News
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.
August 2009 - New website launched
With the growth of TMC Pharma Services Ltd from The Matthews Consultancy 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).
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.