4th Technology Transfer for Biologics -

4th Technology Transfer for Biologics
October 16 - 17, 2017
Boston, MA

Maximizing Quality Control in Technology, Facilities and Project Management as You Transfer and Scale Up Bioprocessing for New Molecules and Markets

Faculty – 4th Technology Transfer for Biologics


Robert Beall
Director, Product Lifecycle Management, PROPHARMA GROUP

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Robert W. Beall, PMP, AD, ProPharma Group has 30 years of industry experience working with products in both the consumer goods and pharmaceutical arenas. He has led international product transfers utilizing both internal company transfers and CMOs at Boehringer Ingelheim, Biogen and Bayer HealthCare LLC. Robert developed a technology transfer process for implementation and monitoring the program. He is currently leading creation of ISPE’s Process Validation Good Practice Guide. He is a graduate of the Rochester Institute of Technology (RIT) with a B.S. in engineering and has completed advanced degree studies at Syracuse University, University of Michigan and The Ohio State University, as well as completing his PMP certification. He is an international speaker/author for multiple industry forums.


Jose Caraballo
Director of Quality, Product Quality Steward, Product Supply Biotech, BAYER

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Jose Caraballo is Director of Global Quality, Product Quality Steward, Product Supply Biotech at Bayer U.S., where he is responsible for end-to-end product quality oversight for Hematology products. He serves as quality and technical expert on strategic projects related to technology transfers and the expansion of biotech manufacturing capabilities. Prior to joining Bayer, Caraballo had roles at Amgen and Abbott Laboratories in manufacturing, development, and quality.


Kumar Dhanasekharan
Senior Director and Head, Biologics Process and Analytical Development, AMICUS THERAPEUTICS

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Dr. Dhanasekharan is Senior Director of Process and Analytical Development at Amicus Therapeutics responsible for late stage development and scale-up of biologics. He is currently heading the development for the lead enzyme replacement therapy program ATB200. Previously, he was responsible for process and analytical development at Cook Pharmica, a contract and development organization (CDMO) in Bloomington, Indiana. Previously, he was at Genzyme-Sanofi in various roles including process development, process engineering and was Associate Director of Process Sciences and Technology at Genzyme in Framingham, Massachusetts. He was responsible for continuous process improvements and process monitoring and Continued Process Verification (CPV) program in driving a science and risk-based strategy including improved control strategies, cell culture productivity, and downstream recovery improvements. In a previous role, he led the implementation of Quality by Design (QbD) principles in development and successfully led a QbD based Lyophilization scale-up and tech. transfer project for approval. He also led efforts in viral risk mitigation which resulted in an invention and patent on a UV-C based viral inactivation device. He also provided technical leadership for several projects related to Consent Decree remediation. Prior to joining Genzyme, Kumar led small-molecule process development focused on API crystallization at Bend Research Inc., Bend, OR. Prior to that he was group leader for consulting services at Fluent Inc. (Now ANSYS Inc.) with a focus on both small-molecule and biologics development and manufacturing challenges across upstream, downstream, and Fill/ Finish operations. Kumar has a Ph.D. in Food Science from Rutgers University and a Bachelor’s in Chemical Engineering from Indian Institute of Technology, Chennai, India. He has over 50 conference presentations and over 10 peer-reviewed publications.


Adam Elhofy
CSO, BIO-ESS LABORATORIES

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Dr. Adam Elhofy is the Chief Science Officer at Bio-Ess Laboratories, LLC. Dr. Elhofy developed the core technology for the Ess line of products and aided in creating patents around novel uses of materials. He has over 14 years of scientific research experience in the areas of immunology, neuroscience, and oncology. He was funded by both the National Institutes of Health and the Multiple Sclerosis society as an investigator at Northwestern University Medical School. His doctoral research won him the award of the Top 5 trainee scientists by the American Association of Immunologists. Dr. Elhofy has 14 scientific publications in peer reviewed journals. He has played a variety of roles with start-up biotech companies ranging from Principal Investigator to Director of Corporate Development.


Steven Ferguson
Special Advisor, NIH OFFICE OF TECHNOLOGY TRANSFER

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Steven M. Ferguson currently serves as Special Advisor for Technology Transfer for the NIH Office of Technology Transfer where he has worked since 1990. The biomedical technology transfer program at NIH is one of the world’s largest with a portfolio that includes about 1300 active licenses, 400 of which report product sales in aggregate greater than $6B per year.

A former chemist at the National Cancer Institute and biotech industry product manager, Mr. Ferguson holds Master’s Degrees in Business Administration (George Washington University) and Chemistry (University of Cincinnati) as well as Bachelor’s Degree in Chemistry (Case Western Reserve University).

A registered Patent Agent and a Certified Licensing Professional (CLP), Mr. Ferguson is faculty and Technology Transfer Department Chair at the Foundation for Advanced Education in the Sciences (FAES) Graduate School at NIH and the Biotechnology Industry Organization “BIO Boot Camp” along with being an Executive-in-Residence at the Johns Hopkins University Cary School of Business.

He has received the AUTM President’s Award (AUTM Band), the NIH Director’s Award, the FAES Instruction Award, three “Deal of Distinction” awards from the Licensing Executive Society, six Federal Laboratory Consortium Awards, and fifteen NIH Merit Awards in recognition of his service and activities in the area of technology transfer.


John Herberger
Chief of Staff, New Product Introductions (API), AMGEN

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Mr. John Herberger is currently Director of Process Development at Amgen Inc. Mr. Herberger joined Amgen in 1997 and has held numerous leadership roles in Drug Delivery/Formulation, Device Development, Technology Transfer (Drug Product & Drug Substance) and Global Operations. With over 25 years of diverse experience in biotechnology and drug delivery he thrives on complex technical and managerial challenges. In his 16 years at Amgen John has demonstrated expertise in leading geographically diverse cross functional teams, and developing strategy for new technologies as well as commercialized products. He serves on the University of Rhode Island College of Environmental & Life Sciences Dean’s Advisory Council; and Bio Science Leaders Forum.
Prior to joining Amgen, John was a Research Scientist at Alkermes Inc., where he contributed to the development of novel drug delivery systems and authored several publications and patents in the field. John started his career at the Institute of Molecular Biology where he was a founding member of this start-up Biotech Company which was working to develop soft tissue, bone and nerve regeneration therapies. John relocated from southern California in 2011 to East Greenwich, RI with his wife Caroline and their 5 children. He enjoys cycling, SUP, coaching youth sports and supporting URI rowing.


Seth Kitchener
Associate Director, Cell Line and Upstream Process Engineering, IMMUNOGEN

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Seth Kitchener is the Associate Director of the Cell Line and Upstream Engineering department focused on development and implementation of cell lines and upstream processes for GMP production of antibodies for ImmunoGen’s Antibody Drug Conjugates (ADCs). Seth joined ImmunoGen in 2011 with nine years of experience in development and GMP support at Regeneron Pharmaceuticals and Sanofi (Genzyme). He holds a B.S. in Chemical Engineering from the University of Massachusetts, Amherst. Since joining ImmunoGen, Seth has worked towards the establishment and advancement of ImmunoGen’s antibody production platform including cell line, media, upstream, and harvest manufacturing processes and subsequent support for transfer, scale-up and GMP manufacturing.


Suresh Nulu
Senior Engineer II, BIOGEN

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Suresh Nulu is a Sr. Engineer within the Drug Product, Engineering and Technology Organization in Biogen Inc. He has over 10 years of experience in applying Computational Fluid Dynamics and other first principle models to Biopharmaceutical processes and equipment. At Biogen, he develops and implements fit –for-purpose models to ensure rapid and efficient Drug Product development and tech transfers. He passionately advocates for the use of high fidelity models across all aspects of biopharmaceutical processing, to ease resource and fiscal burdens on organizations.


Pankaj Paranjpe
Director of Biologics Manufacturing-Drug Product, CELGENE

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Pankaj Paranjpe is currently Director of Biologics Manufacturing-Drug Product at Celgene in Summit, NJ. Prior to Celgene, Pankaj was at Bristol-Myers Squibb Company for nearly a decade and held various positions in sterile product development, tech transfer, and manufacturing technology. Pankaj holds degrees in Pharmaceutical Sciences and his areas of interest include Sterile/Biologics drug product manufacturing, tech transfer, and commercialization.


Adnan Sabir
QA Associate Director, 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.


Nick Vrolijk
Vice President, Manufacturing Operations, CELLDEX THERAPEUTICS

Emily Xiao
Scientist, BRD Formulation & Stability Platform, SANOFI PASTEUR

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Emily Xiao is a process development scientist at Sanofi Pasteur. She is responsible for a bioprocess design and scale-up for vaccine formulations. She focuses on process definition, process scale up and technology transfer from lab scale to scale up and from non-GMP process to GMP clinical manufacture. She also had a lot of experience with designing single use technology (SUT) and integrating process analytical technology (PAT) to the process scale up. Several of the projects she has been involved with have completed technology transfer successfully from non-GMP to GMP clinical manufacture.


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