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SMi’s 4th Annual Conference
Lyophilization USA
November 15 - 16, 2018 | Iselin, New Jersey
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16% of the top 100 pharmaceutical drugs and 35% of biologic drugs are lyophilized. With more than 30% of the FDA-approved parenterals lyophilized and soon more than half injectable drugs to require lyophilization there is ample room for standardization and expansion of the lyophilization process in pharmaceuticals.
However, lyophilization is one of the most time consuming and expensive unit operations. There are many issues within lyopilization which need addressing, and improved drying technologies are needed for current and future products.

Join us this November 2018, as we look toward the future of lyophilization. Network with industry experts, discuss regulatory challenges and unmet needs within lyophilization, gain insights into innovative technologies and strategies to challenges within freeze-drying, discover new methods of scale-up and technology transfer, and explore alternative processes beyond conventional lyophilization.

View agenda on the Download Centre

Register to attend by September 28 to save $100 on booking fee

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Exclusive Q&A sessions with speakers
on key challenges within lyophilization field
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  • Alex Langford - Pfizer
  • Mohamed AbouGhaly - Purdue University 
  • Fabrice Schlegel - Amgen 
  • Timothy McCoy - Sanofi
  • Pouya Tavousi - University Of Connecticut

Interviews available on the Download Centre

Developing on last years’ success, Lyophilization USA 2018 will bring together industry experts to discuss and analyze the latest advancements and challenges within lyophilization. Some notable areas of interest have been new technologies and developments within lyophilization, challenges and unmet needs in lyophilization, regulatory challenges and validation of lyophilized products, scale-up and transfer and alternatives beyond conventional lyophilization methods

View agenda on the Download Centre

At the SMi’s 4th Annual Lyophilization USA 2018 Conference you will gain insight into:

  • Comparison between two methods of controlled nucleation from an industry perspective 
  • Freeze dryer characterization and application to drug product development and scale up 
  • Formulation and excipient selection for lyophilized product development of vaccines 
  • Challenges in lyophilized product development 
  • Panel discussion on process modeling  and simulation
  • Methods beyond lyophilization: Spray drying, foam drying and microwave drying
  • The future of lyophilization through participation in LyoHub

View agenda on the Download Centre

Key Job Titles: 

Presidents, Vice Presidents, Managing Directors, Directors, Associate Directors, Chiefs, Heads, Principals, Managers and Analysts of::

Freeze-drying/ Lyophilization
Formulation Scientist
Drug Products Development
Bioprocessing
Process Development
Sterile/ Fill-Finish
Production
PAT
CMC
Chemistry
Manufacturing
Quality Assurance/QA
Analytics
Technical Support
Manufacturing
Packaging
Technology Innovation
Engineering

Global Presence:

Attendees from all over the world attend our events, gain hands on insight from representatives from UK, Europe and USA.

Abon Pharmaceuticals LLC; Allergan; Amgen; Arlenda; Bayer Consumer Care; Bristol-Myers Squibb; Celgene Corporation; Cellphire; Coriolis Pharma ; Cureport, Inc; Ellab Inc; Elusys Therapeutics; Emergent BioSolutions Inc.; Explicat Pharma GmbH; Fujifilm Diosynth Biotechnologies; Genentech; GSK; iQ-Mobil; Janssen Pharmaceutical Company; Johnson And Johnson; KB Consulting ; Lyophilization Technology Inc; Lyophilization Technology, Inc.; Melinta Therapeutics Inc; Merck & Co.; Merck Research Laboratories; Patheon; PaxVax Inc; Pfizer; PROCESS SYSTEMS ENTERPRISE LIMITED; Regeneron Pharmaceuticals; Regeneron Pharmaceuticals Inc; REGENXBIO Inc.; Sandoz Pharmaceuticals; SCHOTT North America, Inc. Pharmaceutical Packaging; Takeda; University of Kentucky; Urogen; W.L. Gore & Associates, Inc; Windtree Therapeutics, Inc.;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Timothy McCoy

Timothy McCoy, Associate Director, Pharmaceutical Development Biologics , Sanofi
View Bio

9:10 Stability of lyophilized albumin formulation: role of excipient crystallinity and molecular mobility

Sampreeti Jena

Sampreeti Jena, Postdoctoral Associate, University of Minnesota
View Bio

  • Effect of pre-lyophilization composition
  • Characterization of crystalline forms
  • Characterization of secondary conformation of model protein
  • Characterization of secondary relaxation mechanisms in lyophiles
  • 9:50 Challenges of lyophilized product development

    Yanming Zu

    Yanming Zu, Director, R&D, Abon Pharmaceuticals LLC
    View Bio

  • Formulation challenges
  • Excipients selection
  • Dosage forms: solution, suspension, & oral melt
  • Route of administration: iv, im and oral
  • Solvents: aqueous and non-aqueous
  • API: biologics & small molecules
  • Process challenges
  • Device selections
  • 10:30 Morning Coffee

    11:00 ssHDX/MS for solid protein formulations

    Mohamed AbouGhaly

    Mohamed AbouGhaly, Post-Doctoral Research Associate, Purdue University
    View Bio

  • Current methods used for the characterization of protein stability in lyophilized formulations.
  • Solid state hydrogen deuterium exchange coupled with mass spectrometry (ssHDX/MS).
  • ssHDX/MS provide better correlation with accelerated stability results compared to other techniques.
  • Current understanding of ssHDX/MS and its limitations
  • 11:40 Reconstitution challenges of lyophilized highly concentrated protein products

    Robin Bogner

    Robin Bogner, Professor of Pharmaceutics , University Of Connecticut
    View Bio

  • Why highly concentrated protein products are difficult to reconstitute
  • Formulation strategies to improve reconstitution
  • Processing strategies to improve reconstitution
  • Packaging strategies to improve reconstitution
     
  • 12:20 Networking Lunch

    13:30 A new approach to drying pharmaceuticals: The atmospheric spray freeze drying (ASFD) process

    Tom Robinson

    Tom Robinson, Managing Director, Aerosol Therapeutics
    View Bio

  • The ASFD process itself and why it is such an innovative approach  
  • How ASFD differs from standard lyophilization and spray drying
  • Prospects for an efficient, cost effective alternative to standard manufacturing processes
  • Great potential for the broad utility of the ASFD process in drying pharma solutions
  • 14:10 Freeze dryer characterization and application to drug product development and scale up

    Timothy McCoy

    Timothy McCoy, Associate Director, Pharmaceutical Development Biologics , Sanofi
    View Bio

  • Characterization of bench, pilot and industrial scale freeze dryers
  • Product characterization & measurement of Rp
  • Application of models to the development of a lyophilization cycle
  • Scale up
  • PAT applications to development and scale up
  • 14:50 Afternoon Tea

    15:20 Embedding predictive in-silico models into Amgen’s lyophilization processes

    Fabrice Schlegel

    Fabrice Schlegel, Senior Engineer, Amgen
    View Bio

  • Operationalizing in-silico models through the deployment of web-based applications for:
  • Lyo process development
  • Tech transfer and scale up
  • Recovery from process deviation at the manufacturing scale (models as soft-sensors)
  • Beyond the vial model:
  • Roadmap for more complex first principle model
  • 16:00 Formulation and excipient selection for lyo product development of vaccines

    Sushma Kommareddy

    Sushma Kommareddy, Associate Director, Takeda
    View Bio

  • Challenges in handling labile vaccine antigen
  • Approaches for excipient selection and formulation
  • Long term product stability and potency assays
     
  • 16:40 Chairman’s Closing Remarks and Close of Day One

    Timothy McCoy

    Timothy McCoy, Associate Director, Pharmaceutical Development Biologics , Sanofi
    View Bio

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Mrinal  Shah

    Mrinal Shah, Sr. Manager, Global Pharmaceutical Technology, Allergan

    9:10 Comparing and contrasting two methods of controlled nucleation for use in lyophilization: A live viral vaccine (LVV) perspective

    Morrisa Jones

    Morrisa Jones, Senior Scientist, Merck

  • Evaluation of two methods of controlled nucleation: pressurization/ depressurization technology and “ice fog” technology
  • Can controlled nucleation impart consistency whilst maintaining vaccine potency?
  • Impact on cycle time, consistency and moisture levels
  • 9:50 Continuous monitoring of sublimation rate for individual containers in freeze drying processes

    Pouya Tavousi

    Pouya Tavousi, Postdoctoral Fellow, University Of Connecticut
    View Bio

  • Negating the need for conventional gravimetric measurements
  • Providing more accurate measurements than TDLAS
  • Introducing minimal disturbance to the freeze drying process
  • Facilitating data acquisition for recipe design
  • 10:30 Morning Coffee

    11:00 Development of Lyophilized Anthim® for Injection

    Colin Campbell

    Colin Campbell, Director, Process Development, Elusys Therapeutics

  • Liquid Drug product developed into Lyophilized Drug Product
  • Process Development, Transfer, Scale Up and Validation
  • Working with several CMOs
  • Working within US Government funding and regulatory restrictions
  • 11:40 End user challenges, perspectives and advantages of freeze drying technology

    Alexander Tambovzev

    Alexander Tambovzev, Project Engineering and Development Leader, OPTIMA pharma GmbH

  • Freeze dryer market trends
  • Cross contamination handling and process challenges
  • Considerations for lyophilization
  • 12:20 Networking Lunch

    13:30 Panel session: Process modelling and simulation

  • Need for modelling and simulation tools to support the design of lyophilized products
  • Developing models and simulations to characterize the impact of process variations on product quality using physics based and statistical approaches
  • Need for user friendly models
  • Simulations needed for accelerated lyophilization process development and closed-loop control
  • Fabrice Schlegel

    Fabrice Schlegel, Senior Engineer, Amgen
    View Bio

    Pouya Tavousi

    Pouya Tavousi, Postdoctoral Fellow, University Of Connecticut
    View Bio

    Timothy McCoy

    Timothy McCoy, Associate Director, Pharmaceutical Development Biologics , Sanofi
    View Bio

    14:10 How the freezing protocol can influence protein stability during lyophilization

    Rui Fang

    Rui Fang, Senior Scientist, Merck Research Laboratories
    View Bio

  • Understanding freezing-induced stresses to proteins
  • Impact of controlled ice nucleation on protein stability and batch uniformity
  • The role of residence time in the freeze-concentrate on protein stability
  • 14:50 Afternoon Tea

    15:20 Vacuum-foam drying of biotherapeutics: Process considerations and stabilization of human T cells

    Alex Langford

    Alex Langford, Senior Assoicate Scientist, Pfizer Inc
    View Bio

  • Development of vacuum-foam drying technology
  • Comparison of foam drying and freeze-drying
  • Future direction
  • 16:00 The future of lyophilization through participation in LyoHub

    Alina Alexeenko

    Alina Alexeenko, Associate Professor, Purdue University

  • Overview of unmet needs in lyophilization
  • Strategies to address these unmet needs
  • Future direction of lyophilization
  • LyoHub key action points
  • 16:40 Chairman’s Closing Remarks and Close of Day Two

    Mrinal  Shah

    Mrinal Shah, Sr. Manager, Global Pharmaceutical Technology, Allergan

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    FEATURED SPEAKERS

    Alex Langford

    Alex Langford

    Senior Assoicate Scientist, Pfizer Inc
    Alina Alexeenko

    Alina Alexeenko

    Associate Professor, Purdue University
    Fabrice Schlegel

    Fabrice Schlegel

    Senior Engineer, Amgen
    Morrisa Jones

    Morrisa Jones

    Senior Scientist, Merck
    Robin Bogner

    Robin Bogner

    Professor of Pharmaceutics , University Of Connecticut
    Rui Fang

    Rui Fang

    Senior Scientist, Merck Research Laboratories
    Sushma Kommareddy

    Sushma Kommareddy

    Associate Director, Takeda
    Timothy McCoy

    Timothy McCoy

    Associate Director, Pharmaceutical Development Biologics , Sanofi

    Alex Langford

    Senior Assoicate Scientist, Pfizer Inc
    Alex Langford

    Alex Langford is a Senior Associate Scientist in the Biotherapeutics Pharmaceutical Sciences division at Pfizer Inc. in Chesterfield, MO. Key areas of interest include; drug product development of protein-based therapeutics and vaccines, investigation of vacuum-foam drying to stabilize biologics in the dried state, and characterization and process development of suspension-based products. Alex is currently a graduate student in Pharmaceutical Chemistry at the University of Kansas and holds a B.S. in Chemistry.

    Alexander Tambovzev

    Project Engineering and Development Leader, OPTIMA pharma GmbH
    Alexander Tambovzev

    Alina Alexeenko

    Associate Professor, Purdue University
    Alina Alexeenko

    Colin Campbell

    Director, Process Development, Elusys Therapeutics
    Colin Campbell

    Dena Flamm

    Business Development Manager, Optima Machinery Corporation
    Dena Flamm

    Dena Flamm is a Business Development Manager for Optima Machinery Corporation. She is responsible for freeze dryer development in the North American market and has over 17 years of experience in the pharmaceutical industry. Studies include, an MBA in International Management from the University of St. Thomas with an undergraduate degree in Business and Physics.
     

    Fabrice Schlegel

    Senior Engineer, Amgen
    Fabrice Schlegel

    Fabrice has an MSc in Applied Mathematics and Scientific Computing from the MATMECA Engineering School (Bordeaux, France) and a MSc+PhD in Mechanical Engineering from MIT. As part of the Digital Integration and Predictive Technologies (DIPT) team at Amgen, he drives the development and deployment of computational models across the product lifecycle, to achieve the best patient experience. Fabrice has managed and completed several key projects with process development, spanning the spectrum of the drug substance, drug product, device and supply chain verticals.

    Mohamed AbouGhaly

    Post-Doctoral Research Associate, Purdue University
    Mohamed AbouGhaly

    Mohamed AbouGhaly is a postdoctoral researcher in Dr. Elizabeth Topp’s protein formulation lab at Purdue University. Originally from Cairo, Egypt, Mohamed received his BS in Pharmacy, MSc and PhD in Pharmaceutical Sciences from Cairo University where he started his academic career as an assistant professor. His MSc and PhD work focused on the formulation of controlled release gastroretentive and fast-melt sublingual tablets and bioequivalence studies in humans. A formulation scientist by training, Mohamed first joined Dr. Keith Chadwick’s lab at Purdue University in 2015 researching pharmaceutical process intensification by direct crystallization of drugs in porous matrices. In his current research, Mohamed focuses on studying the application of solid state hydrogen deuterium exchange coupled with mass spectrometry (ssHDX/MS) as a high-resolution technique for analyzing protein structure and matrix interactions in lyophilized formulations.

    Morrisa Jones

    Senior Scientist, Merck
    Morrisa Jones

    Mrinal Shah

    Sr. Manager, Global Pharmaceutical Technology, Allergan
    Mrinal  Shah

    Pouya Tavousi

    Postdoctoral Fellow, University Of Connecticut
    Pouya Tavousi

    Throughout my research career, I have focused on the development of state-of-the-art approaches for addressing one of the most challenging science problems, namely characterization and understanding the behavior of nanoscale biological systems as well as design, fabrication and manipulation of such systems. I have developed new techniques and computational and physical tools for studying biomolecular systems and the related manufacturing processes. My tools enable characterization, design and analysis of nanoscale biomolecular systems and facilitate the processes related to manufacturing such systems.

    Robin Bogner

    Professor of Pharmaceutics , University Of Connecticut
    Robin Bogner

    Dr. Bogner is Professor of Pharmaceutics in the Department of Pharmaceutical Science at the University of Connecticut where she is also a member of the Institute of Materials Science. She received her B.S. in Pharmacy from Rutgers University, M.S. from the University of Iowa, and Ph.D. from Rutgers University after which she joined the faculty of the University of Connecticut. Dr. Bogner’s research interests are focused on the characterization and dissolution of pharmaceutical solids, both freeze-dried parenterals and oral dosage forms. She teaches a course in mass transfer and in a freeze-drying course at the University of Connecticut. Dr. Bogner has served on several editorial boards, a USP committee, an FDA advisory committee and in various leadership roles in the American Association of Pharmaceutical Scientists (AAPS). Dr. Bogner is a faculty member of the National Institute for Pharmaceutical Technology and Education, a group of faculty from 17 universities with the mission of improving the way medicines are designed, developed and manufactured to meet the needs of patients in the 21st century (https://nipte.org/).She has been involved in the NIPTE since its inception, Dr. Bogner is a Teaching Fellow at the University of Connecticut, and Fellow of the AAPS.
     

    Rui Fang

    Senior Scientist, Merck Research Laboratories
    Rui Fang

    Rui Fang is currently a senior scientist in the sterile formulation sciences group at Merck. She received her Ph.D. degree in Pharmaceutical Sciences in the University of Connecticut co-advised by Prof. Robin Bogner and Michael Pikal. Her research is in the area of lyophilization to stabilize protein therapeutics. Prior to joining UConn, Rui received her B.S. in Pharmacy from Dalian Medical University, and an M.S. in Biochemistry from the University of Northern Colorado. Her research received the Thomas Jennings award at ISLFD and a Baxter Young Investigator award. Rui also dedicated herself in professional service activities such as organizing the 2015 and 2017 Gordon Research Seminar in Preclinical Form and Formulation for Drug Discovery.

    Sampreeti Jena

    Postdoctoral Associate, University of Minnesota
    Sampreeti Jena

    Sampreeti Jena received her PhD degree (2017) from Mechanical Engineering, University of Minnesota, where she pursued research in the Bio-stabilization lab. During PhD, she was the recipient of several prestigious awards, including the the Timasheff Award for best poster presentation at the 2015 Colorado Protein Stabilization Conference and the 2017 AAPS Graduate Student Research Award in Analysis and Pharmaceutical Quality. She is currently a postdoctoral associate in the Biochemistry department, University of Minnesota. Her research focuses on the development and characterization of biosensors for in vivo quantification of enzymatic activity. She completed her Bachelors (BTECH) in Mechanical Engineering from National Institute of Technology, Rourkela (2013).

    Sushma Kommareddy

    Associate Director, Takeda
    Sushma Kommareddy

    Sushma Kommareddy has a Ph.D. in Drug & Gene delivery with twelve years of experience in development of vaccines. She is currently working as an Associate Director of Formulation & Drug Product Development at Takeda Vaccines. In her experience at Takeda and Novartis, she worked in different capacities to lead multiple viral, subunit and nucleic acid vaccine candidates through clinical development. During this period, she also served as Principal Investigator of external collaborations on exploring new technologies for delivery of vaccines and related biologics. In her current role, she is responsible for development of lyophilized multi-dose product for Takeda’s dengue vaccine.

    Timothy McCoy

    Associate Director, Pharmaceutical Development Biologics , Sanofi
    Timothy McCoy

    In his current role, Tim has responsibility to lead the Global Lyophilization Center of Excellence at Sanofi R&D, leading Drug Product development programs from first in human to commercialization & launch and leading a team of scientists in execution of development studies associated with these programs. Tim’s responsibility also includes Drug product leadership from first in human through to commercialization and launch. Tim has approximately 17 years’ experience in fill finish and specifically freeze drying spanning from development & scale up, through to manufacturing. Tim joined Sanofi R&D in March 2018, having being with Sanofi industrial Affairs (IA) for 5.5 years. While in IA, Tim led a drug product manufacturing sciences team, with expertise in bioinjectables and specifically, Lyophilization development and scale up. Tim previously held positions at Wyeth, Ireland and Boehringer Ingelheim, USA. In his career to date, Tim has worked with small molecules, vaccines and proteins in both aqueous and co solvent systems. Tim also focuses on freeze dryer system comparability and scalability, where he works on modeling heat and mass transfer of both bench and commercial freeze dryers to simplify cycle development and scale up. Tim holds a Bachelor’s Degree in Biochemistry and an MSc by research in Biopharmaceuticals. His MSc thesis was focused on Freeze Drying of Protein formulations above the collapse temperature.

    Tom Robinson

    Managing Director, Aerosol Therapeutics
    Tom Robinson

    Dr. Robinson is a founder of Aerosol Therapeutics and serves as Managing Director. He focuses on the Atmospheric Spray Freeze Drying (ASFD) process, starting with intellectual property and extending to all aspects of ASFD development. This includes testing, to scale-up, to equipment manufacturing. Dr. Robinson worked in pharmaceuticals as a physician for over 20 years at several companies such as Pfizer and Sankyo. His broad experience spans a number of positions in clinical development, marketing, and management. He has worked in many different product categories and has guided several programs, including Procardia, Procardia XL, and Benicar, through the NDA approval process.

    Yanming Zu

    Director, R&D, Abon Pharmaceuticals LLC
    Yanming Zu

    Dr. Yanming Zu is currently the Director of Formulation R&D at Abon Pharmaceuticals, responsible for the generic and proprietary product development. Abon’s product portfolio encompasses diversified Drug Delivery Systems (DDS) and dosage forms including immediate and extended release products via intramuscular, subcutaneous, intravenous, oral, ocular, and transmucosal routes of administration. Dr. Zu received her Ph.D. in Pharmaceutics from University of Illinois at Chicago and is a Registered Pharmacist. Dr. Zu started her career as a Formulation Scientist at Barr Pharmaceuticals in 2001, and served as Senior and Principle Scientists. She joined Abon Pharmaceuticals in 2009 at the startup of the company. Dr. Zu’s research and development work contributed to a number of ANDA filings and approvals, and generated several patents, research papers, review articles and presentations.

    Sponsors and Exhibitors

    Official Associations

    Supporting Media Partners

    Workshops

    Current and Future Freeze-Drying Technologies and Methods
    Workshop

    Current and Future Freeze-Drying Technologies and Methods

    Renaissance Woodbridge Hotel
    14th November 2018
    Iselin, USA

    NIPTE: Insight into the fundamentals of Freeze-Drying / Lyophilization
    Workshop

    NIPTE: Insight into the fundamentals of Freeze-Drying / Lyophilization

    Renaissance Woodbridge Hotel
    14th November 2018
    Iselin, USA

    VENUE

    Renaissance Woodbridge Hotel

    515 US Highway 1 South, Iselin, New Jersey, USA

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

    HOTEL BOOKING FORM

    Chair Letter - Timothy McCoy, Sanofi

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    Presentation by Dr. Andrea Weiland, Explicat Pharma GmbH

    Download

    Presentation by Melissa Lash, Janssen

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    Presentation by Adam Viverette, Melinta Therapeutics

    Download

    Presentation by Pavol Rajniak, PSE

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    Presentation by Katherine Bowers, Diosynth Biotechnologies

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    Presentation by Kelly M. Forney-Stevens, GSK

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    [INTERVIEW] - Yanming Zu, Abon Pharmaceuticals

    Download

    [INTERVIEW] - Alex Langford, Pfizer

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    [Programme] - Lyophilization USA

    Download

    [Interview] - Pouya Tavousi, University of Connecticut

    Download

    [Interview] - Timothy McCoy, Sanofi

    Download

    [Interview] - Mohamed AbouGhaly, Purdue University

    Download

    [Interview] - Fabrice Schlegel, Amgen

    Download

    [Speaker Line-up]

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    [Programme] - Workshop B

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    [Programme] - Workshop A

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    [Attendee list]

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    Sponsors and Exhibitors


    Ellab

    Sponsors and Exhibitors
    http://www.ellab.com

    Ellab is an industry leading manufacturer of wireless dataloggers and wired thermocouple validation systems used in the pharmaceutical industry. Outside of temperature sensors Ellab offers vacuum, pressure, CO2, and RH sensors. Specifically, for the lyophilization process, Ellab specializes in analyzing shelf and product temperatures within a full lyophilization cycle.


    Optima

    Sponsors and Exhibitors
    http://www.optima-packaging.com/en-us

    Optima Pharma develops and manufactures packaging technologies for pharmaceutical products. Systems from Optima Pharma are used to process blood plasma products, vaccines, oncology and biotech products. Our extensive technology portfolio includes washing machines, sterilization tunnels, filling and sealing, robotic product handling, freeze drying systems, isolator technology and other functions.

    Media Partners


    Pharma Journalist

    Supporting Media Partners
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    IPI

    Supporting Media Partners
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    pharmaphorum

    Supporting Media Partners
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    World Pharma News

    Supporting Media Partners
    http://www.worldpharmanews.com/



    Biocompare

    Supporting Media Partners
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Technology Networks

    Supporting Media Partners
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    American Laboratory

    Supporting Media Partners
    http://www.americanlaboratory.com

    For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.


    Pharmalicensing

    Supporting Media Partners
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc


    Drug Discovery Today

    Supporting Media Partners
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today is one of the most cited review journals in the field of drug discovery, with an impact factor of 6.422.
    Drug Discovery Today will benefit your research by helping to keep you up-to-date with all of the fast-moving and emerging topics in drug discovery. Each issue is packed full of the latest research news, peer-reviewed articles and comment and opinion from leading research scientists.


    Pharmaceutical Outsourcing

    Supporting Media Partners
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Gate2Biotech

    Supporting Media Partners
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    American Pharmaceutical Review

    Supporting Media Partners
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy

    Official Associations


    Swiss Biotech Association

    Official Associations
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.

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    Renaissance Woodbridge Hotel

    515 US Highway 1 South
    Iselin 08830
    USA

    Renaissance Woodbridge Hotel

    Your simple delights will become memorable moments at Renaissance Woodbridge Hotel. This distinctive hotel in Edison, New Jersey, features 269 modern guest rooms, including 42 suites, and more than 25,000 square feet of flexible meeting space. Our hotel's location is centrally located amidst corporate offices and tourist attraction. Our accommodations stand out from other hotels in Edison, NJ, and provide a sophisticated retreat for families and business travelers alike. Marriott's Plug-in panels and 37-inch LCD HD TVs allow guests simultaneous connectivity to laptops, iPods and DVD players. We are one of the most conveniently situated hotels at the crossroads of U.S. Routes 1 and 9. We are also just five minutes from Woodbridge Center Mall, 15 minutes south of Newark Liberty International Airport (EWR) and less than one mile from the Metropark train station. With our premier location and amenities, our Edison accommodations provide an advantageous travel destination.

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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