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Speakers

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Richard Steiner
Business Development Manager Continuous Technologies
GEA Process Engineering nv

Gerard Gach
Chief Marketing Officer
YMC PROCESS TECHNOLOGIES, INC.

Gerard Gach is the Chief Marketing Officer (CMO) of YMC Process Technologies bio/pharma systems’ business globally. His present role is identifying new growth segments within the life science space, providing strategic direction and aligning industry collaborators and developing product value insights. Previously Gerard spent 12+ years with General Electric as Global New Products Manager. He 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 30 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, Strategy Development and Business Development. Gerard has a BS from St. John’s University with a focus in Chemistry and further course studies in Marketing, Business Law and Business Management. Gerard was the 2012 GE Corporate Life Time Community Service Award winner.

Martin Gadsby
Director
Optimal Industrial Technologies Limited

Georgie Gjoka
Engineer, Continuous Manufacturing Skill Center
Sanofi

Xhorxhi Gjoka is a downstream processing engineer working in the continuous manufacturing department at Sanofi based out of Framingham, Massachusetts. Xhorxhi worked in applications R&D and new product development at Pall for almost 7 years before joining Sanofi. His experience is focused on continuous end to end manufacturing of monoclonal antibodies. He holds an MBA and B.Sc. in Biomedical Engineering.

Manuel Osorio
Senior Scientist & Program Lead for Emerging Technologies
FDA/CBER

Day One

Thursday 13th December 2018

8:30 am | Opening Address: The New Launch: CBER’s Advanced Manufacturing for Complex Biologics Products

Ganapathy Mohan
Executive Director, Head of External Affairs (Quality)
Merck & Co., Inc.

Ganapathy Mohan leads the Global External Advocacy and strategies for Global Quality and Compliance. Prior to this until April 2017, he was the head of Small Molecule Development Quality, which is responsible for ensuring GMP compliance and release of all materials and investigational Medicinal Products for use in clinical trials. Mohan was the head of Global CMC regulatory Affairs at Merck until April 2015.  Prior to joining Merck, he was Associate VP of Global Analytical Sciences at Sanofi and was there for 23 years. Mohan has a Ph. D in Analytical Chemistry from Kansas State University and his area of interests are in separation sciences, application of PAT and science driven risk-based approaches towards global registrations of pharmaceuticals and biologics. Mohan was past Chair of the AAPS Regulatory Sciences Section, board member of PQRI and has served in the Council of Experts for the United States Pharmacopeia till 2015. He currently represents Merck in the PhRMA GQMWG and is the PhRMA Lead on the ICH Q13 Continuous Manufacturing Guidance Development Expert Working Group. He also serves as the member of the Quality Coordinating Committee of IQ Consortium and APIC.

Day One

Thursday 13th December 2018

3:30 pm | Creating a Common Language and Framework to Support Continuous Manufacturing Globally

Justin Moser
Director – Advanced Manufacturing Technology
Merck & Co., Inc.

Justin Moser is a Director in the Advanced Manufacturing Technologies group within Merck & Co., Inc. manufacturing division.  Currently, he is leading cross-functional teams targeted to implement new technologies in the manufacturing division at Merck including continuous manufacturing of oral solid dosage drug products.  He has a B.S in Chemical Engineering from The Pennsylvania State University and has been working at Merck for over 17 years.  Justin has held roles of increasing responsibility from bench level scientist through team leader of cross-functional teams developing oral solid dosage drug products from drug candidate approval into phase 3 and registration lot execution.  He has also led technology implementation of spray drying at Merck for over 11 years including managing outsourced development and manufacture, design and installation of a pilot scale spray drying plant and authoring several core sections of the dossier for Merck’s first spray dried amorphous dispersion product Zepatier.  He is an author on 10 publications, co-inventor on 8 patents and presented at over 15 conferences.

Day One

Thursday 13th December 2018

9:30 am | The Possibility of End-to-End Implementation of Continuous Manufacturing – From Development to Supply

Malcolm Berry
Founder
mbchemistryconsulting

Malcolm studied for a PhD at Imperial College (1993) and he has 28 years’ experience working in the pharmaceutical industry as an organic chemist; with the last 26 years at GSK, working in process research and development in R&D.  Malcolm is best known as a one of the leading innovators in the field of continuous processing for small molecules.  Since 2000, he led the development of the lab-based technology and the ways of working for the development of continuous processes for Active Pharmaceutical Ingredients (API) at GSK.  He was heavily involved in the design, construction and commissioning of the first multifunctional pilot plant for continuous flow chemistry, within the pharmaceutical industry.   Malcolm led the teams that developed the first 5 processes that ran in this facility, producing cGMP API for clinical evaluation and transfer to manufacturing.   The highlight of his GSK career was to successfully lead a large multifunctional matrix team of >50 people across R&D and multiple manufacturing sites, to redevelop an existing GSK asset – Fluticasone Propionate (FP) – from a batch process into a continuous process.  This was the first multistage continuous process to an API anywhere in the GSK manufacturing network and may be the first to be approved across the industry.  The factory module was installed in Singapore in 2015, commissioned in 2016, validated in 2017 and the new process was filed with regulatory agencies in Europe and USA in 4th quarter 2018.

Pre-Conference Focus Day

9:30 am | A Discussion of Selected Regulatory Feedback Ahead of and After Filing a Multistage Continuous Process to API

Jana Spes
Head of Pharmaceutical Development & Manufacturing Sciences
Ironwood Pharmaceuticals

Pre-Conference Focus Day

1:30 pm | Continuous Manufacturing – Go or No Go?

Jon-Paul Sherlock
Global Technology Strategy Director
AstraZeneca

Jon-Paul Sherlock is the Global Technology Strategy Director for AstraZeneca Operations, responsible for implementation of manufacturing technologies that improve quality and process robustness, improve supply chain agility and reduce cost.  He joined AstraZeneca after completing a PhD in Chemical Engineering and has over 20 years’ experience of pharmaceutical research and development.  He has held senior roles in chemical, analytical and product development, supporting multiple therapeutic areas and all clinical phases including commercialisation and most recently led the development of innovative digital health solutions for emerging and established respiratory medicines.  He is a is a chartered chemical engineer and Fellow of the IChemE and has founded significant collaborations between industry and academia in the areas of formulation and physical processing, advanced manufacturing technologies and future pharmaceutical supply chains.

Day Two

Thursday 13th December 2018

9:30 am | AstraZeneca’s Journey in Continuous Manufacturing – From Technology Strategy to Pre-Competitive Collaboration

Nick Thomson
Senior Director, Chemical Research & Development
Pfizer Inc.

Nick graduated from the University of Edinburgh with a BSc (Hons) in Environmental Chemistry before completing a PhD in organic synthesis under Prof. Gerry Pattenden at the University of Nottingham.   Nick worked briefly at Zeneca Fine Chemicals Manufacturing Organization, Grangemouth (UK) and joined Pfizer in 1997 as a synthetic chemist in Process Research & Development.  Nick spent his early Pfizer career in the evolving process chemistry departments in Sandwich (UK), Sittingbourne (UK) and Holland, Michigan (USA).  From 2005 to 2010, Nick led the Sandwich Research Active Pharmaceutical Ingredient (API) department, with accountability for delivery of API technology from lead development to proof of concept.  In 2011, Nick joined the Pfizer Chemical Research and Development department in Groton, Connecticut (USA), as a Director of API Process Chemistry Laboratories, with accountability for the Quality by Design development and submission of late stage candidates.  In 2014, Nick became head of the Technology API line for Pfizer Chemical Research and Development, with accountability for Technology Strategy, High Throughput Screening, Biocatalysis and Flexible API Supply Technologies (Continuous).  Nick has been active in cross pharmaceutical precompetitive collaboration, as Chair of the IQ API Leadership Team and a board member of the Enabling Technologies Consortium.

Douglas 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.

Sune Klint Anderson
Principal Scientist in Particle Engineering
Janssen R&D

Ph.D. in Chemical Engineering – Nanoparticle Technology MBA in Management & Technology Main interests and professional experience include development of drying processes for biopharmaceuticals, small & large molecules, drug substance & product, excipients, scale-up. Furthermore, application of Quality-by-Design in drying processes, validation and qualification of spray dryers, advantages & disadvantages of spray vs freeze drying processes, continuous manufacturing, mathematical modelling of drying processes, aseptic spray drying, particle engineering, innovative drying processes and enabling technologies. Been with Janssen since Apr-2017 and before that 10 years at Novo Nordisk (spray and freeze drying of peptides & proteins) and 8 years with GEA Niro A/S (spray drying, fluid bed drying, equipment design).  

Atul Dubey
Director, Pharmaceutical Continuous Manufacturing
US Pharmacopeia

Pre-Conference Focus Day

9:00 am | US Pharmacopeia and ICH Q13 Quality Draft Guidance Updates

Lawrence de Belder
Senior Principal Engineer
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 25 years of experience designing and implementing different Manufacturing Technologies of which 14 years in Pharma and 7 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, 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 One

Thursday 13th December 2018

9:00 am | Continuous Manufacturing as a Default Platform for Oral Solid Drug Products

5:15 pm | Chair’s Closing Remarks & End of Day 1

8:15 am | Chair’s Opening Remarks

Day Two

Thursday 13th December 2018

3:25 pm | Chair’s Closing Remarks & End of Summit

8:45 am | Chair’s Opening Remarks

Carla Luciani
Group Leader of Future Manufacturing Innovation, Associate Engineering Advisor
Eli Lilly & Co.

Dr. Luciani received her B.S in chemical engineer from Universidad Nacional de Mar del Plata and PhD in Chemical Engineering from Universidad Nacional del Litoral. She spent 4 year at University of Maryland, initially as a postdoctoral fellow and then as a research professor. She joined Small Molecule Design and Development at Eli Lilly in 2011 as a process engineer. In 2014, she started leading the drug substance modeling & simulation group. In that role, she guided a group of chemical engineers and developed models for both hybrid and continuous drug substance processes. She became an engineer advisor in 2016 and she led the Future Manufacturing Platforms (FMP) Innovation Capability between 2017-2019. The goal of the FMP team was to guide investment by identifying, designing, developing or testing new manufacturing platforms and ensuring that chemistry, formulation, engineering and analytical solutions met future manufacturing needs for both small and medium molecules. In that role, she has supported innovation by identifying new technologies, established collaborations with academia and CMOs, and promoted the implementation of innovation for the manufacturing of both medium and small molecules. She recently joined a leadership team to explore new modalities. She is currently the Chief Editor of Pharmaceutical Discovery, Development and Manufacturing Forum (PD2M) Newsletter at the American Institute of Chemical Engineers.

Day Two

Thursday 13th December 2018

9:00 am | Opening Address: Small Molecule Design & Development Approach at Eli Lilly in Driving Future Manufacturing Platforms

Marcus Fiadeiro
Associate Director, Continuous Manufacturing
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.

Bradley Campbell
Research Scientist
Eli Lilly & Co.

Day Two

Thursday 13th December 2018

2:25 pm | Implementing Robust Process Analytic Tools to Ensure Quality from Continuous Processes

Klaus Kaiser
Head Downstream Development, Product Supply, Pharmaceuticals
Bayer AG

Dr. Klaus Kaiser is Head of Downstream within Biological Development at Bayer in Wuppertal, Germany. He also serves as lead of several strategic projects in the field of protein purification. He received a Diploma degree in Technical Biology from University of Stuttgart with the focus on Biochemical Engineering and a Doctor degree in Biochemistry from the Ludwig-Maximilians-University in Munich where his research activities focused on the control of class II gene transcription. After joining Bayer in 1997 Klaus worked several years in Technology Development to support biotechnological processes as well as blood plasma fractionation with focus on cell culture perfusion and virus safety topics. Until now he held different roles in process development and clinical manufacturing. His recent responsibility focuses on early and late stage development and process transfer from clinical scale to commercial production. Klaus shares a broad knowledge and experience in process characterization and production of different bulk drug substance modalities like antibodies and antibody drug conjugates. Specific interests cover downstream processing platform technologies, single-use applications and continuous manufacturing. Klaus also served as member in the DECHEMA expert committee “Bioprocess Technology” and in the “Qualification of scale down models for bioprocess” Point Share within the cross industry collaboration BPDG.

Day One

Thursday 13th December 2018

4:00 pm | Continuous Downstream Processing – Where Are We in Regard of Comparability and Regulatory Challenges?

Joon Chong Yee
Associate Director, Upstream Process Development
Codiak BioSciences

James Angelo
Scientist II
Bristol Myers-Squibb

Elçin Içten-Gençer
Senior Engineer, Pivotal Drug Substance Process Development
Amgen

Elçin Içten-Gençer is a Senior Engineer in Drug Substance Technologies (DST) within Process Development at Amgen. As a part of Synthetic Technologies and Engineering group within Pivotal DST, she has supported development of batch and continuous processes for drug substances and subsequent technology transfer of batch and continuous processes to CMOs. Elçin has been leading the Virtual Plant Model Development Project for Synthetic Continuous Manufacturing in collaboration with Braatz group at MIT Chemical Engineering. Elçin holds a B.S. from Bogazici University, Istanbul, Turkey and a Ph.D. from Purdue University, both in Chemical Engineering. During her graduate studies she focused on manufacture of individual dosing: development and control of a dropwise additive manufacturing system for pharmaceutical products.

Day Two

Thursday 13th December 2018

2:55 pm | Towards End-to-End Continuous Manufacturing – Development of a Virtual Plant

Kaid Harper
Senior Scientist
AbbVie

I did my BS degree in chemistry at Brigham Young University and did research with Merritt Andrus developing asymmetric phase transfer catalysts for asymmetric alkyations.  I then went up the road to the University of Utah and worked with Matt Sigman on developing new multidimensional analysis for asymmetric catalysts.  I was the Camille and Henry Dreyfus Post-Doctoral Fellow in Environmental Chemistry with Eric Jacobsen at Harvard University where I developed new catalysts for stereoselective glycosylation.  I join Abbvie in 2015 and have received Abbvie’s EHS Excellence Award for work in flow chemistry and Abbvie’s Excellence Award for work in Photo-Flow Chemistry.

Daniel Milano
Senior Manager, ADC Development & Manufacturing Outsourcing
ImmunoGen

Daniel is a Senior Manager in the Conjugation Development Group at ImmunoGen. He serves as the technical lead for all late-stage conjugation development activities. His primary focus has been the process characterization and validation activities surrounding ImmunoGen’s lead product candidate mirvetuximab soravtansine. Prior to joining ImmunoGen, Daniel received his PhD in chemical engineering from Northeastern University.

Dave Berry
Manager of Complex Particles
CPI UK

Nathan Domagalski
Senior Principal Scientist
Pfizer Inc.

Thomas de Beer
Head of Laboratory of Pharmaceutical Process Analytical Technology
University of Ghent

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

Thursday 13th December 2018

10:00 am | Panel Discussion: Is Continuous Manufacturing for Legacy Product Only? Can we be Courageous and Use it for NDA?

Bob Lenich
Director, Life Sciences Business
Emerson

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 13th December 2018

10:00 am | The Future – Automated Continuous Manufacturing

Miguel Gonzalez
Senior Director, Chemical Engineering
Asymchem

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.

Hans Johansson
Global Applications Director, Life Sciences
Purolite

Hans J Johansson is Global Applications Director at Purolite Life Sciences, Llantrisant, Wales. He has spent more than 30 years in the Biotech industry. Most of the time in research and development at Pharmacia/Amersham/GE Healthcare with a special focus on design and applications of industrial chromatography resins intended for antibody purification. He frequently publishes in scientific journals and is the holder of more than ten patents around resin design and large-scale protein purification. He is currently working with development and applications of novel, agarose-based, chromatography resins.

Thomas Erdenberger
Process Development Consultant
Sartorius Stedim Biotech

Tom has 33 years of experience as a Biotechnologist in industrial and biopharmaceutical products. He has extensive background in biopharmaceutical process development, tech transfer, facility start-up, process optimization and cross-functional project management, as well as in industrial bioprocess technology development, and single-use technology and engineering. Tom was an early adopter of Single Use technology in the early 1990's and after long experience as an end user, transitioned to the supplier side. Tom holds a degree in Applied Microbiology from Bowling Green State University and has co-authored numerous process and single-use product patents.

Ian Leavesley
President
Modern Pharma Consulting

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.

Ernie Hillier
Founder
EJH Consulting

After 39 years at Waters Ernie has retired and has formed EJH Consulting with the focus on helping the industry continue to evolve in Process Analytical Technology in order to implement Continuous Manufacturing. During his career the roles have been in new systems and chemistry evaluation, Product Marketing for Detectors, Operations as Manager of the Technical Product Management Group responsible for Quality. In this last role this experience has led to a better understanding of process which has led to his current role His current role is Principal Systems Product Manager for PATROL (PAT), Alliance and Breeze Systems. He has a BS degree in Chemistry and Biology from Northeastern University.