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SMi is proud to announce the 3rd Annual Pharmaceutical Microbiology East Coast Virtual Conference taking place on October 28th – 29th, 2020.

The pharmaceutical microbiology industry has seen many changes during the progression into the 21st century. With advances in rapid microbiological methods, revisions being made to regulations in the industry, enhanced knowledge of the human microbiome, and novel testing methods, innovative approaches in ATMP facilities, this industry is ever expanding. Join leading experts to discuss and analyze the latest advances and challenges within the industry. Network with industry professionals, discuss revisions in regulatory and guidance documents, explore data integrity considerations for conventional and rapid microbiology methods, analyze arising issues with environmental monitoring to best control contamination and gain insight into an industry perspective on automated endotoxin testing and process automation.

 

 

Pharmaceutical Microbiology East Coast will discuss the ongoing complication of personnel derived contaminations from the FDA. Gain valuable insight towards microbiological quality considerations in non-sterile manufacturing and control of BCC from Parexel. Learn from the perspective of the US Pharmacopeia on container closure integrity evaluation and explore the work at Genentech covering technical considerations for microbial QC of raw materials used in biotechnology and the past, current and future state of Mycoplasma testing.

 

The SMi Virtual Conference Platform will deliver the following benefits:

Live and On Demand speaker content: Get access to the latest strategies and case studies from your market place online!
Network with all the event attendees: Connect, see who’s attending, chat and share contact details with all online delegates, speakers and sponsors
Exhibit a Virtual Booth: You can pack your customized booth full of documents, videos and even show who is manning the booth during the event and hosting meetings
Host & Join Meetings & Socials: Join preferred speaking sessions, host you own meetings and even a virtual Networking social, with in built Zoom functionality
 

• Senior Microbiologist
• Lead Scientist
• Laboratory Manager
• QA Specialist
• Drug Substance External Manufacturer
• QC Scientists
• Heads of Quality
• Business Development Manager
• Pharmaceutical Microbiology Consultant
• Higher Pharmacopoeial Scientist
• Analytical Standards Specialist

 

Amneal Pharmaceutical; Amneal Pharmaceuticals LLC; Analytical Lab Group LLC; Associates of Cape Cod; Association of Cape Cod, Inc; Atara Biotherapeutics; Banelle; Baxter Corporation; bioMerieux Industry; bioMerieux, Inc.; Bioscience International; BioTekPro AB; Biotherpeutics; BioVigilant Systems; Bristol Myers Squibb; Charles River; CTL - Mat; DuPont; DuPont de Nemours Luxembourg sarl; Dupont Personal Protection; Eagle Analytical Services (Former FDA); Eli Lilly And Company; Emergent Biosolutions; Genentech; ImmuneBiotech AB; Infinity Laboratories; InnovaPrep; International Serum Industry Association; Ipsen; Lantheus Medical Imaging; Lonza; Lonza Walkersville, Inc.; Merck; Meridian Medical Technologies; Mettler Toledo; Microbiological Consulting, LLC; Microrite, Inc.; Novartis Pharmaceuticals Corporation; Novatek International; Ocular Therapeutix; Organogenesis Holdings Incorporated; Pfizer; Pfizer Inc; Pharmaceutical and Healthcare Sciences Society; Pharmalucence, Inc.; Regeneron; Regeneron Pharmaceuticals Inc.; Sanofi; Sanofi Genzyme; SCA Pharma; Seres Therapeutics; Steris Corporation; Sun Pharma Boston; Takeda; Takeda Pharmaceuticals; United Therapeutics; University Of Calgary; University Of Guelph; University of Veterinary Medicine Vienna; Vericel Corporation; Zeteo Tech LLC;

Conference programme

8:30 Chair's Opening Remarks

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

8:40 Microbiological Quality Considerations in Non-sterile Pharmaceutical Manufacture and Control of BCC

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

• Introduction of the FDA’s impending guidance on this topic
• Regulatory Expectations for microbial control of non-sterile drugs
• Case studies of microbiological contamination of non-sterile drug products to demonstrate the impact on product quality and the manufacturing process
 

9:20 Evaluating the ongoing complications of personnel derived contaminations

Maria Jose Lopez Barragan

Maria Jose Lopez Barragan, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, Barragan BioConsulting
View Bio

• Understanding a key microbial reservoir: the human microbiome and a regulatory update of cleanliness expectations
• Discussing personnel behaviour, training and cleanroom garment and fabric considerations
• Exploring the current utility of robotics and automation in controlled environments
• Future outlook
 

10:00 Networking Break

10:15 Adopting the rFC (recombinant Factor C) assay for endotoxin detection in your laboratory

Lakiya Wimbish

Lakiya Wimbish, Product Manager, Lonza
View Bio

• Why switch to rFC testing?
• Comparable data to traditional LAL endotoxin assays;
• Validation that meets regulatory requirements;
• Sustainability
 

10:55 Monocyte Activation Test: The In-vitro Pyrogen Test Based on Human Immune Cells for Batch Release Testing of Medical Products

Shabnam Solati

Shabnam Solati, Co-Founder, CEO, CTL - MAT
View Bio

• Presenting the MAT as a robust, reproducible, sensitive and human specific pyrogen testing
• An end-to-end process: MAT kit generation, test performance and product-specific validation
• Presenting the solution to the recent EP criteria: MAT as risk assessment for the endotoxin test and replacement of RPT
• The solution for pyrogenicity tests of medical devices
 

11:35 Recent Advances and New Developments in Mycoplasma Control of Blood-derived Cell-based Medicinal Products

Renate Rosengarten

Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting
View Bio

• Mycoplasma species potentially present in blood-derived raw materials and starting materials used in the manufacture of cell-based medicinal products
• PCR-based mycoplasma safety testing of blood-derived products: required product-relevant mycoplasma species coverage including the group of haemotropic Mycoplasma species - trivial name 'haemoplasmas'
• Targeted detection of haemoplasmas by a newly developed generic Real-Time PCR method for application as supplementary in-process control and release test for blood-derived products of human origin and for bovine serum used as cell culture medium supplement
• Representative product-relevant haemoplasma DNA reference standards for use in product-specific haemoplasma Real-Time PCR validation
 

12:15 Networking Lunch

12:45 Mycoplasma Testing: Past, Current, and Future State

Kenneth Tai

Kenneth Tai, QC Scientist, Genentech
View Bio

• Compendial Methods
• Real-Time PCR testing, Considerations
• At-line Testing and Next Generation Sequencing
 

13:25 Container Closure Integrity Evaluation: USP Perspective

Leslie Furr

Leslie Furr, Associate Scientific Liaison, US Pharmacopeial Convention
View Bio

• Historical considerations of CCI testing
• Overview and application of USP’s guidance on package integrity testing
• Stakeholder engagement: Hot topics, industry needs, future direction
 

14:05 Container Closure Integrity and Controls Strategies Ensuring Product Sterility

Michael Song

Michael Song, Associate Director, Heron Therapeutics
View Bio

• Explore and learn when the utilize the different container closure integrity (deterministic and probabilistic) test methods mentioned in FDA guidance and USP<1207>
• New technologies with increased sensitivity… what is a good detection limit to target and when to draw the line
• How and when to utilize microbial challenge to help set manufacturing parameters
• Holistic approach in defining your container closure integrity controls strategy and aseptic assurance
 

14:45 Chair’s Closing Remarks and Close of Day One

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

8:30 Chair's Opening Remarks

Lynne Ensor

Lynne Ensor, Vice President, Technical, Parexel International
View Bio

8:40 Culturing Contamination Prevention - Building a Sustainable Microbial Control Program from the Ground Up

• Drivers for establishment of a successful microbial contamination control program (CCP)
• Implementation of a company’s CCP will be outlined, emphasizing the importance of perspective and partnership between local/global functions
• Focus on CCP sustainability and continuous improvement for contamination prevention
• Case studies/examples of identified best practices and lessons learned will be presented
 

Hilary Chan

Hilary Chan, Principal QC Scientist, Takeda
View Bio

Maria Dunnells

Maria Dunnells, Right First Time Program Manager, Takeda Pharmaceuticals
View Bio

9:20 Alternative methods for endotoxin testing: focus on equivalency of recombinant reagents to lysate reagents

Veronika Wills

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

• Status of recombinant reagents as alternate tests
• Requirements for alternate reagents
• Comparability testing of recombinant reagents
 

10:00 Networking Break

10:15 A Sustainable, Ecological and Efficient rFC Endotoxin Testing Solution

Brendan Tindall

Brendan Tindall, Global Solutions Manager and Program Director, BioMeríeux
View Bio

• Sustainable, Ecological and Repeatable
• Efficient Microplate Solutions
• Update to current regulations
 

10:55 Microbial Control & Sterility for Biotech Products: What The Regulators Want to Know

Scott Nichols

Scott Nichols, Quality Compliance Lead, Kite Pharma
View Bio

  • Regulatory Framework & Filing Process
  • Organization of Quality Micro Data in the eCTD
  • Common Filing/Review Deficiencies
  • Common inspectional findings
  • 11:35 Panel Discussion: COVID-19 and Contamination Control

  • What risk mitigation practices have been put in place in response to the global pandemic?
  • An insight into control strategies for COVID-19 mitigation
  • Measures to keep staff safe and keeping the product safe
  • Has the pandemic impacted the way we implement microbial control strategies?

     

  • Lynne Ensor

    Lynne Ensor, Vice President, Technical, Parexel International
    View Bio

    Maria Jose Lopez Barragan

    Maria Jose Lopez Barragan, Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, Barragan BioConsulting
    View Bio

    Hilary Chan

    Hilary Chan, Principal QC Scientist, Takeda
    View Bio

    Diane Raccasi

    Diane Raccasi, Principal Consultant, Parexel Consulting

    12:15 Networking Lunch

    12:45 Global Impact Assessment Process for Aseptic Process Simulations

    Austin Kuo

    Austin Kuo, Principal Research Scientist, Sterility Assurance, Eli Lilly And Company
    View Bio

    • Assessing the impact of facility/process changes on sterility assurance controls
    • Establishing an aseptic process simulation (APS) strategy (e.g., duration, number of iterations) to validate the aseptic manufacturing operation
    • Developing a process to drive consistency of APS validation assessments and strategies across a global manufacturing network

     

    13:25 Common Myths and Urban Legend Regarding Cleaning and Disinfection

    James N. Polarine Jr

    James N. Polarine Jr, Senior Technical Service Manager, Steris Corporation
    View Bio

    • Isopropanol kills everything
    • Cleaning more often will resolve the contamination
    • Residues from disinfectants will inhibit sporicides
     

    14:05 Audit and Trends

    Kashyap Bhatt

    Kashyap Bhatt, Manager GPV Quality Operations, Takeda
    View Bio

    • Outlining the auditor’s expectations
    • Determine which audit finding classifications could be utilized
    • Notable examples of recent audit observations
    • Ensuring compliance
     

    14:45 Chair’s Closing Remarks and Close of Day Two

    Lynne Ensor

    Lynne Ensor, Vice President, Technical, Parexel International
    View Bio

    +

    FEATURED SPEAKERS

    Austin Kuo

    Austin Kuo

    Principal Research Scientist, Sterility Assurance, Eli Lilly And Company
    Brendan Tindall

    Brendan Tindall

    Global Solutions Manager and Program Director, BioMeríeux
    Hilary Chan

    Hilary Chan

    Principal QC Scientist, Takeda
    James N. Polarine Jr

    James N. Polarine Jr

    Senior Technical Service Manager, Steris Corporation
    Kashyap Bhatt

    Kashyap Bhatt

    Manager GPV Quality Operations, Takeda
    Kenneth Tai

    Kenneth Tai

    QC Scientist, Genentech
    Lakiya Wimbish

    Lakiya Wimbish

    Product Manager, Lonza
    Leslie Furr

    Leslie Furr

    Associate Scientific Liaison, US Pharmacopeial Convention
    Lynne Ensor

    Lynne Ensor

    Vice President, Technical, Parexel International
    Maria Dunnells

    Maria Dunnells

    Right First Time Program Manager, Takeda Pharmaceuticals
    Maria Jose Lopez Barragan

    Maria Jose Lopez Barragan

    Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, Barragan BioConsulting
    Michael Song

    Michael Song

    Associate Director, Heron Therapeutics
    Renate Rosengarten

    Renate Rosengarten

    Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting
    Scott Nichols

    Scott Nichols

    Quality Compliance Lead, Kite Pharma
    Shabnam Solati

    Shabnam Solati

    Co-Founder, CEO, CTL - MAT
    Steve Walton

    Steve Walton

    Microbiology Scientist, Mylan
    Veronika Wills

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod

    Austin Kuo

    Principal Research Scientist, Sterility Assurance, Eli Lilly And Company
    Austin Kuo

    Mr. Kuo brings over 16 years of experience in parenteral manufacturing, with a focus on sterility assurance and environmental monitoring programs. He has led Quality and Technical Services organizations supporting environmental monitoring, aseptic process simulations (media fills), aseptic technique, personnel gowning and hygiene, aseptic interventions, sterile filtration validation, sanitization programs and agent validation, and sterility assurance risk assessments supporting parenteral operations.

    Brendan Tindall

    Global Solutions Manager and Program Director, BioMeríeux
    Brendan Tindall

    Brendan Tindall is the Global Solutions Manager at bioMerieux. Brendan has almost 15 years of experience in various roles in Healthcare including Lifesciences, Medical devices and Pharmaceuticals. He has worked in local, regional and global roles. Brendan holds a bachelor of science and a masters of management.

    Diane Raccasi

    Principal Consultant, Parexel Consulting
    Diane Raccasi

    Hilary Chan

    Principal QC Scientist, Takeda
    Hilary Chan

    Hilary Chan is a Principal Quality Control Scientist in Global Microbiology Management at Takeda and is based out of Lexington, MA. In her current role, Hilary is responsible for leading various technical improvement initiatives related to microbiological issues/contamination control for Takeda’s global manufacturing operations. She is a business process owner for environmental monitoring as well as a contamination control community of practice network lead for Takeda. She is an invited speaker at industry conferences and has authored various scientific publications. Hilary has 19 years of experience in the biotech industry and holds a Bachelor’s degree in Zoology from Colorado State University and a Master’s degree in Biomedical Science from Northeastern University.

    James N. Polarine Jr

    Senior Technical Service Manager, Steris Corporation
    James N. Polarine Jr

    Mr. Polarine is a senior technical service manager at STERIS Corporation. He has been with STERIS Corporation for nineteen years. His current technical focus is microbial control in cleanrooms and other critical environments. Mr. Polarine is a 2019 PDA Michael S. Korczynski Award recipient. He has lectured in North America, Europe, Middle East, Asia, and Latin America on issues related to cleaning and disinfection and microbial control 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. Mr. Polarine teaches industry regulators as well as the pharmaceutical, biotech, and medical device industries at the PDA and the University of Tennessee. Mr. Polarine currently teaches the cleaning and disinfection course as part of the PDA’s Aseptic Processing Course and at the University of Tennessee’s Parenteral Medications Course. Mr. Polarine is current President for the PDA Missouri Valley and Technical Coordinator for the IEST. Mr. Polarine graduated from the University of Illinois with a Master of Arts in Biology. 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.

    Kashyap Bhatt

    Manager GPV Quality Operations, Takeda
    Kashyap Bhatt

    I am an accomplished Quality Assurance and Regulatory Affairs professional with 8+ years of experience in the pharmaceutical and biotechnology industry. I have a thorough knowledge of Drug Development, Drug Substance, and Drug Product standards within a GMP/GLP facility. I have contributed to the creation and standardization of Good Documentation Practices (GDP) at both developing and mature manufacturing sites, and have used various techniques to train quality/manufacturing staff in appropriate methods to ensure product quality and inspection readiness. I have provided QA and decision-making support for Process Development (PD), Manufacturing, Quality Control (QC), Facilities & Engineering (F&E), and Validation teams. In terms of inspections, I have a thorough knowledge and ability to perform facility, department, vendor and for-cause inspections at all regulated facilities within biotech/pharma organizations.

    Kenneth Tai

    QC Scientist, Genentech
    Kenneth Tai

    Kenneth received his Ph.D. in genetics, molecular, and cell biology. After graduation, he began his career at Life Technologies (now Thermofisher) where he worked on Real-time PCR assays, reagents, and instruments. In 2014, he started his career at Genentech for the global adventitious agents testing group. His focus is on method transfer and validation of real-time PCR-based assays for Mycoplasma, MVM, and Leptospira. He is currently evaluating Next Generation Sequencing as a viable option to replace current tests.

    Lakiya Wimbish

    Product Manager, Lonza
    Lakiya Wimbish

    Lakiya Wimbish is a Product Manager for Endotoxin Detection at Lonza, with a primary focus on alternative methods like the recombinant Factor C Assay and other rapid microbial detection platforms. She joined Lonza in 2007 as an Applications Development Scientist before transitioning into her current role. Prior to Lonza, Lakiya was a contractor for the United States Navy’s Biological Defense Research Directorate, developing QC PCR-based assays for the detection of bio-warfare agents in the field.

    Leslie Furr

    Associate Scientific Liaison, US Pharmacopeial Convention
    Leslie Furr

    Leslie Furr is an Associate Scientific Liaison to the Compendial Science-General Chapters group at the United States Pharmacopeial Convention. She has been with USP since 2018 where she is a liaison to the Packaging and Distribution, Dosage Forms, and Microbiology Expert Committees. Before becoming a liaison at USP she was an Expert Committee volunteer for the Chemical Medicines group with expertise in antibiotic testing. She holds a certification from the American Society for Microbiology as a Specialist Microbiologist in Pharmaceutical and Medical Device since 2012. Prior to working at USP, she was a Senior Microbiologist in the pharmaceutical industry where she spent 14 years in method development, R&D, and manufacturing support for non-sterile products. She obtained her B.S. in Microbiology from the University of North Carolina at Charlotte and her M.S. in Pharmaceutical Sciences at the University of Florida.

    Lynne Ensor

    Vice President, Technical, Parexel International
    Lynne Ensor

    Dr. Lynne Ensor is a Vice President, Technical, for Parexel. As a 21-year veteran of the FDA, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, and regulatory policy development. She served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/OPQ/CDER, responsible for new, generic, and biologic drug product quality review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the OPS’s New and Generic Drug Product Quality Microbiology staff, and Director of OGD’s Division of Microbiology. Lynne was previously employed at Roche Biomedical Laboratories, the University of Maryland at Baltimore’s School of Medicine, and earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.

    Maria Dunnells

    Right First Time Program Manager, Takeda Pharmaceuticals
    Maria Dunnells

    Maria Dunnells is a Right First Time Program Manager in the Manufacturing department at Takeda based out of Lexington, MA. In her current role, Maria represents the contamination control program for the Massachusetts Biologics manufacturing facilities. As part of this role, she drives the site’s strategy for contamination reduction through project ownership, leads the site contamination control team, and represents the site in the global contamination control community of practice. Maria has 7 years of experience in the biotech industry and holds a Bachelor’s degree in Chemical Engineering and a Master’s degree in Biotechnology, both from Northeastern University.

    Maria Jose Lopez Barragan

    Founder, Barragan BioConsulting, formerly CMC Product Quality Reviewer, FDA, Barragan BioConsulting
    Maria Jose Lopez Barragan

    María José (Pepa) Barragán is a former U.S. FDA regulator and founder of Barragan BioConsulting, where she offers Regulatory and Compliance consulting services to pharmaceutical companies globally. Pepa has 15 years of combined experience in Regulatory Affairs (CMC) and multiple aspects of drug development and research and has participated in the approval of 15 original and biosimilar biologic license applications, focusing on microbiology product quality and sterility assurance aspects. Pepa has been lead inspector in multiple regulatory inspections of pharmaceutical manufacturers in 8 countries. Previously, Pepa held Senior Scientific positions at GlaxoSmithKline and GeneDx and is co-author of 20 scientific peer-reviewed publications and one biotechnology patent. Pepa earned a PhD in Biochemistry and Molecular Biology from Universidad Complutense de Madrid (Spain) and completed a 5-year postdoctoral program in the U.S. National Institute of Allergy and Infectious Diseases, Bethesda, MD.

    Michael Song

    Associate Director, Heron Therapeutics
    Michael Song

    Michael Song currently is Associate Director of Packaging and Device Manufacturing at Heron Therapeutics where he leads medical device and combination product commercial readiness. Prior to Heron, he led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where his group oversaw device functionality portion of device development; primary container science and technology; biocompatibility; container closure integrity programs; and digital connectivity. Prior to AstraZeneca, he was head of Device, Package, and Process Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

    Renate Rosengarten

    Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna/Mycosafe Consulting
    Renate Rosengarten

    Prof Renate Rosengarten’s career originated from her academic research work which is for more than 40 years marked by a continuous interest in the infection biology of mycoplasmas, and their detection, prevention and control. Her passion for mycoplasmas took her to the University of Veterinary Medicine Hannover in Germany, the University of Missouri-Columbia in the US, and the Hadassah Medical School of the Hebrew University in Jerusalem, Israel. Since 1996 she has been Professor and Chair of Bacteriology and Hygiene at the University of Veterinary Medicine Vienna in Austria. Besides her numerous former functions and activities in organizations and committees, such as President of the International Organization for Mycoplasmology (IOM), President of the Austrian Society for Hygiene, Microbiology and Preventive Medicine (ÖGHMP), Scientific Advisory Board Member of the German Robert Koch Institute (RKI) in Berlin, and Working Group Leader of the Mycoplasma Task Force of the Parenteral Drug Association (PDA), Prof Rosengarten has long-standing entrepreneur and business experience in the area of mycoplasma safety testing. In addition to her academic duties as mentor, lecturer, reviewer, scientific advisor, and committee member, Prof Rosengarten serves since 2004 as an independent mycoplasma expert, key opinion leader and consultant for biopharma, biotech and cell therapy companies under her own international brand Mycosafe® and has recently established a consulting and licensing enterprise.

    Scott Nichols

    Quality Compliance Lead, Kite Pharma
    Scott Nichols

    Former FDA lead inspector of drug substance and drug product manufacturing facilities for biotechnology drugs, and former FDA reviewer of biotechnology drug applications for microbial control, sterility assurance, and microbiological product quality. Scott has expertise in cGMP compliance, microbial control, sterility assurance, and aseptic processing. Scott provides advice on remediation strategies for biopharmaceutical manufacturing, including control strategies (bioburden control, cross-contamination control, multi-product manufacturing control), qualification/validation strategies (sterile processes, microbial methods, equipment IQ/OQ/PQ, high-risk emerging technologies including continuous manufacturing), sterile biopharmaceutical manufacturing and testing, and low endotoxin recovery. Scott has extensive knowledge implementation and interpretations of USP; ICH and FDA guidances; FD&C Act; PHS Act; 21 CFR Parts 210-211, 314, 600-610, and other FDA regulations.

    Shabnam Solati

    Co-Founder, CEO, CTL - MAT
    Shabnam Solati

    Shabnam Solati developed a Monocyte Activation Test to meet all the end-to-end MAT needs in the industry, with pyrogen detection and quantification levels that are unprecedented. With the expertise of MAT and the knowledge regarding all the test’s potential abilities, Shabnam is dedicated to build the future of MAT even beyond where it is today. Therefore, research, development and innovative technologies are continuous focus points at CTL-MAT.

    Steve Walton

    Microbiology Scientist, Mylan
    Steve Walton

    Steve Walton is an ASQ Certified Pharmaceutical GMP Professional with more than 11 years’ experience in microbiology, sterility assurance, contamination control, and aseptic processing. Steve has served in facilities with terminal sterilization (Baxter Corp.), aseptic drug product manufacturing (Alcon/CIBA Vision, a Novartis company), biotechnology (Sanofi Pasteur), and is currently serving at a commercial compounding pharmacy (Baxter Corp.)

     

    Veronika Wills

    Manager, Technical Services, Associates of Cape Cod
    Veronika Wills

    Veronika has been working in the endotoxin industry for the past 12 years and currently manages the Technical Services department at Associates of Cape Cod, Inc. Veronika is a specialist on testing complex samples, method development, regulatory aspects of endotoxin testing, development and delivery of educational and technical contents. She attends and 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

    Exhibitors

    Official Media Partner

    Supporters

    Workshops

    VENUE

    Online Virtual Event

    Online Virtual Event , USA

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    Pharmaceutical Microbiology EC 2020 Preliminary Attendee List

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    Speaker Interview with Maria Jose Lopez Barragan, Barragan BioConsulting, formerly FDA

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    Speaker Interview with Kenneth Tai, Genentech

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    Speaker Interview with Hilary Chan

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    Pharmaceutical Microbiology East Coast 2020 Brochure

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    Conference Program

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    Workshop Program

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    Chair Letter Invite - Lynne Ensor

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    Speaker Interview with conference chair Lynne Ensor

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    Speaker Interview with Brendan Tindall

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    Past Attendee List (2018-2019)

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    Conference Speakers with Biographies

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    SMi's Remote Access 2020

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    Past Presentation 2019 - Pfizer

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    Past Presentation 2019 - Roche

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    Past Presentation 2019 - Eli Lilly and Company

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    Past Presentation 2019 - BioTekPro AB

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    Past Presentation 2019 - PHSS

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    Past Presentation 2019 - Steris

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    Sponsors


    Associates of Cape Cod

    Sponsors
    http://www.acciusa.com/acc/index.html

    Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1- > 3)-ß-D-glucans detection products and services for nearly 45 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


    bioMérieux

    Sponsors
    http://www.biomerieux-usa.com/biopharma

    bioMérieux, Inc. helps our clients unlock greater value from their organizations with expert consultation and a complete line of diagnostic solutions that enable more rapid, confident results. Clients benefit from improved productivity and profitability by minimizing errors and reducing time to result, as well as brand protection and safer and healthier consumer products.


    CTL-MAT

    Sponsors
    http://WWW.CTLMAT.COM

    CTL-MAT - The MAT Company has been established to serve any and all of your Monocyte Activation Test needs, offering MAT Kits, Pooled PBMC, Batch Release Testing, Product-specific Validation and Consultation Services. The MAT is the only quantitative, in-vitro, true pyrogen test - measuring endotoxins and non-endotoxin pyrogens alike.


    Lonza

    Sponsors
    bioscience.lonza.com

    At Lonza Pharma & Biotech we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need.

    From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome, at the time when you expect it.

    Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges. Together, we can bring your next medicine to life.


    Exhibitors


    Microbiologics

    Exhibitors
    http://www.microbiologics.com

    At Microbiologics, our mission is: "To provide the highest quality biomaterials for a safer, healthier world." We are the leading provider of ready-to-use QC microorganisms for quality control testing in the clinical, pharmaceutical, food, water and educational industries. With over 900 strains available in a variety of user-friendly formats, we offer the largest and most diverse line of QC microorganisms including qualitative, quantitative, Certified Reference Material and Parasite Suspensions. Our products are manufactured in accordance with the industry’s highest standards. We have achieved ISO 13485 certification, as well as ISO 17025 and ISO Guide 34 accreditations. In addition, we are an FDA registered establishment and offer many CE Marked products.


    MilliporeSigma

    Exhibitors
    https://www.emdmillipore.com/US/en?bd=1

    MilliporeSigma is a top player in industrial microbiology and process monitoring providing state-of-the-art testing methods, regulatory expertise, and outstanding service to provide that one invaluable result: maintaining the safety of your products. The portfolio includes hardware, consumables, validation, and method development for bioburden, sterility, environmental monitoring, and media fill.


    PHC Corporation of North America (PHCNA)

    Exhibitors
    http://www.phchd.com/us/biomedical

    PHC Corporation of North America is a leader in laboratory equipment for biopharmaceutical, life sciences, academic, healthcare and government markets. The company is operated as a subsidiary of PHC Holdings Corporation, Tokyo, Japan, which is a global healthcare company involved in the three core businesses of Medical Devices, Healthcare IT and Life Sciences. Product lines under the new PHCbi brand include the space saving and energy efficient VIP® ECO, TwinGuard® and VIP Series ultra-low temperature freezers, cryogenic and biomedical freezers, pharmacy and high-performance refrigerators, cell culture CO2 and multigas incubators, programmable heated and refrigerated microbiological incubators, cell processing work stations and Drosophila/plant growth chambers. For more information, please call PHC Corporation of North America at 800-858-8442, email info@us.phchd.com or visit http://www.phchd.com/us/biomedical/.

    Media Partners


    Biocompare

    Official Media Partner
    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.


    SelectScience

    Official Media Partner
    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.


    Medical Design Briefs

    Official Media Partner
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/PMEAST20

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.


    Genetic Engineering News

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

    Genetic Engineering & Biotechnology News (GEN) is the most authoritative and widely read biotechnology news publication in the world.Published 21 times a year,GEN's unique news and technology focus include the entire bioproduct life cycle from early-stage R&D to applied research and bioprocess through to commercialization. GEN is the only publication that provides the full range of the biotechnology market coverage in areas such as omics, drugs and biomarker discovery, bioprocessing, clinical research, molecular diagnostics and biobusiness. For a free subscription go to: http://www.genengnews.com/subscriptions.aspx


    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
    https://www.rapidmicrobiology.com

    rapidmicrobiology.com is a well-established on-line resource for microbiologists worldwide, find the right products for your microbiology lab using our specially designed search functions. To keep up-to-date with the latest microbiology news get our free weekly newsletter which includes updates on products, services, webinars, training courses and conferences.

    Media Partners


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!


    Swiss Biotech Association

    Supporters
    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.


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    pharmanews hq

    Supporters
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the 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. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    pharmaphorum

    Supporters
    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


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharmaceutical-Review

    Supporters
    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.


    Labcompare

    Supporters
    http://www.labcompare.com

    Labcompare is a product of American Laboratory, and is already included in the AL logo on your website. I have attached the standalone Labcompare logo and info is below, but if you do add this one separately, could you exchange the American Lab logo with the one attached? For laboratory managers and researcher scientists across analytical chemistry and applied sciences who need to find product solutions, advice, and access scientific tools. Labcompare provides an industry-leading, comprehensive, online resource of product information to support the laboratory’s needs. Labcompare supports every step of the buying journey by focusing on core and new product technology, supplies, tips, and buyer’s guides.


    Contract Biotechnology

    Supporters
    http://www.contract-biotechnology.com

    Contract-Biotechnology.com is a web-based platform for laboratory outsourcing solutions. It is an online R&D matching tool that connects Scientifics and service and product providers worldwide. The platform Contract-Biotechnology.com would help you in the process of finding the right partner saving time and money, because with one single and secure application you would be able to receive multiple quotes quickly, keeping your contact information confidential. Contract-Biotechnology.com is the new Collaboration Network Model for Discovery Research and Development. Contract-Biotechnology.com team has extensive experience working for pharmaceuticals, biotechs, universities and academic research institutes and can help you addressing your key gaps.


    Pharmalicensing

    Supporters
    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.


    BioChem Adda

    Supporters
    https://www.biochemadda.com/

    BioChem Adda is a Not-just-for-Profit organization which aims to bring out the most reliable and transparent information about everything related to jobs, careers, education, news, articles, and events from the field of BioSciences and Chemistry!


    Gate2Biotech

    Supporters
    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.


    Journal for Clinical Studies

    Supporters
    http://www.jforcs.com

    JCS – Journal for Clinical Studies is peer reviewed. Supported by a team of industry experts, JCS brings you contemporary and authoritative articles which will guide the industry in the best practice in regulatory issues, market analysis, drug discovery, development, drug design, clinical research, data analysis, safety and efficacy, recruitment and retention, laboratories, analytical testing, custom and contract manufacturing, primary and secondary packaging and logistics and supply chain management.


    Technology Networks

    Supporters
    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


    IPI

    Supporters
    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.


    IBI - International Biopharmaceutical Industry

    Supporters
    http://www.biopharmaceuticalmedia.com

    IBI - International Biopharmaceutical Industry, provides the biopharmaceutical industry with comprehensive coverage of key scientific, technology, regulatory and business topics. The editorial mix of peer-reviewed papers, practical advice on managing bioprocessing and technology, regulatory and business columns, and expert commentary provides comprehensive coverage of upstream and downstream processing, manufacturing operations, regulations, formulation, scale-up/technology transfer, drug delivery, analytical testing and more. The insight and analysis covers biologic – based therapies including We will report on emerging trends, strategies and best practices in the key areas.


    Drug Target Review

    Supporters
    http://www.drugtargetreview.com

    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.

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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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