MDSL International: Jo Marshall. Providing data management and statistical services to the pharmaceutical industry.




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Video title: MDSL International: Jo Marshall. Providing data management and statistical services to the pharmaceutical industry.
Released on: January 25, 2013. © PharmaTelevision Ltd
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In this episode of PharmaTelevision News Review, filmed at the PharmaTelevision Studios, Oxford, UK, Fintan Walton talks to Jo Marshall, Managing Director at MDSL International
Overview of MDSL International's clinical data management business
Fintan Walton:
Hello and welcome to PharmaTelevision News Review here in Oxford, in England. On this show I have Jo Marshall, who is the Managing Director at MDSL International, based here in the UK, welcome.
Jo Marshall:
Thank you very much.
Fintan Walton:
Jo, your company is a data management statistics company specializing obviously in the area of clinical trials, you are a CRO effectively, could you tell us a little bit more about what your business is, and the business model you have?
Jo Marshall:
Sure yes, we at MDSL International we work mainly on behalf of the biotech companies, pharmaceutical companies who don't have their own data management and statistics in-house, so that we can work with them, help them with their clinical trials and manage their data for them.
Fintan Walton:
Okay, so I mean obviously the industry is highly dependent on the clinical results, so what is it that makes your firm different to other choices that companies may have?
Jo Marshall:
So it is all about the people that we have at MDSL, hugely qualified people and they really love working for the company, so they really love working for our clients as well, and also we have a great consultancy on where we can offer advice to our clients, help them with their drug development programs, make sure they get the right trials running in their programs, make sure they start off well and also carry that all the way through to the submissions of their drugs to make sure that they work well with the regulatory authorities and that the right data gets submitted for that program.
Geographical reach and role of MDSL
Fintan Walton:
Right, now obviously you are based in the UK, how far is your actual reach in terms of client base?
Jo Marshall:
Mostly we work with UK, and Europe. We've done some work in the US as well, but mostly we stick with the UK, and Europe.
Fintan Walton:
Okay, so obviously once you are in the clinical trials business and obviously pharmaceutical companies, biotech companies all of them have to get it right basically, it's a risk business, they have to invest in these clinical trials, obviously again the results out at the very end are critical, so how does that work for you I mean in terms of your business model because presumably a company could chose to use a large CRO and they do everything, what would be the advantage of using you, just on your own and then having other parties conducting the actual clinical trials?
Jo Marshall:
Sure, you are right and most people would focus on the clinical when they are positioning a clinical trial working out which vendors to use, they will focus on the clinical, it's the major part of the work, but actually it's the data that you get out of the project at the end that's really important, so by giving that data, your data management and your statistics to a separate provider you get additional over sight on your study to make sure that everything throughout your clinical phase is going according to plan, and you also get a specialist company who is going to give your data the attention it really deserves.
Risk managements in product development and clinical trials
Fintan Walton:
Okay, so let's just looking at how the industry is going at the moment, I mean generally speaking pharmaceutical companies are cutting back obviously on some of their R&D spend, it's much more expensive to take a drug through clinical trials, we've talked about risk, the risks are getting high, because the regulatory authorities are getting more demanding and also the pricing reimbursement issues, so as somebody who is watching the industry from your perspective, what are the key changes that you are seeing, your clients are seeing?
Jo Marshall:
Like you say our clients are finding it, they have to spend much more time concentrating on exactly the right program that they are going to run. It's really important to make sure that they get the right studies to maximize what they need to get out of their drug. So what's really important for them really is making sure that they take all the advice that they can to really bring the correct program through for their drugs, so making sure that they are making the right decisions on the type of studies to run for their programs, and the type of outcomes that they want to get from their programs and making sure that they design their trials to get the right outcomes that they need.
Data management, statistics and consultancy services
Fintan Walton:
So clinical trial design is paramount obviously in all of this, but also equally I suppose the analysis of the data, statistical analysis of course is really important for clinical trials, I mean how much does the, once you've got the data and you've got to get to the next stage in your clinical trial, how important is the analysis the interpretation of the results is and then the subsequent clinical trials that you have to design?
Jo Marshall:
Well the analysis is key really, because everything that you do with your drug in the future is based on the analysis of that trial, so you need to make sure that A you design a trial to get the right outcomes, but also that you then deliver those outcomes based on the statistical work that you do on the studies, from there you can look at what else needs to be done in your programs and carry that forward all the way through.
Fintan Walton:
And in terms of the way a data is handled, and the way analysis is done has that changed over the years?
Jo Marshall:
It has changed a lot, I mean obviously the progress that you get with the computing has a major impact on exactly what you can do with your data and how you work it, but also the regulatory authorities, the way that they progress, what their requirements are, has a major impact on these studies. So for example recently we've had quite a large focus on the standards of data to try and get pharmaceutical companies to all use the same standards when they are submitting data to regulatory authorities, makes it easier for the authorities to handle the data if they know already what format its coming in. So there is a big, big push to get that across all the companies to have the same standards throughout the industry.
Fintan Walton:
Right, so that is one of the key changes I suppose that's going to become more demanding to get that absolutely right?
Jo Marshall:
Exactly.
Overview of credit crunch in pharma and biotech sector
Fintan Walton:
So again just finally I suppose is really to understand how, what things do you see changing now going into the future? What are the big issues that both pharma and biotech companies have to face particularly as you see it from the MDSL International point of view?
Jo Marshall:
Well as we said before that one of the biggest issues that we have at the moment is trying to counteract the effects of the credit crunch I suppose, the way that companies are being forced to run less studies to get more out of their studies try and minimize the amount they spend on getting a drug all the way to market, so making sure that you get your data right from the beginning and that you plan your programs really, really well is really important to that, because it's going to give you the edge to make sure that you can get your drugs to the market in the quickest time and for the least amount of money.
Fintan Walton:
Jo Marshall, thank you very much indeed for coming on the show.
Jo Marshall:
Thank you.
Fintan Walton
Dr Fintan Walton is the Founder and CEO of PharmaVentures . After completing his doctoral research on the genetics of cell proliferation at the University of Michigan(US)and Trinity College (Dublin, Ireland), Dr Walton gained broad commercial experience in biotechnology in management positions at Bass and Celltech plc (1982-1992).
Jo Marshall
Managing Director
At the time of this PTV interview Jo Marshall serves as Managing Director at MDSL International. Jo has been with MDSL International since company employees had a choice of working at home or in the founder's converted garage and now she holds the reins as the Managing Director and the general keeper of happiness for the employees and clients. She sees her role as creating the environment so that the team feels inspired and the customers feel valued and she achieves both consistently. Having worked at some of the big hitters in the industry including Searle, Pharmacia and Pfizer and an MSc in Data Management under her belt, Jo climbed the corporate ladder steadily working in and managing Global Data Management teams. It was at this point in 2003 she had her entrepreneurial vision and left to work with the founder of MDSL International with the aim of growing the company, an aim she achieved immediately as her recruitment caused the company to immediately double in size. What a change in direction but understandable for a scuba diving, mountain hiker. She has grown the company steadily and now MDSL International manages clients and studies across Europe. Jo lives in a small village in Oxfordshire with her husband Paul, two children and Sam the cat.
PharmaVentures
PharmaVentures is a corporate finance and transactions advisory firm that has served hundreds of clients worldwide in relation to their strategic deal making in the pharmaceutical, life science and healthcare sectors. Our key offerings include: Transactions / deal negotiations; Product / technology valuations; Deal term advice; Due diligence & expert reports; Strategy formulation; Alliance management; and Expert opinion for litigation/arbitration cases. PharmaVentures provides the global expertise to ensure our clients generate the highest possible return on investment from all their deal making activities. We have experience of all therapeutic areas and can offer advice on both product and technology commercialization.
MDSL International
MDSL International is a private company and was founded by the Executive Chairman Dr. Edmund Otun in April 1996 to provide data management and statistical services to the pharmaceutical industry through a network of consultants. As the company became more established, the number of employees began to increase and the company has seen steady increase in size since its inception. MDSL International's head office has always been in the Maidenhead area of Berkshire, and have established partners throughout Europe, while trying to support local suppliers where ever possible and as a measure of our diversity, have provided advice on statistical significance in California, data quality in Cowley and clinical processes in China. The principles upon which the company was founded are as valid today as they were in 1996. They are to provide superior service and quality with commitment and integrity whilst providing a work life balance for employees conducive to flexibility, motivation and versatility.