history of innovation. From Ingebrand’s perspective, the culture of innovation continues into the drug delivery area by leveraging the company’s expertise and vast technological capabilities. Ingebrand sat down with Outsourced Pharma (OP) to share his insights into key trends and how the 3M culture is positioned to capitalize on them.

89. Albumin Addresses Need For Better And Longer-Lasting Drugs

    A recent article in the Wall Street Journal addressed the most recent research and technologies in pharma that are making drugs more efficient. One protein that is leading the advancements in this area is albumin.  

    The albumin developed by Novozymes makes it possible to produce better and longer lasting drugs. The development started more than 20 years ago in Nottingham, UK, when the Bass Brewery was seeking novel ways to generate value from its waste yeast. To do so, it established a company to assess the feasibility of making albumin from brewer’s yeast. The brewery eventually sold off the company, and Novozymes has since acquired the technology. Novozymes now produces albumin for a number of pharmaceutical companies, although the process currently uses a more efficient yeast developed by Novozymes rather than brewer’s yeast.