Articles By Ed Miseta

  1. Are You ASKING For An FDA Warning Letter? 7/15/2014

    Quality agreements, the contracts signed between drug sponsors and contractors, continue to be an object of interest for the FDA. The agreements are intended to define and explain the roles and responsibilities of parties involved in the making and handling of drugs and drug products. By stating who is responsible for what, they not only ensure regulatory compliance, but define responsibilities in the event of an adverse outcome. With the number of FDA 483s (Notice of Inspectional Observations) and warning letters on the rise, it is more important than ever for companies to not only have a quality agreement in place, but to make sure both sides adhere to its provisions.

    In this article attorney Alan Minsk explains why there has been an increase in warning letters issued over the last few years, why you MUST have a quality agreement in place, and the three quality issues you must always be aware of if you want to avoid getting one.

  2. Pennsylvania Continues Aggressive Push For Life Sciences 7/14/2014

    When you attend the BIO International Convention, you expect to see large pavilions from states heavily involved in the life sciences. This year’s show was no exception. Major time and financial investments were clearly made by California, Georgia, Massachusetts, Texas, New Jersey, and … Pennsylvania? Yes, Pennsylvania (PA).

  3. Covance Brings Together Pharma And Biotech To Speed Drug Development 7/14/2014

    Having the right connections can be critical to any business. In life sciences, having the right connections can make or break a discovery company. For a small biotech firm, standing out in a crowded field of companies attempting to reach pharma partners can be a chore, especially during the early phases of development.  With that in mind, Covance has created Covance MarketPlace, a tool designed to help pharma and emerging biotech companies easily and securely forge new partnerships.

  4. What Can Be Done To Change The Reputation Of Pharma? 7/3/2014

    Thinking back on the week I spent at the DIA 2014 Annual Meeting, I was able to reflect on many enjoyable and informative meetings. None, however, was as memorable as the opportunity I had to be part of the reporter roundtable session and to speak alongside two knowledgeable members of the pharma press: Ben Comer, senior editor of Pharmaceutical Executive and Mandy Jackson, west coast editor for Scrip Intelligence.

  5. 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.

  6. 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.”

  7. Is It Time To Update The Drug Approval Process? 5/20/2014

    Congressman Fred Upton, who currently serves Michigan’s 6th District, likes to marvel at the technology changes that have occurred in his lifetime. Years ago, disease diagnosis was based on clinical symptoms. Drug approvals at the time were, accordingly, based on the evaluation of symptoms.

    Today much has changed. Indications of illnesses are now measured at the molecular level. We can determine the proteins and enzymes that cause the growth of cancer and now have new and novel ways of detecting and stopping that growth. In addition, computers and networking have evolved in amazing ways as well. “Patients, doctors and scientists are now linked like never before,” says Upton. “These technologies are the future of medicine.”

  8. AstraZeneca: “Pfizer's Final Proposal…Is Inadequate” 5/19/2014

    You have to hand it to AstraZeneca for standing its ground and holding firm to its principles. In rejecting previous offers from Pfizer, the company insisted it was worth more. In rejecting the latest offer over the weekend, it is clear AstraZeneca believes its pipeline is being significantly undervalued.  

    Pfizer’s final proposal was comprised of 45% cash (£24.76) and 55% stock (1.747 Pfizer shares) per AstraZeneca share. This represents a total value of £55.00 per AstraZeneca share based on the Pfizer closing price on May 16th. According to a statement released by the company over the weekend, the proposal undervalues the company and its prospects and was therefore rejected by the board.

  9. 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.

  10. 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.