Boosting clinical trial research in London

insights from industryDr. Jorg TaubelCEO,Richmond Pharmacology

An interview with Dr. Jorg Taubel, CEO, Richmond Pharmacology, conducted by April Cashin-Garbutt, MA (Cantab)

Can you please give a brief introduction to Richmond Pharmacology’s new research facility in London Bridge? What was the vision behind this opening?

Richmond Pharmacology is a clinical trials company, we’ve been running clinical trials since 2001, predominately for the pharmaceutical industry.

This is the fourth facility we've opened and the new site has been used for this type of work for more than 30 years. It's in an ideal location embedded in the University and teaching hospital campus.

The location means we can access key opinion leaders and academic research staff. Also, we have the additional comfort of being nearby a hospital in case we need them for advice.

As this is our fourth unit, we have put a lot of thought and experience into it, and I believe it's our best. We completely removed the old facilities in the building and designed all the floors from scratch.

(Left to right) Sarah Haywood , Dr Jorg Taubel, Cllr Kath Whittam, Professor John Camm and MP Neil Coyle in attendance at Richmond Pharmacology’s London Bridge Opening Event

How important is the central London location?

The central locations is very important to us, there are two aspects which drove us to this site.

Firstly, we run a lot of clinical trials with patients, and these trials tend to run over a long period of time, ranging from six months to two years. During this time, the patients will have to make frequent visits to our facilities, therefore a location that is central with railway stations nearby is very important.

The second aspect is that even in today's digital age, I am a great believer of meeting face to face. Being surrounded by world leading academics here in central London, many of whom we collaborate with our clinical trials, I can easily arrange for face to face meetings. It can be done in a much more informal way than in the past, when we had to travel relatively far.

With all of this, I think we should see quite an improvement in the way that we work.

Dr Jorg Taubel and Baroness Walmsley discuss Richmond Pharmacology’s future plans.

What collaborations do Richmond Pharmacology hope to develop with teaching hospitals?

The company was founded out of St. George's University in Tooting. As a public private partnership, this allowed us to generate income for the university to fund academic research, research fellows and so forth.

We pursue the same business model today, allowing us to generate income, which is largely coming from the pharmaceutical industry by carrying out clinical trials for them, whilst still being able to carry out a lot of academic research.

Now, with more opportunity to engage with academics around us, here in central London, I hope to build on this model.

An example of a successful collaboration that Richmond Pharmacology was a part of is the ENDEAVOUR clinical trial in 2014. This was a clinical trial in a rare disease, transthyretin-mediated amyloidosis (ATTR), where we worked with an American sponsor, Alnylam. We also worked with a national amyloidosis centre, based at the Royal Free Hospital, in the UK.

It is typical for key opinion leaders to have far more patients than capacity to run the clinical trial. This meant in the partnership they would recruit the patients for the study and support us with expert advice in conducting the trial whilst we provided first rate clinical trial facilities and had sufficient capacity to become the largest center worldwide and the first center to recruit patients globally for this disease.

We made up 10% of this trial, which ran internationally in the United States, across Europe, etc. This is an of example of the type of collaborations we seek and are a part of.

Which areas will the new facility be specializing in?

The new facility will be a phase I specialist, and specialize in the running of clinical trials. In terms of branching out into therapeutic areas, we first find a key opinion leader or clinician who would be willing to participate and we then get the best possible team together. We have a key opinion leader with expert medical knowledge and we provide the clinical trial facility.

The new unit has been operational since 25th March with on-going patient feedback excellent. 

What impact do you think the London-base will have on patient recruitment?

I think it will have a positive impact, as we often recruit nationwide, often patients like to come to London and therefore being central is a distinct advantage. For example, being in a location which has ample hotels, plenty of tourist attractions, makes it a pleasant experience for patients visiting, and that adds to everything else we've always had.

Do you think the facility will help the UK’s efforts to grow as a global hub for life sciences?

Definitely. The Medicines of Healthcare Regulatory Agency or MHRA is scientifically driven and offer sponsors from all over the world, scientific advice meeting in advance of formal applications, and this is greatly appreciated by the pharmaceutical industry worldwide. Our consultancy work often introduces companies from abroad to this opportunity.

We already have quite a lot of attraction, and again, if you take the ENDEAVOUR example I've outlined earlier, that of course provides academic and other research organisations a good opportunity to make significant contributions to global clinical trials.

Despite the United Kingdom not being a big country, with only about 60 million people, relative to our size, I think we make a much bigger contribution.

What do you think the future holds for clinical trial research in the UK?

The Prime Minister has made a clear statement that life science is important and I have some faith that we will end up with a healthy and forward going life science sector.

What is Richmond Pharmacology’s vision for the future?

Over the years we've recognized that in order to have high quality standards in clinical trials and ensure the safety of participants, we need comprehensive regulation surrounding clinical trials.

As a consequence, the process of running trials has become slower and more expensive, and we’re looking at ways to create opportunities within that framework so that we have the high-quality standards and the safety procedures derived from the regulations, whilst simultaneously becoming more nimble in what we do so we can compensate for this.

The MHRA have allowed us to create adaptive study protocols, which deviates from the conventional model, in that they focus on a framework. They set out what we do in this clinical trial, setting boundaries, outlining what the worst case may be rather than describe in rigid detail every step. For example, the highest dose, the highest number of patients involved, the longest duration of their participation, but not the detail below that threshold.

We put a lot of emphasis on the way in which the trial is controlled, for example, how we look at the interim data and how we make decisions in steering the trial. This allow us to sheer the trial in accordance with the data that emerges during the trial making changes within our “roaming space”. That saves a lot of time, and it also allows us to remove from these trials any aspects or measurements which turn out to not be very useful, and redirect the funding towards more relevant tests. Consequently, we can work within a budget and create a lot of data. That is something which we're very passionate about, and I think that the future will work this way a lot more. We've seen that our competition is also starting to adopt this approach because it is the most logical.

As I sit here today, (25TH March) Richmond Pharmacology has just been given the full MHRA accreditation for our new facility, which means following inspection, our facilities have been deemed satisfactory and we're ready to get started.

Where can readers find more information?

http://www.richmondpharmacology.com/

About Dr. Jorg Taubel, MD FFPM (CEO)

Dr Jorg Taubel is a medical practitioner and CEO of Richmond Pharmacology which he co-founded in 2001. He has worked in clinical pharmacology for 24 years and during that time he has conducted more than 400 early phase studies in patients and healthy volunteers; usually in the capacity of Principal Investigator since 1995. His experience ranges from first time in man (FTIM) to proof of concept (POC) studies. He has extensive experience in cardiology, neurology, gastroenterology, ethnic bridging studies.

His work currently focusses on providing expert advice in cardiac safety assessments and ethnic comparison studies. Dr Taubel is an honorary fellow at St George's University and author of over 50 publications in scientific journals. He is currently researching the role of hyperglycaemia in relation to sudden cardiac death in Type I diabetic patients. He presented his research at numerous international meetings and workshops in Europe, US and Japan.

Dr Taubel is a Fellow of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom and the Institute of Directors (IOD). He is a Regent in the Arbeitsgemeinschaft Angewandte Humanpharmakologie (AGAH). He is a member of the (British) Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI) and the Royal Society of Medicine. His international memberships include the Japanese Society of Clinical Pharmacology and Therapeutics (JSCPT), the American College of Clinical Pharmacology (ACCP).

He is currently representing CCRA in the MHRA stakeholder discussions reviewing the MHRA Phase 1 Accreditation Scheme for clinical trials units in the UK. Since 1999 he has been involved in the design, programming and implementation of a pan-European research volunteer registry, designed to prevent study participants from oversubscribing to clinical studies.

He teaches on the AGAH course in Basic Pharmacology in Germany and an internal training program for junior doctors working at Richmond Pharmacology enrolled in Higher Medical Training in Pharmaceutical Medicine. He is actively participating in discussions to set up a pan-European training scheme for principal investigators jointly with the Faculty of Pharmaceutical Medicine currently involving societies in the UK, France, Belgium and Germany. He is an appraiser in the Faculty of Pharmaceutical Medicine.

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