Pharma Journalist

Aseptic Processing Conference
2021-09-22 - 2021-09-23 | COPTHORNE TARA HOTEL, Scarsdale Place, Kensington, London, W8 5SY, United Kingdom
SMi’s Aseptic Processing Conference
Exploring aseptic facility design and operation to implement agile contamination control strategies Conference: 22 – 23 September 2021
Location: Copthorne Tara Hotel, London, UK
Website: http://www.asepticprocessing.co.uk/PJWL
SPONSORED BY: Innerspace & Steris
CHAIRED BY: James Drinkwater, Head of Aseptic Processing & Containment Special Interest Group, PHSS and Richard Denk, DACH Affiliate, ISPE

The aseptic processing industry has seen many changes during its progression towards the 21st century. With advances in innovative therapeutic manufacturing such as ATMPs, pragmatic barrier system applications, adaptability and modularity in fill finish, robotics and automation, small and agile product manufacturing, just to name a few. In 2018, the global aseptic processing market was valued over $56 trillion and is estimated to increase in net revenue upwards $124 trillion by 2027, with a CAGR growth of 9.18%.
The industry is ever changing and with the advent of innovative therapeutics taking hold, regulators and industry leaders are prompted to take proactive approaches to get treatments to patients faster.
Join us to explore novel and developing technologies that tackle the most pressing challenges and push innovation in the world of aseptic processing and sterile manufacturing.
Event Hashtag: #SMiAseptic
At the Aseptic Processing Conference, you will gain insight into:
Featured 2021 Speakers include:

Scott Nichols, Microbiologist, FDA
Serena Ambrosini, Sterile Manufacturing Manager, AstraZeneca
Jim Polarine, Senior Technical Service Manager, Steris Corporation
Di Morris, Audit Manager CAG, GSK
Stephen Yang, Director, Global Sterile Validation COE, Merck
Kevin Jenkins, Consultant, Quality Excellence Consulting

KEY HIGHLIGHTS INCLUDE FOR 2021

Discuss the latest regulatory updates in the industry from leading regulatory bodies
Listen to global case studies in aseptic competence from companies pioneering in the pharmaceutical industry
Explore advances in ATMP facility design that are revolutionising aseptic manufacturing
Delve into the newest contamination control technologies from VHP disinfection to fully automated pipelines

PLUS – Pre-conference workshop on…
Contamination control measures in Good Manufacturing Practice (GMP) applied to Aseptic processing
Workshop leaders: James Drinkwater, Head of Aseptic Processing and Containment Special Interest Group, PHSS and Kevin Jenkins, Consultant, Quality Excellence Consulting
View the brochure and to download visit http://www.asepticprocessing.co.uk/PJWL

4th Annual Neuropsychiatric Drug Development Summit
2021-09-28 - 2021-09-30 | Online
This last year has been a brutal reminder as to how crucial it is that we tackle the impending global mental health crisis and find a path towards successful neuropsychiatric drug development.
We are proud to be the industry’s definitive and unrivalled forum focused on encapsulating the recent clinical advances across this extremely arduous field. This timely meeting provides a much-needed platform for industry and academic thought leaders to:

Investigate new treatment paradigms to support schizophrenia patients with Sunovion, Merck, Cerevel and BioXcel
Strive for useful biomarkers in clinical practice and explore novel electrophysiological biomarkers of synaptic plasticity in humans with Lundbeck, Daniel Javitt and Takeda
Hear patient-centric approaches towards developing efficacious and engaging digital therapeutics with Thomas Insel, MindMed
Decipher the recent hype in psychedelics by evaluating new data emerging on hallucinogens with Psilera, MAPS, Eleusis, ATAI and Perception Neuroscience
Discover the major advances in understanding neuroinflammation across CNS indications and how can we use this to help us further understand psychiatric conditions with Johnson & Johnson and Inmune Bio

Don’t miss out and join over 80 of your peers at this timely event to take a step closer towards your ambitious goal of drastically improving the lives of individuals living with neuropsychiatric disorders.
To know more about 4th Annual Neuropsychiatric Drug Development Summit please click here.

12th Annual World Bispecific Summit
2021-09-29 - 2021-10-01 | Virtual Event
The 12th Annual World Bispecific Summit will deliver a greater scope and penetration of innovative technical content than any other meeting. This year’s re-imagined agenda will cover unique discovery, translational, and manufacturing challenges faced in the bispecific field. Whatever your role and interest, you will leave the meeting with concrete methods to employ into your strategy and pipeline to convert the promise of bispecific therapeutics into a reality for patients.

Discover who the 45+ expert speakers are, and the topics they will examine, including how:

OSE Immunotherapeutics is pioneering their unique platform BiCKI a bispecific platform optimized for the development and manufacturing of bispecific cytokine fusion proteins
GT Biopharma and Light Chain Bioscience are showcasing the next generation of innate cell engagers for the treatment of solid tumors
Merus, Pfizer, and Innate Pharma are expanding the boundaries of biotherapeutics with tri-specific and multi-specific antibodies
Genentech, Pfizer, and City of Hope are discussing approaches to reduce on-target off-tumor toxicities including dosing strategies in liquid and solid tumor indications
Xencor, Harbour Biomed, and Harpoon Therapeutics will discuss their unique platforms and CMC strategies for scale-up and production
IGM Biosciences and MacroGenics will evaluate biomarker strategies for bispecific candidates during clinical development

To know more about 12th Annual World Bispecific Summit please click here.

11th World Clinical Biomarkers & CDx Summit
2021-09-29 - 2021-09-30 | Digital
Accelerating R&D to Commercialization by Leveraging Predictive Biomarkers & Clinical Diagnostics Evidence for Best Patient Outcomes in Target Populations
The 11th World Clinical Biomarkers & CDx Summit returns in 2021 as the only end-to-end industry-led meeting diving deep into the science of transitioning biomarkers to the clinic, their clinical validation and later commercialization with a CDx.
With over half of drugs approved by the FDA now supported by a biomarker and as new CDx collaborations are announced on an almost weekly basis, demand for diagnostic tools enabling earlier, more precise, therapeutic interventions is at an all time high. Join with 650+ key stakeholders across biomarker, translational, clinical, regulatory and commercial functions to tackle end-to-end challenges and deliver game-changing drug-Dx products to market.
Across 2 days of comprehensive content, 65+ global expert speakers will share fresh data paired with inspiring stories from innovative partnership collaborations to help you overcome your most pressing challenges and accelerate curative medicine for heterogeneous patient populations.
With 3-tracks addressing the entire lifecycle of biomarker-driven drug development, explore biomarkers and Dx movement within bioanalytical analysis, AI/ML application, data sharing and the regulatory and payer landscape. Covering immune-oncology, neurodegenerative, metabolic, autoimmune and rare indications, gain a diverse picture of today’s expanding personalized medicine ecosystem.
This is your unmissable event, bringing you the tools, insights and techniques to design a clinically robust biomarker and commercially competitive CDx!
To know more visit: https://world-cdx.com/

9th Annual MarketsandMarkets Biomarker and Companion Diagnostics Virtual Conference (EST TIME ZONE)
2021-10-05 - 2021-10-08 | Virtual Event
Leveraging next gen technologies beyond conventional biomarker drug discovery
The emergence of the need for safety and efficacy of a drug subjected to individual patients has made companion diagnostics one of the most sought after topics in the field of In-Vitro Diagnostics. The surge of investment in companion diagnostics has brought forward issues regarding regulations and their intricacies and boosted new trends in immuno-oncology, immuno-therapies, data interpretation and unconventional design of clinical trials.
The 9th Annual MarketsandMarkets Biomarker and Companion Diagnostics Virtual Conference scheduled to be held from 5th – 8th October 2020 would address the gaps between early-stage biomarker development and the commercialization stage of biomarkers.
This conference would also highlight case studies on leveraging emerging technologies in Digital Biomarkers, Precision Medicine and Big Data. Regarding the commercialization of biomarkers, leading industry and academic experts would share their case studies focusing on advancements in the companion diagnostics area. The keynote presentations would also help the attendees understand the issues related to the clinical translation of biomarkers.
Event Website: https://events.marketsandmarkets.com/9th-annual-marketsandmarkets-biomarker-and-companion-diagnostics-virtual-conference/
Registration link: https://events.marketsandmarkets.com/9th-annual-marketsandmarkets-biomarker-and-companion-diagnostics-virtual-conference/register

2nd Annual B&T Cell-Mediated Autoimmune Disease Drug Development Summit
2021-10-05 - 2021-10-07 | Digital Event | EST
The 2nd Annual B&T Cell-Mediated Autoimmune Disease Drug Development Summit is the only event uniting key B&T cell decision-makers to advance the therapeutic future of autoimmune diseases.
Join this community of 60+ pioneers to aid discovery, development, optimization and strategy for a new generation of treatment within this area of vastly unmet clinical need.
This cross-disciplinary program featuring keynote talks from 32+ clinical KOLs from large pharma, biotech and academia, will give you insight into the full therapeutic opportunity of drug candidates against various plasma, B and T cell targets.
Unite with other B & T cell researchers as we look to optimize therapeutic targeting of the bidirectional interactions between B and T cells, B cell functions (autoantibody production, antigen presentation, T cell help & cytokine production) and autoreactive T cells contribution to autoimmune pathogenesis and disease progression.
View our full event guide to see our complete speaker line-up, latest agenda, and workshop details. https://ter.li/0zk3pp
Key Discussions you Can’t Afford to Miss:

Delve into the exciting world of cell engineering and novel targets for rare autoimmune diseases and what they mean for the field with Abcuro, Polyneuron, Apitope, NYSCF, UTHSC & Cabaletta Bio
Discover the novel and promising candidates targeting B cell development factors and related cytokines with Eli Lilly & Co, UCL, Kyverna, Immunic AG, Nurix & GSK
Uncover the pathologies and targets for the B & T cell co-stimulatory pathways and novel mechanisms in disrupting collaboration with Artax Bio, Cytocom, Horizon, AltruBio & Novartis
Explore targets, considerations and strategy for targeting autoantibody producing plasma cells, organ specific and systemic diseases with UCB, Provention Bio, IM Therapeutics & Biogen
Optimize application and patient outlook through combination strategies, early detection and emerging biomarkers and look to next steps in your drug development with Oklahoma Medical Research Foundation, Bristol-Myers Squibb & Eli Lilly & Co

Find out more https://ter.li/0zk3pp

SMi's 2nd Next Generation Pharmaceutical Cleanroom Conference
2021-10-06 - 2021-10-07 | Copthorne Tara Hotel, London, United Kingdom
SPONSORED BY: Elis Cleanroom and Innerspace
CHAIRED BY: Matts Ramstorp, CEO & Founder, BioTekPro
Addressing the Microbiological Aspects in Cleanroom Design & Engineering
SMi Group are pleased to announce the 2nd Annual Next Generation Pharmaceutical Cleanroom Europe Conference. An event that focuses on cleanroom technology in the pharmaceutical industry, the conference will serve to bridge that gap between the two areas while simultaneously providing a unique selling point.
This one-of-a-kind meeting will facilitate networking opportunities with key opinion leaders from all areas of pharmaceuticals, biologicals, and cleanroom industry experts to explore hot topics within cleanroom design and engineering, best practices and regulation, environmental and contamination control, and pharmaceutical microbiology.

In 2025, the global cleanroom technology market is expected to reach nearly $5 billion. Stringent regulatory standards for product approvals, technological advancements in cleanrooms, initiatives taken by private organisations to create awareness regarding cleanroom and growth of the healthcare sector globally are among the few factors expected to drive the market.
This event will look in-depth at the significant change that the cleanroom industry is going through. From the new operating practices that keep the product as sterile as possible, to the developments in technology that are enabling this to happen. Whether through robotics, automated disinfection, or data driven environmental monitoring- this conference will highlight the developments that are fundamentally changing the industry.
Event Hashtag: #SMiCleanroom
HIGHLIGHTS FOR 2021:

UNDERSTAND the current regulatory landscape from both designer and regulator perspectives
EXPLORE the innovations in technology that are shaping the next generation of cleanroom facilities
DETERMINE the best approaches to cleanroom design and operation from global case studies
GAIN insight into the latest developments in cleanroom protocol from leading industry experts

FEATURED 2021 SPEAKERS INCLUDE:

Tim Sandle, Head of Microbiology and Sterility Assurance, Bio Products Laboratory Ltd
Conor Murray, Principal, Irish Cleanroom Society
Joseph McCall, Associate Director, QA Technical Service, ADMA Biologics
Benoît Ramond, Head of Microbiology & Sterile Technology, Sanofi
Walid El Azab, Senior Manager Technical Services, STERIS
Dawn Tavalsky, Senior Director Global Sterility Assurance, Sanofi Pasteur
Patrizia Muscas, QA & Sterility Assurance, Eli Lilly
Christine Arbesser-Rastburg, Director, Head of Global Microbiology, Takeda

WHO SHOULD ATTEND:
Senior Micro Manager, QC Manager, Quality Director, Clean Room Design Managers, Design, Qualify and Testing – Clean Room (across the board), Head of Clean Room Technologies, Head of Compounding Pharmacies, Head of Clinical Drug Products, Head of Clinical Medical Device
ADDED VALUE – 2 x Pre-Conference Workshops on…
Workshop A – 08.30 – 12.30: Applying ISO and EN Standards to Non-Viable and Viable EM in the context of the new Annex 1 guidance and a CCS in GMP Cleanrooms
Workshop Leader: Conor Murray, Principal, Irish Cleanroom Society
Workshop B – 13.30 – 17.30: Cleanroom Garments – need, function and use
Workshop Leader: Matts Ramstorp, CEO & Founder, BioTekPro
View the brochure and to download visit www.cleanroomtechnology.co.uk/PJwl

Wearable Injectors and Connected Devices Conference
2021-10-18 - 2021-10-19 | Copthorne Tara Hotel, Scarsdale Place, Kensington, London, W8 5SY, United Kingdom
The latest innovations in digital health and on-body drug delivery for the pharmaceutical industry
SMi’s 2nd annual Wearable Injectors and Connected Devices Conference will explore real world case studies of on-body device design and development for large volume delivery while engaging in the latest digital applications for wearable devices with industry case studies from pharma thought leaders. The conference will consider key developments in the wearable injectors field, including the enhanced demand for on-body injectors and digitalised health as the pandemic highlights the need for self-administered at-home care, managing sustainability in the field, and opportunities for development in oncology.

Key regulatory updates including guidance on MDR requirements and the impact of Brexit on data collection will be presented by regulatory experts for a comprehensive outlook of this exciting and ever-growing field, and the importance of considering human factors in order to enhance the user experience will be presented by industry experts.
This two-day agenda offers you peer-to-peer networking with Global Device Development Managers, Senior Connectivity Engineers, Leaders in Device Data Generation, Human Factors Directors and many more.
We look forward to welcoming you to the conference in October.
For more information and to register: www.wearable-injectors.co.uk/pjwl
BENEFITS OF ATTENDING:

Gain insight into developments in wearable devices in clinical trials and adapting to decentralised trials during the pandemic
Explore design strategies for connectivity and digital health with sessions from Novartis and Bayer
Hear key regulatory updates from regulatory and notified bodies including TÜV SÜD
Discover advances in device design for large volume delivery via on-body injectors
Explore and benchmark against industry developments through case studies and real-world examples in device development for on-body injectors

Plus, two interactive half-day workshops – Wednesday 20th October 2021
A: Cross company collaboration to develop digital therapeutic solutions using connected devices
Workshop Leader:
Digby Harris, Global Procurement Lead – Digital Therapeutics, AstraZeneca
B: Optimising Patient Engagement and Creating Novel Company Value through Digital Technologies
Workshop Leaders:
Alex Gilbert, Digital Medicine, Huma
Early-Bird Rates

BOOK BY JUNE 30TH TO SAVE £200
BOOK BY AUGUST 31ST TO SAVE £100

SOCIAL MEDIA HANDLES
Twitter: @SMiPharm #SMiWearables
LinkedIn: follow our company page – search ‘SMi Pharma’

2nd Annual Dry-AMD Therapeutic Development Summit
2021-10-19 - 2021-10-21 | Online
Returning for its 2nd year as the world’s leading industry forum, Dry-AMD Therapeutic Development establishes meaningful clinical endpoints using the latest diagnostic imaging techniques to prove therapeutic safety and efficacy in specific patient populations.
In the context of unprecedented Phase III progress, and as new investigational pharmacological agents enter the clinic, Dry-AMD Therapeutic Development will deliver a greater breadth and depth of technical content than any other meeting in this field with 3 days and 2 tracks of dedicated content.

Uniting large pharma, biotech and academic KOLs with a reimagined agenda, this year’s meeting devotes specific content to the unique discovery, pre-clinical, translational, clinical development and commercialization challenges encountered within the dry-AMD space. Ensuring that whatever your role in the field, you will leave with tangible actions to implement into your strategy and pipeline, to translate the promise of dry AMD therapies into a reality for patients.
Join the 200+ expert community, as they unite under a common goal of accelerating the approval of next generation therapies for this progressive eye disease.
To know more about Dry-AMD Therapeutics Summit please click here.

Medical Wearables for Biosensors USA Conference 2021
2021-10-25 - 2021-10-26 | Sheraton Boston Hotel, Boston, USA (Virtual Attendance Option Available)
Exploring therapeutic applications of connected on-body devices
The global wearable biosensors market is a rapidly expanding industry with increasingly growing potential for applications in healthcare and technological advances. With potential in remote patient monitoring, diagnosis and detection of disease, biosensors and wearable devices are gaining substantial interest due to their opportunities to offer continuous and reliable physiological information allowing for better support of patient needs.
With that in mind, SMi is proud to present the Designing Biosensors for Medical Wearables Conference, taking place on the 25th – 26th October 2021 in Boston.

BENEFITS OF ATTENDING:

Engage in case studies from leading experts on wearable devices for remote diagnostics and patient monitoring
Explore how industry is using on-body biosensors for a patient centric-approach to therapeutics
Delve into the regulatory landscape of digital health and data management with regulatory body and leading expert addresses
Uncover the evolving research into smart vaccines for COVID-19 and accelerating accessibility of new wearable technologies

Register online: www.biosensors-medical-wear.com/pjwl
Plus, two interactive half-day workshops – Wednesday 27th October 2021
A: Digital Integration within Clinical Trials
Workshop Leaders:
Gary McNamara, Senior Delivery Manager, Aparito
Daniel Lewi, Head of Business Development, Aparito
B: Energy Harvesting Systems for Body-Worn Sensors
Workshop Leaders:
Veena Misra, Distinguished Professor, Director, NSF Center for Advanced
Self-Powered Systems of Integrated Sensors and Technologies (ASSIST)
Early-Bird Rates

BOOK BY JUNE 30TH TO SAVE $200
BOOK BY AUGUST 31ST TO SAVE $100

SOCIAL MEDIA HANDLES
Twitter: @SMiPharm #SMiBiosensors
LinkedIn: follow our company page – search ‘SMi Pharma’

4th Targeted Protein Degradation Summit
2021-10-26 - 2021-10-29 | Digital Event, EDT
As the most comprehensive, industry-focused and ‘must-attend’ event in the field, the 4th Targeted Protein Degradation Summit returns to once again explore the latest approaches, perspectives, and data-drive case studies that will continue to advance PROTACs, molecular glues, and other degrader modalities towards clinical success.
With 70+ world-class speakers and over 500 senior attendees from around the globe, join the largest community of protein degradation experts for a deep dive into clinical development progress, lessons learnt and novel strategies to develop safe, selective and effective PROTACs, molecular glues, lysosomal degradation, autophagy-mediated degraders as well as uncovering novel degrader modalities and approaches for oncology and beyond.
Key Highlights:

Evaluate the exclusive updates of ongoing clinical trials to accelerate towards the first clinically approved therapy with insights from Kymera Therapeutics, Arvinas, Nurix Therapeutics & Bristol Myers Squibb
Deep dive into the methodologies of enhancing target engagement by improving target specificity, uncovering strategies to find novel ligases and modelling of covalency to develop next generation degraders with insights from Eli Lilly, FogPharma, GSK & Janssen
Review the plethora of disease indications that are being targeted by PROTACs and molecular glues including Alzheimers, Parkinsons, COVID-19 and AML with insights from Bristol Myers Squibb, Progenra & Origami Therapeutics
Explore the different approaches to penetrating the blood brain barrier, comparing and contrasting the discovery, development and optimization of PROTACs and molecular glues for neurodegenerative indications with insights from C4 Therapeutics & Progenra
Outline the core mechanisms of PROTAC resistance and the approaches to overcoming this to successfully progress through preclinical and clinical studies with insights from University of Dundee, Ranok Therapeutics & Captor Therapeutics

To know more about 4th Targeted Protein Degradation Summit please click here.

5th Complement-based Drug Development Summit
2021-10-26 - 2021-10-28 | Virtual/Online
Discover the Intricacies of Complement Pathways to Accelerate Clinical Validation & Maximize Complement-Targeting in the Pan-Disease Setting
Built with Alexion, Apellis and Annexon, the 5th Complement-based Drug Development Summit returns for its fifth year as the definitive industry dedicated forum to maximize complement-targeting in the pan-disease setting.
With pivotal clinical readouts poised to be released in 2021, this year’s summit will once again unite thought leaders in complement-based drug development.

Expect to be involved in interactive discussions on:

How dysregulated complement signaling contributes to disease and how to identify novel drug targets up and downstream of C3 and C5
Preclinical and clinical pipeline progress of diverse drug modalities, including gene therapy approaches, small molecule inhibitors, antibodies, protease inhibitors, nucleic acids & more!
Leveraging complement proteins in precision-based medicine as disease biomarkers and companion diagnostics
Addressing clinical challenges of complement-targeted therapeutic sequencing, combinations and timing of administration
Expanding the clinical utility of complement inhibitors across rare diseases, as well as autoimmune, ophthalmic, neurological and cancer settings

New for this year, you’ll have a two-tracked agenda with more speakers, more content and more networking opportunities than ever before! As the growth potential of novel complement-targeting therapeutics becomes apparent, join the conversation to realize the clinical and commercial potential of complement proteins as pan-disease targets!
To know more about 5th Complement-based Drug Development Summit please click here.

6th Annual Neoantigen Based Therapies US Summit 2021
2021-10-26 - 2021-10-28 | Digital Event
Your Comprehensive End-to-End Guide to Transforming the Clinical Development of Cell & Vaccine Based Neoantigen Therapies
The growth and comeback of the neoantigen space has resulted in an abundance of new data, innovative insights and valuable lessons learned on how to drive meaningful clinical responses, all of which will be shared at the 6th Neoantigen Based Therapies US Summit.
Exploring the potential of shared neoantigens vs. personalized neoantigens and optimizing the selection and identification of the best and most immunogenic neoantigens, the world’s leaders from the likes for BioNTech, Gritstone, Advaxis, Genocea, Treos Bio and many more will gather at the only 3-day summit focused on the exploding field of Neoantigen based Therapies.
Join over 100 experts to discuss what the optimal control, clinical and combination trial designs should look like, advances in accurate and robust validation assays, and explore how we can manufacture effectively and at scale both shared and personalized neoantigen based therapies.
Leave this meeting equipped with new collaborations across pharma, biotech and academia, and learn how to supercharge vaccine and cell immunotherapies for solid tumors and beyond.
To know more about 6th Annual Neoantigen Based Therapies US Summit 2021 please click here.

2nd Supply Chain and Logistics for Cell Therapies Summit
2021-10-26 - 2021-10-28 | Virtual Event | Eastern Time
At the virtual 2nd Supply Chain and Logistics for Cell Therapies Summit, your community will gather to network, share exclusive insights in case-study led sessions, and propose best practice for seamless vein-to-vein delivery at the clinical and commercial scale.
Implement robust, patient-centric supply chains for clinical to commercial readiness:

Build your supply strategyand manage risk and forecasting at scale by designing for growth
Maximize your cloud-based and integrated systems and hear the latest innovations in chain of identity

Manage materials, external manufacturing and facility design

Optimize patient care with best practice guidelines and integrated platforms:

Understand clinical requirementsand develop clinical strategies for seamless therapeutic delivery
Discuss and establish industry best practices and understand which standard practices can apply across a range of cell modalities

Maintain product quality at scale for seamless delivery of autologous and allogeneic therapies:

Optimize front-end processes and develop patient care organisations
Discuss quality control and site audits to ensure best standard of care and product quality

Find out more >>> https://ter.li/mt5mh1

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
