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Sheng |
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Cui |
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Executive Director CMC |
Boston Pharmaceuticals |
https://proventainternational.com/wp-content/uploads/2020/02/Cui-Sheng-Boston-Pharmaceuticals-CMC.jpeg |
Session – Selecting the right route to ensure fast development and scale-up across all the project phases and supporting the API projects requirements
Cui Sheng is a CMC pharmaceutical development leader with extensive experience in advancing synthetic drug candidates from discovery to commercialization with major contribution/leadership roles on numerous IND, INDa, NDA and major post-approval variations for Boston Pharmaceuticals. Cui Sheng has a proven track record of driving innovation while balancing strategic development considerations to align innovation with business objectives and maximize the value of innovation. With demonstrated success in partnering with CROs and CMOs for process development, innovation, supply and continuous improvement.
Cui Sheng received his Bachelor’s degree in Chemistry from Nankai University and his PhD in Chemistry from Case Western Reserve University. Notably, Cui Sheng has 19 publications in the CMC sector as well as 5 patents. |
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Stan |
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Russell |
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Former Vice President, Quality |
TCR2 Therapeutics Inc. |
https://proventainternational.com/wp-content/uploads/2020/01/Stan-Russel.jpg |
Stan Russell is a 30+ year Life Sciences veteran, working in Engineering, Manufacturing, Quality, Supply Chain, and IT. He has advanced formulations, technologies, and therapeutic areas from discovery through commercial production; playing critical roles in submission, approval, and launch of therapies, diagnostics, and nutritionals. His career progression includes individual contributor roles at Abbott Laboratories and management to executive positions with Automated Systems, Baxter/Baxalta/Shire, Alexion, Sebela, and TCR2.Stan serves on the board of Playworks and will soon take a short-term missionary trip supporting Children’s Impact Network in Honduras. He holds both BSChemical Engineering and Executive MBA degrees from Northwestern University |
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Qinghai |
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Zhao |
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VP Technical Development and Manufacturing (Chemistry Manufacturing Controls) |
Forty Seven Inc. |
https://proventainternational.com/wp-content/uploads/2020/02/Qinghai-Zhao-Forty-Seven-Inc.jpeg |
Session – Early stage CMC development strategy to speed IND
Qinghai Zhao, PhD VP Technical Development & Manufacturing Qinghai has over 25 years of experience in biological CMC development and manufacturing and is the company’s Vice President of Technical Development and Manufacturing. Prior to Forty Seven, he was Vice President of CMC/Manufacturing at AnaptysBio. Prior to that, he held various CMC leader positions including Head of CMC at NGM Biopharmaceuticals, Director of CMC Management at Teva Biologicals USA and Associate Director of Process Development at Cogenesys. Qinghai has extensive knowledge of all biological CMC functions with executive experience of developing CMC strategy from early stage to late-stage for commercialization. Prior to Cogenesys, he was a Sr. Scientist of Lead Development at Human Genome Sciences and a Research Fellow at National Institute of Health and Georgetown University Lombardi Cancer Center.
Qinghai received his PhD for Biomedical Research at Uppsala University, Sweden. |
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Nick |
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Dunwoody |
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Vice President, CMC |
Tetraphase Pharmaceuticals, Inc. |
https://proventainternational.com/wp-content/uploads/2020/01/Nick-Dunwoody-e1590593926200.jpeg |
Session – How to ensure clarity and communication of goals and expectations for successful technology transfer during drug development with your CDMO
Nicholas Dunwoody has served as Vice President, CMC at Tetraphase Pharmaceuticals since April 2015, responsible for all CMC functional areas including clinical supply chain. Dr. Dunwoody joined Tetraphase in June 2008, and in his tenure has held various positions in Analytical Chemistry and Formulation Sciences. Prior to joining Tetraphase, Dr. Dunwoody served as Director of Analytical Chemistry and Pharmaceutical Services at Nucryst Pharmaceuticals, Inc. from 2004-2008. Dr. Dunwoody began his professional career as an investigator at Vertex Pharmaceuticals, from 2000-2004. Notable achievements in his career include the development of 14 small molecule products, one biologic pharmaceutical product and a series of nano-materials in pharmaceutical and medical device applications. Dr. Dunwoody has been pivotal in the development of Tetraphase’s first commercial product, XERAVATM (eravacycline for injection), launched in September 2018 for the treatment of complicated intra-abdominal infections (cIAI). |
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James |
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Stahl |
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Senior Director (Chemistry Manufacturing Controls) |
Promedior |
https://proventainternational.com/wp-content/uploads/2020/01/James-Stahl-1.jpg |
Session – Development and Transfer of Analytical Assays for Polysorbate Excipients in your Drug Product
I have lead Analytical Development activities at Promedior since 2013. Responsibilities include person-in-plant activities for manufacturing, QC release of drug substance/product, overseeing project management for drug development, writing/maintaining sections of CMC submissions to Agencies; developing, validating, troubleshooting assays and managing testing; maintaining release and stability programs at contract laboratories; conducting experiments to evaluate critical quality attributes; and developing new/improved formulations for the drug. In 2012, I was the Laboratory Director at Blue Stream Laboratories. From 1999 – 2011, I worked at Stryker Biotech, first as a Scientist and from 2005 as Head of Analytical Development
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Art |
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Faulkner |
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Vice President, Regulatory CMC |
TG Therapeutics, Inc. |
https://proventainternational.com/wp-content/uploads/2020/01/Art-Faulkner-new2.jpg |
Session – Strategies to manage differing country-specific requirements for submissions
Art Faulkner has worked in the pharmaceutical industry for over 30 years, with more than 20 years experience in regulatory CMC. He is currently the head of regulatory CMC at TG Therapeutics in New York. He has also worked at Edge Therapeutics, Pfizer and worked at Merck He has global experience in Regulatory CMC for initial registrations and post approval changes. He attended University of Scranton (B.S), Bucknell University (M.S.) and Rutgers University (graduate coursework). |
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Fernando |
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Aleman |
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Founder and CSO |
Navega Therapeutics |
https://proventainternational.com/wp-content/uploads/2020/04/Fernando-Aleman.jpg |
Fernando Aleman obtained his PharmD at University of Granada and his PhD at University of Murcia, both in Spain. He then performed postdoctoral studies at the University of California San Diego and the Scripps Research Institute in molecular biology, transcription factors and immunology. Dr. Aleman is the co-founder, president and current Chief Scientific Officer of Navega Therapeutics where he has secured more than $8M in non-dilutive funding. He leverages his pharmaceutical, research and industry background to provide medical oversight and strategic direction for all development activities, define regulatory strategy and business development activities, and serves as the pharmaceutical point of contact for external stakeholders.
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Daniela |
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Drago |
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Senior Director Regulatory Sciences |
Biogen |
https://proventainternational.com/wp-content/uploads/2020/04/Daniela-Drago_Headshot-1.jpg |
Session – Regulatory Challenges and Opportunities for the Global Development of Gene Therapies
Daniela Drago, Ph.D., RAC is Senior Director Regulatory Sciences at Biogen. Prior to joining Biogen, she has held senior positions in global regulatory and medical affairs at F. Hoffman-La Roche, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb. During her career, she was an Associate Professor at George Washington University’s School of Medicine and served as a Premier Consultant at NDA Partners. Daniela has significant global experience in the development of small molecules, biologics, and gene therapies in rare and common disease areas, including oncology, ophthalmology, and neuroscience. She received the TOPRA Award for Regulatory Excellence and the RAPS Community Leadership Award. She serves on the Regulatory Affairs Certification Board, is the former Chair of the RAPS DC/Baltimore Chapter, and is a member of the Advisory Council to the TOPRA Board of Directors.
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Daniel |
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Hogan |
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Associate Director Tech Transfer and Manufacturing |
Portola Pharmaceuticals |
https://proventainternational.com/wp-content/uploads/2020/04/Daniel-Hogan.jpg |
Session – How to generate value for clinical stage companies with CMC strategy for commercial readiness
Daniel Hogan is a formulation and tech transfer scientist with over 20 years experience working for a wide range of companies and a broad collection of products and dosage forms. He has brought products over the counter and prescription products to the market using his comprehensive knowledge of pharmaceutical manufacturing processes. Daniel has an extensive background in validation and product life cycle management having been responsible for managing a multitude of products from ideation, through launch and sustainability. |
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Alex |
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Goraltchouk |
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Vice President, Operations |
Anika Therapeutics |
https://proventainternational.com/wp-content/uploads/2020/03/Alex-Goraltchouk.jpeg |
Session – Using “one-stop-shop” CDMOs compared to using providers best suited for each step of the process – advantages and disadvantages
Alex Goraltchouk joined Anika Therapeutics, Inc. as Vice President of Operations on June 11, 2018. Most recently, Mr. Goraltchouk served as Vice President of Operations at Avedro, Inc. where he was responsible for managing all aspects of Clinical and Commercial Production, Technical Operations, Procurement, and Supply Chain Management for the organization. Prior to his work at Avedro, Alex held senior leadership roles in Operations, Supply Chain Management, and R&D for several firms including Allergan, Inc., Regeneron, Inc., and Biogen, Inc.
Mr. Goraltchouk holds a B.S. in Materials Engineering and an M.S. in Chemical Engineering from the University of Toronto, as well as an M.B.A. and M.S. in Finance from Indiana University. He is a Cornell Certified Six Sigma Black Belt and holds professional certifications from Stanford University (Genetics and Genomics), Massachusetts Institute of Technology (Supply Chain Management), and the Project Management Institute (Project Management Professional). |
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Cecile |
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Riboud |
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Senior Director Europe |
IQVIA Integrated Global Compliance (Regulatory, Safety and Quality) |
https://proventainternational.com/wp-content/uploads/2020/05/Cecile-Riboud-Headshot-cropped-Sept-30-19.png |
Session – Ensuring Business Continuity during Mergers & Acquisitions, Divestments and Portfolio Swaps
Cecile is currently responsible for IQVIA’s Global Integrated Technology and Compliance Solutions in
Europe, including regulatory, safety/pharmacovigilance and quality compliance. She has over 17 years of
life sciences experience across Scientific Information Management, Global Regulatory Affairs, Mergers
and Acquisitions and Product Development. Having worked for large pharmaceutical groups and
companies of all sizes in Europe, Cecile has an excellent understanding of the pharmaceutical and MD-
IVD industry. She has held global management leadership positions leading large international
programs, projects and teams of experts. Prior to joining IQVIA, Cecile worked at a well-known
regulatory consulting firm in Germany, where she served as acting deputy head of an office totaling 60
international consultants and led global project regulatory activities involving 70 consultants worldwide.
She was responsible for client delivery and was actively involved in Business Development. Cecile holds a
M.Sc. in Analytical Sciences from the University of Strasbourg, France and an Executive MBA from
EMLyon Business School, France – Shanghai, China. |
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Lisa |
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Kelsey |
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Head of Commercial Labelling |
Genentech |
https://proventainternational.com/wp-content/uploads/2020/04/Lisa-Kelsey.jpg |
Session – Regulatory Partnerships on Human Factor/BLA/NDA Labeling
Lisa M. Kelsey, M.A, LMFT is the Head, Commercial Labeling, Associate Group Director at Genentech. She received her Bachelor of Arts in Psychology, May 1997 at San Francisco State University, and her Master of Arts in Psychology, May 2001 from College of Notre Dame in Belmont. She became licensed as a Marital Family Therapist, May 2011 and has a thriving private practice in Burlingame, California.
She has 20 years regulatory experience and became Head of Commercial Labeling group in 2015. Her group consists of 9 hard working, dedicated members that she manages directly. In her role she enjoys collaboration, coaching, and partnering with her team to grow, learn, lead and broaden their visibility throughout the organization. The team focuses on the commercial printed labeling for product launches, human factor studies and maintenance of labeling changes for the full US portfolio. She prides herself in both careers and helping patients and clients on a daily basis. |
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Karin |
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McIntosh |
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Executive Director |
Stemline Therapeutics |
https://proventainternational.com/wp-content/uploads/2020/01/Karin-McIntosh.jpg |
Session – Implementing change control in a newly commericalised company
Karin McIntosh is a Regulatory CMC Executive Director for Stemline Therapeutics Inc. with a Master of Pharmacy and 15 years of pharmaceutical industry experience including 12 years within Regulatory Chemistry, Manufacturing & Controls. Proven track record of high-quality submissions for EU, US and global markets covering pre-approval (clinical), initial registrations and post-marketing for small molecules, large molecules (biologics) and combination products. |
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Marcel |
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J. Velterop |
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President – Drug Discovery Services & CDMO |
Jubilant Biosys Limited |
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Session – Difficulties in Development
Marcel J. Velterop, as President Drug Discovery Services & CDMO will lead Jubilant Drug Discovery Services and Contract Development & Manufacturing Organisation (CDMO) to provide an integrated solution to our life science customers from drug development to scale-up and then commercial manufacturing designed for maximum speed and compliance.
Marcel brings over 25 years of business, pharmaceutical & CDMO experience and leadership to JDDS. He is a chemical engineering graduate from Delft University of Technology and has an in-house DSM course in business management from Rotterdam School of Management. He started his career with DSM in 1989 where he held various roles in Marketing, Logistics, Sales, Product Management & Strategy Development. He has also been associated with Dr Reddy’s where he held Senior Leadership roles for Europe, Japan & North America. In a career spanning almost three decades, Marcel has had rich experience across diverse businesses and global markets. |
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Roger |
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McDonald |
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Business Development – CMC services |
MercachemSyncom |
https://proventainternational.com/wp-content/uploads/2020/05/Image-e1590156328271.jpeg |
Session: Intermediates & API – Appropriate Development: why, what and when…
Roger has 30 years’ experience in business development in API CDMOs. He was a founding director of a Hungarian CDMO, spent 10 years with Cambridge Major Laboratories and joined Syncom as a consultant in 2017. In 2020 following the acquisition of the former Alcami development operations in Weert, The Netherlands, he has now rejoined old colleagues in the newly formed MercachemSyncom organisation |
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Jim |
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Stout |
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VP CMC |
Shattuck Labs |
https://proventainternational.com/wp-content/uploads/2020/02/jimstout1_resized.jpg |
Session – Mitigating risks associated with API suppliers
Jim Stout has over 25 years of experience in biopharmaceutical process development, manufacturing sciences, and technology with large biopharmaceutical and smaller biotechnology companies and is currently working for Shattuck Labs. He has utilized all the tools gained from the advanced training to enter into biopharmaceutical process development and manufacturing, where he started at Alexion Pharmaceuticals and continued advancing bioprocess and people leadership at Medarex, Inc.; Abbott Bioresearch Center; Amgen; Shire HGT; Immunogen; Natrix Separations, Inc./EMD Millipore_Sigma; HOST Therabiomics, Inc.; and BioVectra, Inc./Mallinckrodt Pharmaceuticals. Jim managed many different recombinant protein programs at various stages from Research, all Clinical Phases, and Commercial and was privileged to contribute to the advancement of commercial Humira® and Enbrel®.
He received his B.S. in Chemistry from Denison University and a PhD in Biochemistry (with a minor in Analytical Chemistry) from the University of Cincinnati. Jim extended his education in protein chemistry and separation science with an NIH post-doctoral Fellowship at the University of Cincinnati College of Medicine in the Department of Pharmacology & Cell Biophysics (mostly working with animal-derived membrane proteins from tissues) and further expanded his knowledge/ experience at the Blood Research Institute, The Blood Center of Southeastern Wisconsin, in the Department of Immunochemistry (working on human systems, Red Blood Cells and membrane proteins). |
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Dean |
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Edney |
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Head of Process Research & Development (API) |
Sai Life Sciences Ltd |
https://proventainternational.com/wp-content/uploads/2020/03/Dean-Edney-Sai-Life-Sciences-scaled.jpg |
Session – CMC Complexities & Challenges in Drug Development
Dean Edney is an accomplished scientific leader with over 25 years of experience in small molecule pharmaceutical process and product development. He joined Sai Life Sciences as the Global Head of Process R&D in January 2020 with a mandate to enhance the organization’s process research & development capability, across the UK and India, allowing its customers to accelerate their research and development programs through the rapid application of high quality science to all areas of API process research, development and manufacturing. Throughout his previous career at GlaxoSmithKline Dean demonstrated a strong track record of cross-functional leadership to deliver projects and develop capability across all phases of API process research & development, from early non-clinical supply and route scouting through to validation of commercial control strategies. He also has experience of developing both inhaled and oral solid dose
pharmaceutical products including physicochemical developability criteria; the importance and control of physical properties and the regulatory requirements at each phase of development.
Dean received his BSc in Chemistry and Ph.D. in Synthetic Organic Chemistry from the University of Nottingham, UK.
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Praveen |
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Prasanna |
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Senior Director Technical Operations |
AVEO Oncology |
https://proventainternational.com/wp-content/uploads/2020/02/Career-Source-Headshots-0051RESIZED.jpg |
Session – Preparation and Process Validation Practices for Drug Product Development & Manufacturing and Concerns Surrounding Outsourcing Partners
Praveen Prasanna is currently Senior Director and Head of Biologics Development and Manufacturing at AVEO Oncology. He is responsible for the development of AVEO’s biologics pipeline including Ficlatuzumab and AV-380. Praveen previously worked at ImmunoGen as Director, External Manufacturing and Supply Chain and Shire as Associate Director and Principal Engineer. Praveen facilitated the process transfer, validation, routine manufacturing initiation for four commercial products including liquid vials, lyophilized vials, and pre-filled syringes. Praveen is active in the Parenteral Drug Association and was a co-author of Technical Report 60. His interests are phase appropriate QbD implementation and external manufacturing best practices.
Praveen Prasanna received his Bachelors and Masters of Engineering from McGill University and his PhD in Chemical Engineering from Tufts University. |
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Branden |
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Lee |
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Director Business Development |
Birdotech |
https://proventainternational.com/wp-content/uploads/2020/05/Branden-Lee-scaled.jpg |
Session – It is not enough to have the best chemistry – working well with upstream and downstream partners makes for seamless collaboration.
Branden Lee started his career as a medicinal chemist with companies like Pfizer, Celgene, and couple of start-up biotech. After working a string of high profile therapeutic targets, a few entered the clinic. In his words, drug discovery is an indescribable thrill of building up the SAR, clearing the tox hurdles, and declaring the drug candidates. More recently, he has taken up project management and CMC responsibilities working with CRO. Throughout his experiences, he finds that high quality work, and on-time delivery are the two most important deliverables. While projects may be shelved for a variety of reasons, waking up every day and doing the best he can on the two area he can control is why he enjoys his work |
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Theodore |
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Martinot |
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Head of Chemical Development |
Infinity Pharmaceuticals |
https://proventainternational.com/wp-content/uploads/2020/02/Theodore-Martinot-CMC.jpeg |
Session – Maximising the value and impact of a technology transfer package by facilitating the interplay between data, its integration into the knowledge base, decision making based on said knowledge based and ensuring data integrity
Theodore Martinot is a scientific innovator, skilled problem-solver, synthetic organic chemist, and CMC professional from Infinity Pharmaceutical. Demonstrated success in methodology development, total synthesis of natural products and complex pharmaceutical targets. Theodore Martinot has fostered direct interaction with regulatory agencies and authored multiple regulatory filings, from IND to NDA | Leader in Quality by Design (QbD) by implementing a Design of Experiments (DoE) approach to projects in all stages of development. He is an innovator for the Laboratory of the Future (LotF) through the deliberate application of automation and data capture, driving efficiency improvements and progress via knowledge infrastructure (Lab Equipment Integration, Data-Rich Experimentation, etc.).
Theodore Martinot received his Bachelor’s of Science in Chemistry and PhD in Organic Chemistry from the University of Florida.
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Yuyi |
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Shen |
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Vice President, Technical Operations |
Abcuro,Inc. |
https://proventainternational.com/wp-content/uploads/2020/04/Yuyi-Shen.jpg |
Yuyi Shen is an inspirational CMC thought leader with management experience in biopharmaceutical development, manufacturing, and clinical supply chain. She is an accomplished program leader in the early to late phase development and commercialization of a wide range of recombinant proteins for immuno-oncology, infectious and rare disease drug platforms. She brings extensive expertise in CDMO selection and oversight, facility/team build- out, technology transfer, budget planning, partner collaboration, and CMC strategic direction of global regulatory filings. She is also an industry-recognized innovation-driven CMC expert on disruptive technology implementation, including process modeling, to deliver with high efficiency and better quality under an accelerated timeline.
She served various leadership roles in CMC at large pharma to emerging biotech companies, including Bolt, XOMA, Bayer, BioMarin, and Grifols. She holds a Ph.D. degree in Chemical Engineering from the University of California, Davis. |
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Angela |
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Johnson |
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Senior Director Regulatory Affairs |
Sigilon Therapeutics, Inc. |
https://proventainternational.com/wp-content/uploads/2020/04/Angela-N.-Johnson.jpg |
Session – Drug-Device Combination Treatments & Diagnostics
Angela N. Johnson, MSE, PMP, RAC, is the Senior Director Regulatory Affairs at Sigilon Therapeutics, and previously held roles as Director of Regulatory Strategy at IQVIA (Quintiles) and Senior Manager of Global Clinical Affairs Operations at GE Healthcare. Angela has over 20 years of global regulatory strategy and clinical development experience in a novel drug delivery devices, diagnostics, digital therapeutics, and combination biologic products— with expertise in new technologies that challenge traditional regulatory frameworks. She is affiliated with Texas Tech University’s communication research program with multiple peer-reviewed publications in regulatory strategy, and has authored multiple chapters on medical devices and advanced therapies for the best-selling Regulatory Affair Professionals Society (RAPS) Fundamentals textbook series. |
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Ramzan |
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Tabasum |
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Head of manufacturing quality |
CSL Behring |
https://proventainternational.com/wp-content/uploads/2020/05/Ramzan-Tabasum-e1590476016707.jpg |
Session – Green/Brown fields – managing quality, regulatory and supply chain aspects for chemical raw materials and consumables during tech transfer
Ramzan Tabasum is an executive in manufacturing/operation and quality is contributing in improving the quality of lives of fellow humans. He is convinced that people are valuable assets to the success of any mission/objective. He has a proven track record of practicing emotional intelligence, tact and diplomacy to achieve organizational goals. He is multilingual and has 15 years of management experience in cross-functional and multicultural teams at top pharma/biotech companies. He has worked in a variety of roles from product/process development, quality compliance, supply chain and production management. He is specialized in green/brown field and tech transfer projects, procedures harmonization following merger and acquisition, and audits and quality compliance. |
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Subhadip |
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Jana |
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Emerging Market Regulatory Lead, Global Regulatory Affairs |
Takeda Pharmaceutical Company |
https://proventainternational.com/wp-content/uploads/2020/05/Subhadip-Jana-scaled.jpg |
Session – Development to Registration – challenges for Regulatory Affairs in global environments
Subhadip Jana is a regulatory affairs leader with extensive experience in global regulatory strategy, planning and successful market access. He has proven expertise in managing complex Health Authority interactions; providing registration strategy for global products; improving regulatory process and compliance, and leading global submissions (NDA, MAA, BLA, IND, Briefing Books etc.). He led regulatory affairs in many cross-functional activities related to regulatory strategy, stakeholder communication, submission documents, regulatory compliance and collaboration with teams from early drug development to post-approval for compounds in Oncology, Gastroenterology, CNS therapeutic areas. He is passionate about improving the life of patients |
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Weijun |
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Li |
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Director, Analytical Development and Quality Control |
Allakos Inc. |
https://proventainternational.com/wp-content/uploads/2020/05/Weijun-Li.jpg |
Session – Knowledge based CQA assessment for BLA submission
Dr. Weijun Li has more than 15 years’ experience in biological research, development, and product manufacturing. He is the Director, Analytical Development and Quality Control at Allakos Inc., a bay area company that is developing antibody therapeutics. Previously, he held various roles in analytical development and commercial QC functions at Bayer and contributed to the approval of Kovaltry® and JIVI®. He holds a Ph.D. in Chemical Technology from Chinese Academy of Sciences and completed postdoctoral training in drug and gene delivery at UCSF |
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Trey |
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Putnam |
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Vice President, Regulatory Affairs and CMC |
FAST BioMedical, Inc. |
https://proventainternational.com/wp-content/uploads/2020/05/Trey-Putnam-headshot-e1590593856816.png |
Dr. Putnam is Vice President of Regulatory Affairs and CMC for FAST BioMedical, Inc where he is responsible for all aspects of chemistry, manufacturing and controls and regulatory affairs. Previous to FAST BioMedical, Dr. Putnam served as the general manager for Cardinal Health’s Scientific and Regulatory Consulting Division (Cardinal Health Regulatory Sciences) where he was responsible for strategic, managerial, and operational aspects of the business. Dr. Putnam also has an appointment at Texas Tech University Health Sciences Center’s School of Pharmacy. Dr. Putnam holds MS and PhD degrees in Organic Chemistry from Washington University in St. Louis. |
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Van |
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Leang |
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Sr. Director Global CMC Operations |
HJB Bio |
https://proventainternational.com/wp-content/uploads/2020/05/Van-Leang.jpg |
Session – Implementation of Continuous Upstream and Downstream Operations in Clinical Manufacturing
Van Leang is a Sr Director of Global CMC Operations at HJB Bio, a biologics CDMO. Our company’s mission is to employ cutting-edge technology to reduce cost and timeline for clients as they look to develop, manufacture, and deliver their therapeutic to patients. As Sr Director of Global CMC Operations, Van is responsible for overseeing the entire CMC process to ensure the development, manufacturing, and testing activities meet the client’s timeline. Prior to the current role, Van was head of Purification Process Development group at HJB |
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Arul |
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Joseph |
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Senior Director, Pharmaceutical Development and Clinical Supply Chain |
Avanir Pharmaceuticals |
https://proventainternational.com/wp-content/uploads/2020/05/Arul-Joseph.jpg |
Session – Lifecycle Approach to Process Validation
Arul Joseph leads the Pharmaceutical Development and Clinical Supply Chain function at Avanir Pharmaceuticals. He has about 15 years of experience in chemistry, manufacturing, and controls (CMC) and has held roles of increasing responsibility at Gilead Sciences, Merck, and Schering Plough. Before joining the pharmaceutical industry, he conducted postdoctoral research at the Scripps Research Institute in La Jolla, CA. Arul earned his PhD in Organic Chemistry from the University of Maryland in College Park, MD, and an MBA in Strategy and Finance from New York University’s Stern School of Business in New York, NY |
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