Articles By Ed Miseta

  1. Data Explosion Is Set To Create Opportunities And Challenges 5/9/2014

    At one time data, any data, was incredibly valuable. It was gathered, cleaned, stored, and mined with the greatest of care, regardless of how good it was. It seemed any information must hold some value for companies. But that was before the information explosion. Today companies have data coming in so quickly, and from so many different sources, that many are not sure how to handle all of it. Add to that the fact that much of the data will have no use for companies whatsoever, and you begin to see the scope of the problem many firms are facing.  

    At the recent Oracle Industry Connect in Boston, company president Mark Hurd started off the two-day event with a short presentation on the state of the industry. Noting the size of global commerce today is around $71 trillion, he queried the audience on how much of that spend is on IT. What do you think it is? If you’re like most of those in attendance, your guess was way too high. The answer: just $2 trillion. At less than 3% of the total, IT does not seem like a substantial portion. However, Hurd was quick to note that without that $2 trillion, the rest of the spending does not happen. There would be no stock trades, no plane tickets, almost no purchasing at all, and certainly no drug discovery. “Virtually everything in that $70 trillion is enabled by the $2 trillion,” says Hurd.

  2. Translational Imaging Center Set To Change Drug Development 5/6/2014

    MPI Research would like to change the way drug development is performed. The company’s cyclotron, part of its newly completed Translational Imaging Center (TIC), is set to do just that. Tours of the facility, which included an opportunity to view the cyclotron, were part of the Grand Opening ceremony held on May 2nd at the MPI Research headquarters, in Mattawan, MI.

    The multi-million dollar project (10,000 square feet housed in a two-story building) was the result of a joint venture between MPI Research and partners inviCRO, and 3D Imaging. This new addition makes MPI Research the only full-service CRO in the world with a cyclotron attached to a vivarium facility, which the company believes will create significant opportunities to advance the drug development process. The cyclotron was acquired from Pfizer, which has since given its blessing to the new facility.

  3. The Promise Of ADCs Create Increased Interest In Oncology 5/1/2014

    Millennium: The Takeda Oncology Company has been working in the ADC (antibody-drug conjugate) space for over a decade, and have established a specific expertise and strong market presence in the development and commercialization within this drug category. In 2009, Millennium and Seattle Genetics entered into a global co-devlopment and commercialization partnership for Adcetris® for intravenous infusion in two indications: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates and patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. Adcetris gained US approval in 2010.  Petter Veiby, senior director of Biotherapeutics, believes has drawn a lot of attention to ADCs and demonstrated their value to the patient population.

  4. AstraZeneca To Pfizer: Thanks But No Thanks 4/28/2014

    A possible merger between two Big Pharma heavyweights, Pfizer and AstraZeneca appears to be dead, at least for the time being. On April 26th the Board of AstraZeneca declined a request from Pfizer to issue a joint statement announcing the two companies had entered into discussions to merge. Per the Board, absent a specific proposal, engaging in discussions would be premature.

    Rumors regarding a possible consolidation have been floating around for approximately five months. They began in November 2013 when Pfizer Chairman CEO Ian Read contacted AstraZeneca regarding a possible merger. At the time, AstraZeneca Chairman Leif Johansson expressed confidence in his company’s ability to continue to operate independently. However, AstraZeneca did agree to an exploratory meeting and the two companies met on January 5th, 2014 in New York.

  5. 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. 

  6. Outsourcing Partnerships: What's Working, What Isn't, And What Can Be Improved 4/24/2014

    The latest Pharmaceutical Outsourcing Monitor from Michael Martorelli and the folks at investment banking firm Fairmount Partners shows the pharmaceutical outsourcing industry moving along at a very healthy pace. The pace of consolidation, which picked up in 2013, has continued on into 2014. Investment in outsourcing companies continues to come in from both public and private sources, and strategic partnerships continue to garner more attention and evolve. All this seems to indicate 2014 will be a year of growth for the industry.

    The report points out several consolidations that will impact the outsourcing arena in 2014 and beyond. At the top of the list is the merger between Patheon and the Pharmaceutical Products division of DSM. Also garnering significant attention was the acquisition of ReSearch Pharmaceutical Services and CRI Lifetree by PRA International and the acquisition of CCBR-SYNARC by BioClinica. The CCBR-SYNARC acquisition continues the growth trend for BioClinica, which we reported on last year after the company acquired CoreLab Partners (Growing To Meet The Needs Of Big Pharma). Also worth noting were the acquisitions of Novella by Quintiles, HERON Group by PAREXEL, and Acurian by PPD. The report notes consolidation across the pharma outsourcing industry is now a fact of life, and the lineup of the largest companies will continue to evolve and change.

  7. Quintiles Enters Strategic Five-Year Agreement With Biogen Idec 4/24/2014

    Biopharmaceutical development and commercial outsourcing firm Quintiles has announced it is entering into a strategic five-year deal with Biogen Idec, a developer of treatments for neurodegenerative diseases, hemophilia, and autoimmune disorders. According to a release by the companies, the agreement is intended to leverage the experience and expertise of both companies to optimize the clinical development process at Biogen Idec.  

  8. Where Are Salaries In The Global CRO Industry Headed? 4/11/2014

    HR+Survey Solutions conducts annual industry surveys to provide organizations with information focused on compensation plan design as well as assessment of appropriate levels of compensation. Its latest report, The 2013-2014 CRO Industry Global Salary Planning Survey, was designed to show industry professionals how salaries are increasing against planned budgets in 52 countries across the globe.

  9. The Future Of Clinical Trials 3/27/2014

    Timothy S. Krupa, MS, MBA, is currently president of TSK Clinical Development, LLC, a consulting firm providing leadership guidance and solutions in the clinical development space. Specifically, Krupa consults on clinical planning, clinical project management, clinical operations, and strategic partnering for the biotech and pharmaceutical industries. Tim recently took some time from his consulting practice to share his perceptions on outsourcing and strategic partnering in the clinical space.

  10. Data Support Clinical Validity Of Pharmacogenomic Testing 3/21/2014

    In 2007, a technical review by the Evaluation of Genomic Applications in Practice and Prevention group (EGAPP) conducted testing that concluded there was insufficient evidence at the time to determine the clinical value of pharmacogenomic testing for adults beginning treatment with SSRI antidepressants.  Since then, extensive new published evidence is available to refute those findings. C. Anthony Altar, chief science officer of personalized medicine company Assurex Health, is the lead author of a study published last fall in the International Review of Psychiatry, which validates the clinical use of pharmacogenomic testing to help predict patient response to psychiatric medications.

    Dr. Altar, who has a Ph.D. in psychology with an emphasis in neuroscience, has spent over 30 years working in the life science industry dealing with pharmaceuticals and drug discovery. He was instrumental in the discovery of Abilify, one of the most commonly prescribed antipsychotic medications, and has done extensive work in developing drugs for the nervous system.