7th Gene Therapy for Rare Disorders Summit
2024-03-26 - 2024-03-29 | The Westin Copley Place, 10 Huntington Avenue, Boston, MA, 02116, United States
This past year has seen more gene therapies approved by the FDA than the previous five years combined, and almost triple the number of clinical trials in gene therapy have been initiated in H1 of 2023 compared to the same time frame in the previous year.
To maximize the value of your late-stage gene therapy assets, the 7th Gene Therapy for Rare Disorders Summit is returning to tackle head-on the significant clinical, manufacturing, regulatory, and commercial challenges facing gene therapy programs today.
Bringing together key figures from industry, regulatory bodies, patient non-profits, payers, and key service providers, this is the field’s foremost meeting for collectively progressing rare gene therapy programs into and through the clinic.
Join us to leverage essential insights from over 300 peers from leading biopharma companies with direct experience in driving gene therapies through the clinic and into the market. Keep your finger on the pulse, form connections with top decision-makers, and address your specific clinical, manufacturing, regulatory, and commercial bottlenecks to safeguard against costly delays and progress your gene therapies through the pipeline quickly and safely.
To know more visit: https://ter.li/x4qqur

Measuring Patient Engagement Summit
2024-04-09 - 2024-04-11 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
The Measuring Patient Engagement Summit is the definitive conference for practical answers. This event will act as the honeypot gathering for leading patient engagement experts to share their latest experiences of how they are successfully measuring patient engagement to: inform decision making in improving patient engagement, quantify the impact of patient engagement on recruitment and retention, and ensure the most meaningful outreach to patients and advocacy groups.

Join 70+ Chief Patient Officers, Patient Engagement leaders and Patient Advocacy experts, from esteemed pharmaceutical and biotech companies, such as Novartis, Otsuka, Boehringer Ingelheim, AstraZeneca and many more, to establish a roadmap to quantify the success of your patient engagement work.

Check out the full event guide now: https://ter.li/cqba4m

3rd ADC Analytical Development Summit
2024-04-16 - 2024-04-18 | Hilton Boston Bay Back, 40 Dalton St, Boston, MA, 02115, United States
The 3rd ADC Analytical Development Summit is your only industry-dedicated meeting providing you with the key insights to ensure you are developing a high-quality ADC product within regulatory boundaries.
Next year’s program promises to give you even more focused content to better quantify DAR and drug distribution, overcome species separation challenges, and better utilize impurity assays to measure free-linker drug and process-related impurities.
Get an exclusive sneak peek of the agenda here.
Not only is this meeting packed with technical content that will allow you to influence, gain a deeper understanding, and improve product quality, but it will also give you the opportunity to interact with industry experts including:

Nailing Zhang, Lead Biologist, FDA
Linda Nelson, Executive Director, RA-CMC, Daiichi Sankyo
David Lee, Executive Director, Analytical Chemistry, Mersana Therapeutics
Chris Woods, Scientist, Analytical Development, Seagen
Madhumati Mukherjee, Senior Scientist, AstraZeneca
Dengyun (Daisy) Sun, Principal Scientist, Cell Based Sciences, Merck & Co.
Yan-Hui Liu, Director, Analytical Development, GlaxoSmithKline

…and many more!
See the full speaker lineup and agenda sessions here.
We hope you can join us to network with like-minded colleagues and scientists and have the in-depth technical conversations needed to address the common analytical bottlenecks in ADC development.

4th Fc-Mediated Function Summit
2024-04-16 - 2024-04-18 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
Discover & Shape the Future of Biologics & Antibody Therapies at the 4th Fc-Mediated Function Summit
FINAL 5 PASSES REMAINING – Register Now at https://ter.li/g5st7q
At the intersection of groundbreaking research, clinical innovation, and collaborative networking, the 4th Fc-Mediated Function Summit stands as a beacon for advancing the frontier of FcRn, FcγR, and IgG therapeutics. Our mission is to supercharge molecular development, elevate clinical utility, and explore novel therapeutic applications through a comprehensive understanding of targets and biology.
In a landscape where clinical data is expanding, and partnerships like the Argenx-Genmab powerhouse exemplifying the potential of antibody therapies, the spotlight on biologics Fc modulation as a therapeutic target has been more intense than ever. The 4th Fc-Mediated Function Summit continues to be at the forefront of this movement, uniting experts and enthusiasts alike.
Key Highlights:
Targeting FcRn & FcγR Biology:
Unlock the secrets of molecular engineering and real-world clinical outcomes by focusing on the critical targets – FcRn and FcγR. Gain insights into the intricacies of their biological pathways, and understand how molecular modifications can translate into tangible clinical benefits.
Unrivaled Content:
As the only conference dedicated exclusively to FcRn, this meeting will comprehensively cover the landscape. Attendees can expect to be immersed in cutting-edge research, the latest advancements, and a holistic understanding of the subject matter. This focus ensures that participants are at the forefront of knowledge and equipped with insights that are not diluted by unrelated topics, setting this summit apart as a beacon of specialized expertise.
Exceptional Networking:
Forge meaningful connections with a diverse cohort of professionals spanning immunology, antibody engineering, pharmacology, toxicology, and immuno-oncology. The summit provides a unique opportunity to engage with 80+ peers, facilitating cross-disciplinary partnerships and knowledge exchange.

4th Annual Gene Therapy for Muscular Disorders
2024-04-16 - 2024-04-18 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
Discover the forefront of gene therapy at the 4th Gene Therapy for Muscular Disorders Summit (April 16-18, Boston). Following the groundbreaking approval of Sarepta’s DMD gene therapy in June 2023, our April 2024 gathering explores key challenges in translating research into clinical breakthroughs. With a sharp focus on safety and efficacy, we unite experts to advance transformative treatments for muscular disorders lacking viable options. Join us to propel innovation forward and make a tangible impact on patient care. This is your opportunity to shape the future of muscular disorder treatments in just one event.
Want to learn more? Check out the event guide here: https://ter.li/cjxppp

Pre-Filled Syringes and Injectable Drug Devices East Coast Conference and Exhibition
2024-04-22 - 2024-04-24 | Boston, USA
SAE Media Group’s 11th Annual Pre-Filled Syringes East Coast Conference will return to Boston in April 2024 to bring you the latest advances in the combination product drug delivery space. The 2024 conference will be bigger and better than ever, bringing you 3 days of expertise, comprising of a pre-conference focus day exploring the advances in PFS design for enhanced drug delivery proceeded by a two-day main conference with morning keynote plenaries and parallel afternoon topic streams addressing the industry’s hottest topics through case studies and industry insights.
This event will not only bring you key insights needed to expand and enhance your injectable device portfolio but will also give you the opportunity to network with key players throughout the industry. We hope to welcome you to this must attend event in April 2024!
Why attend:

3 full days of networking opportunities
40+ presentations with 75% of speakers from the top 20 big pharma companies
The agenda has been curated by an advisory board of big pharma and biotech opinion leaders providing expertise focused on device development, regulatory affairs and quality
Access a focus day and 4 dedicated streams addressing the hottest topics in the industry

This year’s agenda has been validated by our 2024 advisory board:
John Schalago, Executive Director, Senior Global Program Director, Novartis
Khaudeja Bano, Vice President, Combination Product Quality, Amgen
James P. Wabby, Global Head, Regulatory Affairs – Emerging Device Technologies and Combination Products, AbbVie
Mark DeStefano, Director, Combination Products and Devices R&D, Teva
Michael Song, Director, Drug Product Development, Moderna
What you will gain:

Collaborate with pharma, biotech and device developers across 3 full days on the latest trends, advancements and challenges within the pre-filled syringe and injectable device market
Hear about new technological advances for challenging to delivery drugs such as large volume, highly viscous and lyophilised formulations with case studies on wearable injectors and more
Understand the latest regulatory requirements from experts surrounding combination products and engage in opportunities for collaboration and needs for advancing innovation in the field with an advisory board fireside chat
Gain insight into how big pharma is incorporating sustainable approaches into drug device design and lifecycle management
Delve into the growing potential of digital health to improve patient experience and treatment, and the challenges facing its implementation
Examine how container and packaging development can support the ever-evolving innovations drug development, including case studies on CCIT in deep-cold storage and formulator perspectives

To know more visit: www.pfsamericas.com/PharmaJournalist-Event-Listing

5th TCR-based Therapies for Solid Tumors Summit
2024-04-23 - 2024-04-25 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
The 5th TCR-based Therapies for Solid Tumors Summit returns is back as the exclusive gathering where TCR pipelines take center stage. It serves as the premier platform for networking with biopharma industry leaders dedicated to expediting the clinical and commercial development of TCR-based therapeutics.
This summit serves as the epicenter for exploring these transformative advancements, poised to showcase the long-term efficacy of TCR therapies in the treatment of solid tumors, marking a monumental milestone in the field’s evolution.
This is your opportunity to accelerate next generation TCR engineering, enhance target identification, & improve solid tumor persistence to transform clinical & scalable development for patients in need. Join TScan Therapeutics, Marengo Therapeutics, T-Cypher Bio and more to gain invaluable insights into the future of TCR-based therapies.
Find out more here: https://ter.li/f8jhfw

2nd mRNA Process Development & Manufacturing Summit Europe
2024-04-23 - 2024-04-25 | Crowne Plaza Frankfurt – Congress Hotel, Lyoner Str. 44 -48, Frankfurt am Main, 60528, Germany
As European biopharma seek regulatory clarity to progress their mRNA process development and manufacturing, the 2nd mRNA Process Development & Manufacturing Summit Europe returns to help you improve and optimise purification processes, platforms for circular and saRNAs and drug product formulation.
Where: Crowne Plaza Frankfurt – Congress Hotel, Frankfurt, Germany
When: 23-25th April, 2024
Website: https://ter.li/d3ggdb

Reuniting directors, heads and senior scientists pioneering the European mRNA space, this three-day industry forum will navigate key bottlenecks from mRNA sequence design to in vitro transcription and scaling up processes.

Gain clarity on regulatory quality standards and comparability changes with the MHRA and CureVac
Explore continuous platform technologies to accelerate low cost manufacturing
Glean insights into purification and computational modelling approaches to optimise downstream processes
Harness platform technologies for circular and self-amplifying RNAs to enhance their manufacturability
Improve your drug product formulation and manufacturing for personalised mRNA-based medicines

What’s next:

Download your copy of the brochure: https://ter.li/d3ggdb
Register your place: https://ter.li/lzwg6z

Exosome Characterization & Analytical Development Summit
2024-04-23 - 2024-04-25 | The Westin Boston Seaport District, 425 Summer Street, Boston, MA, 02210, United States
In the ever-evolving exosome field, the past year has witnessed remarkable progress. From Kimera’s FDA IND approval to Brexogen’s recent deal with HK inno.N and advancements in analytical technology, the landscape is rapidly advancing. Developing robust techniques is increasingly crucial, serving as the cornerstone for exosome therapeutics, alongside drug delivery applications and advancements.

The Exosome Characterization & Analytical Development Summit offers a comprehensive forum, equipping you with the skills needed to establish robust techniques, select the best instruments, ensure quality, and seamlessly navigate regulatory processes.
Across three days in April, this hotly anticipated summit will unite key experts from AbbVie, Aegle Therapeutics, Vesigen Therapeutics, and more to unite an industry on:

In depth technical content of exosome analysis and parameters for confidence in quality
Defining standardized tools and techniques while keeping regulatory guidance in mind for clinical progression
Bridging communications and networking between Analytical Experts and Decision Makers

To learn more, and secure your place, check out the official event website here: https://ter.li/v1xubp
Download the full event guide here: https://ter.li/182ula

Peptide Based Therapeutics Summit
2024-04-23 - 2024-04-25 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
Positioned in the goldilocks spot between small molecules and biologics, peptide therapeutics have undergone an exciting uphill trajectory within the last decade. Fuelled by advances in synthesis and screening technologies, together with novel design and delivery strategies to surmount their inherent drawbacks, this modality is showing new levels of promise. The momentum behind this exciting modality is evidenced in the billion-dollar deals from industry giants such as Genentech and Merck, signalling a surge in interest from an expanding array of companies venturing into the field of next-generation peptide-based drugs.
The first industry-focused event dedicated towards this exciting new modality, the Peptide Based Therapeutics Summit will unite pioneers from Johnson & Johnson, Fog Pharma, Genentech & PeptiDream, spanning diverse diseases and therapeutic approaches. Whether you’re focused on peptide-drug conjugates, bicyclic or macro-cyclic peptides, PCSK9, GLP, or any other peptide based therapeutic, this is an invaluable opportunity to learn from peers, accelerate discovery and de-risk the development of your peptide therapeutics.
As we enter the third wave of peptide-based therapeutics, this therapeutic and disease agnostic meeting will bring together the leading minds in early discovery, pre-formulation, heads of peptide drug development and pioneering peptide chemists. Together, we will dissect challenges related to improving peptide stability, raising oral bioavailability and balancing cell permeability with intracellular target selectivity, as well as exploring how the latest cutting-edge technology can help you arrive at the optimal lead compound.
Learn more about this meeting that helps to shape the trajectory of these remarkable drugs across various therapeutic landscapes: https://ter.li/2qs54c

3rd LNP Formulation & Process Development Summit
2024-04-29 - 2024-05-02 | The Westin Boston Seaport District, 425 Summer Street, Boston, MA, 02210, United States
Following the success of the first 2 years of the LNP Formulation & Process Development Summit, we are hugely excited to announce the much-anticipated return of this world-leading summit in 2024.
This April, the 3rd LNP Formulation & Process Development Summit returns to Boston, bringing together over 400 experts in LNP Biology, Chemistry, Formulation, Analytical Development, Process Development, Manufacturing and more. This is your ultimate platform for sharing insights, learning new concepts and networking to propel more LNPs into the clinic in 2024.
Join the ever-growing community of LNP pioneers as they tackle the challenges associated with developing safe, compliant and efficacious LNPs, to treat a variety of disease indications at a variety of target organs. This starts with the in vitro discovery of LNPs through to the manufacturing processes, with end-to-end synergy fundamental.
Hear from industry powerhouses Pfizer, Moderna, Alnylam and more, as well as new companies to share their insights to this community including Capstan Therapeutics, AbbVie, Mana Bio, Serina Therapeutics, Karma Biotechnologies and more.
With an expanded content offering and a 4-track, 4-day summit format, we continue to be the most comprehensive, premium LNP content available to industry. Part of this year’s content growth, the addition of the ‘LNP IP & Commercial Partnerships Focus Day’ has evolved with the current industry trends to secure long standing partnership to demonstrate clinical results, as well as gaining a further handle on the current IP and legal landscape.
To know more visit: https://ter.li/s96la3

3rd Next Generation RNA Therapeutics Summit
2024-05-07 - 2024-05-09 | Hilton Boston Bay Back, 40 Dalton St, Boston, MA, 02115, United States
The field of next generation RNA therapeutics continues to progress towards clinical translation, poised with investments and collaborations. Yet, key challenges like sequence design, purity, stability, safety and translatability into clinical settings continue to prevent their full therapeutic potential from being realized.
Reuniting everyone involved in next generation RNA therapeutic development, from Scientists and Academics to C-Level Executives, the 3rd Next Generation RNA Therapeutics Summit returns to cover the depth and breadth of next generation RNAs, including circular RNA, self-amplifying RNA, and more.
Where: Hilton Boston Bay Back, Boston, Massachusetts
When: May 7-9, 2024
Website: https://ter.li/7sk7zz

20+ brand new case studies from leading biopharma, including Pfizer, Strand Therapeutics, and Laronde
Investment and collaboration fireside chat
3 interactive workshops on targeted delivery, purification challenges, and enabling next generation RNA therapeutic production
Your opportunity to share your work in the Scientific Poster Session

What’s next:
Download your copy of the brochure: https://ter.li/7sk7zz
Register your place: https://ter.li/5jyjfj

Injectable Drug Delivery Conference and Exhibition
2024-05-08 - 2024-05-09 | Hilton London Kensington, 179-199 Holland Park Ave, London, W11 4UL, United Kingdom
The Injectable Drug Delivery Conference returns this year with an unparalleled agenda dedicated to revolutionizing the pharmaceutical and biotechnological landscapes. This pivotal event focuses on cutting-edge advancements in drug-device co-development, advanced therapeutic modalities, and the sustainability of injectable drug delivery systems.

Why Attend?

Explore how devices can be co-developed alongside drug products to foster a collaborative approach, improving biocompatibility and effective toxicological testing.
Expand your knowledge on design strategies for injectable delivery of advanced therapies, including cell and gene therapies, large molecule delivery, and navigating the challenges of sub-zero device requirements.
Dive into focused presentations tailored to a technical device development and primary packaging audience, covering vial material selection, silicone layer thickness studies, and the standardization of primary container formats.
Gain comprehensive insights into sustainable device materials, from development and selection through to disposal.
Learn from major device developers about streamlining product development and CMC practices for effective compliance post-NDA/MAA approval.

Who Should Attend?
This conference is designed for scientists, R&D professionals, regulatory specialists, and anyone at the forefront of drug delivery technology and pharmaceutical device development seeking to network with peers, learn from industry leaders, and stay ahead of the curve in injectable drug delivery innovations.
Additional Information:
Attendees can expect to leave with actionable insights and strategies to apply within their own practices and organisations. This conference offers a unique opportunity to connect with like-minded professionals and pioneers in the field.
Register now to secure your spot at the forefront of injectable drug delivery innovation!

GLP-1-Based Therapeutics Summit
2024-05-15 - 2024-05-16 | Hilton Philadelphia City Avenue, 4200 City Ave, Philadelphia, PA, 19131, United States
The GLP-1-Based Therapeutics Summit is the Ultimate Industry Forum for Developers of GLP-1-Based Therapeutics Across Different Indications
The GLP-1-Based Therapeutics Summit is a once-a-year event, uniting 60+ industry experts to help advance more specialized, durable, and efficacious GLP-1s while investigating commercial opportunities to crystallize pipeline strategy and indication expansion.
Grab your copy of the full agenda
Amidst the resounding success of Novo’s SELECT trial, the clinical trial landscape finds itself inundated with a surge of innovative GLP-1 treatments. Each passing week witnesses the unveiling of new multi-million-dollar investments, propelling GLP-1 players to the forefront of pharmaceutical revenue growth.
If you are looking to differentiate your GLP-1 products, forge new relationships with fellow GLP-1 developers, or discover the newest innovations in improving the tolerability, efficacy, and durability of GLP-1s, there has never been a more appropriate time to unite and navigate this rapidly evolving space at the GLP-1-Based Therapeutics Summit this May!
Key Highlights:
Unraveling Exciting Opportunities to Apply GLP-1 Receptor Agonists Across a Wide Range of Indications
Including cardiovascular, renal, obstructive sleep apnea, MASH, and neurodegenerative diseases with Eli Lily, D&D Pharmatech, and Altimmune
Optimizing the Efficacy of GLP-1-Based Therapeutics
Hear the newest innovations raising the benchmark for more successful weight loss with Diasome Pharmaceuticals and BioAge Labs
Developing a Robust Commercial Strategy
Differentiate your GLP-1 products from your competitors, to effectively target specific patient segments with Altimmune and Regor Therapeutics

6th Annual Treg-Directed Therapies Summit
2024-05-21 - 2024-05-23 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
Driving Next Gen Treg Stimulation for Autoimmunity, Transplantation & Inflammation
Returning to Boston for its 6th year, the 6th Treg-Directed Therapies Summit stands as the singular industry forum shining a spotlight on the groundbreaking research and clinical advancements in CAR-Treg and IL2 mutein therapies. Witness the convergence of leading industry and academic experts as they unite to propel the clinical efficacy of Treg therapies to new heights.
As the pioneering and longest-tenured meeting dedicated to optimizing and manipulating Treg-based approaches, this summit invites you to become part of a community at the forefront of innovation. Gain unparalleled insights into the latest developments driving specificity, delve into novel cell product design, and explore the engineering of CAR-Tregs to enhance cell stability and durability.
Don’t miss this unique opportunity to stay ahead in the dynamic landscape of Treg therapies. Join us and contribute to the ongoing dialogue that shapes the future of cutting-edge medical advancements.
To know more visit: https://ter.li/gfpnb0

5th Gene Therapy Analytical Development Europe Summit
2024-05-22 - 2024-05-24 | 15Hatfields, Chadwick Court, London, SE1 8DJ, United Kingdom
The 5th Gene Therapy Analytical Development Europe – What to Expect in 2024?
In the face of evolving regulatory guidelines and mounting scrutiny, the 5th Gene Therapy Analytical Development Europe Summit will discuss ways you can apply contemporary analytical tools to guarantee the consistency, quality, and safety of your gene therapy products.
Join leading CMC, regulatory, QC, analytical and process development experts to gain access to novel data and recent case studies by industry professionals from AstraZeneca, the MHRA, Novartis, Sarepta Therapeutics, Roche, Sanofi, and many more.
Enjoy in-depth, valuable networking opportunities with scientists and senior decision makers from small biotech through to large pharma – perfect for those looking to further industry relationships.
To know more visit: https://ter.li/vz0jr4

4th Gene Therapy Patient Engagement Summit
2024-05-29 - 2024-05-31 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
Patient engagement is a crucial responsibility of any gene therapy company if they’re serious about progressing safe, effective, and meaningful therapies to patients. The 4th Gene Therapy Patient Engagement Summit is returning in 2024, sitting at the unique interface of patient engagement and gene therapy, from embarking on first in-human trials through to commercial therapeutics.
Delve into key challenges including engaging in R&D and managing expectations of gene therapies, language and nomenclature used to educate on what gene therapies are and what it means to participate in a clinical trial, outlining informed consent to support clinical trial enrollment, and understanding the latest regulatory requirements to effectively demonstrate that these transformative therapies are meaningful to patients.
Join 80+ patient advocacy and engagement professionals from gene therapy companies and patient advocacy groups to gain actionable insights that you can immediately implement into your own gene therapy programs. Unite with the leading voices in this community to develop solutions to the challenges that are unique to the gene therapy space.
To learn more and discover the full agenda, visit the official event website at genetherapy-patient-engagement.com

Computational RNA Design & Delivery Summit
2024-06-04 - 2024-06-06 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
AI and computational science are revolutionizing the field of RNA therapeutic discovery, which is empowering biopharma companies to harness the potential of this technology. Join the conversation at the world’s first industry-dedicated Computational RNA Design & Delivery Summit taking place in Boston this June 4 – 6 2024.
Hear what industry pioneers from Sanofi, Moderna, Nava Therapeutics, Nutcracker Therapeutics, and more have to say, and deep dive into harnessing AI, Machine learning, deep neural networks, and predictive algorithms for RNA design and delivery to scale and accelerate novel, cost-effective RNA-based therapeutics.
Here’s a snapshot of the speaker faculty:

Mihir Mektar, Principal Scientist, Moderna
Sarah Spencer, Senior Expert II Data Science, Novartis
Benjamin Mead, Principal Data Scientist, Nava Therapeutics
Dinghai Zheng, Machine Learning Senior Scientist, Sanofi
Evan McCartney-Melstad, Director of Bioinformatics, Nutcracker Therapeutics
Kelly Brock, Senior Computational Biologist, Kernal Biologics

This exclusive meeting has been designed with you in mind! Join 80+ data science, computational biology/chemistry, bioinformatic, and delivery experts to accelerate discovery of your mRNA, RNAi, and tRNA modalities and innovate the delivery of these modalities beyond the liver by deep-diving into LNP, peptide-based, and AAV delivery chemistry.
Book your place now, early birds are still available!

6th Allogeneic Cell Therapies Summit
2024-06-10 - 2024-06-12 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
The entire cell therapy field is experiencing a shift towards allogeneic platforms as the potential to achieve a truly off-the-shelf, universal, and efficacious cell therapy offers great advantages such as reduced cost, production and patient accessibility compared to its autologous counterparts.
Placing a spotlight on what has been deemed the ‘future of cell therapy’, the 6th Annual Allogeneic Cell Therapies Summit returns to Boston this June as the leading industry focused meeting dedicated to accelerating the safety, durability and clinical translation of off-the-shelf therapies to deliver affordable and accessible treatments for patients in critical need.
Across a jam-packed agenda consisting of 60+ hours of content, 3 in-depth tracks, 1 Investor & Business Development Focus Day, 1 Beyond Oncology Bootcamp Day and more; our 50+ expert speakers will lead you and your peers in discussions that will help to transform universal cell therapies for patients across the globe.
Learn more here: https://ter.li/aetc0d

Pre-Filled Syringes West Coast
2024-06-10 - 2024-06-11 | SAN DIEGO MARRIOTT LA JOLLA, 4240 La Jolla Village Drive, La Jolla, San Diego, CA, 92037, United States
SAE Media Group’s 8th Annual Pre-Filled Syringes West Coast Conference will be back for 2024 in the West Coast to bring together device developers, biotech and big pharma. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation.

As part of SAE’s leading injectable drug delivery conferences this is a must attend event; not only will the conference bring you key insights to enhance your drug device portfolio, but it will also give you the opportunity to network with key industry players. We hope to welcome you in June 2024!
What will you gain?

Engage in discussions on evolving EU and US regulations as well as reviewing the latest FDA guidance on human factors and drawing insights from successful notified body opinions for streamlined regulatory compliance.
Gain insight into advancements in large volume drug delivery devices with a case study from Halozyme and a panel discussion assessing key considerations, benefits and barriers of such devices for stakeholders including patients, HCPs and pharma companies.
Delve into comprehensive strategies for maximizing combination product manufacturing and effectively managing your product’s lifecycle with key insights from GSK and Merck
Acquire insights into human factors best practices from AbbVie and Regeneron, and discover ways to effectively apply testing and validation approaches for combination products.
Explore collaborative opportunities to advance innovation in the injectables field and gain insight into the latest technology updates and challenges these pose such as leaching in electro-mechanical devices.

3rd Process Development for Cell Therapies Summit
2024-06-11 - 2024-06-13 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
Driving Process Robustness, Scalability, Speed & Affordability
In the dynamic cell therapy landscape, where financial challenges continue to prevail, the emphasis on innovative process development becomes pivotal. Now, more than ever, there’s a heightened demand for cost-effective solutions that bolster scalability and expedite development timelines.
Welcome to the 3rd Process Development for Cell Therapies Summit, your paramount gathering dedicated to advancing process robustness, scalability, speed, and affordability. This ensures the rapid advancement of highly efficacious products through clinical trials, securing a market-ready status with competitive commercial viability.
Whether you’re on the brink of IND or gearing up for BLA submission, this gathering of brilliant minds offers an unparalleled opportunity to glean insights form organizations like BMS, Beam Therapeutics, 2seventy Bio, Takeda, Century Therapeutics, AstraZeneca, and more!
Seize this opportunity to connect with technical experts united in the goal of streamlining process development. Through the sharing of best practices and pre-competitive insights, let’s collectively drive the streamlined development of consistent, scalable, and cost-effective autologous and allogeneic cell therapies. Together, we can shape the future of cell therapy!
To know more visit: https://ter.li/ixkr7z

Structure-Based Drug Design Summit
2024-06-11 - 2024-06-13 | Embassy Suites by Hilton Boston at Logan Airport, 207 Porter St, Boston, MA, 02128, United States
Harnessing Integrative Structural Biology Techniques Including NMR, X-Ray Crystallography, Cryo-EM, & Cryo-ET to Determine 3D Structures of Pharmacologically Relevant Targets & Propel Drug Design
Have you heard the boom created by Cryo-EM? Drug development has been shaken up with the application of Cryo-EM, accelerating and increasing the rate of success of protein targeting by identifying new ways to treat diseases with greater sensitivity and efficiency in the study of 3D structures. Structural biologists, medicinal chemists, and computational chemists need to assess the experimental methods by sharing case study presentations to streamline, rationalize, and optimize drug design.
The inaugural Structure-Based Drug Design Summit  is your opportunity to assess the resolution and speed of the techniques in the toolbox to answer structural biology questions for drug design, assess the gaps, and implement newer techniques for increased specificity and precision
Sharing cutting-edge structural biology methods and applications, including harnessing Cryo-EM and Cryo-ET to visualize protein interactions, structure-based methods as a package of techniques to study integrated biological systems, and incorporating computational methods as a predictive tool for structures; this is a unique opportunity to come together and rationalize drug design by understanding the 3D structure of proteins. Join 50+ industry scientists to delve into 3D protein structure determination using NMR, X-Ray Crystallography, Cryo-EM, and Cryo-ET, to improve resolution and efficiency and rationalize drug development.
Revolutionize the way drugs are discovered and developed to lead to newer and more effective therapeutics for a wide range of diseases, build the complete 3D picture, and go after undruggable targets.

6th Age-Related Disease Therapeutics Summit
2024-06-11 - 2024-06-13 | Hyatt Centric Fisherman’s Wharf, 555 North Point Street, San Francsico, CA, 94133, United States
The 6th Age-Related Disease Therapeutics Summit is returning to San Francisco in June, with 60+ participants including Eli Lilly, Takeda, and Turn Biosciences to dive deep into breakthroughs in cellular programming, senolytic pathways, and epigenetic effects. Explore biomarkers, navigate regulations, and foster collaborations for pipeline support and commercialization.
This is your definitive age-related disease therapeutics forum to gain unparalleled competitive intelligence, scientific advancements and form meaningful partnerships to solve humankind’s fundamental problem.

4th Next Generation Gene Therapy Vectors Summit
2024-06-12 - 2024-06-14 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
Accelerate your capsid and payload design with the 4th Next Generation Gene Therapy Vectors Summit (June 12-14, Boston)
As a recent whitepaper by the Alliance for Regenerative Medicine cites capsid engineering and disruptive delivery platforms as key emerging technologies in the CGT space, drug developers are heavily investing in finding and optimizing the safety, efficacy, and predictability of delivery platforms.
This is 2024’s only meeting covering the latest advances and innovations in vector development for gene therapies, uniting 90+ R&D and business development leaders to advance cutting-edge delivery platforms into the clinic. Data-driven talks, expert panels, and interactive group discussions led by 25+ industry experts will provide you with the ‘latest and greatest’ in both disruptive viral and non-viral vectors.
Join us to gain actionable insights in how to enable targeted gene delivery, reduce immunogenicity & toxicity, enhance downstream manufacturability, expand packaging capabilities, and secure funding and investment for your own vector platform.
Want to learn more? Check out the event guide here https://ter.li/nnkbb3

World CDx Regulatory Affairs & Policy Summit
2024-06-19 - 2024-06-20 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
The highly anticipated World CDx Regulatory Affairs & Policy Summit, is set to debut in Boston from June 19-20, 2024.
From tackling the complexities of LDT regulation and navigating the IVDR maze to understanding reimbursement dynamics, this groundbreaking meeting promises to provide clarity and harmonization in the realm of CDx regulation. Attendance is FREE for drug developers and academics, join us to maintain your clinical momentum, streamline submissions, overcome regulatory bottlenecks, and improve patient access to companion diagnostics.
World Class speakers you have the opportunity to learn from:

Vihanga Pahalawatta, Director – Regulatory Affairs Companion Diagnostics, AbbVie
Andrea Renninger, Senior Director – CDx Regulatory Affairs, Daiichi Sankyo
Claudia Dollins, Vice President – Global Regulatory Affairs, GSK
Debra Rasmussen, Senior Director – Global Regulatory Affairs, Johnson & Johnson
Dun Liang – Executive Director, Regulatory Affairs, CDx, Loxo@Lilly
Siddhartha Mathur – Executive Director – Regulatory Affairs, Merck
Qing Li, Director – Pathology, clinical development, Oncology, Moderna
Jai Pandey, Global Head – Device Regulatory for In Vitro Diagnostics & Companion Diagnostics, Digital Health, Sanofi

This summit is poised to bring together key stakeholders, including Directors, VPs, and SVPs in Regulation, Policy, Reimbursement, Digital Health, and Companion Diagnostics from leading companies as well as regulatory experts, payers, and developers to bridge the gap with clinical practice and ease regulatory pressures. Download the brochure or secure your free place now!

Cell & Gene Therapy Pricing & Reimbursement Summit
2024-06-25 - 2024-06-27 | Marriott Washington Capitol Hill, 175 L Street NE, WA, 20002, United States
Cell and gene therapies are revolutionizing healthcare, offering promising solutions from curative treatments to long-term remission rates. As these treatments enter the market, ensuring fair access while addressing coverage and payment complexities becomes paramount.
Introducing the inaugural Cell & Gene Therapy Pricing & Reimbursement Summit. Biotech, pharma, physicians, healthcare providers, and regulatory and government agencies will unite to address key issues such as the impact of regulatory acts, implementing pricing models, and collaborating on enhanced reimbursement strategies, aiming to expedite the availability of these advanced therapies to patients.
With the recent approval of Casgevy by Vertex Pharmaceuticals and CRISPR Therapeutics, and Lyfgenia by bluebird bio; significant strides in healthcare have been made, offering groundbreaking treatments with transformative potential, yet presenting substantial cost challenges. The Inflation Reduction Act and new Cell and Gene Therapy (CGT) Access Model aim to address these cost concerns by proposing innovative pricing models and reimbursement strategies to ensure affordability and widespread access to these life-changing therapies.
Join us this June to discuss the impacts of this legislation and together, we will optimize patient access and propel the success of commercial cell and gene therapy launches.
See the full agenda here: https://ter.li/d1rn7b

2nd mRNA Quality Control & Compliance Summit
2024-06-25 - 2024-06-27 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
Regulatory guidelines and existing protocols to govern aspects of mRNA quality during development and manufacturing are still evolving, creating a lack of clarity and consensus amongst the mRNA community.
Without a clear path forward, drug developers risk comprising product quality, safety and efficacy, and so the 2nd mRNA Quality Control & Compliance Summit is back to Boston this June as the sole industry-centred forum dedicated to showcasing data and discussions on mRNA compliance and optimized documentation, ensuring streamlined approval for mRNA therapeutics and vaccines!
Reuniting industry experts in quality control, quality assurance, analytical development, and CMC, this forum aims to navigate regulatory guidelines and identify tangible best practices towards optimized documentation, discuss verification processes for platform methods and review method validation used to evaluate critical vaccine qualities, all towards safeguarding faster mRNA drug approvals in line with regulatory expectations.
Download the free brochure or book your place now, early birds are still available!

3rd In Vivo Cell Engineering & Gene Editing Summit
2024-07-09 - 2024-07-11 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
Welcome to the Future of Cell & Gene Therapy
The 3rd In Vivo Cell Engineering & Gene Editing Summit is an annual event uniting C-level in vivo experts to facilitate safe and targeted in vivo delivery of payloads while providing clarity in regulations and appropriate models to advance the next frontier of in vivo editing from research to clinic.
Explore the full agenda – https://ter.li/snxcxi
As promising pre-clinical and proof of concept results continue to emerge, the ‘dream’ of in vivo cell engineering and gene editing is rapidly becoming a reality as numerous companies push towards the clinic.
Join us this July to network with and gain invaluable knowledge from our world-class speaker faculty from Capstan Therapeutics, Editas Medicine, NanoCell Therapeutics, Carisma Therapeutics, Sanofi, and more, offering exclusive insights into their strategies for staying ahead of the curve and shaping the future of cell and gene therapy in the years ahead.
Key Highlights:

Exploring data-driven case studies to outline decision making when selecting viral versus non-viral vectors
Clarifying regulatory expectations for this novel therapeutic approach to map out the future of your pipeline
Benchmarking appropriate preclinical models to support translation to gain valuable data needed by regulatory bodies
Outlining the considerations when scaling up towards the clinic to equip you with the tools to tackle bottlenecks
Emphasizing target specificity and the mitigation off-site toxicities to ensure safety is front of mind in development

Register now for the best savings – https://ter.li/ssnrpz
#InVivoCellEngineeringandGeneEditingSummit

4th mRNA-Based Therapeutics Summit
2024-07-29 - 2024-07-31 | The Westin Boston Seaport District, 425 Summer Street, Boston, MA, 02210, United States
Fast-Track Your mRNA-Based Therapeutics & Vaccines from Discovery to Commercialization by Ensuring Targeted Delivery, Durability & Tolerable Immunogenicity Across All Disease Indications
As mRNA developments continue to dominate industry news, ranging from winning the Nobel Prize to new clinical candidates, positive Phase I readouts and approvals, the industry is set to reunite in Boston this July for the 4th mRNA-Based Therapeutics Summit.
Hear the latest unseen data from proof-of-concept studies, platform development, clinical updates and regulatory insights as 65+ world-class speakers take to the stage. With expert-led sessions by the likes of the FDA, EMA, Moderna, BioNTech and Sanofi, this year’s 4-track agenda will provide unmissable scientific and strategic insights into the biggest challenges faced in discovery, translation, clinical development, and CMC.

Dates: July 29-31, 2024
Location: Westin Boston Seaport District, Boston, MA
Event Program: https://ter.li/fezohk

Join the Next Generation mRNA Delivery or Regulatory Affairs Strategy focus days, exchange business cards in Speed Networking, quiz your peers in the Scientific Poster Session and have your voice heard during the Roundtable Discussions to maximize your experience at this year’s summit.
Download the agenda here: https://ter.li/fezohk
Register your place here (and take advantage of group discounts of up to 20% when sending your team of three or more!): https://ter.li/6vnq38

5th Gamma Delta T Cell Therapies Summit
2024-07-29 - 2024-07-31 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
The 5th Gamma Delta T Cell Therapies Summit will bring together experts from big pharma, biotech and academia to delve into the details of gamma delta biology and its various subsets to offer the audience a well-rounded overview of the landscape currently and the steps needed for it to move forward.
Find out more here: https://ter.li/yryaj1

With a world-class speaker faculty sharing the latest insights in the field, this meeting continues to be the one-stop shop to accelerate your gamma delta T therapies! Hear from IN8Bio, Adicet Bio, Acepodia, Takeda, Luminary Therapeutics, LAVA Therapeutics, OneChain Therapeutics and many more!
As the ONLY industry gamma delta T cell-specific meeting running this year, these three days will expedite the translation of your vd1/vd2 pipelines from bench to bedside, fostering prompt progress in the field. Take this opportunity to upskill your cross-functional team across discovery, translation, clinical development, CMC and manufacturing to successfully translate basic research into your clinical strategy to support your IND submission.
Find out more here: https://ter.li/yryaj1
