Pharma Journalist

6th Annual Gene Therapy for Rare Disorders 2023 Summit
2023-03-20 - 2023-03-23 | Sheraton Boston Hotel, 39 Dalton Street, Boston, MA, 02199, United States
As the gene therapy field continues to break records, there are still significant challenges to overcome relating to safety, efficacy, and accessibility. The 6th Annual Gene Therapy for Rare Disorders 2023 Summit remains devoted to showcasing the top case studies and strategic learnings from the past year. With an expert speaking faculty devoted to bringing safer and more effective gene therapies to rare disease patients, key questions will be answered on how best the field can overcome regulatory, clinical, manufacturing and pricing bottlenecks to progress gene therapies into and through the clinic.
500+ leading experts from innovative biotechs, large pharma, academia and key service providers will be reuniting in Boston for 2023 to capitalize on recent success stories and collaborate over the most pressing industry challenges. An event vital to unlocking the full potential of your rare gene therapy program, join us to keep your finger on the pulse and set up for success in 2023.
To know more visit: https://ter.li/bvmkei

Reuters Events: Pharma USA 2023
2023-03-28 - 2023-03-29 | Pennsylvania Convention Center, 1101 Arch St, Philadelphia, PA, 19107, United States
Patient-first. Collaborative. Data and insights driven. Digitally underpinned.
These are the qualities of a healthcare system that actively serves its purpose – yet instead, the US is hindered by mounting financial toxicity, unprecedented politicization of science and eroding public trust.
To capitalize on three years of extraordinary momentum and lead healthcare’s reform, pharma must embody the traits that healthcare needs to thrive and restructure in pursuit of change.
Seize the moment at Reuters Events: Pharma USA 2023 to lead pharma’s internal revolution and drive this critical systemic transformation. Join North America’s visionary pharma changemakers, leading solution providers, patient experts and industry heavyweights to catapult commercial excellence, ingrain patient-first strategies into the heart of pharma’s fabric and heed the long-awaited rebirth of America’s healthcare system.
To know more visit: https://bit.ly/3uJUp5O

8th Innate Killer Summit
2023-03-28 - 2023-03-30 | HILTON LA JOLLA TORREY PINES, 10950 N. Torrey Pines Road, La Jolla, CA, 92037, United States
Dedicated to driving cost-effective, efficacious, safe, durable, scalable, and globally accessible allogeneic, cell-based, and engager therapies, the 8th Innate Killer Summit returns to cement your end-to-end education in innate immune therapeutics. Your industry-defining Innate Killer Summit brings crucial insights for everyone on your team, with 4 content tracks spanning preclinical development, clinical translation, CMC, process development, and clinical scale manufacturing, this is the definitive meeting to drive concept to commercial success of emerging innate immune therapies.
Download your copy of the Full Event Guide here.
Join over 250 experts from 120+ pioneering companies to drive novel gene engineering technologies, gain regulatory know-how, optimize lymphodepletion and cryopreservation, and contrast cell sources for highly efficacious, scalable off-the-shelf therapies.
Promising brand-new speakers from new companies, interactive discussion, and engaging networking opportunities, attend to forge new collaborations and realize the clinical potential of innate immune therapies.
Register your place here.

4th TCR-based Therapies for Solid Tumors Summit
2023-04-03 - 2023-04-05 | Hyatt Regency Boston, One Ave. de Lafayette, Boston, MA, 02111, United States
The first TCR-based therapy approval in the US and Europe at the start of last year sparked a rush of excitement, investment and collaborations. As further developers move into the clinic and some near commercialization, it’s time for this community to unite to address the critical bottlenecks faced in development, from discovery to approval, to guarantee smooth sailing through the clinic.
The 4th TCR-based Therapies for Solid Tumors Summit is returning to Boston as the must-attend forum for TCR experts to come together to share industry updates and next generation engineered approaches to boost therapy safety and efficacy.
Join leaders and newcomers including Immunocore, Medigene, Immatics, Captain T Cell and Anocca as they collaborate to guarantee tumor-specificity, prevent cross-reactivity, boost TCR and target discovery, enhance solid tumor durability and explore TCR modalities.
Huge milestones were achieved for the TCR field in 2022, however, there’s no time to sit back and relax. Collaborate with like-minded TCR trailblazers to secure clinical validation and streamline the road from discovery to commercialization.
To know more visit: https://ter.li/h6mn96

3rd Annual Ligase Targeting Drug Development Summit
2023-04-11 - 2023-04-13 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
Hijacking E3 Ligases to Mediate Degradation & Modulation of Undrugged Targets
As a family of over 600 known proteins, ligases pose immense potential as viable avenues for harnessing previously undrugged targets. Key challenges remain however to rapidly discover and identify novel and underexploited ubiquitin E3s. Furthermore, bottlenecks exist in the development of the established ligases; Cereblon and VHL.

It is now critical that we harness Cryo-EM, X-Ray crystallography, and other visualization tools to fully understand the structure and function of these lesser-known E3s, accelerate ligand screening with new and improved tools, leverage advances in DMPK knowledge to address concerns over toxicity in Cereblon, propel VHL from ‘academic’ to clinic, and all in, de-risk the translation of candidate ligases to the clinic.
The 3rd Ligase Targeting Drug Development Summit is returning with fresh understanding and data from the forerunners of the field and those who have recently joined the space. Together we will investigate ligase structural and functional biology, screening tools for optimal ligase, linker, and ligand identification, explore tissue specificity, uncover the key modalities where ligases can succeed, and showcase the novel assays that are maximizing validation to ensure success in the clinic.
This dedicated forum will provide an unrivaled meeting point for industry leaders all under one specialized forum to strategically accelerate and de-risk the process of identifying, validating, and therapeutically leveraging cell and tissue-specific ubiquitin E3 ligases for degradation or modulation of targets in oncology, immunology, and beyond.
To know more: https://ter.li/gapgsb

2nd LNP Formulation & Process Development Summit
2023-04-17 - 2023-04-19 | The Westin Boston Seaport District, 425 Summer Street, Boston, MA, 02210, United States
Turbocharging Your Next Gen LNP End-To-End Development to Deliver Curative Promises to Patients
Following exciting industry updates from Verve Therapeutics’ GalNAc-LNP for PCSK9 for HFpEF treatment, to Recode’s 5th element, the 2nd LNP Formulation & Process Development Summit is your must-attend meeting as this nanoparticle continues to dominate the biopharmaceutical industry in 2023.
New for 2023, we have curated 3 streams of content for 2nd iteration of the summit:

In depth discussions divulging IP and regulatory compliance for LNP drug products
Maximized LNP flexibility and versatility for payloads beyond mRNA vaccines with other RNA, DNA, gene therapy and gene editing possibilities
Lipid Chemistry & Discovery Track: Novel lipid discovery and particle engineering to customize LNP composition for next generation delivery vehicle
Formulation & Process Development Track: Optimize your LNP development techniques for enhanced manufacturability and product quality, and overcome stability issues of LNP-nucleic acid drug products
LNP CMC & Manufacturing Track: Elevating your process control, CQAs framework for CMC, GMP compliance for seamless scale-up

This summit will offer the most comprehensive content and exclusive data, equipping you with end-to-end LNP development journey to exploit this lucrative non-viral delivery vehicle for various payloads to your destined cells and organs.
In collaboration with Intellia Therapeutics, Pfizer, Sanofi, ReCode Therapeutics, Akagera Medicines, the 2nd LNP Formulation & Process Development Summit is committed to serving you with their lessons learned to supercharge your pipeline and deliver curative promises to patients.
Join us to stay at the forefront of science, network with 350+ LNP Biology, Chemistry, Formulation & Process Development, Tech Ops & Manufacturing experts to gain competitive advantage to exploit LNP potentials!
To know more visit: https://ter.li/ol6e27

3rd Fc Receptor Pathway Targeted Therapies 2023
2023-04-18 - 2023-04-20 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
The field of FcRn receptor targeting is gaining ground-breaking speed as Argenx, Janssen, UCB and Immunovant compete to tackle myasthenia gravis and biopharma invest in transformative immunological therapy for autoimmune diseases as the next big drug opportunity.
The 3rd Fc Receptor Pathway Targeted Therapies Summit will once again feature unmissable conversations to advance targeting FcR and the subsequent generation of Fc manipulation since real-world proof and clinical value are now at the industry’s fingertips.
Join 100+ of your colleagues at the 3rd Fc Receptor Pathway Targeted Therapies Summit – from the fields of immunology, antibody engineering, pharmacology, toxicology, and immuno-oncology for three days of content that is unmatched in its scope, all focused on the optimization of FcRn, FcγR, and novel Fc.
Put your stake in the ground to revolutionise autoimmune illness and position yourself in front of the next wave of blockbuster drug development.
To know more visit: https://ter.li/y9vxt6

mRNA Process Development & Manufacturing Europe
2023-04-18 - 2023-04-20 | Sheraton Offenbach Hotel, Am Buesing Palais, Berliner Str. 111,, Offenbach am Main, 63065, Germany
mRNA therapeutics have catapulted into the limelight amidst the COVID-19 pandemic with multiple EMA approvals to help combat the virus.
Bringing together KOLs sharing case studies with actionable insights, the inaugural mRNA Process Development & Manufacturing Summit Europe has been established as the first forum in Europe to support your in-house process development and manufacturing strategies.
The 3-day agenda has been carefully co-authored along with the leaders within the industry from the likes of BioNTech, AstraZeneca and Genentech. A snapshot of key topics include:

Assessing how dsRNA formation can be limited to reduce the purification requirements of the manufacturing process with BioNTech SE
Uncovering how to maximise biocomparability when scaling up the batch manufacturing process, including identifying the critical process steps that introduce batch-to-batch variability with Genentech & Roche
A snapshot of robust, high-throughput online novel assays for identifying impurities with CureVac & AstraZeneca
Understanding critical quality attributes and the differences in process development considerations for mRNA therapeutics and vaccines to achieve appropriate drug substance quality with the University of Sheffield & University Hospital Zurich
Hearing how the global market could function with a standard process platform to benefit all patients with Medicines Patent Pool

This is an opportunity to join 80+ mRNA enthusiasts from mRNA manufacturing, analytics, process development, CMC, quality control, and drug substance to get key insights on scaling up mRNA drug substances in Europe whilst navigating mRNA process development and manufacturing regulatory guidelines to create commercially successful mRNA vaccines and therapeutics.
To know more visit: https://ter.li/f3ec38

10th Annual Pre-Filled Syringes East Coast Conference
2023-04-24 - 2023-04-25 | Boston, USA
10th Annual Pre-Filled Syringes East Coast Conference
April 24 – 25, 2023
Boston, USA
Driving Innovations in Device Design, Connectivity and Sustainability for Advanced Parenteral Combination Product
https://www.pfsamericas.com/PJ-Event-listing
The 10th annual Pre-Filled Syringes East Coast conference will once again play host to an international audience of drug delivery, medical device and PFS experts to discuss emerging trends and offer innovative solutions to the challenges facing the pre-filled syringes industry, helping attendees to secure global success for their devices.
The past year has seen significant developments in the injectables landscape with the evolving regulatory landscape, accelerating opportunities in digitilization and simulation to improve device design efficiency, and increased opportunities for connectivity to improve the user experience.
Furthermore, with a growing need for circular economy, this year’s conference will assess case studies of sustainable approaches for device packaging and life cycle management, while panel discussions, FDA and BioPhorum addresses will evaluate current and upcoming combination product guidelines and the potential for harmonization.
As part of SAE Media Group’s leading drug delivery portfolio of events, this event will bring you the key insights you need to expand and enhance your injectable device portfolio and the opportunity to network with senior players throughout the industry.
Benefits of Attending:

Discover the latest industry developments for improved large volume and high viscous delivery via advanced autoinjector and on body delivery system design
Assess the growing opportunities of digitalization and simulation for improved device development efficiency and potential
Engage in an FDA regulatory roundup from the office of combination products, insights into EPR identification from BioPhorum and a panel discussion assessing harmonization of the regulatory landscape
Delve into emerging technologies in injectable device design and case studies on digital integration of medical devices for improved user experience

Benchmark against sustainable device packaging case studies driving the combination product industry towards circular economy

Next Generation Cardiovascular Drug Development Summit
2023-04-25 - 2023-04-27 | Hyatt Regency Boston, One Ave. de Lafayette, Boston, MA, 02111, United States
Welcome to the Next Generation Cardiovascular Drug Development Summit
Executing Cell & Gene Therapy for Cardiac Regeneration
Following technology advancements and the surge of investment in developing the next generation of cardiovascular disease drugs, the opportunity to successfully leverage our knowledge of CRISPR/Cas9, siRNA, autologous iPSC therapy, capsid engineering, and digital medicine to reduce the soaring fatality rate has never been closer.
The Next Generation Cardiovascular Drug Development Summit in Boston is the only industry-led summit committed to overcoming preclinical challenges to advance your ischemic heart disease, arrhythmogenic cardiomyopathy, strokes and hypertension pipelines.
To know more visit: https://ter.li/s7qk9l

5th Cell Engager Summit
2023-04-25 - 2023-04-27 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
The 5th Annual Cell Engager Summit is back in Boston, MA this year – the only industry-led meeting bringing together 100+ pharma and biotech leaders will assemble for a 3-day agenda including 4 unique pre-conference workshops to delve into the biggest challenges cell engager therapeutics face. Breaking into the solid tumor, preventing CRS and maximizing the quality of insights we gain from preclinical modeling.
For unmissable opportunities, including:

Gain first-hand knowledge of the difficulties of developing kinase inhibitors to improve selectivity, cross the blood-brain barrier, and combat resistance
Utilize cutting-edge platforms and technologies to maximise target validation and precisely predict off-target impacts to save time and costs
Establish long-lasting relationships by speaking with top pharma and biotech firms that are working on kinase inhibitor medicines and looking for the best-in-class solutions directly

Join your colleagues from the likes of Apexigen, Regeneron Pharmaceuticals, Genentech, Roche, Amgen, Boehringer Ingelheim and many more at the most comprehensive cell engager event, leaving no stone unturned, this highly focussed meeting covers everything translational and clinical in greater depth and detail than any before it.
Download the full event guide for your sneak peek.

5th Neuroimmunology Drug Development Summit
2023-04-25 - 2023-04-27 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
With increasing prioritization for neuroscience discovery, huge biopharma is investing in expanding its departments, focusing on glial biology, neuroinflammatory biomarkers, and optimizing various approaches to target the likes of LRKK2, TREM2, and more. Therefore, there is a great amount of novel and promising research to be discussed in 2023.
Uniting 100+ neuroinflammation and neuroimmunology experts across all neurological indications, including AD, PD, ALS, and MS, the 5th Annual Neuroimmunology Drug Development meeting will return to Boston to host discovery, preclinical, translational, and clinical experts from the likes of Genentech, Muna Therapeutics, Biogen, Janssen, Bristol Myers Squibb, Sanofi, Takeda, and Roche.
With new speakers from the hottest biopharma in neuroimmunology delivering, a comprehensive program of pioneering and cutting-edge content, don’t miss your crucial chance to join this niche audience of innovators with a shared desire to explore strategy, creation, and implementation of research, biomarker, and clinical hypothesis testing in neuroimmunology.
To know more visit: https://ter.li/w642sd

Gene Therapy Durability Summit
2023-04-25 - 2023-04-27 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
Uniting the leading minds in gene therapy at the Gene Therapy Durability Summit, join us to:

Leverage knowledge from current clinical trials with relevant durability data across a range of indication types using AAV
Better understand what can be extrapolated and how to gain confidence in the data collected
Build study designs with durability in mind and explore how well preclinical models have predicted clinical durability to date

Hear from the likes of Pfizer, Selecta Biosciences, Spark Therapeutics, Rocket Pharmaceuticals, ASC Therapeutics and more across a preconference workshop day, expert presentations, interactive panel discussions, dedicated Q&A time and highly appraised networking opportunities to meet and learn from the leaders of this pioneering field.
When you attend you will:

Understand the regulatory requirements to determine robust durability
Explore the challenges short term immunogenicity has on durability
Navigate how to overcome long term immunogenicity concerns on durability
Optimize vectors constructs to maximize gene therapy durability
Discover how to better predict the translational success of durability when progressing from preclinical to clinical trials

Register to attend with your colleagues and get up to 20% off your tickets – https://ter.li/oeczu3

2nd ADC Analytical Development Summit 2023
2023-04-25 - 2023-04-27 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
The 2nd ADC Analytical Development Summit (April 25-27, 2023 | Boston, MA) is the only meeting focused on optimizing the application of analytical technologies for ADC, from drug-linker and drug substance through to drug product to guide regulatory specifications and submissions, to enhance understanding of your drug and to exert control over your process.
See the complete 2023 event guide here.
With many new ADCs under development, the analytical challenges are only increasing as the existing hurdles keep changing, with the regulatory guidance still being limited. This is a unique touch point for drug developers to discuss the core analytical challenges the industry is facing including drug linkers, drug substances, drug formulation, and drug products.
You and your team can expect to leave this meeting equipped to have a deeper understanding of your drug and confidently enter conversations with regulators with thought-provoking insights from our expert speaker faculty including:

Yuan Gao, Head of Analytical Development, ADC Therapeutics
Jessica Webb, Scientist, Analytical Sciences, AstraZeneca
Guifeng Jiang, Head of Analytical Development Pharmaceutical Operation, Bolt Biotherapeutics
Thomas Gardinier, Head of Materials Analysis, Elucida Oncology
Simon Letarte, Director, Gilead
Adrienne Wildt, Senior Director of Analytical Development, ImmunoGen
Shuwen Sun, Principal Scientist, Merck & Co
Vimal Patel, Vice President, Head of CMC & Supply Chain, Orum Therapeutics
Julie Beaudet, CMC Staff Scientist, Regeneron Pharmaceuticals
Sarah Owen, Senior Scientist Potency Assays, Seagen
Melvin Flores, Director Quality Control Analytical & Microbiology, Sutro Biopharma
May Zhu, Director of Analytical Development- External Interface Management, Takeda

Join them here.
With 100+ attendees, 4+ hours of dedicated networking, and 3 days of exciting new content, including a pre-conference focus day on comparability studies, this is a conversation you won’t want to miss to hopefully, increase knowledge on your ADC quality attributes to understand and strive for regulatory approval

6th Annual Pharmaceutical Microbiology USA Conference
2023-04-26 - 2023-04-27 | Boston, MA, USA
6th Annual Pharmaceutical Microbiology USA Conference
April 26 – 27, 2023
Boston, MA, USA
http://www.pharma-microbiology-usa.com/PharmaJournalistWL
Sponsored by: LONZA
Chaired by: Donald Singer, USP General Chapter Committee Microbiology Chair, US Pharmacopeia
Contamination Control and Microbial Methods Explored to Assure Product Quality and Prevention
Microbiology remains an essential tool in reducing microbial growth in the manufacture of pharmaceuticals, to detect and eliminate microorganisms that would pose a risk to patients and jeopardise product batches.
Ensuring the sterility of the finished product continues to be one of the most critical aspects of drug development, however an array of factors is also sustaining new growth and transformation in this field. The regulatory landscape is changing, firstly with the preparation of Annex I, in addition to increasing requirements pertaining to data integrity. Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement.
On top of this, the developing integration of automation and robotics into the manufacturing pipeline, as well as the increased need for more rapid microbiology methods brought about in part by the surge in ATMPs, are all highlighting the necessity of the field in Pharma.
This industry is ever expanding, join our leading experts at the 6th Annual Pharmaceutical Microbiology East Coast Conference in Boston, USA to discuss and analyse the latest advances and challenges surrounding Pharmaceutical Microbiology. Network with the industry professionals, discuss revisions in regulatory and guidance documents, and gain a deeper insights.
Event Hashtag: #MicrobiologyUSA
Key Conference Highlights:

Review implementation guidance and validation for efficient microbial testing programs
Uncover how to implement effective contamination control for manufacturing and the impact throughout pharmaceutical microbiology
Learn how to control mold contamination and apply risk-based tools to tackle recovery
Delve into the role the microbiologist plays in bioburden assessments and holistic closure integrity testing for new drug modalities
Understand innovative techniques to control contamination as it relates to cell therapy products, combination, and traditional microbiological drug products

View the full agenda: http://www.pharma-microbiology-usa.com/PharmaJournalistWL

4th Annual Gene Therapy Analytical Development Europe Summit 2023
2023-05-02 - 2023-05-04 | The Tower Hotel, St. Katharine's Way, London, E1W 1LD, United Kingdom
Uniting leading CMC, Regulatory, QC, Analytical and Process Development experts, the 4th Annual Gene Analytical Development Europe Summit is the industry’s definitive and only meeting focused on tackling the greatest analytical development challenges in the context of gene therapy drug development.
Hear from the likes of AstraZeneca, MHRA, Gyroscope, REGENXBIO, Biogen, Spark Therapeutics, and more across three days and two tracks of in-depth case studies, interactive panel discussions, dedicated Q&A time, and highly appraised networking opportunities to meet and learn from the leaders of this pioneering field.
Don’t miss the opportunity to network with 80+ analytical experts to overcome your analytical challenges encountered in every stage of the gene therapy development life cycle.
To know more visit: https://ter.li/q8u3rf

4th STING & TLR Targeting Therapies Summit
2023-05-09 - 2023-05-11 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
Facilitating key conversations needed to drive forward the development of safe and effective innate stimulating immunotherapies, the 4th STING & TLR Targeting Therapies Summit will take place, for the first time ever in person, in Boston on May 9-11, 2023.
View the official program here.
Explore innate agonists from discovery to translation with the leaders in the space and gain insight into clinical updates, unpack what went wrong with some failures like ADU-S100 and address critical challenges including driving down toxicity, preclinical model selection and choosing appropriate delivery mechanisms.
Here are some exciting highlights you cannot miss including:

Reviewing the clinical landscape in the past year, key updates in innate agonists that have moved through the clinic, and identifying the root of failed trials through integral discussions led by Beacon Targeted Therapies, Tempest Therapeutics, and #Indaptus Therapeutics
Assessing the best innate agonist delivery approaches, from data on antibody-conjugated STING agonists with Takeda Oncologyand ImmuneSensor to unpacking 7&8 Biopharma’s IV delivery to extracellular vesicle approaches with Codiak Bio
Revisiting cancer vaccines and navigating their development with post-COVID vaccine considerations; with Elicio Therapeuticsand UT Southwestern Medicine, exploring the use of STING / TLR adjuvants to deliver on this promising therapeutic
Venturing beyond oncology to learn from drug developers utilizing STING & TLR agonists to treat infectious diseases and adding these potent innate activators to our arsenal to be better equipped for the next pandemic

View the complete agenda and speaker line-up.
Being the only meeting dedicated to driving forward the development of innate immune agonists, we encourage you to take this exciting opportunity to unite and leverage the industry’s cumulative knowledge and experience to have meaningful conversations that will translate STING & TLR agonists into effective and reliable treatment options.

Highly Potent Active Pharmaceutical Ingredients Conference 2023
2023-05-10 - 2023-05-11 | Copthorne Tara Hotel, Scarsdale Place, Kensington, London, W8 5SY, United Kingdom
The Global High Potency API/HPAPI Market is projected to reach 37 billion USD by 2027, growing at an ever-increasing CAGR of 8.43%. The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and much-needed guidelines to ensure worker safety.
Our 2023 conference brings insights from leading pharmaceutical companies on how to improve hazard identification, integrate advanced containment controls and mitigate the risk of manufacturing HPAPI. Featuring leading speakers including directors, engineers, and experts in validation requirements this conference provides an extensive look at how you can futureproof your pharmaceutical manufacturing facilities.
This two-day conference offers you peer-to-peer networking with industry experts including heads and directors of EHS, Occupational Hygiene, Quality Assurance and more. Expand your community and explore the latest developments in the industry at this two-day event, including key regulatory updates, and leading case studies from leading pharmaceutical and biotechnology companies.
Benefits of Attending the HPAPI Conference:

LEARN how to ensure advanced therapeutic manufacturing is safe for workers and patients
INCREASE the effectiveness of your engineering containment controls by improving harmony between the worker engineer and toxicologist to ensures cost-effective design choices
UNCOVER the best practises & opportunities for pharmaceutical companies to work alongside CMOs to effectively and efficiently scale-up HPAPI manufacturing
REVIEW case studies on the implementation of risk-based hazard identification strategies from leading pharmaceutical companies including AstraZeneca, CSL Behring and Merck

DISCOVER future trends in containment and control technologies to future-proof your HPAPI manufacturing plant to maximsie operator safety
To know more visit: www.highlypotentapi.com/PharmaJournalistEL

5th Annual Injectable Drug Delivery Conference
2023-05-10 - 2023-05-11 | Copthorne Tara Hotel, Scarsdale Place, Kensington, London, W8 5SY, United Kingdom
Exploring Injectable Drug Formulations and Device Development
Sponsors: Victrex
Exhibitors: PHC Group
As Part of Europe’s leading Injectable conference series, the 5th annual Injectable Drug Delivery conference will assess innovations in drug product formulation and biologics, new technologies in device design, along with the latest regulatory considerations for optimal drug delivery.

With increasing demand for vaccines, insulin, and many other modern medicines administered via the injectable route, there is significant growth projected in the biologics market, particularly the injectable drug delivery and prefilled syringe market which is expected to rise at a compound annual growth rate of 12.9% reaching £915 billion by 2027. It is due to this rising demand and increased growth that the industry must come together to discuss and critically evaluate the next generation of injectable drug delivery.
At this year’s event we will highlight the most recent innovations within the industry, with regard to injectable device design and the formulation challenges of long-lasting, highly viscous and high-volume drug delivery. In silico modelling will be addressed as we continue to see a move towards AI utilisation, alongside key CMC concerns and usability of injectable devices in digital health. The conference will also highlight the significance of sustainability within the industry, whilst providing regulatory insight on the changes that have occurred and are forecast in the coming years.
Benefits of attending:

Explore the latest trends within the Injectable drug delivery field, with new insights into in-silico modelling
Expand on current knowledge of device design, with special considerations for primary and secondary packaging
Examine injectable drug formulation strategies, including novel formulation methodologies
Learn how to advance the injectable drug delivery landscape through a review of current regulatory compliance
Realise how Chemical Manufacturing and Control can further expand the industry through digitalisation strategies

To know more visit: http://www.injectable-drug-delivery.com/PharmaJournalist-EI

Reuters Events: Digital Health 2023
2023-05-16 - 2023-05-17 | Mission Bay Resort, 1775 E Mission Bay Dr., San Diego, CA, 92109, United States
It’s a painful moment for healthcare. We face rampant burn out, squeezed operating margins, unhappy patients, massive cost pressures and more competition than ever as disruptors continue to flood the market with convenient, accessible care options.
It’s high time we collaborate around Digital Health. We must listen, take note and work to implement the changes that our care staff and consumers demand to force the disruptive change required. Fixing our broken healthcare system demands a collective effort to connect disparate data, streamline clinical workflows, slash costs, and zero in on consumer orientated, digitally enabled care delivery.
Reuters Events: Digital Health USA 2023 (May 16-17, San Diego) hosts 300+ digital leaders over two intensive days of collaborating, networking, and learning opportunities tailored to digital, strategy, innovation, transformation, information, information security, data science backgrounds, to help accelerate the transformation that our consumers desire and our care teams deserve.
To know more visit: https://bit.ly/3F7cD60

2nd ALS Drug Development Summit
2023-05-16 - 2023-05-18 | Hilton Boston Logan Airport, One Hotel Dr, Boston, MA, 02128, United States
With 3 days of jam-packed content and 35+ world class speakers pioneering the next wave of ALS therapies, the 2nd ALS Drug Development Summit is biopharma’s can’t-miss meeting for the acceleration of ALS drug development pipelines.
Join 100+ of your biopharma peers to uncover cutting-edge ALS biomarkers, including neurofilament light chain, to incorporate into clinical trials, improve in vitro and in vivo ALS preclinical models to improve translation of safe and efficacious therapies and optimize clinical trial design and endpoints to maximise data collection in an evolving standard of care.
Browse the full Event Guide to discover:

37+ expert ALS speakers across 3 jam-packed conference days, spanning all stages of the drug development pipeline

Doubled pre-conference workshop content, with 4 deep-dive workshops facilitating interactive discussions on novel ALS target discovery, preclinical strategy, wearable technology, and clinical trial design

Opening conference discussion on recent and upcoming FDA approvals to learn key takeaways from interacting with regulatory bodies

Hear directly from patient advocates and individuals living with ALS to understand their perspective on ALS drug development and engagement in clinical research

Dedicated networking, roundtable discussion and poster sessions to share your insights with other ALS leaders in the room

To know more visit: https://ter.li/21k4zy

5th Treg Summit
2023-05-30 - 2023-06-01 | Hyatt Regency Boston Downtown, One Ave. de Lafayette, Boston, MA, 02111, United States
With investment into the Treg field at an all time high, excitement is overflowing at the prospect of these remarkable cells being game-changers in the long-term treatment of autoimmunity, inflammation and transplantation. As this enthusiasm coincides with multiple clinical readouts and several more therapies entering the clinic, it remains vital for Treg trailblazers to come together to recognize therapy efficacy, determine safety and translate the next-generation of therapies into the clinic.
The Treg Summit returns for the 5th year to unite this dedicated community of industry and academic experts, and remains the go-to industry forum to advance both cell and non-cell based approaches to unlock the potential of Tregs to treat indications with huge unmet clinical need.
With 3 jam-packed days of content across CAR-, TCR– and polyclonal Tregs as well as IL-2, muteins and small molecules, you won’t want to miss this unrivalled opportunity to collaborate with your peers in the Treg field to explore clinical advances, discuss challenges and discover next-gen methods to take Treg therapies to the next level.
Why Attend Now?

Over $2 billion has been thrown into the Treg space in the past 8 months alone, reflecting the potential of these therapies
2022 saw the first-ever dosing of a human with a CAR-Treg cell therapy paving the way for the rest of the engineered Treg field
Vital clinical updates determine the safety and efficacy of Treg modulating therapies

Secure your place today – https://ter.li/jddnbx

2nd Cell Therapy Potency Assay Summit
2023-05-31 - 2023-06-02 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
The 2nd Cell Therapy Potency Assay will gather 100+ experts working to rationally design better potency assays to smooth the path to regulatory approval and minimize hold times with scientifically rigorous and informative potency measurements.
Whether you are submitting your first IND or gearing up towards BLA submission, this critical meeting of minds is your premier opportunity to join the likes of bluebird bio, Arsenal Bio, Takeda, Merck, Sana Biotechnology and more, to gain critical updates on regulatory interactions and unpick how industry peers are approaching potency assay development.
Leave this meeting equipped with industry insights to understand what potency assays are showing, develop practical, compatible, reproducible assays; and better characterize your cell therapy products for targeted, untargeted, allogeneic and autologous platforms in oncology and non-oncology indications.
To know more visit: https://ter.li/zc871s

5th Age-Related Disease Therapeutics Summit
2023-05-31 - 2023-06-02 | Marines Memorial Club and Hotel, 609 Sutter St, San Francisco, CA, 94102, United States
Whether it’s in cardiovascular disease, Alzheimer’s or osteoarthritis, therapeutic innovations to target the mechanisms of aging are making significant headway to clinical trials. With increased investments and recognition, along with the escalation of the burden of age-related disease, research and development to meet this unmet medical need has never been more important.
The 5th Age-Related Disease Therapeutics Summit is the only industry-focused meeting dedicated to uniting 100+ biopharma drug developers, pioneering academics, and prominent investors striving to develop effective, novel drugs that promote healthy aging and overcome major translational and regulatory obstacles.
Jam-packed with the most cutting-edge insights and opportunities to reunite with and hear from your peers on the next steps forward in developing the safest and most efficacious drug to promote a healthier and enhanced quality of life.
To know more visit: https://ter.li/sl5og6

3rd Oligonucleotides for CNS Summit
2023-06-06 - 2023-06-08 | Hilton Boston Back Bay, 40 Dalton St, Boston, MA, 02115, United States
With approvals in siRNA technology, more ASOs hurtling towards human trials in neurology, and exciting headlines in Alzheimer’s and ALS, the draw of CNS targets for oligonucleotides has never been greater. Massive investments and growing pipelines in pharma and biotech alike are working to make these life-changing therapies a reality for previously undruggable targets.
Join 100+ experts and dedicated scientists at the 3rd Oligonucleotides for CNS, the definitive industry forum bringing together leaders to problem-solve, explore invention, and inspire the creation of next-generation oligonucleotide drugs for neurological disorders. Gather with specialists from Biogen, Ionis, Genentech, Eli Lilly, Servier, and Stoke, spanning disciplines of biology, chemistry, toxicology, and clinical innovation.
Tackle genomic target validation, backbone chemistry, effective intracellular delivery, and potency, increased stability for reduced dosing, novel cerebral organoids, CNS device delivery, and CSF oligo distribution to uncover the best approaches for each phase in your pipeline. Take away invaluable lessons that will translate directly into optimizing your oligonucleotide pipeline for the CNS.
To know more visit: https://ter.li/i5y7zn

4th Annual Gene Therapy for Neurological Disorders Summit Europe
2023-06-06 - 2023-06-08 | Room Mate Aitana, IJdok 6, 1013 MM, Amsterdam, 1013 MM, Netherlands
Returning as the pinnacle event in the industry, the 4th Annual Gene Therapy for Neurological Disorders Summit Europe (6-8 June 2023, Amsterdam) enables you to bring your gene therapy to patients in Europe. This year’s content takes a greater focus on:

Innovation in preclinical models and vector technology
Showcasing novel approaches to improve delivery in a safe manner
Optimizing administration route to reduce the patient
Understanding what needs to be done to crack the European market

Download the agenda to find out more – https://ter.li/1mmd4t
Covering both neurodevelopmental and neurodegenerative disorders, join 80+ of your peers in Amsterdam this June. We’ll be welcoming those leading biopharma and academia, working in preclinical, clinical and market access to help get safer, more efficacious gene therapies for neurological disorders to market in Europe.
As the gene therapy community gets a second wind and as the clinical promise in neurology begins to be realised, now is the time to get your hands on the latest innovations in this field to bring safe, efficacious and commercially successful products to market in Europe.
Register to attend with your colleagues and get up to 20% off your tickets – https://ter.li/azxig5

6th Annual Pre-Filled Syringes West Coast Conference
2023-06-12 - 2023-06-13 | San Diego, CA, USA
Assessing Device Development and Regulation for Advanced Innovation
Sponsors: Datwyler, Haselmeier, Mitsubishi Gas Chemical, Nemera, ZEON
Exhibitors: Credence MedSystems, Kymanox, Noble, Owen Mumford Pharmaceutical Services, SCHERDEL Medtec
SAE Media Group’s 7th Annual Pre-Filled Syringes West Coast Conference will be back for 2023 in San Diego to bring together the device developers, innovative 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.
With the injectable drug delivery industry rapidly advancing year-to-year, administration using pre-filled syringes, auto-injectors, and pen-injectors are increasingly common. Innovations in device technology, such as connected devices are leading the way in device design in addition to injectable delivery devices for novel and large volume drugs. With the need for self-administration growing, there is an enhanced demand for on-body injectors and digitalised health as well as patient centricity. We are beginning to see environmental sustainability being incorporated into aspects of device lifecycle from design to manufacturing and the use of the device. This year’s conference looks to address these hot topics through case studies and industry insights.
As part of SAE’s leading injectable drug delivery conferences this is a must attend event; not only will the conference bring delegates key insights to enhance their drug device portfolio, but it will also give them the opportunity to network with key industry players.
Benefits of Attending:

Engage with industry representatives about the latest technologies and advances within the injectable device market and directions to take to advance your device portfolio
Gain insight into new technologies for wearable injectors he delivery of novel and large volume drugs
Understand the latest regulatory requirements and guidance to ensure your combination products are compliant such as meeting essential performance requirements
Delve into aspects of primary packaging such as material components to consider during device design to ensure drug stability and safety
Explore how digital technologies such as companion apps are being incorporated into drug delivery devices to improve user-centricity

Who should attend:
Directors, Heads of Departments and Managers for the following areas:

Device Development
Device Engineering
Combination Product Development
Drug Delivery Devices
Primary Packaging Development
Digital Health
Large Volume Drug Delivery
Novel Drug Product Formulation
Regulatory Affairs

Early Bird Rates:

EB1 – 28 Feb 2023 – US$400
EB2 -31 March 2023 – US$200
EB3 – 28 April 2023 – US$100

Additional Contact Info:
T: +44 (0)20 7827
E: Hannah.Blake@saemediagroup.com
W: http://www.prefilled-syringes-westcoast.com/PharmaJournalist-El

3rd Annual Gene Therapy Patient Engagement
2023-06-13 - 2023-06-15 | Westin Boston Seaport, 425 Summer Street, Boston, MA, 02210, United States
As the global healthcare system accelerates its acceptance of gene therapies as one-time, potentially curative, treatment options for rare diseases, the role of patient engagement in informing drug development strategy is evolving.
At this interface lies the 3rd Gene Therapy Patient Engagement Summit, uniting patient advocacy and engagement experts from leading gene therapy and gene editing drug developers, along with patient groups and patients themselves. Talks, workshops, and group discussions will shed a light on how to better integrate the patient voice into gene therapy programs at crucial stages of the drug development process.
Join us in Boston this summer to gain the actionable insights, tools, and strategies you need to better implement patient input into patient-centric gene therapy programs.
To know more visit: https://ter.li/rbofji

Temperature Control and Logistics Summit
2023-06-13 - 2023-06-15 | Sheraton Frankfurt Airport Hotel & Conference Center, Hugo-Eckener-Ring 15/Terminal 1, Frankfurt am Main, 60549, Germany
Advance your end-to-end logistics strategy to deliver vital therapeutics at the RIGHT TIME, RIGHT PLACE and the RIGHT TEMPERATURE
Join us in Frankfurt in June 2023 in a brand-new venue at the heart of Europe, as once again, we return live and in-person for 3 days of interactive sessions, collaborative roundtables as well as formal and informal networking to maximise the value of shared insights and open discussions.
We meet at a time of great challenge and opportunity. How can we mitigate risk and ensure quality whilst adopting the new technologies essential to future success? In what ways can we bolster the resilience of our supply chains without compromising operational agility? How can we build a supply chain and logistics network that is both effective and environmentally sustainability?
Only in partnering across the supply chain can we confront these challenges; and as a community that thrives on innovation and collaboration, we’ve built a programme centred on the fundamental challenges of our time, including how we:
>> Drive Digital Transformation Throughout The Supply Chain To Achieve Full End-To-End Visibility
>>Enhance Supply Chain & Logistics Network Design To Bolster Resilience, Security & Efficiency
>> Partner Across The Network To Meet The Demands of An Increasingly Complex Operating Environment
>> Leverage New Packaging Innovation To Ensure Quality & Demonstrate Regulatory Compliance
>> Build An Environmentally Sustainability Temperature Controlled Supply Chain
TCL 2023 will provide a deep-dive into what these industry developments mean for Pharmaceutical Logistics, Quality Assurance & Supply Chain practitioners and focus on delivering a mix of interactive sessions, which will enable delegates to leverage the collective knowledge of their peers and brainstorm solutions to the challenges, which the industry is facing.
TCL doesn’t just stand for Temperature Control and Logistics, now it also stands for Transformation, Collaboration and Learning! >> Download the full agenda to view full speaker line-up, discussion details, sponsorship opportunities, and more!

3rd ILD Summit
2023-06-13 - 2023-06-15 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
Returning for the 3rd year, the ILD Summit will lean into the industry’s key challenges, explore pipeline opportunity development, and look towards the future for ILD therapeutic development from idiopathic pulmonary fibrosis pipelines. From illuminating predictors of progression to define and identify the progressive fibrosis phenotypes for patient stratification to evolving clinical trial design with novel secondary and exploratory endpoints beyond FVC. This is a fantastic point in 2023 for the lung fibrosis community to come together to meet at the intersection of pulmonology and rheumatology to advance therapeutic development for ILDs.
To know more visit: https://ter.li/wc2uto
