Vadim Klyushnichenko

Vice President, Pharmaeutical Development & Quality, CALIBR at Scripps Research
When
May 2021
Where
Dublin, Ireland
Castleknock Hotel, Castleknock, Dublin 15
With more than 30 presentations given over two days, leaders in biopharmaceutical production explore the latest technologies and manufacturing strategies for next-generation biologics and advanced therapies. This meeting focuses on key challenges within the field, evaluating innovative solutions such as continuous bioprocessing, SUTs, data integrity, PAT and the implementation of industry 4.0, all of which aim to increase the efficiency and yield of therapeutic production whilst maintaining high-quality standards. Once again, this meeting features a track dedicated to the manufacturing of cell and gene therapies, exploring both the regulatory and manufacturing challenges of these complex products.
“There was a broad range of topics with high-level of content” Delegate – Medical Solutions Business
“I appreciated the subject matter of presentations and diversity of presenters. The regulatory track was very good.” Delegate Pharmaceutical Company
“The meeting had a really good overall feel to it, and the range of speakers was interesting with some great insight into the challenges that face the industry.” Speaker Pharma company
“This was a great opportunity to network with other participants and with the sponsors. Also the content of the presentations was excellent.” Sponsor
2021 Featured speakers – meet all the speakers here
Day 1 | |
The Biomanufacturing Strategies to Meet the Needs of Multiple Modalities in Biologics Judy Chou, President / CEO, AbGenomics |
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Perspectives of Vaccine Development and Manufacture Tony D’Amore, Vice President, Product R&D, Sanofi Pasteur |
|
High Cell Concentration Banking for Seed Train Reduction on Fluoropolymer Single-Use Bag Jonathan Cartoux, EMEA Field Application Engineer, Entegris |
|
Poster Presentations | |
Track 1: Next-Generation Technologies & Novel Manufacturing Strategies | Track 2: Quality Control, Bioanalytics & the Regulatory Landscape |
Digital Design and Optimization of Bioprocessing Operations Christian Witz, Head of the Computational Bioprocess Engineering Group, Institute for Process and Particle Engineering, Graz University of Technology |
Biologics & Regulation: The Next Generation David Murray, Pharmaceutical (Quality) Assessor – Biologics, HPRA |
Learnings & challenges in industrialization of biopharmaceuticals Amir Goudarzi, Head of Process Engineering,Biologics Pilot Plant, UCB |
Regulatory challenges of ATMP manufacturing Baerbel Grossman, Associate Director, Global Regulatory Affairs CMC, Sanofi |
Solution Provider Presentation – Securecell AG Alexandra Hofer, Business Development Manager Numera, Securecell AG Paul Kroll, Business Development Manager, Lucullus, Securecell AG |
Solution Provider Presentation – Gyros Protein Technologies Maria Gianelli, Field Application Specialist, Gyros Protein Technologies |
Lunch | |
Real-time monitoring of cell viability during a bioprocess Michael Butler, Emeritus Professor and Principal Investigator in Cell Technology, NIBRT |
Attribute-Focused Methods for Building Robust Control Strategy Tapan Das, Director, Analytical Development, Bristol-Myers Squibb |
Monitoring and Controlling Critical Components in Cell Culture Process using Advanced Process Control Ensure process robustness and productivity in scale up operations using advanced process control Caitlin O’mahony Hartett, R&D Scientist, BioTherapeutics Development Large Molecule, Janssen Sciences, Ireland |
An Integrated Multi-Omics (BTI-Biomodel) Platform Includes New Software for Automated Detailed Glycan Analysis to Aid QBD and Process Control Pauline Rudd, Visiting Investigator, Bioprocessing Technology Institute, A*Star Institute |
Polisher ST – A novel salt tolerant flowthrough chromatography technology to improve your downstream process HANI EL-SABBAHY, Life Science Application Engineer. Separation and Purification Sciences Division, 3M Polisher ST – A novel salt tolerant flowthrough chromatography technology to improve your downstream process |
|
Opening the “Black Box”: An Innovative kLa Measurement Procedure for Bioreactor Characterization & Optimization. Thomas Maischiberger, Process Engineer & Project Development, ZETA GmbH |
Solution Provider Presentation Senior Representative 3M |
Poster Presentations | |
Solution Provider Presentation – TQS Integration | Solution Provider Presentation – Malema |
PANEL DISCUSSION: Industry 4.0: Challenges and Implementation Invitations out to Senior Representatives |
Roundtables 1. Control Strategy Cathrina Houlihan, Site Control Strategy Lead, New Product Industrialisation & Devices, Sanofi (Reserved) 2. Reimbursement strategies & health economics Dolores Cahill, Professor of Translational Science, University College, Dublin, Ireland 3. Introducing Quality to Translational Research Elmer Mendez Rosario, cGMP Specialist II, Office of Translational Production & Quality, Houston Methodist Research Institute, USA |
Networking Drinks Reception | |
Day 2 | |
Topic: Transformational Companies in Gene Therapy Rahul Singhvi, Flagship Pioneering |
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Recent Developments in the use of Capillary Electrophoresis in Gene Therapy Research and Development Steve Lock, Marketing and Market Development Manager, SCIEX, CE EMEAI |
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Track 1: Next-Generation Technologies & Novel Manufacturing Strategies |
Track 2: Manufacturing Cell & Gene Therapies |
Towards Continuous Processing In Biopharmaceutical Manufacturing: Approach and Considerations Matthew Cheeks, R&D Director, Biopharmaceutical Development, AstraZeneca |
Lentiviral Vector Manufacturing and analytics – Opportunities, Challenges and Ways Forward Simon Watson, Scientific Investigator, GSK |
Poster Presentations | |
Development and manufacturing of immuno-oncology products through global CDMOs Vadim Klyushnichenko, Vice President, Pharmaceutical Development and Quality, Calibr, Scripps Insititute |
Capillary electrophoresis and liquid chromatography for characterisation of AAV vectors Stuart Taylor, Analytical Development Scientist, Gyroscope Therapeutics |
External Manufacturing, Getting the best out of Contract Manufacturing Miriam Mccarthy, Head of Technical Services CMO EU, Takeda |
Optimisation of Upstream Processes for Viral Vector Delivery Beata Adamiak, Senior Manager, Process Sciences, Allergan |
Solution Provider Presentation – Labware Ltd | Solupore®- Next-Generation Non-Viral Cell Engineering Shirley O’Dea, Chief Scientific Officer, Avectas |
Lunch | |
Interfacing machine learning and process science for next level process development Moritz Von STosch, Senior Manager, Process Systems Biology & Engineering Center of Excellence, GSK Biologicals |
A practical look at Analytical methods across all stages of ATMPs Francesca Bellintani,Downstream Process Development Manager, Molmed |
Case study Mathieu Delannoy, Biotech Process Sciences Development Manager, Merck |
ATMP Manufacturing in CCMI- the story so far Aoife Duffy, Cell and Gene Therapy Operations Manager, Hitech-Health, Ireland |
Gene therapy process and analytics – AAV – TBC Phillip Ramsey,Vice President, Technical Development, Sangamo Therapeutics |
Delivering a Globally Compliant Allogeneic Cell Therapy for Low Back Pain Isaac Erickson, Director of Bioprocess Engineering & Global Market Development, DiscGenics |
Conference Ends |
The 2021 speaker panel is assembled from leaders in biopharmaceutical production and will ensure that you walk away with an increased understanding of novel manufacturing techniques and technologies.
Table 1: Legal Perspective for Cell and Gene Therapies
Lisa Kinsella, Head Legal NTO Biologics, Cell & Gene, Novartis
Table 2: Control Strategy
Cathrina Houlihan, Site Control Strategy Lead, New Product Industrialisation & Devices, Sanofi
Table 3: Reimbursement strategies & health economics
DOLORES CAHILL, Professor of Translational Science, University College Dublin, Ireland
Professor of Translational Science, University College Dublin, Ireland
Scientist BioTherapeutics Development, Janssen
Biotech Process Sciences Development Manager, Merck
Downstream Process Development Manager, Molmed
Vice President, Technical Development, Sangamo Therapeutics
Chief Scientific Officer, Avectas
cGMP Specialist ll, Office Of Translational Production & Quality, Houston Methodist Research Institute, USA
Scientific Investigator, GSK
Marketing and Market Development Manager, SCIEX, CE EMEAI
Field Application Specialist, Gyros Protein Technologies
Business Development Manager Numera, Securecell AG
Business Development Manager Lucullus, Securecell AG
Process Engineer & Project Development, ZETA GmbH
Director of Bioprocess Manufacturing, DiscGenics
Head of Process Engineering, BioPilot Plant, UCB
Associate Director Global Regaultory Affairs CMC, Sanofi
Chief Operating Officer, Takeda Pharmaceutical Company Limited
COO, Longboat Amniotics AB
Cell and Gene Therapy Operations Manager, Hitech-Health, Ireland
Emeritus Professor and Principal Investigator in Cell Technology, NIBRT
Director, Analytical development, Bristol-Myers Squibb
Head of Technical Services CMO EU, Takeda
Vice President, Pharmaeutical Development & Quality, CALIBR at Scripps Research
Senior Manager, Process Sciences, Allergan
R&D Director, Biopharmaceutical Development, AstraZeneca
Head of the Computational Bioprocess Engineering Group, Institute for Process and Particle Technology, Graz Univeristy of Technology
President / CEO, AltruBio, Inc.
Vice President, Product R&D, Sanofi Pasteur
Pharmaceutical (Quality) Assessor – Biologics, Health Products Regulatory Authority (HPRA)
Biopharmaceutical Application Engineering Specialist, 3M Separation and Purification Sciences Division
Analytical Development Scientist, Gyroscope Therapeutics
Professor of Translational Science, University College Dublin, Ireland
Scientist BioTherapeutics Development, Janssen
Biotech Process Sciences Development Manager, Merck
Downstream Process Development Manager, Molmed
Vice President, Technical Development, Sangamo Therapeutics
Chief Scientific Officer, Avectas
cGMP Specialist ll, Office Of Translational Production & Quality, Houston Methodist Research Institute, USA
Scientific Investigator, GSK
Marketing and Market Development Manager, SCIEX, CE EMEAI
Field Application Specialist, Gyros Protein Technologies
Business Development Manager Numera, Securecell AG
Business Development Manager Lucullus, Securecell AG
Process Engineer & Project Development, ZETA GmbH
Director of Bioprocess Manufacturing, DiscGenics
Head of Process Engineering, BioPilot Plant, UCB
Associate Director Global Regaultory Affairs CMC, Sanofi
Chief Operating Officer, Takeda Pharmaceutical Company Limited
COO, Longboat Amniotics AB
Cell and Gene Therapy Operations Manager, Hitech-Health, Ireland
Emeritus Professor and Principal Investigator in Cell Technology, NIBRT
Director, Analytical development, Bristol-Myers Squibb
Head of Technical Services CMO EU, Takeda
Vice President, Pharmaeutical Development & Quality, CALIBR at Scripps Research
Senior Manager, Process Sciences, Allergan
R&D Director, Biopharmaceutical Development, AstraZeneca
Head of the Computational Bioprocess Engineering Group, Institute for Process and Particle Technology, Graz Univeristy of Technology
President / CEO, AltruBio, Inc.
Vice President, Product R&D, Sanofi Pasteur
Pharmaceutical (Quality) Assessor – Biologics, Health Products Regulatory Authority (HPRA)
Biopharmaceutical Application Engineering Specialist, 3M Separation and Purification Sciences Division
Analytical Development Scientist, Gyroscope Therapeutics
Castleknock Hotel, Castleknock, Dublin 15
Porterstown Rd, Diswellstown Dublin, WNR7, Ireland
Castleknock Hotel is a 4 star country hotel located about 2 kilometres from Castleknock Village between The Phoenix Park and Blanchardstown. It was officially opened in April 2005 by an Taoiseach Bertie Ahern as part of the then Tower Hotel Group, since rebranded as FBD Hotels & Resorts in 2009.
Our vision is to be the number one hotel for conferencing, leisure and weddings in West Dublin.
All conference sessions
Lunches and refreshments
Access to exhibition room
All networking forums
Conference workbook
e-documentation pack
Option 1 – Please phone +44 (0) 1865 671957 ext. 207 and we will take your details over the phone
Option 2 – Please complete the form below to pay online
1,499.00€
Standard registration for those not in the categories below
599.00€
Click to select
1,899.00€
Fee for representatives of organisations offering services and/or business & technology solutions and also to business consultants.
Poster presentation sessions will take place in breaks and alongside the other breakout sessions of the conference. Your presentation will be displayed in a dedicated area, with the other accepted posters from industry and academic presenters.
We also issue a poster eBook to all attendees with your full abstract in and can share your poster as a PDF after the meeting if you desire (optional).
Whether looking for funding, employment opportunities or simply wanting to share your work with a like-minded and focused group, these are an excellent way to join the heart of this Congress.
In order to present a poster at the forum you need to be registered as a delegate. Please note that there is limited space available and poster space is assigned on a first come first served basis (subject to checks and successful registration).
We will require the form (downloadable below) to be submitted by the 1st April 2021. To simply have your poster at the meeting, submissions must be made no later than 1st April 2021. This is the formal deadline however space is another limiting factor so early application is recommended. Therefore please contact us with any questions you have as soon as possible.
Providing product purity, while protecting your process quality, efficacy, and efficiency
Discover Aramus™ single-use bag assemblies … see how 50 years’ experience in ultrapure materials offers the most protective, pure, and flexible assemblies. With one gamma-stable fluoropolymer film, one layer, a wide temperature range, and universal application, Aramus assemblies offer the power to increase your confidence, safety, and performance.
Entegris also offers scalable sensors, liquid packaging, and fluid handling solutions, while expertise in chemical delivery, process monitoring, and materials science delivers high performing, low E&L, and corrosion resistant solutions for laboratory to process-scale applications. Entegris provides product purity, faster time-to-market, while protecting process quality, efficacy, and efficiency.
https://www.entegris.com/lifesciences
×LabWare is recognised as the global leader of Laboratory Information Management Systems (LIMS) and instrument integration software products.
The company’s Enterprise Laboratory Platform combines the award-winning LabWare LIMS™ and LabWare ELN™, a comprehensive and fully integrated Electronic Laboratory Notebook application, which enables companies to optimise compliance, improve quality, increase productivity and reduce costs.
LabWare is a full service provider offering software, professional implementation services and validation assistance, training, and world class technical support to ensure our customers get the maximum value from their LabWare products.
Gyros Protein Technologies provides enabling peptide synthesis and bioanalytical solutions. Sensitive, accurate and robust nanoliter-scale immunoassays for bioanalysis and quantitating bioprocess impurities and viral titer are performed on Gyrolab® platforms. Solutions to accelerate development through manufacturing of safer, more efficacious biotherapeutics. Gyros Protein Technologies is a division of Mesa Laboratories.
www.gyrosproteintechnologies.com
×ZETA is one of Europe’s largest provider of engineering, automation and process technology for biopharmaceutical aseptic applications.
The engineering portfolio ranges from concept design for pilot plant and basic engineering, all the way through to detail engineering, automation, installation and commissioning. The interdisciplinary project team, composed of biotech experts, process, mechanical and automation engineers, develop fast-track-projects globally. Process characterization, scaling and design of processes are the key competences of ZETA – from lab to industrial scale.
×Our Vision
Securecell has been developing innovative solutions in bioprocess control for biotech and pharma for more than 25 years. We aim to be the trusted technology provider for optimized bioprocessing workflows through automated sampling and process information management in the bioprocessing environment.
What we offer
With our two main products – Lucullus PIMS and Numera – we offer a unique all-in-one PAT solution through automated sampling (Numera) and efficient bioprocess control and data management (Lucullus).
×Avectas is a cell engineering technology business, enabling the manufacture of cell therapies. Avectas’ technology, Solupore®, delivers advanced molecules such as DNA, mRNA, proteins and gene editing tools to a range of primary cell types including T cells for immuno-oncology and gene editing applications.
×TQS Integration provides strategic competitive advantage for customers via advanced visualisation and data analysis of real-time and historical data.
The strategic mission of TQS is to provide first class services to our valued customers worldwide by bringing together accurate and efficient advanced state-of-the-art techniques.
Developed from TQS Integration’s unmatched knowledge, with the latest technologies in global information technology and process control integration, we provide our customers the competitive advantage they need in an ever changing, highly competitive world.
https://www.tqsintegration.com/
×At 3M we work with our industry partners to develop better, more efficient manufacturing of safer products that transform lives. For over thirty years, our dedicated technical services and laboratory personnel has been solving the most complex biopharmaceutical manufacturing problems, while cutting-edge 3M technology addresses all your filtration needs. At 3M, we offer a portfolio of biopharmaceutical manufacturing products ranging from membranes, to chromatography filters, to depth filtration systems and process hardware that improve process efficiencies.
×As a successful family company in laboratory and process automation, we are a global leader in measurement instrumentation, services and solutions to help you deliver higher yield and improved product quality with reduced contamination risk and improved efficiency. We provide solutions for flow, level, pressure, analytics, temperature, recording and digital communications. Additionally, our Kaiser Raman spectroscopy portfolio provides in situ, real-time analysis of nutrients, metabolites, product quality, and cell viability with a single probe.
https://www.ie.endress.com/en/industry-expertise/life-sciences
×BPS Crowthorne offers a synergetic ‘one-stop shop’ solution specifically for our Irish customers including pharmaceutical and biotech labs, universities, environmental service organisations etc. This is a unique solution in Ireland that offers the combined delivery of services ranging from independent R&D/ lab consultancy services to analytical instruments, validation of your containment and cleanroom facilities to a comprehensive range of freeze drying and process equipment from the market leaders in freeze drying and solvent removal technologies.
×Agilent Technologies Inc. (NYSE: A) is a global leader in life sciences, diagnostics, and applied chemical markets. With more than 50 years of insight and innovation, Agilent instruments, software, services, solutions, and people provide trusted answers to customers’ most challenging questions. To receive the latest Agilent news, subscribe to our Newsroom. Follow Agilent on LinkedIn, Twitter, and Facebook.
×Thermo Fisher Scientific is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
http://www.thermofisher.com/PAT
×From a small beginning in 1984 our business has grown to encompass many services and products, covering different market sectors and geographical regions. The focus of our business, however, remains the same. We are a service orientated company. Our mission is to provide a complete service to all our customers. Specific to Bioprocessing, we supply Bioreactors, MFCs, growth media, and more.
×ChemoMetec is a Danish founded company, which specializes in the development, manufacturing and sales of high-quality automated Cell Counters, Advanced Cell Analyzers and Image Cytometers to help streamline research, process development, and manufacturing processes for maximum efficiency. Our instruments are based on a patented, unique technology platform that ensures high quality analysis of results and consistency between samples.
×Andrew Alliance, a Waters Company, has developed cloud-native software called OneLab where experiments can be intuitively designed, repeatably executed, and tracked. Its award-winning Andrew+ Pipetting Robot and the Pipette+ Intelligent Pipetting System, both seamlessly connect with OneLab, as do its expanding range of connected devices, tools and labware. These enable rapid, programmable shaking and heating/cooling of microplates, magnetic bead separation, micro-elution for solid phase extraction, and the hands-free transfer of microtiter plates and centrifuge columns.
×Select which delegates you would like to meet in a series of prearranged twenty-minute one-to-one meetings, held during breakout sessions from the main conference agenda. Our conference team will be available at the sessions to ensure all your meetings take place on time.
Host your own half or full day pre or post event workshop to a dedicated audience around a subject of your choice. Global Engage will assist with the marketing of your workshop to provide a guaranteed audience.
Market to our event database and / or increase brand awareness through taking a poster position or sponsoring one of the refreshment breaks, lunches, drinks receptions or poster sessions. This can be supplemented by branding options such as placing your logo on the attendee lanyards or conference bags.
Showcase your technologies and products throughout the conference in the dedicated exhibition areas where all refreshment breaks and lunches take place, as well as the networking drinks reception at the end of day one.
Options include:
30-minute speaker presentations
Chairing / panellist positions during a 30-minute panel discussion
Hosting a 1-hour workshop within the conference program
For further details please contact
Tony Couch
Telephone +44 (0) 1865 849841 or
email [email protected]
Bentham Science Publishers is a major STM journal publisher of 130 plus print and online journal. Out of these, 40 journals have already registered good IMPACT FACTORS as per Journal Citation Reports® 2017. These titles have extensive readership mostly in Europe and North America. For a detailed profile please visit our website at http://www.benthamscience.com. Besides, Bentham Science publishes eBooks in all areas of Science, Technology and Medicine. Our eBooks provide professionals, academicians, corporate researchers, graduates and undergraduates worldwide with the most current information in their subject areas of interest. Our eBooks are also available in the ePub and Kindle formats besides the PDF edition here http://ebooks.benthamscience.com/. Bentham is offering attendees of this conference discounts on its publication. For more information click here
×Biobased Press (www.biobasedpress.eu) is an independent, non-sponsored website that takes a helicopter view of the biobased economy: it discusses business and research, and links the biobased economy to neighbouring areas like sustainability, biotechnology, energy, agriculture, policy and the economy. We also host the website www.precisioneconomy.com.
Contact
E-mail: [email protected]
Twitter : @biobasedpress
×Biomall.in is an online e-commerce marketplace that ships lab reagents, lab equipment & supplies worldwide. Visit Biomall.in now to buy laboratory, life science & diagnostic products from India.
×BiopharmaTrend.com is a market analytics agency providing in-depth insights about emerging companies, technologies, innovations and trends in the pharmaceutical and biotech industries. We are building BPT Analytics platform — an interactive market research and report generation tool, which automatically maps and visualizes information about the industry. It allows identifying industry partnership opportunities, tech vendors and CROs, business growth ideas, M&A and investment prospects, and much more.
We also publish insightful commentaries and reviews contributed by industry professionals, researchers, and business leaders.
×BioVox is a specialized life sciences news and communication platform keeping you up to date on the rapidly evolving life sciences sector in Belgium and on global scientific and industry trends. BioVox brings exclusive news, in-depth interviews, opinions, and insights on healthcare, agriculture and the bio-based economy.
×Mediaplanet are producing the 2019 Future of Manufacturing campaign which is launching through the Irish Independent and online at www.businessnews.ie from November 29th 2019. The campaign will feature expert thought leadership from key opinion leaders such as Matt Moran (BioPharmaChem Ireland).
Read more at www.businessnews.ie from November 29th.
×Global Information, Inc. is an information service company holding offices in 6 countries and have sales agency contracts with over 300 research companies around the world. We sell 30,000 market research reports published by these publishers and accept custom-made researches.
×Greater Copenhagen Life Science Magazine is the primary mouthpiece for the Medicon Valley region’s many companies and organizations within biotech, medtech and pharma as well as companies who have this segment as their customers or suppliers. The magazine is a place of gathering for all life science companies in Scandinavia.
×Insight Pharma Reports are written by experts in consulting and industry who collaborate with us to provide a series of reports that evaluate the salient issues in pharmaceutical technology, business, and therapy markets. Insight Pharma Reports are used by leading pharmaceutical, biotech, diagnostic, consulting, and financial companies to keep abreast of the latest advances in pharmaceutical R&D, their potential applications and business impacts, and their current and future position in the marketplace.
×The Medicine Maker is a new publication focusing on manufacturing and development in the pharmaceutical and biopharmaceutical industry. The development and manufacture of new drugs and biological medicines draws on the talent, passion and experience of a wide range of professionals. The goal of The Medicine Maker is to integrate all aspects of the process, from clinical research through to commercial-scale production. The Medicine Maker combines topical news coverage with practical, pragmatic articles that are meaningful to the daily working life of experts in the regulatory, development and manufacturing fields. Feature articles tell the stories behind the biggest concepts, issues and advances in the field, covering business, policy and career development.
×Pharma Journalist is a paramount B2b online magazine platform exhibiting targeted and succinct information concerning the world of Pharmaceutical Industry therefore keeping a tab on the updated and latest updates and trends concerning the field.
×PharmaVOICE magazine provides readers with insightful and thought-provoking commentary about the challenges and trends impacting the life-sciences industry in a multiple-perspective format through articles covering a range of issues from molecule through market. PharmaVOICE’s more than 41,000 BPA-qualified subscribers are also kept abreast of the latest trends and information through additional media resources, including WebLinx Interactive WebSeminars, Podcasts, Videocasts, White Papers, E-Surveys and e-Alerts.
×World Pharma Today is a leading Magazine featuring latest industry developments for the Pharmaceutical C-level executives.
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