Articles By Ed Miseta

21. 7 Essential Steps To Hiring A Pharmaceutical Consultant 2/26/2014

    In preparation for the spring 2014 hiring season, The CECON Group has recently developed guidelines for choosing the best consultant for a project. Selecting and managing a technical consultant can be a challenge, especially if the subject matter is well outside of the hiring manager’s field of expertise. In the pharmaceutical industry, consultants can help companies of any size to deal with various aspects of drug development, including the selection of suppliers and outsourcing partners.  

22. Cobra Biologics Extends GMP Certification 2/11/2014

    In December 2013, business growth necessitated CMO Cobra Biologics install a new Thermo Scientific 1000L HyClone Single-Use Bioreactor (SUB) at the company’s centre of excellence for mammalian antibody and recombinant protein production. In announcing the expansion, the company cited a ten-fold increase in antibody business over the prior two years, growth in contract manufacturing services, and its continued commitment to single-use disposable technologies.  

23. Johnson & Johnson Subsidiary Submits FDA Application For New Drug To Treat Castleman Disease, A Rare Blood Disorder 12/9/2013

    Clinical trials conducted by Janssen Research & Development, LLC points to evidence that its experimental drug, siltuximab improved symptoms and shrank growths in patients with Castleman disease, a rare blood disorder that causes enlarged lymph nodes. This condition can lead to a multitude of symptoms and weaken the immune system, making it hard to fight infection.  Infections in people with Castleman can be very serious and even fatal. No other approved therapies currently exist for the disease.

24. NovoNordisk Drug Demonstrates Superior Blood Sugar Control 12/9/2013

    NovoNordisk, the Denmark-based global leader in insulin production announced the results of its phase 3 trials of IDegLira, its new diabetes drug, at the World Diabetes Conference of the International Diabetes Federation. The results of the study indicate superior glycemic control and weight loss combined with a low incidence of hypoglycemia in adults with Type 2 Diabetes uncontrolled on basal insulin.

25. WIB Profile: Best Practices For Buying, Selling, And Maintaining Used Laboratory Equipment 11/27/2013

    In this Women In Bio (WIB) profile article, Dawn Hocevar, director of national development for BioSurplus, discusses her job, trends in the market for used lab equipment, and best practices to keep in mind when shopping for used equipment. She also discusses what WIB can do for young women entering the pharma and biopharmaceutical industries.

26. 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.”

27. 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.”

28. 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.”

29. Handle Challenges And Avoid Common Mistakes In Drug Product Packaging 10/11/2013

    Michael Rooney, Business Support Manager for Almac, has spent over 12 years working in the pharmaceutical industry. Prior to joining Almac, he spent time working as an associate scientist at ABC Laboratories and an analytical chemist at Nicobrand. In his current position, he assists clients with guidance and advice on packaging issues. I spoke with Rooney about the challenges companies in the pharmaceutical industry face with regard to packaging.

30. 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 2^nd and 3^rd), 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.