Jan 30 – Feb 1, 2018
Boston, MA

Register by Friday, December 15 to save up to $500!

Speakers

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Marcus Peiker
Process Development Consultant
Sartorius Stedim Biotech GmbH

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.

Day One

Wednesday January 31, 2018

12.40 | Integrated End-To-End Continuous Bioprocessing – An Industry-Wide and US Government Sponsored Initiative for Steady-State Manufacturing of Biologics Using Continuous Countercurrent Tangential Chromatography (CCTC)

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 One

Wednesday January 31, 2018

15.40 | Planning Automation to Deliver Continuous Manufacturing Benefits

Aleksandar Cvetkovic
Head of Continuous Manufacturing Skill Center
Sanofi Genzyme

Day One

Wednesday January 31, 2018

12.10 | Strategy for Continuous Capturing of Antibodies from Perfusion Processes

Yanxi Tan Cain
Executive Director, Global Quality Assurance, Global Head, Quality Management System
Merck

Day Two

Thursday February 1, 2018

13.55 | Quality Management System to Facilitate CM Implementation

Jon Coffman
Global Head of Innovation, Technology Biopharm
Boehringer Ingelheim

Day Two

Thursday February 1, 2018

11.35 | Bridging Continuous, Integrated & Batch Processing as a Path to Implementation

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 Two

Thursday February 1, 2018

09.10 | Opening Address: Manufacturing the Future: The Journey from Batch to Continuous Manufacturing from an Industry Perspective

Kevin Cole
Principal Research Scientist, Small Molecules Design & Development
Eli Lilly & Co.

Kevin received a Ph.D. in chemistry from the University of Minnesota in 2005 and then pursued postdoctoral studies with Prof. KC Nicoloau at Scripps in San Diego.  In 2007 he joined the process chemistry group at Eli Lilly and Company.  Since 2010 Kevin has worked in the continuous processing group, developing continuous processes for developmental APIs intended for internal and external manufacture.  

Day Two

Thursday February 1, 2018

09.40 | Continuous Small Molecule API Manufacturing: Development & Technology Transfer to a CMO

Jorgen Magnus
Head of Bioprocess Technology
Bayer AG

Jørgen Magnus is the Head of the group for Bioprocess Technology at Bayer. He has an MEng in chemical engineering and a PhD in biotechnology. He worked for NNE Pharmaplan for three years designing biopharmaceutical facilities before he joined Bayer in 2009 working in the department of technology development.

Day Two

Thursday February 1, 2018

10.55 | Mastermind: Redefining Continuous Manufacturing Workflow

Robert Fahrner
Senior Principal Scientist & Group Leader, Bioprocess R&D
Pfizer, Inc.

Rob Fahrner is a Senior Principal Scientist and Group Leader in Purification Process Development, Bioprocess R&D at Pfizer.  He has 28 years of experience in the biopharmaceutical industry, including five years at Pfizer and sixteen years at Genentech.   Rob has worked on commercializing several mAb products, and developed Rituxan and Herceptin from Phase II through commercialization and post-BLA process improvements.  He has published extensively on developing a mAb platform process, significant improvements in Protein A chromatography, understanding membrane separations and modes of chromatography, and alternatives to chromatography processes.  He has led teams responsible for end-to-end development, from cell line to GMP manufacturing, and he is currently part of the Next Generation Manufacturing project in collaboration with Boehringer Ingelheim.

Day One

Wednesday January 31, 2018

11.40 | End-to-End Integrated Processing Using Continuous/Batch Hybrid Systems

Michelle Bailey
Associate Director, Head of Validation for Continuous Manufacturing & Automation
Vertex Pharmaceuticals

Day One

Wednesday January 31, 2018

16.10 | Project Update: One Year On & Launch of Second Commercial CM Rig

Indrajeetsinh Yadav
Investigator (Secondary Continuous), Drug Product Development
GSK

Indra Yadav is a Research Investigator at GlaxoSmithKline R&D in UK, and he has been working in the pharmaceutical industry for approximately 16 years. Indra has extensive experience in early to late-phase new drug product development, and has led formulation development, manufacturing process scale-up and technical transfer activities for oral solid dose forms. In recent role, Indra has been working on secondary continuous manufacturing of oral solid dose products and played a pivotal role in driving the adoption of continuous manufacturing in Product Development at GSK.  

Day Two

Thursday February 1, 2018

12.05 | The Roll Out – Smooth Implementation of Continuous Manufacture of Small Molecules

Nathan Collins
Vice President, Applied Research & Technology Development
SRI Biosciences

Nathan Collins specializes at the interface between innovative, translational R&D, and commercialization. He has more than 20 years of experience in the biotechnology industry ranging from basic research through to clinical development of small molecule and biologic drugs.Nathan currently leads a number of programs including SRI’s SynFiniTM platform, which is focused on automating the chemistry design and scale up process from discovery through to manufacturing, to maximize reproducibility and transferability of the synthesis process. 

Day One

Wednesday January 31, 2018

14.40 | Get it Right First Time – Designing Your Synthetic Process for CM at the Drug Discovery Stage

Engin Ayturk
Senior Manager, Technical Development
Biogen

Engin Ayturk, is a Senior Manager at Biogen, leading the Cambridge Process Biochemistry (PBC) small and pilot scale purification development teams, and responsible for the development of purification processes for clinical and commercial biologics programs. Prior to Biogen, Engin was the Sr. R&D Manager at Pall Life Sciences, where he led the BioPharm Applications R&D Integrated Continuous BioProcessing team and the Filtration Groups for the development and commercialization of next generation novel bioprocess platforms and technologies In addition to his primary focus on product, process and technology development, characterization, scale-up and tech transfer, Dr. Ayturk brings a strong emphasis on process modeling, bioprocess economics and the development of process control strategies for various technologies and is well recognized for cross-functional team leadership, internal/external collaborations and partnerships management as has numerous business certifications on project and people management, agile product development and innovation coaching modules. Dr. Ayturk holds M.Sc. and Ph.D. degrees both in Chemical Engineering and previously worked as a Research Assistant Professor at Worcester Polytechnic Institute (WPI).

Day One

Wednesday January 31, 2018

14.10 | Progress & Challenges in Bridging the Gap – End-to-End Continuous Processing

Gerard Gach
Chief Marketing Officer
LEWA Bioprocess Technologies

Gerard Gach is the Chief Marketing Officer (CMO) of LEWA-Nikkiso Bioprocess Technologies Group. He leads company in identifying growth segments within the life science space, directing the business strategy to support the commercial growth of LEWA-Nikkiso on a global basis. Previously Gerard was the Global Strategic Leader, Bioprocess Cell Culture of General Electric’s Health Care (GEHC) Life Science Division. At GEHC Gerard also served as Director of Product Management for Bioreactors, Disposables, and Membrane business where his team was responsible for developing and bringing to market an entirely new platform over 250 single use products while managing membrane based products for the GE business involved in bioprocess, protein science and lab products. He has previously served as Global Marketing Leader, for the Advanced Separations business of GE Water & Process centered on novel membrane and chemical separation technology. His employment history includes over 28 years in the filtration / separations industry with GE,  Osmonics, Koch Membrane Systems and Pall Corporation in capacities of R&D Supervisor, Sales and Sale Management and Business Development.

Day One

Wednesday January 31, 2018

13.55 | SPOTLIGHT: Pioneering Technologies – Advanced Multi-Column Chromatography Platform

Morten Munk
Global Technology Partner
NNE

Morten Munk has over 30 years of industry experience in biopharmaceutical development and manufacturing and is a globally recognized technical expert in the field. He has authored or co-authored a number of technical articles and guidelines. Morten Munk joined NNE in 2015 as Global Technology Partner, supporting all aspects around biopharmaceutical development and manufacturing. In 2001 Morten co-founded CMC Biologics A/S, where he held a position as Vice President for Business Development. Prior to founding CMC Biologics, Morten held a position as principal scientist at Novo Nordisk A/S in which he was responsible for the CMC part of several projects, which have been commercialized successfully, including development of the slow acting insulin analogue, named Levemir / Detemir.

Jeffery Odum
Global Technology Partner, Strategic Manufacturing Concept Group
NNE

Jeff Odum is the Managing Partner, Strategic Manufacturing Concept Group, and a Global Technology Partner at NNE in the US Office located in Durham, North Carolina.  He has over twenty-five years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, and pharmaceutical industries. A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over seventy articles and four Industry reference books on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities.  He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project management and GMP compliance.   Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the ISPE Biotechnology Community of Practice Steering Committee, and a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management and commissioning and qualification.  He is a member of the PDA and ISPE technical training faculties and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing and a Guest Instructor for the North Carolina Community College System BioNetwork Program.  He has led training efforts in fifteen countries, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.

Sanjeev Kothari
Senior Director of Pharmaceutical Chemistry and Formulations
Ardelyx, Inc.

Sanjeev Kothari has over 20 years of industry experience in formulation, process development and manufacturing of small molecule pharmaceuticals. He's currently the Functional Head of Pharmaceutical SCiences at Ardelyx with responsibilities from discovery support through commercialization of drug products, management  of activities at CMOs, and in-house scientific staff. He's demonstrated leadership of CMC teams taking projects from Phase 1 through validation/ commercialization of oral and injectable formulations. Prior to joining Ardelyx, Sanjeev led cross-functional CMC teams at BMS and Genentech/Roche, supporting evaluation of continuous manufacturing.

Day One

Wednesday January 31, 2018

09.40 | Roundtable Discussion: Establishing a Winning Business Case for Investment

Ding Ming
VP, Research & Innovation
U.S. Pharmacopeia

Ding Ming, PhD, is Vice President, Research & Innovation at United States Pharmacopeia Convention, responsible for a global Research and Innovation strategy, organization, and operation to (1) lead overall R&D innovation strategic development to balance near term research activities with the long term investment strategies that warrant business sustainability; (2) lead innovation infrastructural development to build up a high performing global organization; and (3) drive scientific capability development and functional offer to our customers and consumers. At this capacity, Dr. Ding Ming works closely with FDA, academics, and industries to explore new healthcare related technology, Pharma/CPG/Nutrition product innovation, and regulation development in Digital Healthcare, Personalized Medicine, Microbiome, and Pharmaceutical Continuous Manufacturing to facilitate paradigm transitions of healthcare.

Day One

Wednesday January 31, 2018

09.10 | The Need to Define & Standardize Global CM Guidance

Roger-Marc Nicoud
Founder & CEO
Ypso-Facto

Roger-Marc Nicoud, founder and CEO of Ypso-Facto, has forged a successful career as an entrepreneur in the life sciences industry. Roger-Marc Nicoud earned a PhD in process simulation for the nuclear industry from the University of Lorraine (Nancy, France). In 1987, he began his career at Separex, a leader in supercritical fluid technologies. Meanwhile, he held a position of Professor and Head of a research laboratory in thermodynamics at University of Lorraine between 1993 and 1995. With a vision to develop comprehensive solutions to produce bio- and synthetic molecules, Roger-Marc Nicoud took an opportunity to spinout half of Separex and create a new company: in 1995, he founded Novasep. As President and CEO until 2012, he led the company’s growth from 10 to 1,300 employees, with a EUR 300M turnover. Through his stewardship, Novasep became a leading player in the life sciences industry and has built-up a world-class portfolio of innovative technologies. Between 2012 and February 2014, Roger-Marc Nicoud held the position of non-executive Chairman of Novasep’s supervisory board. Roger-Marc Nicoud founded Ypso-Facto in 2014 as a service company offering assistance to industrial firms to develop, optimize and secure their chemical and bioprocesses. He recently wrote a book entitled: Chromatographic processes: modeling, simulation and design.1  

  1. Chromatographic Processes - Modeling, Simulation, and Design, Roger-Marc Nicoud, 672 pages, Cambridge University Press, Cambridge Series in Chemical Engineering, New-York (2015), ISBN: 9781107082366.

Terry Seanard
Principal Engineer
New England Controls, Inc.

Terry is currently a Principal Engineer and the Continuous Manufacturing Program Technical Lead at New England Controls.  His formal education in Chemical Engineering and Bioengineering is supplemented by almost 15 years of experience supporting many of the large scale biotech manufacturers in the Boston area. His experience ranges across design, management, implementation, site startup, and life cycle support of complex process control systems and manufacturing operational enhancement projects, primarily in the life sciences industry.

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.

David Pfister, PhD
Project Manager
Ypso-Facto

David is a chemical and biochemical engineer with expertise in process modeling, reaction engineering and separation science. He holds a PhD in Chemical and Bioengineering from the Eidgenössische Technische Hochschule Zürich (EHT Zürich, Switzerland) and has a post-doctoral experience. His worked focused mainly on the development, improvement and modeling of processes for the production of PEGylated proteins. He investigated both the kinetics of the conjugation reaction and its purification aspects to propose integrated and innovative processes. Meanwhile, David worked on different polymerization reactions either for the modeling of cross-linking polymerization reactions or for the synthesis of renewable polymers by ring opening polymerization.

Jana Spes
Former VP, Technical Operations
Apotex

Day Two

Thursday February 1, 2018

14.25 | Continuous Process Development & Monitoring

António Grilo
Researcher, Biological Systems Engineering Group
Imperial College

Day One

Wednesday January 31, 2018

16.30 | Poster Session: Towards Model-Based Bioprocess Design: An Upstream In-Silico Model of Cell Cycle, Metabolism & Apoptosis