#global enteric multicenter study

[its-a-date]

Only in the last decade, with global surveillance and advanced genomics, has the relative importance of various pathogens been reliably measured. The Global Enteric Multicenter Study, completed in 2013, was the largest-ever study of the global diarrhea burden.

"Plagues Upon the Earth: Disease and the Course of Human History" - Kyle Harper

[pcrtisuyog]

Which Tools and Software Are Taught in Advanced Clinical Research Courses?

Clinical research has evolved significantly over the past few decades. With the growing demand for skilled professionals in this domain, advanced clinical research courses are now designed not only to deliver theoretical knowledge but also to train students in cutting-edge tools and software. These tools play a crucial role in conducting, managing, and analyzing clinical trials efficiently and accurately.

For aspiring clinical research professionals, gaining hands-on experience with industry-standard tools provides a significant edge in the job market. If you're wondering which tools and software are taught in advanced clinical research courses, this comprehensive guide covers the most widely used platforms and systems in the industry today.

Why Learning Clinical Research Tools Is Essential

Before we dive into specific tools, it's important to understand why these are integrated into clinical research training:

Improve accuracy and compliance with regulatory standards.

Enhance productivity and reduce the time taken to manage trial data.

Enable real-time collaboration among research teams across locations.

Ensure data integrity and security, especially in multicenter studies.

Help students transition smoothly into professional roles post-certification.

Key Tools and Software Taught in Advanced Clinical Research Courses

Advanced clinical research programs usually include both theoretical modules and practical training with the following tools:

1. Clinical Data Management Systems (CDMS)

Clinical data management systems are used to collect, clean, and manage data generated during clinical trials.

Oracle Clinical

Medidata Rave

Clinical

REDCap (Research Electronic Data Capture)

These tools help students understand how data is entered, queried, cleaned, and locked in a clinical trial environment.

2. Electronic Data Capture (EDC) Systems

EDC systems allow the collection of clinical trial data electronically instead of paper-based methods.

OpenClinica

Castor EDC

Medrio

Viedoc

Hands-on training with EDC systems enables students to navigate electronic CRFs (case report forms), reduce errors, and accelerate data collection processes.

3. Statistical Analysis Software

Advanced courses also emphasize training in tools used for biostatistical analysis, vital in interpreting clinical trial outcomes.

SAS (Statistical Analysis System)

SPSS (Statistical Package for the Social Sciences)

R Programming

STATA

Students learn how to use these platforms for statistical programming, data mining, and preparing reports for submission to regulatory agencies.

4. Randomization and Trial Supply Management (RTSM) Tools

These tools help in managing patient randomization and supply logistics for clinical trials.

IXRS (Interactive Voice/Web Response System)

IRT (Interactive Response Technology)

Almac Clinical Technologies

This training helps students understand how clinical supplies are managed and how trial participants are randomized to avoid bias.

5. Clinical Trial Management Systems (CTMS)

CTMS platforms are used to plan, track, and manage the operational aspects of clinical trials.

Oracle Siebel CTMS

Medidata CTMS

BioClinica CTMS

These tools are vital for managing site performance, budgets, and timelines, giving students an overview of the trial lifecycle from start to finish.

6. Pharmacovigilance and Safety Databases

Adverse event reporting is a crucial part of clinical trials. Courses often cover tools used for pharmacovigilance:

Argus Safety

ARISg

Oracle AERS (Adverse Event Reporting System)

Students learn how to collect, assess, and report serious adverse events (SAEs) and ensure compliance with global safety regulations.

7. Regulatory and Document Management Software

Advanced courses also introduce learners to documentation and regulatory submission tools:

eTMF (Electronic Trial Master File) Systems

Veeva Vault

MasterControl

WCG Velos

These systems are crucial for storing trial documents and supporting audit readiness.

Bonus Tools: Additional Technologies Often Covered

Many clinical research training institutes also introduce students to supportive or emerging tools like

Microsoft Excel for basic data manipulation

Tableau or Power BI for visualizing clinical data

Clinical Research Management Portals (for real-time dashboards)

Artificial Intelligence and Machine Learning tools (in advanced analytics modules)

Conclusion

In a rapidly growing field like clinical research, being familiar with the latest tools and software can dramatically improve your career prospects. Advanced clinical research courses are designed to equip students not just with theoretical insights but also with practical skills on industry-standard platforms.

To summarize, here's what you can expect to learn:

Clinical Data Management Systems (CDMS)

Electronic Data Capture (EDC) platforms

Statistical analysis software like SAS and R

CTMS and RTSM tools for trial logistics and management

Pharmacovigilance databases for safety reporting

Regulatory software for compliance and documentation

Whether you're a fresher or a working professional looking to upskill, mastering these tools through a structured program is a strategic investment in your clinical research career.

[csrgood]

Government of Ghana Makes Hydroxyurea Available to People With Sickle Cell Disease Through First of Its Kind Public-private Partnership With Global Medicines Company Novartis

Today, the Government of Ghana announced the availability of hydroxyurea for the treatment of people with sickle cell disease (SCD), marking the official launch of a first of its kind public-private partnership to improve the diagnosis and accelerate treatment for people with SCD. The launch follows the signature of a  Memorandum of Understanding in January among the Ministry of Health of Ghana, Ghana Health Service, the Sickle Cell Foundation of Ghana and global medicines company Novartis to create a holistic approach to help manage the disease. Ghana is the first African country to commit to offering the global standard of care for their people with SCD.

“I am proud of this bold partnership, and it is my hope that, through this collaboration, we will help ease the pain and improve the lives of people living with sickle cell disease in our country. We are committed to put SCD among the priorities on our national health agenda and to take the necessary steps to make treatment broadly available through our National Health Insurance Scheme, bringing much-needed relief to families struggling to cover the cost of care for their loved ones,” said H.E. Alhaji Dr. Mahamudu Bawumia, Vice President of the Republic of Ghana. “Our collective goal is to reimagine what the future could look like for people with sickle cell disease: where children do not need to miss out on school or be singled out; where young adults can have equal opportunity for employment; and where families can flourish and continue to be the bedrock of our civil society—in a nutshell, we will make every effort to ‘normalize’ sickle cell disease within the Ghanaian society.”

To date, Novartis has delivered more than 20 000 treatments of hydroxyurea. Initially, the therapy will be made available through 11 trained treatment centers, as well as through private distribution channels, and is expected to cover the needs of patients for up to 12 months. The partners aim to open more treatment centers by the end of the year, and Novartis is committed to delivering a total of 60 000 treatments. Discussions are aleady underway for inclusion of the medicine and associated laboratory testing in the National Health Insurance Scheme, as well as prioritizing SCD as a national program.

Hydroxyurea is a commonly used medicine for patients with SCD in developed countries, and is approved for use in both adults and children. In October 2018, the Ghana FDA granted marketing authorization to Novartis hydroxyurea, making it the first time that hydroxyurea will be available for this indication in Ghana. A recent study, published in the New England Journal of Medicine3 indicates that hydroxyurea treatment is effective and safe in children with SCD in sub-Saharan Africa and reduces the incidence of pain events (vaso-occlusive crises),  malaria, blood transfusions, and death.

“All the traditional names by which SCD is known allude to the episodes of severe pain experienced by people with the disease,” said Prof. Kwaku Ohene-Frempong, MD, President of the Sickle Cell Foundation of Ghana and Program Coordinator for the National Newborn Screening Program for Sickle Cell Disease. “Hydroxyurea is a drug with proven efficacy in reducing pain episodes and other complications of the disease. Currently, the highest standard of care for people with SCD starts with early diagnosis through newborn screening followed by penicillin prophylaxis to prevent early death from infection, and hydroxyurea therapy to ease the pain, prevent other complications and improve quality of life.”  

At the same time, Novartis has committed to develop a child-friendly formulation of hydroxyurea and has announced plans to conduct two clinical trials in Ghana and Kenya for its next-generation treatment for SCD, crizanlizumab. Crizanlizumab is a novel targeted biologic therapy that is expected to help reduce pain crises in people with SCD. The trials are expected to start in 2020; this will be the first time that a biologic therapy, which is not a vaccine, enters multicenter clinical trials in sub-Saharan Africa (excluding South Africa)4.

“Novartis is deeply committed to reimagining medicine for patients in Ghana and across Africa,” said Vas Narasimhan, MD, CEO of Novartis. “Building on our long heritage of addressing malaria and leprosy in Africa, we’re excited to help improve the diagnosis and treatment of people with sickle cell disease here in Ghana. Novartis is proud to join this pioneering partnership, which could accelerate efforts to forge a healthier future for children across the continent.”

Sickle cell disease is recognized by the World Health Organization as a public health priority and a neglected health problem in sub-Saharan Africa. Approximately 80% of individuals with

SCD globally are born in sub-Saharan Africa, and there is evidence to suggest that more than half of affected individuals may die before the age of five due to preventable complications. In Ghana, it is estimated that 15 000 babies are born with sickle cell disease every year2.

The five-year partnership aims to improve and extend the lives of people with SCD through a comprehensive approach to screening and diagnosis; treatment and disease management; training and education; and elevating basic and clinical research capabilities. Specifically, the partners aim to collaborate on field testing and implementation of SCD treatment guidelines, the establishment of centers of excellence across regions and the implementation of newborn screening at these centers. In addition, partners plan to employ digital technologies to monitor and evaluate patient registration, report real-time data and help ensure safe large scale roll-out of medicine.

In parallel, Novartis is working with Zipline, a California-based automated logistics company, to make sickle cell treatments widely available, especially in rural areas. Zipline is already operating two distribution centers in Ghana, in Omenako and Asante Mampong, with plans to open two more in the near future.

In addition, in order to help further ensure a sustainable supply of high quality hydroxyurea, Novartis has entered a strategic collaboration with Olon, a manufacturer based in Italy that supplies the active ingredient for the drug. “We are proud to collaborate with Novartis and its partners to help make hydroxyurea more broadly available and in a sustainable way,” said Paolo Tubertini, CEO of Olon. “As a demonstration of our commitment to patients with sickle cell disease and this program, we will also contribute, without cost, the active ingredient to cover approximately 12 000 thousand treatments. Our hope is to continue to meet the needs and challenges of those living with sickle cell disease and their families to improve access to quality health care.”

About Sickle Cell Disease

Sickle cell disease is a deblitating, inherited blood disorder. It causes affected red blood cells to become sickle-shaped, stiff and fragile – easily breaking apart. Blood vessels and blood cells become sticky due to damage caused by sickle cells and ongoing chronic inflammation5,6. That leads to blood cells sticking to each other and to the blood vessels and causing blockages – called vaso-occlusion -  which can lead to the acute episodes of pain (known as sickle cell pain crises or vaso-occlusive crises), stroke and other life-threatening complications5,7. It is a lifelong illness that can put an emotional, physical, and financial burden on patients and their families8,9.

SCD is a global health problem, with the highest burden of disease concentrated in sub-Saharan Africa. In countries in West, Central and East Africa, the prevalence of the sickle cell gene is between 10 to 30 percent, while in some areas it is as high as 45%10. It is estimated that approximately 1 000 children in Africa are born with SCD every day and more than half die before they reach five years of age11. This is due primarily to lack of early diagnosis through newborn screening, penicillin prophylaxis, parental education, and comprehensive care. In resource-poor countries, more than 90 percent of children with SCD do not survive to adulthood12. Despite the adoption by the WHO of an SCD strategy for Africa in 2010, the disease is largely absent from the global or national health agenda.

References

One treatment equals one month’s supply for an adult patient above 33kg of weight

Odame I. Perspective: We need a global solution. Nature. 2014 Nov;515(7526):S10

https://www.nejm.org/doi/full/10.1056/NEJMoa1813598

https://www.clinicaltrials.gov

Gutsaeva D, Parkerson J, Yerigenahally S, et. Inhibition of cell adhesion by anti–P-selectin aptamer: a new potential therapeutic agent for sickle cell disease. Blood. 2011;117(2):727-735.

Sparkenbaugh E, Pawlinski R. Interplay between coagulation and vascular inflammation in sickle cell disease. J Haematol. 2013;162(1):1-22.

Steinberg M. Management of sickle cell disease. N Engl J Med. 1999;340(13):1021-1030.

Sanger M, Jordan L, Pruthi S, et al. Cognitive deficits are associated with unemployment in adults with sickle cell anemia. Journal of Clinical and Experimental Neuropsychology. 2016;38(6):661-671.

Anim M, Osafo J, Yirdong F. Prevalence of psychological symptoms among adults with sickle cell disease in Korie-Bu Teaching Hospital, Ghana. BMC Psychology. 2016;4(53):1-9.

https://www.afro.who.int/health-topics/sickle-cell-disease

Scott D. Grosse, Isaac Odame, Hani K. Atrash, et al. Sickle Cell Disease in Africa: A Neglected Cause of Early Childhood Mortality. American Journal of Preventive Medicine 41, no. S4 (December 2011): S398-405.

Bernadette Modell and Matthew Darlison. Global epidemiology of haemoglobin disorders and derived service indicators. Bulletin of the World Health Organization 86, no. 6 (June 2008): 480-487.

source: https://www.csrwire.com/press_releases/43038-Government-of-Ghana-Makes-Hydroxyurea-Available-to-People-With-Sickle-Cell-Disease-Through-First-of-Its-Kind-Public-private-Partnership-With-Global-Medicines-Company-Novartis?tracking_source=rss

[healthcarebiz]

Merck and Pfizer to Present Data Highlighting Potential of Avelumab in Challenging Cancers at ASCO 2017

DARMSTADT, Germany and NEW YORK, May 18, 2017 /PRNewswire/ --

Not intended for US, Canada and UK-based media 

A total of 13 abstracts across seven hard-to-treat cancers highlight the progress of avelumab as a monotherapy and potential novel combination treatment option  

New data in metastatic Merkel cell carcinoma and previously treated metastatic urothelial carcinoma, following recent US FDA accelerated approvals 

Merck and Pfizer today announced that 13 avelumab* abstracts across seven challenging tumor types will be featured at the 53rd American Society of Clinical Oncology (ASCO) Annual Meeting held June 2-6, 2017 in Chicago, IL. Key presentations include data for avelumab in first-line metastatic Merkel cell carcinoma (mMCC) and in previously treated metastatic urothelial carcinoma (UC), as well as results from the Phase Ib trial investigating avelumab in combination with the tyrosine kinase inhibitor axitinib, in advanced renal cell carcinoma (RCC).

"Our ASCO presence adds to what has already been a momentous year for the alliance, coming shortly after the US FDA granted two accelerated approvals for avelumab," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck, which in the US and Canada operates as EMD Serono. "We're particularly excited to share the latest avelumab data in both metastatic Merkel cell carcinoma in the first-line setting and previously treated metastatic urothelial carcinoma with the cancer community."

"Our data at ASCO this year underscore the potential of avelumab as a monotherapy treatment, as well as part of combination regimens," said Chris Boshoff, M.D., PhD, Senior Vice President and Head of Immuno-Oncology, Early Development, Translational Oncology, Pfizer Global Product Development. "Now with accelerated approvals in two indications for avelumab in the US, we are entering the next chapter of our clinical development program to provide meaningful new treatment options for patients who need them most."

Highlights of avelumab data at ASCO 2017 include the following:

Preliminary data from the ongoing JAVELIN Merkel 200 trial, an open-label, multicenter study conducted in first-line mMCC investigating avelumab in patients who had no prior systemic treatment for mMCC, will be presented for the first time at a medical congress.

Data from a pooled analysis of two metastatic UC cohorts of the JAVELIN Solid Tumor trial, a Phase Ib, open-label, single-arm, multicenter study of avelumab in the treatment of various solid tumors, will be presented.

An oral presentation of results from the JAVELIN Renal 100 trial, a Phase Ib, open-label study evaluating the clinical activity and safety of the combination of avelumab and axitinib for the first-line treatment of advanced RCC.

Beyond mMCC, metastatic UC and RCC, the Merck-Pfizer Alliance will also showcase avelumab abstracts in non-small cell lung cancer, metastatic castrate-resistant prostate cancer, locally advanced squamous cell carcinoma of the head and neck and relapsed or refractory diffuse large B-cell lymphoma, as well as updated safety data in solid tumors.

The alliance's rapidly accelerating JAVELIN clinical development program now involves at least 30 clinical programs, including nine Phase III trials, and more than 5,200 patients across more than 15 tumor types. Results from JAVELIN program trials have supported two FDA accelerated approvals in 2017.

A list of accepted avelumab abstracts is included below. The abstracts are also available on the ASCO website.

Title

Lead Author

Abstract ID / Poster No.

Presentation Date / Time

Session

Oral Presentations

Renal Cell Carcinoma

(JAVELIN Renal 100)

First-line avelumab + axitinib therapy in patients with advanced renal cell carcinoma: results from a phase 1b trial

Choueiri TK

4504

  Monday, June 5  8:00-11:00 a.m.

Genitourinary (Nonprostate) Cancer

Poster Sessions

Head and Neck Cancer (TiP)

(JAVELIN Head and Neck 100)

JAVELIN Head and Neck 100: a phase 3 trial of avelumab in combination with chemoradiotherapy (CRT) vs CRT for 1st-line treatment of locally advanced squamous cell carcinoma of the head and neck (LA SCCHN)

Lee NY

TPS6093

Monday, June 5

1:15-4:45 p.m.

Head and Neck Cancer

  Lymphoma (TiP)

(JAVELIN DLBCL)

Phase 1b/3 study of avelumab-based combination regimens in patients (pts) with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL)

Chen R

TPS7575

Monday, June 5

8:00-11:30 a.m.

Hematologic Malignancies-Lymphoma and Chronic Lymphocytic Leukemia

  Merkel Cell Carcinoma

(JAVELIN Merkel 200)

First-line avelumab treatment in patients with metastatic Merkel cell carcinoma: preliminary data from an ongoing study

D'Angelo SP

9530

Saturday, June 3

1:15-4:45 p.m.

Melanoma/Skin Cancers

Merkel Cell Carcinoma

(JAVELIN Merkel 200)

Exploratory biomarker analysis in patients with chemotherapy-refractory metastatic Merkel cell carcinoma treated with avelumab

Shapiro I

9557

Saturday, June 3

1:15-4:45 p.m.

Melanoma/Skin Cancers

  Non-Small Cell Lung Cancer

(JAVELIN Solid Tumor)

Exposure-response and PD-L1 expression analysis of second-line avelumab in patients with advanced NSCLC: data from the JAVELIN Solid Tumor trial

Gulley JL

9086

Saturday, June 3

8:00-11:30 a.m.

Lung Cancer-Non-Small Cell Metastatic

Pan-Tumor

(JAVELIN Solid Tumor)

Safety profile of avelumab in patients with advanced solid tumors: a JAVELIN pooled analysis of phase 1 and 2 data

Kelly K

3059

Monday, June 5

8:00-11:30 a.m.

Developmental Therapeutics-Immunotherapy

Prostate Cancer

(JAVELIN Solid Tumor)

Avelumab in metastatic castration-resistant prostate cancer (mCRPC)

Fakhrejahani F

5037

Monday, June 5

1:15-4:45 PM

Genitourinary (Prostate) Cancer

Renal Cell Carcinoma

(JAVELIN Renal 101)

Avelumab plus axitinib vs sunitinib as first-line treatment of advanced renal cell carcinoma: phase 3 study (JAVELIN Renal 101)

Choueiri TK

TPS4594

Sunday, June 4

8:00-11:30 a.m.

Genitourinary (Nonprostate)

  Urothelial Carcinoma

(JAVELIN Solid Tumor)

Updated efficacy and safety of avelumab in metastatic urothelial carcinoma: pooled analysis from 2 cohorts of the phase 1b JAVELIN Solid Tumor study

Apolo AB

4528

Sunday, June 4

8:00-11:30 a.m.

Genitourinary

(Nonprostate) Cancer

  Publications

Merkel Cell Carcinoma

(JAVELIN Merkel 200)

Non-progression during avelumab treatment is associated with clinically relevant improvements in health-related quality of life in patients with Merkel cell carcinoma

Bharmal M

e21070

Merkel Cell Carcinoma

(JAVELIN Merkel 200)

Patient experiences with avelumab vs chemotherapy for treating Merkel cell carcinoma: results from protocol-specified qualitative research

Kaufman HL

e21065

Non-Small Cell Lung Cancer

(JAVELIN Solid Tumor)

Comparative study of two PD-L1 expression assays in patients with non-small cell lung cancer (NSCLC)

Feng Z

e20581

*Avelumab is under clinical investigation for treatment of NSCLC, RCC, DLBCL, SSCHN and mCRPC and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for NSCLC, RCC, DLBCL, SSCHN and mCRPC by any health authority worldwide.

About Avelumab  Avelumab is a human antibody specific for a protein called PD-L1, or programmed death ligand-1. Avelumab is designed to potentially engage both the adaptive and innate immune systems. By binding to PD-L1, avelumab is thought to prevent tumor cells from using PD-L1 for protection against white blood cells, such as T-cells, exposing them to anti-tumor responses. Avelumab has been shown to induce antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Indications   The US Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO®) for the treatment of (i) metastatic Merkel cell carcinoma (mMCC) in adults and pediatric patients 12 years and older and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. Avelumab is not approved for any indication in any market outside the US.

Important Safety Information   The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with avelumab include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

About the Merck-Pfizer Alliance  Immuno-oncology is a top priority for Merck and Pfizer Inc. The global strategic alliance between Merck and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer's PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://ift.tt/P4xUC9 to register online, change your selection or discontinue this service.

For further details and press materials about Merck in oncology please visit http://ift.tt/2f4bC24

About Merck  Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the "Merck" name and brand except in the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Pfizer Inc.: Working together for a healthier world®  At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.pfizer.com. In addition, to learn more, please visit us at http://www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice  The information contained in this release is as of May 17, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), the Merck-Pfizer Alliance involving anti-PD-L1 and anti-PD-1 therapies, and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; the risk that clinical trial data are subject to differing interpretations, and, even when we view data as sufficient to support the safety and/or effectiveness of a product candidate, regulatory authorities may not share our views and may require additional data or may deny approval altogether; whether and when drug applications may be filed in any jurisdictions for potential indications for BAVENCIO, combination therapies or other product candidates; whether and when any such applications (including the pending application for BAVENCIO for metastatic Merkel cell carcinoma in the EU) may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of BAVENCIO, combination therapies or other product candidates; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

Your Contacts Merck Media Gangolf Schrimpf +49-6151-72-9591 Investor Relations                       +49-6151-72-3321 Pfizer Media (US) Sally Beatty +1-212-733-6566 Media (EU) Lisa O'Neill +44-1737-331536 Investor Relations Ryan Crowe +1-212-733-8160

Read this news on PR Newswire Asia website: Merck and Pfizer to Present Data Highlighting Potential of Avelumab in Challenging Cancers at ASCO 2017

[pakistaneducation-blog]

publishedPakistan Education News | CAP SSC HSSC BISE Date sheet result exams

PostGlobal Enteric Multicenter Study

KARACHI - The Global Enteric Multicenter Study, GEMS, an extensive, ground-breaking study in the developing world, has come up with the clearest picture yet of the most common causes and impact of diarrheal diseases — the second leading killer of young children globally after pneumonia. The...

http://pakedu.net/pakistani-education-news/global-enteric-multicenter-study/