Articles By Ed Miseta

  1. Selecting Strategic Partners – The Lilly Way 10/31/2013

    As VP of Lilly Research Laboratories’ (LRL) operations and LRL Europe, Andy Dahlem puts his reputation on the line every day. When Eli Lilly and Company implemented its new outsourcing strategy several years ago, he was tasked with implementing it. The transformation took Lilly from a fully-integrated pharmaceutical company (FIPCO) to a fully-integrated pharmaceutical network (FIPNET) with numerous external partners.

    In this position, Dahlem carries much of the responsibility for work done by external partners. If he seems very serious when discussing breakdowns in quality and reliability, it’s because he holds himself personally accountable for those lapses. “When I make a deal with a service provider to do the work, it’s my reputation that is at risk,” he states. “That is not a responsibility I take lightly.”

  2. Lilly's Success Depends On Strategic Partnerships 10/29/2013

    Eli Lilly and Company developed several new products in 2003. By 2009 the company had invested six years of R&D into building the portfolio, and the products were ready to move from Phase I to Phase II. That is when Lilly created its Development Center of Excellence (DCOE), with the idea that it would help the company be prepared when the products were ready to move into Phase III. The DCOE is now responsible for clinical development, product R&D, toxicology, and project management. Today, to say the DCOE is critical to ensuring the success of its pipeline would be an incredible understatement.

    “John Lechleiter’s (Lilly president, chairman, and CEO) vision for the DCOE was to aggregate these disciplines together under one roof,” says Tom Verhoeven, SVP and co-leader of the Development Center of Excellence, Lilly Research Labs (LRL). “Success will be measured by the number of molecules getting through Phase III, as well as the data generated. The idea behind the DCOE was to become more reliable when getting data and to have the portfolio moving in a predictable way through the different phases of development.”

  3. How Should Big Pharma Partner With Academia? A Perspective From Lilly 10/24/2013

    In preparation for upcoming patent expires, Eli Lilly and Company (NYSE: LLY) has been transforming itself to better deal with the increasing costs of developing life-saving medicines and possible decreases in revenue. One of the primary goals of the company has been to move away from a model where virtually 100% of R&D was in-house. By decreasing fixed expenditures, and increasing flexible spending, the company would be in a better position to manage its clinical and manufacturing costs.

    More recently, that plan is evolving into academic partnerships as well. “We are now asking if, in the ecosystem of drug development and discovery, there is a fundamental place where we can work in a systematic way with academic institutions,” says Andy Dahlem, VP of Lilly Research Lab (LRL) Operations and LRL Europe for Eli Lilly and Company. “The proposition has become more interesting because of the increasing pressures being placed on academic institutions and their business model. This is occurring at the same time Pharma faces increased cost pressures.”

  4. Global Trials Roundtable – Controlling Cost And Mitigating Risk 10/24/2013

    The current economy, patent expirations of multibillion dollar drugs, and the rising cost of clinical trials (and drug development in general) has many in the pharma industry placing an increased emphasis on controlling costs. Companies must do this while continuing to take more trials to a global market and seeking out more strategic relationships with clinical partners.

    To gain a better understanding of the current trends in clinical outsourcing, and what can be done to control the cost of trials, Clinical Leader conducted a roundtable discussion with executives from several CROs. The panel included: Paula Brown Stafford, president of clinical development at Quintiles; Wendel Barr, CEO of SynteractHCR, James D. Esinhart, CEO of Chiltern, Wanda Dobrzanski Nisiewicz, VP of Clinical Operations Latin America & North America at inVentive Health Clinical; Silvia Zieher, VP, Clinical Development, Latin America Operations at INC Research; and Ramita Tandon, SVP and general manager at inVentive Health Clinical.

  5. Best And Worst Outsourcing Experiences: WIB Profile With Pfizer Executive Director of Clinical Development 10/24/2013

    In this Women In Bio (WIB) profile article, Pam Garzone, executive director, biotechnology, clinical development at Pfizer WRD (worldwide research & development), discusses her job, lessons learned from her years in clinical outsourcing, and her thoughts on being involved with WIB.

  6. What is the Current State of eTMF? 10/17/2013

    So much has been written and published about the use of electronic trial master files (eTMFs) that it is difficult to understand exactly where the industry stands on acceptance of the technology. At times it seems some firms are not even referring to the same thing when referencing eTMFs. Enterprise software company NextDocs has conducted a survey of 60 companies to gain both qualitative and quantitative insights into the use and perceptions of eTMFs by end users. The results have been released in a report titled The State of Trial Master Files. 

    “The biggest trend we see in the clinical space is a gap that exists between the great strides made by some of the industry leaders (especially ones where legacy document management is not as entrenched) and firms that seem to be laggards in regard to adopting the technology,” says Kevin Potts, VP of marketing for NextDocs. “The firms that are slow to adopt the technology seem to believe eTMF is nothing more than a system used to scan and archive documents after you are done using them. Many companies will tell you they are already using eTMF, but the bigger question is what are they really doing with it.”

  7. Eli Lilly Looks Ahead To 2014 And Beyond 10/9/2013

    If you have read any of the coverage of Eli Lilly by some in the pharmaceutical press, you would already be selling the stock or shorting as many shares as possible. Sensationalized articles about the patent cliff, coming drops in revenue, and Phase III disappointments would have even the most confident of stockholders feeling squeamish. At the recent media and investor meetings held at Lilly headquarters in Indianapolis (October 2nd and 3rd), the company sought to convince members of the investor and pharmaceutical communities that it has a strong pipeline of molecules and is ready to take on the challenges that lie ahead.

  8. MPI Research Breaks Ground On Imaging Center 9/19/2013

    In June 2013 pharmaceutical research firm MPI Research formed a strategic partnership with imaging informatics provider INVICRO and 3D Imaging, a provider of radiopharmaceuticals. To date, the three companies have collaborated on over 100 unique imaging projects. The goal of the partnership was to unite molecular imaging, radiochemistry, and informatics under one roof, so as to accelerate the drug discovery and development process for drug sponsors. On September 6th the three companies held a groundbreaking ceremony for a new world-class Imaging Center. The center is set to open in spring 2014, although many of the expanded imaging solutions, including nonhuman primate PET and CT imaging capabilities, became available in July 2013.

  9. 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.

  10. Phase I Trials Become More Complex 9/16/2013

    Executive Insights From Women In Bio

    This is the first in a series of articles we will publish on industry trends in the bio and outsourcing space from representatives of Women In Bio (WIB). In this piece Lisa Bjornestad, director of business development for DaVita Clinical Research, discusses trends in Phase I trials. Bjornestad has been involved with clinical research for over a decade, working in both operations and management. Her specialties include clinical operations, project management, CRO services, research sites, and subject recruitment. Prior to joining DaVita, she spent time with Radiant Research in Dallas, TX and San Diego, CA.