Articles By Ed Miseta

11. 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.  

12. 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."

13. 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.

14. 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.  

15. 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.

16. 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.”

17. 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.”  

18. 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.

19. 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."

20. 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.