Pharma Journalist

9th Advanced RWE Applications in Pharma
2021-10-26 - 2021-10-28 | Virtual
Real-world evidence is at the root of an ongoing and critical transformation in medical care. By incorporating data from the real world into their development programs, drug developers can now improve their clinical trial success by identifying and retaining suitable patients through increased patient stratification.
These are exciting times to reunite at the 9th Advanced Real-World Evidence Applications in Pharma to discuss the efforts to advance real-world evidence’s effective generation and utilization.
The stage is set for a collaborative discussion platform bringing together you and other stakeholders from functions across clinical development, RWE, RWD, Data Science, Regulatory Affairs, Medical Affairs, HEOR, and many more!
Join us in October to overcome critical challenges in generating and implementing real-world evidence to enhance clinical R&D, support regulatory submission and decision-making, and ultimately drive commercial success.
Click here to download the event guide for the full agenda

What’s New in 2021?
2020 was an exciting year for real-world data (RWD) and real-world evidence (RWE) experts within pharma and biotech. The FDA’s high-profile acceptance of RWD as part of their review for COVID-19 treatments and vaccines for emergency use authorization was a big moment for the industry. This is now energizing RWD and RWE into R&D and clinical activities – expediting novel treatments for patients and substantially reducing drug developers’ R&D spend.
However, major questions still need answers urgently. The 9th Advanced Real-World Evidence Applications in Pharma will return in October 2021 to delve into the core industry challenges, including:

Assessing the global regulatory environment for future RWE application
Advanced data acquisition and analytics to enable your R&D and clinically informed decision making
Leverage RWE in your clinical activities – from patient selection to synthetic trial arm
How to create a robust, regulatory-compliant RWE framework and data package for your successful IND filing
Maximizing your product lifecycle through a comprehensive observational data program
Establishing pre-competitive collaboration to deepen your understanding of diseases, offering patients a personalized and effective treatment through RWE & RWD

Book now to save up to $750

Protein Engineering Global USA
2021-10-27 - 2021-10-28 | Holiday inn San Jose- Silicon Valley, 1350 North 1st Street, San Jose, CA, 95112, United States
The series brings together a global audience and global lineup of biocatalyst and protein modifications specialists to share how to implement the new technologies. With the applications growing across pharmaceutical, flavour & fragrance, consumer goods, food & beverage and agrochemical sectors, we have created a protein and enzyme engineering platform that will allow the community to improve capabilities to industrialize sustainable enzyme products and increase product efficiency globally.
Understand the challenges and requirements of the industry in their internal R&D projects to support scale-up processes, next-generation mutant library screening, or knowledge of machine learning and AI to optimize biocatalysts for industrial applications.
Expand your commercial opportunities and market growth by learning what new industry sectors are seeing the benefit of enzyme engineering to synthesize unprecedented molecules of interest and engage and network with these industries to form new third-party collaborations, allowing you to advance your market growth.
Demonstrate advancements in your service capabilities by actively promoting the work of your technical teams through bespoke webinar opportunities, presentations, and interactive discussion with the industry.
We are delighted to be hosting Protein Engineering Global 2 miles from San Jose International Airport SJC, and offer a special bedroom rate to the attendees of the Protein Engineering Congress:
$199 + tax per room per night – Please call +1 408-453-6200 and quote Kisaco research/Protein Engineering.
Download agenda: www.proteinengineeringglobal.com/

5th Antifibrotic Drug Development Summit - AFDD
2021-11-01 - 2021-11-03 | Digital Event
The 5th Antifibrotic Drug Development Summit will provide a unique opportunity to gain cross-discipline actionable insights into how the latest scientific research is being applied to fibrosis pipeline progress. Network with industry pioneers in hot areas of drug development, specifically IPF, NASH, scleroderma, IBD, ILD, CKD, and more to apply disease-specific lessons agnostically, and understand how the industry can achieve the crowning glory of pan-fibrosis antifibrotic drugs.
Unmissable Highlights for 2021:

Join the active discussion surrounding redefining approvable clinical endpoints with the FDA to enhance opportunities for creative clinical trial design and drive your clinical development
Engage with early initiatives to establish clinical development programs in IBD-associated fibrosis with Cleveland Clinic to kickstart your intestinal fibrosis pipeline as this grows in interest for biopharma
Investigate the buzz around reprogramming epithelial cells to promote tissue repair in fibrotic disorders with Genentech to understand new strategies for regenerative medicine and overcome mechanistic bottlenecks
Gain vital insights from Pfizer on how the industry can revolutionize the translatability of current disease models and collaboratively guide the creation of technologies that can better mimic human physiology
Embrace more successful clinical trial design with an enhanced focus on patient-reported outcomes with Novartis to identify precision medicine approaches, promote patient engagement, and discuss regulatory barriers to novel endpoints

Hear from 35+ industry heavyweights including Genentech, AstraZeneca, FDA, GSK, Boehringer Ingelheim, Pfizer, Takeda, and more to understand transformative mechanistic strategies for promoting tissue regeneration and repair, discover more robust predictive models to improve translatability; and assess emerging non-invasive biomarkers that identify early signs of efficacy and drive successful clinical trials.
To know more visit: https://ter.li/afddpjel

Gastrointestinal Cancer Drug Development Summit
2021-11-02 - 2021-11-04 | Digital Event | EST
The Gastrointestinal Cancer Drug Development Summit is the only biopharma-led conference dedicated to identifying and progressing therapeutic opportunities in targeted and immunotherapies, ADCs, and precision oncology to address the large unmet clinical need in GI cancers.
**This meeting is free-to-attend for drug developers, research institutions, and not-for-profit organizations**.
Register free to attend here: https://ter.li/t83wdr
This industry-dedicated meeting offers a comprehensive insight into developing optimal clinical programs for targeted, immune, and ADC therapies in these solid tumors. Join us and our 39+ expert speaker faculty as we navigate cancer heterogeneity and develop biomarker-driven enrichment strategies to direct better treatments to specific patient subsets and invest in rationale therapeutic combination approaches for this vastly unmet clinical need.
Whether your group is targeting microsatellite instable (MSI) and stable (MSS) CRC, a rare GI malignancy or treatment-resistant HCC, this unique forum is your opportunity to establish clinical collaborations, plan new combinatorial studies and assess how a future drug candidate can change the clinical landscape.
Explore the full conference guide here: https://ter.li/9m9m8u
**A “drug developer” or “researcher” must have a pipeline candidate and/or work for an academic institution, and must not provide solutions or services for a fee to any other company. All bookings under the drug developer/researcher category are subject to organizer approval.

2nd Applied Biocatalysis Summit
2021-11-03 - 2021-11-04 | Digital Event
Understanding the most recent developments in enzyme-catalyzed processes, computational technologies, and cutting-edge methodologies in biocatalytic cascade reactions is key to help the API and chemical industries apply biocatalysis more effectively.
Specifically designed alongside experts in the field, this conference will delve into the key technology, enzyme design, manufacturing, and scale-up challenges that must be overcome to achieve the commercial promise of biocatalysis.
Join us online for 2 days of insightful content, live Q&As, and 2+ hours of networking, as we bring together medication developers, chemical manufacturers, agriculturists, and researchers working on the complex and difficult development of biocatalyst technology.
This is your comprehensive virtual guide to defining your commercial potential of implementing biocatalysis methods in 2021.
To know more visit: https://ter.li/s09i3k

LEAP TA Life Sciences
2021-11-08 - 2021-11-10 | Digital Event
LEAP TA: Life Sciences is a unique open platform for the boldest talent leaders in the industry to engage in genuinely disruptive dialogues. Meet 80+ of your peers to rethink your recruitment approach, allowing you to find better people faster in an increasingly competitive talent market.
Taking part in this live online event will help you redefine your processes in an uncertain world, and successfully navigate the new normal operating environment.
This is your opportunity to fill the gap between reading an article and hiring an external consultant to help you solve your own recruitment challenges for the short, medium, and long term.
To know more visit: https://ter.li/od0sc4

Biomarkers for Rare Diseases Summit
2021-11-09 - 2021-11-10 | Digital
As reports predict the global biomarker test market will exceed $16bn in coming years, the ability to identify and utilize predictive, diagnostic and prognostic biomarkers is a priority for drug developers. In rare disease, affecting over 400 million worldwide and where clinical insights exist for only around 400 of the 7000+ disease identified, biomarkers are a valuable tool to accelerate drug development where there is current great unmet need. With this, we are excited to announce the launch of the inaugural Biomarkers for Rare Diseases Summit.

Uniting world leaders developing novel therapeutics for rare disease, we will discuss learnings, challenges and future directions at the only summit dedicated to approaches to identify, test and proof clinical biomarkers in rare disease for regulatory approval. From identifying disease driving biomarkers, robust assay validation, harnessing latest technologies and demonstrating therapy efficacy, we bring you the definitive platform to accelerate bench to bedside rare disease development towards regulatory filing and patient populations.
To Know more visit: https://bit.ly/3AX0FIt

Medical Devices and IVD conference 2021
2021-11-15 - 2021-11-16 | London, UK | Virtual Attendance Option Available
Navigating new legislations and strategies to comply with regulatory requirements
SMi is proud to announce the launch of their Medical Devices and IVD conference to be held in London in November 2021.
The MDR and IVDR updates will have a profound impact on the medical device industry, bringing certain products into regulatory scope that were previously excluded, introducing new manufacturing requirements, and increasing the burden for post-market surveillance. What does this mean for the future of the Medical Devices and IVD industry?
SMi’s inaugural Medical Devices and IVD conference will provide insight into the latest updates in EU MDR and IVDR regulations and will discuss strategies for how to best comply with these new regulations. In addition, the conference will examine MHRA Guidance on Post-Brexit IVD Regulations and consider the evolving regulatory landscape for digital health software. Join Europe’s leading Medical Device and IVD Conference which will address post-market surveillance and vigilance, clinical evaluations and investigations, medical device regulatory affairs in global markets, and much more.

BENEFITS OF ATTENDING:

Engage with notified body and competent authority representatives addressing key MDR and IVDR requirements
Gain insights from pharma regulatory experts in compliance and companion diagnostics
Understand the latest guidance on Post-Brexit IVD Regulations to overcome common challenges, in addition to considering evolving global regulations
Examine post-market expectations for surveillance and vigilance of your medical devices
Delve into how COVID-19 has impacted the MDR and IVD regulations

View the full agenda and speaker line-up online: www.medicaldevices-ivd.com/pjwl
Plus, post-conference workshop will be taking place on 17th November in London:
Implementing the EU MDR and Article 117, An Industry Perspective
Workshop Leader: Blake Green, Senior Manager Regulatory Affairs, Amgen
EARLY-BIRD RATES:

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

Registrations can be made on the event website at: www.medicaldevices-ivd.com/pjwl
CHAIR FOR 2021:
Andreas Stange, Vice President, TÜV SÜD
HEAR FROM EXPERT INDUSTRY SPEAKERS:

Jessica Wilkerson, Cyber Policy Advisor, FDA
Susan Neadle, Executive Director, Combination Products, Devices, Diagnostics & Digital Health Regulatory Affairs, Amgen
Claudia Dollins, Head, Precision Medicine & Companion Diagnostics, Bristol Myers Squibb
Michael Benecky, Senior Director, Global Regulatory Affairs, UCB Biosciences
Christophe Driesmans, Head of the Materiovigilance Entity, Federal Agency for Medicines and Health Products (FAMHP)
Melanie Donguy, Head Regulatory Affairs EMEA, Bayer Radiology
Marc Moal, Head of Product Delivery & Project Management, Merck Connected Health & Devices
Jim Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
Louise Place, Director, Devices, GlaxoSmithkline
Stefan Strasser, Head of Department, Austrian Medicines and Medical Devices Agency

5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases
2021-11-16 - 2021-11-18 | Hilton Boston/Woburn, 2 Forbes Rd, Woburn, MA, 01801, United States
In the unprecedented array, and steady stream of novel, topical, and systemic agents entering various phases of drug development, for critical inflammatory and autoimmune dermatological conditions this year, the 5th Annual Dermatology Drug Development Summit for Inflammatory Skin Diseases, returns to Boston for 2021. As the world’s leading, and only forum committed to overcoming significant R&D hurdles, and sharing of best practices for advancing efficacious next generation therapies for chronic inflammatory skin conditions, this forum is not to be missed.
With the rising demand for consolidation and precision medicine, along with multiple new agents edging closer to market for Atopic Dermatitis towards the end of the year, the 5th annual meeting addresses advances and challenges in genetic discoveries, antibody drug development, delivery strategies and predictive and diagnostic technologies when developing safe and effective drugs for moderate-to-severe, inflammatory skin conditions.
Ensure you join this year’s 150+ expert community, in-person, to uncover recent studies evaluating critical inflammatory and auto-immune pathways, gain a deeper understanding of promising biologics targeting IL-13, IL-31, IL-33, whilst continuing to assess emerging efficacious targeted approaches when developing safer treatments to patients with debilitating skin diseases. Additionally, obtain clarity on novel clinically validated endpoints within the regulatory landscape for critical dermatological conditions with high unmet need such as Hidradenitis Suppurativa and Vitiligo.
Leave this year’s meeting having overcome innovative modelling challenges by gaining simulation tools/strategies to support your clinical drug development pipeline, evaluate optimal dose and dosing regimen to support formulation changes for your approach, whilst having debated what makes a dermatology investment most successful when advancing therapies for inflammatory and autoimmune skin conditions to market.
To find out more visit: https://ter.li/e93ads

3rd Inflammasome Therapeutics Summit
2021-11-16 - 2021-11-18 | Virtual/Online
Discover the Intricacies of Inflammasome Regulation, Leverage Inflammasome Proteins as Biomarkers & Accelerate Novel Inflammasome Therapeutics into Proof-Of-Concept Clinical Trials & Beyond
Built with Ventus Therapeutics, Inflammasome Therapeutics, Merck & more, the Inflammasome Therapeutics Summit returns for its third year as the only industry-dedicated forum to discover the intricacies of inflammasome regulation and accelerate novel inflammasome therapeutics into proof of-concept clinical trials and beyond!
With a plethora of inflammasome-targeted drugs poised to enter the clinic in 2021, this year’s summit will once again unite thought leaders in inflammasome drug development.
Expect to be involved in interactive discussions on:

How dysregulated inflammasome activation, formation and signaling contributes to disease and how to identify novel drug targets beyond NLRP3
The interface of inflammasome signaling with innate immunity, microbial interactions, metabolism, neuroimmune and other systems
Leveraging inflammasome proteins in precision-based medicine as disease biomarkers and companion diagnostics in both the preclinical and clinical setting
Identifying and translating the most promising therapeutic applications of inflammasome-targeted drugs across monogenic diseases, as well as infectious, ophthalmic, neurological and cancer settings

This year’s meeting has two parallel tracks of learning with 30+ speakers sharing highly anticipated case studies. As the growth potential of novel inflammasome therapeutics becomes apparent, join the conversation to validate novel inflammasome targets beyond NLRP3 and realize the clinical and commercial potential of inflammasome proteins across different diseases!
To Know more visit: https://ter.li/bdw0tf

3rd Exosome Based Therapeutic Development Summit
2021-11-16 - 2021-11-18 | Digital Event, EST
The 3rd Exosome-Based Therapeutic Development Summit returns with a more comprehensive agenda than ever before, reuniting leading pharma, biotech, technology providers and academic teams to advance therapeutically relevant exosome-based therapeutics in regenerative medicine, autoimmunity, COVID-19 and beyond.
Deep diving into the key challenges such as sourcing, characterization, cargo loading, manufacturing and clinical development, this year’s summit will be your comprehensive roadmap to realizing, strategizing and advancing the full therapeutics and drug delivery opportunities offered by exosomes.
Tailor-made to showcase the latest innovations and interactively discuss the industry’s most important talking points, join leading biopharmaceutical Directors, VPs and C-Level Executives to successfully optimize, accelerate and scale your exosome-based therapeutics as next generation drugs for unmet clinical needs
Key Highlights:

Shining a spotlight on orally delivered bacterial extracellular vesicles with unique pharmacological profiles with striking anti-inflammatory effects, an exciting new approach for exosome therapeutics with Evelo Biosciences

Deep dive into the latest data coming out of the clinic with key learnings from phase I/II trials of Covid-19, oesteoarthirtus and gastrointestinal diseases with insights from Organicell, University of Athens & University of Louisville

Navigating the complex regulatory landscape for exosomes to understand what the FDA requires to progress through each development stage and the potential for successful applications into 2021 with insights from Rion

Exploring proteomic insights in understanding EVs and the mechanisms of action of EV-mediated RNA delivery to enable more efficient and efficacious exosome therapies with Exogenus Therapeutics Aruna Bio, Stem XO & Baker Heart and Diabetes Institute

Expanding the boundaries of engineering exosomes including cell selection, applications of the technology, monitoring biodistribution and enabling direct delivery with Exogenus VivaZome Therapeutics, OmniSpriant & Exogenus Therapeutics

To know more visit: https://ter.li/h99vsb

Wnt & β-Catenin Targeted Drug Discovery Summit
2021-11-17 - 2021-11-18 | Digital Event
The Wnt & β-Catenin Targeted Drug Discovery Summit is the only meeting uniting leading pharma, pioneering biotechs and reputed academics under a mutual and ambitious objective of accelerating your novel Wnt/β-catenin candidates into clinic and market.
Built with Leap Therapeutics, Fog Pharma, Surrozen, Iterion Therapeutics, Genentech, and other leading companies, the summit will allow you to gain knowledge on the inhibition and activation of the Wnt pathway. You can be sure to take away practical insights and actionable strategies on how to harness this previously undruggable target.
With 24+ expert speakers, this is your definitive opportunity to be a part of this exciting and growing community, and this dedicated virtual summit will ensure you get your answers to your questions.
To find out more and view the 2021 speaker line-up, download the full event guide.

5 unmissable keynotes include:

Supercharging Your Wnt/β-catenin Clinical Program by Surrozen, Iterion Therapeutics, AntlarA & Leap Therapeutics
Getting a Grip on Wnt Biology to Theorize the Latest Opportunities & Understandings with Iterion Therapeutics, Genentech & Auburn University
Opportunities to Aid Drug Discovery & Further Research Efforts with Biovista & the DTRF
Delving into Immuno-Oncology to Further Oncological Treatment Efficacy, brought to you by UAB, Duke Cancer Institute & Shandong First Medical University
Harnessing Novel Pathways Approach to Drive Preclinical Insights delivered by
Fog Pharma, RedX Pharma & The University of Oxford

To know more about the Wnt & β-Catenin Targeted Drug Discovery Summit please click here.

Microbiome Connect: Gut Therapeutics USA
2021-11-17 - 2021-11-18 | 275 Tremont St, Boston, MA 02116, United States, MA, United States
Microbiome Connect: Gut Therapeutics USA, a two-day conference from the 17th – 18th of November 2021 and will bring you essential solutions to the challenges you face in the microbiome field. This industry-leading event will facilitate discussions concerning new clinical research, microbiome biomarkers, the latest regulatory developments, gut-organ axis, human clinical updates and much more. Hear from experts like Bernat Olle, CEO of Vedanta Bioscience, regarding the state of the market post-C Diff. therapy approval, and Diwakar Davar, to discuss his ground-breaking immuno-oncology research.

The event will have dedicated manufacturing steam; attendees will witness a showcase of solutions to scaling up your bacterial fermentation operation, highlighting the different culturing methodologies along with discussions regarding commercialization preparation. Joined by companies such as Takeda, Merck, and PRI, who will discuss the microbiome’s clinical future as a diagnostic and endpoint and examine how the industry can and should develop standardized biomarkers. Leading biotechs will discuss their latest clinical updates, mechanistic data, experimental methods, and clinical trial design.
Microbiome Connect will be hosting their annual skin and oral event at the same venue and dates, which all gut attendees will have access to. Download the agenda https://hubs.ly/H0RQsBQ0.

Microbiome Connect: Oral USA
2021-11-17 - 2021-11-18 | Join the Microbiome Connect community at the picturesque Courtyard by Marriott, Boston Downtown Boutique Hotel, 275 Tremont St, Boston, MA, 02116, United States
The Oral Microbiome is the second largest and diverse microbiota in the human body, harboring over 700 species of bacteria. A complex and constantly changing habitat, it is crucial in maintaining not only oral health and oral diseases, but systemic health conditions across the body. To date, over 50 systemic diseases have been linked to an unbalanced oral microbiome, and research in this space is accelerating. Further developing a collective understanding of the role of the oral microbiome in health and disease will allow further developments in drug development, oral health, and targeted therapies in the future.
Join us at the 6th Annual Microbiome Connect to discover the latest research relating to the oral microbiome, and its critical and underappreciated role in human health. Be a part of the discussion surrounding pre- and pro-biotics, innovative therapies.
Find out more >>> https://hubs.ly/H0T0d430

Microbiome Connect: Skin USA
2021-11-17 - 2021-11-18 | Boston, MA, USA
Love the skin you’re in? How about the bugs on it?
Over the six years we’ve run Microbiome Connect: Skin, the field has changed drastically. In a short period, the field has gone from fringe to mainstream, from quantifying the size of bacterial populations to understanding their function. As the field continues to commercialize, it is time to ask how this research can benefit consumers. How can the skin microbiome be leveraged as a source of biomarkers, as a therapeutic modality, as an understandable term to consumers?
Join us in Boston for a two-day face-to-face event, attended in the past by the likes of P&G, Jackson Laboratory, and the FDA. Unravel the function of the skin microbiome and apply the latest findings to your future products. See you in November!
To know more visit: https://hubs.ly/H0W7lQ90

CPhI & P-MEC China Virtual Expo Connect 2021
2021-11-18 - 2021-12-18 | Online
Virtual Expo Connect” is the digital extension of the physical CPhI & P-MEC China event that offers an online alternative for global pharma professionals. Powered by PharmaSources.com, Virtual Expo Connect builds an online platform to be accessed from anywhere, adding valued services and infinite opportunities to connect, learn, trade and grow.
To know more visit: https://bit.ly/3ASODPZ

Ophthalmic Drugs Conference 2021
2021-11-22 - 2021-11-23 | Holiday Inn, Kensington, London, UK, London, United Kingdom
Exploring the future of ocular drug development
SMi proudly presents the 4th Annual Ophthalmic Drugs Conference taking place on the 22nd-23rd of November 2021, in London.
The global ophthalmic drug market is forecast to surpass $60 billion USD by 2025 with increasing focus from the industry on alternative delivery approaches and improving the effectiveness of the current repertoire of drugs in order to grow away from intravitreal injections and other surgical approaches to ocular therapy. With 50% of the global population predicted to have complications in their sight within the next few decades, ophthalmic medicine is set to become one of the biggest industries in pharmaceuticals.

As Europe’s leading Ophthalmic Drugs conference, we will explore new discoveries in the treatment of ocular disease, innovations in combination technologies, and the utterly unique challenges that are faced in the treatment of one of the most complex organs in the body.
This two-day agenda will offer peer-to-peer networking opportunities with leaders in the ophthalmic sphere, from Heads of Drug Development and Senior Directors of Ophthalmology, all the way to academic forerunners in the research into ocular therapy.
To register or for more information visit: www.ophthalmicdrugs.com/pjwl
BENEFITS OF ATTENDING:

INSIGHT into the newest techniques in ocular drug design and delivery
EXPLORE the impacts and applications of controlled release technologies
LEARN how advanced medical devices are changing the face of combined therapy
UNDERSTAND the latest developments in overcoming the challenge of treating such a complex organs

WHO SHOULD ATTEND:

Ophthalmic Lead
Clinical Director
Senior Medical Advisor
Franchise Head
Business Manager
Senior Scientist
Senior Vice President
Medical Director
Therapeutic Area Head
General Manager
International Scientific Advisor

Early-Bird Rates

BOOK BY JUNE 30TH TO SAVE £300
BOOK BY SEPTEMBER 30TH TO SAVE £100

SOCIAL MEDIA HANDLES
Twitter: @SMiPharm #OphthalmicDrugs
LinkedIn: follow our company page – search ‘SMi Pharma’
Additional Contact Info:
T: +44 (0)20 7827 6088
E: hsidhu@smi-online.co.uk

5th Annual NASH Summit 2021
2021-11-29 - 2021-12-01 | Digital Event
Grounding the scientific data into actionable insights for drug sponsors, the 5th NASH Summit is the outstanding forum and unrivalled platform for biotech and pharma to regroup, reassess and realign their NASH pipeline strategy.

Uniting 100+ NASH experts from the EMA, Novartis, Gilead, Pfizer, Eli Lilly, Takeda, AstraZeneca, Merck, Janssen, Ionis, Novo Nordisk, the FDA and more, including stakeholders at the helm of NASH drug development and on the periphery, this industry focused forum is bringing together content perfectly aligned with wherever you sit on prioritising NASH, so you can continue to keep on top of this huge unmet medical need and massive opportunity for drug sponsors to scratch the pad of available, approved, NASH therapeutics.
To know more visit: https://nash-summit.com/

Cytokine-Based Cancer Immunotherapies Summit Boston
2021-11-30 - 2021-12-02 | Hyatt Regency Boston, One Ave. de Lafayette, Boston, MA, 02111, United States
The only in person dedicated industry forum supporting the development of robust cytokine-based cancer immunotherapy platforms (cytokine muteins, antibody-cytokine fusion proteins (immunokines), anticancer vaccines, and cancer-directed antibodies) to deliver targeted, durable therapeutic interventions to solid tumor and hematological cancer indications.
This comprehensive, drug development focused agenda will showcase the latest concepts and molecular engineering approaches being utilized by biopharma and research groups to help you overcome the challenges in:

Toxicity management – engineering selectivity, targeting and half life modulation
Optimizing the risk benefit by dose and schedule optimization
Achieving safe and acceptable delivery
Understanding the potentials for combination
Delving into the clinical data to understand the translational side

You will have the opportunity to join a pre-conference workshop day exploring pre-clinical models for cytokine research and the world of cytokines in inflammatory disease, providing insight into where the world of cytokine research is going beyond oncology.
Join this exclusive community of cytokine pioneers to network and learn from the leading experts in pharma, biotech and academia, as we discuss how to successfully and safely deliver cytokine therapies to a plethora of cancer indications.
Across 3 content packed days, 30+ experts will converge to discuss novel cytokines, the shortfalls of these therapies and how to learn from the pitfalls of the first cytokine era – this is not one to miss!
To know more visit: https://ter.li/gwz2x1

Rare & Genetic Kidney Disease Drug Development Summit
2021-11-30 - 2021-12-02 | Digital Event
Marrying unmissable insights from global renal experts, the 1st Rare & Genetic Kidney Disease Drug Development Summit is uniquely positioned to provide you with transformative perspectives from identifying genetic drivers of rare kidney diseases to innovative trial design in small disease populations to accelerate progress of your genetic kidney disease pipeline.
Hear from industry heavyweights including Sanofi Genzyme, Alexion, AstraZeneca, Regulus Therapeutics, Chinook Therapeutics, Ionis Pharmaceuticals, Novartis, Otsuka Pharmaceutical Companies and many more to ignite your entry to the rare and genetic kidney disease landscape and confidently progress from proof of concept to the clinic.
Discover pivotal advances in disease modelling with stem cell-derived kidney organoids, explore opportunities for comprehensive genetic diagnosis and patient stratification, and join the conversation on progressing surrogate biomarkers and endpoints to guide strategic decisions on your pipeline in ADPKD, Alport Syndrome and more.
Get involved to understand why interest in rare and genetic kidney diseases is exploding and keep up to date with the latest opportunities for genetic intervention.
To know more visit: https://ter.li/k0fu1i

3rd Gene Therapy for Neurological Disorders
2021-12-06 - 2021-12-09 | The Colonnade Hotel, 120 Huntington Ave, Boston, MA, 02116, United States
Returning to Boston this December, the 3rd Gene Therapy for Neurological Disorders meeting will welcome discovery, preclinical, translational and clinical industry scientists to share, learn and network for the shared goal of successfully and safely delivering gene therapies to the CNS.
With 40+ expert leaders from the likes of Taysha Gene Therapies, Passage Bio, AskBio, Neurogene, Affinia Therapeutics and Alcyone Therapeutics sharing their progress, don’t miss the chance to join the industry’s definitive physical conference to make new connections and reconnect with your friends and colleagues.
Over 4 comprehensive days of networking, presentations and discussion sessions, this meeting will enable you to:

Discuss the latest DRG toxicity and immunogenicity research to understand the biology behind AAV toxicity in the CNS
Evaluate current safety and toxicity strategies to navigate off target effects including redosing options
Evaluate intraparenchymal, intra-cisterna magna, lumbar intrathecal and systemic delivery routes for CNS indications to assess CNS tropism and biodistribution
Hear from neurosurgeons at the forefront of delivery and explore the most up to date delivery devices to identify novel innovations and areas for development
Review pharmacological concepts for preclinical dose selection in NHP biodistribution case studies to optimize dose extrapolation
Learn about the different vector discovery strategies used to identify vectors with improved CNS tropism and specificity
Optimize clinical trial design considerations for both paediatric and adult neurological patient populations to showcase efficacy to regulators and deliver value for patients
Discover the novel indications being targeted by gene therapies such as epilepsy, neuropathic pain and hearing disorders to improve your knowledge of current CNS pipelines

View your copy of the event guide now: https://ter.li/yrofx9

iPSC-Derived Cell Therapies Summit
2021-12-07 - 2021-12-09 | Virtual/Online
Capitalize on the Scalable & Diverse Potential of iPSC-Derived Therapies By Defining Differentiation Protocols, Optimal Cell Line Selection & Optimizing Gene Engineering To Accelerate Successfully Into the Clinic
The explosion of excitement and investment in the iPSC field has ushered in a new era of cell therapy, with these cells establishing its place as the optimal starting material for cell therapies targeting cancer, autoimmune, cardiac disease and much more.
The iPSC-Derived Cell Therapies Summit is your dedicated forum exclusively focused on the common challenges across disease indications which are limiting the clinical translation of iPSC-based approaches for cell therapy, including safety concerns with differentiation protocols, lack of regulatory guidance, and licensing issues.
Get caught up to speed on this dynamic industry with expertise shared from the likes of Shoreline Biosciences, Kite Pharma, HeartSeed, and Exacis, to understand the broad applicability of iPSCs, advances in novel gene engineering approaches, and translational lessons learned to advance your pipeline to clinical success.
Leave this meeting with the knowledge and connections to landscape the clinical progression, outline GMP compliant processes for scale up, and share strategies to ensure consistency in starting material.
This is your opportunity to collaborate with 80+ iPSC senior level experts from biopharma and academia and be at the forefront of the future of cell therapy by joining the mission to develop safe, scalable and cost-effective iPSC-derived therapies.
To Know more visit: https://ter.li/e7gdu7

Synthetic Biology-Based Therapeutics Summit
2021-12-07 - 2021-12-09 | Digital | EST
Engineer ‘Intelligent’, Controllable Drugs at the First Technical Meeting Dedicated to Advancing the Therapeutic Applications of Synthetic Biology
This year, the synthetic biology market has seen fledgling companies rise to IPO smashing power players, as the demand for high-quality, engineered biomolecules and controllable therapeutics grows exponentially.
The therapeutic potential of novel synthetic units is huge, but challenges remain in demonstrating proof-of-concept, developing assays, functional characterization, manufacturing scale-up, and identifying therapeutic applications for commercial development.
With an agenda curated by leaders in synthetic biology-based therapies at Synlogic, Merck, Bayer, Senti Bio, MIT and GSK, the Synthetic Biology-Based Therapeutics Summit will provide strategic insights to deploy synthetic biology as a tool for discovery, through to therapeutic applications.
Explore innovations in circuit design and implementation, harnessing the power of computation and AI to better design functioning circuits and uncover novel components which elicit therapeutic benefit. Tackle manufacturing challenges to scale up synthetic biology-based therapeutics with gold-standard quality control and characterization.
To Know more visit: https://ter.li/19 mj8t

3rd Annual Targeted Radiopharmaceuticals (TRP) Summit
2021-12-07 - 2021-12-09 | Berlin Germany, & Online
The 3rd Targeted Radiopharmaceuticals (TRP) Summit returns at a crucial time for the entire industry. Spurred on by positive Phase III VISION trial data, there has been huge research investment, on both sides of the Atlantic, on how to deliver radiation therapy directly and specifically to tumours.
For the 2021 edition of this conference, there will be the opportunity to attend either in-person in Berlin or remotely via a dedicated digital networking platform with all the access to the conference content.
You can expect a wider array of insights from recent case studies to help you accelerate the development of the next generation of radioligand therapies from clinical approval to commercialisation.
As the only industry-led platform for discussing challenges and opportunities facing developers of theranostic radioligand therapies, we strive to tackle topics that are on every drug developer’s mind:

How do we identify and validate new targets?
Can we combine Targeted Radiopharmaceuticals with immunotherapy or other targeted oncology methods?
How do we improve current clinical design methodologies and patient selection strategies?
Where can improvements be made to the current supply and fulfilment models?

To know more visit: https://ter.li/r1oll2

4th Commercializing Clinically Validated Digital Therapeutics Summit
2021-12-07 - 2021-12-09 | Virtual Event
The 4th Commercializing Clinically Validated Digital Therapeutics Summit returns in December of 2021 as the only industry-led meeting deep-diving on stakeholder alliance and partnership to accelerate DTx scalability, to enable building sustainable & viable business models.
DTx is happening, and happening fast on a global scale. The amount of investment continues to surge, and is expected to reach $15,176m in 2027. Following the pandemic, with more emphasis on digital medicine, telemedicine, and decentralized clinical trials, DTx adoption has peaked. Now is the time to join with key stakeholders across regulatory, pricing, physician engagement, real world evidence, commercial functions, patient adherence and adoption to combat the challenges and ensure delivery of cutting edge DTx to your patients.

Furthermore, the pandemic has been the major catalyst to DTx adoption with tremendous benefits brought to patients, physicians for treatment, and remote clinical trials that made 2021 an inflection point for the DTx industry.
Across 3 days covering extensive and valuable content, we will bring together expert speakers to share their data on case studies of lessons learnt and keys to success, as well as insights into venturing into effective partnerships. This will give you the tools to conquer your most crucial challenges and accelerate sustainable scalability and adoption of your digital therapeutic.
Whether you are a drug, med device or a DTx developer, this is your must-attend event in 2021. Hear from your peers’ journeys and lessons learned, and re-engage in the long awaited dialogue to generate clinical and RWE, in order to serve our patients in need beyond just a pill!
To know more visit: https://ter.li/cyw0ze

4th RNA-Targeted Drug Discovery Summit
2021-12-07 - 2021-12-09 | Digital Event, EST
The 4th RNA-Targeted Drug Discovery Summit is returning once again this December, to reunite the largest community of thought leaders and experts in biology, chemistry and RNA therapeutics to discuss cutting-edge small molecule strategies capable of interacting with and modulating RNA with improved specificity, selectivity and drug-like properties.
Join the leading RNA small molecule forum alongside 150+ biopharmaceutical Directors, VPs and C-Level Executives to hear the latest pioneering case studies and successfully translate your discovery and pre-clinical strategies into robust pipelines of RNA-targeted small molecule drugs that realize the full potential of this up-and-coming field.
We’re back in 2021 with a more comprehensive program than ever before & we’d love you to join us!
Key Highlights:

Expand your knowledge of the RNA landscape by gaining exclusive insights and data-driven updates to streamline the success of your RNA candidates from leaders of the field such as Nymirum, Arrakis, PTC Bio& Expansion Therapeutics

Optimize and advance your RNA structural insights to guide the successful discovery & development of your RNA targeted small molecule with insights from Novartis, AstraZeneca, Stanford University &National Cancer Institute

Evaluate tested & novel structure-based methods for understanding RNA-ligand interactions and binding sites alongside academic leaders Hashim Al-Hashimi, Matthew Disney,Amanda Garner, Aaron Frank & Anthony Mustoe

Overcome selectivity, specificity & toxicity challenges and accelerate the translation of your RNA small molecule pipeline into clinical development with discussions from
Anima Biotech, MD Anderson Cancer Center & AstraZeneca

Discovery of novel chemical matter & new chemical space for small molecule intervention with insights from Roche, University of Michigan, Baylor College Medicine, Remix Therapeutics, Ladder Therapeutics &Biosplice Therapeutics

To know more visit: https://bit.ly/3mWyANC

Microbiome Connect: Gut Therapeutics Europe
2021-12-07 - 2021-12-08 | Amsterdam, Venue TBC
Join us in Amsterdam from 7th – 8th December 2021 to find out more about why biotherapeutic products are progressing through clinics worldwide. As this trending topic gains more exposure and fast approaches commercialisation various challenges have presented themselves. Issues in areas such as key regulatory, manufacturing and supply chain are amongst some of the themes emerging.
Companies such as Stellate Therapeutics, TargEDys, EVERIMMUNE, Nestlé are amongst those committed to the event, and you can reach out to them directly by securing your place.
Download the agenda here to view the speaker faculty and partners for 2021: https://hubs.ly/H0X0Lk_0

TIGIT Therapies Summit
2021-12-07 - 2021-12-09 | Digital
TIGIT therapies have seen promising clinical validation, spearheading the next wave of Immune Checkpoint Inhibitors. As such there has been an explosion of interest and high-scale investment into this exciting space.
Arriving at a critical point for TIGIT development, the 2nd Annual TIGIT Therapies Summit is the definitive industry-led event focused at propelling this next generation inhibitor to clinical use.
Ensure your TIGIT program reaches full clinical potential through hearing from experts about optimizing the mechanism of action, refining Fc receptor co-engagement, devising effective drug design, rationalizing checkpoint combinations and utilizing biomarkers to harness the therapeutic potential of the TIGIT and DNAM-1/CD226 axes.
Join leaders in TIGIT development from GSK, Gilead Sciences, Arcus, iTeos, Compugen, BeiGene, Seattle Genetics, Mereo BioPharma, Harvard, Stanford and more!
This event will allow you to address the key challenges associated with TIGIT therapy development and propel TIGIT to clinical use. Download the event guide to see how you can get involved.

INDIAN PHARMA EXPO & BUSINESS EXCELLENCE AWARDS 2021
2021-12-10 - 2021-12-11 | Hall 12 A, Pragati Maidan, New Delhi, New Delhi, 110001, India
Indian Pharma Expo (IPE) will provide an opportunity for the participating companies to display their products & services to the gamut of visitors, globally from pharma and healthcare industries. The 2-day expo will bring together eminent personalities from various sectors of pharma, non-pharma and healthcare industries. IPE is one stop juncture to all those who are planning to expand their business through various channels of franchise and distribution; as well as wholesalers and hospital purchase personnels who seek to buy bulk products on concessional rates.
The Indian Pharma Expo will also showcase the latest trend and technologies in the pharmaceuticals, drugs and formulations. The Expo is expected to witness approx. 10,000 visitor’s footfall displays of latest pharmaceutical machinery, packaging equipments, software technology for pharma industry and management and more. Direct access to highly targeted senior pharma executives, buyers, procurement managers, contract manufacturers and hospital administration. Multiple meetings will be held with managers and business development managers who are looking for new supplies, building strategic partnerships or entering into new ventures. The Expo will feature international-cum-pharma machinery pavilion. The Expo aimed at bringing together all the pharma professionals under one roof, the pharmaceutical exhibition focused on knowledge, technology and business development.

SMi's Pre-Filled Syringes and Injectable Drug Devices
2022-01-12 - 2022-01-13 | Virtual Conference: Online Access Only
SMi’s Pre-Filled Syringes and Injectable Drug Devices
12th January to 13th January 2022,
Virtual Conference: Online Access Only
Conference: 12 – 13 January 2022
Focus Day: 11 January 2022
Location: Virtual Conference: Online Access Only
Website: http://pre-filled-syringes.com/pharmajournalist/WL
Sponsored by: BD Medical – Pharmaceutical Systems, Crux, Nemera, Zeon Europe GmbH
Chaired by:
Bjørg Kaae Hunter, Department Manager, RA CMC & Device; RA NextGen Drug-Device, Novo Nordisk and Daniel Latham, Head Connected Health Product Development, Novartis
The Future of Drug Delivery and Combination Product Device Design
The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to aid self-administration and deliver biologics, high concentration, and large-volume drug products. This year’s conference will explore the exciting advances in the combination product delivery space including insights into how the industry is adapting to the delayed EU MDR, takeaways from the global pandemic and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation. Part of the leading injectables series of events, SMi’s 14th annual conference will bring you the key insights you need to grow and enhance your pre-filled syringes portfolio and discover what the future holds for the PFS and combination products industry.
#PFSSMi
Key Reasons to Attend:

Engage with industry leaders on the key takeaways from the pandemic and how this can be applied to future accelerated development
Explore updates to drug device combination product design approaches putting the user first with industry case studies from big pharma
Assess the current landscape of device delivery mechanisms and how industry can work together to promote innovation
Understand the landscape of delivery for novel drug products, fragile molecules and long acting injectables in the interactive panel discussion

Download the brochure at: http://pre-filled-syringes.com/pharmajournalist/WL
Who Should Attend?
Drug-delivery developers, Medical Device Engineers, Primary Packaging material designers, Secondary packagers, Smart device developers, Training device developers, Device-safety solution providers, Drug developers
