Articles By Ed Miseta

31. Learning From Mistakes: Ulo Palm, SVP, Drug Development and Research Operations, Forest Laboratories 11/14/2014

    I have always been taught you can learn as much from your mistakes as you can from your successes. Oftentimes the lessons learned are much more valuable than what you glean from those positive outcomes. While all learning experiences are valuable, unfortunately some can come at a fairly high price. If the lesson is learned at work, and the cost is sufficiently high, you may even have concerns about your career. That is a situation that Ulo Palm, SVP of Drug Development and Research Operations for Forest Laboratories (recently acquired by Actavis), once faced. Palm shared this personal story during the Dirty Laundry session at the 2014 Disruptive Innovations conference.

    “This lesson happened years ago during what I like to call the dark ages of patient recruitment,” says Palm. “Back then, we did not have the Internet, social media, and other sophisticated tools. You had to review investigator lists and call them to find out how many patients they could enroll in a study. Those who have done this can tell you it is not a very efficient way of managing recruitment.”  

32. MPI Research And Jasper Clinical: Getting Decisions To Sponsors Faster 11/13/2014

    The Upjohn Company was founded in 1886 in Kalamazoo, MI to make friable pills, which were easily digested and could be “reduced to powder under the thumb.” In 1984, the company decided it needed an internal Phase 1 testing unit and felt Kalamazoo would be the best place to construct it. In 1995, Upjohn merged with Pharmacia. A subsequent merger in 2003 made Pharmacia a part of Pfizer. That same year, the Phase 1 testing unit became Jasper Clinic, an independent operation. In October 2014, that facility, now known as Jasper Clinical Research and Development with more than 80 staff members, became a part of the MPI Research family.

    That acquisition by MPI includes the Jasper Clinic, a 50-bed clinical trial unit providing early-stage study services, including pharmacokinetic and pharmacodynamics, drug interaction and methodology studies, and biomarkers. The 25,000 square-foot facility is located on the campus of Bronson Hospital and is physically connected to the hospital’s Level 1 Trauma Center.

33. Will Pharma Talent Help Transform CROs Into CSOs? 11/5/2014

    It's no secret that Big Pharma is shedding scientific talent. Large layoffs, which have traditionally involved management, sales, and marketing personnel, are increasingly affecting scientists and researchers as well. "This scientific talent has to end up somewhere, and more and more they seem to be migrating to smaller biotech companies and CROs," says Emily Hickey, DVM, Ph.D. and VP for In Vivo Discovery at Charles River. "As Big Pharma continues to shrink, they will rely even more on those two segments. Biotech firms will assist them with target discovery while CROs will assist with efficiently interrogating such targets, be it through chemistry or in vitro and in vivo studies. With more scientific talent in those areas, it can be a win/win situation."

    Hickey has first-hand experience with this trend. She herself worked for a top 10 Big Pharma company prior to migrating to the CRO side of the house. In her previous position she was part of a team that evaluated CROs, deciding which ones had the best qualifications and would be the best fit with her company. Working in this capacity, and dealing with all of the challenges that came with it, gave her a lot of the experience she now uses to ensure her company can best meet the needs of pharma clients. As other scientists from Big Pharma make that same transition, both pharma and CROs stand to benefit.

34. The Essential Elements Of A Good Sponsor/CRO Relationship 11/5/2014

    The pharma/CRO relationship can be a complicated one. Each side knows what it wants to gain from the relationship, but those goals or the route to achieve them do not always align. Having a fundamental understanding of what the other side is hoping to accomplish is critical to the relationship developing and maturing in a productive and harmonious manner.

    Emily Hickey, DVM, Ph.D. and Corporate VP of InVivo Discovery at Charles River has experienced this relationship from both sides of the aisle. Prior to joining Charles River, she spent several years working in outsourcing at a large, global pharmaceutical company. Hickey notes outsourcing was not a particularly interesting option for them until just a few years ago. In her capacity in the outsourcing department, she was responsible for developing relationships with CRO partners.

    "We did the world tour of CROs," she admits. "We reviewed who could do what, which areas each company excelled in, how pricing lined up, and more. Based on our findings, we made decisions on where to place much of the outsourced preclinical work. Our overriding goal was to ensure the quality of our science was maintained, whether we did the work internally or with an outside partner."

35. M&As And Specialty Products Give Hope To Global Pharmaceutical Outlook 11/5/2014

    All is not rosy in the pharmaceutical world, as lingering effects of the patent cliff and negative rating activity cast a bit of a shadow on companies. But increased M&A activity and the growth of specialty pharmaceuticals will give some companies in the pharmaceutical space something to be hopeful about. This according to a new report from Standard and Poor’s on the outlook for the global pharmaceutical industry.

    Despite the lingering effects of the last recession, the S&P Industry Report Card projects the U.S. pharmaceutical market will grow somewhat independent of overall global GDP, posting gains of between 4% and 5% in 2014 and 2015, due primarily to ongoing pricing power in the U.S, strong growth in the specialty drug segment, an aging population more prone to using prescription drugs, and increasing disposable income and medical coverage in emerging markets. These gains would be double the global GDP growth rate.

36. Don't Miss The Networking Event Of The Year! 11/3/2014

    Next week, Life Science Leader and Outsourced Pharma are hosting our first conference, an event called Outsourced Pharma West to be held in San Francisco. As Rob Wright, Life Science Leader chief editor pointed out in a recent blog, we didn’t want this conference to be like many others you have attended. We set out with the goal of having informative sessions and some of the best speakers in the pharma world, but also to make it an event where you can easily connect with partners and build your network.

37. FDA Regs Help Secure The Global Supply Chain 10/27/2014

    A better strategy, coordination, and additional tools will help keep medicines and ingredients safe.

38. ISPE Releases Drug Shortages Prevention Plan At Annual Meeting 10/15/2014

    ISPE has released its Drug Shortages Prevention Plan at a media conference held during its annual meeting at Caesars Palace in Las Vegas. Present at the conference were new president and CEO John Bournas, strategic advisor John Berridge, and Drug Shortage Prevention Plan leaders Joe Famulare, Paul D'Eramo, Donna Gulbinski, and Sam Venugopal.

39. ISPE Set To Address Drug Shortages At Annual Meeting 10/6/2014

    Drug shortages continue to plague the pharmaceutical industry. According to a GAO report on shortages, dated February 2014, the number of shortages continues to increase in the U.S., as well as around the world. In 2007 there were 154 shortages, 114 new shortages and 40 ongoing from a prior year. In 2012, there were 456 shortages, 195 news ones and 261 ongoing. As of June 30, 2013, there were already 73 new shortages and 288 ongoing.

    The public health importance of these shortages cannot be overemphasized. Shortage situations have included zinc for parenteral nutrition in neonates and premature infants, doxorubicin for ovarian and other cancers, and Propofol for anesthesia.

    Clearly something needs to be done. “ISPE believes efforts to address this complex and multi-faceted problem of drug shortages requires close collaboration and clear communication between the pharma industry and global health authorities,” says Francois Sallans, VP and chief quality officer for Johnson & Johnson, and presenter at the 2014 ISPE-FDA CGMP Conference. “We believe The Drug Shortages Prevention Plan being assembled by ISPE will provide guidance to pharma and global health authorities to manage drug shortages more effectively. But more importantly we are looking into ways for the two groups to manage these shortages more proactively as well. That is an important component that we need to have in place in order to make these shortages rare, but short-lived.”

40. Pfizer Issues A Challenge – Cook Pharmica Delivers 9/24/2014

    When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the five driving principles (quality, cost, adaptability, timeliness, and risk) that were crucial to Pfizer.