Jan 29 – Jan 31, 2019
Boston, MA

2019 Confirmed Speakers

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David Cho
Senior Advisor
FDA

David Cho, Ph.D., M.P.H., is a Senior Advisor for Counterterrorism and Medical Countermeasures within the Office of the Director in the Center for Biologics Evaluation and Research (CBER) at FDA.  His duties include advising on potential and emerging policy issues, formulating appropriate program responses in support of new initiatives, and guiding overall CBER operations regarding emerging threat preparedness and emergency response activities.  In addition, he is also responsible for coordination of emerging technologies for CBER.  Prior to joining CBER, he was an influenza program officer within the Division of Microbiology and Infectious Diseases (DMID) in the National Institute of Allergy and Infectious Disease (NIAID) at NIH.  Previously, Dr. Cho was a post-doctorate fellow in the Influenza Branch at the Centers for Disease Control and Prevention in Atlanta, GA., and he received his Ph.D. and M.P.H. through the School of Public Health at the University of Michigan.

Day One

Wednesday January 30, 2019

08:35 | Opening Address: FDA’s CBER’s Advanced Manufacturing Initiative

Giustino Di Pretoro
Associate Director – Continuous Manufacturing
Johnson & Johnson

Giustino Di Pretoro is an Associate Director at Janssen Pharmaceutica, a Johnson & Johnson Company. Dr. Di Pretoro is a subject matter expert and drug product development lead for continuous manufacturing, and coordinator for a series of academic collaborations within the field. Before joining Johnson & Johnson, Giustino was Team Leader and Principal Scientist at Novo Nordisk AS (DK), where he was heading a formulation team focusing on oral delivery of biomolecules, and prior as R&D and Business Development Manager for a Swiss CMO, focussing on novel technologies for particle size reduction and solubility improvement of class II BCS drugs. Giustino’s main area of research is oral solid formulation of small- and bio-molecules, novel drug delivery systems and pharmaceutical development.   Giustino holds a Ph.D. in Pharmaceutical Technology and Msc. in Industrial Pharmacy, from the University of Milan (I). Within his Ph.D. he worked as Research Scientist at the University of Cambridge (UK) in the Chemical Engineering and Biotechnology department, and later as visiting postdoc in Pharmaceutical Technology at the University of Düsseldorf (DE).  

Day One

Wednesday January 30, 2019

09:30 | Case Study: Janssen's Success Story in Implementing Continuous Manufacturing

Sujit Jain
Group Leader, Downstream Process Development & Technology
Shire

Sujit Jain is currently a group leader/Sr Engineer II in Downstream Process Development at Shire. He currently leads a team that is responsible for technology development, early and late stage downstream process development for biologics. In technology development his team is focussing on continuous biomanufacturing, PAT, in-process analytics, and mechanistic modelling. Prior to joining Shire, Sujit has worked at leading biotech and pharmaceutical companies, including Genzyme, Lonza and Merrimack in Process Development and Manufacturing Science functions. He has a Masters in Chemical Engineering and Graduate certificate in Biotechnology Bioprocessing from University of Massachusetts.

Douglas B. Hausner
Associate Director
Rutgers University/C-SOPS

Doug is currently the Associate Director of the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) based at Rutgers University in New Jersey, USA. C-SOPS focuses on the science based development of pharmaceutical products and processes.  C-SOPS has been directly involved in working with major pharmaceutical companies and the FDA on some of the first processes for continuous manufacturing of pharmaceutical solid dose products.

Robert Ronnback
Director of Innovation Centre
Ferring Pharmaceuticals

Day Two

Thursday January 31, 2019

09:40 | An Innovative Continuous Sterile Liquid Fill & Finish Process

Marcus Fiadeiro
Associate Director, DSP, Continuous Manufacturing Skill Center
Sanofi

Marcus Fiadeiro is the associate director of downstream processing in the continuous manufacturing department at Sanofi, based in Framingham, Massachusetts.  He has worked in biopharma for almost 20 years and the last 15 in purification process development at Pfizer and previously Amgen. His experience includes mabs, non-mabs, vaccines, polysaccharides, and conjugation in both early and late stage projects. He holds an M.S. from Johns Hopkins in Biotechnology and a B.S. in Biochemistry from Virginia Tech.

Lawrence De Belder
Senior Principal Engineer, Continuous Manufacturing
Janssen

Lawrence De Belder is a Senior Principal Engineer at Johnson & Johnson Technical Operations, a group in the Janssen Supply Chain which provides support to Janssen Commercial Operations. He has 23 years of experience designing and implementing different Manufacturing Technologies of which 12 years in Pharma and 6 years in Oral Solid Dose Continuous Manufacturing. He is the Program Manager for Continuous Manufacturing in the Janssen Supply Chain where he manages all projects and activities on continuous manufacturing for Oral Dosage Drug Product throughout the different parts of the organization. He has published several relevant articles, represents J&J on the most important conferences, as a speaker or as organizing committee member and is leading several consortia (CM Work Group of the IQ Consortium, GEA User group, and CM Community of Practice at ISPE), where he connects the strongest experts in the industry within the landscape of Continuous Manufacturing in Solids Small Molecules.

Day Two

Thursday January 31, 2019

09:10 | Keynote: Cost-Risk Benefits – Convincing Your Stakeholders of CM Benefits

Neil Soice
Director, Drug Substance Technologies
Amgen

Day One

Wednesday January 30, 2019

16:30 | Leverage Continuous Manufacturing to Reduce Facility Footprint

09:40 | Panel Discussion: Tailoring your Technology and Business Strategy for Success

Day Two

Thursday January 31, 2019

09:40 | An Innovative Continuous Sterile Liquid Fill & Finish Process

Flavien Susanne
Fellow, Product Development & Supply Continuous Processing Lead
GSK

Flavien Susanne graduated in 2001 with a Master in Engineering and in 2003 from a Chemical Engineering degree from the University of Normandy, France. In 2004, Flavien joined Pfizer UK, working in the R&D department. In 2006, he joined the new continuous process development team, leading the development of the first Pfizer end to end flow process. In 2011, Flavien joined Novartis Switzerland, working in the Continuous Manufacturing Unit, leading the development of flow process development and the implementation in GMP facilities. In 2014, Flavien joined GSK leading the continuous process engineering team. Flavien has been really active with the academia in all these years working closely with CMAC and MIT for the development of new methodology and technology for flow processing.

 

Salvatore Mascia
Founder & CEO
CONTINUUS Pharmaceuticals

Salvatore Mascia is the Founder & CEO of CONTINUUS Pharmaceuticals. He was the former Strategic Project Manager at the Novartis-MIT Center for Continuous Manufacturing, where he led the integration of the first end-to-end continuous manufacturing process for pharmaceuticals. At the end of the project, he was presented with the “Leadership Award” that recognized his leadership role at the Center. Salvatore has gained experience in strategic management and fund raising in addition to leadership skills via various roles of responsibility within the entrepreneurial ecosystem. Among those, he co-founded “Professionisti Italiani a Boston” in 2009, and served as President of the “Cambridge University Technology and Enterprise Club” in 2006/07. He also ran a pharmacy business for 2 years. Salvatore completed a post-doc at MIT in Chemical Engineering and holds a PhD in Chemical Engineering from the University of Cambridge, UK and a BS and MS in Pharmacy (summa cum laude) from University of Perugia, Italy.

Day One

Wednesday January 30, 2019

09:40 | Panel Discussion: Tailoring your Technology and Business Strategy for Success

Gregory Connelly
Associate Director, Formulation, Continuous Manufacturing
Vertex Pharmaceuticals

Greg Connelly is an Associate Director in Formulation Development at Vertex Pharmaceuticals in Boston, MA. He is the Drug Product Continuous Manufacturing (CM) Lead and he has been a key driver of the Vertex CM initiative from its inception. He has guided the successful development of several Vertex products which have been filed and approved as fully continuous processes. His team works to increase fundamental understanding of the various unit operations which comprise Vertex’s Drug Product CM rig, and they manage all design, testing and qualification of process equipment and software changes on the system. Greg holds a BS in Physics and Mathematics from Loyola University and a PhD in Biophysics from the University of Pennsylvania. He is also a member of the IQ consortium Continuous Manufacturing Working Group. Over the past 17 years, his work in the pharmaceutical industry has spanned the range from early-stage research to commercial product development.

Frederic Buono
Senior Principal Scientist
Boehringer Ingelheim

Dr. Frederic Buono has 14 years of experience in Pharmaceutical Industry and he is working for past 6 years in Boehringer Ingelheim as Senior Principal Scientist, where he is leading continuous process. Dr. Frederic Buono is originally from France, where he got his PhD in organic chemistry and chemical engineer degree from “Ecole Centrale de Marseille”. He then moved to England to do his postdoctoral under supervision of Pr. D. Blackmond, where he works in the area of physical organic chemistry and where he developed several kinetic models of mechanism of organic reactions. Prior to Boehringer, he started his career with Bristol Myers Squibb (NJ) in Process Group, particularly in a Technology group. In his current position at Boehringer Ingelheim, he is leading, developing and implementing continuous flow technology for several projects from gram to multi-kilogram scale process, by using in-situ monitoring techniques, kinetic studies and modeling for process optimization. He is author of many publications and book chapters in topic of flow chemistry.

Day Two

Thursday January 31, 2019

14:40 | Breaking Barriers to Manufacturing: Innovation with Continuous Flow Technology

Avril Vermunt
Continuous Program Manager
GE Life Sciences

As GE’s Connected Biomanufacturing Program leader, Avril brings strong experience within large scale bioprocessing and a profound understanding of process intensification. Avril joined GE in 2015 as a Bioprocess Hardware Specialist. She loves lending her large-scale bioprocess expertise to help colleagues select and implement process solutions that optimize efficiency and productivity. Her contributions have led to several successful tech transfers globally, including Amgen Singapore’s Next Generation Manufacturing facility. Prior to her time in Amgen’s process development organization, she worked in manufacturing and process engineering at Diosynth. She currently serves as an ISPE Rocky Mountain Chapter board director and a Facility of the Year Award (FOYA) committee co-chair, and has been an ISPE member since joining the student chapter at North Carolina State University where she received her degree in Chemical Engineering.

Joshua Hanson
Consultant Engineer, Small Molecule Design & Development
Eli Lilly & Company

Joshua Hanson is a Consultant Engineer in the Small Molecule Design and Development organization at Lilly. Since joining Lilly in 2013, Josh has served as a lead process engineer for the development of a continuous direct compression line within Lilly’s R&D organization, leading to establishment of a network of identical CM lines at R&D and Manufacturing sites. Josh is one of Lilly’s subject matter experts on the CM process equipment, automation, and control strategy. Josh has worked to implement CM for multiple drug products at Lilly including Verzenio®, Lilly’s first marketed CM product. He holds a Bachelor’s degree in chemical engineering from Purdue University and is a Professional Engineer.

Miguel Angel Gonzalez
Senior Director, Chemical Engineering
Asymchem Inc.

Mr. Miguel Gonzalez has over 18 years of experience with proven track record of supporting Bulk-Chemical / Bulk-Biotech and Medical Devices facilities for startup, qualification, and operations implementation.  Recently, applying new technologies and directing flow chemistry projects at research/development and production scale for Contract Manufacturing Operations (CMO).  Miguel started his engineer career at Eli Lilly & Co. in Puerto Rico, his native country, where he held several positions supporting Environmental Controls, Utilities, and Manufacturing.  Later, he was transferred to Eli Lilly in the United States where he diversified his career with positions in Environmental Operations, Research & Development, and Biotechnology.  During this time, Miguel collaborated in the design of continuous process unit operations (reactions, reactive/cooling crystallizations, and liquid-liquid extractions) to allow production of kilo-scale material to supply API starting material and reduced the process mass intensity (PMI) of new and established processes using flow chemistry. After his tenure at Eli Lilly, he moved to work on the medical device field with Alcon (Novartis) where he was responsible for the design, startup, and implementation of a solvent/waste storage & distribution system (tank farm), managed the area operational/maintenance team, supported the implementation of Process Safety Management (PSM) across the site, and led operational excellence projects to streamline and optimize processes.  Nowadays, Miguel works at Asymchem, Inc. (US Office) as a Senior Director of Chemical Engineering, where he is responsible for the integration of flow chemistry technologies into the overall business.  Miguel has a Bachelor of Science in Chemical Engineering from the University of Puerto Rico – Mayaguez Campus and a Masters of Science in Industrial Technology from Purdue University.

Luke Webster
Associate Consultant Engineer
Eli Lilly & Company

Luke Webster is an Associate Consultant Engineer with Eli Lilly and Co.  He has worked in continuous drug substance process development for four years.  During this time, he has transferred continuous processes to both internal and CMO manufacturing sites.  His interest include continuous reactors and process – analytical interfaces.  He holds both a Bachelor’s and Master’s degree in chemical engineering from Bucknell University.

Robert Worsham
Director of Manufacturing Science & Technology
Insmed Inc.

Robert Worsham (BS, ME) is a Biochemical Engineering PhD student at the University College London (UCL) and the Director of Manufacturing Science & Technology at Insmed, Inc. He has worked in various roles for numerous pharmaceutical and medical device companies, specializing in aseptic process development. He obtained his Bachelor’s in Chemical Engineering from the University of Cincinnati and Master’s in Biomedical Engineering from Tufts University.

Jeff Doyle
Senior Manager, Manufacturing Process Analytics & Control
Pfizer

Day Two

Thursday January 31, 2019

14:10 | Multivariate Process Characterization

Jorg Thommes
Head of CMC
Bill & Melinda Gates Medical Research Institute

Dr. Jorg Thommes is the Head of CMC at the Bill & Melinda Gates Medical Research Institute in Cambridge, MA. The Institute is a non-profit biotech organization and our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world's poorest people. The Institute’s CMC group is responsible for physical product development, manufacturing, and distribution across the entire portfolio. Prior to joining the Bill & Melinda Gates Medical Research Institute, Dr. Thommes was the Senior Vice President Pharmaceutical Sciences and Technology at Visterra. In this role he was responsible for all aspects of CMC development, manufacturing, and drug supply for Visterra’s products. Prior to the role at Visterra, Dr. Thommes was at Biogen, Inc., where he served among other positions as Senior Vice President, Engineering and Technology, and his responsibilities included process development for all therapeutic modalities, global and site engineering, and manufacturing sciences. Previously, Dr. Thommes was the Director, Protein Purification Development, at IDEC Pharmaceuticals and prior to IDEC, he held a research and teaching position at the Institute of Enzyme Technology at University of Dusseldorf, Germany. He serves on the board of the Recovery of Biological Products conference series and was chairman of that board from 2014 to 2016. Dr. Thommes received a Diplom-Chemiker degree from University of Bonn, Germany, a Doctorate of Natural Sciences from University of Bonn, Germany, and a Habilitation Degree in Biochemical Engineering from University of Dusseldorf, Germany.

Day One

Wednesday January 30, 2019

09:40 | Panel Discussion: Tailoring your Technology and Business Strategy for Success

Fred Ghanem
North American Business Manager
Purolite Life Sciences

Fred has over 23 years of global experience in ion exchange resins, adsorbents, chromatography, catalysis and purification of small and large molecules.  With Purolite Life Sciences, Fred is responsible for supporting new and existing chromatographic separation resins (both agarose and synthetic), enzyme carrier resins, immobilized enzymes, ion exchange and adsorbent products in the North American market. He holds a Master of Science (MSc) in Chemical Engineering and Bioprocessing from the University of Massachusetts.

Narasimha Rao Nedunuri
Managing Director & CEO
CLONZ Biotech Pvt Ltd.

Narasimha Rao Nedunuri is one of the founding members of CLONZ Biotech, an 8 year old  Clinical stage Biosimilar Monoclonal Antibody start-up company based in Genome Valley, Hyderabad, India. He is currently serving the company as the Managing Director & CEO. Nedunuri, a Molecular Biologist turned Entrepreneur has 18 years of experience in the field of Life Sciences Research including Cancer Biology, Proteomics, and Molecular diagnostics. He also had business experience in a USA based company, with the responsibility of establishing the business for new product range for its Indian subsidiary. Nedunuri at CLONZ , along with the co-promoters coming from recognized leaders who launched complex Biosimilar MAbs, driving the company to emerge as a significant Global Biosimilar MAb company.        

Lisa Graham
VP, Analytics Engineering
Seeq

Dr. Lisa Graham leads the Analytics Engineering team at Seeq Corporation. She holds her Ph.D. in chemical engineering and is a registered professional chemical engineer. With 20 years of experience across many industries, including pharmaceuticals and life sciences, and specialty chemicals, Lisa’s technical strengths include chemical engineering, product development, and process model development. She has a well-developed acumen in crafting process analytical technology and data analytics solutions to help drive innovation and growth, while reducing costs. Lisa has a strong business background established through C-Level leadership positions, including COO and SVP roles at Bend Research (now Lonza), and founding Alkemy Innovation in Bend, Oregon. She is actively involved in supporting higher education and specific STEM education initiatives. Specific efforts include serving as Director on the Oregon Governor's STEM Investment Council and as Chair of the Oregon Board of Trustees for Oregon Tech University.

Day One

Wednesday January 30, 2019

09:40 | Panel Discussion: Tailoring your Technology and Business Strategy for Success

Morten Munk
Global Technology Partner
NNE

Morten has over 30 years' experience in biopharmaceutical development and manufacturing. He joined NNE in 2015 as the Global Technology Partner. Prior to that he was the VP for Manufacturing, Downstream Development and Business Development at CMC Biologics A/S. Morten is specialized in Process Development, Facility Design, Single Use Systems, Process Validation, QbD, Tech Transfer and Regulatory Affairs. He's also the author and co-author of technical articles and guidelines, as well as renowned presenter at international conferences. Morten is an active member at a number of international industry associations, including ISPE and PDA.

Workshop A

TUESDAY, JANUARY 29, 2019

08.00 | Establish a Robust Design and Quality Control Strategy for Industrializing Continuous Bioprocessing

Thomas Erdenberger
Process Development Consultant
Sartorius Group North America

Day Two

Thursday January 31, 2019

10:10 | Tech Talk: Perspectives on Intensified & Continuous Processing

Niels Guldager
Global Technology Partner
NNE

Niels has 22 years of experience with biotech and pharmaceutical processes. This includes hands-on experience as production engineer in large scale biopharm upstream and downstream manufacturing, and extensive project experience as process specialist, front-end study leader, process lead, and process engineer. He holds a MSc. in Chemical Engineering from Denmark's Technical University and an Excetuive MBA from Copenhagen Business School. His focus is process and technology in front-end project activities such as feasibility studies, conceptual and basic designs. He has a strong ability to capture customer strategy and requirements and transform these inputs to a well defined process and facility design scope. Recent projects include mAb production and development facilities, vaccine facilities and in general next generation and multi-product facilities. Niels heads NNE Pharmaplan’s Biopharmaceuticals design group and is currently engaged in single-use technology community work for industry organisations PDA and ISPE. He is also a member of PDA’s task force for Gene and Cell Based Therapies. He holds the Certified Pharmaceutical Industry Professional™certification from ISPE.

Workshop A

TUESDAY, JANUARY 29, 2019

08.00 | Establish a Robust Design and Quality Control Strategy for Industrializing Continuous Bioprocessing

Keith Selvitelli
Scientist - Technical Development
Biogen

Keith Selvitelli is a scientist in the Drug Product, Engineering and Technology organization in Biogen with 15 years of experience in downstream protein purification and chromatography development for products at all phases of a biotherapeutics lifespan.  At Biogen he acutely balances the need for innovation with process manufacturability.

Ian Leavesley
President
Modern Pharma Consulting, LLC

Ian Leavesley is president of Modern Pharma Consulting and specializes in consulting on all aspects of drug product continuous manufacturing.  Prior to this, he initiated the continuous drug product effort at Eli Lilly, established the approach for integrating the technology with business objectives and led the process and automation components of continuous DP through to submission of Lilly’s first CM product.  He has also pursued other advanced manufacturing and data analysis technologies. He has had multiple other roles at Eli Lilly including corporate engineering particle technology expert, QbD SME, and led the first science-based scale-up of batch wet granulation at Lilly.  Before moving to the pharmaceutical industry, Ian worked in product and process development at Procter & Gamble for 17 years.  Ian holds a BSE from Princeton University in Chemical Engineering.

Workshop B

TUESDAY, JANUARY 29, 2019

15.30 | How to Adopt Continuous Manufacturing? From Proof of Concept to Submission to Implementation

Tommy Alfast
Senior Process Engineer
NNE

Tommy Alfast holds a Master of Science in Engineering (Biotechnology) from Royal Institute of Technology, Stockholm and Technical University of Denmark. In previous employment, Tommy has worked in different positions in Novo Nordisk A/S, including Production, R&D, Global Quality and Lean. Currently, Tommy works at the pharma engineering company NNE as Senior Process Engineer.

Workshop A

TUESDAY, JANUARY 29, 2019

08.00 | Establish a Robust Design and Quality Control Strategy for Industrializing Continuous Bioprocessing

Satish Sharma
Senior Scientist, Process Development Analytics
Bristol-Myers Squibb

Satish has been leading process impurities analytics for commercial process development since 2016 at BMS. Previously, he worked with impurities assay development at Janssen Pharmaceuticals. He did his postdocs at University of Pennsylvania and Thomas Jefferson University, Philadelphia, where his focus was on respiratory biology. Satish worked for his PhD at VP Chest Institute, University of Delhi, India.

Bob Lenich
Life Science Business Director
Emerson Automation Solutions

Bob is a life-long learner who stays engaged in new technology and organizational trends in order to adapt them to solving operating issues across the process industries. He works with a wide variety of organizations to identify operational problems, evaluate how to make improvements, and then justify and sell the approach. Bob loves seeing the successful deployment of a solution and then sharing the benefits so that others can take advantage of the approach. Bob gets special gratification from seeing how those improvements help areas like Life Science manufacturing improve people’s lives. Bob currently is responsible for planning Emerson's strategy for growing our automation business in the Life Science industry globally.  He then collaboratively works across the various business units in Emerson to implement the strategy and build the business. Bob has a BS in Chemical Engineering from Rose Hulman Institute of Technology and an MBA from the University of Texas.

Day Two

Thursday January 31, 2019

10:40 | Agile and Continuous, How to Automate Next Generation Manufacturing

Thomas Muller-Späth
Senior Scientist
ETH Zurich

Thomas Müller-Späth, Ph.D., holds a senior scientist position at the Swiss Federal Institute of Technology (ETH Zurich) , Switzerland.  He is also one of the founders of ChromaCon AG the company where he is active as Chief Operating Officer. Thomas studied chemical engineering at the Technical University of Hamburg, Germany, and at the University of California, Berkeley (USA). He obtained his PhD in the area of the multi-column-technology for the purification at ETH Zurich in the group of Prof. Morbidelli in 2008. Thomas has published numerous articles on continuous chromatography for biopharmaceuticals.

Day One

Wednesday January 30, 2019

16:00 | Spotlight Talk Sponsored by LEWA-YMC: Scale-Up & Validation Aspects of Continuous Twin-Column Chromatography for mAb Capture

Oleg Shinkazh
Founder & CEO
ChromaTan Corporation

Oleg Shinkazh is a founder of ChromaTan and inventor of “Countercurrent Tangential Chromatography.” He is a chemical and biotechnology engineer with 17 years of experience in R&D and technical support in the biotechnology industry, specializing in downstream processing/purification of human biologics. Oleg has extensive experience with all unit operations in the modern marketplace and has worked and collaborated with multiple industry leading bioprocess end-users and supplier companies.

Blair Brettmann
Assistant Professor
Georgia Institute of Technology

Blair Brettmann received her B.S. in Chemical Engineering at the University of Texas at Austin and her Ph.D. in Chemical Engineering at MIT. Her PhD was with the Novartis-MIT Center for Continuous Manufacturing of Pharmaceuticals. Following her Ph.D., Dr. Brettmann was a Senior Research Engineer at Saint-Gobain, where she worked on solution-based coatings and dispersions for commercial applications. Later, Dr. Brettmann served as a postdoctoral researcher in the Institute for Molecular Engineering at the University of Chicago. Her lab at Georgia Tech designs and studies new processing and characterization technologies, focusing on linking molecular to micron scale phenomena to product performance, with a specific interest in applications for pharmaceutical product development.