Pharma Journalist

Pharmaceutical Microbiology West Coast
2021-06-17 - 2021-06-18 | Hyatt Regency Mission Bay Hotel, 1441 Quivira Road, San Diego, CA, CA 92109, United States
SMi’s 4th Pharmaceutical Microbiology West Coast Conference
Novel approaches and best practices for tackling current industry contamination control challenges
SMi’s 4th Annual Conference Pharmaceutical Microbiology West Coast
NEW DATE: June 17 – 18, 2021
Location: Hyatt Regency Mission Bay Hotel, San Diego, CA, USA
Website: http://www.pharma-microbiology-usa.com

SPONSORED BY: Associates of Cape Cod, bioMérieux, Bioscience International, Microcoat, Millipore Sigma and Mettler Toledo
Co-chairs Jim Polarine, Senior Technical Service Manager, STERIS Corporation & Geeta Singh, Plant and Network Technical Specialist III, Genentech
Following on the success of the last West Coast event, SMi proudly presents the 4th Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on June 17th and 18th 2021 bringing microbiology experts to focus on innovations in rapid methods and contamination control strategies. Microbes such as bacteria, fungi, parasites and viruses that can contaminate current and novel pharmaceutical products or therapies may stem from various sources such as raw materials and human operators, are taken into consideration.
This concern is critical in advanced products/therapeutics facilities where often distinct areas within manufacturing are slowly merging, providing potential new sites for contamination events. The conference showcases sessions that cover alternative endotoxin testing and rapid mycoplasma testing as well as implementation of in-line biodurden monitoring to control water systems, to name a few. Due to the complexities brought about by more advanced therapeutic products, both drugs and patients are time dependent and rapid methods are ever more desired.
A significant portion of the conference will focus on contamination control strategies and facilities support/novel technologies such as a look at a sustainable global contamination control program, cleanroom pass thru best practices and a case study executing rapid transition from clinical to commercial manufacturing and more. Also see a regulatory session discussing objectionable organisms in non-sterile drug products and an all-women panel discussion: ‘culturing’ successful women microbiologists.
Event Hashtag: #SMiPharmaMicroWC
KEY HIGHLIGHTS FOR 2021 INCLUDE:

Discuss the guidance, regulations and case studies for objectionable organisms in non-sterile drug products from ValSource, Inc.
Gain insight into changing paradigms – moving to in-process testing from Johnson & Johnson
Examine alternative endotoxin test methods for products exhibiting LER from Amgen
Explore how to effectively scale up from clinical to commercial in three moves from Bristol-Myers Squibb
Join us for our first All-Women Panel Discussion on ‘Culturing’ successful women microbiologists

Plus a half day interactive workshop on Wednesday, June 16th 2021:
Afternoon Workshop: Data Integrity in Environmental Monitoring: Causes and Solutions
Led by: Ziva Abraham, CEO, Microrite and Morgan Polen, SME, Cleanroom Contamination Control Expert, Microrite
View the full agenda: http://www.pharma-microbiology-usa.com
WHO SHOULD ATTEND
Senior Microbiologist, Lead Scientist, Laboratory Manager, QA Specialist Drug Substance External Manufacturer, Business Development Manager – Testing, Pharmaceutical Microbiology Consultant, Higher Pharmacopoeia Scientist, Analytical Standards Specialist
SOCIAL MEDIA HANDLES
Twitter: @SMiPharm
Event Hashtag: #SMiPharmaMicroWC
LinkedIn: follow our company page – search ‘SMi Pharma’
ADDITIONAL CONTACT INFO
Simi Sapal – Marketing Manager
Pharmaceutical Division – SMi Group Ltd
T: +44 (0)20 7827 6100
E: ssapal@smi-online.co.uk

6th Annual Oncolytic Virotherapy Summit
2021-06-17 | Westin Copley Place, 10 Huntington Ave, Boston, MA, MA 02116, United States
In its most exciting year yet the field of oncolytic virotherapy has seen the highest number of clinical read-outs, the emergence of next generation viruses, and never-before-seen combination therapies.
Now in its 6th year, the Oncolytic Virotherapy Summit is the industry’s definitive guide to turning viral vehicles into clinically effective therapeutics across oncology indications. With 3 days of in-depth cutting-edge case studies and the highest caliber of industry discussions, The OV Summit will provide the roadmap to oncolytic virotherapy market success.

Uncover fresh studies from pharma and biotech companies of all sizes, as well as clinicians and leading academics for a complete picture of the current challenges and opportunities.
This year’s Summit will help you to:

Understand how viral backbone modification can achieve intravenous delivery
Harness carefully selected payloads to achieve systemic effects
Scale virus production for commercialization
This year, over 100+ drug developers will converge at the OV Summit to disseminate the latest findings, build a comprehensive network of like-minded peers who share the same challenges and search for the latest combination and genetic engineering strategies.

Join the leading minds in oncolytic virus development to optimize the development of viral immunotherapies and improve patient outcomes in combination therapies.

HER2-Targeted Therapies Summit 2021
2021-06-22 - 2021-06-24 | Virtual Event
Welcome to the Digital HER2-Targeted Therapies Summit 2021 – The First Conference Focused on Exploring New Frontiers of HER2 as a Pan-Tumor Target
HER2 expressing patients are experiencing drug resistance, suboptimal duration of response and refractory/relapsed disease, stimulating new frontiers for HER2-targeted drug development. Impressive clinical data are being reported for next-generation anti-HER2 approaches in breast, gastric, lung, colon cancers and beyond. However, efforts to expand the clinical utility of HER2 as a pan-tumor target don’t stop there, with a flood of news on priority reviews, fast track approvals, IPOs and collaborations.
As such, the HER2-Targeted Therapies Digital Summit 2021 arrives as the first ever cross-disciplinary meeting for large pharma, biotech and academia, to maximize HER2-targeting in the pantumor setting. Expect to be involved in interactive discussions on the diversity of next generation anti-HER2 drugs in the clinic including ADCs, bispecifics, TKIs, CAR approaches & more.
This is your chance to overcome challenges of resistance against anti-HER2 approaches and accelerate therapies to patients in need. Examine HER2 heterogeneity across different tumors to maximize the commercial potential of this target. Discuss how quantitative pathology is helping to match HER2 expression with therapeutic response.
As the clinical and commercial growth potential of next generation HER2-targeted therapies becomes apparent, this is a timely and comprehensive forum giving you the opportunity to connect with leaders of the field directly.
Be part of this unique forum to strengthen your pipeline by expanding the clinical utility of your anti-HER2 candidate across tumor settings with the greatest unmet medical need.
To know more about HER2-Targeted Therapies Summit 2021 please click here.

CPhI & P-MEC China E-Trade Season- Sino-India Pharmaceutical Exchange
2021-06-22 15:00 - 19:00 (Asia/Shanghai) | Online
CPhI & P-MEC China has launched the “E-Trade Season 2021” from March to June 2021 to provide the pharmaceutical industry with online learning and trading opportunities. One of the themed sessions, named Sino-India Pharmaceutical Exchange, will be focusing on Indian & Chinese pharma markets, with online learning and trading opportunities.
The live stream webinar will look into policies, trends and practice, etc. of both Chinese and Indian pharma markets, covering topics including Development Trend of China’s API Industry and Cooperation Prospect with India, Requirements and Practical Procedures of Imported Drug Registration in China, and Development of Indian APIs and Generic Drugs in Indian and Chinese Market, with guest speakers from China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), China Chinopharma Limited, and Dr. Reddy’s Laboratories.
The webinar is FREE for anyone to register and attend. Registered attendees will receive access to the webinar.

3rd Annual Blood-Brain Barrier Summit
2021-06-28 - 2021-06-30 | Online
Now in its 3rd year, the Blood-Brain Barrier Summit is the industry’s definitive blood-brain barrier conference, focused exclusively on evaluating innovative approaches to tackling the single biggest challenge for CNS drug developers.
Building on the success of last year’s meeting, this year’s program will uncover how leading companies and academics are working to enhance BBB penetration through the use of antibody therapies, nanoparticle engineering, AAV capsids, focused ultrasound, extracellular vesicles and more! New for this year we also explore the mechanisms of SARS-CoV-2 brain entry.
As we gather the best minds in this ever-challenging field, from the likes of AbbVie, Novartis, Roche, Merck and Ossianix, join this intimate forum to be part of the conversation focused on enhancing drug delivery across the blood-brain barrier and network and build meaningful partnerships with over 80 blood-brain barrier specialists.
To know more about 3rd Annual Blood-Brain Barrier Summit please click here.

6th Microbiome Movement - Drug Development Summit
2021-06-29 - 2021-07-01 | Virtual
Close the Clinical Gap, Discover the Next Generation of Microbiome-based Therapeutics, and Establish New Partnerships to Accelerate Your Research
The advancing scientific and clinical landscape mixed with the high-quality audience that we bring together has made this the must attend conference for those translating microbiome science into clinically successful therapeutics.
There is increased excitement around this years’ discussion; the community is now closer than ever to the first approved and commercially available microbiome-based therapeutic, key functions are beginning to be understood and the number of clinical candidates are increasing. However, there still remains an abundance of significant hurdles that must be overcome in order for continued success to be seen within the microbiome field. We are proud to bring together those at the forefront of tackling those challenges and is once again the centre of the 6th Microbiome Movement – Drug Development Summit.

The Microbiome Movement will provide the perfect opportunity for a collaborative approach between the biopharmaceutical and academic communities in order to pursue the causal role of the microbiome in disease and develop a new generation of microbiome-targeted therapeutics with predictable modes of action and consistent clinical outcomes.
From understanding microbiome functionality, leveraging lessons from clinical development and scaling manufacturing processes, through to leveraging microbiome biomarkers for patient stratification and diagnostics, our discussion will cover the latest scientific findings and industry updates from the end-to-end development of microbiome therapeutics.
There is still so much we can continue to do to make this complex science a clinical reality that improves the lives of patients, and we hope that you can join this years’ discussion to help towards the development of effective treatments across a range of indications and push microbiome products closer to commercialization.
To know more about 6th Microbiome Movement – Drug Development Summit please click here.

Induced Proximity-Based Drug Discovery Summit
2021-06-29 - 2021-07-01 | EST | Digital
Since the start of the 20th century, there have been three major waves of innovation in drug discovery. We are now at the start of a fourth wave, multispecific medicines, that will pave the way for new treatments aimed at thousands of disease targets currently viewed as “undruggable”. By inducing proximity between two or more proteins, multispecifics can harness the power of biology to go well beyond what conventional drugs can achieve.

As such, the inaugural Induced Proximity-Based Drug Discovery Summit arrives as the dedicated scientific and networking forum for large pharma, innovative biotech and research institutes to seize the endless potential of induced proximity- based drug discovery strategies to develop novel therapies for paradigm changing multispecific drugs of the future.
Join 100+ thought leaders of Chemically Biology, Screening Biology and Molecular Biology from the likes of Amgen, Ranok Therapeutics, Proxygen and more at the Induced Proximity- Based Drug Discovery Summit to advance your knowledge, differentiate your pipelines and be at the forefront of this new wave of innovation that will revolutionize drug discovery as currently known.
To know more about Induced Proximity-Based Drug Discovery Summit please click here.

JAK Inhibitors Drug Development Summit
2021-06-29 - 2021-07-01 | Virtual Event
Returning to the digital stage this summer, the 2nd JAK Inhibitors Drug Development Summit brings you the only dedicated JAK inhibitor conference that will allow you to utilize the knowledge of the greatest minds and thought leaders within the realms of the JAK pathway across dermatology, rheumatology, gastroenterology, oncology and hematology.
Focusing on optimized selectivity, drug-drug interactions, safety and efficacy challenges, this summit will give you the insight to successfully translate and develop the next generation of superior JAK inhibitors.
Ensure you attend this conference to learn, to network and to strengthen your pipeline, and implement the right clinical strategy.

3rd Cell Engager Summit
2021-06-30 - 2021-07-01 | Virtual Event
The 3rd Annual Cell Engager Summit is the only industry-led forum dedicated to developing multi-specific cell engaging therapies in liquid and solid tumor indications, accelerating early discovery innovation into the clinic.
This forum comes at a critical point for the cell engager field as the success observed in the hematological field has not been obtained with solid tumors yet. Preclinical and early clinical data for cell engagers targeting solid tumors have been hugely promising.
If you are part of a research team that is looking to accelerate the approval of cell engager therapies, then this conference has been curated with you in mind.
Below are a few highlights you won’t want to miss:

Drive efficacy in solid tumors with solid tumor targets addressed by Roche, Amgen, Pfizer, Merus, andCompass Therapeutics
Modulate the immune system to drive efficacy via co-stimulatory targets in solid tumors with Xencor, Harbour Biomed, Crescendo Biologics, Pieres,and Aptevo
Harness the power of the innate system for cell engagers and overcome the tumor microenvironment with Merck, Lava Therapeutics, Verseau Tx, andoNKo-Innate
Improving the therapeutic window of cell engagers – addressing toxicity, half-life, and CRS withAmunix, Synaffix, Revitope, and TeneoBio

To know more about 3rd Cell Engager Summit please click here.

ARDS Drug Development Summit 2021
2021-07-13 - 2021-07-15 | Virtual
The inaugural ARDS Drug Development Summit will bring 60+ biopharma leaders together to discover how the rise of SARS-CoV-2 ARDS, emergence of novel targets, and the past 12 months of unprecedented global focus on ARDS research has transformed this graveyard of drug development failures into a starting point for the next generation of therapeutics addressing not just ARDS, but broader, systemic inflammation.
Virtually uniting dedicated and experienced industry experts from Aqualung, Bone Therapeutics, Boehringer Ingelheim, Athersys and more, this trailblazing new meeting will help you overcome your most urgent drug development challenges.

mRNA Based Therapeutics Summit
2021-07-13 - 2021-07-15 | Virtual Event
The mRNA-Based Therapeutics Summit will unite the world leaders developing mRNA therapeutics to discuss learnings, challenges and future directions concerning translation and manufacturing of your novel mRNA modality. From mRNA vaccine development for infectious disease and oncology, effective mRNA gene therapies and novel delivery strategies, we bring to you an all-inclusive platform dedicated to accelerating successful translation of mRNA into a transformative class of medicines.
To know more about mRNA Based Therapeutics Summit please click here.

Non-Small Cell Lung Cancer Drug Development Summit
2021-07-13 - 2021-07-15 | Digital Event
The Non-Small Cell Lung Cancer (NSCLC) Drug Development Summit is the definitive industry-led forum for drug development in the largest solid tumor indication.
This is a strategic conference designed to bring drug development teams together to address critical challenges surrounding therapeutic potency, tumor resistance and relapse and expanding the clinical utility of targeted and immuno-therapies, either in combination or monotherapies.

As checkpoint inhibitors are on the brink of entering the perioperative setting and the approval of novel bispecifics with dual oncogenic targeting, this forum will enable you to see a full picture of the clinical trial landscape and identify what MoAs and targets future biopharma investment will be put towards.
Join Global Innovators To:

Leverage the knowledge gained from the current EGFR-TKI successes to implement it into strategies for improvement, best application strategies and potential combination partners with AstraZeneca, Puma Biotechnology, Cullinan Oncology and Takeda
Unravel the potentials of targeting currently untreatable acquired resistances through small molecules and biologics to develop novel agents against mutations with AbbVie, Merus, Black Diamond, AOM Biosciences and Mirati Therapeutics
Dive into the exciting advancements in the NSCLC rare mutations space, with the novel therapies in targeting BRAF, NGR1 fusions and HER2 with Kinnate Biopharmaceuticals, Elevation Oncology and Boeringer Ingelheim
Harness the power of the immune system to treat NSCLC by delving into the current best, novel targets and combination strategies to improve patent outlook with Merck & Co, Immutep, BerGenBio and Bristol-Myers Squibb
Advance the efficacy of companion diagnostics and look to the future of early disease detection, application and differences in patient populations and how combination therapy can best be exploited to beat this drastically unmet clinical need with UAMS, Takeda, Novartis, BloodPAC and Amgen
A deep-dive workshop explores how to utilize EGFR-targeting in solid tumors outside of NSCLC with Maverick Therapeutics, Black Diamond Therapeutics and Harvard Medical School

Network with 100+ executive biopharma leaders over 3-days of comprehensive insights to uncover the latest industry knowledge on the molecular heterogeneity of lung cancer, the implications for therapeutic design when considering acquired resistance and optimal application of new drugs in the clinic.

GxP Cloud Compliance Summit
2021-07-14 - 2021-07-15 | Virtual Event
Develop & implement your practical roadmap to migrate your GxP regulated applications to the cloud with regulatory, security & partner selection guidance.
Establish robust documentation practices to maintain CFR 11 compliance, accurately assess data security risks for migrating to cloud infrastructure & select the right partner to ensure sustained continuous compliance.
Nothing is more important in the pharmaceutical and life sciences industries than patient safety and meeting regulations. This past year and the global disruption have highlighted how life sciences organizations need to respond to radical shifts through digitization. The 2nd GxP Cloud Compliance Summit will return to discuss the next steps following initial feasibility study and implementation – designed to help you achieve GxP regulated security, privacy, transparency and compliance at any scale when migrating to the cloud.
With 18 trailblazing stories from AbbVie, Orchard Therapeutics, AWS, USDM, Chef/Progress, we will share practical takeaways from CFR21 part 11 to mapping out data migration to selecting the right cloud providers. Across 2 days, you will gain the tools to streamline processes, facilitate on demand scalability, increase efficiency and reduce costs.
This is the only dedicated industry-led meeting focused on GxP cloud adoption in the life sciences industry, join us this July to learn how to overcome the barriers of GxP cloud compliance, increase knowledge for data-powered business and empower collaboration between your organization and platform partners – providing a much more efficient operation and effective infrastructure to support your research and clinical activities.
Find out more >>> https://ter.li/xv45we

2nd Gene Therapy for Neurological Disorders Europe
2021-07-19 - 2021-07-21 | Digital Event
Returning digitally in 2021, the 2nd Annual Gene Therapy for Neurological Disorders Europe meeting will possibly be your last chance to attend a European meeting without the airmiles!
Focusing on the industry’s challenges of developing and delivering gene therapies to the CNS and bringing fresh faces and emerging companies into the conversation, this is not one to miss as you seek to accelerate the development of your neurological gene therapy.
Discover the latest neurological targets, familiarise yourself with the European landscape, and debate and discuss with the leading minds of the field from the likes of UCB, Lysogene, UniQure and AskBio, as they seek to harness the opportunity and move from rare to common disorders such as Alzheimer’s, Parkinson’s and epilepsy.

Focusing on translation and ‘what’s new’ in the gene therapy for neurological disorders field, this year’s 3-day agenda has been developed alongside neurological experts from AskBio, Handl Therapeutics, Novartis and Spark Therapeutics to capture the most pressing challenges and new opportunities facing the field.
Discussing rare to common neurological disorders, attend the digital meeting in July to:

Hear the latest clinical updates from the most advanced companies to inform your future strategies
Discover the novel neurological targets being pursued by gene therapy developers to learn of the latest CNS opportunities
Discuss how to optimise the use of preclinical models and biomarkers for improved translation and reduced risk to patients
Ask the European Medicines Agency questions related to the specific regulatory challenges of designing trials for both rare and common disorders
Weigh up the advantages and disadvantages of established and novel routes of administration for CNS gene therapy delivery
Raise questions to the neurosurgeons at the forefront of neurosurgical delivery and hear their thoughts on the technical challenges facing different programs
Be a part of the debate and discussion related to measuring and overcoming CNS immunogenic responses

Don’t miss your opportunity to benchmark against your competitors, hear the state of the art technology advances and research in the field, and make new connections at the last digital European meeting, to revolutionise the development and delivery of your neurological gene therapy.

In-House Impact: Life Sciences
2021-07-20 - 2021-07-21 | Exclusive Virtual Conference
In-House Impact: Life Sciences is a new type of forum, designed for and by legal leaders in the Life Sciences, to help legal teams move from enterprise defenders to enablers of innovation and cross-functional competency.
This conference isn’t just unique in offering an industry-specific platform for the most progressive legal leaders to maximize their own business value; it’s also unique in that it rips up the rulebook of traditional conferences.
We guarantee that your time out of the office and money are well spent. With thought-provoking case studies, action-led discussions and ensuring every story shared is evidenced by the business improvement it delivers, we’ve no doubt this strategic discussion will leave you feeling inspired to make big change.
To know more about In-House Impact: Life Sciences please click here.

Cell-Mediated Therapies for Infectious Disease Summit
2021-07-20 - 2021-07-22 | Digital | EDT
In the fight against emerging coronavirus variants, the need for long-lasting immunity is greater than ever… which is why the field is looking beyond antibodies and turning to T cells.
The Cell-Mediated Therapies for Infectious Disease Summit is the first industry-dedicated meeting to understand and stimulate the immune cell response to develop long term immune memory to infectious disease pathogens. See more – https://ter.li/bo7qq7
Join over 80 industry and academic leaders pioneering this new paradigm of research, and for the first time discuss novel advances in t-cell epitope-directed vaccines, as well as CAR-T, TCR and NK cell therapies designed to provoke durable immunity.
With strategic insight and clinical advances shared from Gilead, Merck, Vaccibody, TScan Therapeutics and more, join the discussion to assess:

Bioinformatic tools to identify immunogenic targets
Vaccine design and delivery to trigger strong T cell responses
Bridge the gap from translatable preclinical models to IND approval

Leave this meeting with a greater understanding of next-generation approaches to target, prevent and cure HIV, EBV and SARS-CoV-2 infection.
See more – https://ter.li/bo7qq7

Next Generation Food Allergy Drug Development
2021-07-20 - 2021-07-22 | Online | EDT
In the context of dramatically increasing food allergy incidence and a breakthrough approval in the field, the Next Generation Food Allergy Drug Development Summit will unite large pharma and innovative biotechs to overcome the unique drug development challenges involved in turning promising food allergy biologics into clinical and commercial realities.
Join us to investigate the latest technological innovations, benchmark against your peers, build global connections and streamline your drug development pipelines for food allergy, with insights being shared from a range of companies and institutions including Prota Therapeutics, Allergy Therapeutics, Intrommune, Vedanta Biosciences and University of North Carolina.
To know more about Next Generation Food Allergy Drug Development please click here.

2nd Gene Therapy Immunogenicity Summit
2021-08-03 - 2021-08-05 | Digital Event
The 2nd Gene Therapy Immunogenicity Summit is the industry’s definitive forum enabling you to better modulate, measure and predict immune response to your gene therapy candidate.
In the context of ever-increasing gene therapy clinical activity and uncertainty around immunogenicity challenges, the Gene Therapy Immunogenicity Summit will unite large pharma and innovative biotechs to ensure that you’re up to speed on the latest approaches to predict, measure and overcome every immunogenicity challenge you encounter.
Focused specifically on examining gene therapy immunogenicity, this event will enable you to learn how to evaluate and overcome pre-existing immunity to AAV vectors, understand how immune-modulatory approaches could enable re-dosing and learn the reality of regulatory expectations around immunological assays.
Incorporating insights from leading immunological, bioanalytical and translational experts, this is your opportunity to gain extensive technical information on the contrasts between immunogenicity encountered across organs and administration routes, how models can be enhanced to enable comparative immunology between species and what the latest clinical data tells us about how to adapt existing approaches to address immunogenicity.
Join your peers online and discover:

How Chameleon Bioscience are developing an immune evasive AAV for repeat dosing
The impact of innate and anti-transgene immunogenicity on AAV vector-mediated gene transfer with Genethon
Strategies to monitor anti-AAV cell-based transduction inhibition assay supporting clinical trials with Sangamo Therapeutics
Performances of biosafety analytical assays commonly used in gene therapy development
Immunogenicity risk assessment for AAV-based gene therapies with Roche
How to define the seroprevalence and titer of pre-existing antibodies with age and geographical location with Novartis
AAV capsid neutralizing antibodies and associated complement mediated immunotoxicties with IU Edu
Regulatory considerations for immune responses to gene therapies with the US FDA
Role of innate immunity in CD8+ T cell responses in AAV gene transfer with The NIH
Mitigation of AAV vector immunogenicity with tolerogenic nanoparticles with Selecta Bioscience

View the full event guide now to find out more!

4th Microbiome Movement – Skin Health & Dermatology Summit
2021-08-03 - 2021-08-05 | Virtual Event
Translating Scientific Findings of the Skin Microbiome into Commercially Viable Therapeutics & Cosmetic Products That Improve Skin Health
With improvements in the tools and technologies that enable deeper analysis of the skin microbiome, the community’s understanding of the skin microbiome is becoming clearer. This has led to the development of a number of breakthrough dermatological, skincare and cosmetic solutions that tap into this ecosystem on our skin for improved health.
However, there still exists several unique areas of basic and clinical science within the skin microbiome field that need addressing before the true potential of this field is realized.
Celebrating our fourth year, the Microbiome Movement – Skin Health & Dermatology Summit continues to unite researchers from academia and industry to address the unique areas of scientific R&D, as well as the consumer interfacing aspect of this industry. Bringing together 25+ expert speakers and 100+ key decision makers across 3 days, we will hasten the development of microbiome-targeting therapeutics and cosmetics through a series of presentations, panel discussions and networking opportunities.
Join us to fast-track the development of microbiome-targeting therapeutics and cosmetics that focus on characterization, clinical testing and product commercialization.
Tightly focused on translating academic discussions into cosmetic and therapeutic development, this unrivalled program addresses the latest scientific findings and key translational challenges to aid the development of your scientifically validated skin microbiome products so you can bring them to the hands of patients and consumers faster.

Prostate Cancer Drug Development Digital Summit
2021-08-17 - 2021-08-19 | Virtual Event
The inaugural virtual Prostate Cancer Drug Development Summit lands at a crucial time as the first and only dedicated conference for large pharma, biotech and pioneering academics to unite under a common and ambitious goal of accelerating the practical discovery, translation, and clinical development of safe and effective treatments for prostate cancer.

Here’s a sneak peek of crucial topics to be addressed:

Amgen examining Bi-specific T-cell engager immune therapies for the treatment of prostate cancer ​​​​​​
Novartis and Advanced Accelerator Applications revealing PSMA, re-envision survival
​​​​​​Noxopharm evaluating whether Veyonda is the answer to safe and effective prostate cancer treatment
The National Cancer Institute and the National Institutes of Health teaching optimization potential role for immunotherapy in biochemically recurrent prostate cancer
The University of Texas, MD Anderson Cancer Center demonstrating strategies for overcoming the immunosuppressive prostate tumor microenvironment and whether there is still a role for chemotherapy and chemotherapy combinations

To find out more and view the 2021 speaker line-up, download the full event guide.
Join 60+ thought-leaders converging at the first industry-led meeting to gain the latest scientific insights with renowned Urologists/Oncologists and those striving to advance safe and effective therapeutic breakthroughs to patients in need.
To know more about Prostate Cancer Drug Development Digital Summit please click here.

Integrin-Targeted Drug Discovery Summit
2021-08-17 - 2021-08-19 | Virtual Event
The excitement surrounding integrins has been growing over the past few years, culminating in recent clinical success, innovative biology and medicinal chemistry advancements blazing the way to tackle previously undruggable disease modalities through novel integrin targets
The Integrin-Targeted Drug Discovery Summit is not just the first, but the only industry-driven event sharing pioneering advances, expert insights and exclusive updates on the field of integrin drug discovery and development – from solid tumors to autoimmune diseases, from ophthalmology to fibrosis, revealing the therapeutic windows of integrins!
With the vast potential of integrins as targets, this inaugural 3-day summit will unite industry trailblazers including Pliant Therapeutics, Morphic Therapeutics and 7 Hills Pharma with academic leaders, such as pioneer Dean Sheppard, to delve into the biology and chemistry of different integrins classes, MoA and explore the best approach to regulate integrins, driving translational and clinical success.
Join a global community of 80+ experts on August 17-19 to tackle issues of safety, selectivity and specificity in drug development, further your understanding of the structure and function of integrins to inform your R&D decisions and leverage the lessons learned over the past 20 years to enhance your bed to bedside progression.
Find out more >> https://ter.li/g4kols

2nd Annual Biomarkers for Alzheimer’s Disease Summit
2021-08-24 - 2021-08-26 | Online Event
The 2nd Annual Biomarkers for Alzheimer’s Disease Summit is the industry’s only digital forum dedicated to sharing innovations in identifying new novel biomarkers and solving the challenges of developing clinically validated biomarkers for the earlier detection and diagnosis of Alzheimer’s Disease that are predictive of outcome measures and accurately reflect a therapeutic effect on target engagement.
Back for its 2nd year, there will be a continued emphasis on looking beyond amyloid and tau and diversifying the biomarker landscape. This industry-defining meeting delves into blood-based biomarkers, neuroinflammatory markers and ample sharing of industry innovations in identifying novel biomarkers. Through open reflections and sharing competitive knowledge, this meeting will enable drug developers to scale the hurdles preventing the identification and validation of biomarkers to accelerate the development of disease modifying therapeutics for Alzheimer’s Disease.
The Biomarkers for Alzheimer’s Disease Summit is your opportunity to discuss in-depth the cutting-edge advances in biomarker science, convey lessons learned and network to build long lasting partnerships.
To know more about 2nd Annual Biomarkers for Alzheimer’s Disease Summit please click here.

Neuropathic Pain Therapeutics Summit
2021-08-24 - 2021-08-25 | Digital Event | EDT
New this year, the Neuropathic Pain Therapeutics digital summit is the only meeting for large pharma, biotech and pioneering academics addressing the industry’s key challenges of understanding the underlying pathophysiology of neuropathic pain, identifying novel therapeutic targets for neuropathic pain and more!
With an ageing global population and unabating opioid crisis, the clinical need for novel neuropathic pain therapeutics has reached a critical level. This meeting will be the center point for exploring novel drug modalities for neuropathic pain including: NaV1.7 channel inhibitors, antisense oligonucleotides, matrix metalloproteinase inhibitors, gene therapy, anti-TRPV1 antibody, cannabinoid-derived pharmaceutical, neuroimmune-targeted, medical device approaches and more.
From harnessing preclinical models for pain drug discovery to identifying pain biomarkers and novel non-addictive neuropathic pain drug modalities in development, this conference will delve into challenges that have obstructed the clinical success of neuropathic pain therapeutics.
Learn from 20+ thought leaders in our expert speaker faculty, access 18+ hours of content exploring the latest advances in the neuropathic pain therapy field and form meaningful connections during the multiple and varied hybrid networking sessions built into the event.
Join this industry-dedicated virtual forum as we unite drug developers and academics to tackle the most critical drug development challenges in accelerating novel neuropathic pain therapeutics into the clinic and to patients in need.
To know more about Neuropathic Pain Therapeutics Summit please click here.

PI3K Therapies Summit
2021-08-24 - 2021-08-26 | Virtual Event
With 5 currently approved PI3K inhibitors in the market, and countless investments, M&As and candidates entering the clinical stages, the PI3K pathways space has experienced significant growth in recent years.
The inaugural PI3K Pathways Summit is the industry’s only definitive conference providing in depth exploration of the biochemical basis of the pathway, the successes and setbacks in gaining approval for PI3K inhibitors and the future advances which will potentially aid in overcoming issues with tolerability, toxicity and resistance associated with PI3K inhibitors.
Join the online discussion at the only digital platform dedicated to bringing together the community of PI3K experts from large pharma, innovative biotechs and research institutes for a unique opportunity to address the challenges of targeting the PI3K and AKT pathway, evaluate strategies for overcoming these challenges to define next generation PI3K drugs and participate in cross-disciplinary discussions with fellow industry peers.

5th IPF Summit
2021-08-25 - 2021-08-27 | Virtual Event
Overcome Translational & Clinical Challenges to Develop Disease-Modifying Drugs for IPF, the Archetypal Fibrotic Disease. From Dissecting Mechanisms of Epithelial Dysfunction to Discovering Patient Reported Outcomes for More Meaningful Clinical Trials, Uncover Scientific Advancements & Actionable Insights to Optimize IPF Drug Development.
Returning with a revitalized agenda including 25 brand new speakers, the hotly anticipated two-tracked summit is back!
As epithelial targets return to the limelight, innovations in translational models hit their stride and clinical trial competition dramatically heats up; there’s more translational and clinically relevant science for IPF now than ever before, catapulting this archetypal fibrotic disease right to the top of biopharma’s priority list.

Dedicated to providing you with the insights you need to create clinically defining IPF therapeutics, this premier industry forum will unite industry experts from AstraZeneca, Genentech, Ionis, AbbVie, Gilead, Lassen Therapeutics, Pliant, Galecto and more with leading academia, for you to gain back-to-back insights on the science propelling IPF drug development forward.
From dissecting the fibrotic lung microenvironment and comprehensively analyzing multiple translational models alongside bleomycin to including patient-reported outcomes as an endpoint in clinical trials; the 5th IPF Summit is the only end-to-end forum presenting scientific advancements as actionable insights for more innovative and clinically effective drug development.
As organizations across fibrosis, autoimmunity and inflammatory disease turn their heads towards IPF in a bid to capitalize on its strategic opportunity, Join 150+ IPF drug developers this August at this unique forum for a dynamic mix of formal presentations, audience discussions, panel discussions and organized networking and leave with the expertise your team needs to optimize your IPF R&D for 2021 and beyond.
Want to learn more about our brand new 2021 agenda and expert speaker faculty? Click Here

6th CAR-TCR Summit
2021-08-30 - 2021-09-02 | Digital | EDT
The CAR-TCR industry has started 2021 with a bang! With the 4th CAR-T gaining long-awaited approval, Bristol-Myers Squibb have stepped onto the commercial stage, and the CAR-TCR field continues to boom with excitement as the competition heats up.
The current approved therapies have encountered significant difficulties in the commercial market. Cell Therapies come with a high price tag, little long-term efficacy data, and expensive manufacturing processes. Now, your community must gather to:

Achieve consistency in manufacturing, focusing on automation, allogeneic platforms, scalability, and engineering techniques
Demonstrate durable response with enhanced construct design,optimized trial design, and long-term follow-up data
Overcome solid tumor hurdles with combination strategy, specialized clinical delivery, and next-generation engineering strategies

These challenges require ground-breaking work, from discovery through to commercialization. Join the 6th CAR-TCR Summit to learn from the key opinion leaders, and international innovators of the CAR-TCR community, this September.
See more – https://ter.li/ofwzn3

Next Generation Cancer Vaccine Development Summit 2021
2021-09-07 - 2021-09-09 | 100% Digital Event
Cancer remains one of the most challenging diseases we face today. Standard treatment protocols (chemotherapy, radiotherapy, and surgical intervention) are often hampered by toxic side effects and concomitant malignancies. Vaccines offer a promising alternative to unleash the most powerful force against cancer: our own immune system!

At the inaugural Next Generation Cancer Vaccine Development Summit (September 7-9, Digital Event) join the likes of Gritstone Oncology, BioNTech, Janssen, (and much more!) as we come together to delve deep into understanding the tumor microenvironment, optimising antigen selection, and analyzing a multitude of novel platforms and combination therapies to finally bring safe and effective cancer vaccines to market.
Learn more here: https://ter.li/m1zx7a

2nd Operationalize: Decentralized Clinical Trials Summit
2021-09-07 - 2021-09-09 | Virtual Event
By bringing together the world’s leading Decentralized Clinical Trials thinkers, the 2nd Operationalize: Decentralized Clinical Trials Summit will clarify the complex issues through end-to-end remote, decentralized, and siteless clinical trial program operationalization. Through open discussion, sharing best-practice case studies, and removing the hypothetical: this meeting is your best chance to solve your challenges based on the wealth of experience collected in the last year of trial adaption.

Whether it’s trial set-up, technological integration, negotiating with stakeholders, hybridization, patient communication, and choice provision: ensure you aren’t repeating past mistakes by hearing global leaders recall their experience with a shared goal of providing you with pragmatic solutions to solve these complex hurdles.
Featuring real-life case studies and experiences as well as interactive panel discussions and virtual roundtables from the likes of PRA Health Sciences, Boehringer Ingleheim, Janssen, Decentralized Trials & Research Alliance, and the Digital Medicine Society, this is your opportunity to find the answers to your most burning decentralized clinical trials challenges.
Join us to lead the industry by offering patients more flexibility through decentralized trials.
To know more about 2nd Operationalize: Decentralized Clinical Trials Summit please click here.

Multiscale and multi-modal insights into drug formulation
2021-09-07 | Webinar | 15pm BST
SMi Group are delighted to introduce a free exclusive webinar taking place on 7th September 2021 at 3pm BST, hosted by Zeiss.
Synopsis / Webinar Overview:
The majority of pharmaceutical powders require a size <500 μm for ease of manufacture and biopharmaceutical performance. Powder behaviour of particles in this size-range spans cohesive to aeratable powders. Powder performance is dependent on the powder bulk density and micromeritic properties of individual particles, but also crucially the structuring of particles within the powder bed. Micromeritic assessment is also routinely performed using image analysis or particle sizing techniques such as laser diffraction analysis. However, there is a clear need for techniques that provide non-destructive granular information of pharmaceutical powder structures.
Formulation equivalence between different batches of products or between comparator innovator and generic products has emerged as a hot topic of consideration in regulatory science. Microstructural equivalence (Q3) for powder products is complex, and particularly in the case of Dry Powder Inhalation (DPI) formulations. It is in the characterization of the bulk powder that microstructural assessment is a particular challenge. Current methods for measuring critical material attributes such as the particle size and shape suffer from low resolution, image in 2D or make shape assumptions.
In this webinar, we will present some new approaches using X ray Microscopy (XRM) from nano- to micro-scale that can be utilized for characterizing inhalation powder blends non-destructively to obtain fully 3D information on particle size and shape, its distributions, and powder bed packing. Novel methodologies developed to identify individual chemical phases within blends, their crystal orientations and interactions in 3D will also be presented. The results show the promise for XRM as a valuable powder characterisation technique that develops our fundamental understanding of powder microstructure, and microstructural descriptors for the United States Food and Drug Administration Q3 microstructural assessments.
Register your free place: http://www.drug-formulation-zeiss-webinar.com/pjwl
Who will be speaking?
Dr Hrishikesh Bale – Marketing Solutions Manager, Engineering Materials
Carl Zeiss – Research Microscopy Solutions
Key Takeaways
In this webinar you will learn:

About the importance of pharmaceutical powder microstructure and the current landscape of the methods for microstructural characterization
How X-ray Microscopy (XRM) can provide information on key microstructrual metrics, as well as the interaction between formulation components
How the unique microstructural insight provided by XRM can help understand powder performance
About a range of applications of XRM to pharmaceutical powders, including powder beds and complex inhalation formulations

Register your free place: http://www.drug-formulation-zeiss-webinar.com/pjwl
Who is this webinar aimed at?
This interactive webinar is designed for all users, from both academic and industrial sectors, who are interested in powder characterisation. The webinar is suitable for both a technical and non-technical audience and will provide insight into applications of XRM as a microstructural characterisation technique.
Additional Contact Info:
T: +44 (0)20 7827 6088
E: hsidhu@smi-online.co.uk

Pre-filled Syringes San Francisco 2021
2021-09-13 - 2021-09-14 | Hyatt Centric Fisherman’s Wharf, San Francisco (Virtual Attendance Option Available)
As part of SMi’s leading Injectables series, this year’s event will address the key drivers of the pre-filled syringes and combination products industry to give a comprehensive insight into the latest device innovations, regulatory updates and future insights for the coming year. With the global market for prefilled syringes estimated to exceed $9.7bn by 2025, the field is evolving at an exponential rate with connectivity and digital health strategies for devices and studies at the forefront. Furthermore, this event will delve into the key takeaways following the global pandemic and discover how this will be used to enhance future drug delivery device development.
This comprehensive overview will explore the changing global market and latest innovations in device design and development for injectable drug delivery. Case studies from leading industry and regulatory experts will explore platform approaches for combination products, enhanced device design and usability considerations, change management and compatibility for novel drug products.
The two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.
Plus, two interactive post conference workshops:
A: Connected Devices and Digital Health: How to Navigate the U.S. FDA Usability Engineering Requirements
Workshop Leader: Shannon Clark, CEO, UserWise
B: Postmarket Safety Reporting: The Current Regulatory Environment with a Global Impact
Workshop Leader: Khaudeja Bano, Executive Medical Director, Combination Product Safety Head, Amgen
Benefits of attending:

Engage in case studies from big pharma leading experts on smart devices and connected delivery to aid the user experience
Explore evolving device design and innovations for high volume and high viscous delivery
Delve into regulatory updates on device development and human factors with insights from industry and regulatory bodies
Uncover how industry is incorporating risk management and controls into early stages for a holistic development process

Chairs for 2021:

Shannon Clark, CEO, UserWise
Paul Upham, Head Smart Devices, Roche/Genentech

Featured 2021 speakers include:

Alan M. Stevens, Acting Director – Division of Drug Delivery, General Hospital, and Human Factors, CDRH, FDA
George Cusatis, Director, Regulatory Affairs, Merck
James Robert Wise, Associate Senior Consultant Engineer, Eli Lilly
Jim Leamon, Director of Biologics Device Development, Jazz Pharmaceuticals
Scott Surrette, Manager Combination Product Development, Regeneron
Jace Blackburn, Smart Device Engineer, Roche/Genentech
Alasdair Young, Senior Director, Device Engineering, Coherus BioSciences
Rachel Poker, Human Factors Engineering Manager, Device Development, AstraZeneca
Young Chun, Associate Director – Lead Human Factors and User Research, R&D/Medical Devices Center of Excellence, Takeda
Mehak Mehta, Scientist II, Protein Drug Product Development, Biogen
Alie Jahangir, Sr. Principle Engineer, Combination Products and Emerging Technologies, Janssen Pharmaceuticals
Sindhuja Kuchibhatla, Device Development Engineer, New Technologies Management, Regeneron Pharmaceuticals

EARLY-BIRD RATES:

BOOK BY 28TH MAY AND SAVE £200
BOOK BY 30TH JUNE AND SAVE £100

Additional Contact Info:
T: +44 (0)20 7827 6088
E: hsidhu@smi-online.co.uk
LinkedIn: @SMi Pharma
Twitter: #smipfsusa
