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Monday, June 19 • 11:00am - 12:15pm
#121: Effective Life Cycle Management

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000198; RN 1.25

During development of a novel pharmaceutical candidate, the focus is often on near term and immediate success as costs and attrition need to balance across a portfolio of candidates. However, subsequent to regulatory approval, commercial asset teams are obliged to address several important life cycle expectations. How do organizations manage this space and allocate resources to support? What work/planning can or should be completed pre-approval that would set the program up for success? This forum will give an overview of typical life cycle management activities and walk through some case studies that highlight different approaches (e.g., serial planning, parallel planning).

Learning Objectives

Discuss activities and resources needed to effectively manage product life cycle.

Chair

Keith Ruark, MBA

Speaker

The State of Life Cycle Management Planning Today: Observations and Lessons Learned
Keith Ruark, MBA

From Lab to Launch: Optimizing Intellectual Property Rights in Life Cycle Management Strategy
Maria Isabel Manley, LLM

US Legal Framework and Core Regulatory Intellectual Property Rights
Kellie B. Combs, JD



Moderators
avatar for Keith Ruark

Keith Ruark

Executive Director, Strategy Consulting, INC Research
Keith Ruark is a practice lead for Commercial & Medical Strategy Consulting within INC Research. He has 20+ years of experience in the healthcare industry, spending much of his career in roles and functions at the interface of research & development and commercial. He has led mul... Read More →

Speakers
avatar for Kellie Combs

Kellie Combs

Partner, Ropes & Gray LLP
Kellie Combs is a Partner in the Washington, DC office of Ropes and Gray, where she advises pharmaceutical, biotech, and medical device companies on a range of FDA regulatory issues, including promotional compliance, lifecycle management, and regulation of clinical research. She... Read More →
avatar for Maria Manley

Maria Manley

Partner, Head of the Regulatory Legal Group, Bristows LLP
Marie Manley is a Partner at Bristows & heads the Regulatory Practice. She specialises in bio/pharmaceutical products & medical devices within the UK/EU regulatory & competition fields. She represents leading pharmaceutical companies before the UK/EU courts & institutions, includ... Read More →
avatar for Keith Ruark

Keith Ruark

Executive Director, Strategy Consulting, INC Research
Keith Ruark is a practice lead for Commercial & Medical Strategy Consulting within INC Research. He has 20+ years of experience in the healthcare industry, spending much of his career in roles and functions at the interface of research & development and commercial. He has led mul... Read More →


Monday June 19, 2017 11:00am - 12:15pm
S505ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616