KIMCo Drug Development Workshop

The A-to-Z of Global New Drug Development: Strategic Roadmap for Korea Biopharma

A joint workshop with the Korea Innovative Medicines Consortium (KIMCo)

October 11, 2022 | 2pm – 5:30pm KST

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Beginning with the end in mind: how do you find that diamond in the rough and take it through to market (Ken Lee)

Finding an optimal asset often begins with the end in mind. Understanding where we want to go from a geographical, disease area and market segment will provide a guiding light on the asset we select and the strategy to bring it to market.

Now that you have your asset, how to you accelerate your development from POC (Nicholas Kenny)

We’ll examine the challenges of creating a harmonized global clinical development plan; engagement with regulatory authorities; impact of recent events (e.g. BREXIT). We will consider how to “start with the label in mind;” ensure development plans are focused on critical elements; where/when/types of evidence (clinical/medical, regulatory, HEOR) must be generated during development to meet stakeholder needs (payers, regulators, investors, clinicians, patients). Lastly, we will look at some examples of innovative study designs/regulatory pathways.

Ensuring late phase / phase 3 success for your asset (Stephanie Gonzalez & Suma Ramadas)

This discussion will provide guidance on regulatory consultation, planning and key considerations for conducting phase 3 trials, including operational logistics and KOL and site engagement strategies to ensure success.

Building a value creating R&D function and partnership ecosystem that can deliver through to phase 3 (Suma Ramadas & Stephanie Gonzalez)

This topic will discuss best practices for sponsors looking to drive their medicine assets through development. Discussion points include the three builds biotechs need (maximizing product value through aligned cross-functional strategy, organizational and functional capabilities needed to execute product strategy and enabling talent to innovate in an evolving organization). The ideal timing for functional capabilities build, how to get the best from partners and RFP selection best practices will also be covered.

The biotech landscape – a crystal ball look to the future (Nicholas Kenny)

In this session, we’ll look at what we can learn from recent investment trends in the biotech sector, what these tell us about what investors look at to guide their decisions. How are investors looking at novel markets (drugs and geographies) versus “better” drugs in existing settings, the impact of disease subtyping based on actionable molecular mutations, “grouping” of investments e.g. around rare disease portfolios, and long- vs. short-term strategies. What will be the expectations of your investors?

 

Ken Lee General Manager and Head of Asia Pacific, Clinical Development Syneos Health	Nicholas Kenny Chief Scientific Officer Syneos Health	Stephanie Gonzalez Senior Vice President, Global Head of Biotech Solutions Syneos Health	Suma Ramadas Executive Vice President, Medical Affairs Syneos Health

 

 

PANEL DISCUSSION: Challenges for the Success of Global New Drug Development by Korean Biopharmaceutical Companies

 

Hanlim Moon MediRama	Howard Lee SNU/SNUH	Kihwan Park KAIST

 

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