8th CMO Quality Oversight & Risk Management Summit - Boston, MA

8th CMO Quality Oversight & Risk Management Summit
March 21–22, 2018
Boston, MA
Boston, MA

Ensuring Compliance and Robust Partnerships Through Rigorous Discourse and Disseminations of Tactical Operations, Oversight and Quality Systems

Faculty – 8th CMO Quality Oversight & Risk Management Summit


Michelle Bailey
Associate Director, GMP Validation, VERTEX PHARMACEUTICALS

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Michelle Bailey is the Head of GMP Validation at Vertex Pharmaceuticals. In this role, she provides validation leadership and support to the GMP Manufacturing facility including continuous manufacturing (CM) at Vertex and CMO sites. She is also the Project Manager overseeing implementation of Vertex’s 2nd Gen CM Process Control System. Since joining Vertex in 2005 Michelle has cultivated a culture of quality risk management through the establishment of key validation/quality functions and programs with demonstrable success in inspections (FDA & EMA). Michelle started her career in Formulation Development and throughout her 27-year career, she has held various leadership roles to develop business units, programs and standardized practices for validation across varied healthcare companies including pharmaceutical, biotechnology, medical device, CMOs and software providers. This diverse exposure has provided Michelle with a broad and balanced perspective on effective system compliance and validation approaches.


Sonali Balwani
Quality Control, Lead, ADVAXIS

Natasha Bussard
Director of Research and Development, UPM PHARMACEUTICALS

Sandra Edwards
Director, Corporate Quality Compliance and Risk Management, TARO PHARMACEUTICALS

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Sandra Edwards is the Director, Corporate Quality Compliance and Risk Management for Taro Pharmaceuticals Inc. She is responsible for the alignment of Taro sites and ensuring inspection readiness for all markets. Other responsibilities include involvement with supply/business, pharmacovigilance, and quality agreements as well as industry intelligence. Sandra has been with Taro since 1990 in various roles in both Regulatory Affairs and Quality. Sandra’s experience with Taro includes regulatory inspections (FDA and Health Canada), customer and supplier inspections, internal auditing, deviations, change control, CAPA, recalls, Field Alert reporting, documentation, annual product reviews, quality operations, customer quality management, vendor management, establishment licensing, product launch, controlled drugs, labeling, ISO 13485 (medical devices) and risk management.


Amnon Eylath
Associate Vice President, Head of Quality, KARYOPHARM THERAPEUTICS

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Amnon Eylath, Senior Director, Quality Assurance, GENZYME

Amnon Eylath is responsible for GxP quality oversight and compliance of the global development and manufacturing of Karyopharm’s clinical products and the support of CMC, Clinical Trails, Pharmacovigilance and Regulatory Submissions in the US and Europe. Additionally, Amnon leads the development and deployment of Karyopharm’s GxP Quality Management System, U.S. and international auditing of Contract Manufacturers, Clinical Research Organizations, Testing Labs, and Distribution Centers.

Prior to his leadership position at Karyopharm, Amnon’s prion leadership positions included being Senior Director of QA at Genzyme and other leadership positions at Ariad Pharmaceuticals, Eli Lilly, Amgen, ImmuLogic, Cellcor Therapies and Massachusetts General Hospital. Amnon has more than 25 years of R&D and biopharma experience, including the complete life cycle of biotech/small molecule drug development from discovery through process/method development, facility construction/validation, GCP quality, QA systems and operations, product commercialization, and post-launch disposition and compliance. Amnon is experienced in the due diligence, qualification and QA oversight of contract manufacturing and distribution organizations and contract labs across the US, Europe and Asia/Pacific.

Amnon collaborated closely with global SMEs from the FDA, EMA, biopharma companies, consultants and academia in developing the PDA Technical Report: TR No. 56: Application of Phase-Appropriate Quality Systems and GMP to the Development of Therapeutic Protein Drug Substance. He is co-author of PDA Technical Report 65: Technology Transfer. He has delivered training and seminars at PDA and ISPE venues as well as in the academic setting.


Julia N. Hart
Head of Quality, APTEVO THERAPEUTICS

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Julia Hart is the Head of Quality for Aptevo Therapeutics in Seattle. Aptevo is a biotech company focused on bringing novel oncology and hematology therapeutics to market. Julia is a Quality professional with over 25 years of experience within the biotech and pharma industry within companies at all stages of product and corporate development. Within her current role, Julia actively fosters the Quality culture for the company by exhibiting strategic insight, leadership, and implementing tools of Quality risk management to maintain a competitive advantage in the development, production and overall lifecycle management of highly complex clinical and commercial stage immunotherapy products. She retains overall responsibility for corporate quality control, quality assurance and compliance functions.


Nadine Jahn
Senior Manager, Third Party Quality Management,
BOEHRINGER INGELHEIM

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Nadine is currently Senior Manager, Third Party Quality Management of the Operations Division of Boehringer Ingelheim’s (BI) headquarters in Ingelheim, Germany. She is responsible for 3PQM management oversight to ensure cGMP and regulatory compliance of products supplied by CMOs and the implementation and maintenance of 3PQM systems and procedures within BI, with a special focus on the CMO management organization within Asia.

Besides working in a pharmacy, Nadine has almost 16 year’s experience in the pharmaceutical industry, working mainly in production and IT related quality assurance roles and project management within Operative Units as well as global headquarters.

Nadine majored in Pharmaceutical studies at the Freie Universität Berlin and has a Dr.rer.nat degree (equivalent to Ph.D.) in Pharmaceutical Pharmacology from the University of Bonn, Germany.


Laura Kalegaric
Associate Director, Quality Assurance, AKEBIA THERAPEUTICS

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Laura Kalegaric is an Associate Director of Quality Assurance for Akebia Therapeutics. In this role, Laura is responsible for Supplier Qualification and Vendor Management as well as Material Disposition. She is responsible for ensuring compliance of Akebia’s CMO’s from Raw Materials Suppliers to Packaging & Labeling vendors. Other responsibilities include managing quality agreements, inspection readiness, auditing, vendor metrics and material disposition. Prior to her experience at Akebia, Laura’s experience also includes Quality Management Systems (change control, deviations, CAPAs), manufacturing and laboratory equipment validation and writing Annual Product Reviews. Laura holds a biology degree from The University of North Carolina at Wilmington.


Paula Katz
Director of Manufacturing Quality Guidance and Policy, Office of Compliance, CDER, CDER, FDA

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Paula R. Katz, J.D., is Director of Manufacturing Quality Guidance and Policy in CDER’s Office of Compliance. She leads an interdisciplinary staff of senior compliance officers and technical experts who focus on CGMP enforcement and drug quality policy issues. Ms. Katz frequently advises Center and Agency leadership regarding manufacturing supply chain controls, contract manufacturing, data and application integrity, administrative law and procedure, and regulatory policy development and enforcement strategy. Ms. Katz has chaired Agency working groups and directed the development of guidance for industry, regulations, and legislation; managed responses to Congressional oversight and other stakeholder inquiries; and conducted domestic and international inspections, case evaluations, and enforcement actions. She is a frequent presenter at industry and agency meetings, conferences, and training events. Prior to joining FDA in 2009, Ms. Katz was a litigation associate at a large law firm in Washington, D.C., where her practice included regulatory compliance, white-collar crime, and general commercial litigation. Ms. Katz is a graduate of the University of Virginia and the University of Virginia School of Law.


Joseph Kudla
Associate Director QA Operations/Systems, ASTRAZENECA/MEDIMMUNE

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Joseph Kudla is Associate Director of External Quality at MedImmune, the biologics R&D arm of AstraZeneca. He is responsible for all external quality relationships for GMP clinical development. These Quality relationships span from intercompany sites to traditional vendor supplier quality to Business Development/Alliance Collaborations in clinical development. He provides strategic operational and Quality direction during business development negotiations and oversight and maintenance during the lifecycle of the alliance. Before this role, Joseph was Director of Regulatory Compliance for CMC development of MS1819 for Protea Biosciences and later AzurRx BioPharma for 6 years. Prior to that, he worked at the United States Patent Office as a patent examiner and Mylan Pharmaceuticals. Joseph earned his B.S. in Chemistry from the University of Florida.


Suzanne Murray
VP of Quality, AGIOS PHARMACEUTICALS

Prakash Patwardhan
Senior Director, Quality Systems Harmonization, MEDTRONIC

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Prakash Patwardhan is a Director at Medtronic with experience in Quality, Operations, Project Management, Operational Excellence and a passion for nurturing a quality centric mindset through employee empowerment and engagement.

He received his engineering degree from India and MBA from the UK.

Prakash has more than 20 years of experience, having worked in India, Germany, Ireland and the UK in Automotive, Medical Device and Pharmaceutical sectors.

In his present role, he is leading “Quality Begins with Me” roll-out to reinforce Medtronic’s mission of alleviating pain, restoring health and extending life. Additionally, he is responsible for Operational Quality at Medtronic.


Eyad Salman, MSQA
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.


Wendy Summers
Director of Quality, CHIESI USA

Eva Urban
Senior Manager, OpEx Risk Management, CELGENE

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Eva Urban is the Senior Manager of OpEx Risk Management for Celgene’s Business Operational Excellence Department. Eva has 25 years of experience in biotech/biopharmaceutical custom manufacturing organization (CMO) services and in the biopharmaceutical industry. Prior to March 2017 Eva was Senior Manager of Global Quality Risk Management as Celgene. She was working in R&D, manufacturing, quality assurance/compliance and the quality systems area.

During this time some key activities and achievements are as follows: lead of cross-functional teams for biotechn, API (active pharmaceutical ingredient) tech transfer, process qualification, scale up, and process validation and commercial production (biotechnological and chemical synthetic steps), responsible for the first commercial cGMP API production campaign in the biotech plant. For the new biopharmaceutical production plants, Eva developed the strategy and the establishment of quality systems as cleaning/cleaning validation, clean utilities/environmental monitoring and the site internal quality audit program based on risk-based approaches. Primary focus areas were also host health authority inspections, lead auditor for internal and external audits and project evaluations.

In 2011, Eva joined Celgene, working for CMO quality oversight of sterile lyophilized drug product. Currently she is establishing a Global Center of Excellence Risk Management by leading and supporting several cross-functional initiatives and corresponding teams, and implementing efficient and harmonized risk-based approaches. Eva is volunteering for PDA and ISPE.
Eva has a MSc. in biology (biotechnology) from University Kaiserslautern (Prof. Dr. T. Anke), Germany.


Gerald Zemble
Senior Quality Specialist III, Supplier Quality, PURDUE PHARMACEUTICALS

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Gerald (Jerry) Zemble has been involved in the pharmaceutical industry for 20 years. Jerry is the Senior Manager, Supplier Quality at Purdue Pharmaceuticals. His current roles include review and approval of validation documents, customer complaints, corrective action preventive action (CAPA), and approval of annual product reviews. Jerry also reviews supply and quality agreements, participates in audits, helps troubleshoot and optimize processes and helps train junior level people on root cause analysis, document reviews, and document preparation.

Jerry’s broad range of experience at Purdue includes product and process development, validation, technical troubleshooting, equipment design and installation, quality oversight for complaints, CAPAs, change controls and complaints and now quality oversight for some of the 3rd party companies that Purdue utilizes.

Jerry lives in Wilson with his wife, Hita, and their son, Jerry. His hobbies include work, bicycling and racquetball. Jerry has a Bachelors in Chemical Engineering and recently completed his Masters in Engineering.


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