AbbVie is expanding into oncology with a pipeline of over 15 investigational oncology compounds across different cancer types, including 7 in Phase 1, 1 in Phase 2, and 3 in Phase 3. AbbVie aims to transform cancer treatment through innovative platforms and collaborations to develop novel therapies with improved efficacy and safety. Their late-stage pipeline focuses on hematological malignancies and solid tumors, with global clinical trials enrolling over 1,100 patients in 2014.
The ACSS Consortium And The Generic Medicines Work-Sharing TrialTGA Australia
TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
Text for news feed: TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
The ACSS Consortium And The Generic Medicines Work-Sharing TrialTGA Australia
TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
Text for news feed: TGA presentation on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work-Sharing Trial.
PANEL 4: Speeding up chemical assessments: from novel information to new management approaches, what works? - Erika Kunz, Head of Global Registration and Evaluation of Chemicals, Clariant, Germany
Speaker Presentation from U.S. News Healthcare of Tomorrow leadership summit, November 2-4, 2016 in Washington, DC. Find out more about this forum at www.usnewshot.com.
Pharmaceutical & biotech manufacturing quality controlGenScript ProBio
The manufacture of medicines and biotherapeutics requires continuous validation of the whole mass production. Many products also require compensatory energy or release bioassays, as well as routine infertility tests.
For more information, visit our website.
Representing Clients in Front of ECHA - Chemical Services Case StudyCovance
Covance was approached by a client about an older substance originally registered under Notification of New Substances (NONS), but assessed under Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation. The client approached Covance after the European Chemicals Agency (ECHA) had issued a draft decision, which requested extensive additional studies. Covance was asked to plan a strategy to address the draft decision, as well as to support the client, as a nominated representative, at a Member State Committee (MSC) meeting to discuss the draft decision.
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...OECD Environment
Humans and the environment are exposed every day to chemicals. How do we make sure that these chemicals are safe?
Industry is required to test these chemicals to understand how they may affect people and the environment. In the past, these tests were most commonly carried out on animals. As scientific methods and tools progress, the use of animals to test a product designed for humans are becoming obsolete, in addition to being unethical. With new methods being developed, it is possible to perform these tests on human and animal cell cultures with equally rigorous and robust results. Because the OECD is committed to chemical safety and animal welfare, a new ground-breaking Guideline on Defined Approaches for Skin Sensitisation (OECD GL 497: https://doi.org/10.1787/b92879a4-en) was released on 14 June 2021. It is the first ever Guideline that uses non-animal methods to predict whether a chemical can cause skin allergies. The OECD organised a webinar on 18 October 2021 at 14:00 to discuss the implementation of the Defined Approaches on Skin Sensitisation for chemical safety in member countries. This webinar paved the way for companies and authorities to determine the environmental toxicity of chemicals without having to resort to animal testing.
Speakers:
- Nicole Kleinestreuer: NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) - Silvia Casati: European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
- Anna Lowit: U.S. Environmental Protection's Office of Pesticide Programs (US EPA OPP)
- Paul Brown: U.S. Food and Drug Administration (US FDA)
- Laura Rossi: European Chemicals Agency (ECHA)
- Andre Muller: National Institute for Public Health and the Environment (RIVM)
Access the video replay and more information about our work at: https://oe.cd/testing-assessment-webinars
On December 18, 2006, the European Parliament passed the final REACH Directive. Work on this legislation began in 2003. REACH will begin to be phased in on June 1, 2007.
REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States. Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations.
This regulatory briefing provides a summary of some of the key elements and concepts of the REACH Directive. For more information on EH&S and product responsibility services, go to:
http://calthacompany.com/compliance-programs-ems-auditing
New requirements for sponsors and laboratories for analyzing clinical trial s...complianceonline123
Learn compliance requirements for clinical laboratories analyzing samples from clinical trials. Understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
Understand how we work with NICE to embed information standards into their products and digital services, so that the health and care system can implement NICE guidelines more easily, and derive greater benefit.
PANEL 4: Speeding up chemical assessments: from novel information to new management approaches, what works? - Brian Richards, Executive Director, Office of Chemical Safety, Australia
Prof Angela Timoney
Presentation at EIPG - Royal Pharmaceutical Society Scientific Symposium "Advances in Technology Impacting the Pharmaceutical Industry" at the University of Strathclyde, Glasgow 2015.
Jim Jones, US EPA Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, delivered the keynote presentation at the Commission for Environmental Cooperation's (CEC) Chemicals Management Forum held in San Antonio, Texas, on May 15, 2012
PANEL 4: Speeding up chemical assessments: from novel information to new management approaches, what works? - Erika Kunz, Head of Global Registration and Evaluation of Chemicals, Clariant, Germany
Speaker Presentation from U.S. News Healthcare of Tomorrow leadership summit, November 2-4, 2016 in Washington, DC. Find out more about this forum at www.usnewshot.com.
Pharmaceutical & biotech manufacturing quality controlGenScript ProBio
The manufacture of medicines and biotherapeutics requires continuous validation of the whole mass production. Many products also require compensatory energy or release bioassays, as well as routine infertility tests.
For more information, visit our website.
Representing Clients in Front of ECHA - Chemical Services Case StudyCovance
Covance was approached by a client about an older substance originally registered under Notification of New Substances (NONS), but assessed under Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation. The client approached Covance after the European Chemicals Agency (ECHA) had issued a draft decision, which requested extensive additional studies. Covance was asked to plan a strategy to address the draft decision, as well as to support the client, as a nominated representative, at a Member State Committee (MSC) meeting to discuss the draft decision.
Implementation of the Defined Approaches on Skin Sensitisation (OECD GL 497) ...OECD Environment
Humans and the environment are exposed every day to chemicals. How do we make sure that these chemicals are safe?
Industry is required to test these chemicals to understand how they may affect people and the environment. In the past, these tests were most commonly carried out on animals. As scientific methods and tools progress, the use of animals to test a product designed for humans are becoming obsolete, in addition to being unethical. With new methods being developed, it is possible to perform these tests on human and animal cell cultures with equally rigorous and robust results. Because the OECD is committed to chemical safety and animal welfare, a new ground-breaking Guideline on Defined Approaches for Skin Sensitisation (OECD GL 497: https://doi.org/10.1787/b92879a4-en) was released on 14 June 2021. It is the first ever Guideline that uses non-animal methods to predict whether a chemical can cause skin allergies. The OECD organised a webinar on 18 October 2021 at 14:00 to discuss the implementation of the Defined Approaches on Skin Sensitisation for chemical safety in member countries. This webinar paved the way for companies and authorities to determine the environmental toxicity of chemicals without having to resort to animal testing.
Speakers:
- Nicole Kleinestreuer: NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) - Silvia Casati: European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM)
- Anna Lowit: U.S. Environmental Protection's Office of Pesticide Programs (US EPA OPP)
- Paul Brown: U.S. Food and Drug Administration (US FDA)
- Laura Rossi: European Chemicals Agency (ECHA)
- Andre Muller: National Institute for Public Health and the Environment (RIVM)
Access the video replay and more information about our work at: https://oe.cd/testing-assessment-webinars
On December 18, 2006, the European Parliament passed the final REACH Directive. Work on this legislation began in 2003. REACH will begin to be phased in on June 1, 2007.
REACH is an acronym that stands for “Registration, Evaluation and Authorisation of Chemicals”. REACH replaces about 40 different EU regulations and provides a uniform approach to evaluating, approving, and if necessary, restricting the manufacture, import and uses of chemicals within EU Member States. Because REACH also addresses the uses of chemicals, this directive can have a direct impact on a wide range of organizations.
This regulatory briefing provides a summary of some of the key elements and concepts of the REACH Directive. For more information on EH&S and product responsibility services, go to:
http://calthacompany.com/compliance-programs-ems-auditing
New requirements for sponsors and laboratories for analyzing clinical trial s...complianceonline123
Learn compliance requirements for clinical laboratories analyzing samples from clinical trials. Understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
Understand how we work with NICE to embed information standards into their products and digital services, so that the health and care system can implement NICE guidelines more easily, and derive greater benefit.
PANEL 4: Speeding up chemical assessments: from novel information to new management approaches, what works? - Brian Richards, Executive Director, Office of Chemical Safety, Australia
Prof Angela Timoney
Presentation at EIPG - Royal Pharmaceutical Society Scientific Symposium "Advances in Technology Impacting the Pharmaceutical Industry" at the University of Strathclyde, Glasgow 2015.
Jim Jones, US EPA Acting Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, delivered the keynote presentation at the Commission for Environmental Cooperation's (CEC) Chemicals Management Forum held in San Antonio, Texas, on May 15, 2012
Putting the Strategy in Client Strategy by JESS3JESS3
Made with love and learnings by JESS3. Originally presented by JESS3 Associate Director of Client Strategy Sheri Cook to the University of Oklahoma AdClub on November 27, 2012.
Before you start creating content, you need to build your strategy. We collected such valuable insights from over 40 major brands and thought leaders that we are rereleasing this ebook to help make your content marketing successful.
This presentation examines global public opinion about climate change. Using the Pew Research Center’s spring 2015 Global Attitudes survey, issues such as concern about climate change and support for action on climate change are addressed. It is based on 45,435 face-to-face and telephone interviews in 40 countries with adults 18 and older conducted from March 25 to May 27, 2015.
The famous educational philosopher, John Dewey, stated “We do not learn from experience, we learn from reflecting on experience.’ Maker education involves hands-on and experiential activities. Learning can occur through the act of making but having learners reflect on their making experiences increases the likelihood of learning. It is not left to chance.
AbbVie has acquired Stemcentrx. Learn more from the first outside investor and board member, Stuart Peterson: https://medium.com/artis-ventures/congratulations-stemcentrx-e65576762d28
Accelerating the translation of medical research - 27 JuneInnovation Agency
Slides from the event focusing on translational research in Liverpool and North of England and why companies are establishing and growing operations in the region.
OneMedForum New York 2010 - Company Presentation. Access Pharmaceuticals, Inc., a emerging biopharmaceutical company that focuses on adding value to exciting product concepts in research by advancing those products through clinical development.
company presentation. Development of the prostate cancer diagnostic test and in-vitro diagnostic device for the point-of-care diagnosis of prostate cancer
The cure for cancer still eludes us. The next best thing to a cure is the early detection of cancer. In most cases if you detect cancer early enough it can be treated successfully. The holy grail of cancer diagnostics would be a simple blood test with high specificity and sensitivity. VolitionRx (VNRX) is a clinical stage cancer diagnostic company working on a series of blood-based tests for a range of cancers, beginning with Colorectal Cancer (CRC). The company is starting a lucrative 11,000 patient clinical trial in early 2014 to validate their CRC test. The company expects to have multiple data points throughout 2014 and 2015. If early results prove successful, Volition’s current $25 million valuation will likely expand closer to comparables such as Exact Sciences (EXAS) $950 million valuation.
Crystal Research Associates, LLC has initiated coverage on SpectraScience, Inc. (SCIE-OTC) with the release of a 48-page Executive Informational Overview.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Navigating Challenges: Mental Health, Legislation, and the Prison System in B...Guillermo Rivera
This conference will delve into the intricate intersections between mental health, legal frameworks, and the prison system in Bolivia. It aims to provide a comprehensive overview of the current challenges faced by mental health professionals working within the legislative and correctional landscapes. Topics of discussion will include the prevalence and impact of mental health issues among the incarcerated population, the effectiveness of existing mental health policies and legislation, and potential reforms to enhance the mental health support system within prisons.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
R3 Stem Cells and Kidney Repair A New Horizon in Nephrology.pptxR3 Stem Cell
R3 Stem Cells and Kidney Repair: A New Horizon in Nephrology" explores groundbreaking advancements in the use of R3 stem cells for kidney disease treatment. This insightful piece delves into the potential of these cells to regenerate damaged kidney tissue, offering new hope for patients and reshaping the future of nephrology.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
1. ABBVIE: A NEW PLAYER
IN ONCOLOGY
Todd Manning
General Manager, AbbVie Ltd
2. “The AbbVie oncology products
are all investigational in nature
and are currently not licensed
in any country. The ultimate
licensing of these compounds is
subject to regulatory review
and approval.”
2
3. AbbVie Oncology Vision
We will accomplish this by:
• Leveraging our leading-edge platforms
• Working closely with academia, diagnostic companies and cooperative
groups
• Bringing to market novel therapeutics with transformational increases in
efficacy and safety
Transform the Lives of
People with Cancer
It starts with science…
…and continues with AbbVie’s commitment to research and development
3
4. Oncology is a new focus for AbbVie
AbbVie has a rich oncology pipeline in more than 15 different tumour types
AbbVie’s late phase pipeline includes treatments for both haematological
malignancies and solid tumours
4
Phase 1
7 molecules
Phase 2
1 molecule
Phase 3
3 molecules
PARP inhibitor
(solid tumours)
potential
indications6
Phase 2/3 trials19
BCL-2 inhibitor
(haem malignancies)
potential
indications6
Phase 2/3 trials7
EGFR ADC
(glioblastoma)
potential
indications2
Phase 2/3 trials2
PI3K inhibitor
(haem malignancies)
potential
indications6
Phase 2/3 trials10
5. 5
Global Trials in Solid Tumours
Brain Metastases Breast
NSCLC SCLC
Colorectal Ovarian
Gastric Glioblastoma
In 2014 -
• ~1100 subjects enrolled in Phase 1-3 trials
• ~60 trials performed across multiple tumours
• Studies conducted in 44 countries
AbbVie’s oncology clinical development is founded on deep scientific and clinical
expertise
Global Trials in Haem. Malignancies
Acute Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Multiple Myeloma
Non-Hodgkin’s Lymphoma
Current Trials in Ireland
Squamous non-small cell lung cancer
Glioblastoma
6. Manufacturing in Ireland: 2 of AbbVie’s 3 oncology compounds in phase 3
trials are manufactured in Ireland
• Each of the uniquely focused sites in
Ireland manufactures portions of
AbbVie’s top 20 products
• The company has 12 sites in total across
the United States, Europe and Puerto
Rico, as well as strategic partnerships
with third-party manufacturers
• Of the 3 oncology compounds in phase 3
trials, 2 are manufactured in Ireland
6
7. In addition to organic development of new compounds, AbbVie is also
investing heavily in the oncology pipeline
7
8. Summary
• AbbVie is new to oncology, and has a
number of compounds in pre-clinical,
early phase and late phase development
• Late phase trials include both solid
tumours and haematological
malignancies, and enrolled over 1100
patients in 2014
• AbbVie is investing in acquisitions and
licensing compounds, in addition to the
discovery and development process
8
Editor's Notes
Understand and align on tumor unmet needs
What are challenges and opportunities in specific tumour populations?
Assess tumor opportunity unmet need against Discovery pool
Any targets in play that do not address an unmet need in the specific tumour type?
Any tumors of interest not adequately covered by current discovery target?
If so, what approaches are best suited for new therapies?
