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REFORM OF GLOBAL RESEARCH AND DEVELOPMENT ORGANIZATION AND CHANGES OF CORPORATE OFFICERS <effective as of July 15, 2022>

<Changes of Corporate Officers, effective as of July 15, 2022>

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New ResponsibilityCurrent ResponsibilityName
Senior Vice President
Global Alzheimer's Disease Officer
President, Americas Region
Chairman & CEO, Eisai Inc.
Senior Vice President
Neurology Business Group
Global Alzheimer's Disease Officer
President, Americas Region
Chairman & CEO, Eisai Inc.
Ivan Cheung
Senior Vice President
Chief Scientific Officer
Japan and Asia Medical
Safety
Senior Vice President
President, Oncology Business Group
Japan and Asia Medical
Safety
Takashi Owa
Vice President
Chief Clinical Officer, Alzheimer's Disease and Brain Health
Vice President
Chief Clinical Officer, Neurology Business Group
Lynn Kramer
Vice President
Chief Portfolio Officer
Alzheimer's Disease Filing and Registration Japan / Asia Lead
Quality
Vice President
Head of Medicine Development Center
Alzheimer's Disease Filing and Registration Japan / Asia Lead
Quality
Akiko Nakahama

°®¶¹´«Ã½. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company has reformed its global Research and Development (R&D) organization from the former business group structure to a new R&D organization with the concept of DHBL (Deep Human Biology Learning), effective as of July 15, 2022. With this organization reform, Eisai aims to realize DHBL drug discovery based on the best of our own technologies with creating synergy of “C&I” (Collaboration & Incubation)/ “A&I” (Academia/ Industry Alliance).

 

Under the new DHBL drug discovery and development, diseases will be viewed as Disease Continuum, and comprehensive analysis of genomic information, pathophysiological information and clinical information associated with the root cause of the disease is the first step in redefining the disease concept. Eisai aims to create innovative and efficient next-generation drug discovery concepts by deepening human biology and acquiring data that will lead to the next-generation drug discovery using AI and other technologies based on information such as biomarkers and imaging from patients on our drugs. Furthermore, Eisai defines DHBL drug discovery and development as data-driven drug discovery starting from reverse translational human biology based on clinical data and aim to transform neurodegenerative diseases/ cancer into curable diseases by the cycle of DHBL drug discovery process.

 

On the other hand, the clinical development, regulatory, medical, value and access, marketing, and alliance management functions related to Disease Modifying Therapies (DMT) for Alzheimer's disease (AD) and related brain health diseases, including the next-generation AD treatment lecanemab, which is our most important project, will be reorganized as Alzheimer's Disease and Brain Health (ADBH) under the Global AD Officer toward obtaining approval and building a solid launch structure for AD-DMT.

 

The full-scale launch of the new organization is scheduled for October 1, 2022, with smooth transitions in a phased approach. With this transition, Neurology Business Group, Oncology Business Group, Medicine Development Center, and hhc Data Creation Center will be dissolved.

 

The DHBL drug discovery and development consists of five "Domains" based on Eisai's strengths in human biology based on the neurology and oncology areas and five ”Functions” classified according to R&D phases from drug discovery hypothesis formulation to obtaining regulatory approval.

 

1. Five Domains

The following five Domains based on Human Biology are responsible for execution of DHBL drug discovery and development from drug discovery hypothesis formulation to regulatory approval.

 1) Protein Integrity & Homeostasis Domain

 2) Microenvironment Dynamics Domain

 3) Cell Lineage & Differentiation Domain

 4) InflammAging & Senescence Domain

 5) Pathogen & Body Defense Domain

 

2. Five Functions

The following five Functions support the five Domains at each stage from drug discovery hypothesis formulation to regulatory approval. Each Functions are also responsible for providing technical support for project planning and promotion, and optimizing the shared research foundation.

 1) Human Biology Integration Function

 2) Discovery Concept Validation Function

 3) Discovery Evidence Generation Function

 4) Physiological Product Design Function

 5) Clinical Evidence Generation Function

 

3. Establishment of DHBL Office

With the aim of optimization, allocation of business resources, swift decision making from a view of overall DHBL drug discovery and development, we will establish the DHBL Office, consisting of a Chief Scientific Officer (CSCO), Chief Portfolio Officer (CPOO), and six groups (Portfolio/Project Management, Budget Management, Human Resource Strategy & Operations, IT Strategy, Collaboration & Incubation and Academia/ Industry Alliance). We will centralize information and governance in DHBL Office, and enhance efficiency by establishing shared functions and standardizing operations of existing related functions.

 

 

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