News

The latest from TMC...

September 2016: TMC Pharma Ltd to present a case study “LEVERAGING RBM TO ACHIEVE COMPLIANCE“ at 7th Clinical Quality Oversight Forum 17-19 October 16, Philadelphia

TMC Pharma Ltd are pleased to announce that Sarah Blondell & Gareth Ridge will be presenting at the CQOF event in Philadelphia this October. We will be co-presenting with Duncan Hall of TRI (Triumph Research Intelligence) showing how quality management and risk-based monitoring do not need to be complicated, expensive or the domain of only large CRO and Pharma companies. TMC Pharma and TRI are working together to provide a simple, cost-effective solution to risk-based monitoring for smaller pharmaceutical and biotech companies. We look forward to seeing you there!

exlevents.com/7th-clinical-quality-oversight-forum

September 2016: New Dublin office

TMC is delighted to announce the opening of their office in Dublin, Ireland. The Irish office will ensure that TMC continues seamlessly with a solid foothold in the EU; regardless of what may happen with the UK exit.

June 2016: BREXIT (Britain Exiting Europe): What does it mean for TMC?

Britain has voted to leave the European Union.

TMC's ability to conduct business in Europe is unchanged.

First: Britain has two years to negotiate the terms of its departure before the split takes effect. Nothing changes during this period.

Second: TMC's operating company in Ireland can enact any regulatory relationships that may still be required to be based within the European Union after any potential changes take effect.

The full implications of this major political change will take time to become clear. Whatever they are, TMC's uniquely flexible attitude and infrastructure will position us well to react quickly and appropriately to ensure continuity of service to our clients, whether inside or outside the European Union.

Please feel free to call Dr Mike Matthews on +44 (0)1252 842255 should you wish to discuss this matter further.

June 2016: TMC launches TMC Pharma Japan KK

Representatives of TMC’s senior management team travelled to Japan in June 2016 to consult with our local representatives, and some potential clients and collaborators about the launch of our new Japanese company, TMC Pharma Japan KK.

Our plans were very well received regarding assisting Japanese companies to extend their development effort beyond Japan, and about encouraging companies from other parts of the world to include Japan in their drug development plans at an early stage.

As a result of the visit we have forged sound links with local experts who are willing to act as part of TMC project teams, and have already identified Japanese clients with whom we are agreeing projects.

March 2016: MHRA PV inspection

TMC had a routine MHRA Pharmacovigilance inspection. Three inspectors spent three days on site with us, reviewing pharmacovigilance systems. Their report has now been issued with no critical findings. We are very pleased to take the opportunity to further consolidate our professional standards with the guidance that arises from these inspections.

January 2016: New Director of Clinical Services appointed

TMC is delighted to welcome Gareth Ridge to the Clinical Services team, as Director of Clinical Services. Gareth joined the industry in 1995 as a CRA, with an MA in Pharmacology. He has held several senior roles within Triumph Consulting, SRA Global and, just prior to joining TMC, was Head of Operations at hVIVO (Retroscreen Virology).

Gareth will be overseeing the current portfolio of projects as well as developing and expanding TMC’s capabilities and infrastructure in the clinical and related areas.

January 2016: New website launched

With the growth of TMC Pharma Services Ltd it was time for a complete revamp of our website to better reflect the wider range and greater scope of our services. We hope you will take a look at the result (and let us know if we have left anything out).

January 2016: TMC to attend ASCO GI in San Francisco, 21/22 Jan

TMC would be delighted to meet old and new clients and colleagues at their stand.

December 2015: European Commission award Grant funding of €6M

TMC joined in, as a major partner, a successful bid for EC Horizon 2020 funding. The Consortium has been awarded €6 Million to fund a clinical trial with a novel device/stem cell combination product. The study will be fully managed by TMC and will run in 5 countries.

September 2015: New Pharmacovigilance staff and new PV database

TMC is pleased to welcome to the full-time permanent staff Preti Patel, who joins TMC to increase our in-house capability in Pharmacovigilance & Clinical Drug Safety. Preti brings with her over 10 years’ experience in Pharmacovigilance and clinical monitoring.

TMC has successfully implemented and validated PcVmanager- a safety database hosted by Extedo GmBH that allows TMC to manage the case processing and reporting of adverse events & reactions arising from our clients’ pre- & post-marketing projects.

Recruitment of dedicated PV staff and the validated of PcVmanager are supported by further developments to our PV Quality Management System- enabling TMC to provide efficient and quality services across a broad range of PV activities.

July 2015: first study to be run in the UK with a particular controlled drug

TMC is supporting a virtual company to run first studies in volunteers with a particular controlled drug encompassing innovative study designs. Under the TMC umbrella we have located and managed manufacturing, Phase I unit and all clinical and regulatory activities.

Mar 2015: TMC granted Local Education Provider (LEP) status by Faculty of Pharmaceutical Medicine (FPM)

Following a successful inspection of TMC by the FPM in February 2015, TMC were granted status as a ‘Local Education Provider’. Dr David Bell, Senior Speciality Advisor for the Faculty, confirmed that the scope of medical activity at TMC meets the requirements of the August 2010 curriculum, and the GMC’s standards for specialty training. On the 1st April 2015, Dr Clare Halcro became TMC’s first employee to enter the Pharmaceutical Medicine Specialty Training (PMST) programme, supervised by TMC’s Senior Director of Medical Services, Dr Hubert Bland, as her Educational Supervisor.

March 2015: TMC engages with key research sites in South Korea

TMC’s Senior Director of Clinical Services conducted capability assessment of 3 key sites in South Korea including the world renowned Asan and Samsung Medical Centres.

January 2015: TMC enhances Regional Project Management Services

With the engagement of highly experienced Associates in the US and Australia in addition to the established European team of Project Managers, TMC now offers Project Management of clinical trials on a global basis. With the local expertise and real time oversight of activities the quality and flexibility of our services are solidified.

Nov 2014: TMC’s medical department continues to grow

Dr Clare Halcro BM BS joins TMC’s medical department as a Drug Safety Physician. In her role at TMC she provides medical monitoring services, particularly in the pharmacovigilance sphere, and medical input to company projects.

June 2014: New Director of Pharmacovigilance Services appointed

TMC welcomes Kieran O’Donnell BSc MSc to the management team as the new Director of Pharmacovigilance Services. Kieran has over 13 years of pharmaceutical and CRO experience with Pharmacovigilance & Clinical Drug Safety and has served as Deputy Qualified Person for Pharmacovigilance. His other experience includes taking a key role in MHRA GCP and PV inspections. His broad experience across the PV spectrum includes case processing, safety surveillance, PSURs, DSURs, labelling, SDEAs, and training.

April 2014: TMC expands clinical trial delivery into Japan

TMC partnered with EPS Associates to deliver a pivotal clinical trial in mesothelioma in Japan. Fully integrating Japan into the global clinical trial with aim of securing the marketing authorisation in parallel with the US and EU.

February 2014: New Senior Director of Clinical Services appointed

TMC is delighted to announce the appointment of Sarah Blondell MSc CSci to the TMC Management Team as Senior Director Clinical Services. She brings to TMC 20 years’ experience in clinical trials. A Chartered Scientist, with a Masters in Clinical Pharmacology, Sarah has extensive clinical, project and personnel management expertise, gained within pharmaceutical companies and Contract Research Organizations, with management of global trials across all phases of development.

September 2013: MHRA GCP inspection

TMC had a routine MHRA GCP Inspection during which the inspector reviewed our procedures focusing on a high-profile stem cell study that we are managing. Their report has now been issued with no critical findings. We are proud to be associated with a great team at Moorfields Eye Hospital in London for this study.

August 2013: TMC’s medical department grows

TMC is pleased to welcome to the full-time permanent staff Lesley McAllister RN, who joins TMC to increase our in-house capability in adverse events case processing and administration.

January 2013: TMC’s Regulatory Department has a new Associate Director

TMC is very pleased to have appointed Allison Gillespie as Associate Director of Regulatory Affairs. Allison has over 15 years’ experience of submitting human pharmaceutical regulatory and clinical applications, variations and amendments to regulatory authorities worldwide. Allison has particular expertise in submissions to Australia and New Zealand for Category 1, 2 and 3 submissions, orphan drug designations, pre-submission meetings and strategic advice for new marketing authorisations.

January 2013: MHRA Pharmacovigilance Inspection

TMC had a routine MHRA Pharmacovigilance inspection. Three inspectors spent three days on site with us, reviewing pharmacovigilance systems. Their report has now been issued with no critical findings. We are very pleased to take the opportunity to further consolidate our professional standards with the guidance that arises from these inspections.

January 2013: new Senior Director of Medical Services appointed.

TMC is delighted to announce the appointment of Dr Hubert Bland MB ChB to the TMC Management Team. Hubert takes up the role of Senior Director of Medical Services, and will help us to manage the continuing increase and broadening of TMC’s portfolio of clients and services. Hubert brings to this role considerable clinical and industry experience, having worked in general medicine, anaesthetics and intensive care, clinical pharmacology and oncology before entering the pharmaceutical industry 14 years ago. He has held a range of medical roles in clinical development, having worked at Pfizer, Boehringer and BOC/Linde and most recently as Chief Medical Officer of the Phase I Unit at the University of Surrey. Hubert’s clinical and development experience will add considerable strength in depth to TMC’s medical capabilities as we continue to expand.

Jan 2012: First patient in Europe receives human embryonic stem cell therapy in a trial facilitated by TMC.

A patient with Stargardt’s disease, an inherited juvenile macular dystrophy resulting in blindness, became the first person in Europe ever to receive a human embryo-derived stem cell transplant as therapy on 20th January 2012 at Moorfields Hospital in London. The cell therapy (human embryonic stem cell retinal pigment epithelial cells [hESC RPE) was developed by Advanced Cell Technology Inc (Massachusetts, USA). TMC is providing ACT with support for all EU activities and we have secured orphan designation for hESC RPE in Europe, obtained regulatory and ethics approval for the European study, and are managing the trial.

Jan 2012: Positive opinion for orphan designation

The EMA Committee for Orphan Medicinal Products (COMP) gave a positive opinion for Orphan designation of topical chlormethine, a product sponsored by TMC, intended to treat patients with Cutaneous T–Cell Lymphoma (CTCL).

July 2011: TMC takes over as temporary Marketing Authorisation Holder (MAH) for Relistor in the EU

Relistor (methylnaltrexone) is used for the treatment of opioid-induced constipation in advanced illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.

July 2011: TMC’s Director of Medical Services represents the Faculty of Pharmaceutical Medicine on Paediatric Medicines group

Dr Susan Tansey, Director of Medical Services at TMC, is the Faculty of Pharmaceutical Medicine’s observer on the Joint College of Paediatrics and Child Health (RCPCH) / Neonatal and Paediatric Pharmacists Group (NPPG) Standing Committee on Medicines. This group advises on various issues pertaining to the use of medicines in children, involving itself with Government consultation documents, and other official submissions from agencies such as NICE.

June 2011: New Director of Medical Services

TMC is delighted to announce the appointment of Dr Susan Tansey MBChB, MRCP, MRCPCH, MFPM to the TMC Management Team.

Susan takes up the new role of Director of Medical Services, created in response to the further increase and broadening of TMC’s portfolio of clients and services. She brings to this role considerable clinical and industry experience, having qualified in both internal medicine and paediatrics before entering the pharmaceutical industry more than 10 years ago. She has held a range of medical roles in clinical development for major pharmaceutical companies, most recently working as Director of Vaccines Clinical Research, with Pfizer. Her international drug development experience has involved working with development teams on both sides of the Atlantic and in China. Her clinical and development experience will be invaluable in consolidating TMC’s capabilities as we continue to expand.

March 2011: New Director of Regulatory and Clinical Services

We are delighted to announce the appointment of Nicola Kidman to the TMC Management Team.

Nicola takes the new role of Director of Clinical and Regulatory Services, created in response to TMC’s steadily increasing workload. She brings to this role over ten years of industry experience working in both Pharma companies and latterly CROs (most recently as Director of Regulatory Affairs for Parexel in the UK), where she has been supporting both niche and blue-chip clients on a variety of programmes. Nicola’s extensive breadth of knowledge of Regulatory Affairs will add strength to our management of this key area of our business.

March 2010 - Pharmacovigilance inspection by the MHRA

TMC had a routine MHRA Pharmacovigilance inspection. Two inspectors spent three days on site with us, reviewing pharmacovigilance systems. Their report has now been issued with no critical findings. We are very pleased to take the opportunity to further consolidate our professional standards with the guidance that arises from these inspections.

December 2009 - GCP Inspection by the MHRA

TMC had a routine MHRA GCP Inspection and two inspectors reviewed our procedures. Their report has now been issued with no critical and no major findings. We are very pleased to have passed this important hurdle, our first inspection.

November 2009 - New offices

After 9 years in the same office, TMC’s expansion has required a move to something bigger. The new office is in Hampshire, UK, not far from the old one, but offers much more space and better facilities for our growing staff. Our new address and telephone numbers are at the foot of this page.

October 2009 - TMC now Preferred Provider for one of the Top Five global pharmaceutical companies based in Geneva

After a formal assessment process, TMC has been granted preferred provider status for one of the top five global pharmaceutical companies, working for their Consumer Health Division. The first project under the new arrangement will be to chair and report an Expert Advisory Board in Switzerland.

September 2009 - TMC presents at FDA ODAC

TMC Chief Medical Officer, Dr Mike Matthews, presented the safety data on Gloucester Pharmaceuticals’ new HDAC inhibitor romidepsin at the FDA’s Oncology Drugs Advisory Committee (ODAC) meeting in Bethesda on September 4th 2009 and answered the Committee’s questions on the safety data, see http://www.drugs.com/nda/romidepsin_090902.html. FDA subsequently approved romidepsin (‘Istodax’) in cutaneous T-cell lymphoma on 6 November 2009 see http://www.medicalnewstoday.com/articles/170146.php

August 3rd 2009 - New UK office administrator appointed by TMC

We are pleased to announce that Michelle Nickless has joined the company to run all office functions at TMC headquarters in Hampshire, UK. Michelle comes from an IT administration background with one of the world’s largest IT system suppliers.

8 July 2009 - TMC takes over as temporary Marketing Authorisation Holder (MAH) in the UK of Osmoprep™

Osmoprep™ is indicated for cleansing of the bowel when required as a preparation for certain diagnostic procedures such as colonoscopy. Osmoprep™ 1500mg Tablets will be available shortly (PL08637/0017).

19 June 2009 - TMC takes over as temporary Marketing Authorisation Holder (MAH) for Vasovist in the EU

Vasovist (gadofosveset trisodium) is for diagnostic use only, it is indicated for contrast-enhanced magnetic resonance angiography for visualization of abdominal or limb vessels in patients with suspected or known vascular disease. See http://www.emea.europa.eu/humandocs/Humans/EPAR/vasovist/vasovist.htm

January 2009 - TMC launched – a new company growing from The Matthews Consultancy

Clients who have been used to working with The Matthews Consultancy Ltd in the past will be interested to see that our company has grown and changed a lot in the last couple of years. TMC Pharma Services Ltd is still led by the same team but has expanded to offer not only consultancy services but a wide range of drug development and marketing support services through a global network of Associates.