QSP | Jotup

U.S. FDA Renews DILIsym® Software Licenses for 7th Year

Retrieved on:

Thursday, April 4, 2024

Dr. Paul B. Watkins, chair of the Scientific Advisory Board of the DILI-sim Initiative, said, “It is now known what properties to avoid to minimize liver toxicity in a new drug candidate -- but these same properties are often necessary to have therapeutic efficacy. By predicting safe dosing regimens of such drugs, DILIsym is now enabling successful development of important therapies that might otherwise be abandoned.”

Key Points:

DILIsym is the industry gold standard for quantitative systems toxicology (QST) software designed for the prediction and investigation of drug-induced liver injury (DILI).
The one-year renewal provides the FDA with continued access to the DILIsym platform for authorized employees across all FDA divisions.
It also allows the FDA to evaluate the potential DILI risk across multiple populations, which supports informed decision-making regarding drug approvals.
Companies interested in a free trial version of the DILIsym software can request it here .

Restaurant Brands International Announces Leadership Changes to Support Long-Term Growth

Retrieved on:

Thursday, March 14, 2024

RBI, PepsiCo, Growth, Little Caesars, International, Harvard Business School, QSP, MBA, TSX, Investment, Restaurant, QSR, CMO, Marketing, Popeyes, Easy to Love, Management

Today's leadership changes are effective immediately and a new President of EMEA and Chief Marketing Officer ("CMO") for Popeyes will be named at a later date.

Key Points:

Today's leadership changes are effective immediately and a new President of EMEA and Chief Marketing Officer ("CMO") for Popeyes will be named at a later date.
Under his leadership, Popeyes has achieved record levels of sales, restaurant growth, and profitability, recently solidifying the brand as the #2 chicken player in the US.
"I want to thank David and Matt for their years of service in building our Company and growing our restaurant brands.
As a result of David and Matt's leadership over the years, we are very well set up for our next period of growth," concluded Mr. Kobza.

Biogen Highlights New Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024 Annual Meeting

Retrieved on:

Monday, March 4, 2024

OGA, Research, BIIB, Investment, Eisai, Alpha-synuclein, Amyloid, Conference, Biogen, Quantitative systems pharmacology, Dementia, MCI, QSP, Clarity, MAPT, Brain, Vaccine

The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.

Key Points:

The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.
In addition to BIIB113, Biogen is researching the potential of tau reduction in AD with its investigational antisense oligonucleotide targeting the microtubule associated protein tau (MAPT) gene (BIIB080).
Oral presentation: Results of the first in-human, randomized, blinded, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers.
Oral presentation: Lecanemab for the treatment of early Alzheimer’s disease; the extension of efficacy results from Clarity AD.

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on:

Wednesday, February 14, 2024

Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

Page 2/14

1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides).
Guideline work led by other working parties
?
Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024.
Guideline work led by other working parties and committees
?
Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008).
There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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2.3.
?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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4.2.
?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

To deliver an improved access to raw data (e.g.
?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area.
?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology.
The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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Goldstorm Metals Discovers Multiple High-Grade Precious and Base Metal Zones on the 100 % Owned Crown Project, Located in Northwestern British Columbia, Canada

Retrieved on:

Wednesday, January 24, 2024

OEX, Hazelton Formation, Anomaly, Orion, Arctic, The, Crown, Attention, Property, QSP, Triton, Galileo Galilei, Zinc, Copper

The Program at Fairweather and Delta focused on prospecting newly exposed outcrops due to recent glacial ablation and building upon the historical discoveries made on the Property.

Key Points:

The Program at Fairweather and Delta focused on prospecting newly exposed outcrops due to recent glacial ablation and building upon the historical discoveries made on the Property.
(See tables 1 and 2 below for select rock samples taken from the Fairweather and Delta zones).
This zone can be traced approximately 500 east-west by 200 m north-south and remains open in all directions.
Veining was associated with a large gossan colour anomaly measuring 600 x 200 m along a northwest axis.

Restaurant Brands International to Report Full Year and Fourth Quarter 2023 Results on February 13, 2024 and Host an Investor Event on February 15, 2024

Retrieved on:

Monday, January 22, 2024

Restaurant Brands, RBI, TSX, QSR, QSP

TORONTO, Jan. 22, 2024 /PRNewswire/ - Restaurant Brands International Inc. ("RBI") (TSX: QSR) (NYSE: QSR) (TSX: QSP) will release its full year and fourth quarter 2023 financial results on Tuesday, February 13, 2024 and will host an investor conference call that morning at 8:30 a.m. Eastern Time.

Key Points:

TORONTO, Jan. 22, 2024 /PRNewswire/ - Restaurant Brands International Inc. ("RBI") (TSX: QSR) (NYSE: QSR) (TSX: QSP) will release its full year and fourth quarter 2023 financial results on Tuesday, February 13, 2024 and will host an investor conference call that morning at 8:30 a.m. Eastern Time.
The earnings call will be webcast on the company's investor relations website ( https://rbi.com/investors ) and a replay will be available for 30 days following the release.
As previously announced, RBI will host an investor event with Chief Executive Officer, Josh Kobza, and Executive Chairman, Patrick Doyle, at the New York Stock Exchange on Thursday, February 15, 2024, starting at 1:00 p.m. Eastern Time.
A live webcast of the event will be available on the company's investor relations website and a replay will be available for 30 days following the event.

Burger King® Company to Acquire Carrols Restaurant Group

Retrieved on:

Tuesday, January 16, 2024

Hand, Jefferies Group, Partnership, Committee, QSP, Restaurant Brands, RBI, TSX, Acquisition, Hart–Scott–Rodino Antitrust Improvements Act, Webcast, Marketing, Carrols Restaurant Group, Restaurant, QSR, Burger King, Growth

TORONTO, Jan. 16, 2024 /PRNewswire/ -- Restaurant Brands International Inc. ("RBI" or the "Company") (TSX: QSR) (NYSE: QSR) (TSX: QSP) and Carrols Restaurant Group, Inc. ("Carrols") (NASDAQ: TAST) today announced that they have reached an agreement for RBI to acquire all of Carrols issued and outstanding shares that are not already held by RBI or its affiliates for $9.55 per share in an all cash transaction, or an aggregate total enterprise value of approximately $1.0 billion, representing a 23.1% premium to Carrols 30-day volume-weighted average price as of January 12, 2024 and a 13.4% premium to the January 12, 2024 closing price.

Key Points:

Carrols is the largest Burger King® franchisee in the United States today, operating 1,022 Burger King restaurants in 23 states that generated approximately $1.8 billion of system sales during the twelve-months ended September 30, 2023.
Tom Curtis, President of Burger King U.S. and Canada commented, "Carrols has demonstrated strong and improving restaurant operations over the years.
Deborah Derby, President and CEO of Carrols said, "Today's announcement is a testament to our more than 24,000 Carrols team members who have helped drive the company to record levels of profitability over the past 12 months.
Carrols has a team of strong, experienced operators who, in partnership with Burger King's operations teams, will operate the acquired restaurants.

Restaurant Brands International Inc. Announces Revised Segment Reporting

Retrieved on:

Monday, January 8, 2024

Depreciation, AOI, FHS, QSP, Popeyes, PLK, Restaurant Brands, Kobza, QSR, Bank statement, Adjustment, BK, Burger King, Growth, Investment, RBI, TSX, Firehouse Subs

The TH, BK, PLK and FHS segments include results from each brands' operations in the United States and Canada.

Key Points:

The TH, BK, PLK and FHS segments include results from each brands' operations in the United States and Canada.
INTL includes consolidated results from each brands' operations outside of the United States and Canada.
In addition, RBI has transitioned its definition of segment income from Adjusted EBITDA to Adjusted Operating Income ("AOI").
We have four amazing brands being led by five ambitious leaders across our home markets and international.

Certara Acquires Applied BioMath Expanding Its Biosimulation Portfolio to Industrialize New Capabilities for Optimal Dosing for Novel Therapies

Retrieved on:

Wednesday, December 13, 2023

Drug, QSP, Drug development, Prevalence, AI, Mathematical and theoretical biology, Biomarker, Toxicity, Pharmaceutical industry

Nine out of ten new therapies that enter the clinic do not achieve regulatory approval or commercialization primarily due to lack of efficacy or unmanageable toxicity.

Key Points:

Nine out of ten new therapies that enter the clinic do not achieve regulatory approval or commercialization primarily due to lack of efficacy or unmanageable toxicity.
The popularity and prevalence of the QSP methodology has grown in recent years as a strategy to de-risk drug development.
“Together, Applied BioMath and Certara have the scientific and computational expertise to industrialize QSP biosimulation methods,” said William F. Feehery, CEO of Certara.
Biology-Focused Drug Development: As drug development becomes more biology-focused, the combined team will build more reusable models to optimize novel and combination therapies for groundbreaking results.

New demonstration of the predictive power of an in silico clinical trial in oncology

Retrieved on:

Monday, November 13, 2023

These predictive findings were shared with the Janssen-Cilag France team a week in advance of the trial results being unveiled at the 2023 ESMO conference.

Key Points:

These predictive findings were shared with the Janssen-Cilag France team a week in advance of the trial results being unveiled at the 2023 ESMO conference.
Prof. Michaël Duruisseaux was involved as an investigator, but not in the steering committee and was not informed of the non-public data from the trial.
Employing such techniques in the future will enable us to establish better clinical trial designs," commented Prof. Duruisseaux.
Novadiscovery provides its jinkō clinical trials simulation platform to biotech and pharma companies, academic research centers and university hospitals.