Veeva’s Survey Reveals Clinical Operation Professionals’ Desire For Unity

Veeva Systems, a California-based cloud computing company, recently released the 2017 Unified Clinical Operations Survey, their annual survey with clinical operation professionals. The results of the survey reveal a desire to unify applications across clinical operations.

According to the survey results, 99% of respondents cite the need to unify applications, including clinical trial management systems (CTMS), electronic data capture (EDC), and electronic trial master files (eTMF), across clinical operations. Veeva wrote in their publication of the survey results that faster study execution (65%) and improved study quality (63%) are the top drivers for a unified clinical model, according to the respondents, which is characterized by end-to-end processes and systems, seamless collaboration among stakeholders, and greater insights across the clinical lifecycle to improve study performance.

300,000 surveys were initially sent out to individuals who marked themselves as clinical operation professionals, and 1,000 of those were completed. From there, Veeva checked the qualifications of the respondents, making sure the respondents did hold clinical operations and if they were involved with a sponsor or a CRO. Of 1,000 completed surveys, 300 were certified.

Veeva has been conducting this survey since 2014, though the focus of the survey has changed over the years. Initially the survey was focused in on the challenges and opportunities surrounding moving the eTMF from primarily a paper set of processes and artifacts to an electronic set of processes and artifacts, Jennifer Goldsmith, senior vice president of Veeva Vault at Veeva Systems, told Clinical Informatics News.

“Part of the reason for that was that around that timeframe we started to see the global health authorities taking a much greater interest in how TMF information was being managed and stored. So in section readiness as well as quality timeliness metrics became very important for those organizations. Those first couple of surveys really focused in on that movement,” she said. “This last survey we shifted [the focus]. We started looking not just at the one component, which is the [eTMF], but really at the broader clinical ecosystem to understand from a clinical trial perspective what are some of the challenges and the opportunities facing clinical operations professionals today.”

The “challenges and opportunities” that clinical operations professionals face stem from the complexity of today’s clinical trial space. Goldsmith says there was a push several years ago towards outsourcing, with several products in the space today being codeveloped and comarketed. According to the results of Veeva’s survey, easier collaboration is a must-have among 52% of the global stakeholders surveyed in order to unify clinical operations.

A tangible result from this need can be found in the use of eTMF as opposed to paper TMFs. In the 2014 survey, only 13% of trial sponsors reported using an eTMF application. According to the 2017 survey, that number has increased to 31%. Also, only 16% of sponsors say their clinical operations departments use paper for most or all of their TMF documents. This is a notable change compared to the 2014 survey where 41% of sponsors were using paper.

“It doesn’t surprise me,” Goldsmith said when reflecting on this shift from paper to electronic trial master files. “What we’ve seen in the last two years is a massive shift for pharma, which, as you know, typically moves very slowly… Which I think has been driven [without any direct correlation] by a couple of key factors. One is the need to execute more quickly on all processes, the pressure to get things to market faster with less cost, as well as the need to increase quality overall.”

Veeva’s official release of the 2017 survey comments that “Modern cloud-based eTMF applications have a direct impact on improving collaboration. When asked what benefits were achieved after implementing an eTMF application, almost half (45%) of sponsors report easier collaboration with partners.” Goldsmith spoke about this statistic and its standing with the 16% of sponsors who still use paper TMFs. Geography plays a big factor in the continual use of paper, she said. “I would speculate that if you’re in an area of the world where you may not have access to the types of information systems you would have in the US or in Europe, that would prevent you from [using eTMFs].”

Overall Goldsmith is optimistic about where the clinical application space is going, and sees areas where both the space and the survey itself can improve.

“We need to dig a little bit more deeply into the why of why people find it important to have a unified environment,” Goldsmith said. “One of the interesting things to me were the challenges that bore out [the 99% agree on collaboration]. None of the systems today are highly unified or highly integrated… What I hope to see over the course of the next few years is that these challenges overall become less prevalent.”

New Recommendations for speeding approvals of Global Clinical Trials

In 34th Apex Committee which was held on 02 June 2017, there were recommendation to remove three tier review of the studies in India. Here are the highlights

The Committee was apprised that the system of examination of proposals in CDSCO has since reached a maturity and, therefore, it will be appropriate that the approval processes should be streamlined. After discussion, it was decided that:

(i) the proposals relating to GCT (Global Clinical Trials) should be placed before the SEC and where these are accepted/rejected by the SEC, no further approval of the Technical Committee or Apex Committee will be required;

(ii) in cases, where DCGI is not in agreement with the recommendations of SECs in case of clinical trial application, the matter may be placed before the Technical Committee for a final decision within a month of the recommendations of the SEC;

(iii) the cases rejected by the SEC shall, in case the applicant feels aggrieved, be placed before the Technical Committee for its consideration. Where the Technical Committee decides, for reasons to be recoded in writing, to overrule the SEC, the decision of the Technical Committee shall be final;

Please find attached the full minutes of the meeting

Minutes of 34th Apex Committee 2 june 2017

Once the recommendations are implemented, the approval timelines shall significantly reduces to 3 months or less from present 6 months.

India to unveil new drug policy: officials

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India is expected to roll out a new and devise rules for clinical trials that may bring new projects to the country, a top Indian official have said.

A team of Indian officials led by G N Singh, Drug Controller General of India, said a set of new procedures to facilitate clinical trials are expected to be unveiled shortly.

Addressing the annual US-India BioPharma and Healthcare Summit in Boston on Thursday, Singh said the Indian government is working with stakeholders to devise new rules for clinical trials that are expected to bring new projects to India.

Over the last few years, clinical trials in India slowed down amid tedious court litigation and rising protests from health activists on issues related to informed consent and compensation norms, an official statement said.

The government, in consultation with stakeholders, has devised new rules that will require more information of the patients enrolling themselves for clinical trials, Singh said at the day-long conference organised by the ‘USA-India Chamber of Commerce’.

In his remarks, Singh talked of efforts to integrate scattered laboratories that can help avoid duplication of research and accelerate the process of drug development.

The government is keen to work on three broad categories: harmonise standards, convergence of regulatory practises and avoid duplication, Singh told the leaders from pharma industry and research companies.

This year prominent attendees included Elias Zerhouni, global R&D head at Sanofi, Andrew Plump, chief medical and scientific officer, Takeda Pharmaceuticals, William Chin, executive VP and chief medical officer, PhRMA, William Hait, global head, R&D, Janssen Pharmaceutical, James Bradner, president, Novartis Institute of Biomedical Research, David Nicholson, chief R&D officer, Allergan and Martin Mackay, executive VP and global head of R&D, Alexion Pharmaceuticals.

In his address, R K Vats, additional secretary, Union Health Ministry, underlined the government’s commitment to make business easier for the industry.

He also asserted on the need to have affordable drugs for the Indian patients given that most of the healthcare expenses in the country is paid by the patients, unlike reimbursement models followed in developed markets like the US.

Leaders participating in the summit represent over $45 billion of the R&D budget. This represents over 70 per cent of the global R&D spent in the private sector, said Karun Rishi president of the

“This is huge. This group of committed and passionate people are a source of hope for the patients. India has a great, yet unrealised potential to play an important role in the BioPharma research and development,” Rishi said.

During the meeting, speakers participated in engaging discussions that ranged from the latest trends in drug discovery to development of rare and neglected diseases and how those could be made accessible in resource-starved settings.

Discussions also focused on developing of vaccines to be prepared for unforeseen medical emergencies such as the outbreak of Zika and Ebola viruses that can potentially cause devastating consequences and kill thousands of people.

Most speakers agreed that given the longer timelines required to develop vaccines, there is a general lack of sustained attention for vaccines research, the statement said.

Current Challenges in Clinical Research Compliance

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Compliance with the rules and regulations related to clinical research is like working your way through a maze, and the federal agencies tasked with clinical research oversight can sound like alphabet soup to the uninitiated. Clinical research regulatory oversight is the responsibility of governmental agency: the Central Drugs  Standard Control Organization  (CDSCO), Institution Ethics committee (IEC) and Sponsor. Keeping abreast of all the rules, regulations and compliance issues related to clinical research can be a daunting task.

Human subject protection is the highest priority while conducting clinical research. In recent years, clinical research has come under increased public scrutiny due to media attention related to institutional research “shut downs” and subject deaths. Due to this level of heightened awareness, the compliance bar has risen for clinical research. This is all the more important for Indian Pharma companies as India is the largest provider of generic drugs globally with the Indian generics accounting for 20 per cent of global exports in terms of volume.The balance of this paper highlights challenges and opportunities related to clinical research compliance including areas possibly targeted by federal regulators, IEC and Sponsors.

95%  of Regulatory Consultant hired by Pharma companies and CRO are not skilled enough to understand the science behind the clinical development of product. Knowing how to ensure a submission is fileable, reviewable, and approvable requires specific experience, not just extrapolation from early phase work. In addition, gaining approval from a new indication for a marketed product has some  similarities to a new NDA or BLA, but is less complex and has fewer cross-functional challenges

 A survey conducted by Deloitte suggested poor compliance management, internal controls, secured data and quality systems and lack of skilled resources are big concerns for India’s fast growing life sciences sector. About 55 per cent of survey respondents indicated that their compliance teams were not adequately trained to address regulatory requirements. Around 48 per cent of survey respondents felt that compliance strategy was not a key area earmarked for investment in their organisations, indicating that perhaps the senior management did not consider this area as high-risk with serious consequences in the event of non-compliance, said the report.

India has about 546 facilities approved by the US drug regulator, the US Food and Drugs Administration (FDA) and 857 facilities have approval from the UK regulator MHRA. In the last two years, the US FDA and Canada’s regulator Health Canada had banned or warned over 25 Indian drug firms for non-compliance with the standards. These include many leading drug companies like Sun Pharma, Ranbaxy, RPG Life Sciences and Wockhardt.

In a bid to bring drug quality norms in India on a par with global standards, the Central Drugs Standard Control Organization’s (CDSCO) engagement with global regulators has increased significantly over the last two years. Indian regulators have been a part of 30% of about 150 inspections conducted by the US FDA in the last one year. On its part, the US FDA has been informing the CDSCO at least seven days in advance about their routine inspections of drug manufacturing facilities in India.

Sharing of information between US FDA and CDSCO has increased and both the regulators are interacting almost on a weekly basis, Mathew Thomas, director of US FDA’s India office said in a presentation at the conference.

Meanwhile, the UK Medicines and Healthcare Products Authority (MHRA) has signed a Memorandum of Understanding (MoU) with CDSCO for collaboration on quality management.

The increasing dialogue between regulators is important as it helps Indian Pharma industry to understand the expectations of global inspectors when they visit their manufacturing facilities and also helps in upgrading Indian quality norms.

The IEC is tasked with protecting the rights, safety and welfare of participants in research studies. The IEC is guided by the Belmont Report and is subject to regulation by federal oversight agencies, including Schedule Y requirements. The Principal Investigator must ensure the IEC is provided with all necessary and relevant information to allow an effective review of the research prior to study commencement. After the initial approval, the IEC must be kept informed of the progress of the study through the continuing review process and be informed of any changes to the research.

Indian industry needs to change its mindset towards compliance. Specially, the convergence of four key technologies to drive innovation; social networking, mobile computing, analytics and cloud computing (SMAC). Though each of these technologies has its unique impact, they also complement each other in order to drive business transformation. Social media defines ‘who we work with’ and enables collaboration and communication with employees as well as customers. Mobile devices create a platform ‘where we work’ providing anytime, anywhere access to applications stored within the cloud and other data sources. Analytics identifies ‘what we work on’ and helps us make actionable sense of data. Cloud enables ‘how we do the work’ and contains information and applications. These technologies, jointly foster innovation through new ways of product development, customer service and interaction, partnerships, thereby creating value and stimulating success. Although Pharma managers are knowledgeable about the standards and guidelines for compliance, poor application of that knowledge in day-to-day work and lack of emphasis on training operating personnel, causes serious issues. Shop floor managers also need to overcome pressures from senior management on delivery targets. 

Pharma companies need to take a 360-degree approach for their compliance programmes encapsulating not only compliance with regulatory requirements but also their internal code of conduct and ethics code. 

A compliant Pharma or life sciences company with a strong tone at the top will gain better competitive advantage in this economic environment in the long run.

About the author:

Tarun Pandotra is a clinical operation professional with over twenty year’s experience of clinical research in project management, clinical operations and regulatory affairs roles. Involvement in phases I – IV with experience from study start up through to close out. Tarun has a wide experience of therapeutic area indications most recently  Oncology, haematology, cardiology & Infectious diseases.

Tarun has worked with many Pharma companies like AstraZeneca, UCB Pharma and CROs like PPD and PRA. He is currently Founder and Director of Global Regulatory & Consumer Insights (GR-CIS).

He has extensive international experience, with commitment to delivering quality results, establishing ethical guidelines, and motivating staff for peak performance and program success.

 

 

EMA Offers Draft Guideline on Trial Master Files

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections. 

“This guideline aims to collate and explain the requirements for the TMF as covered in the Regulation [(EU) No 536/2014] and ICH-GCP E6 to assist organisations in maintaining a TMF that facilitates trial management, GCP [good clinical practice] compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitization and consecutive destruction of paper documentation,” EMA notes.

Sponsors and investigators are expected to keep the TMF up to date and ensure that it is complete at the end of a trial, EMA says, noting that sponsors are also recommended to conduct routine quality assurance checks of the TMF.

In terms of preparing for a TMF inspection, the guideline says inspectors should have read-only access, though organizations “should be aware that GCP inspectors may have rights to seize original trial documentation if circumstances arise that require it.”

And according to Article 58 of the clinical trial regulation, the sponsor and the investigator “shall archive the content of the clinical TMF for at least 25 years after the end of the clinical trial.”

Guidelines on Trial Master Files

Google Offshoot Starts A 10,000-Person Study To Plumb Human Biology

It’s a realistic blueprint for how tech could change medicine. But it’s also an emblem of how long that transformation will take.

Verily, formerly known as Google Life Sciences, plans to begin a long-awaited 10,000-person study to explore the biology of healthy people in the next several months, the company says. The study will initially be run at Stanford University and Duke University, and could take a decade.

“No one has attempted this deep a dive into so many individuals over so long a time,” says Sam Gambhir, chair of the department of radiology at Stanford, of the effort, called the Blueprint Study.

Each patient will undergo a battery of physical tests, including genome sequencing, a CAT scan of the chest to check for the buildup of calcium in heart arteries, eye exams and blood tests. They will return every year for five years for follow-up tests. They will also wear Verily’s new investigational device, the Study Watch, which will measure electrocardiogram (ECG), heart rate, electrodermal activity and inertial movements, and keep a sensor under their mattresses to measure how well they sleep.

 None of this will happen overnight. Google Life Sciences first announced something called the Baseline Study in July 2014. At the time, the company described a 175-person effort. Jessica Mega, the chief medical officer at Verily, says that was a pilot study. As of yet, no results from it have been published.

Gambhir says a 10,000-patient effort was in the works from the moment he first met with Verily chief executive Andy Conrad three years ago. What took so long? For one thing, developing the Study Watch, a device that was robustly able to track real-time data, and also developing technology that would allow patients to enter new health information in real time in a smartphone, Mega says. More than that, the study required developing a new data infrastructure to keep track of all the data and to make it searchable.

But it’s going to take a long time for the effort to run. Gambhir says it’s currently expected that it will take four years to recruit all 10,000 patients, starting at Stanford and Duke and expanding to other academic medical centers over the coming years. Each patient will be followed for at least five years, meaning it will be almost a decade before the initial phase of the research is complete.

Mega and Gambhir say that they expect information will emerge faster that that. Hypothetical queries could include whether sleep affects blood test results that are correlated to the immune system, or if particular proteins raise the risk of cancer.

Still, even many of those results will not be answers, but hints. A result from a study like this can only sometimes be taken as medical truth. More often, Gambhir says, it will be a new hypothesis that must be tested in a second clinical trial. Tech types sometimes like to imagine big data approaches could replace clinical trials. Alphabet (formerly Google), the parent company of Verily and Google, seems to have come to a different conclusion.

Technology has improved the kind of data we can collect about the human body, and will allow us to deal with a lot more data. But getting information will require the same kind of time-consuming collection of information that led us to start understanding the causes of heart disease, with the Framingham Study. It started following people in 1948, and has now tracked three generations and resulted in a thousand scientific papers.

The tech may be fast. But biology is still slow.

FDA in India – Championing a Culture of Quality

One of FDA’s most strategic outposts is in India, the seventh largest supplier of food and second largest supplier of pharmaceuticals and biologics to the United States. The agency’s office, located in the capital, New Delhi, works to ensure the safety and security of food and the safety and efficacy of medical products exported from India to the U.S.

To achieve that goal, the India Office, directed by Mathew Thomas, conducts inspections of Indian medical products and foods facilities that export to the U.S. The office also assists and trains regulators, industry, and other stakeholders in developing and maintaining the quality, safety, and effectiveness of the FDA-regulated products they export.

It’s important for the office to consult regulatory authorities in India to build confidence in each other and to develop quality standards that both countries can trust.

I had the privilege of joining Director Thomas last month for meetings with our regulatory counterparts – the Indian Export Inspection Council (EIC), the Food Safety Standards Agency of India (FSSAI), the Drugs Controller General of India (DCGI), and the Joint Secretary of the Ministry of Health and Family Welfare.

Despite the diversity of these agencies’ mandates and priorities, a common theme coming out of these meetings was the recognition of the mutual benefits we realize by working together to enhance the effectiveness of our regulatory systems and to advance risk-based and science-based approaches to food and medical product regulation.

Along with other FDA experts, I also participated in a Global Food Safety Partnership (GFSP) Governing Council meeting and the Indian Pharmaceutical Alliance (IPA) Second Forum, titled “Towards Excellence in Quality.” Hosted by the Word Bank, the GFSP is a public private partnership, established in 2012, which brings together governments, industry, multilateral organizations, and other stakeholders in support of stronger food safety systems. Since its founding, the GFSP has worked with China, Indonesia, and Vietnam. During my visit, we had initial GFSP meetings with Indian regulators, to explore potential synergies as they look to bolster their food safety systems and maximize their investments. FDA’s India Office is well-positioned to help the Partnership and India explore how best to meet these goals.

The IPA Forum brings together CEOs of pharmaceutical firms, manufacturers, regulators, and other national and global stakeholders who have a role in shaping India’s complex and diverse manufacturing environment to produce safe, effective, high-quality medical products.

Over the past decade, the Indian pharmaceutical market has grown by nearly 14 percent and continues to experience massive growth. However, in order to fully realize the nation’s potential as an important player in the global pharmaceutical industry, India’s regulatory infrastructure must keep pace to ensure that global quality and safety demands are met. Quality issues are an ongoing challenge for the Indian pharmaceutical industry. Of 42 warning letters issued by FDA’s Office of Manufacturing Quality last year, nine went to Indian facilities. The IPA is working to communicate to its diverse members why quality matters and how to achieve it. Thus, the general theme of its Second Forum “Towards Excellence in Quality,” was an incredibly relevant topic if the global market for FDA-regulated products is to be strong and secure.

No one wants resources wasted on ineffectual development and weak processing or manufacturing systems that could actually impede product success. We all want greater competition, increased options for consumers and patients, and more affordable alternatives to comparable products.

Participants agreed that achieving quality requires regulators and industry alike to champion and advance a quality culture throughout the product life-cycle, by effectively employing the use of data and science and requiring greater transparency.

While I was in India, it was really gratifying to witness the high-esteem and trust Indian regulators and industry have for FDA, and our India Office. In turn, whether it is through their response to inspectional observations, their participation in trainings and seminars or their readiness to share strategic information, we see India committing to quality and compliance. Indian regulators and industry both recognize that a quality culture is imperative if India is to increase productivity, reduce compliance risk, lessen rework, and minimize supply interruptions that result in lost revenue and increased risks to public health.

This greater emphasis on quality will also allow India to participate more fully in existing global venues such as the International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S) – which will enable stronger collaboration and synergies among regulators.

Quality is good for economic development, the market, and most importantly, patients and consumers everywhere. FDA’s Office in New Delhi looks forward to continued collaboration with our Indian regulatory colleagues to champion a culture of quality.

Mary Lou Valdez is FDA’s Associate Commissioner for International Programs

Report: Global clinical trial service market will reach $64B by 2020

Research and Markets research forecasts that the global clinical trial service market will likely reach more than $64 billion by 2020, up from $38.4 billion at present, representing a CAGR of 9% between 2015 and 2020. By 2020 the average clinical trial outsourcing penetration will likely reach around 72%. In other words, by then close to three fourths of clinical trials will likely be performed by professional CROs.

The report, “The New Trends of Global Clinical Development Outsourcing Market,” provides unique insights into the current development states and the future growth potentials of the global clinical trial service market. The report is designed to reveal the latest development trends of this outsourcing service market in both the developed countries and the emerging countries, including the detailed insights of the new clinical trial outsourcing strategies of major pharma and R&D-focused biotech companies and their current service demands in each of these regions.

The report provides readers a complete picture of the current state of the global clinical trial service market and a clear insight of its future growth potential.

Key Findings of the Report

  • It has commonly agreed that clinical trials have become increasingly complicated and take more effort to manage.
  • Moreover, the current global environment is also forcing drug companies to come up with better drugs that are developed at lower cost.
  • Challenged by the situation, a new model of virtually integrated drug development has evolved.
  • At present the developed countries still dominate the global clinical trial market.
  • Today those major CROs in the developed countries that have sufficiently large facilities, globe-wide capacity, networked investigators, patient database and effective recruiting tools, etc. are increasingly approached by drug companies for close partnership collaboration. It thus results in more consolidations through M&As in the CRO industry.
  • On the other hand, because of the increasing complexity of clinical trials, those small to medium-sized CROs that possess niche technical capability are still needed for functional services.
  • In parallel to the two CRO sectors, the global clinical trial service market is also split between the developed countries and the emerging markets.
  • Among the emerging countries, Asia has become a prominent location for clinical trials
  • As clinical trial cost is still a concern to all drug companies, the CRO model in the low cost regions is considered a right model as long as they are able to deliver the desired quality of service.
  • In the forecasted global market, the developed countries will likely account for about 66.8% by 2020, down from 76% at present; whereas the emerging countries combined together will likely account for 25.2%, up from 15.7% at present.

The top 10 drug launches of 2017

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After an unusually slow year for new drug approvals—the FDA greenlighted just 22 meds in 2016—it remains to be seen whether drugmakers can do much better in 2017. One thing’s for sure, though: No matter what total the industry tallies up this year, the crop will bring some would-be blockbusters and market disrupters.

The top 10 drug launches of 2017

1. Ocrevus 6. Baricitinib
2. Dupixent 7. LEE011
3. Semaglutide 8. KTE-C19
4. Durvalumab 9. Ingrezza
5. Niraparib 10. Spinraza

At the top of the list, according to EP Vantage’s 2017 preview, which ranks the year’s rollouts by 2022 sales, is Ocrevus (ocrelizumab), the Roche multiple sclerosis drug that’s promising to shake things up in more ways than one. In clinical trials, the candidate bested Merck KGaA’s standard therapy Rebif, and it’s also gone where no other MS drug has gone before, posting positive data in patients with the primary progressive form of the disease. Those data will put the heat on other meds—and invite payers to pile pressure onto the segment, too.

Ocrevus isn’t the only new med slated to break into a brand-new market. Analysts think Sanofi and Regeneron hot-shot Dupixent (dupilumab) could make a big splash in severe atopic dermatitis, assuming payers don’t get in the companies’ way. Ditto for Biogen’s Spinraza, which in December became the first FDA-approved product to treat spinal muscular atrophy—but whose high sticker could raise eyebrows at a time when U.S. President Donald Trump is threatening pricing action.

Several of 2017’s launches will mark particularly pivotal points for their companies as their inaugural rollouts. Tesaro is looking for its second-ever FDA approval, while Neurocrine is going after its first, in ovarian cancer pill niraparib and tardive dyskinesia therapy Ingrezza, respectively. And Kite Pharma is aiming to get the first-ever CAR-T cancer drug to market, with a candidate, KTE-C19, that the oncology community will be watching closely as the next big thing in immunotherapies.

Other big 2017 launches won’t necessarily be pioneers in their fields or for their companies, but they could make competitors sweat. Take Novartis’ ribociclib, aka LEE011, which aims to challenge Pfizer’s Ibrance in the CDK 4/6 breast cancer space. Or semaglutide, Novo Nordisk’s weekly GLP-1 drug, a would-be successor to the company’s blockbuster Victoza; the Danish drugmaker boasts some early cardiovascular outcomes data to use in the market-share fight against Eli Lilly’s weekly Trulicity.

And then there are those that have their work cut out for them if they want to crack the industry leaderboard. Eli Lilly’s rheumatoid arthritis remedy baricitinib is hoping to carve out a billion-dollar opportunity in a market where Pfizer’s Xeljanz has faltered. And AstraZeneca’s durvalumab will be weighing into the already-racing immuno-oncology field, to see how many checkpoint inhibitors that market can send to blockbuster land.

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