Articles By Ed Miseta
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21st Century Cures Gets Closer To Revolutionizing The Pharma Industry
2/5/2015
If you’re a regular reader of my articles, you know my background is in economics, and I tend to favor free markets over more central control. But when I first became aware of the 21st Century cures initiative last year, I felt it was something the industry needed.
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Will The State Of New York Stifle Pharma Innovation?
2/2/2015
An anti-trust lawsuit is pending in the U.S. Court of Appeals for the Second Circuit that could have an impact on the ability of a pharmaceutical company to innovate and invest in medicines they think will best serve patient needs.
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Pharma, Mobile Health, And Patients: How Stakeholders Can Better Advance Clinical Trials
1/28/2015
Clinical trials are evolving. The cost, along with issues surrounding patient recruitment and retention, are forcing many sponsors and CROs to rethink the conduct of trials. One innovation that will certainly have an impact will be mobile health technologies.
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Lilly Moves From Patent Expirations To New Product Growth
1/7/2015
Eli Lilly and Company has announced its 2015 financial guidance and outlined growth plans for the remainder of the decade. The company’s refined strategy places an emphasis on growing revenue and expanding margins by providing a greater focus on research and commercial activities, while maintaining a sustainable flow of innovative medicines.
"We are successfully moving from a challenging period of patent expirations to a period of resumed growth, led by diabetes, oncology and animal health," says John C. Lechleiter, Ph.D., Lilly's chairman, president, and CEO. "We are launching new products and competing more effectively. We also retain one of the strongest pipelines in our history. Our refined strategic direction gives us a blueprint that will provide greater focus for our research and commercial activities and help Lilly respond to an ever more challenging environment. In these ways and more, we'll continue to create value for all our stakeholders while improving the lives of patients."
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The Impact Of The Surging Biotech Market On New Startups And CMO Outsourcing
12/12/2014
With such strong market demand for new biotech companies with innovative assets, most analysts believe the outlook for the sector remains quite promising. This would potentially seem like good news for contract manufacturing organizations (CMOs) as market enthusiasm and gains would be expected to stimulate investment in new biotechnology startup companies.
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WIB Profile: Nektar Therapeutics Develops Drug Candidates with Improved Patient Benefits
12/9/2014
As a Scientist II at Nektar Therapeutics, Vidula Dixit-Duarte has a wide range of responsibilities from laboratory scientist to project team lead to new product concept analyst. Nektar has a robust pipeline of products based on its advanced polymer conjugate technology. The company also partners with top pharma and biopharmaceutical companies to help bring new products and product advancements to market. The company’s technology and drug expertise has resulted in nine approved products in the United States or Europe through partnerships with leading biopharmaceutical companies. For those reasons and more, we chose to feature Vidula Dixit-Duarte in this installment of our Women in Bio profile.
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Outsourced Pharma Announces Inaugural Editorial Advisory Board
12/9/2014
Erie, PA – Outsourced Pharma is dedicated to pharmaceutical drug development services. With regular sections on drug development, contract manufacturing, contract research services, contract packaging services, formulation and development, API manufacturing, and more, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace. Our goal is to help facilitate connections and faster collaborations between sponsors and CMOs and other equipment and service providers.
To ensure we are providing readers with the content they will find timely and valuable, we rely on the feedback of pharma industry professionals and consultants to guide our focus and direction. With that in mind, we are proud to announce the launch of our inaugural editorial advisory board for the website. The board, made up of consultants and executives from the pharma and bio industries, will help guide the direction and focus of the site’s editorial content.
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Getting The Right Drug To The Right Patient At The Right Time
12/5/2014
It’s no secret that there are patients across the globe with a high degree of unmet medical needs. These patients are desperate for access to new and innovative medicines that are either still in clinical development or not available commercially in their country. “The primary way for them to access those medicines is via a clinical trial,” says Mark Corbett, SVP of Clinigen Group’s Global Access Program. “Unfortunately, if they are in a situation where they don’t live near a clinical trial site, or the trial is not available in their country, there are mechanisms that exist outside of clinical trials to allow patients with a high unmet medical need to access these medicines. We work within these mechanisms to provide global access programs on behalf of pharma and biotech companies, providing access to their innovative new medicines to patients in dire need.”
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Implementing A Vendor Oversight Quality Management System: Insights From Biogen Idec Data Management
11/21/2014
As the volume and complexity of outsourcing increases, it becomes important to implement a risk-based approach to vendor oversight. Regulatory agencies expect that sponsor companies will ensure qualified personnel are working on their behalf, following GCP-compliant processes and have adequate controls in place to ensure patient safety and data integrity.
Unfortunately, it is also common for silos to exist in many large organizations. Much of what the data management area might do is contained within that department. What the clinical operations department does might be confined to clinical operations. As a result, not all information generated on vendor interactions will be passed through all of the functional areas requiring access to the information.
When those regulatory inspectors do show up at your door, it is not uncommon for them to ask “what have you done to oversee this vendor?” or “what evidence of vendor oversight can you produce?” As the sponsor is ultimately accountable for the quality of the data and the study conduct, it is important to ensure that oversight is applied throughout the lifecycle of the study. At the same time, it is important to not duplicate effort, micromanage the vendor, or fix issues that should be resolved by the vendor. Oversight is essential, but spending time on unnecessary activities can have the effect of decreasing quality.
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Merck Announces Positive Results From Phase 2b HIV Combo Therapy Study
11/21/2014
Merck has announced data from a 48-week Phase 2b clinical trial that evaluated the safety and efficacy of once daily oral doravirine plus tenofovir/emtricitabine (TDF/FTC). Doravirine is an investigational next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI). The study compared doravirine plus TDF/FTC to efavirenz plus TDF/FTC, in previously untreated patients with HIV-1 infection.
The treatment of HIV has changed considerably since the early days of the epidemic. Initially there were no therapies, which eventually gave way to single therapies. Today multiple classes of therapies are available which target different parts of the virus lifecycle are available. It has now become clear to researchers that combination therapies are key to battling the disease. With combination therapies, patients are able to live lives much closer to normal without the HIV complications that would often be fatal.