Outline | Jotup

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on:

Tuesday, March 12, 2024

Filtration, Vespula, Toxicity, Histamine, EAACI, Immunotherapy, Asthma, Report, Allergy, Skin, Pregnancy, PR, EEC, MITES, RNA, Criterion, History, CMR, Contraindication, HEP, Draft, Guideline, Patient, Ames test, Diagnosis, Dermatitis, Venom, Literature, Trial of the century, Reproduction, Silicon–germanium, SPT, Food allergy, Cosmetics, EECS, Absorption, Marketing, Safety, Data collection, Directive 2001/83/EC, GMP, ID50, Antibody, Documentation, European, Type IV hypersensitivity, Genotoxicity, Applicant (sketch), Aeroallergen, CHMP, PRIME, Immunoglobulin G, Type, Publication, Biology, Pollen, DNA, Environment, Immune system, Toolbox, NLN, AIT, Atopic dermatitis, Fatality, Chapter, Anaphylaxis, Process validation, ICH, Antigen, Rhinitis, Clinical trial, Erythema, Knowledge, Prescription, Human, Network, Medication, Scope, VIT, ICT, EMA, Collection, Macrophage, Outline, Metabolism, Registry, Inflammation, Immunoglobulin E, Nature, European Pharmacopoeia, Food, Risk, Prevalence, Mastocytosis, Observation, Cytokine, NPP, Patient safety, Disease, Finished, Medical device

16

Key Points:

16
Guideline on allergen products development for
immunotherapy and allergy diagnosis in moderate to lowsized study populations

17

Table of contents

18

Executive summary ..................................................................................... 3

19

1.
Specific effects ................................................................................................. 17
14
15

Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 2/18

53

12.
Management for allergies may involve avoidance of the allergen, medications to relieve
66

symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.
71
Recommendations are made on the clinical development, potential study designs and safety

72

considerations for allergen products within the scope of the guideline.
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 3/18

88

While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

89

there is no such treatment available for type IV allergies.
93
Several guidelines applicable for allergen products are available (see section 3) and provide advice on

94

quality and clinical development according to the current knowledge.
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 4/18

127

However, this guideline does not cover the indication of atopic dermatitis or asthma as these

128

conditions will require separate clinical trials (see Section 6).
129
In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

130

DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

131

substantially to the allergen products as discussed above.
1
156

?

Guideline on the clinical development of products for specific immunotherapy for the treatment

157
158

of allergic diseases - CHMP/EWP/18504/2006
?

159
160
161

Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

?

Guideline on process validation for finished products - information and data to be provided in
regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 5/18

162

?

Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

163

4.
In any
199

case, a reduced validation should include all relevant manufacturing process steps that are considered
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 6/18

200

product specific.
290
Diagnostic allergen products (Type I allergy)

291

A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

292

intracutaneous or provocation testing.
298
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 9/18

305
306

7.1.
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 11/18

377

8.
Clinical development of products for AIT: Study design,
efficacy and safety
378

In general, the clinical development should be performed according to current guidelines.
In such single trial, the suitability as a test allergen as well as the
376

Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 12/18

415

dose finding for the therapeutic allergen could be investigated.
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 13/18

454
455

8.2.1.
493
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 15/18

527

In general, sensitivity and specificity of the product should be determined.
540
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 16/18

561

10.2.
Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024
Page 17/18

595

4.
Allergol Immunopathol, 1989;
602

17(2):53-65

603

Guideline on allergen products development for immunotherapy and allergy diagnosis
in moderate to low-sized study populations
EMA/CHMP/72790/2024

Page 18/18

Preliminary QIG Considerations regarding Pharmaceutical Process Models

Retrieved on:

Tuesday, March 12, 2024

6

Key Points:

6
Preliminary QIG Considerations regarding Pharmaceutical
Process Models

7

Background

8

This Quality Innovation Group (QIG) document follows on from the first QIG Listen & Learn Focus

9

Group (LLFG) on Continuous manufacturing and the second QIG LLFG on Digital novel technologies,

5

10

held on 13 March 2023 and 12-13 October 2023 respectively.
12
It is recognised that regulatory expectations for process models in pharmaceutical manufacturing are

13

evolving; the intent of this document is to share QIG?s current thinking with stakeholders and seek

14

their comments.
This, in turn, supports adoption of advanced process
25

control strategies, continuous process verification, real-time process monitoring and optimisation, and

26

automated or even autonomous operation and management of manufacturing processes.
Process
27

models play an increasingly important role in process design and validation, in control strategies and

28

during manufacturing process lifecycle.
The expected outcome from the use of process models is
29

enhanced process understanding, (multivariate) monitoring and control, robustness, performance and

30

adaptability.
31
A model (in the context of pharmaceutical manufacturing) is a mathematical representation of a

32

physical or biological process or system.
Empirical models (e.g., multivariate models used for Statistical Process Control, regression models
39

derived from data collected from Design of Experiments), and

40

3.
45
Scope

46

This document addresses preliminary considerations (general principles) for process models, reflecting

47

the use of performance-based approaches in pharmaceutical manufacturing processes.
48
The scope of this document is limited to process models such as first-principle models, regression

49

models, system models, multivariate statistical process control models, and Machine Learning models

50

(ML).
Complex datasets need not be
Preliminary QIG Considerations regarding Pharmaceutical Process Models
EMA/90634/2024
Page 3/7

113

submitted.
137
Preliminary QIG Considerations regarding Pharmaceutical Process Models
EMA/90634/2024

Page 4/7

151

Of note, these are just examples.
Process validation for finished products ? information and data to be provided in regulatory submissions
(EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1,Corr.1)
Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory
submission (EMA/CHMP/BWP/187338/2014)
4
5
Preliminary QIG Considerations regarding Pharmaceutical Process Models
EMA/90634/2024

Page 5/7

163

Some models may have a dual purpose e.g., used for process development and used as part of the

164

control strategy e.g., to set control limits.
200
Process validation (as described in the process validation guidelines) has an overarching role to ensure

201

that the process consistently delivers material of the intended quality.
Depending on the model risk, a model verification protocol may be requested,
Preliminary QIG Considerations regarding Pharmaceutical Process Models
EMA/90634/2024
Page 6/7

209

including the model performance metrics and the manufacturing process IPC and CQAs that should be

210

followed, the respective acceptance criteria, the number of additional data (independent) that would be

211

used, and the monitoring period (parallel testing).
Preliminary QIG Considerations regarding Pharmaceutical Process Models
EMA/90634/2024
Page 7/7

Seismic Therapeutic to Present Preclinical Data for Novel Immunoglobulin Sculpting Enzyme at AAN Annual Meeting

Retrieved on:

Friday, March 8, 2024

Health, Neurology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, AAN, Myasthenia gravis, Immunoglobulin G, Autoimmunity, Outline, Novel, Pharmacology, BCR, American Academy, Vaccine

Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will present preclinical data for its pan-immunoglobulin G (IgG) sculpting enzyme candidate, S-1117, at the American Academy of Neurology (AAN) annual meeting taking place on April 13-18 in Denver.

Key Points:

Seismic Therapeutic, Inc ., the machine learning immunology company, today announced that the company will present preclinical data for its pan-immunoglobulin G (IgG) sculpting enzyme candidate, S-1117, at the American Academy of Neurology (AAN) annual meeting taking place on April 13-18 in Denver.
S-1117 is a novel engineered pan-IgG protease for the potential treatment of a range of chronic and acute autoantibody mediated diseases, including the chronic neuromuscular autoimmune disorder, myasthenia gravis.
The presentation at the AAN annual meeting will outline key preclinical in vitro and in vivo results supporting the differentiated profile of S-1117 compared to therapeutic benchmarks in chronic autoantibody mediated diseases.
Title: Preclinical Pharmacology of S-1117, a Novel Engineered Fc-fused IgG Cleaving Enzyme, for Chronic Treatment of Autoantibody-mediated Diseases

South Africa Used Car Market Report 2024-2029 - ResearchAndMarkets.com

Retrieved on:

Thursday, March 7, 2024

Automotive, General Automotive, African, Lead, Hatchback, Outline, Professional, Smartphone

The "South Africa Used Car Market Outlook, 2029" report has been added to ResearchAndMarkets.com's offering.

Key Points:

The "South Africa Used Car Market Outlook, 2029" report has been added to ResearchAndMarkets.com's offering.
South Africa's Used Car market is forecasted to expand significantly with a CAGR of more than 8% from 2024 to 2029.
Technology advancements have played a pivotal role in revolutionizing the South African used car market.
Key Insights from the South Africa Used Car Market Report:
The South African used car market not only serves as a reflection of economic factors and cultural influences but also as a major contributor to the nation's economy.

BARR Advisory to Showcase Healthcare Compliance Solutions at HIMSS24

Retrieved on:

Tuesday, March 5, 2024

BARR Advisory aims to shine a light on the link between cybersecurity and patient trust at the Healthcare Information and Management Systems Society (HIMSS) 2024 Global Health Conference in Orlando next week.

Key Points:

BARR Advisory aims to shine a light on the link between cybersecurity and patient trust at the Healthcare Information and Management Systems Society (HIMSS) 2024 Global Health Conference in Orlando next week.
The event will bring together more than 35,000 healthcare executives, providers, and IT professionals March 11–15 to discuss new challenges and developments in health technology.
Members of the BARR Advisory team will appear at the conference for the fourth consecutive year to showcase the firm’s growing suite of solutions for healthcare organizations pursuing compliance against cybersecurity standards including HITRUST, PCI DSS, ISO 27001 and 27701, SOC 2, and HIPAA.
The event will also feature a presentation from Steve Ryan, attest services manager and head of healthcare services at BARR, who will outline key security risks posed by third-party vendors and share strategies for healthcare organizations aiming to face these issues head-on.

Spruce Point Capital Management Announces Investment Opinion: Releases Report and Strong Sell Research Opinion on Zillow Group, Inc. (Nasdaq: Z)

Retrieved on:

Tuesday, March 5, 2024

Key indicators show Zillow is experiencing a rapid decline in web traffic, which is the foundation for the Premier Agent business.

Key Points:

Key indicators show Zillow is experiencing a rapid decline in web traffic, which is the foundation for the Premier Agent business.
Spruce Point believes these practices require significant management judgement as some consumers may have multiple commitment letters from different banks/vendors.
Spruce Point believes Zillow should provide more disclosure around assumptions on the timing and conversion of leads and mortgages.
As a reminder, our full report, along with its investment disclaimers, can be downloaded and viewed at www.SprucePointCap.com .

Budesonide in Primary Biliary Cholangitis Research Report 2024: Comprehensive Market Insights to 2032 with Focus on 7 Major Markets - ResearchAndMarkets.com

Retrieved on:

Tuesday, March 5, 2024

Biotechnology, Pharmaceutical, Health, Outline, Ursodeoxycholic acid, Chronic liver disease, Budesonide, Strategic planning, Drug development, SWOT, Primary, PBC, Primary biliary cholangitis, Patient, UDCA, Research, Pharmaceutical industry

The healthcare industry witnesses a significant milestone as the Budesonide Market Size, Forecast, and Drug Insight - 2032 report is introduced to the research inventory.

Key Points:

The healthcare industry witnesses a significant milestone as the Budesonide Market Size, Forecast, and Drug Insight - 2032 report is introduced to the research inventory.
This latest analytical document delineates the progressive outlook of budesonide in treating primary biliary cholangitis (PBC), providing a detailed market forecast and insights into drug development and innovation within the pharmaceutical arena through to 2032.
Primary biliary cholangitis, a chronic liver disease, presents a therapeutic challenge, compelling industry stakeholders to eagerly explore new treatment avenues.
With a thorough research methodology encompassing secondary and primary data, industry expertise, and comprehensive market analysis, the report equips stakeholders with pivotal insights.

Snowflake Partners with Mistral AI to Bring Industry-Leading Language Models to Enterprises Through Snowflake Cortex

Retrieved on:

Tuesday, March 5, 2024

Snowflake (NYSE: SNOW), the Data Cloud company, and Mistral AI , one of Europe’s leading providers of AI solutions, today announced a global partnership to bring Mistral AI’s most powerful language models directly to Snowflake customers in the Data Cloud.

Key Points:

Snowflake (NYSE: SNOW), the Data Cloud company, and Mistral AI , one of Europe’s leading providers of AI solutions, today announced a global partnership to bring Mistral AI’s most powerful language models directly to Snowflake customers in the Data Cloud.
View the full release here: https://www.businesswire.com/news/home/20240305158817/en/
Snowflake Partners with Mistral AI to Bring Industry-Leading Language Models to Enterprises Through Snowflake Cortex (Graphic: Business Wire)
With the new Mistral AI partnership, Snowflake customers gain access to Mistral AI’s newest and most powerful LLM, Mistral Large, with benchmarks making it one of the world’s top-performing models.
Mistral AI shares Snowflake’s values for developing efficient, helpful, and trustworthy AI models that advance how organizations around the world tap into generative AI,” said Arthur Mensch, CEO and co-founder of Mistral AI.
Snowflake is continuing to invest in its generative AI efforts by partnering with Mistral AI and advancing the suite of foundation LLMs in Snowflake Cortex, providing organizations with an easy path to bring state-of-the-art generative AI to every part of their business.

Trane Technologies Named One of the 2024 World’s Most Ethical Companies® by Ethisphere

Retrieved on:

Monday, March 4, 2024

Trane Technologies (NYSE:TT), a global climate innovator, has received the 2024 World’s Most Ethical Companies® recognition by Ethisphere, a global leader in defining and advancing the standards of ethical business practices.

Key Points:

Trane Technologies (NYSE:TT), a global climate innovator, has received the 2024 World’s Most Ethical Companies® recognition by Ethisphere, a global leader in defining and advancing the standards of ethical business practices.
“At Trane Technologies, we hold our team members and business partners to the highest legal, moral and ethical standards, expecting them to do what’s right, always,” said Dave Regnery, chair and CEO of Trane Technologies.
“That’s why it’s a tremendous honor to be recognized by Ethisphere as one of the World’s Most Ethical Companies®.
Trane Technologies was named to the JUST 100 for the third consecutive year and finished first in industry for the second consecutive year.

Fidelity Investments® Study Finds Three Key Money Moves That Minimize Financial Stress Among Women

Retrieved on:

Friday, March 1, 2024

With financial stress a reality for more than 9-in-10 women, new research from Fidelity Investments® reveals the financial steps women can take to de-stress and increase their financial confidence.

Key Points:

With financial stress a reality for more than 9-in-10 women, new research from Fidelity Investments® reveals the financial steps women can take to de-stress and increase their financial confidence.
Taking financial action, however, makes the biggest difference in decreasing stress, with women who made financial moves in the past 6 months indicating less stress than women who haven’t.
Once women save three months’ worth of emergency savings, only 1-in-4 women (26%) report high stress levels.
Saving for Retirement: Small increases in retirement savings can lead to big results when it comes to financial stress.