TMC Pharma Japan KK

A Unique Pharmaceutical Development Organisation Providing a Full Range of Expert Pharma/Biotech Support Services Now Present in Japan
あらゆる分野の専門的医薬/バイオ技術サポートサービスを提供する 独自の医薬品開発組織がついに日本に登場しました。
We would welcome approaches from companies wishing to discuss and evaluate drug development activities in Japan and South Korea.
弊社では世界のその他の地域における医薬品開発について協議、評価することを望んでいられる日本企業からのコンタクトを歓迎いたします。

TMC Pharma is a privately-owned company, with headquarters based near London in the UK.

We have successfully grown our business, working globally with clients in the USA, Europe and beyond, and we are now assisting our clients to include Japanese development in their global strategy earlier than has traditionally occurred. We are successfully helping clients to establish a dialogue with the Japanese authorities and to bring Japanese investigational sites into global pivotal trials; which will allow NDA submissions in Japan to occur in a similar timeframe to submissions to USA/EU and other first-tier regions.

We have now established a Japanese company, TMC Pharma Japan KK, to offer even more support to our clients based outside Japan. TMC Pharma is offering the same suite of services in Japan and South Korea as it does in the rest of the world. With our partners in Japan and other local regions, TMC provides consultancy, regulatory and full clinical trial activities.

TMC Pharma Japan KK offers Japanese companies the opportunity to benefit from our global network and extend their activities into the other major world markets such as North America and Europe.

Of course, there are differences between the regulatory requirements for medicinal products in Japan and those in many other areas of the world. TMC can help both ex-Japan and Japanese companies to strategise and implement plans for product development inside and outside of Japan.

Our work can encompass any therapeutic area and we have a particularly strong background developing advanced therapy products (ATIMP) and products with orphan indications.

TMC Pharma Japan KK
Level 7, Wakamatsu Building
3-3-6 Nihonbashi-Honcho Chuo-ku
Tokyo, 103-0023
Japan
Telephone 03 6202 7232 (within Japan), +81 3 6202 7232 (from outside Japan)

Email info@tmcpharma.com

TMC Pharma は2000年に非公開会社として設立され、英国ロンドン近郊に本社を置いています。

弊社は米国、欧州他のお客様に協力することで順調に事業成長を遂げ、2013年以降は、日本に製品をお届けするため、お客様を支援してまいりました。

この度、弊社はTMC Pharma Japan KKを設立いたしました。これにより、日本外にプレゼンスを持たない日本企業を対象に、弊社のグローバルネットワークの恩恵を受けられることで、北米、欧州といったその他の世界主要市場へと事業を拡大されていく機会を提供いたします。

当然のことながら、日本における医療品の規制要件と世界のその他多くの地域における規制要件との間には違いがあります。 TMCは日本企業が日本外で製品開発計画の戦略を策定し、実施するのをご支援いたします。

TMCの支援活動は製品製造や前臨床試験に関する助言に始まり、その後は、臨床試験を含んだ製品開発の全段階を通じ、グローバルな製品販売承認を取得するまで、継続的に助言を行ってまいります。 TMCはまた規制当局対応、ファーマコビジランス、科学的サービスなどで、医薬品販売承認後のお客様の支援もいたします。 弊社の業務はあらゆる治療分野にまたがっていますが、特に先端医療医薬品（ATIMP）と奇病関連製品で優れた実績を誇っています。

TMCは世界中のあらゆる種類の医薬/バイオ技術会社と協力しており、その対象は世界トップの多国籍企業からバイオ技術の新興企業に至るまで多岐多様です。

弊社の強みはお客様とのパートナーシップによる協力関係にあります。 お客様のニーズを評価した後で、弊社は最善の解決策を提供し、順調に結果を生み出すまでこれをフォローするのにまさに必須の専門知識を備えたプロジェクトに特有のチームを割り当てます。 弊社は実践的な問題解決を行い、各プロジェクトには独自の困難な問題が生まれるとの事実に前向きに取り組んでいます。

TMC Pharma Japan 株式会社

〒103-0023 東京都中央区日本橋本町3-3-6 ワカ末ビル7階

海外からおかけ頂く場合：03 6202 7232

日本国内からおかけ頂く場合：+81 3 6202 7232

Eメール:info@tmcpharma.com

TMC Pharma Services Ltd
Lodge Farm Barn
Elvetham Park Estate,
Fleet Road, Hartley Wintney,
Hampshire RG27 8AS
United Kingdom

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+44 1252 842255
info@tmcpharma.com
Registered in the UK, No. 4241825

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Achi

Vice President Clinical

Victoria joined TMC Pharma in 2022, bringing with her over 20 years of clinical development experience within global clinical research, including both project management and line management.

A medically qualified doctor, her extensive experience covers all clinical trial phases across a broad range of indications and therapies with particular expertise in oncology/cell therapy.

Victoria’s Clinical Services team comprises experienced and highly capable Project Directors, Project Managers, CRAs and CTAs allowing her direct oversight and governance of all aspects of our projects.

Dr Victoria Datsenko

Vice President Clinical

Victoria joined TMC Pharma in 2022, bringing with her over 20 years of clinical development experience within global clinical research, including both project management and line management.

A medically qualified doctor, her extensive experience covers all clinical trial phases across a broad range of indications and therapies with particular expertise in oncology/cell therapy.

Victoria’s Clinical Services team comprises experienced and highly capable Project Directors, Project Managers, CRAs and CTAs allowing her direct oversight and governance of all aspects of our projects.

Quentin Clarke

Head of Pharmacovigilance

Quentin has been working in the pharmaceutical industry for over 30 years, starting in Medical Information at Leo Pharma, where he moved into pharmacovigilance. Subsequently, he moved to run PV departments in service organizations such as MDS Pharma and Aptiv solutions. He has been an EU QPPV for multiple projects and more recently a UK QPPV.

Quentin has vast experience in both pre-and post- marketing PV surveillance and case management. His very broad experience of course encompasses managing PSMFs, EU and local RMP documents, periodic reports etc. as well as signal detection /review processes.

Quentin joined TMC in 2020

Andrew Green

Head of Finance

Andrew started his career in a variety of roles including a significant period as a Junior Partner in accounting practice.

In November 1998 Andrew joined Quintiles, then the largest CRO, and since has had a varied career working in most of the service lines, including Clinical Operations, Centralised Monitoring, Data Sciences, Safety and Regulatory where he gained Orphan Drug experience, and therapy areas including Oncology, Cardiovascular and CNS.

Andrew has supported annual revenues of up to $1bn and teams of up to 9000 staff across the world.

Andrew joined TMC in November 2021. He is a Fellow of the ACCA.

Catherine Moncad

Head, Regulatory Services

With a Joint Honours degree in Biochemistry and Biology, Catherine entered the pharmaceutical industry taking a Data Management role at PAREXEL before moving to Regulatory Affairs, via R&D, at Reckitt Benckiser.

Catherine has since held regulatory roles at Dr. Reddy’s, Smith & Nephew, Chiltern and PRA gaining experience in OTCs, generics, devices, prescription pharmaceuticals and wide clinical trial experience.

Acting as Global Director of Regulatory Affairs at PRA, Catherine managed a team of ~50 regulatory affairs staff across the UK, Russia, Ukraine, Georgia and Germany.

Catherine joined TMC in March 2017.

Marcelo Vaz, MD, PhD, FFCP

Head, Medical Services

Having qualified in 1992 and with an early career specialising in Pulmonary academia and clinical practice, he moved to the pharmaceutical industry in 2007, initially as a Senior Clinical Research Physician before becoming a Medical Director at a large CRO.

Marcelo developed clinical research expertise across the range of respiratory diseases, including COPD, Asthma, Lung Cancer, Cystic Fibrosis, Respiratory infections, Sepsis, mechanical ventilation, ARDS and SIRS.

Other areas of clinical research experience include CV, TGI, rheumatology, woman’s health, oncology, ENT, CNS, DM. His rare diseases expertise includes supporting strategic creation of drug development plans, protocol concepts, and from classic to adaptive study designs.

Marcelo joined TMC Pharma in 2022.

Carol Woodward

Chief Operating Officer

After completing her initial degree at the University of East Anglia, Carol joined the pharmaceutical industry, working at Lederle Laboratories, Schering AG before joining Shire Pharmaceuticals. In the latter she contributed to the drug development process as a Program Leader. During this time Carol also completed an MSc in Clinical Research at the University of Wales.

Carol has extensive experience across many therapeutic areas, particularly oncology, and all development phases and held roles in both Pharmaceutical and Clinical Research Organisations including senior positions such as the Global Therapeutic Head of Haematology/Oncology at PPD and Vice President Development Innovations and European Operations at Sarah Cannon.

Carol joined TMC in March 2020.

Julie Matthews

Chief Executive Officer

Trained in microbiology, Julie ran an academic hospital research laboratory in Cambridge (UK) prior to joining Warner Lambert Clinical Development Group in 1986, where she ultimately became International Therapy Area Director. She then joined Rhone Poulenc Rorer in France, where she was involved first in oncology clinical development, and subsequently as Head of Anti-infectives Clinical Development.

Julie then joined Orphan Europe in Paris as Head of Clinical Development and Regional Business Manager, before going on to set up and run the company’s UK affiliate, as General Manager responsible for drug and business development, regulatory affairs, sales and marketing.

Julie started TMC in the year 2000.