Articles By Ed Miseta

  1. Professionalize Your Clinical Research Personnel 6/11/2014

    Clinical research professionals need to be properly educated and trained to ensure regulatory compliance, subject safety, and data integrity. A strong knowledge base facilitates quicker approvals and fewer trial delays.

    But how does your staff get the training needed to develop the skills most in demand? And from where is formal education coming? When training opportunities are available, how do you ensure employees learn from them and that you see tangible results? These are questions facing the industry that the Association of Clinical Research Professionals (ACRP) is addressing.

  2. Pfizer's Five Year Plan Moves From Integration To Optimization 6/2/2014

    In 2010 Pfizer decided to evaluate its clinical development and operations model. The goal was to change the process to make it more effective and efficient. At that time the company had 17 large-scale vendors, as well as numerous smaller ones performing various aspects of clinical trial execution. “We were essentially utilizing a staff augmentation/functional sourcing model,” says Coleen Glessner, VP, Head of Clinical Trial Process & Quality at Pfizer. “We had data service providers, monitoring providers, study management providers, programming providers, and medical writing providers performing services for us in 67 countries. We realized at that point we needed better line of sight into the performance of our nearly 550 clinical trials.”

  3. WIB Profile: Challenges And Benefits Of Performing Trials In India 5/16/2014

    Mithra Bindhu is an entrepreneur at heart who currently serves as the executive director of Asiatic Clinical Research, a CRO that is headquartered in India. Bindhu, based in Atlanta, GA, is the founder and one of the principal investors in Asiatic and currently serves as the vice-chair for the Atlanta chapter of Women In Bio, which she co-founded. Bindhu is a marketing professional with a successful track record in international markets. She was also a co-founder of FAST Inc. NY and worked as head of sales from 1993 to 1999, playing a key role in the company reaching revenues of $20 million.

    We recently spoke with Bindhu about her company and the challenges/opportunities for companies conducting clinical trials in India.

  4. Survey: Strategic Partnerships Perceived As Most Effective Outsourcing Model 5/16/2014

    A report issued by PAREXEL has revealed that strategic partnerships are the most effective biopharmaceutical outsourcing model when it comes to meeting key sponsor needs. The report, titled Strategic Partnerships 2014: Driving Biopharmaceutical Outsourcing Effectiveness, was released at the 23rd annual Partnerships in Clinical Trials Conference.

    The goal of the report was to provide insights and highlights into the value of multi-year, highly-integrated engagements between sponsors and CROs. The data contained in the report is the result of an online survey of 148 senior-level executives representing large, mid-sized, and small biopharmaceutical companies. The survey, conducted by Blue Pyramid Consulting, a subsidiary of the Avoca Group, included both quantitative and qualitative questions, as well as single- and multiple-response questions.

  5. 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.

  6. 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.

  7. 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. 

  8. 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.  

  9. 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.

  10. 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.