MediRama
Connecting Science to Life With Strategy and Ownership

Connecting Science to Life
Driven by this simple yet impactful mission, MediRama, the first clinical development company (CDRO) in Korea, is making a mark in the industry by providing clinical strategy and clinical development services. It assists biotech companies dedicated to developing new drugs, developing a strategy, and conducting clinical trials when they entrust candidates with non-clinical candidates. It offers the best-fit services or co-development for clients by maximizing the value of their assets and technologies, from wellthought-out development strategies to seamless business development.

Supported by experienced professionals in clinical development, business development, and commercialization, MediRama’s approach is based on a deep understanding and expertise in the clinical development of drugs, diseases, and clinical practice aligned with ultimate patient benefits.

“I emphasize connecting science to lives because it is fundamental for our company to contribute to drug development and ultimately to human health,” says Dr. Hanlim Moon, CEO of MediRama.

MediRama delivers results specific to an organization’s phases of development and requirements. It directly implements clinical trial strategies for domestic biotech companies experiencing difficulties in clinical development while acting as biotech’s clinical development headquarters. It delivers optimal patient benefits by transforming Korea’s new drug development ecosystem with quality and speed.

Biotech Clinical Development Headquarters

Intense competition in the drug discovery and development sector has made it challenging to speed up the process since each site is engaged in various trials. Korea’s biotech companies face difficulty navigating to New Drug Application (NDA) or Biologics License Application (BLA), as they require phase 3 trials. Modern principles of pharmaceutical sciences, clinical pharmacology, and information technology are being researched and employed to improve the productivity of new drug development.

Leveraging higher levels of science, MediRama intends to secure a unique relationship with top university hospitals that contributes to the success rate of drug development. MediRama maximizes the probability of clinical development success by identifying target indications, developing trial strategies to generate NDA and BLA-enabling data in 36 months, and operating with speed and efficiency.

MediRama’s definition of success is to enable NDA and BLA for compounds in development.

“We act as the clinical development headquarters of biotech, having ownership, strategy, and the know-how to run the study. MediRama establishes a clinical strategy to generate NDA data for the US FDA and help optimize the speed and quality of clinical trials,” states Dr. Moon.

The standard of care in the oncology space changes weekly as the drug development landscape evolves. In 2021, around 66 drugs or indications were approved, indicating the standard of care changes once or twice a week in some disease areas. That said, MediRama contributes to the success of biotech firms, focusing on collaboration with a dynamic strategy.

MediRama also provides trial excellence and R&D and BD consulting. R&D consulting delivers services in response to requirements from new drug development companies at various stages of the process. It helps with clinical protocol design, BD strategy for outlicensing, and NDA-related tasks.

Ensuring Strategy, Quality, and Speed

MediRama focuses on getting the compound into the market to patients and physicians. To do this, its model allows it to engage with collaborators and biotech companies to provide the best outcomes.

For instance, when MediRama collaborates with biotech companies, it divides the responsibilities from preclinical to biotech. Whenever it needs more preclinical or wet lab data, biotech companies work for that. Once it reaches Investigational New Drug (IND) Application preparation, MediRama takes the fundamental role of a sponsor, benefiting clients.

MediRama currently has three cases in clinical development, running the trial with target product characteristics and clinical development strategy to go for actual clinical development. MediRama leaves no stone unturned while engaging with clients, providing the best services by maximizing the value of their assets and technologies. Dr. Moon firmly believes MediRama will work with many successful cases within three years.

In addition, it is vital to monitor the environment and work with agile and flexible partners for the most effective development and discovery results. For example, MediRama engages with biotech companies to determine the most appropriate target for discovery. Despite the proliferation of advancing sciences, it focuses on the targets of recent scientific discoveries. If a target is found and it is a high-profile research topic in the basic sciences, MediRama discovers patients with a higher expression level of that target if it is associated with their prognosis.

I Emphasize Connecting Science to Lives Because that is Fundamental for our Company to Contribute to Drug Development and Ultimately to Human Health

MediRama reviews all targets identified in any disease or cancer area. It encourages its partners to identify targets that need or are partially developed. When a target is developed, MediRama begins formulating a strategy. It also creates a detailed target product profile (TPP) and a precise execution plan, including a timeline, resource, quality standard, and risk mitigation plan.

Drug Discovery Today and Tomorrow

The healthcare sector is rapidly evolving. In the coming years, there will be many changes in human vectors. Clinical development has become more patient-centric and predictor-based, and businesses are increasingly collaborating and integrating. The collaboration is wider than the original developer or contract research organizations (CRO).

MediRama intends to collaborate more with academic societies and hospitals.

MediRama is collaborating with the Samsung Medical Center for a pancreatic cancer trial as the platform trial to accelerate drug development. CROs, academic societies, and pharmaceutical societies collaborate with MediRama. The organization’s future concept is to contribute to the community through integration or collaboration.

“Working with different partners, we bring them to a different set of clinical development or clinical trials to pursue the best efficiency and best collaboration model,” adds Dr. Moon.

Dr. Moon, a clinical expert, has led oncology R&D drug related consulting since 2017, emphasizing the need for a comprehensive plan that considers clinical trials and commercializing actual drugs. Building on this idea, MediRama facilitates the commercialization of new medicines through technology transfer, investment attraction, and domestic listing, unlike CROs that merely conduct clinical trials.

Nearly 5,000 clinical trials in combination with approved anticancer drugs are still in progress, and many anticancer drugs or treatment methods are expected to emerge within the next five years. Organizing and hosting an anticancer drug development forum with the National New Medication Development Foundation, MediRama is committed to improving the clinical success rate of Korean drug development.