2nd Rare and Genetic Kidney Drug Development Summit
2022-10-04 - 2022-10-06 | Hilton Woburn, 2 Forbes Road, Woburn, MA, 01801, United States
Uniting industry experts dedicated to accelerating the frontier of transformative therapeutics, the 2nd Rare & Genetic Kidney Disease Drug Development Summit is the definitive industry forum sharing cross-industry insight to understand genetic drivers of disease, uncover early biomarkers of efficacy, and navigate disease specific endpoint development.
From clarifying molecular characteristics to reclassify disease subtypes to enrolling patient cohorts in rare disease populations, join industry experts in-person from Travere Therapeutics, FDA, Sanofi, Chinook Therapeutics, Goldfinch Bio, Takeda, Regulus Therapeutics, Otsuka and many more to accelerate life-changing therapeutics for the treatment of ADPKD, ARPKD, IgA, FSGS, Alport Syndrome.
To know more visit: https://ter.li/rzowfh

4th Macrophage-directed Therapies Summit
2022-10-04 - 2022-10-06 | Crowne Plaza Boston Woburn, 15 Middlesex Canal Park Dr, Woburn, MA, 01801, United States
4th Macrophage-directed Therapies Summit, taking place from 4-6 of October in Boston, will bring together professionals to accelerate the clinical validation of macrophage-directed therapies, manipulating and fixing phenotypic plasticity to develop safe, targeted therapies for oncology, autoimmunity, inflammation and beyond.
Join your peers in person and delve into:

CD47 targeting and other ‘don’t eat me’ signals
Safety concerns due to model translatability and dosing
Optimal combination or monotherapy discovery

You can view the event guide here: https://ter.li/ezyi0h
Secure your place at the summit here: https://ter.li/x9p0ua
We are looking forward to welcoming you to Boston this October!

2nd Annual Next Generation Pharmaceutical Cleanroom
2022-10-05 - 2022-10-06 | Copthorne Tara Hotel, Scarsdale Place, Kensington, London, W8 5SY, United Kingdom
2nd Annual Next Generation Pharmaceutical Cleanroom
5 – 6 October 2022
London, UK
http://www.nextgen-pharmacleanroom.com/PJwl
Sponsored by Ecolab, Elis Cleanroom, Innerspace, Microgenetics, Novatek
Co-Chaired by: Conor Murray, Chairman, Irish Cleanroom Society and Connor McMorrow, Aseptic Lead Cell Therapy, Takeda
Advances in Pharma 4.0 for an Improved, Efficient and Contaminant-Free Cleanroom
SAE Media Group are pleased to announce the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference. An event that focuses on cleanroom technology in the pharmaceutical industry, the conference will serve to bridge that gap between the two areas while simultaneously providing a unique selling point.
This one-of-a-kind meeting will facilitate networking opportunities with key opinion leaders from all areas of pharmaceuticals, biologicals, and cleanroom industry experts to explore hot topics within cleanroom design and engineering, best practices and regulation, environmental and contamination control, and pharmaceutical microbiology.
In 2025, the global cleanroom technology market is expected to reach nearly $5 billion. Stringent regulatory standards for product approvals, technological advancements in cleanrooms, initiatives taken by private organisations to create awareness regarding cleanroom and growth of the healthcare sector globally are among the few factors expected to drive the market.
This event will look in-depth at the significant change that the cleanroom industry is going through. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Whether through robotics, automated disinfection, or data driven environmental monitoring- this conference will highlight the developments that are fundamentally changing the industry.
Event Hashtag: #PharmaCleanrooms
Key Reasons to attend:

Learn how to maximise the latest cleanroom technologies to modernise your contamination control strategy
Maximise the cost-effectiveness of your cleanroom and navigate best practises for cleanroom design
Optimise your preparation for upcoming regulatory changes, including the impending Annex 1
Increase your cleanroom availability & accessibility through streamlined approaches to contamination control

WHO SHOULD ATTEND:
Senior Micro Manager, QC Manager, Quality Director, Clean Room Design Managers, Design, Qualify and Testing – Clean Room (across the board), Head of Clean Room Technologies, Head of Compounding Pharmacies, Head of Clinical Drug Products, Head of Clinical Medical Device
View the brochure and to download visit http://www.nextgen-pharmacleanroom.com/PJwl

SAE Media Group's 3rd Annual Wearable Injectors and Connected Devices Conference
2022-10-10 - 2022-10-11 | London, UK
SAE Media Group’s 3rd Annual
Wearable Injectors and Connected Devices Conference
10 – 11 October 2022 | London, UK
http://www.wearable-injectors.co.uk/Pharmajournalist
The Latest Innovations In Digital Health And On-Body Drug Delivery For The Pharmaceutical Industry
SAE Media Group’s 3rd annual Wearable Injectors and Connected Devices Conference will explore on-body device design and development whilst also engaging in the latest advances in connectivity and digital health applications for wearable devices with industry perspectives from big pharma representatives. The conference will consider key developments in the wearable injectors field, including the enhanced demand for on-body injectors and digitalised health as the need for at home self-administration and routes for delivery of time-dependent, high volume and viscous drugs grow.
Benefits of Attending:

Engage with key regulatory updates surrounding digital health and medical devices
Discover advances in device design and development for large volume delivery via on-body injectors
Explore the key drivers of novel drug products for the development for on-body injectors
Hear insights into the growing potential of digital health to improve patient experience and treatment
Develop your understanding of design strategies for connectivity and digital health

Delegates will have the opportunity to network with the following companies:

Johnson & Johnson
Biogen
AstraZeneca
Merck KGaA
Novartis
Novo Nordisk
Boehringer Ingelheim

And many more!!
Who Should Attend:

Executives, Directors, VPs, Heads, Principals, Managers of:
Drug-Delivery Developers
Autoinjectors
Device Engineering
Human Factors
Injectables
Packaging
Regulatory Affairs
Connectivity
Medical Device Data
Novel Product Technology
Smart Device Developers
Device Safety Solution Providers
or anyone who works with Wearable Devices/ On-Body Injectors within pharmaceuticals, biotech, device developers and solution providers.

The two-day conference will bring you high-quality insights and industry connections on the latest advances in wearable injectors and connectivity, and a platform for exchanging ideas.
For more information contact:
Nikisha Galoria | Marketing Executive | SAE Media Group
Email: ngaloria@smi-online.co.uk
Phone: +44 (0) 20 7827 6164
Follow us on:
LinkedIn: SAE Media Group Pharma
Twitter: @SAEMGPharma

Reuters Events: Pharma 2022
2022-10-11 - 2022-10-13 | Nice Acropolis Convention Center, Nice, France
Comprehensive frameworks for equitable access and accelerated digital transformations are soon to be realized. But progress is slowing, risking a return to the old model plagued by persistent health disparities.
To thrive, each strategy and tactic must be centred with a whole-human approach, ensuring an agile, patient-driven, technology-enabled change.
You must advance intelligent automation, delivering value-driven content that enhance patient and HCP experiences, activate new skillsets for field teams to strengthen clinical practices, whilst collaborating with stakeholders – and competitors – to drastically improve equitable access to the vast galaxy of innovation improving patient outcomes and propelling commercial growth.
Reuters Events: Pharma 2022 (11-13 October, Nice France – formerly eyeforpharma Barcelona) is the only place where patient experts, leading solution providers, and pharma changemakers – from commercial, marketing, medical affairs, patient engagement, market access and RWE – commit to business transformation as the catalyst for maximum patient impact.
To know more visit: https://bit.ly/3xVKqN8

10th IMPACCT Real World Evidence Summit
2022-10-11 - 2022-10-13 | Crowne Plaza Woburn, 15 Middlesex Canal Park Rd, Woburn, MA, 01801, United States
Returning in person for its 10th year anniversary, the IMPACCT: Real World Evidence Summit will deep dive into the use of RWE for regulatory submissions and improved clinical trial design to help you navigate the regulatory landscape.
Following recent FDA and EMA guidelines, this comprehensive industry-led forum will address how drug developers can leverage RWE from beginning to end of study, ensure clinical studies are well-designed, include appropriate protections for their patients and upload data integrity.
Join 100+ senior leaders in RWE, RWD, real world analytics experts & epidemiologists from pharma and biotech to take part in this three day summit with over 18 hours of exclusive content.
To know more visit: https://ter.li/tymfzh

3rd Commercializing Flow Chemistry Summit 2022
2022-10-11 - 2022-10-13 | The Bostonian, 26 North St, Boston, MA, 02109, United States
With the exciting proof-of-concept milestones from Phlow, commitments from global regulatory agencies, and breakthroughs from the likes of AbbVie, AstraZeneca, Merck and BMS, over the last 12 months flow chemistry continues to take off at an exponential rate, further evidenced by the significant investments from CDMOs such as Almac, Corden Pharma, Sterling and Cambrex.
Showcasing the steep progress being made whilst addressing the field’s most front-of-mind challenges to enable the full potential of continuous chemistry to come to fruition, the 3rd Annual Commercializing Flow Chemistry Summit is back to bridge the gap between academic and industry innovation as your only meeting bringing both technical and strategic flow chemistry intelligence under one roof in Boston this October.
Uniting 100+ Process Development, Chemistry & Control, PAT, CMC, Continuous Manufacturing and Engineering experts across biopharma, academia, CDMO and fine chemical & API organizations for the first time in person, this is your prime opportunity to turn flow chemistry into industrial applications and implement advanced process control strategies to ensure product quality and meet regulatory expectations.
For practical takeaways across technical chemical engineering, process development, batch to flow transitions, novel chemistries, scale-up, PAT implementation & more, reduce your development cycle and enhance operational efficiency by attending the 3rd CFC Summit 2022!
To know more visit: https://ter.li/pqcevv

Innate Killer Summit Europe
2022-10-18 - 2022-10-20 | Hilton London Kensington, 179-199 Holland Park Ave, London, W11 4UL, United Kingdom
The Innate Killer Summit Europe gathers 80+ key European Gamma Delta T, NK, and Macrophage developers in October to chase the holy grail of efficacious, off-the-shelf, solid tumour immunotherapies through innate cell targeting and engineering.
Seize your chance to network with innate immune trailblazers from the likes of Sanofi, Takeda, Gamida Cell, Glycostem and Bayer and gain a comprehensive overview of candidates to inform your strategic development and progress the field together with an industry brain trust.
Bridging the gap between the technicalities of early discovery through to process optimisation and leaping regulatory hurdles, this is the must-attend meeting to accelerate safe and scalable therapies in Europe.
To learn more, visit: www.innate-killer-europe.com

Process Development for Cell Therapies Summit
2022-10-18 - 2022-10-20 | Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
“The Process is the Product” – Drive Process Excellence at the Only Summit Dedicated to Process Development for Cell Therapies

As momentum continues to build for the cell therapy industry, process development looms as a huge potential bottleneck to overcome. The inaugural Process Development for Cell Therapies Summit will give you unprecedented access to an industry melting pot of process development tools and experience to drive down cost of goods, maximize scalability and achieve regulatory compliance.
Join your peers who will all be gathering to learn how to identify and plug platform gaps for automation, global scale-out, faster phase development, increased affordability, and more!
With 20+ case studies being presented, you will come away with tried and tested strategies informed by industry leaders such as BMS, Kite, Lyell Immunopharma, and Immatics Biotechnologies. There is no other event of this kind which is focused specifically on Process Development for Cell Therapy, delivering case studies to provide actionable insights.
Now is the time to gather with the industry gurus to unpick shared challenges in process development and share best practices to de-silo the industry and bring better therapies to patients faster.
Find out more about the meeting, who’s attending and what you could learn by downloading the latest event guide: https://ter.li/lbtpp0
We look forward to welcoming you to Boston in October!

3rd Annual Gene Therapy Immunogenicity Summit
2022-10-18 - 2022-10-20 | The Colonade, 120 Huntington Ave, Boston, MA, 02116, United States
The 3rd Annual Gene Therapy Immunogenicity Summit is industry’s definitive forum enabling you to better modulate, measure and predict the immune response to your gene therapy candidate.
In the context of ever-increasing gene therapy clinical activity and uncertainty around challenges posed by immune responses to delivery, this summit will unite large pharma and innovative biotech’s to ensure that you’re up to speed on the latest approaches to evaluate and overcome pre-existing immunity to AAV vectors, understand how immune-modulatory strategies can help to ensure efficacy and safety and learn the reality of regulatory expectations around immunological assays.
Incorporating insights from leading immunological, bioanalytical, and translational experts, this is your opportunity to gain extensive technical information on the contrasts between immunogenicity encountered across organs and administration routes, how models can be enhanced to enable comparative immunology between species and what the latest clinical data tells us about how to adapt existing clinical mitigation strategies to address immunogenicity.
With 35+ industry-based speakers covering pre-clinical and clinical immunogenicity challenges over 2 tracks and 3 packed days of content, don’t miss your chance to join over 100+ fellow industry experts to network in person and share your research as you seek new and improved ways of predicting immunogenicity in the clinic to ultimately ensure the safety and efficacy of gene therapies.
To know more visit: https://ter.li/acp4lt

Operationalise: Early Access Programmes Summit Europe
2022-10-18 - 2022-10-20 | Hilton London Kensington, 179-199 Holland Park Ave, London, W11 4UL, United Kingdom
With over 100 early and managed access, compassionate use, and named patient programmes running across the continent, the Operationalise: Early Access Programmes Summit Europe has been carefully curated to help you address difficulties with supply, logistics and cost, challenges with navigating European regulations, and planning and running equitable, patient-first early access programmes.
Download the full event guide to view the world-class speaker faculty of over 20 experienced EAP leaders, who will be sharing their insights through best-practice case studies.
Immerse yourself in three days of interactive sessions and discuss your peers’ approaches to involving the patient voice, engaging different stakeholders, planning considerations for a successful EAP and more.
With a specific focus on real-world case studies and practical applications, join us to gain a greater understanding and clarity of the end-to-end management of running an early access programme in Europe.

4th TIL Therapies Summit
2022-10-24 - 2022-10-26 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
Commercialization looks set to propel TIL therapy into the spotlight for adoptive cell therapy, and the 4th TIL Therapies Summit arrives to finally reunite the community in-person this October in Boston, MA.
From preclinical conversations to the latest developments in streamlined manufacturing this year’s meeting will be the most comprehensive guide for addressing the unique challenges of TIL development to bolster and strengthen your pipelines to achieve your 2022/23 milestones.
With 20+ world-class speakers and over 100 senior attendees from around the globe, join the largest community of TIL-targeted drug development experts for a deep dive into clinical development progress, lessons learnt and novel strategies to maximize TIL-targeting to recognize and capitalize on this outstanding approach in adoptive cell therapy!
Here’s your exclusive snapshot of the world class speaker faculty:

Michael Lotze, Chief Cellular Therapy Officer, Nurix Therapeutics
Mark Dudley, Chief Scientific Officer, InsTIL Bio
Daniel J Powell Jr, Associate Professor of Pathology and Laboratory Medicine, University of Pennsylvania
Parameswaran Hari, SVP Clinical Sciences, Iovance Biotherapeutics
Nick Restifo, Stealth Explorer, Immunotherapy
Karrie Wong, Director Cell Therapy, KSQ Therapeutics
Andrew Weinberg, Chief Scientific Officer, AgonOx
Jan Ter Meulen, Chief Scientific Officer, Obsidian Therapeutics
Tom Henley, Chief Scientific Officer, Intima Biosciences
Stephanie Woodall, Director – Head of Quality, KSQ Therapeutics
Sylvia Lee, Associate Professor, Program in Immunology Clinical Research Division, Fred Hutchinson Cancer Research Center
Ulrik Cordes, Founder & Chief Executive Officer, Cbio

Learn from pioneering trailblazers in TIL development from the National Cancer Institute & University of Pennsylvania alongside leading industry representatives from the likes of Iovance, Instil Bio and Obsidian Therapeutics.
As a host of developers look to bridge to the next generation of TIL therapies, now is the time to leverage actionable insights to ensure you are set to capitalize on this achieve significant expansion in your development.
Join senior leaders from leading biotech, clinical and academic institutes to discuss data-driven and solution-based approaches to supercharge your TIL therapy towards commercialization.
To know more visit: https://ter.li/ygtovu

SAE Media Group’s 2nd Annual Biosensors for Medical Wearables
2022-10-24 - 2022-10-25 | Boston, MA, USA
SAE Media Group’s 2nd Annual Biosensors for Medical Wearables
*In collaboration with Medical Design Briefs*
24th – 25th October 2022 | Boston, MA, USA
Sponsored by: Raumedic
http://www.biosensors-medical-wear.com/PJWL
Advances in development and therapeutic applications of on-body sensors
SAE Media Group is proud to present the Biosensors for Medical Wearables Conference, taking place on the 24th – 25th October 2022.

As part of SAE Media Group’s leading series of medical device conferences, this year’s event will be exploring the key drivers and innovations of the wearable medical biosensors landscape with insights into the latest technologies uncovering the therapeutic scope of medical biosensors and the potential of wearable sensors for decentralized diagnostic testing. With growing digital application, the 2022 agenda will also assess the potential of Artificial Intelligence coupled with sensors and understand how industry is managing digital outcomes.
Chairing the Conference this year will be industry giants James Mault, MD, Founder and CEO, BioIntelliSense, Inc and Andreas Caduff, Strategic Advisory Board, Digital Medicine Society (DiMe).
The featured 2022 speakers include:

Carrie Northcott, Director and Project Lead, Digital Medicine, and Translational Imaging (DMTI), Early Clinical Development (ECD), Pfizer, Inc
Eric Richardson, Vice President of Applied Research, MedRhythms, Inc.
Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)
Samir Shah, Director, AstraZeneca
Tero-Pekka Alastalo, Chief Medical Officer and General Manager, US Operations, CardioSignal Inc
John Ralston, CEO and Founder, Neursantys, Inc.
Christine Guo, Chief Scientific c Officer, ActiGraph
Xina Quan, Co-Founder and CEO, PyrAmes, Inc.
Pierre-Alexandre Fournier, Co-founder/CEO, Hexoskin

Why should you attend?

You will explore the latest in biosensor technologies for wearable medical devices for therapeutics applications
You will uncover the potential of wearable sensors for decentralized diagnostic testing
You will delve into the evolving research and technologies to overcome unmet needs of the field including battery technologies for wearable sensors
You will assess the growing opportunities and sensor technologies being developed in industry for digital medicine and therapeutics
You will engage in platforms and opportunities for sensors coupled with AI and understand how industry are managing digital outcomes

Checkout the early bird offers:

BOOK BY 30TH JUNE AND SAVE $300
BOOK BY 31ST AUGUST AND SAVE $200

For more information please contact:
Nikisha Galoria | Marketing Executive | SAE Media Group
Email: ngaloria@smi-online.co.uk
Phone: +44 (0) 20 7827 6164
Follow us on:
LinkedIn: SAE Media Group Pharma
Twitter: @SAEMGPharma
#MedicalWearables

6th Annual Gene Therapy for Rare Disorders Europe Summit 2022
2022-10-25 - 2022-10-27 | London Marriott Hotel Regents Park, 128 King Henry’s Road, London, NW3 3ST, United Kingdom
As more and more companies gear up for clinical activity and near approval decisions, the need to have an in-depth understanding of the regulatory frameworks and how these feed into clinical development and manufacturing processes is as vital as ever.
This year’s summit is dedicated to gaining European regulatory clarity to progress efficient and robust gene therapies for rare diseases. By giving voice to pioneering drug developers with success stories to share, experts in regulatory affairs, and the regulators themselves, this meeting is your comprehensive guide to unpicking the thorniest regulatory challenges.
Across three carefully curated days, this streamlined one-track summit will unite key gene therapy leaders from large pharma to ground-breaking biotech, academics to exciting service providers, all with the purpose of paving a way forward to successfully launch gene therapy products in Europe.
To know more visit: https://bit.ly/3ysiVts

7th Annual Computational Drug Development (CDD) for Biologics Summit
2022-10-25 - 2022-10-27 | Boston Marriott Burlington, One Burlington Mall Road, Burlington, MA, 01803, United States
Returning to Boston this October, the 7th Annual Computational Drug Development (CDD) for Biologics Summit will continue to build on the reputation of past meetings while diving into the latest innovations in the industry. This year’s summit will highlight methods and best-practices to extrapolating data & leveraging deep learning for novel, complex biologics pipeline progression.
Across 3 days, we will unite leading experts including AbbVie, GSK, Amgen, Genentech, Takeda & many more to:

Overcome data availability and collection challenges to support machine learning and in silico drug discovery and development for biologics
Refine high throughput screening methods for novel antibody candidates to shorten your drug development cycles
Advance the next generation of computational biology in designing complex antibodies – including multifunctional, multi-specific antibodies
Empower the predictability of protein structures and protein-protein interactions for better drug development
Optimize your development cycle and decision making using computational data

Find out more – https://ter.li/ec2qbx

Protein Engineering Biocatalysis Congress
2022-10-26 - 2022-10-27 | Philadelphia, USA (venue TBC)
The Protein Engineering Biocatalysis Congress is the unique meeting point of industry, academia and service providers which will enable protein engineering and biocatalysis enthusiasts to industrialize sustainable enzyme products and increase product efficiency globally.
This event will highlight case studies on scaling up protein engineering technologies for commercial scale. It is your opportunity to analyze developments in protein engineering for biocatalysis to establish sustainable, scalable and cost-efficient API manufacturing.
To know more visit: www.proteinengineeringglobal.com

6th Dermatology Drug Development Summit
2022-11-01 - 2022-11-03 | Boston Park Plaza, 50 Park Plaza, Boston, MA, 02116, United States
The 6th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases returns to Boston this fall.
Ensure you join this year’s 150+ expert community in-person to:

Uncover recent studies evaluating critical inflammatory and auto-immune pathways
Gain a deeper understanding of promising biologics targeting IL-13, IL-31, IL-33, versus IL-17 associated diseases
Assess emerging efficacious targeted approaches in the plethora of conditions outside of these pathways.
Obtain clarity on novel clinically validated endpoints within the regulatory landscape for critical dermatological conditions with high unmet needs such as Hidradenitis Suppurativa, Vitiligo, Rare Disease, and Alopecia Areata

View the event program here: https://ter.li/g3z67z
Register here: https://ter.li/vu3tx9
If you have any further questions regarding the summit, please contact us at info@hansonwade.com.

6th Microbiome Movement – Human Nutrition Summit
2022-11-07 - 2022-11-09 | TBC
Returning to Boston for 2022, the 6th Microbiome Movement- Human Nutrition Summit is the only industry focused meeting dedicated to exploring the latest innovations, practical applications and clinical benefits of microbiome targeting food, beverages and supplements to pave the route to commercial success in the consumer health setting.
Get up to speed on this dynamic industry with expertise shared from the likes of Bayer, Postbiotics Plus, Amazentis and many others, as the titans of industry unite to:

Showcase the latest scientific findings on the mechanism and functional role of novel microbiome targeting ingredients
Shine a spotlight on the future of postbiotics, and advance commercialization of microbiome-targeted nutritional interventions
Advance commercialization of microbiome-targeted nutritional interventions

With consumers demanding to have greater control over personal health and wellbeing, join your community of 100+ industry experts from global CPG companies, innovative start-ups and biotechs to usher in a new wave of personalised nutrition.
To know more visit: https://bit.ly/3clIDZQ

6th Antifibrotic Drug Development Summit (AFDD)
2022-11-09 - 2022-11-11 | Crowne Plaza Woburn, 15 Middlesex Canal Park Rd, Woburn, MA, 01801, United States
Returning for the 6th year, the Antifibrotic Drug Development Summit (AFDD) will host the transferrable insights you need from IPF, NASH, CKD and more in one place at one time, so you can advance the progress of your antifibrotic therapies.
From exploring cellular mechanisms to identify a common fibrotic pathway to bridging the translational gap to prove early therapeutic effectiveness; this unique cross-organ, cross-disease, cross-discipline discussion forum is here to transform your fibrosis research.
Join 100+ industry super giants from Boehringer Ingelheim, Genentech, Gilead, Pfizer, Novartis, and many more in Boston to harness the knowledge you need for your 2022/23 antifibrotic research and drug development.
To know more visit: https://ter.li/u60ni5

Medical Devices and IVD 2022
2022-11-14 - 2022-11-15 | London, UK
SAE Media Group’s Inaugural Conference…
Medical Devices and IVD 2022
14 – 15 November 2022
London, UK
www.medicaldevices-ivd.com/PJ
Navigating The MDR and IVDR and Best Strategies for Compliance
SAE Media Group is proud to announce the launch of the Medical Devices and IVD Conference, taking place on 14 – 15 November 2022 in London, UK.

The MDR implementation last May has highlighted issues within the industry that need to be addressed and the upcoming IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing requirements, and increasing the burden for post-market surveillance.
The conference will provide insight into the latest updates in EU MDR and IVDR regulations and will discuss strategies for how to best comply with these regulations. In addition, the conference will consider the evolving regulatory landscape for digital health software.
BENEFITS OF ATTENDING:

Engage with notified body and competent authority representatives addressing key MDR and IVDR requirements
Gain insights from pharma regulatory experts in compliance and companion diagnostics
Understand the latest guidance on IVD Regulations to overcome common challenges, in addition to considering evolving global regulations
Examine post-market expectations for surveillance and vigilance of your medical devices
Delve into advancements in the digitalisation of medical devices and the regulatory considerations surrounding this

WHO SHOULD ATTEND:
Executives, Directors, VPs, Heads, Principals, Managers of:

Device Manufacturing
Regulatory Affairs
IVDR
MDR
CMC
Compliance
Risk Management
Traceability
Vigilance
Product Development
PFS
Combination Products

To find out more, please visit: www.medicaldevices-ivd.com/PJ
EARLY BIRD RATES:

BOOK BY 30TH JUNE TO SAVE £200
BOOK BY 30TH SEPTEMBER TO SAVE £100

ADDITIONAL CONTACT INFORMATION:

E: ngaloria@smi-online.co.uk
T: +44 (0) 20 7827 6164

FOLLOW US ON:

Twitter: @SAEMGPharma

LinkedIn: SAE Media Group Pharma

Microbiome Connect: USA 2022
2022-11-16 - 2022-11-17 | The Westin Boston Seaport District, 425 Summer Street, Boston, MA, 02210, United States
The 7th Annual Microbiome Connect: USA 2022 is dedicated to showcasing the leading drug development platforms applying microbes, microbe modulators and microbial-derived components to prevent or treat human diseases or make medical diagnosis. As the first FDA approved microbiome-targeted therapeutic emerges, drug developers will have the opportunity to benchmark their rational drug platforms, targeting validated pathways in gastrointestinal, neurological, metabolic disorders, as well as oncology-based indications. Furthermore, the manufacturing challenges associated with reaching commercialization specific to microbiome-based drugs will be addressed in depth. With talks from Live Biotherapeutic Product manufacturing experts, including the Head of CBER, on topics including how to handle USP 61/62, and achieving co-culturing capabilities. Join us to hear from microbiome biotechs, pharma voices, investment bodies, and more on how to develop robust, scalable, and reproducible formulations for microbe-derived/-targeting products entering late-stage investigations and reaching for the market.
To know more visit: www.microbiomeconnectusa.com

Liquid Biopsy Surveillance & Early Detection Summit
2022-11-16 - 2022-11-17 | Wyndham Boston Beacon Hill, 5 Blossom St, Boston, MA, 02114, United States
Recognize Disease Hallmarks Earlier for Improved Patient Outcomes
Gain Clarity Across Next Generation Non-Invasive Testing Technologies Revolutionizing Cancer Monitoring, MRD & Earlier Detection to Support Novel Pre-Metastatic Drug Development with Maximized Access
In the wake of new FDA guidance and exciting MRD partnership announcements between Grail & AstraZeneca, Amgen & Bristol Myers Squibb the liquid biopsy industry is experiencing a paradigm shift. Touted as having the potential to transform clinical practice as we know it, technical progress and mounting investment in premetastatic applications are creating huge industry-wide excitement for liquid biopsy-based screening & surveillance for novel precision drug development.
With technology maturity on the near horizon, the inaugural Liquid Biopsy Surveillance & Early Detection Summit is your only dedicated platform providing much-needed clarity on the industry’s emerging assays increasingly opening the doors to novel trial design and better patient outcomes.
As drug & diagnostic developers look to realize the commercial impact of early detection & MRD while shifting pipelines from the metastatic setting, here lies your best opportunity to harness game-changing technologies to define leading stratification, surrogate endpoint, and regulatory strategies – accelerating the delivery of breakthrough therapies into the clinic.
Providing a path forward for early detection & surveillance to become a widespread patient reality, unite with 80+ Translational, Biomarker, Clinical, Regulatory, Precision Medicine, Medical Affairs & Diagnostic experts at your only forum prioritizing liquid biopsy applications for earlier intervention.
To know more visit: https://ter.li/0kjtfi

4th Annual Gene Therapy Analytical Development Summit 2022
2022-11-28 - 2022-12-01 | Westin Boston Seaport, 425 Summer Street, Boston, MA, 02210, United States
The past twelve months have culminated in an unprecedented level of excitement, investment, and clinical progress within the gene therapy field. As the field strives to strike a delicate balance between safety and efficacy, in the context of increased regulatory scrutiny and safety challenges, attending the 4th Annual Gene Therapy Analytical Development as an analytical scientist has never been so important.
This year’s summit returns in-person to Boston to reunite 300+ analytical experts in innovative biotech, pharma and academia to continue to develop resilient, long-lasting and robust analytical tools to enhance the safety, quality and efficacy of gene therapy products.
Whether you are focusing on specific characterization methods, enhancing your genome sequencing, advancing your understanding of full and partial particles, or advancing your early-stage bioassays, with 4 tracks, 8 pre-conference workshops and a post-conference focus day, the 4th Gene Therapy Analytical Development Summit will encompass all aspects of analytical development, giving you the chance to address and overcome challenges.
If you work in quality control, quality assurance, or process development – we’ve listened and we’ve answered. This year’s agenda includes a novel track designed for quality control and process development groups working in gene therapy. Talks include enhancing the knowledge transfer between departments, bridging between analytical methods with regards to QC/PD, and enhancing in-process development support.
Whether you’re working with AAV, non-viral vectors or lentiviral vectors, this is your opportunity to enhance your existing analytical methods and explore innovative new tools to support safe and effective gene therapy development.
To know more visit: https://ter.li/w2diiu

2nd Rare CNS & Neurodevelopmental Drug Development Summit
2022-11-28 - 2022-11-30 | Wyndham Boston Beacon Hill, 5 Blossom St, Boston, MA, 02114, United States
Developing New Outcome Measures, Functional Biomarkers & Clinical Research Regulatory Frameworks for Disease-Modifying Therapeutics Across Neurodevelopmental & Rare, Genetic CNS Disorders
With more clinical data emerging, neurodevelopmental drug development is advancing from hypotheticals to real-life clinical results, outcomes, and functional biomarkers, catapulting this critical field forwards.
Join 100+ peers this November at the 2nd Rare CNS & Neurodevelopmental Drug Development Summit – the only industry dedicated drug development forum for large pharma, biotech, academia, and patient advocacy groups, paving the way towards symptomatic and successful disease modifying treatments.
Tightly focused on industry progress, stakeholders will explore ASOs, gene therapies and small molecules across autistic syndromes and seizure phenotypes at this unique drug sponsor conference.
Don’t miss out on this definitive opportunity to collaborate with patient groups and gain regulatory clarity on clinical trial design, endpoints and delivery and toxicity concerns as well as deep diving into functional and molecular biomarkers, emerging therapeutic targets and translational biology.
If you are working towards treatments for rare CNS and neurodevelopmental disorders, including (but not limited to) Angelman Syndrome, Rett syndrome, Fragile X, Dravet Syndrome and CDKL5 Syndrome or discovering new frontiers in anti-epileptic therapeutics, this is the platform you need.
To know more visit: https://ter.li/9yzux5

4th Inflammasome Therapeutics Summit
2022-11-29 - 2022-12-01 | Boston Park Plaza, 50 Park Plaza, Boston, MA, 02116, United States
The 4th Inflammasome Therapeutics Summit is the only industry-led forum uniting large pharma, biotechs, and academic KOLs, with the common goal of accelerating the practical translation and clinical development of inflammasome-targeted drugs, which are shaking up the immunology R&D landscape.
As the space eagerly awaits data readouts from proof-of-concept trials, and with more companies than ever before with active inflammasome therapeutic pipelines; this is your opportunity to be involved in interactive discussions on:

Deciphering the intricate mechanisms underlying dysregulated inflammasome signaling within the wider context of the immune system
Overcoming limitations of preclinical models, identifying clinically meaningful biomarkers of inflammasome inhibition, and defining good clinical endpoints
Taming inflammation and achieving optimized safety profiles using the next frontier for inflammasome-targeted drugs including those targeting NLRP3 and novel targets
Delving into specific disease groups to demonstrate where inflammasome therapeutics will be most impactful

Join 120+ fellow peers and industry heavyweights this Fall including NodThera, Novartis, Zyversa Therapeutics, and more, to build meaningful partnerships and propel the next frontier of inflammasome therapeutics from pipeline development into a clinical and commercial reality.
Access the official event guide here to learn more.

6th Obesity & NASH Drug Development Summit
2022-11-29 - 2022-12-01 | Revere Boston Common, 200 Stuart St, Boston, MA, 02116, United States
The first wave of investment in NASH is dispersing in the wake of highly demanding biopsy endpoints, but opportunities to target obesity and metabolic syndrome are catalyzing increasing excitement. Pivotal readouts in GLP-1 receptor agonists and exciting progress in regenerative medicine and microRNAs are redefining the drug development landscape for metabolic disorders.

With mounting competition for the market in obesity and all eyes on the next wave of NASH candidates, the 6th Obesity & NASH Drug Development Summit, (previously the NASH Summit) is dedicated to reuniting industry leaders in metabolic syndrome to consolidate targets directly implicated in disease pathology and traverse the regulatory hurdles to commercialization.
Join 150+ industry pioneers in Boston including pioneers Novo Nordisk, Eli Lilly, Boehringer Ingelheim, Pfizer, Inventiva, Regeneron, FDA, AstraZeneca, and more to advance your pipeline towards approved treatment.
Access the official event guide here to learn more.

3rd CRISPR 2.0 Summit
2022-11-29 - 2022-12-01 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
Recognized with a Nobel Prize in 2020, CRISPR has opened the floodgates for a new era of gene editing therapies, promising to transform genetic disease treatments. With a well-established early field of genomics research, drug developers and researchers have been busy establishing the next-generation CRISPR toolkit, including Cas nucleases, base and prime editing technologies, and innovative delivery platforms.
The 3rd CRISPR 2.0 Summit is devoted to showcasing the latest and greatest innovations by uncovering how the next generation of CRISPR tools are radically enhancing efficacy, minimizing off-target effects & enabling efficient tissue-specific delivery to help you progress your program into and through the clinic.
Across three days of content, co-designed with 27+ industry thought leaders, this streamlined one-track summit will unite 100+ key players in the CRISPR space, from large pharma to ground-breaking biotech, academics to exciting service providers, all with the purpose of paving a way forward to market for your CRISPR gene editing program.
Here’s a snapshot of our 27+ thought leaders:

Kiran Musunuru, Professor of Medicine, Perelman School of Medicine, University of Pennsylvania
Amy Simon, Chief Medical Officer, Beam Therapeutics
Jane Grogan, Chief Scientific Officer, Graphite Bio
Liron Walsh, Head of Development; In Vivo Programs, Intellia Therapeutics
Jeremy Duffield, Chief Scientific Officer, Prime Medicine
Eric B. Kmiec, Executive Director & Chief Scientific Officer, Christiana Care Gene Editing Institute
Rafi Emmanuel, Senior Vice President – Research & Development, Emendo Biotherapeutics
John Murphy, Chief Scientific Officer, Arbor Biotechnologies
Inge Yung-Chih Cheng, Principal Scientist, Pfizer
Joey Riepsaame, Head of Genome Engineering, University of Oxford
Rammohan Devulapally, Principal Scientist, GenEdit

Be part of the community as we dive deep into:

Refining non-viral tissue targeted CRISPR delivery methods for maximized safety and efficacy, with help from GenEdit and the latest research from the David Liu Lab.
From bench to bedside: translating basic CRISPR research into a viable therapeutic product, with Beam Therapeutics
Leverage the latest base and prime editing technology for enhanced precision treatment of inherited disorders, with Prime Medicine and UC Irvine.

And more!
Join this unmissable summit and network experts from the likes of Beam Therapeutics, The David Liu Lab, Pfizer, GenEdit, AZ, GSK, Caribou Biosciences, Prime Medicine, Intellia Therapeutics and many more.
To know more visit: https://ter.li/vumobp

PAT & Real Time Quality Summit
2022-12-01 - 2022-12-02 | Hilton San Diego Gaslamp Quarter, 401 K Street, San Diego, CA, 92101, United States
The time has come to remove the pharmaceutical industry’s reliance on archaic off-line testing and embrace the cost and speed-to-market savings of online control and real-time product quality.
The PAT market is projected to reach USD 4.96 Billion by 2027, spurred on by the recent ICH Q14/ Q2 (R2) guidelines, there has never been a more opportune moment to leverage regulator’s support of QbD, real-time control, and process intervention to achieve meaningful business impact in your organization, through reduced downtime, manufacturing footprint, ease of scale-up and product consistency for approval.
Whether you’re applying in small molecules, biologics, or ATMP, bridge the gap in technology, culture, or regulatory experience that is the bottleneck to your organization saving an average 50% reduction in process cycle time and winning speed to market, with the strategical implementation of smart process analytical technologies and quality by control (QbC).
Join a senior community of experts in process development, manufacturing, regulatory & quality to understand how to monitor critical quality attributes with reactive and predictive control systems and discover novel PAT technologies as the industry moves the needle toward realizing real-time release.
To know more visit: https://ter.li/080rbc

4th Annual Gene Therapy for Neurological Disorders
2022-12-05 - 2022-12-08 | The Westin Seaport District, 425 Summer St, Boston, MA, 02210, United States
Delivering the Next Wave of Gene Therapies to the CNS
With systemic toxicity challenges plaguing the AAV field, direct administration for CNS indications creates an ideal target for gene therapy. This is an exciting year for the neurological space with clinical data to show and new biotechs coming out of the woodwork to release the next wave of gene therapies with more advanced CNS targeting for a wider selection of neurological targets.
The 4th Annual Gene Therapy for Neurological Disorders Summit will unite gene therapy developers with an industry-focused agenda across 4 days and 2 dedicated tracks of content to solve the preclinical, translational and clinical challenges of targeting a wide range of neurodevelopmental and neurodegenerative disorders with both ‘first’ and ‘next’ generation gene therapies.
Join the expanding audience of gene therapy experts to:

Streamline CNS drug delivery devices for improved brain biodistribution
Discover novel vectors for CNS specificity & tropism
Optimize gene therapy strategy for pediatric & adult neurological disorders

To know more visit: https://ter.li/rluqrj

4th Annual Cell Therapy Analytical Development Summit
2022-12-05 - 2022-12-07 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
Cell Therapy Analytical Development Summit US is back for its fourth year, taking place in Boston (December 5-7). Join 180+ colleagues from analytical development, process development, quality control and regulatory affairs, to standardize analytical testing and take advantage of unrivalled content across:

3-days
6 deep-dive workshops
2 tracks

Seize an unmatched opportunity to delve into cell potency, safety, viability, sterility and more across both autologous and allogeneic cell therapy products.
Please use this URL – https://ter.li/ghwxjk
