Julie Matthews, CEO, TMC Pharma Services LTD
The pursuit of innovation has been a major driving force in the pharmaceutical Industry. The sector has always been on a quest for novel, ground-breaking drug development. However, with the increasingly stringent regulatory requirements, intense competition, and demands for lower prices, many pharmaceutical companies are consequently lagging behind in optimizing the benefits of new models of innovation. To remain competitive, they need a reliable partner who can help them in improving their efficiency while reducing costs and leveraging limited resources. One such partner is TMC Pharma Services Ltd, a leading pharmaceutical development company that helps pharmaceutical firms to mitigate the industry challenges by providing a comprehensive range of expert support services.
TMC Pharma Services Ltd began its journey in the year 2000as a pharmaceutical consultancy firm to address the regulatory, clinical, medical, and pharmacovigilance aspects of drug development. With its pre-eminent pharmaceutical development services and strong expertise in Orphan diseases, it was able to quickly differentiate itself in the market. TMC’s services were so much in demand that its founders decided to expand its capabilities and widen its focus from mainly consultancy to consultancy plus resourcing.
Over time, the company grew steadily in geographical reach and scope of activities to culminate into a leading global pharmaceutical development organization with a full range of expert pharma support services. Today, its services encompass all product development stages – from pre-clinical, through clinical activities to global marketing approvals and even post-marketing support. For smaller client companies, TMC essentially provides all the resource of a medium-size pharma company and also helps them to source funding.
In 2016, the pioneering company established its presence in Japan with the launch of TMC Pharma Japan KK. The goal was to enable faster global development of novel medicines by working with Japan. Prior to this, it had already assisted US and European pharma companies in navigating earlier entry into the Japanese market by including Japan in the pre-approval clinical development stage.
“We facilitated early engagement with the PMDA as well as Japanese involvement in pivotal clinical trials by forming trusted partnerships with local Japanese experts, particularly in regulatory, clinical and marketing” says Julie Matthews, the CEO of TMC Pharma Services Ltd.
Today, TMC Pharma’s goals in Japan have further evolved to assist Japanese companies in entering the global markets earlier, particularly in the area of regenerative medicine.
Creating a Difference through a Unique Operating Model
While many factors contributed to the success story of TMC, one primary attribute that makes it stand out in the market is its unique operating model. TMC has a Head Office team of mature, highly experienced senior staff who drive global projects working with TMC’s large group of Associates around the world to provide expert support and local services. Each project is resourced with hand-picked teams that have the specific expertise and experience required. This enables the company to provide tailored solutions that respond directly and uniquely to the requirements of the clients.
This flexible and bespoke operating model, along with its vision to conduct development work simultaneously across the US, Europe and Japan, streamlines the development pathways for TMC and thus puts its clients’ products in a favourable position to be first-to-market. The innovative approach also causes relatively low business overheads which allow TMC to provide full-service development support at a much more competitive price than the large CROs.
“Our goal is to bring this unique operating model to the pharmaceutical industry worldwide, providing focused solutions to novel drug development challenges by mobilizing bespoke teams in response to each request for support,” elucidates Julie.
Solving Novel and Unusual Development Challenges
TMC has been an early participant in many cutting-edge technologies spanning pharmaceutical, immunological and regenerative therapies. With its ability to quickly adapt innovative technologies, it has solved several unique challenges in the industry.
For instance, TMC worked with an American client to set up and run the first-ever clinical study with a human embryonic stem cell in Europe, for an inherited form of blindness. The study presented unique challenges in gaining regulatory approval, in international and time-sensitive cold-chain logistics, and conduct and reporting. But, TMC pioneered many advantages for the sponsor in this study, including a protocol modification mid-study that led to a time saving of 6 months in its completion.
In another case, when a unique medicine/device combination presented potential safety challenges, TMC addressed the issue by recommending, developing and gaining health authority approval for a change to the product’s labeling. The new label clarified the operation of the device, thereby reduced a potential hazard.
TMC’s history of working with highly unusual Orphan products and complex clinical development programs has repeatedly demonstrated its ability to quickly adapt new technologies and devise innovative processes.
TMC can also provide its smaller ‘virtual’ client companies with all the support services that are required after marketing approval, including acting as the Marketing Authorization Holder if required, in most of the key countries in the world.
“A strong background in Orphan diseases has underpinned TMC’s success in many of these projects, giving us experience in assembling teams of experts accustomed to solving novel and unusual development challenges,” asserts Julie.
Committed To Deliver an Exceptional Customer Experience
Good service speaks for itself and the repeat customers and referrals earned by TMC undoubtedly reflect its commitment to great client experiences.
“When working with Biotechs, we have often found that, after moving on, their former staff has sought TMC out from their new companies, and in this way one client has become many,” shares Julie.
She further adds, “Many times we may have started with a relatively specific role on a project, and then it has swiftly grown to a much larger role as the project progresses.”
Equipped with highly experienced consultants and management staff with a proven track record, the company is able to quickly develop operational plans and facilitate a timely risk assessment process for its clients.
Planning To Expand Its Reach
Speaking of TMC’s future, Julie adds, “We aim to continue establishing long-term partnerships with pharmaceutical and biotech companies worldwide, and to grow particularly in Japan and the Asia Pacific region.” Moving forward, the company intends to grow organically by reputation while maintaining its unique business model which benefits both the company and the clients. Meanwhile, it is also focusing on maintaining and expanding its network of expert consultants in all relevant subjects and all parts of the world.