ManuPharma 2019

03 - 04 December, 2019

Contact Us: 44 (0) 207 036 1363

2017 Speakers

Wolfgang Baiker
Wolfgang Baiker
Member Human Pharma Executive Committee, Head of Human Pharma Supply
Boehringer Ingelheim
Bharath Sundararaman
Bharath Sundararaman
Global Leader Supply Chain Visibility and Analytics
Merck
Bharath partners with senior supply chain and manufacturing executives across Merck in identifying opportunities to drive best in class performance through advanced statistics, data mining, rich visualisation and new technologies. He is responsible for driving digital transformation at Merck using big data, cloud and mobility, IoT and advanced analytics.
Andrew Share
Andrew Share
Advanced Manufacturing Technologies Director
GSK
As lead of the (AMT) team, Andrew is responsible for delivering a long-term strategic change to the way GSK manufactures medicines. IN 2015 Andrew was seconded onto the Medicines Manufacturing Industry Partnership and the returned to GSK in 2016. He now leads teams located in both Europe and Asia. Andrew has a PhD in Synthetic Organic Chemistry from the university of Nottingham.
Rudolf Hausmann
VP Technical Development & Operations
Santhera Pharmaceuticals Ltd
More than 10 years experience in Big Pharma and >8 years in Small Biotech, strong expertise in pharmaceutical production, development & project leadership, CMO management and alliance management / BD&L activities, worked with >20 projects from early stage up to commercial launch with small molecules and monoclonal antibodies. Strong leadership / interpersonal / communication skills and experience in both line functions and matrix organizations. Strategic thinker with strong analytical skills and detail-orientation where required, efficient in implementing tasks in time and with high quality and ambitious working in an innovative, global environment
Frederic Zwahlen
Frederic Zwahlen
Vice President, Head of Pharmaceutical Manufacturing
ViforPharma
Frederic leads all pharmaceutical manufacturing for VIfor, overseeing 4 manufacturing sites (in Switzerland: Ettingen; Fribourg, Geneva and in Portugal: Lisbon). The technology range cover includes manufacturing of biological API by Biotechnology and drugs manufacturing for non sterile oral or topical formulation (coated tablets, capsules, syrups; suspensions, nasal sprays, gels and ointments).
Dirk Schrader
Dirk Schrader
EVP - Head of Technical Operations
Vifor Pharma
Dirk leads TechOps for the third biggest and fastest growing pharmaceutical company in Switzerland. Vifor Pharma has five manufacturing sites and about 700 people in Tech Ops. Dirk joined Vifor Pharma in 2012, coming from Astra Zeneca where he lead the Asia Pacific/Japan Manufacturing & Supply and their global Lean & Operational Excellence Program. Prior to that he was with Bristol Myers-Squibb and Bayer HealthCare. He will introduce a real “smart manufacturing” application for which Vifor Pharma is the global pilot. Using Augmented Reality technology, the system developed by Goodly Innovations helps Vifor Pharma to significantly reduce set up and change-over times and more…
Marco Maioli
Marco Maioli
Industrial Operations Director
Sigma-Tau
Marco has worked across a number of different positions within industrial operations, from quality assurance to lean manufacturing, operations management and product transfer. Prior to Sigma-tau he was an industrial technology expert at Sanofi as well as holding positions within manufacturing and operational excellence at the CMO; Catalent.
Ulrich Korneck
Head of Global Operational Excellence and Vice President
Merck
Ulrich is head of Global Operational Excellence with Merck’s Biopharma operations, including manufacturing operations, with a global remit. He joined from Merck in January 2015 from Porsche Consulting’s Pharmaceuticals, Biotech and Medical Device Practice. Ulrich has previously held management positions with Boehringer Ingelheim and Camelot Management Consultants.
Paul Hanson
Director Commercial Technical Operations
Takeda
Paul Hanson is currently head of the commercial biologics API programs at Takeda. In this role he has begun leveraging statistical process control strategies to drive Takeda's nascent continuous process verification program. This program reduces the company's API supply chain risk through improved line-of-site into the commercial production process.
Silke Gotthardt
Silke Gotthardt
VP Launch Transfer Operations
Boehringer Ingelheim
Dr. Silke Gotthardt currently works as VP of Launch and Transfer Operation for Boehringer Ingelheim, where she is the central connecting point within the deveopment organisation. She is also the key point of contact for Boehringer Ingelheim's global network of sites, managing both internal site operations and external CMO activity.
Jean Philippe Giraud
Jean Philippe Giraud
Director, Head of Technical Transfers, Global Manufacturing & Supply
Merck Serono
Jean-Philippe leads the implementation of all technical transfers for Merck's global pharma organisation. His current remit includes 40 transfers ongoing around the global, leading a team of seven technical transfer managers and a PMO manager. His key focuses are upon supporting pharma reliability and volume growth by executing CMO and internal dual sourcing strategy, localisaing manufacturing operations where possible to maintain market access (particularly in emerging markets) and supporting supply flexibility andd scalability.
Mark  Wright
Mark Wright
Site Lead
Piramal
Andy  Jones
Andy Jones
Head of Manufacturing Science and Technology
AstraZeneca
Andy recently left the post of the Head of Manufacturing Science and Technology at AstraZeneca. Andy started his career with ICI in Chemical Process Development where he was fortunate enough to be involved in the development of a three major cancer therapies Faslodex, Arimidex and Zoladex, all of which went on to become multi-billion dollar products impacting the lives of millions of patients. Following the breakup of ICI and the creation of Zeneca and subsequent formation of AstraZeneca Andy held a number of senior technical, site management and project management roles culminating in becoming Head of Projects and Portfolio Management for AZ Pharmaceutical Development function. Andy’s career path then changed when he took over as Head of Innovation for Pharm. Development where he was responsible for Science and Technology Strategy, Innovation, Insight and IP and the management of internal incubators in new Technology Areas, a role he held until moving to Head of MS&T this year.
Martin  Fusek
Martin Fusek
Global Head of IT Testing Service
Novartis
Over the past two years Martin has set up and lead the global testing centre of Excellence for Novartis, providing managed testing serviecs for IT application of all business areas of one of the world's largest pharmaceutical companies. Much of this focus has been upon the manufacturing execution systems within the organisation. He held a number of senior MES and TechOps IT focused roles within the industry before joining Novartis, including Head of TechOps IT at Salutas Pharma and MES Manager for HEXAL AG.
Stephen Closs
Stephen Closs
Vice President
Global Technical Operations
Stephen has more than 28 years of experience in engineering and pharmaceutical research and development. He currently oversees the global strategic technical activities related to the development, scale-up, commercialization and continued performance of multi-drug product portfolios for clients. He currently also oversees novel technology introduction projects including continuous manufacturing. Mr. Closs has led Centers of Excellence teams for Design of Experiments (DOE), Process Analytical Technology (PAT) and Quality by Design (QbD).
Marianne	 Leth
Marianne Leth
VP Manufacturing and GM
Biogen
• Over 20 years of experience in managing and leading complex global organizations in the pharmaceutical industry • Extensive experience within Biologic Manufacturing • Broad professional experience covering all aspects of pharmaceutical operations in the areas of manufacturing (drug substance, drug product and finished goods), manufacturing sciences, tech transfer, product life-cycle management, quality and regulatory affairs • Financial Responsible for significant operating cost and a significant portfolio of investment projects • Strategic planning and execution by engaging the organization and creating business results are demonstrated and has created top management trust • Solid experience in leading and developing organizations, including change leadership and talent development • Experience with establishing and building up new facilities as well as overseeing major capacity expansion projects • Deep knowledge of the pharmaceutical industry in Denmark and abroad. Broad professional network • Extensive experience in issue management and media communication • Experience in managing manufacturing organizations dealing with different aspects of manufacturing: internal manufacturing, contract manufacturing as well as manufacturing for a joint venture
Anne Marie de Jonge Schuermans
Anne Marie de Jonge Schuermans
Vice President Global Supply Chain Ops & Strategic Partnerships
Biogen
Anne Marie is a results orientaed and enegetic leader within (bio)pharmaceutical manufacturing and supply chain. At Biogen she is responsible for Global Supply Chain Operations (covering API, Biological Drug Substance, Drug Product & Finished Goods), Production & Manufacturing Footprint planning for clinical and commercial manufacturing at internal and external sites/CMOs, Materials Management, Logistics, Warehousing, Process Excellence, ERP, Program Management, Product Life Cycle Management, Oversight of Strategic Partnerships (incl. spin-offs), CMOs & Alliances from Clinical into Commercial.
Philipp Goepel
Vice President Head of Manufacturing - Plant Manager Bovenau
Richter-Helm BioLogics
Philipp leads a GMP multipurpose facility for manufacturing of microbial biopharmaceuticals with a 1,500L maximum fermenter capacity in Bovenau, Germany. Within this role he is responsible for manufacturing & engineering, ensuring close coordination with QC and QA on a site with over 60 employees.
Adam Warzecha
Adam Warzecha
Contiuous Improvement Champion EMEA
Shire
Adam's key responsibilities are to lead and accelerate deployment of Shire Continuous Improvement mindsets and behaviours, systems, tools, mechanisms and processes throughout all site functions to create a continuously learning and improving organization. In doing so his team aim to provide a key competitive advantage for Technical Operations that is instrumental in how Shire achieve their breakthrough objectives for Supply Value Proposition and ultimately the company’s vision.
Craig Johnston
Craig Johnston
Operations Director
Strathclyde Institute of Pharmacy and Biomedical Sciences
Craig is Industry Director at (CMAC) Continuous Manufacturing and Crystallisation. He works with industry including tier 1 multi nationals eg GSK, AZ, Novartis, Bayer and technology companies. Established in 2011, CMAC now has 120 staff across its network of 7 leading universities. It conducts leading research in continuous manufacturing with particle focus.
Kumaran	 Krishnan
Kumaran Krishnan
Associate Director MSL and Digital Transformation
Teva Pharmaceuticals
Kumaran is currently based in Amsterdam where he is spearheading the digital transformation program for Teva across the entire organisation, across the entire supply chain. His deep understanding around the optimisation of the medical affairs function within pharmaceutical companies (having spent over a decade at Sanofi in various functions) gives him a unique view point on the knock on effect that greater visibility on demand from the patient will have upon manufacturing strategy.
Sandra Lee
Sandra Lee
Managing Director - Operations
Accord Healthcare
Thomas Wickert
Head of Microbial Fermentation & Enzymes
Roche Diagnostics
Michael	 De Poortere
Michael De Poortere
Global Analytical Technology Centre Director
Dow Chemical
Michael manages technology transfer at Dow Chemical in order to ensure safe and consistent operations, whilst providing a competitive advantage thruogh the adoption of the most effective and efficient technology and practices available. His role is to lead the Dow Tech Centres (an organisation of over 900 employees, within the larger Dow Chemical organisation), which act as a catalyst between commercial, R&D and manufacturing.
Malcolm Warr
Malcolm Warr
Chair
Tranzparency Group
40 years international defence Humanitarian reconstruction and homeland security experience with an entrepreneurial track record and proven skills in complex project rectification, security, aviation and maritime initiatives . Over the years I have led transformation programmes in defence and security, participated in get well programmes and set up and rectified small businesses as well as working with R&D, Corporates, Governments, Academia and Big Five Consultancies. From my eclectic experience I believe the secret to success is enduring communication at all levels and effective leadership and decision making. I just enjoy working to expand mindsets beyond the every day-to-day aspects of life and helping younger entrepreneurs to prosper.
Geoffrey	 Pot
Geoffrey Pot
Senior Director Manufacturing and Process Science
Shire
Geoffrey has more than 15 years of experience in the Biotech / Pharmaceutical environment, and is now managing an international team of more than 200 individuals across 8 different plants in Europe and US. Developing and coaching team members to become a high performing team is key which has been demonstrated through strong operational results.
Klaus Kunath
Klaus Kunath
Head of Manufacturing Science & Technology, Global Pharma Operations, Merck
Merck KGaA
Klaus' key focus is technical leadership for process robustness improvements at Merck. His 15+ years of experience in the pharmaceutical industry include leadership within manufacturing process development, formulation development and CMC project management.
Joe  Codamo
Joe Codamo
Head of Operations
Sanofi
Joe is currently responsible for both biologics & chemistry operations at Sanofi's Vitry-sur-Seine site in Paris. He has held a number of senior leadership roles in biopharmaceutical development and manufacturing over the last 14 years including General Management, multi-product Project Management and MSAT at Patheon and DSM. He is an expert in fast-track technology transfers, scale-up and validation of mammalian cell culture bioprocesses. Joe is also an experienced and energetic change leader who has been involved in site specific and global culture change programs across bio manufacturing networks in Europe, USA and Australia.
Magda Papadaki
Magda Papadaki
Head of Manufacturing Innovation
ABPI
In addition to Head of Manufacturing Innovation at ABPI, Magda is also Manager of the Medicines Manufacturing Industry Partnership (MMIP), further supporting the UK’s industry-government ATMP Manufacturing Taskforce. Her role involves examining the UK's position in medicines manufacturing and identifying opportunities for improvement in the manufacturing and development of small molecules, biologics, vaccines and cell & gene therapies. Taking a systems view of medicines supply and value chains, Magda supports a number of priority work streams combining technology and innovation landscape, supply chain mapping, investigating the fiscal, regulatory/policy and skills environments, as well as joining up the medicines manufacturing ecosystem, to build the field’s sustainable growth.
Edith Norrant
Edith Norrant
Innovation, Technology & Sciences Director
UCB Pharma
Having been with UCB for over a decade, Edith's key remit now is to develop innovation and new technology in relation to the manufacuture of all new molecules ( chemical and biological compounds) and to introduce innovation in manufacturing plants across the globe.
Stephane	 De Saint Jean
Stephane De Saint Jean
Director of Industrial Operations
BioMerieux
In his current role Stephane heads industrial operations for eight manufacturing sites across France, Italy and Spain, with responsibility for annual OPEX of €165m, CAPEX of €35m and over 1800 employees. He has 20 years of experience in different industrial environments, with strong knowledge in manufacturing operations, culture and strategy, and a focus upon autonomous team development and motivation management. Further areas of expertise include process and equipment capabilities improvement and product flow reliability including agility deployment.
Clive Badman
Clive Badman
Head of Pre-Competitive Collaboration
GSK
Clive is responsible for examining opportunities for collaboration in either Industry/Academia or Industry/Industry situations at GSK. The aim is to drive forward improvement, efficiency and technologies through pre-comoetitive collaboration. He has previously held positions at GSK including VP Investigational Materials Supply and VP Process Technologies and Pilot Plants.
Vijay	 Surapaneni
Vijay Surapaneni
VP Engineering and Capacity Planning
Catalent
Vijay is a Senior Technical Operations Executive with diverse leadership experience spanning Engineering, Facilities, and Manufacturing Operations in Pharmaceutical and Medical Device companies. For over 35 years, Vijay has delivered superior customer service and quality products for global life sciences companies (Catalent, ConvaTec, Bristol-Myers Squibb and Parke-Davis/Warner-Lambert), both in the United States and internationally (Asia, Europe, Latin America). He holds a successful track record of driving strategic alignment across organizations with a focus on growth objectives. His proven ability to manage operations and deliver organizational change has optimized local, regional, and global performance. For both work and leisure, Vijay has traveled to over 25 countries, living and working in both the United States and Ireland.
Matthias  Maaz
Matthias Maaz
Director Life Sciences
Honeywell Process Solutions
Matthias Maaz is leading the global business for Pharmaceuticals and Specialty Chemicals at Honeywell Process Solutions. He started his career with Honeywell in 1990 and held various leadership positions in Projects Management and Sales as well as he is a Managing Director at Honeywell in Germany. Matthias holds a Diplom-Engineer degree for Process Control Technology from the University of Applied Science Leipzig. His office is in Offenbach, Germany.
Aude Cazenave
Aude Cazenave
Technical Director
Aesica
He is also Chair of CMAC (continuous manufacturing and crystalisation); a world class international hub for manufacturing research and training, with teh purpose of transforming current manufacturing processes into the medicine supply chain of the future.
Mary Moran
Mary Moran
Director - Manufacturing Science & Technology
Bristol Myers Squibb
Mary has held a number of senior positions at Britol Myers Squibb over the 22+ years with the company, inculding Manufacturing Manager, OPEX Director and Tech Transfer & External Manufacturing Director. In her current role her core focus is upon continuous improvement and development of advanced manufacturing technology and techniques within the organisation.
Teresa Rodo
Teresa Rodo
SVP Pharma Operations
Merck
Markus Hayek
Markus Hayek
MD Supply Chain & Operations Strategy
Accenture
Markus is currently Managing Director at Accenture Strategy, where he leads the global Life Sciences Supply Chain & Operations Strategy Practice. In this role he leads the consultative efforts of the firm with a range of global pharma and biotech companies on best practice operational strategy, drawing from extensive experience in the industry, including a decade within his current remit.
Coline Monnard
Coline Monnard
Process Data Specialist
UCB BioPharma
Lukas Utiger
Lukas Utiger
President of Drug Substance
Patheon
Dr. Helge Berg
Dr. Helge Berg
Director BioManufacturing Science Network Europe
Merck
Biomanufacturing Science Network expertise continuously gathered in the vaccine, biotech and plasma industry, with European experts in clarification (NFF and TFF), ultrafiltration, chromatography, virus removal filtration and sterilizing grade filtration technology and associated hardware. Personally, in depth expertise in virus removal solutions in the biotech, plasma and vaccine industry. Active support in numerous feasibility, scale-up and implementation projects. Active support in numerous validation spiking studies for the biotech and biopharmaceutical industry (monoclonal antibodies, recombinant proteins, plasma proteins and therapeutic vaccines). Vast experience in virus removal filtration implementation strategies in the biotech and biopharmaceutical industry. Involved in the development of alternative spiking strategies with Millipore’s US Biomanufacturing Science Network experts. Further in depth experience in clarification and membrane filtration applications in the Pharmaceutical and Biopharmaceutical industry. The team involved and experienced in Tech Transfer projects for the biotech and biopharmaceutical industry, making use of the Biomanufacturing Sciences Network expertise. I have publically presented at conferences like the World Vaccine Congress in Lyon (FRA) and Washington (USA) and the Viral Safety Congress in Köln. I am a member of the American Chemical Society (ACS) BIOT division.
Jon-Paul Sherlock
Jon-Paul Sherlock
Director, Intelligent Pharmaceutical
AstraZeneca
I lead Technology Strategy and Process Engineering for AstraZeneca Operations, with responsibility for the implementation of manufacturing technologies that improve quality and process robustness, improve supply chain agility and reduce cost. I am a chemical engineer and joined AstraZeneca after completing a PhD. Prior to my current role, I led the development of innovative digital health solutions for emerging and established respiratory medicines. Before that I held senior roles in chemical, analytical and product development, supporting multiple therapeutic areas and all clinical phases including commercialisation. I am passionate about innovation and founded significant collaborations between industry and academia in the areas of formulation and physical processing, advanced manufacturing technologies and future pharmaceutical supply chains.
Thomas Gübeli
Thomas Gübeli
Executive Director Global Internal Manufacturing Quality
Celgene
Thomas Guebeli has a Master Degree in Pharmaceutical Sciences and a PhD in analytical chemistry from the University of Bern, Switzerland. He completed a post-doc at the University of Washington in Seattle before joining Sandoz in Analytical R&D in 1992. At Sandoz, Thomas did a 2-years job rotation in Japan to build a GMP system in R&D. He then was responsible for the analytical R&D department in chemical & analytical development at Novartis and thereafter joined the Ivers-Lee group as head of Technical Operations before joining Celgene in 2006 as Senior Director International Quality Operations. In his current function, he is responsible for Quality Operations of four internal manufacturing sites as well as for Quality Systems at the Celgene Affiliates worldwide.
Gary Butler
Gary Butler
VP Site Director
Avara
Cornelia Thieme
Cornelia Thieme
Director Global Manufacturing Science Europe
Biogen
Cornelia is a biotech and chemical engineer by training. She has more than 20 years experience in pharmaceutical industry for API, Injectable and oral drug product manufacturing. Cornelia started her career as Scientist in formulation and process development and was in various roles over the years working as Tech Transfer Manager, CMC and Product Manager for developed as well as emerging markets. In 2015 she joined Biogen. In her current role as Director of Global Manufacturing Science she is leading the European teams who provide scientific oversight to products and processes at internal and external manufacturing sites.
Richard Middleton
Richard Middleton
Director, Central Engineering - Europe/Asia
Catalent
Richard leads all pharmaceutical engineering projects >$1M for Catalent in Europe and Asia, covering 18 sites in 10 countries across development, manufacturing and supply. Richard has been in the Pharmaceutical sector for more than 16 years and was with Lilly in a Global Process Improvement role prior to joining Catalent in September 2017. Richard has an MBA, a Degree in Mechanical Engineering for Imperial College London and is a Fellow of the Institution of Mechanical Engineers in the UK.
Cor Muilwijk
Cor Muilwijk
Senior Manager Process Excellence
J&J
Leading the automation department at the modern biotech pharma supply chain facility of Janssen in Leiden, Netherlands. Member Site Leadership Team. Managing the content, execution and visualisation of automated manufacturing processes. Deploying S88, S95 and other industry standards. Developing people, sponsoring local and global program implementations, managing budgets. Global roles in standardization and corporate behaviour (credo). Green belt Process Excellence. ITIL v3 EXPERT certified. Creativity and Innovation Leadership champion. Fluent Dutch, English, pretty good German. Broad interests and diversity/cultural awareness.
Brian Boland
Brian Boland
Manufacturing Technology Director
Bristol Myers Squibb