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Industry-led plans to breathe new life into the UK’s £64-billion life sciences sector have been unveiled alongside details of £160 million in government funding to fuel progress in the field.

The Life Sciences Industrial Strategy report, penned by immunologist and geneticist Sir John Bell, outlines the findings of an independent sector-led review on how the government can work with industry to help the UK “become an international benchmark for success”.

The recommendations will now be “considered carefully” by the government and used to work towards a sector deal between government and the global life sciences sector, it said.

“We have created a strategy which capitalises on our strong science base to further build the industry into a globally-unique and internationally competitive life sciences eco-system, supported by collaboration across industry, government, the NHS, academia, and research funders to deliver health and wealth,” said Sir John.

The strategy is organised under five key themes – science, growth, NHS, data, and skills – with proposals to build on the UK’s strengths in each area.

Recommendations include reinforcing the UK science offering with a funding boost for basic science and also by improving the country’s clinical trial capabilities, and ensuring the country has the talent and skills to underpin future life sciences success through a reinforced skills action plan across the NHS, commercial and third sectors.

Elsewhere, it calls for a tax environment that will support growth and attract substantial investment, and the establishment of up to five regional innovation hubs providing health data to help researchers make better use of evidence available.

Encouraging collaboration with the NHS is also a central theme and, as such, the report is recommending that the Accelerated Access Review be adopted with national routes to market streamlined and clarified, including for digital products.

Delving deeper into the detail, the strategy lists measures to further improve access to innovation, including conditional reimbursement for therapies that have shown promise in UK based trials at the point of licensing, a forum to facilitate early engagement between industry, NHS and NICE to agree commercial deals, and expansion of NICE tools beyond the QALY to assess value.

£160 million to support advanced therapies, vaccines
Alongside its publication Health Secretary Jeremy Hunt has unveiled £14 million in funding to support 11 medical technology research centres to further encourage collaboration between the NHS and industry in developing and bringing new technologies to patients through the National Institute for Health Research (NIHR).

In addition, Business Secretary Greg Clark announced the first phase of the government’s new investment in life sciences with funding of £146 million of funding for ‘cutting-edge’ projects, which is also expected to leverage more than £250 million of private funding from industry. The investment will be spread over four years and covers five major projects supporting advanced therapies, advanced medicines and vaccines development and manufacturing.

Mike Thompson, chief executive of the ABPI, welcomed the plans. The Strategy “is an impressive document which captures the importance of our sector to a successful post-Brexit Britain. We want the UK to be one of the best places in the world for discovering, developing and adopting new medicines and this Strategy provides the focus for all life science partners to work together to deliver exciting medical innovations for patients.

“We look forward to working with Government and other partners to implement these recommendations – including through a sector deal with the bio-pharmaceutical industry and a voluntary agreement on UK medicines policy between industry and the Department of Health. These measures will provide confidence for global companies to invest in the UK during and beyond Brexit.”

Also commenting on the strategy, Professor Sir Robert Lechler, president of the Academy of Medical Sciences, said it “recognises the importance of funding across basic and discovery science, and translational research.

“Maintaining and enhancing an environment which supports research across the whole ecosystem including academia, industry, the NHS and charities, is essential to allow the UK’s life sciences sector to continue to flourish,” he stressed, and also emphasised the importance of supporting life sciences clusters, regional strengths and cross-sector collaboration.”

The government will respond formally to the proposals in its life sciences sector deal, expected later in the year.

Disruptive forces made Clinical Research Organisations(CROs) looking at all options to boost growth and competitiveness. In one hand CRO industry under tremendous pressure to constantly  increase efficiency and drive innovation in their operations on the other hand many Pharma companies are also looking forward to CROs for risk sharing in clinical development of the product.

While organic growth remains an important driver there is an increasing shift toward inorganic growth drivers. Compared to 10-15% in October 2016, 25% of executives now expect growth to come from M&A activity with an additional 21% growth coming from joint ventures and alliances in the next 12 months.

In the last few weeks, several mergers and acquisitions were announced that continue the trend of consolidation in the contract research and development space, as demand for these services has continued to heat up.

• Pamplona Capital Management acquired Parexel International in a $5 billion deal to take the CRO private in June.
• In June, Albany Molecular Research Inc. was acquired and taken private by Carlyle Group and GTCR for $922 billion.
• Chiltern picked up a Japanese CRO Integrated Development Associates in May.
• In May, two of the largest CROs – INC Research Holdings and InVentiv Health – merged in a $4.6 billion deal.
• In 2016, Charles River Laboratories went on an acquisition spree, snapping up other CROs.
• In 2016, Quintiles Transitional merged with IMS Health in a $8.75 billion deal. Together, the company provides clinical research and health information technologies, which goes beyond what’s traditionally considered a CRO.
• Back in 2015, LabCorp acquired Covance in a $6.2 billion deal.
• Recently Labcorp acquired Chiltern in a $1.2 billion deal.

Moving on to the impact, there are several ways to look at how biopharma is (and will be) affected by this wave of CRO consolidation. Lets start with the positive, which is related to the impetus mentioned previously. Simply put, CROs that are in growth mode are typically growing by way of expanding their global reach, which allows for scale and creates cost efficiencies. While some of the small-mid size biopharma companies may not have enough leverage to benefit from such efficiencies, global CROs are sometimes able to pass cost savings down to potential anchor clients (i.e. big pharma). Whether or not they are actually willing to do so hinges on several factors and is a topic for another day.

For most pharmaceutical companies, CRO pricing is not a driving factor in choosing which companies to choose for outsourcing research and services. So, changes in costs for CRO services produced by consolidation won’t have as large an impact as might be expected.

Therapeutic expertise and quality in trial design, enrollment and being able to navigate IRBs are more paramount factors. Most drugs get just one shot at approval, and if the quality of the clinical trial is sacrificed, there’s a long-lasting, if not permanent, impact.

Since pharmaceutical companies are still striving for improved quality and efficiencies in conducting research and running clinical trials, however, it’s likely that growth and consolidation among CROs will continue.

Consolidation will in turn have a beneficial impact on the bottom line for many CROs. In the past, CROs have been formed by clinical entrepreneurs, but as CROs continue to grow and merge, it’s likely that more private equity investors will buy these companies.

As a result, CROs will have more financial resources as well as more business discipline that will appeal to their pharmaceutical clients.

Looking through a more realistic lens, more times than not, consolidation causes disruption. Because of how the CRO industry operates, there is really never an ideal time to integrate. For example, lets say that two large CRO players, each with a fully functioning lab, merge. This consolidation will likely result in a lab (or multiple labs) being shut down in the middle of a running a critical trial. This means that all of the samples, data, knowledge etc. must be transferred to a new site that likely does not have the same level of global standardization as the previous lab. Additionally, what if the new designated site for the trial does not have any available capacity? In short, the new site will need some time to get up to speed and integrate effectively, which almost guarantees an impact on ongoing trials.  To no one’s surprise, biopharma clients are never keen to hearing that there has been any sort of hiccup with their multi-million dollar investment.

In terms of drivers for deal activity, strategic growth remains a top priority for boards as CROs look to grow market share and expand into new geographies. CROs will also likely continue to pursue deals that drive scale to maximize reimbursement, ease pricing pressures and improve R&D capabilities in core therapeutic areas. CROs also see M&A as the fastest route to future-proofing their businesses in an environment of technological innovation, digitization and increased competition from outside the sector. This helps explain why joint ventures and alliances are seen as a key component of any inorganic growth strategy.

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India is expected to roll out a new drug policy 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 USA-India Chamber of Commerce.

“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.

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.

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.

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