MediRama announced on the 21st that the online training program “Oncology Drug Development Strategy: Clinical, Regulatory and Commercial Planning,” co-hosted with the Korea Drug Research Association (KDRA), was successfully held.

The program was organized to share strategic perspectives that span the entire lifecycle of oncology drug development and to explore ways to connect clinical, regulatory, and business development strategies.

In the first session, MediRama CEO Hanrim Moon explained the purpose of the training, emphasizing that the Clinical Development Plan (CDP) is not merely an execution document but “a core tool that serves as a roadmap for development strategy.” He particularly highlighted the importance of Indication Prioritization, illustrating through real-world examples how early strategic decisions can affect future approval and commercialization outcomes.

Next, Heejeong Lee gave a lecture titled “Target Product Profile: A Strategic Tool for Clinical Development.” She described the Target Product Profile (TPP) as a key strategic instrument that guides clinical development, noting, “Developing a TPP is like drawing the face of the intended drug—only when that portrait is clear can research (R) and development (D) move in the same direction.”

Inyoung Kim presented on “Clinical Endpoints and Comparator in Oncology Drug Development.” He emphasized the importance of setting key efficacy endpoints and selecting comparators in oncology clinical trials. Kim introduced strategies that combine statistical and clinical approaches, demonstrating their practical impact on development efficiency, which drew strong interest from attendees.

In the following session, Myungjin Kim spoke on “Oncology Drug Development Strategy: Regulatory, Clinical and Commercial Plan.” He discussed the importance of advanced data management technologies and real-time quality assurance/control (QA/QC), emphasizing that “data is no longer a byproduct of clinical trials—it is the engine that drives development speed.”

Hyunjung Roh delivered a lecture titled “Commercial Plan in BD Perspective.” She outlined commercialization strategies from a business development standpoint, focusing on the global licensing process (target selection – confidentiality agreement – due diligence – term negotiation – main contract – technology transfer). Roh stressed that “the success of clinical development is not complete with approval alone—it is only realized when it leads to market entry and patient access.” She concluded by emphasizing the need to integrate business development considerations from the early R&D stages.

Participants from the industry commented that the program was “highly practical and applicable to real-world work” and praised the “integrated perspective that connects clinical and business development.” A KDDRA representative added, “This program provided oncology developers with an opportunity to understand each other’s language and collaborate more effectively. We plan to continue offering practical training that bridges clinical, regulatory, and business development domains.”

Despite being a one-day online program, the event garnered strong participation and engagement thanks to its in-depth presentations. Both KDDRA and Medirama stated that the training reinforced the importance of comprehensive, end-to-end strategies—from R&D to commercialization—in strengthening the global competitiveness of Korea’s oncology drug development efforts.

Source: The Bio News (https://www.thebionews.net)