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Committee & Speaker Biographies

Committee & Speaker Biographies

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2020 PDA Universe of Pre-Filled Syringes and Injection Devices

Commercialization of Combination Products from Best Practices to Innovative Technology

October 5-8, 2020 Learn more
  • Olivia Henderson

    Olivia A. Henderson, PhD

    Amgen Inc.

    Dr. Olivia A. Henderson works in the Mechanical Engineering Methods Department at Amgen in Thousand Oaks, California, where she leads a group to qualify, validate, and transfer physical methods for combination products. Prior to joining Amgen, Olivia worked at Biogen for 13 years and has extensive experience in CCI, extractables/leachables, single use systems, parenteral filling operations, and contract manufacturing/analysis. Olivia earned a BS in Chemistry from Truman State University, and MS and PhD degrees in Pharmaceutical Science from the University of Missouri-Kansas City. Olivia is an active member of Parenteral Drug Association; she is the Pre-filled Syringes Interest Group Leader for North America and a member of the Biopharmaceutical Advisory Board.

  • Roman Mathaes

    Roman Mathaes, PhD

    LONZA

    Roman Mathaes is Head of Pharmaceutical Services at Lonza DPS. In this role, he is responsible for primary packaging development and testing as well as device testing, tox and technical batch drug product manufacturing and the Lonza DPS lab automation group.

    In his previous role at Lonza DPS, he was a Sr. Group leader in the Analytical Department performing drug product stability studies and leading the Lonza particle core facility.

    Before his assignment Roman, worked within the Roche/Genetech network Basel/San Francisco.

    Roman is a pharmacist by training and holds a PhD in pharmaceutical technology.

    Roman is a adjunct member of the Pharmaceutical Department University Basel and authored 30 research papers in the field of Biotech Drug Product Development.

  • Frank Bamberg

    Frank Bamberg, MBA

    CSL Behring

    Frank Bamberg has close to 20 years’ experience in the pharmaceutical industry in various leading roles such as in research & development, business development, and project management.

    Before joining CSL Behring in Bern CH as Associate Director for Medical Device and Primary Packaging, Frank has been with Hoffmann-La Roche since 2011 as Section Head Pre-Fillable Syringe responsible for the development of primary packaging and devices which will be in contact with the drug.

    Frank has gained experience in various positions at SCHOTT Pharmaceutical Packaging. He was also leading the global business development & customer service for Pre-Fillable Syringes.

    Frank holds an MBA in Industrial Engineering and Management from the University of Bern/Zürich and he is Plastics Engineer by training.

  • Theresa Bankston

    Theresa Bankston, PhD

    Becton Dickinson

    Theresa Bankston leads the WW Technical Services group for BD Medical – Pharmaceutical Systems that is responsible for providing technical support, solutions, and services around delivery systems for injectable drug therapies.

    She has over 20 years of combined experience in the pharmaceutical and medical device industries. Her areas of expertise include process chemistry and engineering development, analytical method development, and drug-container integration science.

    Theresa received her BS in Biochemistry from Florida State University and her doctorate in Chemical Engineering from the University of Virginia.

  • Markus Bauss

    Markus Bauss

    SHL Connect, SHL Group

    Markus has over 10 years' experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development.

    Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, Markus started his technology Start-Up company ConnectMeSmart GmbH in 2013.

    In 2015 SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their potential application within each of SHL Group’s companies.

    Markus graduated from Clausthal University of Technology with a degree in Process Engineering and Chemical Engineering.

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    Nic Bowman

    Pfizer
    Nic Bowman is the head of the Devices Centre of Excellence (DCoE) at Pfizer Ltd, based in Cambridge in the UK. Nic moved to Pfizer in 2008, as Director of Device Design and Development with responsibility for the design and development of novel drug delivery devices for Pfizer. Nic was promoted to Head of DCoE in 2011. Nic is a Fellow of the Institution of Mechanical Engineers (FIMechE). He is a regular conference speaker, and is named in more than 20 patents.
  • Anil Busimi

    Anil Busimi started his professional career in 2003 at SCHOTT AG in Germany. He worked in different positions including business development manager for microarrays, project manager for new business, and consultant in corporate strategy and development. In 2005, he moved to the business segment Pharmaceutical Packaging and played a key role in building long-term business strategy, market intelligence, product management and innovation for pharmaceutical systems business. From August 2009 until June 2016, he held various positions in global product management for pre-fillable syringe business (glass and polymer).  Currently, he is in the strategy & innovation team as senior global product manager for Cartridges and leads the iQ™ Platform market launch. He is a regular speaker at many conferences including PDA events.

    He holds M.Sc degree in Agriculture and Genetics and a MBA.

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    Joel Cotten

    Aptar Pharma

    Joel Cotten is the Business Development Manager at Aptar Pharma

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    Tibor Hlobik

    West Pharmaceutical Services Inc.

    Tibor Hlobik is the Sr. Director, Product Management at West Pharmaceutical Services Inc.

  • Laurent Jeanmart

    Laurent Jeanmart, PhD

    GSK Vaccines

    Laurent Jeanmart is head of Primary packaging and medical devices at GlaxoSmithKline Vaccine worldwide. He has more than 15 years of experience in the chemical and pharmaceutical sectors and worked for different companies. He has managed life cycle activities such as qualification, validation and implementation of elastomeric compounds (stoppers,…), new containers like vials, syringes, LDPE tube but also single use systems (bags,..).

    He has performed several studies about the compatibility between primary packaging and vaccines and also led life cycle development of secondary packaging items.

    Laurent is Chemical Engineer and graduated from Louvain-La-Neuve University (UCL Belgium) specialized in Polymer Science. He also has a PhD in Material Sciences based on glass surface treatments. He’s member of pharmaceutical associations and writer of scientific articles and patents.

  • Philippe Lauwers

    Philippe Lauwers

    Terumo

    Philippe Lauwers has been active in the medical device and pharmaceutical packaging sector for the last ten years with growing responsibilities in business development and technical roles. He is currently Director of Technology and Development at Terumo in Belgium.

    Philippe graduated in Biotechnology from the University in Ghent, Belgium and worked as a scientific researcher at the Catholic University of Leuven.

    Upon obtaining an additional degree in Biomedical Engineering at the Catholic University of Leuven he moved from an academic to an industrial environment.

    Philippe also serves as expert in ISO technical committees TC76 and TC84.

  • Lee Leichter

    Lee H. Leichter, MBA, RAC

    P/L Biomedical

    Lee Leichter has over 40 years experience, providing hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 20 years.  Projects have encompassed business, technical, regulatory and quality issues, mostly relating to drug delivery and combination products for marketing in the USA, Europe and Canada.  He has worked with large multi-national companies and start-ups successfully navigating the challenges posed during the development, testing and marketing approval of products that merge drugs with device systems.

    He serves as an independent expert on AAMI and ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and Human Factors committees, helping establish international standards for safety and performance of these products.  He initiated, and leads the ISO Workgroup developing a standard for Bolus injectors.  He has directly proposed and responded to FDA positions and proposals covering combination products, most recently as a consultant to the Combination Products Coalition.  He is also the Chairman of the PDA Combination Product Interest Group.

    He has helped organized and chaired several conferences dedicated to Combination products and Human Factors and has trained and presented on a multitude of topics over the last 20 years.and EU Regulatory Affairs from RAPS.

  • Manfred Maeder

    Manfred Maeder, PhD

    Novartis Pharma AG

    Manfred Mäder is Head of BTDM (Biologics Technical Development and Manufacturing) for Devices & Combination Products, Development and Commercialization since October 2015. Prior to this, he held the position Head of Global Compliance & Audit for Devices & Combination Products overseeing all Alcon, Pharma, and Sandoz sites producing this type of products and Global QA Head of Technical Research and Development at Novartis Pharma starting in February 2011.

    Prior to this position, he was Senior VP of Quality Management & Regulatory Affairs, at Ypsomed, a company producing Medical Devices and Combination Products starting in 2007. Previously, he was responsible for Quality Assurance Management at Sanofi-Aventis for the Frankfurt Injectables site. Before then, based in Kansas City/ US, he had a global responsibility for Quality and Regulatory for one of the Aventis Blockbuster products. Prior to that, he held several positions in QA and QC.

    By training, he is pharmacist and holds a doctorate in pharmaceutical analytics and statistics by the University of Wuerzburg/ Germany.

  • Hanns-Christian Mahler

    Hanns-Christian Mahler, PhD

    Lonza AG
    Since September 2015, Dr. Mahler has been leading the product development organization at Lonza AG. Prior this position, he led the department Pharmaceutical Development & Supplies, Biologics EU at Roche, Basel, Switzerland from 2010 to 2015 and as Head of Formulation R&D Biologics, Roche, Basel, from 2005 to 2010. From 2000-2005, Dr. Mahler was working at Merck KGaA, Darmstadt, Germany as Principal Formulation Scientist, Lab Manager for Protein Formulation Development and Clinical Trial Manufacturing and CMC Team leader for Erbitux during its submission and launch phase. Dr. Mahler studied Pharmacy at the University of Mainz, Germany, holds in Ph.D. in Toxicology from the Institute of Pharmacy, University of Mainz and Pharmacist specialization degrees in Toxicology & Ecology and Pharmaceutical Technology. He was further trained in Economy and Marketing. Dr. Mahler obtained his venia legendi (German Habilitation) from the University of Frankfurt/Germany in 2010 and is adjunct faculty and lecturer at the universities of Frankfurt (Germany), Kansas (Lawrence, US) and Basel (Switzerland). He was elected an AAPS Fellow in November 2013. His work experience includes early- and late-stage/commercial and line extension formulation development, primary packaging and device development, drug delivery, Drug Product process development, process characterization and validation, transfer to clinical and commercial drug product production and production support and preclinical and clinical (phase 1-3) Drug Product GMP manufacturing of parenteral dosage forms of biologics, small molecules, peptides and oligonucleotides.
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    Alessandro Morandotti

    Stevanato group Pharmaceutical Systems

    Alessandro Morandotti is the Senior Products Platform Leader at Stevanato Group Pharmaceutical Systems

  • Wenzel Novak

    Wenzel Novak, PhD

    Gerresheimer Bünde GmbH

    Wenzel Novak is the Global Senior Director Business Development MDS at Gerresheimer Bünde GmbH

  • Brigitte Reutter-Haerle

    Brigitte Reutter-Haerle

    Vetter Pharma International GmbH

    Brigitte Reutter-Haerle is the Vice President of Marketing / Corporate Communications for Vetter, a leading contract development and manufacturing organization that serves the global pharma/biotech industry. She was called to this new position in September 2014 and is responsible for the company’s international marketing activities, product and service management as well as HR marketing and internal communication. Between 2004 and 2014, she obtained the position of Director Corporate Marketing. In 2009, she led the communications program for Vetter’s U.S. expansion. Ms. Reutter-Haerle joined Vetter in 1996, serving in the company’s sales and marketing function, and transferred to corporate marketing three years later. She began her career in 1983, holding various positions in the sales organizations of firms including Hilton International and TNT Express Worldwide. Ms. Reutter-Haerle earned a B.A. and a degree in Business Administration from Baden-Wuerttemberg Cooperative State University. She has been leading the Prefilled Syringe Interest Group/Europe of the Parenteral Drug Association since 2007.

  • Mathias Romacker

    Mathias Romacker

    Mathias Romacker was most recently Senior Director, Device Strategy at Pfizer HQ in New York City. He joined Pfizer in March 2015. In this commercial role, he focused on the front end of device technology. He worked with multiple functions and sites across the organization to develop a device strategy for Pfizer pipeline and inline products.

    Previously, for a duration of 9 years, Mathias worked in the device area for Amgen in Thousand Oaks, California. Before joining Amgen, he held multiple sales and marketing positions with Becton Dickinson and Gerresheimer in Germany, South Africa, and New Jersey. Mathias holds a Masters equivalent degree in economics from the University of Freiburg/Germany.

    Mathias is on the PDA Board of Directors.

  • Ian Thompson

    Ian Thompson

    Ypsomed AG
    Ian Thompson has been with Ypsomed AG since 1995 in a number of roles in key account management and business development working with pharma companies to develop and bring to market innovative self-injection systems. He studied biochemistry and biotechnology in the UK from 1979-1983, working initially in commercial roles for fermentation technology. He has worked in medical device companies since moving to Switzerland in 1990. Since 2003 his main focus has been business development and new product innovation leading to the development and launch of a range of new pen and autoinjector custom products for Ypsomed Delivery Systems.
  • Karthik Vaideeswaran

    Karthik Vaideeswaran, PhD

    Eli Lilly and Company

    Dr. Karthik Vaideeswaran leads the integrated Surface/Polymer Science, Packaging Systems, Materials Engineering and Performance Testing groups focused on primary containers innovation as well as materials engineering and test methods development for combination-product delivery system development and commercialization.

    Dr. Vaideeswaran earned his Ph.D. in Polymer Science and Engineering from the University of Connecticut in 1997 and completed his post-doctoral fellowship in Surface Science at the University of Cincinnati in 1998. Additionally, Karthik earned an MBA from the University of Kentucky in 2004.

    Karthik has gained significant industrial experience of 20+ years in the areas of polymer engineering and advanced materials technologies while working at Lexmark International, Saint-Gobain Corporation, Celanese Corporation and now, Eli Lilly and Company; in diverse roles encompassing increasing technical and people responsibilities.

  • Gabriel Anderson

    Gabriel Anderson, BS Chemical Engineering

    Novartis

    Gabriel Anderson has over 12 years of experience with pre-filled syringes in the fields of drug product filling, visual inspection, and packaging. He has a chemical engineering degree from North Carolina State University and joined Novartis Vaccines in the US in 2011 as a production engineer responsible for developing the visual inspection and packaging manufacturing processes for vaccines in PFS. In 2014 he moved to Switzerland to take on a global role within Novartis in the manufacturing, science, and technology (MS&T) group for drug product manufacturing of biologics, and most recently has started a position in device and packaging development for biologic drug products.

  • Sujit Basu

    Sujit K. Basu, PhD

    Takeda

    Sujit Basu currently heads the Medical Devices Center of Excellence at Takeda. Sujit joined Shire in 2012 and built a world class device organization with team members in Lexington and Vienna. The scope of the Device CoE includes advanced drug delivery devices, combination products and packaging development, diagnostic devices as well as software, connected devices and eHealth solutions. Sujit has more than twenty five years of industry experience in pharmaceutical R&D, project leadership and manufacturing and is an inventor or author of more than 50 issued patents and patent applications and peer-reviewed publications. Sujit holds a BS in pharmaceutical technology and MS in pharmaceutical engineering from Jadavpur University in Kolkata, India, a PhD in pharmaceutical sciences from the University of Southern California, Los Angeles and certificate in management from Harvard University.

  • Natasha Bolick

    Natasha Bolick, MEngSc, PMP

    BD

    Natasha Bolick is an Associate Director in the Parenteral Sciences Center of Excellence at BD Technologies & Innovation (RTP, North Carolina, USA). She has a Bachelor’s degree in bioengineering from North Carolina State University (Raleigh, NC, USA), Master’s in biomedical engineering from University of New South Wales (Sydney, Australia), and Project Management Professional certification. She is currently pursuing her MBA at Duke University. Natasha has almost 20 years’ experience in medical device R&D, Product Development, Translational Science, Clinical Research, and Management. She has multiple patents and publications in research areas from implantable sensors to drug delivery devices. At BD, she leads a team in parenteral drug delivery technologies with emphasis on translational research through preclinical and clinical implementation.

  • Susan Dounce

    Susan M. Dounce, PhD

    West Pharmaceutical

    Susan is currently Director of Commercial Technology Development at West Pharmaceutical. Prior to joining West, Susan has held various technical, commercial and academic roles in the Healthcare industry with Datwyler, W.L. Gore and as an Adjunct Professor at Temple University.  She also serves as Vice Chair for the PDA Packaging Science Interest Group.  She holds a B.S. in Chemistry from the University of Rochester and a Ph.D. in Physical Chemistry from the University of Pennsylvania.

  • Christoph Egloff

    Christoph Egloff

    SHL Medical

    Christoph Egloff is Senior Manager of Innovation and Development at SHL Medical. Christoph supervises innovation, technical design, and manages teams in the newly established department. He brings expertise in developing products from concept to market. In the past, Christoph was the lead for all device platform technologies and oversaw development from customer request to actual solutions. He also has experience in equipment and installation of manufacturing site development.

  • Philipp Hoerner

    Philipp Hörner, B. Eng.

    Bausch & Stroebel

    Philipp Hörner holds a degree in industrial engineering.

    In 2014, he joined Bausch+Ströbel. He has several years of experience as a product manager in the fields of syringe and cartridge processing. His main responsibilities are market analysis and initiating new product developments to meet future market trends. He also supervises new primary packaging solutions in the market and acts as a member of the DIN group (German Institute for Standardization) for primary packaging.

  • Dewi Kodrat

    Dewi Kodrat

    SHL Medical

    Dewi Kodrat is the manager of Engineering Solutions at SHL Medical, leading a cross functional team that delivers a variety of novel development projects for connected drug delivery. These projects range from an early ideation phase up to transfer to production. Dewi has over 13 years of experience in the engineering field. Prior to joining SHL, she worked in both medical and consumer industries in a variety of design and development positions and has extensive knowledge of the regulated development process for medical devices. Dewi has a MS in Engineering Management from The University of Auckland (Auckland, New Zealand) and a BE in Electronic Engineering from the University of Waikato (Hamilton, New Zealand).

  • Holger Kranenburg

    Holger Kranenburg

    Franz Ziel GmbH

    Dr. Holger Kranenburg is a subject matter expert in No Touch Transfer (NTT) methodology, actively involved in writing guidance documents on NTT (Contamination Control Attributes and Qualification). With ten years of scientific background; Holger combined his passion for science and technology through working for Franz Ziel GmbH, a manufacturer of isolator technology and GMP compliance service provider. At Ziel, Holger has been involved in numerous aseptic filling line projects applying NTT to introduce RTU components. As an active member of the Pharmaceutical and Healthcare Sciences Society (PHSS), Holger strives to improve knowledge on aseptic processing and aseptic containment across the pharmaceutical community.

  • Jakob Lange

    Jakob Lange, PhD

    Ypsomed

    Jakob is an Engineer and Materials Scientist by training with an MSc degree in Chemical Engineering from the Royal Institute of Technology in Stockholm, Sweden and a PhD in Polymer Science from the Swiss Federal Institute of Technology in Lausanne, Switzerland. He has written and published more than 30 peer-reviewed papers on medical devices, packaging materials and polymers and is a regular contributor to technical and scientific conferences.

    Jakob started his professional career as a Research Scientist in packaging R&D with Nestlé at the Nestlé Research Centre in Lausanne, Switzerland. He then worked in R&D Management with GE Healthcare Biosciences in Uppsala, Sweden, before joining Ypsomed in Burgdorf in 2006.

    With Ypsomed he has held different positions within Marketing and Sales as well as in R&D Project Management. Currently he has the role of Senior Director Delivery Systems, overseeing two teams of Product Managers, one managing Ypsomeds autoinjector platforms and the other focusing on customer relationships for device development projects and marketed device products.

  • Hans Peter Manser

    Hans Peter Manser

    SHL Medical

    Hans Peter Manser is Senior Director of SHL Medical's Business Development team. He holds a diploma in Business Administration and Applied Technical Management. After working in the UK, Australia, US, France and Germany, he assumed sales management and executive functions in the communications industry with global responsibilities. Hans Peter transitioned to the pharmaceutical packaging business in 2001 and additionally moved to the medical device arena in May 2011 when joining Weibel CDS AG. There, he was responsible for the set-up and management of all administrative and commercial aspects of the company. In October 2016 he took overall responsibility for the company and successfully sold it to SHL Medical AG in March 2020.

  • Serkan Oray

    Serkan Oray, PhD

    UCB Pharma

    Serkan Oray leads the “Devices, Packaging, and Wearable Technologies” team at UCB Pharma and is based in Belgium. Over his career, he has progressed through diverse functions, including medical affairs, commercial, strategy, and technical operations. Over the past seven years, Serkan has led the device team whose members have successfully developed, industrialized, and launched several drug delivery devices, including those supporting certolizumab pegol. Beyond drug delivery devices, his role also covers all primary and secondary packaging as well as transversal support across UCB for innovative new biosensor technologies. Serkan is passionate about developing his team and providing an environment to drive excellence and deliver patient value.

  • Andrew Snow

    Andrew T. Snow, MSc

    Eli Lilly & Co.

    Andrew Snow, MSc, is a Mechanical Engineer who works within Eli Lilly's Delivery Device Development organization to design and commercialize combination products. Andrew is a proponent of applying adaptive platform design to maximize commercialization flexibility. Andrew has worked in Combination Product Design since 2015, contributing to the successful launches of Taltz, Emgality, and Baqsimi. Prior to joining Lilly, Andrew worked for Rolls-Royce PLC in structure and transmission design for multiple engine products. Prior to this, Andrew worked for Performance Sports Systems designing a broad range of institutional gymnasium equipment. Andrew earned both a Master of Science in Engineering and Bachelor of Science in Mechanical Engineering from Purdue University, West Lafayette.

  • Tom Van Ginneken

    Tom Van Ginneken

    SCHOTT

    Tom studied chemical engineering in Antwerp and added a MBA from the university of Sankt Gallen to his resume.
    After working in the chemical and pharmaceutical sector in Belgium for 3 years he joined SCHOTT in 2008. After different positions in the pharmaceutical product development department he became part of the product management team with focus on the SCHOTT TOPPAC® brand. In this role he works on the strategic orientation and innovation pipeline of the product group.

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2020 PDA Universe of Pre-Filled Syringes and Injection Devices

Commercialization of Combination Products from Best Practices to Innovative Technology

October 5-8, 2020 Learn more