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Wednesday, June 29 • 10:30am - 11:45am
#310: Bridging CMC and Project Management to Achieve High Quality Product Submissions and Launch

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Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: CME 1.25; IACET 1.25; PDU 1.25 PMI 2166-000191; RN 1.25

This session will review case studies of differing delivery modality, to demonstrate diversified perspectives on product development, highlighting the project management-CMC interface.

Learning Objectives

Describe how to integrate the key/critical elements for successful pharmaceutical product project management into a receptive organization; Recognize the key/critical elements (critical path and common decision points) for successful CMC development, submission, and launch of pharmaceutical products.

Chair

Russell Maus, PhD

Speaker

CMC Case Study 2: Combination Device/Biologic Product
Maria Paola Schick, PMP

Case Study 3: Bioequivalency of Inhaled Products
Bela Elkin, PhD



Chair
avatar for Russell Maus

Russell Maus

Director, Merck & Co., Inc.
Russell joined Merck in 2002 in Merck Manufacturing in a role supporting analytical methods for in-line products. In 2006 he moved to Merck Research Labs to provide analytical support for PhI and PhII pharmaceutical development. In 2012 he took on a 2.5 yr stint as Scientific Project Leader in Pharmceutical Sciences, leading CMC development teams for PhI and PhII. In Feb 2015, he accepted a position as Director in Global Project and Alliance... Read More →

Speakers
avatar for Bela Elkin

Bela Elkin

Laboratory Manager, PPD
Dr. Bela Elkin has +30 years of experience in numerous chemistry-related fields, including research, drug development, the pharmaceutical industry, teaching, management and administration. She has +15 years of analytical chemistry laboratory experience in the FDA regulated pharmaceutical industry, with a focus on Inhalation Technologies covering a wide range of studies, including method development, validation, stability and bioequivalency. Dr... Read More →
MS

Maria Schick

CMC Integration Sr. Project Manager, Amgen Inc.
Biotechnology professional with 13+ years of industry experience with a focus on project management to enable commercialization of biologics and combination products by partnering with scientific leads and Global Operations Leads to co-lead and manage cross-functional project teams through early and late stage process development, technology transfer, process validation, and CMC filing deliverables.


Wednesday June 29, 2016 10:30am - 11:45am
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA