A recent Wall Street Journal article reported that in the last 10 months, 23 pharmaceutical and healthcare-related companies have gone public in mainland China and Hong Kong, according to data from Dealogic, a research and investment analytics firm. These deals collectively raised $5.37 billion although most of the deals were small: 17 deals raised less than $200 million and eight deals were for $100 million or less, but one deal stands out in particular. In September 2009, Sinopharm Group, China’s largest pharmaceutical company, raised $1.3 billion in an initial public offering (IPO) on the Hong Kong exchange.

To put that $5.37 billion in pharmaceutical and healthcare IPO funding into context, the US biotechnology sector raised only $547 million through IPOs in the first and second quarters of 2010 and $1.1 billion for all of 2009, giving the US biopharmaceutical sector only $1.7 billion in IPO funding during the past 18 months, according to data from Burrill and Company, a South San Francisco private merchant bank. When total financing into public companies (i.e., IPOs, follow-on public offerings, private investment in public equity, and debt) and funding into private companies (venture capital and other private funding) are taken into consideration, funding for the US biotechnology sector is substantially higher, increasing to $8.1 billion in the first two quarters of 2010 and to nearly $19 billion for all of 2009.

So what does this tell us? Although the aggregate size and financing into the US biopharmaceutical sector is certainly substantial, the sector should not take for granted investor interest in China’s domestic pharmaceutical companies. Why is this important? For the large Western pharmaceutical companies, a better financed Chinese domestic pharmaceutical sector poses competition, perhaps not directly for innovator drugs and higher-valued products, but for access to China’s market, particularly given the preference that would be given in China to domestic products and companies. Moreover, the emerging US-based biopharmaceutical sector also should take notice as China’s domestic bio/pharmaceutical players compete for the all-important IPO dollar and potentially other forms of financing.

According to recent data released by Sinopharm from the China Association of Pharmaceutical Commerce, eight China-based pharmaceutical companies had 2009 sales in excess of 10 billion yuan ($1.47 billion). Ranking these top companies in descending order are: Sinopharm, Shanghai Pharmaceutical Co. Ltd., Jointown Pharmaceutical Group Co., Ltd., Nanjing Pharmaceutical Co., Ltd., Guangzhou Pharmaceuticals Corporation, Anhui Worldbest Pharmaceutical Co., Ltd., Beijing Pharmaceutical Co., Ltd., and Chongqing Medicines Co., Ltd. Among the top 100 enterprises, 18 companies had sales revenues of more than 500 million yuan ($74 million).

With China’s pharmaceutical market valued at $76–$86 billion (based on 2008–2013 IMS Health estimates), the key question is how much of the market will be supplied domestically and to what extent will the projected 23–26% compounded annual growth rate (2008–2013) for China’s pharmaceutical market be an engine for growth for China’s domestic pharmaceutical companies.

The bottom line. Don’t discount the potential competition from China’s domestic bio/pharmaceutical companies.

A recent article in the New York Times cited a report by the outplacement firm Challenger, Gray and Christmas, which said that the pharmaceutical industry has cut approximately 34,987 jobs in the first half of 2010. The figures are based on the activity of US-headquartered companies and foreign companies with US operations and includes losses in the US and outside the US for those companies. The figure represented 12% of the 297,677 job losses in the first half of 2010, according to the report, giving the the pharmaceutical industry the dubious distinction of leading private-sector job losses thus far in 2010. Through the first half of 2010, the government/nonprofit sector ranked the highest among all industries with 98,776 job losses, followed by the nearly 35,000 job cuts in the pharmaceutical industry. The retail sector ranked third in job losses at 26,181, the computer sector fourth at 16,964 job losses, and then the telecommunications industry at 16,005 job cuts. In 2009, the pharmaceutical industry ranked third in job losses at 51,549, outpaced only by the retail sector, which cut 85,698 jobs, and the government/nonprofit sector, which reduced employment by 102,302 positions.

Unlike certain industries, such as retail, the computer, and telecommunications industries, which are closely tied to the cyclicality of the economy, the pharmaceutical industry, by providing a healthcare product, had traditionally been largely immune to macroeconomic vicissitudes. But it is those fundamentals that make the recent job statistics even more troubling. The losses reflect ongoing restructuring by Big Pharma companies following merger and acquisition activity or overall cost-reduction efforts as well as a constriction of the labor force among emerging pharmaceutical companies, many of which faced difficulty in securing financing in the recent economic downturn as well as in the inherent uncertainty in drug development.

So, unlike other sectors, where job growth may return with the gradual improvement of the economy as a whole, the pharmaceutical industry is in a transition as it faces increased generic-drug incursion in the innovator-drug sector, fewer new product introductions, and slowing market growth in the large and established markets in the United States and Western Europe. These trends are not new to anyone in the industry, particularly to those who may have been affected, but given the long lead times for product development inherent in the pharmaceutical industry, it doesn’t seem that job gains will be here anytime soon.

The Bloomberg report indicated that sanofi aventis is in the early stages of considering an acquisition of roughly $20 billion or so. The speculated targets of Allergan, Biogen Idec, or Genzyme have product portfolios that are aligned with industry projections of strong growth, namely for specialty drugs and biopharmaceuticals. The market for specialty pharmaceuticals, defined as a class of medications used to treat complex, chronic conditions, comprised 21% of the US market by value in 2009 and increased 7.5% in 2009, according to IMS Health. IMS projects annual growth of more than 10% through 2014 for drugs to treat oncology, diabetes, multiple sclerosis, and HIV. Industry estimates place biopharmaceutical growth in the double digits. This growth compares with near-term estimates of only a 4–7% gain for the global prescription drug market as a whole, according to IMS.

Allergan, a specialty pharmaceutical company that makes eye-care treatments and Botox, had 2009 sales of $4.5 billion, of which $3.6 billion were in specialty pharmaceuticals. Sales of its specialty pharmaceutical sales increased 5.1% in 2009 compared with 2008. Biogen Idec, which announced the appointment of a new CEO this week, is dependent on three major drugs: two drugs to treat multiple sclerosis, Avonex (2009 sales of $2.3 billion) and Tysabri (2009 sales of $776 million), and Rituxan, used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis, and which netted Biogen Idec 2009 sales of $1.1 billion as part of a codevelopment deal with Roche. Genzyme reported 2009 revenues of $4.5 billion, but has experienced recent manufacturing and revenue problems for some of its key products. The company reported first-quarter 2010 revenue of $1.07 billion compared with $1.15 billion in the same period in 2009, reflecting limited shipments of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta) due to product-supply constraints. The company’s first-quarter net loss (based on generally accepted accounting principles) was $114.9 million compared with net income of $195.5 million in the first quarter of 2009.

If sanofi-aventis decides to purse one of these companies or another company, it will join the list of pharmaceutical companies trying to increase revenues through acquisitions. Although not at the scale of the mega-mergers in 2009 (Pfizer-Wyeth, Merck-Schering-Plough, and Roche-Genentech), an acquisition of $20-billion or so would be greater than another recent mid-sized acquisition: that of Solvay Pharmaceuticals by Abbott for EUR 4.5 billion ($6.2 billion), a deal that was completed earlier this year.

A recent analysis by Datamonitor shows how crucial acquisitions have been and will continue to be to Big Pharma as it struggles to increase revenues through organic growth, which has been hurt by fewer and lower-valued new product introductions and increased generic-drug competition. In 1995, sales from Big Pharma were $84 billion, and based on organic growth only, would be forecast to increase to $195 billion by 2014 (an absolute increase of $111 billion). However, the contribution of merger and acquisition (M&A) activity is forecast to lift 2014 sales to $381 billion, augmenting sales by an additional $186 billion. Thus, as a proportion of absolute growth over the period 1995–2014, M&A activity is forecast to account for approximately 63% of revenue growth for Big Pharma companies.

So the conjecture that another Big Pharma company is evaluating its options for another deal is not surprising. But it will be interesting to see what the next marriage in Big Pharma M&A will be.

The HHS report noted that 80% of approved marketing applications for drugs and biologics contained data from foreign clinical trials. More than half of clinical-trial subjects and sites were located outside the United States. Western Europe accounted for most foreign clinical-trial subjects and sites. Central and South America had the highest average number of subjects per site. Overall, FDA inspected clinical investigators at only 1.2% of all clinical-trial sites for applications approved in fiscal year 2008. It inspected 1.9% of domestic clinical-trial sites and 0.7% of foreign clinical-trial sites. The report said that challenges to conducting foreign inspections and data limitations inhibit FDA’s ability to monitor clinical trials, which included problems of having early-phase clinical trials being conducted outside the US without investigational new drug (IND) applications.

In its report, HHS recommends that FDA require standardized electronic clinical-trial data, monitor trends in foreign clinical trials not conducted by INDs, and to continue to explore ways to expand its oversight of foreign clinical trials. Such recommendations are reasonable, but they also raise larger policy questions that come into play with the increased globalization of the pharmaceutical industry. That is, given the nature of the products being made and the attendant regulation that is required, should a different model of business practices and regulation apply to pharmaceutical products compared with consumer and industrial products? Should another set of rules of apply?

There is no easy answer to that question as it requires a balance of free-market principles with public regulation. Drug products, unlike consumer and industrial products, require a higher level of regulatory oversight to ensure their safety and quality. Products developed or manufactured outside the US are neither implicitly better or worse than products developed or manufactured in the US. But given the limitations of financial resources and jurisdictional authority of US federal agencies outside the US, is it a prudent course to have clinical development or manufacturing of pharmaceutical products that are targeted for the US market, to be performed outside the US? Is this question an economic debate of free trade versus protectionism or a broader policy matter in ascertaining the relevance of domestic regulation in a global marketplace? Should regulation dictate business practice or business practice dictate regulation?

It seems now that we have a hybrid response. During the past several years, FDA has responded with the opening of offices in China, India, Central America, and South America as a way to increase its oversight of pharmaceutical development and manufacturing outside the US, which is a good move in the interest of public safety. But again, it raises another broader philosophical question: should federal resources be used to indirectly support offshoring functions outside the US? There is an ongoing policy debate as to how to increase the US position in science, technology, engineering, and mathematics (STEM) with initiatives supporting STEM activities in education and suggestions to foster competitiveness in innovation. But in the case of pharmaceutical products, is there a disconnect in federal policy, where on one hand we want to encourage STEM activities domestically, but on another hand are indirectly fostering STEM activities outside the US?

A lot to consider. Admittedly, it is a difficult balance of short-term, long-term, economic, and scientific goals, but perhaps one in which the sum of the parts rather than the individual parts should be considered.

“…We have a shared vision of personalized medicine and the scientific and regulatory structure needed to support its growth,” said Hamburg and Collins. “Together, we have been focusing on the best ways to develop new therapies and optimize prescribing by steering patients to the right drug at the right dose at the right time. We recognize that myriad obstacles must be overcome to achieve these goals.”

To that end, Hamburg and Collins said in their commentary that the NIH and FDA will invest in advancing translational and regulatory science, better define regulatory pathways for coordinated approval of codeveloped diagnostics and therapeutics, develop risk-based approaches in reviewing diagnostics to assess their validity and clinical value, and make information about those tests more readily available.

They cited data that showed that only about 10% of labels for FDA-approved drugs contain pharmacogenomic information, underscoring the deficiencies in information for advancing personalized medicine “There has been an explosion in the number of validated markers but relatively little independent analysis of the validity of the test used to identify them in biologic specimens,” they said.

To fill this information void, NIH, with advice from FDA, other Department of Health and Human Services agencies, and other stakeholders, is creating a voluntary genetic testing registry as a single public source of information on the more than 2000 genetic tests that are available through clinical laboratories. The registry will include information such as whether a test has been approved by FDA and data on genetic variants.

NIH and FDA also pointed to other efforts, such as a recent NIH-FDA collaboration on regulatory and translational science, announced in February 2010, which includes joint funding for regulatory sciences. They also pointed to NIH-supported research centers, the NIH Therapeutics for Rare and Neglected Diseases Program, the NIH Clinical and Translational Sciences Award Program, FDA’s efforts under its Critical Path Initiative to improve evaluation tools such as biomarkers and assays, and FDA’s Voluntary Genomic Data Submission Program (a forum under which companies can discuss genomic information with FDA separate from the product-review process) as ways in which policymakers are facilitating the advancement of personalized medicine.

Such collaboration is important, but the key question going forward is whether it will be enough to advance a promising but still unknown field. In their concluding comments, Collins and Hamburg likened the government’s efforts to building “a national highway system for personalized medicine.” Let’s hope that we are going down the right road.

While the “US is the undisputed leader in medical advances,” he said, he cautioned against the “danger that we are losing what has been America’s greatest competitive advantage: our genius for innovation….Despite all this progress, despite all these gains, the evidence is mounting that we are facing today nothing short of an innovation crisis in America’s life-sciences sector.”

He cited a study by the think tank, the Information Technology and Innovation Foundation, which ranked the US sixth among the top 40 industrialized nations in innovative-based competitiveness (Singapore, Sweden, Luxembourg, Denmark, and South Korea ranked first through fifth, respectively), but which rated the US last, or 40th among 40 industrialized countries, in what these countries are doing to become more innovative in the future. The study was based on 16 metrics based on indicators involving human capital, innovation capacity, entrepreneurship, information-technology infrastructure, economic policy, and economic performance to evaluate current and future global innovation-based competitiveness.

Lechleiter outlined four policies that he thinks are necessary to sustain and build innovation in the US:

• Broad improvement in science and math education in grade schools and high schools

• Immigration laws that allow and encourage top scientists to choose to work in the US

• A well-funded basic research infrastructure within academic and government laboratories

• Tax policy that fosters innovation, which would include: making the federal research and development tax credit permanent; a federal investment tax credit to provide early-stage financing of innovation-based companies; and the adoption of tax and economic incentives to boost manufacturing and export-related job growth.

Starting a dialogue on tangible ways in which scientific innovation can be fostered is valuable, but too often it is a debate that does not receive the amount of attention that it deserves. Of course, in theory, no one is against using science as a tool for economic advancement. But the devil is in the details, and the approaches, not just in public policy, but also in business strategy and practices, need to be examined to assess how to best mutually support the goal of increasing innovation-based competitiveness.

Merck said it is launching the network in response to an April 2010 report by the Institute of Medicine (IOM) that recommended changes to transform the National Cancer Institute’s (NCI) Clinical Trials Cooperative Group, the program responsible for conducting collaborative large-scale cancer clinical trials at institutions and community-based practices in the US and aboard. The review of the NCI’s clinical-trial program was initiated because of concerns by NCI stakeholders, which included clinical investigators, patient advocates, leadership within NCI’s Clinical Trials Cooperative Group, industry participants, and the NCI that “the program is falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care,” said the report.

In its statement, Merck noted that according to the IOM report, about half of collaborative cancer studies are never completed due to cumbersome procedures, bureaucracy and poor coordination. The report suggested that collaborative-research approaches could be improved by reducing the number of sites, properly funding research efforts, setting strict deadlines and prioritizing studies. Merck says its new oncology collaborative trials network embodies many of these principles and “could serve as a blueprint for how industry and research institutions can work together more efficiently and effectively to expedite the delivery of innovative cancer therapies to patients.”
Merck’s oncology network site currently consists of 15 sites across North America, South America, Europe, and Asia. Through a proposal and feedback process, the research sites will lead the design and conduct of Phase 0 to IIa clinical studies of Merck’s investigational oncology candidates. Every year, the network will enroll approximately 1200 patients in 30 to 40 clinical trials. These studies will include investigator and company-sponsored trials. Infrastructure to consolidate data, specimen-testing results, imaging-testing results, and patient outcomes is being developed, according to the company. “This approach will lead to more informed, data-driven, and rapid decision-making regarding the efficacy and safety profile of compounds and the utility of biomarkers developed by Merck or its collaborators,” said Merck in it statement.

Although focusing on clinical-trial administration, the network, if successfully executed and indeed becoming a model for improving clinical-trial administration for cancer treatments, as Merck intends, would be important for suppliers of clinical-trial materials as well. Delays and logistical difficulties in clinical trials translate into problems for the supply chain of clinical-trial materials and the development and manufacturing organizations that supply those materials. Oncology therapies are a crucial area of development not only for Merck, but for other drug companies as well. An organized effort by a pharmaceutical company to specifically address problems in clinical-trial administration is valuable for potentially accelerating development in a therapeutic area of critical medical need. But the approach also offers, if successfully executed, the potential for other drug companies to apply the approach to cancer trials and potentially to other areas of drug development. This would be a win-win situation for all stakeholders in clinical trials: the suppliers, the pharmaceutical company, and ultimately, the patient.

[orig. published June 8, 2010]

OSHA issued a press release on May 6 and a notice on the same date in the Federal Register to explain its interest in gaining more information on the strategies currently being deployed in healthcare and related work settings to mitigate the risk of work-acquired infectious diseases. OSHA said it would like to collect information and data on the following: the facilities and the tasks potentially exposing workers to this risk; successful employee infection-control programs; control methodologies being used, including engineering, work practice, and administrative controls, and personal protective equipment); medical surveillance programs; and training.

OSHA will use the information received in response to this request to determine what action, if any, the agency may take to further limit the spread of occupationally acquired infectious diseases in these types of settings. OSHA is asking that the comments be submitted by Aug. 4, 2010.

The Centers for Disease Control and Prevention (CDC) works with the US National Institutes of Health to publish biosafety guidelines for protecting workers and preventing exposures in biological laboratories. CDC’s Office of Health and Safety serves as the World Health Organization’s Center for Applied Biosafety Programs and Training. Biosafety is an important part of biopharmaceutical development and is certainly part of the industry’s environmental, health, and safety protocols. By seeking information on the technology changes and best practices as they relate to biosafety, not only in healthcare facilities, but in laboratories, OSHA is seeking to keep pace with evolving and increasingly complex considerations as they relate to biosafety. It will be important to watch what dialogue and subsequent actions may be generated from this initial round of discussion

The significance of the work is that is showed a “proof of principle that genomes can be designed in the computer, chemically made in the laboratory, and transplanted into a recipient cell to produce a new self-replicating cell controlled only by the synthetic genome,” according to a JVCI press release. The researchers recently published their work online in Science (1). The researchers used several procedures they had developed during the past several years to synthesize a genome and transplant it into a recipient cell.

The researchers designed, synthesized and assemblied the 1.08 million base pair Mycoplasma mycoides JCVI-syn1.0 genome starting from digitized genome-sequence information and transplanted it into a Mycoplasma capricolum recipient cell to create new Mycoplasma mycoides cells that are controlled only by the synthetic chromosome (1). The only DNA in the cells is the designed synthetic DNA sequence, including what the authors referred to as “watermark” sequences and other designed genetic variations as well as mutations acquired during the building process. The new cells exhibit the phenotype expected by the authors and are capable of continuous self-replication (1).

The researchers said their work represented the construction of the largest synthetic molecule of a defined structure–almost double the size of a previously reported synthetically produced DNA molecule, according to the JCVI release. With this proof of principle, JVCI will work on creating an organism that contains the minimal genome required to sustain itself and its replication, to be used as platform for analyzing the function of every essential gene in a cell, according to the JVCI release.

The researchers used DNA units made according to JCVI’s specifications by Blue Heron Biotechnology (Bothell, WA), a biotechnology company specializing in synthesizing DNA. Synthetic Genomics (SGI, La Jolla, CA), a company cofounded by Venter, provided nearly $30 million in funding for the research. SGI has a $600-million agreement with ExxonMobil to develop biofuels from algae. SGI and ExxonMobil formed a long-term research and development alliance in 2009 focused on finding and optimizing (through synthetic genome techniques and other more traditional metabolic engineering techniques) algae to produce biological crude oil replacements.

The work of Venter and his team is without question a scientific accomplishment, but the real challenge lies ahead in one day eventually being able to adapt the technology cost-effectively and at a large-scale. The researchers envision that the knowledge gained by constructing this first self-replicating synthetic cell, coupled with decreasing costs for DNA synthesis, will give rise to wider use of the technology to be applied in the development of a range of therapeutic and industrial products. However, it is not yet clear given the time and cost to design new organisms using the technology, whether the technology will indeed be a better approach than using conventional genetic-engineering techniques.

The technology also raises bioethical and other concerns. Following the announcement last week President Barack Obama directed the Presidential Commission for the Study of Bioethical Issues to examine potential medical, environmental, security, and other benefits as well as any potential health, security, or other risks and to report back to him within six months.

In its release, JCVI said it continues to work with bioethicists, outside policy groups, legislative members and staff, and the public to encourage discussion and understanding about the societal implications of their work and the field of synthetic genomics generally. JVCI conducted a study with the Center for Strategic & International Studies and the Massachusetts Institute of Technology, with a grant funded by the Alfred P. Sloan Foundation, to examine the risks and benefits of this emerging technology, as well as possible safeguards to prevent abuse, including bioterrorism. In December of 2008, JCVI received funding from the Alfred P. Sloan Foundation to examine ethical and societal concerns associated with the developing science of synthetic genomics.

As the feasibility of applying the technology and concerns over its use are debated, it is still useful to take a moment to recognize the scientific accomplishment and consider its potential.

Reference

1. D.G. Gibson et al., “Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome,” Science, online May 20, 2010, DOI: 10.1126/science.1190719.

Varmus brings a strong cancer background to the NCI. Since 2000, he has served as president of the Memorial Sloan-Kettering Cancer Center in New York City and was recently cochair of President Obama’s Council of Advisors on Science and Technology. He was appointed director of NIH in 1993. While at NIH, he was credited with guiding a new clinical center, strengthening the intramural research program, and initiating a doubling of the NIH budget. His research career began as a member of the US Public Health Service at the NIH and as a post-doctoral fellow at the University of California, San Francisco, where he served as a member of the medical faculty for more than 20 years. His research focused on cancer genes and retroviruses.

So what challenges will Varmus face in his new role as head of the NCI? The IOM issued a report in April 2010 to recommend changes to transform the NCI’s Clinical Trials Cooperative Group, the program responsible for conducting collaborative large-scale cancer clinical trials at institutions and community-based practices in the US and aboard. The review of the NCI’s clinical-trial program was initiated because of concerns by NCI stakeholders, which included clinical investigators, patient advocates, leadership within NCI’s Clinical Trials Cooperative Group, industry participants, and the NCI that “the program is falling short of its potential to conduct the timely, large-scale, innovative clinical trials needed to improve patient care,” said the report.

NCI asked IOM to assess the state of cancer clinical trials, review its Clinical Trials Cooperative Group program, and provide advice on improvements. IOM made four major recommendations: improve the speed and efficiency of the design, launch, and conduct of clinical trials; make optimal use of scientific innovations; improve selection, prioritization, support, and completion of clinical trials; and foster expanded participation of patients and physicians.

In taking over as head of NCI, Varmus will have to address not only the organizational and operational concerns raised by the IOM report but will also face the additional challenge of resource allocation for NCI clinical trials. In April 2010, the American Society of Clinical Oncology (ASCO), released the results of a survey that found that one-third of NCI Cooperative Group sites plan to limit participation in federally funded clinical trials because of inadequate per-case reimbursement. Additionally, nearly 40% of sites planning to limit NCI Cooperative Group trials reported plans to increase industry trial participation despite expressing a preference for conducting Cooperative Group trials, a concern for ASCO. “Federally funded Cooperative Group clinical trials often examine questions that the private sector has little incentive to investigate, such as the comparative effectiveness of treatments made by different companies, therapies for rare diseases, and quality of life after treatment,” said ASCO in an April 15, 2010 release.

ASCO said that NCI funding for the Cooperative Group Program has been virtually flat since federal fiscal year (FY) 2003. NCI devotes approximately $145 million annually to the program, including $60 million to the $2000 per-case reimbursement, representing only 1.2% of NCI’s FY 2009 budget of approximately $5 billion, according to the ASCO press release. An ASCO study in 2003 and a C-Change study in 2005 determined that the actual cost of conducting NCI trials was $5000–6000 per case. If NCI reimburses at a more realistic rate of $6000 per patient, tripling the current amount, this would require an additional $120 million, yet total funding would still only account for 3.6% of the NCI budget, according to an analysis by ASCO.

“While funding is not the only factor impacting participation, the significant and growing disparity between actual research costs and the amount provided by NCI to cover those costs serves as a significant deterrent,” said ASCO in its press release. “Without increased funding from the NCI, Cooperative Groups and research sites cannot increase the number of trials, the number of participants enrolled, or maintain current infrastructure to support and conduct clinical trials.”

If the appointment of Varmus proceeds as planned, it will be important to see how he will be able to effectuate improvement in the NCI clinical-trial system in an era of budget constraints and tighter resource allocation. Given the importance of cancer research and NCI’s role in cancer research, let’s hope that he will be up to the challenge.