Articles By Ed Miseta
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Patient Demand, Vaccines, And Drug Delivery: Q&A With Steve Wick Of 3M Drug Delivery Systems
4/24/2014
New technologies are changing the drug delivery approaches used for both small and large molecule manufacturers. Additionally, the more empowered patient is causing many pharma companies to re-evaluate their drug delivery strategies. We spoke with Steve Wick, Senior Technical Director for 3M Drug Delivery Systems, about these topics as well as how the drug delivery landscape might change over the next 5 to 10 years.
What technologies are currently changing drug delivery approaches for small molecules? For large molecules? How will these advances impact the pharmaceutical industry?
For small molecules specifically, I believe that we will see two different trends in drug delivery. The first will be toward the targeting of drug delivery through the use of technology such as nanoparticles or even aptamers.
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Patient-Centric Design: The Next Frontier In Drug Delivery
3/4/2014
Patient-centric is one of those terms we suddenly seem to hear mentioned often. Everyone in pharma wants patients to know that it’s their comfort and well-being that are always at the forefront of development efforts for medicine and delivery devices.
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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.
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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.
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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.
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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.
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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.
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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.”
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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.”
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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.”