Articles By Ed Miseta

31. Global Supply Chain Creates Increased Challenges For Life Science Companies 10/8/2013

    There is no question the life science industry is global in nature. Numerous pharma companies have locations in multiple countries and across multiple continents. According to its web site, Pfizer alone has offices in 45 different countries. Many of those firms now have suppliers, as well as CMO and CRO partners, that are also stretched across multiple continents. That extended global supply chain has made the job of the folks who handle the shipping of drugs and materials to those varied locations ever more complicated.

32. 5 Characteristics To Look For In A Backup Supplier 9/20/2013

    Supply disruptions can have catastrophic consequences on a drug sponsor, costing the company precious time, money, and customers. Having a backup supplier in place is one of the most crucial steps a pharma company can take to protect its delivery schedule and ensure a continuous supply of product.

    “In this industry, choosing a supplier is not always about cost,” says Randy Johnson, director, supply chain for Cook Pharmica. “The three most important factors affecting the supply chain are cost, quality and timing. Although we hear a lot of talk about pricing, most firms will tell you that getting a quality product, and getting it on time, is more important to them than cost. Having a backup supplier in place will help companies get product out on time and with minimal disruptions caused by unexpected increases in demand or regulatory issues with a primary source.”

33. Documentum Continues To Add Functionality For Life Sciences 9/17/2013

    In the late 1970s and early 80s, the home video game industry was ruled by Atari. The company, started in 1972, saw its share of the video game market grow to 80% in just 10 years. Purchased for $28 million in 1976, Atari saw its net worth grow to $2 billion by 1982. In 1983, when the industry hit a slump, the company lost $536 million and reportedly performed a mass burial of games and game systems at a landfill in Texas. After several acquisitions and name changes, the Atari brand is likely unknown to most of today’s young gamers. When not paying attention to the wants of customers, even a dominant firm in an industry can lose its way.

34. Sharing Knowledge To Solve Manufacturing Challenges 7/1/2013

    Innovation is important in the pharmaceutical world. So much so, in fact, that it was difficult to find a booth at the 2013 BIO International Convention that did not seem to mention it in one form or another. New technologies and processes can often make or break a manufacturing firm. For that reason, contract manufacturer Aesica created the Scientific Advisory Board several years ago. Its purpose was to develop new technologies the company could take to customers. When Aesica realized others could innovate just as well, if not better, it disbanded the Advisory Board in 2011 and formed the Aesica Innovation Board (AIB). To continue to advance the efforts of the board, Aesica recently agreed to join process manufacturing think-tank Britest.

35. API Manufacturing: Alive And Well In The U.S. 6/25/2013

    Dr. Stephen Munk, president and CEO of API manufacturer Ash Stevens, had been taking Lipitor for years. But when his insurance company mandated a generic version of the drug, he was switched to one produced by Ranbaxy Laboratories, a manufacturer based in India. In November Munk learned that glass shards were found in the product. “I went to my pharmacy and told them I wasn’t happy about glass particles showing up in a drug I was taking,” he says. “They told me the FDA had not issued any guidance on it, so don’t worry about it. The entire incident was just further proof to me that U.S. API manufacturing was poised for significant growth.”

36. Five Technology Trends That Will Impact Clinical Research 6/11/2013

    Zikria Syed, CEO of enterprise software company NextDocs, has seen many technology advancements in life sciences, including open standards, mobile access, tablets, and cloud computing. However, despite the cost and compliance advantages offered by many of these advancements, clinical research firms are still slow in adopting them. Research conducted by his firm shows this dynamic is about to change.
    
    “Our sales and marketing personnel talk to clinical researchers and their CIOs every day,” he says. “I believe there is a message we are delivering to them that they are finally starting to understand: There is a technology shift going on that your peers are starting to take advantage of. If you do not embrace these changes as well, you will soon be operating at a costly productivity disadvantage.”

37. What Should You Look For When Auditing A CMO? 5/23/2013

    Veda Walcott is no stranger to audits. As the VP of quality for contract manufacturer Cook Pharmica, she often hosts clients performing their annual manufacturing audits of the Cook facility. Last year her company hosted more than 40 such visits by its clients or their partners, and she believes it is only a matter of time before the organization is accommodating at least one audit per week. In her position as VP of quality, Walcott reviews every audit response that goes out. This has made her a bit of an expert on manufacturing audits. She was willing to share some of her insights on the importance of audits in the contract manufacturer selection process.

38. Want To Create A Culture Of Quality? 5/23/2013

    At this year’s Quality Consortium Summit, hosted by pharma consulting firm The Avoca Group, Chris Hilton, VP of Development and Clinical Alliance Management for Pfizer Inc., shared his a-ha moment on the importance of quality. “It was the week I became head of operations and received an FDA warning letter just seven days later,” he said. “It caused me to look at things very differently. There is no question we need to build transparency between everyone involved in the clinical trial process. For most of us it will involve a different way of looking at the world.”

39. A cGMP Facility That's Built For Quality 5/3/2013

    Cook Pharmica looks to the future to meet the needs of the pharma industry today.
    
    Working with a CMO that can meet the FDA’s standards is of paramount importance to drug companies. The right CMO can mean years of trouble-free operations, while the wrong one could mean failed inspections, warning letters, delayed production, drug shortages, and loss of revenue. With the amount of risk aversion that exists in pharma, it’s a wonder that drug CEOs who outsource production get any sleep at all.

40. 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.