Dr. John S. Macdonald Honored at 2018 Luminary Awards

John S. Macdonald, MD, is the Senior Medical Advisor for AGICC (Academic GI Cancer Consortium) and the consolidated Oncology Consortia of Criterium groups, including: AMyC (Academic Myeloma Consortium), ATOMIC (Academic Thoracic Oncology Medical Investigators Consortium) and ABRCC (Academic Breast Cancer Consortium). He is a leading supporter and advocate of the Translational Research methodology.

Dr. Macdonald was one of a few select honorees at The Ruesch Center for the Cure of Gastrointestinal Cancers Annual Luminary Awards on November 30th, 2018.

Dr. Macdonald successfully developed and led the Comprehensive Cancer Center at St. Vincent’s in New York City between 1997 and 2007. He is widely recognized as an industry and academic expert in gastrointestinal oncology and has written and lectured on the advantages of translational research. In addition to his responsibilities at Saint Vincent’s, Dr. Macdonald served as Chief of Medical Oncology there, and as the Lynn Wood Neag Endowed Professor of Medicine at the New York Medical College. He is acknowledged as a leading educator in Medical Oncology. 

Macdonald pioneered the use of chemoradiation after surgical resection of gastric cancers. This treatment regimen, aptly named the “Macdonald Regimen,” has helped turn the idea of a cure into a reality for thousands of patients with gastric cancers. This has also paved the way for the development of new treatment options for gastric cancers.  “[Macdonald] is a groundbreaking researcher, dedicated educator, and outstanding clinician,” said Sunnie Kim, MD, of the Ruesch Center for the Cure of Gastrointestinal Cancers, prior to presenting Macdonald with his award. “He has changed the lives of countless patients with some of the deadliest cancers.”

Dr. Macdonald has authored over 400 articles, abstracts and book chapters and has been both published in, and editor of, many prestigious medical journals. Macdonald has received numerous awards and distinctions, including being named among Good Housekeeping’s Best 300 Doctors in America and, over a seven-year period, New York magazine’s Best Doctors in New York.

Visit the website to see Dr. Macdonald’s profile and all the Consortia groups.

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Hong Kong Dept of Health Approves Biktarvy® for HIV, following FDA and EC

In Phase 3 Clinical Trials, Biktarvy® Demonstrated High Efficacy and Zero Resistance Through 48 Weeks

The triple-combination, single-tablet therapy combines the potency of the novel integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of a guideline recommended dual nucleoside reverse transcriptase inhibitor (NRTI) backbone – Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF). BIC/FTC/TAF provides a convenient once-daily dosing STR without regards to food. Furthermore, BIC/FTC/TAF’s use is not restricted by the patient’s baseline viral load, CD4 cell count or HLA-B 5701 status.

“Safety and resistance profiles are important considerations for HIV patients, as the disease requires long-term care. In addition, potent treatments with convenient dosing can potentially improve adherence and outcomes for patients,” said Dr Chan Kai Ming, Specialist in Infectious Disease, Consultant in Internal Medicine, Union Hospital, Hong Kong.

The Hong Kong Dept of Health has approved Biktarvy® (bictegravir 50mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection in adults*. Hong Kong is the first market in Asia to approve Biktarvy. BIC/FTC/TAF was approved by the U.S. Food and Drug Administration (FDA) on February 7, 2018 and the European Commission on June 21, 2018.

The approval was based upon data from four ongoing Phase 3 studies: Studies 1489 and 1490 in treatment-naive HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a population of 2,414 participants, and BIC/FTC/TAF met its primary efficacy objective at 48 weeks in all four studies, with no participants in any of the four BIC/FTC/TAF studies developing treatment-emergent virologic resistance. There were no cases of renal discontinuation, proximal renal tubulopathy or Fanconi syndrome in the BIC/FTC/TAF arms at 48 weeks. Additional ongoing studies not included in the marketing authorization application involve dedicated studies in women, adolescents and children.

“We welcome the timely approval of BIC/FTC/TAF in Hong Kong, a novel treatment option for people living with HIV,” said Andrew Hexter, Vice President and GM for Gilead Sciences Asia. “We are committed to serving the needs of HIV patients and medical communities in Asia, and are working with public health authorities to make the treatment available in this region.”

Reprint by permission of PRNewswire; Image courtesy of skitterphoto at Pixabay (Free Lic CC0)

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Vaccine for Meningitis Shows Some Protection Against Gonorrhea

Scientists have not been able to develop a vaccine against the sexually transmitted disease gonorrhea, despite working toward one for more than 100 years.? However, they may have stumbled onto something that could provide clues to advance the development of such a vaccine.

Decades ago, in the late 1990s, a strain of meningitis B was reaching epidemic proportions in New Zealand. A vaccine, MeNZB, was developed to protect young people who were at the highest risk of getting this particular type. It did not provide protection against any other strain.

Between 2004 and 2006, MeNZB was given to anyone under the age of 20. Babies and preschoolers were routinely immunized until 2008. People with a high medical risk continued to get the vaccine until 2011. Once the epidemic was over, the vaccination program was stopped.

However, scientists noticed that the meningitis vaccine also seemed to offer some protection against gonorrhea. A study published in the Lancet last month showed that one-third of the people who had received MeNZB did not get gonorrhea, compared to a control group who was not inoculated. The lead author noted that the bacteria causing both diseases share between 80 and 90 percent of their primary genetic sequences.

Dr. Steven Black, an infectious disease expert at Cincinnati Children?s Hospital, noted, ?This is the first time it?s been shown that you could have a vaccine that would protect against gonorrhea. And if these results are confirmed in another setting, that would mean that it would be very reasonable ? to go forward with developing perhaps a more targeted vaccine.? Black’s comments were published in the current issue of JAMA, the Journal of the American Medical Association.? The JAMA article concludes that ultimately, a preventive vaccine could be the only sustainable solution to a fast-changing bug that has proven adept at developing resistance.

The World Health Organization reports?that gonorrhea is becoming harder, and sometimes impossible, to treat, warning that it could become incurable in the not-too-distant future. At the moment, there no new antibiotics being developed to treat this disease.

The U.S. CDC reports that gonorrhea is the second most commonly reported notifiable disease in the United States. All known cases must be reported to the CDC, but officials there estimate that they are notified of fewer than half of the 800,000 new cases each year.

Displayed with permission from?Voice of America via RePubHub FREE LIC; Image courtesy of FREEPIK by marioluengo CC0 License

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2015: Lung Cancer Research Outside the USA

Female Lung Cancer Deaths to Surpass Breast Cancer in Europe

In January 2015, a study by researchers from Switzerland and Italy revealed that lung cancer deaths among women in Europe would overtake those from breast cancer in 2015.[1] Lung cancer is the most common type of cancer, accounting for 13% of all cancer deaths worldwide. That represents a death toll of 1.6 million people, over 80% of who are tobacco users.[2]? While European men have been more afflicted by the disease due to higher smoking rates, the rates among men have been on the decline in the recent past. Meanwhile, the rates among women have been on an upward trend. This year, the prevalence of lung cancer among women in Europe is expected to rise by 9% over 2009 levels to reach 14.24 per 100,000 of population. Meanwhile, the death rate from breast cancer over the same period will fall by 10.2% to 14.22 deaths per 100,000 of population.[3]

The rise is attributed to the delayed effect of the surge in smoking among European women during the period after the 2nd World War and extending to the late 1960s.[4] The UK is one of the main drivers of this trend. Of all the countries surveyed independently, the UK had the highest level of lung cancer deaths, 21 per 100,000 of population.[5] Professor Carlo La Vecchia of the University of Milan, who is also the lead researcher attributed this to the fact that, ??British women started smoking during the second world war, while in most other EU countries women started after 1968.?

Research Shows Personalized Treatments are Underutilized

An international survey conducted between December and January 2015 revealed that the rates of patients receiving personalized treatment for advanced non-small cell lung cancer (NSCLC) remains low despite a large proportion of them (81%) having been tested for EGFR mutations. The results of the study were released in April in Ingelheim Germany, the seat of the Boehringer Ingelheim Pharmaceutical group which is the main sponsor of the study. The results were collected from 562 oncologists from 10 developed countries across Asia, Europe and North America. In Europe, 30% of advanced NSCLC patients were put on first-line treatment before their test results were ready, displaying a huge disparity with Asia (12%). The average global rates were 25%. The main reasons cited by oncologists for non-testing were insufficient tissue, poor patient fitness and protracted process of acquiring results once samples had been taken. Additionally 51% of all oncologists involved in the study stated that their treatment decisions were not dependent on EGFR mutation subtype of their patients. EGFR mutations are present in 40% of East Asian and 10-15% of white NSCLC patients.[6] ESMO clinical practice guidelines[7] recommend the use of EFGR mutation testing results to guide treatment decisions according to each patient?s specific cancer type as this has been shown to improve survival rates at least with the Del 19 mutation[8], the most common type of mutation.[9]

[1] http://annonc.oxfordjournals.org/content/early/2015/01/24/annonc.mdv001.full
[2] http://www.cancerresearchuk.org/about-cancer/causes-of-cancer/smoking-and-cancer/smoking-facts-and-evidence#smoking_facts0
[3] http://annonc.oxfordjournals.org/content/early/2015/01/24/annonc.mdv001.full
[4] http://www.theguardian.com/society/2014/oct/07/smoking-falls-lowest-level-uk-recording-started-1940s
[5] http://annonc.oxfordjournals.org/content/early/2015/01/24/annonc.mdv001.full
[6] https://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/17_april_2015_oncology.html

[7] http://annonc.oxfordjournals.org/content/early/2014/08/11/annonc.mdu199.full.pdf+html
[8] Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials
??? Yang, James Chih-Hsin et al., The Lancet Oncology , Volume 16 , Issue 2 , 141 – 151
[9] http://link.springer.com/article/10.1007/s00330-015-3697-0/fulltext.html

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Advantages and Challenges of Conducting Clinical Research in South Africa

Get To Know The South African Healthcare System

The South African healthcare system consists of public healthcare, which is financed and managed by the South African government, and private healthcare, which is primarily funded by health insurance and private direct fee for service payments. Private healthcare consumes more than 50% of total healthcare spending in South Africa, but only services about 20% of the population able to afford health insurance or direct funding of their healthcare needs.

South Africa Flag RoundThe Attraction of South Africa as Clinical Research Destination

South Africa is classified internationally as a developing country and is often viewed by the less-informed as a poorly developed African country. This is far from the truth.? South Africa has a long history of conducting clinical research; this translates to interest of the medical profession in furthering their knowledge and remaining at the cutting edge of medical development. This is a good indication of the pool of experienced clinical research staff available for research, which is growing and developing as the research environment changes over the years. Clinical research experience is of paramount importance in the South African research environment: it is a regulatory requirement that investigators may only participate as principal investigator after having participated in at least two different clinical trials as a sub-investigator.

A Sophisticated Infrastructure and Clinical Trial Support System

South Africa has a sophisticated infrastructure and clinical trial support system available. Laboratory support to process and analyze blood and tissue samples is readily available in all the large metropolitan cities in South Africa. Most, if not all, of the major laboratories have a clinical trial division that specifically caters for the clinical trial environment, and usually have some partnership/working relationship with the large multinational analytical laboratories. All FREEPIK Medical Imagesthe clinical laboratories are audited and accredited by SANAS. These facilities meet all of the international standard requirements.

Product Depots with Strict Control Mechanisms in Place

As South Africa is located quite a distance from the major manufacturing facilities in the USA, Europe and Asia, investigational product depots are often used to import and distribute clinical trial products to site. These facilities adhere to all international packaging and manufacturing (GMP) and clinical trial requirements (GCP). As they generally receive, store, and distribute clinical trial investigational product for a number of different studies and companies, they have very strict control mechanisms in place to ensure confidentiality and safety of clinical trial product. They are able to manage all types of investigational product at all temperature ranges.

Interested in more in-depth information on this topic? Download our complete article from the May 2014 Journal for Clinical Studies:

CTA Button So Africa




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Immune Manipulation in Cancer Treatment: From Wishful Thinking to Tumors Shrinking

Colin Weekes MD PHD AGICCDr. Colin D. Weekes, Ph.D, PI at UC Denver for The Academic GI Cancer Consultant Consortium (AGICC) of The Oncology Consortia of CRITERIUM, INC.

The Holy Grail of cancer therapy has been to cause tumors in patients to disappear with minimal adverse effects on normal tissues. It has been clear, in concept, that one way to achieve this end would be to use the specificity implicit in the human immune system to recognize and destroy cancer cells while sparing normal cells.

Over the last 40 years there have been many attempts to stimulate the immune system in cancer patients in the hope that the this nonspecific stimulation would cause the immune system to recognize and destroy cancer cells. The literature is peppered with trials using non-specific immune stimulating adjuvants like BCG (Bacillus Calmette Guerin). Although some studies suggested some traces of antitumor activity, the overall assessment was negative. Dramatic and clinically meaningful responses didn’t occur. Other approaches to stimulate immunity by infusing patients with cells thought to have antitumor activity using auto and allogeneic stem cell transfer were both toxic and clinically disappointing. The adoptive transfer lymphoid cells, which had been ‘educated’ in vitro to recognize and destroy patient’s cancers (IL2/LAK and TIL infusions) tended to be very toxic. Although significant responses occurred, they were rare and were obtained with toxic side effects that were frequently very severe.

Recently, there have been examples of more significant, more specific and more sophisticated Chemistry behind cancer researchimmune manipulation that may be the leading edge of immune therapies that will be widely applicable to patients with cancer. What may be a ‘breakthrough strategy’ of immune manipulation in cancer has been demonstrated in melanoma. The FDA recently approved the monoclonal antibody Ipilimumab for use in patients with metastatic melanoma. This therapy is unique because its mechanism of action is to increase T-cell antitumor activity by blocking factors suppressing T-cell antitumor activity. Thus the intrinsic antitumor immunity in patients is allowed to function and results in meaningful clinical results (improved survival). Ipilimumab has the capability of producing autoimmunity since it blocks suppression of immune activity. However, clinical toxicity seems manageable. Other types of cancer may benefit from Ipilimumab or therapies with a similar mechanism of action.

The second example of a very intriguing immune manipulation in cancer has been reported this week from Rosenberg and colleagues work at the NCI. This group has been studying Adoptive Cell Transfer (ACT) in patients with metastatic cancer for the last 35 years. ACT, although frequently very toxic especially when given with high dose interleukin-2 (IL2), occasionally resulted in tumor regression. Rosenberg’s group now report results in a patient with metastatic bile duct carcinoma who had had very meaningful tumor responses to ACT using a subset of TIL (Tumor Infiltrating Lymphocytes) selected to be cytotoxic to cancer cells carrying a mutation, ERBB2, of an ERBB2 interacting protein. Toxicity of ACT in this setting is manageable and the patient’s performance status after therapy is excellent.

So why be excited about Ipilimumab and the admittedly, very early results of the newest iteration of ACT from the NCI group? First, the use of immunotherapy may be able to circumvent inherent chemotherapy resistance. Secondly one can imagine that ACT with specific tumorcidal T-cells might combine very nicely with Ipilimumab like agents which enhance T-cell mediated tumor cell death. Further evaluation of this strategy may warrant further testing.

Maybe, indeed, we are leaving the age of wishful thinking and are closing in on a new age of tumor shrinkage in the immune therapy of cancer.

For more information on the consortia model for drug development in oncology trials, please visit our webpage for AGICC and AMyC.

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A Novel Drug for Treatment of Necrotizing Soft-Tissue Infections

Criterium, Inc., a full-service CRO is proud to be the CRO of record as the supplier of services and support for this important trial. Further study details are provided by the pharmaceutical development sponsor, AtoxBio Ltd. on ClinicalTrials.gov

Clincial Trial Results ReportA complete article detailing the trial and its current progress was highlighted in JAMA’s April 2014 issue in print and online (http://archsurg.jamanetwork.com/article.aspx?articleid=1859986). This is a study to evaluate the safety and pharmacokinetics profile of different doses of AB-103 administered to patients diagnosed with Necrotizing Soft Tissue Infections that are scheduled for an urgent surgical intervention as part of their standard of care. The primary study hypothesis is that AB-103 can be administered safely to the patients presenting with Necrotizing Soft Tissue Infections. Secondary endpoints are efficacy by exploratory descriptive analyses of specific efficacy endpoints from three outcome domains to demonstrate treatment benefit of AB-103 in comparison to placebo in patients with Necrotizing Soft Tissue Infections.

The efficacy domains Lab-Beakersare:

  1. Clinical status domain
  2. Pharmacoeconomics domain
  3. Systemic and local inflammatory biomarker domain

Criterium, with extensive experience in dermatology and infectious disease indications, particularly with wound and burn treatments, provided services for data and project management, clinical and medical monitoring, biostatistics, safety, regulatory support, and medical writing.

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Clinical Trials Monthly Case Study Analysis

Each month, we investigate a different Clinical Trial Case Study that posed us with a challenging question; this month it’s a look at INFECTIOUS DISEASE, regulatory issues and patient enrollment:

We asked ourselves:
A Phase III study required by the World Map Color - NOAM-SOAMFDA for approval was stalled at its North America sites and regulatory processes in South America prevented significant contribution to these studies. There were multiple rejections because this infectious disease study required a placebo control. The study recruitment by another CRO was not met in the previous two seasons.

Criterium offered an experienced team in the Southern Hemisphere to get approval by the regulatory authorities of this placebo-controlled respiratory infection study, to extend the recruitment to 10 months of the year and to enroll at a higher rate per site than the previous seasons’ site enrollment rates.

Criterium’s team averaged more patients per site than the Northern Hemisphere at a high compliance rate for the target micro-organisms.

What If: The client could have continued recruiting patients in the Northern Hemisphere winters, thereby further extending the length of the study.

Results: Criterium managed the regulatory process to receive approval for the study on the first agency reviews and accelerated enrollment with its experienced team in South Africa and New Zealand.

Read more of our successful case studies: https://www.criteriuminc.com/case_studies.php

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How does Criterium Rescue a study experiencing recruitment obstacles?

Global Clinical TrialsOne of the major requirements for a clinical trial to be successful involves the recruitment of an adequate number of participants so that?accurate scientific conclusions can be made. “Adequate” means that an appropriate sample size has been calculated such that even when some drop out of the study, as is commonplace in clinical research, the remaining enrollment will be adequate to allow meaningful evaluation of data.

A problem arises when a study is in progress, but too many participants leave the program so that the remaining number is too small to provide the required amount of data to provide a statistically significant result. It is our experience that this occurrence often leaves the Sponsor in a position where they begin to seek alternative options in managing the study.

Analyzing the fall-off to get back on track

As a CRO we are experienced clinical trial project management specialists. We know how to turn a slow recruiting or high dropout study into one that fulfills the requirements of the statistical analysis plan. We return the study to a viable and productive state using the most cost effective methods. We analyze recruitment and retention plans and identify the problems.

Once identified, we provide suggestions and an implementation plan for how they can be resolved. Our step-by-step approach includes the following:

1) An intense review of the study with the study team. We develop a thorough understanding of all aspects of the clinical trial including the recruitment strategy that was implemented to understand the shortfalls.

2) We gather as much information as possible in order to identify what the recruitment and retention problems might be caused by through the conduct of the following types of field interviews.

  • People working at sites that are successful and sites that are struggling
  • Other identified knowledgeable sources that are not actively involved in the study but may provide valuable input,
  • Physicians and community groups who have the potential to provide referrals

3) We analyze the data we have collected in order to identify the factors that are responsible for recruitment and retention obstacles.

4) We provide you with a detailed report of our findings and the most cost effective solution(s).

5) We meet with you in person, whenever possible, to review, discuss and brainstorm ensuring that we rank the obstacles from most to least critical.

In this way, we prioritize the solutions — especially when dealing with budgetary constraints. Clinical Trial RescueBy gaining important feedback, using our own experience and by working together through a team approach, our clinical trials project management team is able to provide you with a complete understanding of the recruitment and retention obstacles faced by your study.

Our experience and confidence in this approach allows you to take immediate action to get your study back on track towards meaningful and significant results.

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Global Clinical Research – Israel’s Development Environment

As clinical research is an essential step for pharmaceutical companies, Israel has become a hub for clinical research opportunities, and is becoming known as an excellent arena in which to initiate trials. Israel has made significant theoretical and practical contributions to the biotechnology revolution and has developed an advanced infrastructure of medical and paramedical research as well as bioengineering capabilities. Biotechnology, biomedical, and clinical research account for over half of all scientific publications. The country’s industrial sector has increased its activities in the medical field to capitalize on its extensive knowledge base. All research resources are provided to local pharmaceutical companies and related institutions.

Israel Pharma Development
Globally competitive with excellent resources and talent

From the Global Competitiveness Report 2012-2013:
Israel is rated 1st in R&D expenditure as % of GDP 1
Israel is rated 1st in quality of scientific research institutions 2
The country’s main strengths remain its world-class capacity for innovation (3rd), which rests on highly innovative businesses that benefit from the presence of the world’s best research institutions geared toward the needs of the business sector. Israel’s excellent innovation capacity, which is supported by the government’s public procurement policies, is reflected in the country’s high number of patents (4th). Its favorable financial environment, particularly evident in the ease of access to venture capital (3rd), has contributed to making Israel an innovation powerhouse.

Knowledge and Skill
What sets Israel apart from other potential options? One of the major reasons associated with Israel becoming an excellent research option relates to its knowledgeable workforce. The number of doctors and/or scientists per capita is high within Israel. Global clinical research performed within the nation succeeds because of the proficient talent on hand. These doctors and scientists include some of the finest minds in the world. 6 Israelis in the last 10 years have been awarded Nobel Prizes in the fields of Economics or Chemistry.

One of the fastest growing technology businesses in Israel is life sciences, with over 1,000 companies exporting over $6 billion in pharmaceuticals and medical devices. One well-known Israeli invention is Given Imaging‘s Pillcam, which allows physicians to examine a patient’s gastrointestinal tract with a swallowable camera. The generic pharmaceuticals giant Teva has played an important role in lowering the price of many drugs, as well as bringing to market novel drugs such as Copaxone for multiple sclerosis.

Israel provides an excellent Pharma development environment
Israel provides an excellent Pharma development environment

FDA Recognition
Why is Israel an outstanding option for your pharmaceutical development? It may have something to do with the nation being recognized by the FDA for all related clinical trials and associated research. FDA clinical trials can be launched immediately in Israel. International companies are enthusiastic to join Israel’s rise as a place for global clinical research. World renowned companies are launching ventures to produce high-quality testing facilities within Israeli cities. All research and manufacturing takes place within these facilities. Interested companies have access to their well-regarded doctors aiming at progress and innovation.

Efficiency Creates Quality
Clinical research is successful when there is an organized, efficient set up to help support it’s functioning. Israel is a cohesive nation that is controlled under one national health program. This enables access to all citizens in the form of their identity cards. All clinical trials launched and established in Israel get off the ground quickly in comparison to other nations around the world. Pharmaceutical, Biotechnology and Medical Device companies are typically approached by Israel to conduct clinical trials within the nation for clinical trials ranging from cardiovascular diseases to neurodegenerative disease. International companies are able to run thorough, professional research trials in an organized manner. This efficiency is important for companies aiming to deliver top-quality results in a short period.

OECD Science, Technology and Industry Scoreboard 2011.
Israel’s Ministry of Foreign Affairs (www.mfa.gov.il)
1 International Institute for Management Development (IMD) Global Competitiveness Yearbook 2011.
2 World Economic Forum (WEF) Global Competitiveness Report 2012-2013.

Top photo of Jerusalem by Alex Bruda

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