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9th CMO Quality Oversight & Risk Management Summit - Hyatt Regency Boston Harbor

9th CMO Quality Oversight & Risk Management Summit
September 23 - 24, 2019
Hyatt Regency Boston Harbor
Boston, MA

Enhance the collaboration of sponsors and CMOs by understanding the complexities of risk management, quality systems and vendor relationships.

Faculty – 9th CMO Quality Oversight & Risk Management Summit

Scott Duncan

Scott Duncan, Director of Chemistry, Technical Operations, STEALTH BIOTHERAPEUTICS

Amnon Eylath

Amnon Eylath, Senior Director, Quality Assurance, GENZYME

Rosemary Gibson
Author of “China Rx,” Senior Advisor, THE HASTINGS CENTER

Heidi Hoffmann
Executive Director, CMC and Supply Chain, SUTRO BIOPHARMA

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Heidi Hoffmann, Executive Director, Manufacturing at Sutro Biopharma, has 22 years of experience in biotechnology, specializing in process development, technology transfer, and the manufacturing of vaccines and biological therapeutics. Directly after receiving her Ph.D. from the University of California, Berkeley in 1994, Dr. Hoffmann began her career at Aviron, where she worked on process development and the production of vaccines for EBV, PIV and influenza (FluMist?). She then joined Valentis, where she led the team responsible for process development, technology transfer and clinical production of plasmid DNA for gene therapy. In 2002, Dr. Hoffmann returned to vaccine work by joining VaxGen, where she was responsible for process development and manufacturing of anthrax vaccine. Later, she transitioned into a technology transfer role, hiring and leading the VaxGen oversight team for the successful transfer of production of Bristol-Meyer Squibb’s Orencia? (abatacept) into the Celltrion manufacturing facility in South Korea. After the completion of that project, Dr. Hoffmann joined non-profit Global Solutions for Infectious Diseases (GSID) as Project Director responsible for coordinating the outsourcing of process development and the manufacture of HIV vaccines. Dr. Hoffmann joined Sutro in February 2011 to direct scale-up and cGMP manufacturing of protein therapeutics using Sutro’s proprietary cell-free protein expression system.

Li-Chung Huang
Executive Director, CMC Management, WUXI BIOLOGICS

Gerd Kochendoerfer
Senior Vice President, Head of Operations, PELLEPHARM

Ben Locwin, Ph.D., MBA, M.S.
Senior Vice President of Quality, LUMICELL

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Ben is a leader in pharma and healthcare practices and serves on several advisory boards. He is widely published and has brought many of the paradigms of risk management to the pharma industry from other industries in which he’s advised, including petrochemical, agricultural, aerospace and automotive. He has also brought that expertise to molecule development, drug manufacturing and clinical trials in order to guide proper approaches to Quality by Design. In addition, Dr. Locwin has provided guidance in clinical practice to support a risk-based decision-making approach for patient care in the clinical setting. He serves as an expert contact for the American Association of Pharmaceutical Scientists (AAPS) and a committee member in the American Statistical Association (ASA).

Ben also works with academia to develop and refine programs in use across the United States for training students and professionals in pharma/biotechnology, risk management and process improvement.

Jayet Moon

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Jayet Moon specializes in risk based thinking for targeted problem solving. He has lead and participated in multiple cross functional teams which developed risk plans for a variety processes, products and organizational systems. His philosophy of risk management integrates practical cost effective approaches with traditional methods of risk management allowing the organization to be proactive in ensuring safety and effectiveness of its products and services. Jayet holds a Masters in Biomedical Engineering and is a longtime member of the American Society for Quality, holding numerous ASQ certifications.

Terry Novak
Chief Operating Officer, TEDOR PHARMA

Naymisha Patel
Vice President, Quality, OCULAR THERAPEUTIX

Jonathan Patroni
Global Head of Quality Assurance, KYOWA KIRIN BIO-PHARMACEUTICALS

Adnan Sabir
Principal Consultant, Pharma Consulting Services, Former Associate Director of QA, KOWA PHARMACEUTICALS

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Adnan Sabir is currently employed by Kowa Pharmaceuticals of America, a subsidiary of a Japanese company, leading QA/CMC activities. Previously he was a Principal Consultant and Founder of “Pharma Consulting Services, Inc. (PCS),” where he provided solutions for regulatory issues, the implementation of QbD/PAT, and the risk-based development of products to big and small pharma companies globally. He has more than 30 years of hands-on and management experience and a proven track record for formulation and process development and technology transfer working in brand and generic industries such as GSK, Solvay, Actavis and UCB. He also served as a Vice President of R&D at Dr. Reddy’s Lab for three years in 2009 establishing product development optimization. He has significant knowledge in CMC, cGMP, 21 CFR Part 11 and ICH Guidelines, Serialization, and FDA regulations. He is a frequent speaker at various meetings in the United States and other countries globally.

Eyad Salman
Principal Quality Site Manager, GENENTECH

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Eyad Salman has been in Quality function for over 19 years; Eyad has worked previously for companies like Amgen Pharmaceutical, Abbott Laboratories, and others. Eyad has been at Genentech for over 12 years and is currently working as Principal Quality Site Manager Emerging Markets. Eyad has completed technology transfer of formulation and aseptic filling processes in India, Russia and previously to Germany. Eyad is responsible for managing all Quality aspects of supporting business and regulatory strategy, QC, validation and managing the contract manufacturing site to full quality support to local Roche affiliate. Furthermore, providing support for evaluation and audit of local suppliers, vendors and service providers, while also providing training (Risk Management, visual inspection, and Quality mindset) to contract organization and local Roche affiliate. Eyad is currently on Assignment in Switzerland working in the merger and acquisition team and asset transformation projects related to divestments.

Jim Stahl
Senior Director of Analytical Development, PROMEDIOR

Lisa Wyman
Vice President, Quality, ACCELERON PHARMA

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