Tag Archives: R&D

Trials fail due to poor design. Don’t let yours be the next!

Flawed methods in clinical trials have had a big part to play in the poor track record for Neuroscience drug development with consequences for both patients and the pharmaceutical industry.  Nowhere are the consequences for patients more acutely felt than in the area of Alzheimer’s drug development where the industry counts just three Alzheimer’s drug wins in 13 years and 101 losses, according to Pharmaceutical Research and Manufacturers of America (PhRMA). Failed trials also have big consequences for companies, often losing organizations billions in capitalization. In many cases the losses could be avoided through better trial design[1].

Research has shown that clinical programs have a high failure rate, even when drugs are known to be effective. For example, Khan et al. (2002)[2] reviewed the data from nine antidepressants approved by the United States Food and Drug Administration between 1985 and 2000. Of the 92 treatment arms reviewed, less than half showed statistically significant separation from placebo.

Surely we can be doing more at the trial design stage to avoid failed trials. Newer methodologies, such as adaptive designs, patient enrichment and risk based monitoring have been discussed extensively but adoption by the industry has been slow.

In the upcoming webinar sponsored by Covance Inc., leading industry experts share their insights and experiences gathered in the design and execution of novel trial designs in psychiatry – designs focused on speeding availability of effective treatment to patients, selecting patient subgroups most likely to respond and minimizing placebo response rates.

Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants, shares his thoughts on how adaptive designs can reduce length and increase flexibility in exploratory trials. Prospective subgroup analysis and wider dose ranges can be studied without increasing sample size allowing for more efficient use of trial budgets.

Sanjeev Pathak, MD, Senior Medical Director at Alkermes Inc., will review how his group has adopted methodologies that reduce the impact of placebo response while lowering sample size by 20-40%. He outlines his group’s reasons for adopting novel trial designs and lessons learned from discussions with regulators.

By attending the webinar you will –

  • Explore how novel trial designs can benefit your Neuroscience development program
  • Examine the pros and cons of implementing adaptive and enrichment designs
  • Identify barriers to adoption and how to overcome them, including organizational, regulatory and resource related barriers

If you’d like to hear more about how trial design can help improve your chances of success, then join me on November 17th for the Covance-sponsored webinar “Innovation in psychiatry trial design – How to improve the probability of success”.

Webinar Details and Registration
Monday, November 17, 2014
10 am New York, US/15:00 London, UK
60 minutes including Q&A

[1]Becker RE, Greig NH. Why So Few Drugs for Alzheimer’s Disease? Are Methods Failing Drugs? Curr Alzheimer Res. 2010 November 1; 7(7): 642–651

[2]Khan A, Leventhal RM, Khan SR, Brown WA. Severity of Depression and Response to Antidepressants and Placebo: An Analysis of the Food and Drug Administration Database. Journal of Clinical Psychopharmacology. February 2002 – Volume 22 – Issue 1 – pp 40-45

Externalization – a Collaborative Future for Life Sciences R&D

Nowadays, trying to cover the entire research and development (R&D) life cycle in-house makes little economic sense. Externalization is viewed as an effective way of dealing with the twin challenges of managing the immense amount of data generated by modern drug discovery techniques as well as having to find ways to mitigate costs.

Externalizing discovery screening processes has brought a raft of new players to the scene and is challenging old relationship patterns in R&D. We’ve witnessed a boom in the externalization of discovery research upstream of the preclinical and clinical areas, bringing pharmaceutical companies, CROs (Contract Research Organizations), other sector specialists and academia into closer and closer contact.

As these organizations look to collaborate, challenges abound on the road to making sure that externalization results in a win-win scenario for all stakeholders. Efficiency and trust underpin the success of collaboration. The reputational and IP risks inherent to sharing information mean that transparent and reliable infrastructure solutions are key to achieving a positive outcome.

On a more practical level, the data generated by different stakeholders needs to be easily shareable, easy to incorporate back into in-house-systems and its integrity and transparency must ensure it produces fully reproducible results. And if externalization isn’t properly executed, its benefits can be negated by extended decision cycle times. Again, choosing the right infrastructure solution represents the difference between success and failure.

If you’d like to learn more about how you can benefit from the advantages of externalized, collaborative ways of working while mitigating the downsides, join me and Justin Gazard of Pfizer Inc. for our webinar, ‘Externalize costs without breaking the data value chain’ on September 17, 2014.

Andy Vines, Product Manager, Screening Solutions, IDBS

Find out more and register

Andy Vines, Product Manager, Screening Solutions, IDBS

With an academic background in pharmacology and biochemistry, Andy VinesAndy Vines is currently the Product Manager responsible for IDBS’ screening solutions, including the ActivityBase Suite, ActivityMart and XLfit.

Before joining IDBS in 2008, Andy had already gained extensive user experience of ActivityBase, having used it in his previous R&D-centric roles at GlaxoSmithKline (GSK). During an industry career spanning 20 years, Andy was instrumental in driving forward a number of research programs in oncology and cardiovascular therapeutic areas, primarily in research biology and screening functions covering target ID, hit ID, lead optimization and candidate selection.

His industry expertise and experience of discovery screening place him in an excellent position to advise R&D specialists on how IDBS can help them overcome the many challenges facing a fast-evolving scientific domain.

Andy will present IDBS’ webinar ‘Externalize costs without breaking the data value chain‘ on the 17th September at 10am New York/3pm London. You can register now to reserve your place.

1. What will the audience learn from attending the webinar?

Most R&D stakeholders are aware of the benefits of externalizing parts of the discovery screening process. What we aim to explore in this webinar is how to approach externalization successfully so that all stakeholders from big pharma to biotechs to academia and specialist service providers can benefit from this trend and also make it work in practice. We’ll be looking at different approaches to externalization, getting the infrastructure right and how to avoid some of the common pitfalls.

2. How did you get into the industry and what do you most enjoy about your role?

My early years in Africa exposed me to lots of interesting flora and fauna, and developed my passion for life sciences. I joined GSK (then Glaxo) during a period of rapid expansion and found myself in the lab doing oncology research at a time when Information Technology (IT) was starting to take hold. I quickly recognized the potential for informatics to revolutionize research workflows and became an enthusiastic early adopter. By the mid-90s, we’d evolved to using ActivityBase and I became a major driver of its adoption.

When the opportunity arose, it seemed only natural to make the move to IDBS. It was a chance to bring my experience of IT and research to a wider audience and make the most of the data generated in research and development (R&D) processes. I really enjoy what I do at IDBS. The variety of my role and the evolving challenges faced by scientists dealing with increasing volumes of data keep me motivated to continue to turn challenges into opportunities.

3. What has been the best moment in your career?

It’s hard to pick just one! I would say that one of the achievements I’m most proud of was transforming the way discovery screening was carried out at GSK. By embracing the possibilities opened up by ActivityBase technology, we were able to completely transform and automate processes, workflows and decision-making.

4. Who or what is your inspiration?

I’m inspired (and humbled) every time I look up at the night sky. Each star represents infinite possibility and it keeps me striving to achieve more.

5. What 1 item would you take with you to a desert island?

It may be a bit cheeky but I’d have to say a cruise ship! I prefer my desert islands to come without the downside of being marooned.

Remember to register for Andy’s upcoming webinar where you can ask him questions live on the webinar.