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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
Director of CMC, CENTREXION THERAPEUTICS

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Scott is currently Director of CMC for Centrexion Therapeutics in Boston, MA. In his current role he is responsible for outsourcing and management for all aspects of API, Drug Product, Analytical, Bioanalytical and in vitro DMPK to support the non-clinical and clinical programs at Centrexion.

Scott has 25 years of experience in the pharmaceutical industry working with two large Pharma companies, two API CRO’s, mid-size pharma and two virtual pharma companies in a variety of roles across process development, project management, process safety, process improvement / excellence, experimental design and research / manufacturing with small molecules, high potent APIs and controlled substances.

Background includes strong knowledge of cGMP / FDA / ICH / DEA regulatory requirements, writing-reviewing-approval of SOPs, a wide range of cGMP documents, quality agreements, master service/ supply agreements, drafting and review of the drug substance Chemistry and Manufacturing Controls (CMC) sections for INDs, INDAs, IMPDs, and NDAs as well as a proven track record in the development, transfer, validation, and commercialization of Active Pharmaceutical Ingredient (API) manufacturing processes for clinical candidates to support all stages of lifecycle management (i.e. IND enabling studies, non-clinical studies, Phase I – IV clinical studies and commercial launch) in the Biotech and Pharmaceutical Industry.


Amnon Eylath
President, BROAD SPECTRUM GXP COMPLIANCE

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Amnon Eylath, Senior Director, Quality Assurance, GENZYME

Amnon is Head of Quality at Axcella Health where he is responsible for executing the quality vision and leading all GXP Quality activities and operations as a member of the Executive Lead Team. Amnon has an extensive background in Biopharma, that spans from R&D and process development, through clinical development and commercialization for small molecules, biologics and biomolecules.

Prior to joining Axcella, Amnon held roles of increased responsibilities of Quality Leadership at Karyopharm, Histogenesis, Sanofi-Genzyme, Ariad Therapeutics, Eli Lilly and Amgen. In his work, Amnon has played a lead role working with regulators on a global scale resulting in successful navigation of inspections, addressing responses and driving remediation and inspection-readiness activities. Amnon has also as directly influenced and lead activities in GMP facility design construction and validation, deployment of Quality Management Systems, Oversight of QA/QC operations, troubleshooting and improvement of aseptic processes, global GXP auditing, Lean Six Sigma program deployment and Black Belt. As the founder and lead consultant of Broad Spectrum GXP Consulting, Amnon has consulted and audited globally across GXP disciplines, including GCP vendors, CMOs, Underwriting Risk Assessments and Cell Therapy.

Amnon was the founder and chair of the PDA Task Force that issued Technical Report 56 (TR-56) “Application of Phase-Appropriate CGMP and Quality Systems to the Development of Protein Bulk Drug Substance”, working in collaboration with FDA, MHRA, EMA and global Industry peers. He also contributed to PDA’s TR-65 “Technology Transfer” and to various professional articles and presentations/posters. Amnon is Past President of the New England Chapter of the PDA.

Amnon obtained a Masters’ Degree in Biology from Harvard University and a Bachelor of Science Degree in Biology from the University of Massachusetts.


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, PE, CMQ/OE, CQA, CQE, SSBB, RAC
Executive Director, CMC Management, WUXI BIOLOGICS

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Mr. Huang is an Executive Director, CMC Management at WuXi Biologics. He has 20+ years of Biologics & Biosimilar development and commercialization experience and contributions to numerous successful IND, IMPD, BLA and MAA filings and commercial operations of therapeutic biologics. He successfully supported inspections by various agencies (US, EU, Japan, and China). Prior to joining WuXi Biologics, He was the Chief Quality Officer at the Shanghai Henlius Biotech Co. During 20 years in the US, he served as an Associate Director of PD at Eli Lilly, a Product Group Leader for J&J, a Lab Manager at Aventis, and an Engineer/Scientist at Bayer. He is a US-licensed PE and certified RAC, SSBB, CMQ/OE, CQA, and CQE. He was the Chair of Mid-Atlantic Biomedical & Pharmaceutical Discussion Group (2006-2007). Mr. Huang holds a MS in Microbial Engineering from the University of Minnesota and a MBA from the Pennsylvania State.


Nadine Jahn
Senior Manager Third Party Quality Management, BOEHRINGER INGELHEIM (BI)

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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 global 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. In addition, she is heading a team of quality project managers onboarding new CMOs and supporting tech transfers.

Nadine has more than 18 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.) from the University of Bonn, Germany.


Gerd Kochendoerfer
Senior Vice President, Head of Operations, PELLEPHARM

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Gerd has over 20 years of experience in drug development, operations, quality and program management in the biotech and specialty pharma industry. He currently serves as Senior Vice President and Head of Operations at PellePharm, a BridgeBio company. Prior to joining PellePharm, Gerd helped transform Depomed from a small drug delivery company to a specialty pharma company in the pain and neurology space with over $450 million in annual revenue as the executive team member overseeing the technical operations, quality and project management functions. Previously, Gerd held research and drug development management positions at FibroGen, Inc., and Gryphon Therapeutics. During his time, he led more than a dozen drug development programs ranging from early-stage research to NDA approval and multiple global drug development alliances. Gerd earned his Ph.D. in chemistry from the University of California at Berkeley. He has published more than 25 papers in peer-reviewed literature and holds multiple patents.


Simon Levett
Compliance QA, Quality, OCULAR THERAPEUTIX, INC

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Simon Levett is a Quality leader with over 15 years experience working within many Pharma/biotech areas. Currently at Ocular Therapeutix as the Compliance QA Director, he was instrumental to the company achieving PAI success, whilst also providing oversight of various Quality functions including Supplier Quality Management. Prior to joining Ocular, he was the Head of Governance and Product Quality Performance Management at Takeda (Shire). Joining Takeda in 2006, the company was fully outsourced, and he was responsible for establishing the first Quality Systems including Supplier Quality. During his time at Takeda he held various roles related to Quality Systems, Compliance, Quality Governance, Post Market Surveillance and Supplier Quality Management. He began his career at GlaxoSmithKline UK, and moved into Quality and Compliance with Pfizer UK (Wyeth).


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
Quality Engineering Lead, TERUMO MEDICAL CORPORATION

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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.


Naymisha Patel
Vice President, Quality, OCULAR THERAPEUTIX

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Naymisha currently serves as Vice President of Quality at Ocular Therapeutix responsible for driving the corporate quality agenda and implementing Quality Management Systems for GXP operations. Ms. Patel has over 20 years of progressive experience in pharmaceuticals, biologics, devices, and combination products from early to late stage and commercialization. She previously held roles of increasing responsibility at Prothena Biosciences, StemCells, Inc., Geron Corporation, Nektar Therapeutics, and Johnson and Johnson. Throughout her career at various capacity, she has been responsible for all aspects of Quality and Regulatory. Ms. Patel earned a B.S. in zoology from Maharaja Sayajirao University in India, a B.A. in chemistry from California State University, East Bay, and an M.B.A. in Management from Northcentral University, Arizona.


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

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23+ years of experience in the Pharmaceutical sector with several multi-national, mid and small size organizations. Currently the Global Quality Assurance Head at Kyowa Kirin pharmaceuticals with responsibility for providing leadership and expertise in creating, implementing and managing comprehensive strategic and operational plans for all aspects of Quality. This entails development of policies and practices which foster a culture of continuous improvement and high standards of quality throughout the organization. Prior roles included Quality VP at Shire with responsibility for all quality operations, including product disposition and QA oversight of our global manufacturing network. Career began in 1996 with Merck in the Site Product QA Release group, moving into solid oral dosage and vaccine manufacturing. From 2001-2008, held various QA roles within J&J/Centocor Biologics including Global QA Technical Services, Site API/Drug Substance Product Disposition, Site QA Compliance and Validation. Following J&J, worked at Wyeth in the Corporate QA area managing regulatory inspections and implementing/optimizing quality systems, utilizing process excellence methodologies for audits, validation and global complaints. I have always maintained a positive work environment by fostering open communication and exchange of ideas while providing ongoing feedback and career coaching to all my teams. Specialties: Global biological and small molecule, Quality & Compliance leadership, deep technical background, API/DS, drug product, solid oral dosage, blow-fill-seal, aseptic processing, packaging/labeling, medical device, tech transfers, inspection hosting, quality system creation/deployment, global regulations. Also, trained and certified as an ASQ Quality Auditor and certified Six Sigma Process Excellence Green Belt.


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 20 years; Eyad completed his graduate work in organic chemistry and has a Masters of Science degree in Quality Assurance. He has worked previously for companies such as Amgen Pharmaceutical, Abbott laboratories, and others. Eyad has been at Genentech/Roche for 13 years and is currently working in external quality Emerging Market team and 50% of his time in Partnering Quality as a Principal Manager, at Genentech/Roche Eyad started his career in Compliance function as an auditor and joined External Quality in late 2008 and worked on tech transfer fill-finish projects in Germany, India, Russia and currently working on a transfer to Brazil. In addition, managing transfers and relationships for Partners in Algeria, Egypt, Serbia and Saudi Arabia. Eyad also is heavily involved in leadership development programs and has spent 7 months rotational assignment working in the merger and acquisition team at Roche.


David Vario
Vice President, Quality and Regulatory, TEDOR PHARMA INC

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David Vario is currently the Vice President of Quality and Regulatory Affairs at Tedor Pharma and has over 25 years of experience in the pharmaceutical, biotech and medical device industry. He holds an BS in Mechanical Engineering from Northeastern University and is a certified Six Sigma Green Belt. He is well-versed in Quality Assurance, Quality Management Systems, Computer System Validation and Regulatory Affairs activities related to FDA and international regulatory authorities and has held various positions with increasing responsibilities; most recently as Senior Director, Quality Systems at Lantheus Medical Imaging and Senior Director, Quality Assurance Kiniksa Pharmaceuticals.


Lisa Wyman
Vice President, Quality, ACCELERON PHARMA

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Lisa Wyman joined Acceleron in January 2019 as Vice President of Quality, bringing diverse leadership in engineering, manufacturing, and quality to the role. Previously Lisa was at Shire where she assumed global roles with increased responsibility leading 30 plus pipeline development programs from pre-clinical to launch and lifecycle management of 40 plus commercial assets.

Lisa is an accomplished leader who has a strong history of transforming programs, improving regulatory compliance, and driving exponential growth. Recognized as an expert in the industry, she has been honored with an Engineering Leader award by Plant Engineering, Mentor of the Year Award for Advancement of Women in Compliance, and was a 2016 Boston Business Journal Top 40 Under 40 award recipient.

Lisa received her Bachelors of Science from Ithaca College and her Masters Degree in Engineering Management from Tufts University.


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