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Due to the huge success of their UK event, SMi is delighted to present Pharmaceutical Microbiology East Coast, coming to New Jersey in November 2017!

The demand for rapid microbiology in the pharmaceutical industry is at an all-time high, with regulatory bodies expressing their concern about product safety, and the microbiology market constantly growing.
This continuous expanding of the market brings many new challenges, which need to be addressed to ensure prevention of contamination and other safety issues.

SMi’s Pharmaceutical Microbiology East Coast conference will not only discuss the challenges facing the microbiology field regarding the topic of contamination control and cleanrooms, but also take a closer look at strategies for rapid microbial sterility testing, the importance of environmental monitoring to prevent potential risks, bacterial endotoxin testing, quality control and new technologies, as well as regulatory issues and updates, such as the new draft of the annex 1.

 

The 2017 East Coast programme will feature industry relevant presentations and case studies, and an all-new senior professional speaker line-up. Join us this November to expand your knowledge in the microbiology field at this unmissable networking conference!

Previous attendee testimonials from Pharmaceutical Microbiology UK:

"A very enjoyable and informative conference in a good venue"

"Great conference, some valuable learning and networking. Thank you!"

"Very informative. Interesting topics discussed. Good location/services."

"Well organised conference with a good variety of topics!!"

"Great conference. All the speakers were very knowledgeable in their respective fields. Thank you!"
 

Previous attendees included:

 

Abbott Biologicals; Abbott Biologicals B V; Abbott Biologicals B.V; Astrazeneca; Atheris Laboratories; BD Life Sciences; BPL; Clean Air and Containment Review; Confarma France S A R L; Debiopharm Research & manufacturing SA; Dyson Technology Ltd; GE Healthcare; GSK; GSK Manufacturing S.p.A.; GW Pharmaceuticals; Hyglos GmbH; iDev; IDEXX Technologies Limited; Innaxon; International Confederation of Contamination Control Societies ; London Research Institute; Lonza Biologics Plc; Lonza Incorporated; Martindale Pharmaceuticals; MedImmune; Merck; Merck Chemicals Ltd; Merial; Merial Sas; Merial Saude Animal Ltda; Mettler-Toledo Ltd; MSD Animal Health; Nestle Research Center; Nova Laboratories; Novartis Vaccines; Oxford BioMedica; Pharmig; PHSS; Public Health England; Queen’s University, Kingston, Ontario; Sanofi Pharma; Sanofi-Aventis; Sigma Aldrich; STERIS Corporation; Teva UK Ltd; Trafalgar Scientific Ltd.; University of Southampton; Vetter Pharma-Fertigung GmbH & Co. KG; Wickham Laboratories Ltd

Conference programme

8:30 Registration & Coffee

9:00 Chair's Opening Remarks

Somdutta Saha

Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline
View Bio

9:10 The Role of Microbiology in Pharmaceutical Stability Programs

Tony Cundell

Tony Cundell, Principal Consultant, Microbiological Consulting, LLC
View Bio

  • Stability Study Requirements: R&D versus Marketed Products
  • What Microbial Tests are Stability Test Parameters
  • Stability Testing Appropriate for Different Dosage Forms
  • Managing the Stability Commitments in your Regulatory Filings
  • Investigating Stability Test Failures
  • 9:50 How does a Non-GMP Biopharmaceutical Pilot Facility deliver high run rate with high success?

    Geeta Singh

    Geeta Singh, Pilot Plant Technical Specialist III, Genentech
    View Bio

  • CHO and E. coli process development overview
  • Provide an overview of the premier Pilot Plant facility in Biotech USA that executes more than 1500 CHO and E. coli experiments per year to support Genentech’s pipeline
  • Discuss microbial contamination case studies and the lessons learned
  • Discuss how critical it is to maintain good health of the non-GMP facility to achieve high success rate

  • 10:30 Morning Coffee

    11:00 Amplified ATP Bioluminescence Rapid Sterility Test Validation Utilizing a Defined Method for Stressing Microorganisms

    Shawn Sweeney

    Shawn Sweeney, Sr. Process Development Manager, Charles River

  • Provides an efficient, and reproducible method for generating log reductions in microbial cultures
  • Comparative data / illustrations shall be presented to demonstrate stressing procedural efficacy
  • The impact of stressed organisms on Time to Detect, and Limit of detection shall be demonstrated
  • 11:40 Deciphering the Host-Microbe Interaction

    Somdutta Saha

    Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline
    View Bio

  • The microbiome is implicated in several chronic disorders
  • The metabolites produced by the microbes are chemical messengers interacting with host receptors
  • Studying this interaction will have important knowledge building around disease pathologies
  • 12:20 Networking Lunch

    13:30 Benefits of Real-time Monitoring of Airborne Viable Microorganisms

    James Hauschild

    James Hauschild, Principal Scientist, Johnson & Johnson
    View Bio

  • Bio-fluorescent active air particle counting of airborne viable microorganisms
  • Continuous real-time Environmental Monitoring of Classified Environments
  • Risk mitigation
  • 14:10 Iclaprim, a novel diaminopyrimidine, for the treatment of serious Gram-positive infections

    Rajesh Shukla

    Rajesh Shukla, Vice President Clinical Operations, Motif bio

  • Iclaprim addresses an unmet medical need in hospitalized patients with serious and life threatening infections including MRSA
  • Iclaprim possesses a differentiated product profile in target patient populations
  • Iclaprim provides a near-term product opportunity

  • 14:50 Afternoon Tea

    15:20 Microbial Environmental Control Assessment using Microbial Recovery Trends

    16:00 Quality Control Strategy on Low Endotoxins Recovery (LER)

    Joseph Chen

    Joseph Chen, Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical
    View Bio

  • Discuss common formulation ingredients in biologics cause LER
  • Risk assessment approach in mitigating LER impact on product quality
  • Case study on analytical solution to LER and alternatives

  • 16:40 Method Development

    Josephine Chan

    Josephine Chan, Microbiology Supervisor, Teligent Pharma Inc.

  • How to determine the Maximum Valid Dilution (MVD)
  • Endotoxin inhibition / enhancement
  • How to determine endotoxin limits on raw materials and excipients
  • 17:20 Chair’s Closing Remarks and Close of Day One

    Somdutta Saha

    Somdutta Saha, Post-Doctoral Scientist, GlaxoSmithKline
    View Bio

    8:30 Registration & Coffee

    9:00 Chair's Opening Remarks

    Geeta Singh

    Geeta Singh, Pilot Plant Technical Specialist III, Genentech
    View Bio

    9:10 Implementation of a Risk Based Model for Cleaning and Disinfection

    9:50 Training of Media Fill Inspection Operators

    Tony Van Hoose

    Tony Van Hoose, CEO & Founder, Global Aseptic Process Solutions, L.L.C.
    View Bio

  • Training Program Overview
  • Creation of Positive Containers
  • Test/Inspection Conditions
  • Certification of Operators
  • Recertification/Retraining – Frequency and Basis

  • 10:30 Morning Coffee

    11:00 KEY NOTE ADDRESS: Implementation of a Global Electronic Intervention Logging System

    Frederic Ayers

    Frederic Ayers, Consultant Scientist, Indianapolis Parenteral Operations, Eli Lilly And Company
    View Bio

    Sterility is one of the most critical quality attributes that all parenteral products must possess; yet, it is one of the most difficult to consistently and convincingly demonstrate. This presentation discusses an integrated, cross-functional strategy implemented within Eli Lilly and Company’s parenteral manufacturing network. This strategy identifies, assesses, documents, and evaluates the single largest source of microbial hazard within aseptic filling areas – aseptic personnel.

     

  • This presentation will describe an Aseptic Manipulation and Intervention Program, which establishes the requirements for how aseptic interventions and manipulations are identified, assessed, and executed
  • This presentation will describe the Intervention Logging System which allows for real-time electronic documentation of interventions performed on aseptic filling lines
  • This presentation will describe the Intervention Logging System which allows for real-time electronic documentation and approval of non-coded interventions performed on aseptic filling lines
  • This presentation will describe the use of RFID for documentation of Electronic Signature for activities within the aseptic areas

     

    Collectively, these provide quantifiable information that helps mitigate the risk of personnel-induced microbial hazard of products filled in aseptic environments. The discussion of these programs, along with several examples of how the data can be used to make quality decisions, will provide attendees with ideas of how microbiology process controls work together to provide evaluation of sterility assurance and data integrity.

     

    The attendees will understand the importance of developing a robust intervention strategy with appropriate definitions of activities. Additionally, identifying, assessing and mitigating all aseptic interventions and manipulations allow for consistent evaluation of filler performance across a platform.

  • 11:40 Endotoxin detection – What you need to know when running a quantification test

    Veronika Wills

    Veronika Wills, Technical Services Associate Manager, Associates of Cape Cod
    View Bio

  • Understanding the data of the kinetic photometric tests and the potential outcomes
  • Understanding the resolution of the test
  • In-depth discussion on inter-assay variability of the test and the causes
  • How to keep inter-assay variability under control
  • 12:20 Networking Lunch

    13:30 Designed microbiome therapies targeting the microbes and beyond

    Shahram Lavasani

    Shahram Lavasani, CEO, ImmuneBiotech AB
    View Bio

  • The gut microbiome plays an essential role in disease regulation and efficacy of therapies. Altered microbial communities, also termed dysbiosis, has been observed in many intestinal and extra-intestinal inflammatory disorders
  • There is not yet a clear understanding whether dysbiosis is a cause or a consequence of the diseases. Microbial therapies which only target the dysbiosis have shown limited success
  • A healthy gut microbiota exists in an equilibrium with the gut barrier and the immune system
  • The importance of multiple-target drug cocktails comprising commensal bacteria will be discussed. The bacterial library, screening technologies and design of potential and affordable drugs will be presented with particular focus on successful products that treat Irritable Bowel Syndrome (IBS) and Clostridium Difficile Infection

  • 14:10 Rapid microbial-detection methods

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute
    View Bio

  • The benefits, applications, pitfalls and challenges involved
  • Time to result benefits to manufacturing economics
  • Enhanced quality control impact on manufacturing risk
  • Overcoming the hurdles of new technology validation

  • 14:50 Afternoon Tea

    15:20 Biological Treatment of Emerging Contaminants Prevalent in Pharmaceutical Effluents

    Mengyan Li

    Mengyan Li, Assistant Professor, New Jersey Institute of Technology
    View Bio

  • Pharmaceutical wastewater commonly consists of contaminants of emerging concerns, such as antibiotics, estrogens, and 1,4-dioxane
  • Bacteria that can degrade or biotransform these xenobiotic compounds are more widespread than previously recognized
  • Modern culture-independent biotechnologies facilitate the identification of microorganisms with unique biotransformation capabilities
  • Biologically active filtration system is one of top effective and economical techniques for removal of commingled emerging contaminants in pharmaceutical waste streams
  • 16:00 Chair’s Closing Remarks and Close of Day Two

    Geeta Singh

    Geeta Singh, Pilot Plant Technical Specialist III, Genentech
    View Bio

    +

    FEATURED SPEAKERS

    Geeta Singh

    Geeta Singh

    Pilot Plant Technical Specialist III, Genentech
    Joseph Chen

    Joseph Chen

    Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical
    Shahram Lavasani

    Shahram Lavasani

    CEO, ImmuneBiotech AB
    Tony Van Hoose

    Tony Van Hoose

    CEO & Founder, Global Aseptic Process Solutions, L.L.C.

    Andrew Bartko

    Research Leader, Battelle Memorial Institute
    Andrew Bartko

    Dr. Andrew P. Bartko received a B.S. from the University of Pittsburgh in 1997 and a Ph.D. in physical chemistry in 2002. His graduate work consisted of deciphering spatially heterogeneous relaxation dynamics of glass forming systems using novel rotational single molecule microscopy techniques. In 2002, Dr. Bartko joined the Softmatter Nanotechnology and Advanced Spectroscopy Team at Los Alamos National Laboratory where he studied the ultrafast photophysics of semiconducting quantum dots. Dr. Bartko is a senior scientist in Battelle’s Technology Development Group where he contributes to several applied spectroscopy efforts that focus on biological and chemical sensing. He now leads Battelle’s Rapid, Enumerated, Bioidentification System development program.

    Frederic Ayers

    Consultant Scientist, Indianapolis Parenteral Operations, Eli Lilly And Company
    Frederic Ayers

    Mr. Frederic B. Ayers received a B.A. degree in Biology from Franklin College. After graduating, he spent two years working in the contract manufacturing industries (pharmaceutical, food) prior to joining Eli Lilly and Company in 2001. Since joining Lilly, Mr. Ayers has held various technical positions from which he has helped advance Lilly's state of regulatory compliance. He is responsible for developing and implementing sterility assurance related strategies at Lilly’s Indianapolis parenteral manufacturing site. Additionally, Fred is responsible for aligning the sterility assurance strategy throughout the company’s parenteral network.

    Geeta Singh

    Pilot Plant Technical Specialist III, Genentech
    Geeta Singh

    Geeta Singh has over 16 years of experience in Pharma Technical Development, at Genentech, A Member of the Roche Group. Geeta brings a broad and diverse perspective to her role as Technical Specialist in a premier Pilot Plant facility. She has experience in both mammalian and bacterial cell culture from lab to pilot plant scale. In addition to coordinating complex experiments for process development, she focuses on evaluating and implementing new technologies in analytics and process monitoring to enable faster and more efficient process development. Geeta also plays a critical role as team leader responsible for environmental monitoring, microbial controls and non-host contamination investigations in the pilot facility.

    Geeta holds a BS with honors in Business Administration from Notre Dame De Namur University, Diploma in Biotechnology, Clinical Trial Design, and Management, Pharmacy and Fashion Designing.

    James Hauschild

    Principal Scientist, Johnson & Johnson
    James Hauschild

    Jim Hauschild is a broadly trained Ph.D.-level microbiologist who is currently responsible for helping promote industrial microbiology innovations within J&J Sterility Assurance. Jim is a subject matter expert in rapid microbiological methods (RMM) and has a proven track record performing RMM feasibility assessments, assisting with RMM implementations and utilizing RMM instrumentation to design and execute in vitro antimicrobial proof-of-principle studies to help support product and business development within J&J. Jim is also knowledgeable in conventional sterilization technologies and sterilization process validation and has experience working with J&J new product development teams on difficult to sterilize products.

    Jim Polarine

    Senior Technical Service Manager, STERIS Corporation
    Jim Polarine

    WORKSHOP LEADER B: "CONTAMINATION CONTROL IN CLEANROOMS"

     

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for sixteen years. His current technical focus is microbial control in cleanrooms and other critical environments. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection in cleanrooms. Mr. Polarine is a frequent industry speaker and published several PDA book chapters and articles related to cleaning and disinfection and contamination control. He is active as co-chair on the PDA’s microbial investigations task force. He was a co-author on PDA’s Technical Report #70 on Cleaning and Disinfection. He is a member of the PDA’s Environmental Monitoring Group, Contamination Control Group, and Biotech Interest Group. He is president elect with the PDA Missouri Valley Chapter. He is part of the faculty at the University of Tennessee Parenteral Medication course. He is also active with the IEST Special Topics Committee on Cleaning and Disinfection. He has presented at key industry venues for NASA, USP, PDA, ISPE, FDA, SIMB, GBPR, IPA, AALAS, IVT, IEST, University of Tennessee, SWE, STERIS Applied Sterilization Technologies, and Barnett International on cleaning and disinfection, disinfectant validation, and contamination control. Mr. Polarine frequently presents global industry webinars on Cleaning and Disinfection for several industry seminar circuits including Compliance Online, STERIS, and Executive Conferences. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology, and is a member of the PDA, SIMB, ISPE, IEST, ASM, ASTM, AAAS, AOAC, and ACS. He previously worked as a clinical research coordinator with the Department of Veterans Affairs in St. Louis, MO and as a biology and microbiology instructor at the University of Illinois. His main hobby is storm chasing and is very active in tornado research and tornado safety.

    Joseph Chen

    Executive Director, CMC Quality Control, Ultragenyx Pharmaceutical
    Joseph Chen

    Dr. Chen is responsible for the QC function in all CMC analytical aspects from clinical production to NDA/BLA/MAA and product life cycle management at Ultragenyx. This includes operational and technical QC method development, validation and transfer for biologics and small molecule products manufactured at CMOs.

    Prior to joining Ultragenyx in 2015, he was the Director of Global Biologics Quality Control at Genentech/Roche, managing analytical method/technology and global microbiological control programs for 10 biologics production sites and IMP products manufactured at CMOs.

    Dr. Chen did his graduate study at UCSF on developing kinetic LAL assays and holds a PhD in Microbiology and Immunology from University of Rochester in New York. He has 25+ years of business and biopharmaceutical experience, including research and development, quality control, product safety compliance, regulatory CMC and risk management.

    Josephine Chan

    Microbiology Supervisor, Teligent Pharma Inc.
    Josephine Chan

    Mengyan Li

    Assistant Professor, New Jersey Institute of Technology
    Mengyan Li

    Mengyan “Ian” Li is an assistant professor in the Department of Chemistry and Environmental Science at New Jersey Institute of Technology. He received his Ph.D. degree in Environmental Engineering from Rice University in 2013. His primary research interest focuses on uncovering novel biodegradation metabolisms and biotransformation pathways for emerging contaminants and designing genetic forensic tools to facilitate the assessment of microbiological activities in environment. His research has been widely reported by news and web media. His novel catabolic biomarker design to evaluate natural attenuation of 1,4-dioxane won the AAEES Honor Award for the Excellence in Environmental Engineering and ScienceTM Competition.

    Rajesh Shukla

    Vice President Clinical Operations, Motif bio
    Rajesh Shukla

    Robert Ferer

    Strategic Practice Lead, Quality Executive Partners (QxP)
    Robert Ferer

    WORKSHOP LEADER A: "NAVIGATING THE REQUIREMENTS OF A MODERN QC MICROBIOLOGY LABORATORY"

    Shahram Lavasani

    CEO, ImmuneBiotech AB
    Shahram Lavasani

    Shahram Lavasani holds a PhD degree from Lund University (Sweden), in Medical Inflammation Research where he studied the immunoregulation and novel immunotherapies in multiple sclerosis (MS). He is a skillful immunologist with many years of research expertise on gastrointestinal complications in chronic inflammatory diseases. Focusing on Brain-Gut axis he has pioneered research in MS by demonstrating increased intestinal permeability and design of therapies targeting the gut microbiota. He is the founder of ImmuneBiotech, developed a proprietary lactobacilli library and established careful and multiple selection methods to screen and design formulations for the optimal therapeutic management of the diseases.

    Shawn Sweeney

    Sr. Process Development Manager, Charles River
    Shawn Sweeney

    Somdutta Saha

    Post-Doctoral Scientist, GlaxoSmithKline
    Somdutta Saha

    Somdutta Saha is presently working as a post-doctoral scientist at GlaxoSmithKline Plc. in their Collegeville, Pennsylvania, USA site where the broad focus is to computationally search for immunomodulators of microbial origin for fine tuning the microbial imbalance in several autoimmune and cardiovascular disorders. She received her Ph.D. degree in Bioinformatics from the University of Arkansas for Medical Sciences where she investigated the fundamental aspects of antigen-antibody interaction in the tumor microenvironment using several computational approaches under the mentorship of Dr. Thomas Kieber-Emmons. Her area of expertise is structure based drug design, cheminformatics and bioinformatics.

    Tony Cundell

    Principal Consultant, Microbiological Consulting, LLC
    Tony Cundell

    Dr. Tony Cundell consults with a number of pharmaceutical, consumer health and beverage companies, microbiology instrument manufacturers, contract testing laboratories and sterile compounding pharmacies in the areas of microbial risk assessment, regulatory affairs, and microbiological testing. Prior to November 2013 he worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, Tony Cundell worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.

    He is a member of the 2015-2020 U.S.P. Microbiology Committee of Experts. In June 2009, he co-edited with Anthony Fontana a book entitled Water Activity Applications in the Pharmaceutical Industry and contributed two chapters to the book. He was co-chair of the PDA task force responsible for 2014 Technical Report #67 Exclusion of Objectionable Microorganisms from Non-Sterile Drug Products. In 2015 he was appointed to the Advisory Committee of Sterile Compounding to the State of Massachusetts Board of Pharmacy. Recently he received the 2016 PDA Martin Van Trieste Pharmaceutical Science Award for outstanding contributions to the advancement of pharmaceutical science.

    Tony Cundell has a Ph.D. in Microbiology from the Lincoln University, New Zealand.

    Tony Van Hoose

    CEO & Founder, Global Aseptic Process Solutions, L.L.C.
    Tony Van Hoose

    Tony has been involved in the pharmaceutical industry for over 35 years as a Quality Assurance/Quality Control professional both for operating companies and as a consultant. Tony holds a B.S. degree in Microbiology from Auburn University. He has been a presenter at numerous IVT, ISPE, PDA and ASM conferences and has been an invited presenter for the FDA Aseptic Process Inspector Training classes. Currently Tony is employed as a Director of Sterile Technologies Expertise in the Global Manufacturing Quality Operations group at Sanofi. In this role he supports all of the sterile injectable manufacturing sites in from a Quality technical standpoint and manages a sterile technology network within Sanofi to drive harmonization of policies, procedures and best practices throughout the Sanofi group. Currently he is focused on the harmonization of aseptic manufacturing technologies and specifically technologies involving RABS and isolator filling systems and best practices for visual inspection of both final product and aseptic process simulation containers.

    Vanessa Vasadi-Figueroa

    Partner / Microbiologist, Quality Executive Partners (QxP)
    Vanessa Vasadi-Figueroa

    WORKSHOP LEADER A: "NAVIGATING THE REQUIREMENTS OF A MODERN QC MICROBIOLOGY LABORATORY"

     

    Vanessa Vasadi-Figueroa, Pharmaceutical Microbiologist and Consulting Partner, has more than 12 years combined experience in Pharmaceutical, Biotechnology and Medical Device industries. Mrs. Figueroa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Mrs. Figueroa has a Bachelor’s degree in Molecular Biology from State University of New York at New Paltz, and a Master’s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and contributing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.

    Veronika Wills

    Technical Services Associate Manager, Associates of Cape Cod
    Veronika Wills

    Veronika Wills manages the Technical Services group at Associates of Cape Cod, Inc. She joined the team in 2007 and thanks to her strong knowledge of biochemistry, microbiology and immunology, brings an expertise that is vital to ACC customers when it comes to technical support of testing complex samples, Low endotoxin recovery matrixes and troubleshooting of the Bacterial Endotoxins Test at all levels. Veronika speaks frequently at scientific conferences and seminars globally and is an established expert on endotoxin testing. Veronika holds a Master’s Degree in Biochemical Engineering from the Institute of Chemical Technology in Prague, Czech Republic.

    Sponsors and Exhibitors

    Official Media Partner

    Official Publication

    Supporters

    Workshops

    Navigating the requirements of a modern QC Microbiology Laboratory
    Workshop

    Navigating the requirements of a modern QC Microbiology Laboratory

    Renaissance Woodbridge Hotel
    15th November 2017
    Iselin, USA

    Contamination Control in Cleanrooms
    Workshop

    Contamination Control in Cleanrooms

    Renaissance Woodbridge Hotel
    15th November 2017
    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

    ATTENDEE LIST FOR PHARMA MICRO EAST COAST & SUPERBUGS USA 2017

    Download

    The Greatest Regulatory Challenges For Pharmaceutical Microbiology with Motif Biosciences

    Download

    Interview with JOSEPHINE CHAN, MICROBIOLOGY SUPERVISOR, TELIGENT PHARMA INC.

    Download

    Sponsors and Exhibitors


    Associates of Cape Cod, Inc.

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

    Associates of Cape Cod (ACC), a global biopharmaceutical company, was the first company licensed by the FDA to manufacture LAL for use as a quality control test for endotoxin in the pharmaceutical and medical device markets. ACC also operates a Contract Testing Service laboratory specializing in endotoxin and glucan contamination.


    bioMérieux

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

    Like you, we are inquisitive microbiologists who rely on our experience to explore and innovate ways to keep your lab running smoothly and ensure that your products are safe. Visit www.thepeoplebehindthescience.com to see what new science our people are creating for you. Together, we are the people behind the science.


    Charles River

    Sponsors and Exhibitors
    http://www.criver.com/microbialsolutions

    For over 30 years, Charles River has helped customers bring products to market safely and efficiently with revolutionary technologies and exceptional services that have changed the way we conduct microbial quality control. Continuing with a passion to innovate and respond to customers’ needs, our Microbial Solutions group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems of Celsis®. Joining the trusted brands of Endosafe® endotoxin testing and Accugenix® microbial identification, Celsis® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any single provider.

    Media Partners


    American Pharmaceutical Review

    Official Media Partner
    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


    Rapid Microbiology.com

    Official Media Partner
    http://www.rapidmicrobiology.com

    rapidmicrobiology.com - keep up-to-date with all the latest products for your pharmaceutical microbiology laboratory, subscribe to the rapidmicrobiology.com newsletter http://www.rapidmicrobiology.com/Newsletter.php


    Rapid Micro Biosystems

    Official Media Partner
    http://www.rapidmicrobio.com/

    Rapid Micro Biosystems delivers the Growth Direct™ System, an automated, non-destructive rapid detection and enumeration technology based on the compendial method for microbial quality control in pharmaceutical manufacturing. The system automates and accelerates detection and enumeration in the areas of environmental monitoring, bioburden and sterility testing eliminating manual steps and analysis. The Company's Growth DirectTM System detects contamination earlier, delivering compelling economic benefits to manufacturers, while improving their quality process. The Growth Direct System is the first and only automated system that addresses all key microbial QC applications and fits with current regulatory practices, a critical accelerator for adoption. Automated analysis eliminates error-prone manual steps and saves labor; rapidly detecting contamination enables manufacturers to reduce inventory carrying costs, shorten manufacturing cycle time, and reduce product losses, delivering significant cost savings and increased operational efficiency.


    Colorado Bioscience

    Official Media Partner
    http://www.cobioscience.com/

    As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.

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    International Journal of Computational Microbiology and Medical Ecology

    Official Publication
    http://www.inderscience.com/ijcmme

    IJCMME publishes original research contributions on computational microbiology, microbial bioinformatics, and medical ecology. It also covers all aspects of computational microbial ecology. The journal particularly welcomes contributions from studies in the Human Microbiome Project (HMP) and its ramifications in personalised medicine, and considers human microbiome research as a vitally important field of medical ecology, beyond the scope which the eminent microbiologist René Dubos provided regarding the subject several decades ago.


    International Journal of Environment and Health

    Official Publication
    http://www.inderscience.com/ijenvh

    IJEnvH is a fully-refereed scientific journal that provides an international forum for the exchange of information and the advancement of knowledge in the multidisciplinary field of environment and health. The aim of IJEnvH is to stimulate the discussion and communication among scientists, researchers and experts with different background and expertise, involved, at different levels, with the study of environment and health problems.


    International Journal of Ecological Bioscience and Biotechnology

    Official Publication
    http://www.inderscience.com/ijebb

    IJEBB is a peer-reviewed journal offering authors and readers opportunities to share the latest concepts and developments in the increasingly-significant field of ecological bioscience and biotechnology, access current case studies in ecological engineering and explore the market potential for ecological biotechnologies. It covers applications of ecological technology and scientific discoveries to the natural environment, human habitation and environmental sustainability. IJEBB provides a key forum to bring together state-of-the-art research of interest to scientists, engineers and policymakers in related fields worldwide.

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    Pharmaceutical-Review

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    http://www.pharmaceutical-review.com

    Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world.Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-news letters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.


    Medical Device Network

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    http://www.medicaldevice-network.com/

    Medicaldevice-network.com is your one stop for information on the medical device industry, covering everything along the supply chain from biomaterials and materials solutions to electronics, packaging, motors and motion control, outsourcing and more. Through our international team of journalists, we cover diagnosis, prevention, monitoring, standards, treatment and technology – all you need as a professional in the medical industry to stay abreast of the latest developments in your field.


    MDPI Biology Journal

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    http://www.mdpi.com/journal/biology

    Biology (ISSN 2079-7737, http://www.mdpi.com/journal/biology) is an international, peer-reviewed, quick-refereeing open access journal of Biological Science. This journal is supervised by Editor-in-Chief, Prof. Dr. Chris O'Callaghan and Associate Editor, Prof. Dr. Jukka Finne. Biology is supported by an outstanding Editorial Board which includes a 2002 Nobel Laureate as well as other excellent scientists (http://www.mdpi.com/journal/biology/editors/). Biology is indexed by PubMed, Zoological Record, Scopus, etc (http://www.mdpi.com/journal/biology/indexing).


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Mednous

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    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Pharmalicensing

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    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 Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing, and its sister service Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Pharmalicensing is a division of IP Technology Exchange, Inc.


    Drug Discovery Today

    Supporters
    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.


    Swiss Biotech Association

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    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.


    Inderscience Publishers

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    http://www.inderscience.com

    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    Pharmaceutical Technology

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    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Drug Development Technology

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    http://www.drugdevelopment-technology.com

    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


    Absave

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    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Contract Biotechnology

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    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. We are an online R&D matching tool that connects Scientifics and organizations involved in discovery, development and delivery of new healthcare products with service and products providers worldwide. Life science information technology is undergoing a revolution. Part of that revolution involves new, unexplored business models, open innovation, open data and collaboration. If you have a project or idea that you would like to propose, develop or run, we can help. A New Collaboration Network Model for Discovery Research and Development • Effective Platform: the 95% • 5.000 registered users // > 15.000 Newsletter subscribers • Geographical background: 45,5% Europe / 37,5% North America / 16,5% Asia / 0,5% ROW • Professional background: Outsourcing Manager, Project Manager, CEO, Business Developer, CSO, Account Manager, Sales & Marketing People, Scientists, R&D. For further information, please visit our website www.contract-biotechnology.com


    SciDoc Publishers

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    http://www.scidoc.org

    SciDoc Publishers is a major source provider of e-journals in the field of Science, Technology and Medicine (STM). The nature of journals - Open Access and Peer-reviewed. We are aimed with a sole motive in making a mark in the field of Open Access, by propagating the knowledge to the scientific community. Our prime concern involves, the knowledge to reach millions of readers and give them access to scientific publications - online.


    GBI

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    http://www.gbihealth.com/

    GBI is an information, applications, and services company focused on the healthcare industry. Leveraging data from across the healthcare value chain, GBI creates web and mobile applications that enable individuals and organizations to make better decisions and communicate more effectively.


    Gate2Biotech

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    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.


    One Nucleus

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    http://www.onenucleus.com

    Established in May 2010, One Nucleus is the result of the merger of ERBI and London Biotechnology Network. One Nucleus is a not-for-profit membership organisation for international life science and healthcare companies and the largest of its kind in Europe. The company is based in Cambridge UK and London, at the heart of Europe's largest cluster. The 470 members include pharmaceutical, biotech, medical device and diagnostic companies and associated technical and commercial Service Providers.


    SelectScience

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    http://www.selectscience.net/register?utm_source=Media-Partner&utm_medium=Website&utm_campaign=SMI

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    Biosave

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    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Farmavita

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    http://www.farmavita.net/

    Farmavita Net is professional community and network of pharmaceutical licensing and business development executives, innovators and researchers
    Farmavita.Net is the pharmaceutical licensing, technology transfer and regulatory affairs network. We are managing the marketplace of offers and demand for pharmaceutical Dossiers, know-how and technologies. Members of Farmavita.Net network usually find a number of attractive solutions for business development, alliances, joint ventures, co-development and co-marketing of pharmaceutical products. Farmavita.Net is not just a pure Internet portal. We manage a number of regional associates. We are connecting the dynamic network of few hundreds members / pharmaceutical companies interested in license-in and license-out opportunities.


    Pharmavision

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    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    Technology Networks

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    http://www.technologynetworks.com

    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


    EIN Presswire

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    http://www.einpresswire.com/free

    EIN Presswire has a distribution "foot-print" that includes millions of users of our EIN Newsdesk media monitoring services. We also maintain one of the world's leading media directories providing us with up-to-date contacts for media in every country and U.S. state. Further distribution is achieved via RSS, email, partner websites, and social media. We are both a destination (EIN Newsdesk) and a distributor (EIN Presswire) for news. In one place you can distribute your news to the targeted audiences you select and monitor news on that topic published by thousands of worldwide sources. For more information or to try us FREE, please visit www.einpresswire.com/free


    Biocompare

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    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.


    Labsave

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    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/

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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
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