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).
The clinical trial landscape in BRIC countries is changing. Long heralded as a low-cost alternative to Western markets, Brazil, Russia, India and China are experiencing a shift in trial initiation by global sponsors.
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.
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.”
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.
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.
The potential for mHealth to transform the world of clinical trials is unlimited. New devices and technologies are making trials easier and less intrusive for patients while creating opportunities for clinics to simplify the process, see more patients, and substantially reduce costs.
To make this happen, companies will need to embrace and adopt new solutions and blaze a path forward for other pharma companies and CROs to follow. However, while consumers seem ready and willing to jump on every new technology that comes along, pharma can tend to be much more conservative.
That being said, where are we in the technology adoption process, and what companies will be the heroes that make dramatic progress, get their results published, and lead the rest of the industry into the future?
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.
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.
You did all of the required due diligence. You took the time to select what you felt was the right CRO. You verified its track record, qualifications, and expertise. You even took the time to personally visit the site, to ensure the two companies would share a common culture and commitment to quality. Still, despite all of your efforts, the trial was not going as planned. The last thing anyone wants to do is switch CROs in the middle of a trial. But if you get to the point where making a change is your only option, how do you best accomplish this difficult task?
Alicia McNeil and Elizabeth Kelchner, clinical data scientists for Rho, a full-service CRO, know personally how difficult this task can be. The company has years of experience working on dozens of federal and commercial rescue studies for clients. In their positions at Rho, McNeil and Kelchner are often called upon to resolve issues that arise whenever a clinical study does not go as planned with the CRO originally selected by the sponsor. This experience has taught them how to properly identify the red flags that indicate a study may not be going as planned, and is in need of remediation.
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