ARC2015: Regulatory convergence and best practices are next week’s hot topics in Asia

The clock is ticking! In just few days, we will be joining friends and colleagues in Taipei for the Asia Regulatory Conference (4th and 5th of February). The programme was crafted by a Programme Committee, which consists of regulatory professionals from regulatory authorities, industry and trade associations including the Taiwanese Food and Drug Association (TFDA), Singapore’s Health Science’s Authority, Switzerland’s Swissmedic, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Japan Pharmaceutical Manufacturers and Associations (JPMA), the International Research-Based Pharmaceutical Manufacturers Association (IRPMA) and the R&D-based Pharmaceutical Association Committee (RDPAC). The Programme Committee has held regular ‘check-ins’ with an Advisory Committee, consisting of experts from regulatory authorities both within and outside the region. And, rather excitingly, the conference has been endorsed by Asia Pacific Economic Cooperation (APEC).
So what should be expected from the conference?

On day one, there is a focus on good review practices: thought leaders such as John Lim from Duke-NUS Graduate Medical School (former of the HSA, Singapore) and Lembit Rago of the World Health Organization (WHO) will provide keynote speeches followed by a panel discussion between regulators inside and outside the region. These will provide answers to critical questions: what more is needed to make good regulatory practices a reality for the region? Does it necessarily need regulatory amendments or just changes in working practice? WHO has recently developed guidance on ‘good regulatory practices’ so it seemed timely to hear more about this from the regulatory authorities, such as Taiwan’s TFDA, who were closely involved in developing it.

The second session of day one will draw on the key themes and outputs of the previous ARC (which took place in Singapore in 2012): “Co-operation, Convergence, Competency, Capacity, and Communication.” Cordula Landgraf from Swissmedic will explain how this soundbite has been brought to life through work she has done in collaboration with regulators in Australia, Canada and Singapore.

As it would be hard to hold a regulatory conference discussing the current topic of ‘innovative and alternative’ regulatory pathways, we will hear, in the afternoon of the first day, about progress in this area in United States of America (USA), European Union (EU), and Japan. This session will be hosted by John Skerritt from Australia’s Therapeutic Goods Administration (TGA).

On day two, we will enter a day of discussion focusing on good submission practices. Asia’s trade associations have come together to develop good submission guidance, which they plan to showcase in the opening panel discussion. This will be followed by a reflection focusing on industry’s experience of submitting dossiers in the Association of Southeast Asian Nations (ASEAN) – this being of particular interest in light of the ASEAN harmonization initiative which has, in theory, led to harmonization of dossier content and format.

In the afternoon, we will again look to step beyond the main themes of the conference and hear about initiatives that APEC is driving in relation to sustainable regulatory convergence. We will conclude the conference with a panel discussion reviewing the overall outcomes from the conference and teeing up areas for further action and discussion.

We do believe that the programme we have put together is relevant to both the novice and the expert of the Good Regulatory Practices concept.

Have your say and join us and all stakeholders to help contribute to the definition of pragmatic regulatory approaches for improving access to innovative therapies in Asia!

A smart dose of flu shots is direly needed worldwide

The case has been made time and again: the annual flu shot saves lives. Around 3 to 5 million people suffer from severe flu each year and it is estimated 5% to 10% of people die as a result. Children, pregnant women, healthcare workers and the increasing number of people who live with chronic diseases such as heart disease, diabetes, and asthma are most vulnerable and therefore at risk of suffering from flu.

Impfung bei einem ArztSome countries are making great strides to ensure that each flu season more people get vaccinated. However, many countries are still failing to meet the most basic levels of services: vaccine coverage rates of 75% of the elderly, as recommended by the World Health Organization. During the 2010-2011 flu season, coverage rates among the elderly were reported to be as low as 10% or less in some European countries (Poland, Estonia, and Latvia).[1]

In a period when there is so much talk of Universal Health Coverage and resilient health systems, why is there little focus on reaching the 75% influenza coverage rate agreed a decade ago by all 194 countries at the World Health Assembly?

Systematic global data on influenza vaccine coverage rates do not exist. Therefore, since 2008 we periodically analyze seasonal influenza vaccine distribution. We know it’s not perfect, but it gives a very good year on year gauge of the extent to which flu vaccines are used in 157 countries. The latest study “Seasonal influenza vaccine dose distribution in 157 countries (2004–2011)” shows a huge variation and disparity between countries and regions. It does not automatically boil down to differences between richer and poorer countries, as there are also huge disparities within the same WHO regions.

While different countries have different health priorities and associated policies, including those for influenza prevention, the health benefits of influenza vaccines should be not ignored during policy planning. Policy measures include increasing knowledge, addressing attitudes and practices among doctors, nurses, and other healthcare providers, and designing communications programs targeted to those who are the most vulnerable to seasonal flu.

An interesting finding from the study tells us that current distribution rates of influenza vaccines are in striking contrast to the global efforts for pandemic preparedness. Only about half of the global vaccine capacity for a northern hemisphere seasonal influenza vaccine was being utilized in 2011, and even less for a southern hemisphere vaccine. This could potentially compromise pandemic flu preparedness, as the logistic and manufacturing capacity of the countries remains untested.[2]

Global efforts to prepare the world to deal with a new pandemic (including manufacturing, stockpiling, and system preparedness) require huge investments and considerable resources allocated to multi-year projects. These efforts and investments are indeed necessary, and as a result health advocates analyze whether all those involved in these efforts are meeting their obligations. But how can we square this focus on emerging influenza pandemic with the lack of attention given to underutilized, cheap and existing seasonal influenza vaccines that protect vulnerable patients against an annually recurring high burden of disease?  In terms of the impact to people’s lives and reducing the economic burden of flu, season flu vaccination is essential and worthy of more attention than it receives. What’s more, if we don’t have resilient seasonal flu vaccination programs in place; we won’t have the necessary systems in place to manufacture and roll out vaccination programs in the eventuality of a flu pandemic.

Given the annual burden of seasonal flu, the ample scientific evidence on the safety and benefits of seasonal influenza immunization and the recommendations by the World Health Organization, it would make sense for the public health community to take stock and re-evaluate how best to implement seasonal flu vaccination programs to reduce suffering and costs at a huge scale on an annual basis.

[1] Eurosurveillance 2014 –

[2] Palache et al. 2014; Partridge et al. 2013

Forging new approaches to biopharmaceutical innovation in neuroscience

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By Anke Post

As a psychiatrist, I have long worked to address mental diseases such as schizophrenia and depression. Experiencing first-hand the suffering and heavy burden these ailments place on people motivated me early on in my career to better understand the underlying mechanisms of these diseases and to help find new treatment possibilities. This is why I have devoted the majority of my professional life to neuroscience preclinical research, patient care, and clinical drug development.

Major depressive disorder (MDD) is the most common mood disorder, with life-changing impact on people such as decreased quality of life, functional impairment, and increased mortality rate.  In fact, suicide related to depression is a major cause of death in industrialized countries.

While we have had antidepressants since the 1950s, in many cases people with depression still are not correctly diagnosed and treated. This can be due to stigma as well as perceived efficacy.

Biopharmaceutical research continues to improve care by developing novel antidepressants but periodically their benefits in daily practice are questioned. Skeptics sometimes argue that new medicines provide only limited additional efficacy over current therapies. These challenges can complicate biopharmaceutical research in psychiatric disorders but also provide me and others encouragement to take R&D to new levels.

CNS neurons

We’ve long known the pathophysiology of these conditions involves many biological aspects such as mono-aminergic neurotransmitter changes, stress circuits dysregulation, and many other related disturbances. New approaches and new targets are needed. Innovation is not only associated with testing new targets but also with developing new ways to test. We need to identify clinical signals earlier, with more certainty, and in the right populations.

That is what we, at Lilly, are doing – investigating new targets related to those fundamental changes associated with depression. We have discovered molecules which target new mechanisms of action and might lead to treatment advancements for patients with mood disorders and other psychiatric diseases.

Our development work is still early, but current clinical data for one target are exciting enough that we hope to translate some of our preclinical findings and outcomes from animal models into practical clinical knowledge. To understand the potential benefits of this compound, we applied established technologies such as PET and fMRI. These helped us understand our target receptor and functional implication. Moreover, we used behavioral assessments and neurophysiological tools (clinical biomarkers) –new research tools for us – to identify treatment responses earlier.

The basis for the latter approach is that patients suffering from MDD often have cognitive negative biases. That is, they are more likely to remember negative information and pay attention to negative stimuli than to non-depressed subjects. To identify these markers early, we use behavioral paradigms based on psychological testing, and neuroimaging techniques such as fMRI. Using these experimental tools allowed for more effective signal detection and gave new insights in the mechanism of our compound.

Besides such clinical tools, genetics may help us in the next round of discovery and development to identify new targets in psychiatry and overcome the stagnation in the field.

Do you want to learn more about Mental and Neurological Disorders? Check out the DoYouMind? Campaign

For more information about Lilly’s research, visit this website 

The Vaccine Revolution: How Innovation Will Change the World…Again

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by Emilio A. Emini

Over 200 years ago, the first vaccine was created to protect against smallpox, an infectious disease that had afflicted humanity for centuries. That discovery opened the door to a golden period of vaccine development that has led to extraordinary improvements in worldwide public health. Today, vaccine development continues to thrive as scientists advance technologies and approaches to reach more people in new ways. Over the years, our understanding of the immune system has grown considerably. We are now learning how to not only prevent infectious diseases, but also how to train the immune system to assist in fighting non-infectious diseases. The possibilities are boundless as vaccines can be potentially used to treat allergic asthma, to help smokers kick their habit, and to fight off cancerous cells. Here’s a helpful video on the evolution of vaccine research

As vaccine technology continues to advance, we are working towards the development of novel vaccines in areas of continued medical need. Patients being hospitalized represent a particularly vulnerable population. People often arrive at the hospital feeling preoccupied with the medical need that brought them there in the first place, hoping their surgeries or treatments go well and anxious to get better. What they don’t expect is to leave the hospital with an additional ailment. Each year, hundreds of millions of patients around the world are affected by hospital-acquired infections[i]. These infections, caused by bacteria such as Staphylococcus aureus and Clostridium difficile, are highly debilitating and often life threatening. To make matters worse, hospital-acquired infections are becoming increasingly resistant to antibiotics. Therefore, in addition to inventing new ways to treat these deadly infections after they occur, we must also look to developing vaccines to prevent the infections in the first place. As an example, a patient planning an elective surgery would be given a S. aureus vaccine within a defined period prior to surgery to allow protective immune responses to develop. These immune responses could then prevent the patient from contracting the infection during surgery by killing any bacteria that may enter the body during the surgical procedure. If effective, such a vaccine has the potential to greatly reduce the burden of the infection in hospitals, and would potentially save numerous lives of patients who experience infection with treatment-resistant bacteria. When I began my career 30 years ago as a virologist, it was just becoming clear that AIDS was caused by the HIV virus. I had the opportunity to work on developing one of the first highly active anti-HIV therapies that protected infected individuals against disease progression.  The experience of seeing the impact of these therapies on those afflicted by the infection was gratifying.  In a similar way, over the years, I have been fortunate to experience again and again the immediate and profound impact that newly developed vaccines have had on infectious disease burdens, both on the individual and population levels. As the potential for vaccines continues to expand with scientific and technological advances, I hope to continue these experiences well into the future.

To read more about Pfizer’s vaccine R&D: [i]

Constantly Innovating

Andrew JennerAndrew Jenner

Pushing the boundaries of innovation is at the core of the pharmaceutical industry. However, it’s also the “business model” for many diseases. Microbes, including bacteria and viruses, are constantly evolving to cloak themselves from being affected by antimicrobial medicines.  Similarly, aggressive cancers are increasingly becoming unresponsive to first line treatments.  In order to stay ahead of the curve, R&D pharmaceutical companies are rethinking the way they innovate.

Medicines discovery is no longer the step-by-step process that it may have been in the past. Historically, pharmaceutical innovation followed an in-house high risk model.  R&D pipelines were reliant on their own company expertise and compound libraries.  This was largely due to how innovation was conducted: a single company would see through a medicine’s journey from experimental compound to approved medicine all under the same roof.  That process was linear, and a hiccup anywhere along would create inevitable downstream delays.

Today’s innovation model is becoming increasingly networked where partnerships are crucial. Through partnerships, companies can segment innovation into discrete phases.  For instance, early stage molecule discover may be done in collaboration with academia.  Testing the safety and efficacy of a promising compound may be coordinated with firms specializing in conducting clinical trials. The goal of today’s networked innovation model is simple, create an innovation ecosystem to provide patients with more lifesaving medicines, faster.

An R&D ecosystem accelerates innovation because research can be coordinated to include numerous experts and stakeholders. There is a vast amount of research and knowledge inherent in any therapeutic area, yet communication between discrete research groups is often minimal and may result in redundant work.  Public institutes, academic research groups, and even competing firms can benefit from one another by coordinating research efforts.  Through such various partnerships, R&D costs are reduced because they are borne by multiple partners, knowledge and know-how is transferred, and medicines innovation is accelerated.  This leads to increasing healthcare providers’ arsenal of innovative medicines to treat more patients in the most effective manner.

In an interview with the IFPMA President, John Lechleiter (see link) explains what a sustainable ecosystem looks like for innovation to happen in the field of medicines and vaccines. A must watch!

Smart testing in personalised healthcare – ctDNA is set to change the companion diagnostic landscape

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In the pursuit of truly personalised healthcare, AstraZeneca has entered into partnerships with Roche and QIAGEN for the clinical development of novel diagnostic tests based on circulating tumour DNA (ctDNA). These tests will move us to the next generation of companion diagnostics by allowing detection of recognised tumour mutations based on accurate analysis of minute quantities of tumour DNA found circulating in cancer patients’ blood.

AstraZeneca is a pioneer in the cutting edge technology of ctDNA, which uses “smart tests” that can pick out specific signals from a background of normal DNA noise. I have been involved with this exciting development for many years, working with technical experts who have pushed the boundaries of science to take ctDNA testing from a highly exploratory science to a robust technology that can be used in clinical practice for our companion diagnostic projects.

Our first research programme in ctDNA started with a clinical fellowship in 2006. In particular, our experience with EGFR testing in non-small cell lung cancer provided the clinical setting in which to correlate ctDNA to tumour samples. We recognised the potential that ctDNA technology has to improve diagnosis and treatment in this type of cancer, where many patients have limited or no tumour samples for testing.

From my perspective this technology is most exciting because it makes it possible for innovative drugs to become available to patients where no suitable tumour sample is available. Blood can be taken at a medical centre quickly and easily, since it doesn’t require hospitalisation or the use of an expensive diagnostic imaging suite.

Regulators have also been quick to recognise the promise of these novel techniques for patients, and have worked actively with the diagnostics and pharma industries. Of course it is the priority of the regulators to protect patients, but I’ve seen that the authorities were keen to review data and discuss what evidence would be needed to approve companion diagnostics based on ctDNA.

As with most scientific developments, we often forget how many challenges were involved. I am very proud of the tenacity of our scientists; the years of work that went into selecting the best techniques and preparation methods for ctDNA.  To start with, we were even unsure if oncologists would trust test data from blood, when they were so used to dealing with tissue samples. All these obstacles have been overcome.

In the future, I would like to see these tests developed so that they could monitor the progression of cancer and even detect if cancers return. Currently, companion diagnostic testing is done using an individual sample based on the assumption that tumours are static. In reality, however, cancers evolve over time in response to treatment. Some experts have speculated that a more sensitive ctDNA technology could be developed to monitor cancer as it changes its molecular nature, allowing us to prescribe the right medicines throughout the course of therapy. This would represent a real clinical advance and confirm ctDNA as a cornerstone of personalised healthcare.

These partnerships on ctDNA are a significant step in Personalised Healthcare scientific innovation. They move us one step closer to achieving our bold ambition of transforming patients’ lives through personalised healthcare by ensuring that innovative treatments are matched to those patients who will benefit most.

Ruth March is Vice-President and Head of Personalised Healthcare & Biomarkers at AstraZeneca

To read more about AstraZeneca science:

Biotherapeutic Medicines: Putting Patients First


As experts in the field of biotherapeutic medicine meet in Rio de Janeiro on 24th-25th August in the run-up to the 16th International Conference of Drug Regulatory Authorities (ICDRA), they should capitalize on the opportunity to discuss the future of biotherapeutic therapies, as well as address the risk that non-comparable biotherapeutic products pose for patients and health systems globally

Undoubtedly, one innovation that has radically transformed medicines is the development of newer, more sophisticated type of drugs produced by living organisms called biotherapeutics. More than 350 biotherapeutic medicines have benefited to date some 400 million patients worldwide.

Biotherapeutics lead to more targeted therapies, better diagnostics and improved outcomes following a patient’s course of treatment for many of the world’s most prevalent diseases, as well as for less common conditions. Biotherapeutics include innovative products for the treatment of chronic diseases such as cancer, diabetes and rheumatoid arthritis, as well as for acute conditions such as myocardial infarction and stroke – and have two common denominators: biological origin and structural complexity. These products bring genuine differences in saving lives, reducing hospitalization and ultimately, contributing to healthier societies.


The challenges of manufacturing biotherapeutic medicines

Biotherapeutics are very complex molecules made in living organisms by genetically engineering DNA. As such, every step we take in the production of these medicines requires highly controlled testing to ensure consistent quality, safety, and efficacy. On average they undergo 5 times more testing compared to chemically-synthesized or conventional medicines. They are usually proteins that can be up to 1,000 times bigger than conventional drugs and are normally given by injection or infusion.

How Biotherapeutics are made

Step 1: insert the DNA into host cells. Once the DNA is inside the cells, it uses the cells’ machinery to transcribe and translate the DNA message into the biologic.

Step 2: The most effective cell line is selected for expansion and is grown in bioreactors.

Step 3: The biologic is purified and tested to ensure its function and quality criteria are met.

Biotherapeutics, Biosimilars and Non Comparable Biotherapeutics

Once the data exclusivity and patent expires on an innovative biotherapeutic medicine, follow-on products can now appear on the market: these types of medicines are known as biosimilars and non-comparable biotherapeutic products. Let me try to give you a quick overview.

Biosimilar medicines, on the one hand, are developed and assessed through comprehensive clinical testing to demonstrate their therapeutic equivalence to the reference product. Basically biosimilars are highly similar to a biotherapeutic that has already been authorized by a national drug authority after the review of a full regulatory dossier. They are subject to tailored regulatory data package with side-by-side analytical and clinical testing and may have minor variations compared to original biotherapeutic reference product, but with no clinically meaningful differences identified.

On the other hand, non-comparable biotherapeutic products are medicinal products that are developed with limited or no side-by-side comparability exercises and have not been approved via a regulatory procedure in alignment with World Health Organization (WHO) principles. In other words, these products may or may not be similar to the original biologic medicine that they claim to be.  When such medicines are used, patients could potentially be put at risk due to the unknown safety and efficacy of the product. The potential threat to public health is worrisome as continued use of these medicines could reverse years of hard-won progress in the research and development of safe and effective biotherapeutic medicines.

Call to action for biotherapeutic medicines

Government officials and drug regulatory authorities meeting at the ICDRA conference in Rio de Janeiro this week should capitalize on the opportunity to discuss the future of biotherapeutic therapies, considering that manufacturing a safe and effective biotherapeutic medicine requires tremendous effort and vigilance. Our industry is rigorously committed to quality, safety and efficacy as this is the only way to ensure that each dose will be to the patients’ benefit. Governments should adopt appropriate regulations and stringent regulatory processes in harmony with WHO principles to ensure quality, safety, and efficacy are achieved at all levels. This would help in addressing the risk that non-comparable biotherapeutic products pose for patients and health systems globally.  What’s crucial in medicine is to ensure they are safe, improve patients’ health and do not pose any unnecessary risk.

For more, click on everything you need to know about ICDRA

An Infographic on Biotherapeutics – View full size

If hit by a chronic disease, fighting the flu with a shot is your best shot!


Most people think about the seasonal influenza (more commonly known as flu) as a bad cold that one can recover from within a week or two. Flu is not a simple cold. It’s a highly contagious disease caused by a virus and does not spare anyone. WHO estimates that there are as many as 3 to 5 million cases of seasonal influenza each year, resulting in 250,000 – 500,000 deaths worldwide.

The skeptics may say these numbers don’t seem too high when compared to the disease burden and deaths caused by other communicable and non-communicable diseases. There’s a catch though: Flu aggravates the underlying medical conditions, leading to increased hospitalization and rising healthcare costs. Complications arising from influenza are particularly frequent and severe in adults with chronic conditions, such as chronic obstructive pulmonary disease, cardiac disease, cerebrovascular conditions and diabetes. If two comorbid conditions are present (old age and high-risk), influenza-related deaths are over 100 times greater than in healthy adults.

Other high risk groups include the elderly, the immunocompromised (e.g. HIV/AIDS), pregnant women and young children (under five years of age).Healthcare workers are also considered a vulnerable group at high risk of both acquiring and transmitting the virus.NCDs & Influenza Infographic-Flickr

The good news is that the vaccine to prevent influenza is available, safe and inexpensive. It is also effective: According to WHO, vaccination against influenza can reduce influenza-related morbidity by 60% and mortality by up to 80%. And there are even more public health and economic benefits. For example, vaccination reduces healthcare costs by reducing influenza-related hospitalizations and staff absenteeism. Vaccinating pregnant women helps protect not only expectant mothers but also their newborn children up to 6 months of age. Immunization of school children has a fringe benefit of protecting their households and even reducing mortality rates among elderly individuals, since children are commonly the virus transmitters. Immunization of people with chronic diseases is an effective way to reduce the high disease burden among them. One study found that vaccination against influenza was beneficial for old people with cardiac disease and reduced the adjusted risk of winter mortality by 37% during four influenza seasons.

Immunization of health workers is particularly important not only for occupational health reasons but also for protecting their patients and families. There is evidence that vaccination of healthcare workers decreases influenza infections among them by 88% and reduces patient mortality by as much as 50%. Immunization of home-carestaff has been found to reduce mortality in at-risk groups. Despite these benefits, immunization rates of healthcare workers globally remain unacceptably low. The US CDC recommends 100% vaccination coverage of all healthcare workers, while in Europe, most countries recommend the immunization of healthcare professionals without a minimum coverage rate and it is not mandatory with some exceptions.

Not surprisingly, the vaccination coverage in many European countries is very low, ranging from 48% in France to 14% in the UK. Lack of knowledge has been cited as one of the possible explanations for the low coverage of healthcare workers. Restricted access to vaccination guidelines and other relevant information among healthcare workers in hospitals was found to contribute to their not recommending the vaccine to elderly patients.

To overcome the barriers and increase the immunization coverage among healthcare workers and particularly physicians, who can act as role models to their patients, the World Medical Association (WMA), with the support of IFPMA, launched a global campaign in 2013 to increase the awareness of physicians on the importance of the topic and help fill knowledge gaps to improve the immunization practices. The campaign information and materials can be found at:

The campaign has just entered its second phase and aims to enhance physicians’ communication skills to promote influenza immunization among vulnerable groups (the elderly, people living with chronic conditions, pregnant women and children). As part of this campaign, IFPMA and WMA produced an infographic that demonstrates the linkages between influenza and non-communicable diseases (NCDs) and beneficial effects of immunization in people with NCDs. For example, evidence indicates that flu vaccination reduced the risk of hospital admissions of patients with diabetes by 79%. The infographic is available at:

It is clear that the implementation of a targeted vaccination strategy towards NCD patients and other vulnerable groups is very complex and will require a commitment of many stakeholders at multiple levels. Currently, no WHO targets have been set for the vaccination coverage level for patients with chronic conditions or other vulnerabilities, and health promotion campaigns are also lacking for healthcare professionals to council those patients and encourage them get vaccinated. The WMA campaign is just a start, and by involving physicians as role models in the campaign, the possibility of achieving adequate vaccination coverage, particularly in high risk groups, can become a reality.


What ‘The Complex Journey of a Vaccine’ is all about

Stephen Cook

Did you know that with the exception of safe drinking water, no other public health intervention has had such a major impact upon mortality reduction as vaccines have had? Figures talk by themselves. In 2012 alone, 111 million children were given vaccines against life threatening diseases, preventing some 2 to 3 million deaths that year. Yet, the supply chains linked to these two major health interventions, supply of safe drinking water and vaccines, are not always guaranteed nor can they be taken for granted.

I just wonder how many of us know how complex is the journey a vaccine must go through. Connecting the dots between a desperately needed vaccine to a child somewhere out there waiting to be given that silver bullet shot against deadly or crippling diseases can be very challenging.

This is precisely what this new publication, “The Complex Journey of a Vaccine”, is all about. With it, the IFPMA hopes to clearly illustrate the steps that the manufacturers undertake in order to ensure the quality and safety of the vaccine and some of the challenges they face along their way. These mainly revolve around how to ensure a reliable supply of sufficient quantities of vaccines whilst meeting the different regulatory demands that may differ from a country to another at the national health authority level.

Here is a shocker: It can take up to 2 years from the start of the manufacturing process to the final Quality Assurance release of a vaccine. During this time, the vaccine will have undergone many hundreds of tests: tests that assure the quality of everything from the many raw materials that are used in the manufacturing process right through to final vaccine that will be administered to the child.

Every time a manufacturer wants to introduce a change into the production process, be it small or big, it must be ‘green lighted’ by the relevant national health authorities before implementation. The number of changes that may be needed during the products life cycle and the complex regulatory review process, added to the lengthy procedures may all jeopardize the reliability of supply. Understandably, the national regulatory authorities also have a critical job to ensure that high quality and safe vaccines are distributed in a timely manner in their country.

I hope that this brochure helps you understand what’s at stake in the manufacturing segment of The Complex Journey of a Vaccine. To get a better grasp of the whole picture, we are also working on new infographics to illustrate the delivery and R&D segments to be published in the near future.

IFPMA member companies will continue to do their utmost to secure the availability of high quality vaccines in the quantities that are needed. After all, just as safe drinking water is essential for health, vaccines also play a vital role in securing the health and wellbeing of everyone on this planet.Untitled


Pharma innovation – giving value for value received

Andrew JennerAndrew Jenner

The Chief Innovation Officer of the company that invented the way crisps in a tube are packed (rather than the wasteful packages full of air) coined the phrase: “What we’ve done to encourage innovation is make it ordinary.” The bio-pharmaceutical scientists and researchers deal with more complex issues than the humble potato crisp, such as how the human body can be helped to fight off diseases that are constantly evolving. But what we do have in common is that we don’t take enough time to remind ourselves of the impact of medicines and vaccines on our lives and the ability pharmaceutical innovation has to transform societies, making the unimaginable a reality.

Although innovating new medicines and vaccines is getting harder, and there is plenty of scope for new inventions, be it a medicine to cure the common cold or a vaccine to protect from contracting AIDS; there is plenty to be optimistic about. Every year, the US’s Food and Drug Administration approves on average 25 new drugs. In the past decade, over 340 new drugs have been approved to treat different chronic and non-chronic diseases including cancer.


It’s pretty well established that innovation or the process of translating an idea into an approved new drug takes anywhere from 10 – 15 years and costing at least a billion dollars. Such cost comes with some rewards as it supports high value jobs, helps strengthen local communities and the world’s economies alike. Yet it also carries potential risks: failure in proving safety of the new product for example.

Two recently published studies this year reveal that the value of innovation can be considered through two dimensions: the clinical and the economic.

Clinical value

The clinical value is highlighted in a study carried out by Charles River Associates earlier this year, Assessing the value of biopharmaceutical innovation in key therapy areas in middle-income countries.

This study reveals that in the case of rotavirus for example−the most common cause of severe diarrhoea among children in both industrialized and developing countries, claiming the lives of around 450,000 children every year, CRA compared the value that two recently-launched vaccines yielded in Brazil and Australia. The major benefit seen in both countries was a direct drop in hospitalization costs, but in Brazil they also witnessed a major decline in related mortality rates. So obviously both benefitted from these innovations, but given the nature of the disease burden the added value was greater for Brazil.

Economic value

The economic value is evidenced in a recent study carried out by WifOR, “First steps towards measuring the economic footprint of the industry”, the main key findings were that the pharmaceutical sector has roughly generated $441 billion worldwide in direct gross added value, equivalent of the economic strength of Argentina alone for 2011. Another value no less important is that the industry employs some 4.2 million people worldwide, the equivalent of Austria’s labour force which is huge.

There is no doubt that innovation in this sense is vital for the economic development of a given society through a productive workforce, through the ability of children not only to survive scourges of diseases but also to grow and learn making their way into the school system and the ability to later on contribute to the community, to be able to undertake economic activity and attract investment. In a nutshell, innovation is not only saving people’s lives and making them healthier, but also generating high-value opportunities the world needs.

The legacy of the therapeutic innovation

The top 20 companies invest on average 20 percent of their revenues in R&D to develop new medicines and vaccines. It is this investment and drive, year on year, which has given the world the legacy of medicines available to treat the major illnesses, such as diabetes, cancer, heart disease, asthma, HIV/AIDS. The recipes for producing the vast majority of the basic treatments (we call this first line medicines) are now produced by generic companies in India, China, South Africa and sold around to both the developing and developed world. Indeed, 80 percent of generic medicines are sold to the US and Europe. That is the legacy of our innovation.

It’s time to agree on Universal Health Coverage guiding principles


With 1 billion people lacking access to basic health care and more than 2 billion people lacking regular access to essential medicines, governments are increasingly placing emphasis on the promise of universal health coverage (UHC). UHC has become an increasingly salient issue for developed and developing countries alike in the context of the global economic crisis, increasing health care demands, and still unmet medical needs. There is increasing recognition that providing quality universal health coverage is an investment in socio-economic well-being and a key contributor to the wealth and economic productivity of countries. As negotiations on a new set of UN Development Goals progress over the next 18 months, 2014 is a crucial year for global health and offers an opportunity to inject a new vision for health that spans across the health systems and, beyond, across sectors.

The innovation pharmaceutical business is one among many actors in the global health community that has in its power to bring solutions for a healthy world – solutions that make a difference to patients, to communities and society. However, translating the lofty goals of UHC needs in our opinion shared guiding principles to galvanize efforts of all those involved in global health in drawing up well-designed policies. Drawn from our technical knowledge and experience in providing access to high quality health solutions, we have identified eight guiding principles in the areas we believe our industry can contribute.

  1. Equitable Access –All people should have equitable access to essential health care services.
  2. Efficiency – Health systems should use resources effectively and efficiently.
  3. Quality – Health systems should guarantee access to quality infrastructure, service and care.
  4. Inclusiveness – Transition to and implementation of Universal Health Coverage should include engagement of all relevant stakeholders to maximize patient needs.
  5. Availability – Essential health services and products should be available to all those who need them.
  6. Adaptability – Diverse approaches should be encouraged to facilitate UHC based healthcare financing and delivery.
  7. Choice - Health systems should preserve patient choice in health care services and delivery.
  8. Innovation – Society should encourage investments in R&D across the spectrum of prevention, diagnostics, treatment, care and support.

While every country is unique and tailored approaches will be required, there are common challenges and opportunities faced by countries at all stages of UHC. It is with this in mind that we have drawn up eight guiding principles that we think stand up to the test of such diversity, and can help inform the design of global UHC policies.

The process leading to the final intergovernmental decision is complex, but we believe the business community and the biopharmaceutical industry in particular have an unprecedented opportunity to contribute to this debate and present the vision and the value that industry brings towards achieving healthier societies around the world. So, as countries work toward UHC, these principles may offer guidance to policy makers, industry, and other stakeholders who seek to improve health care and meet the health needs of all citizens.

Please tell us what you think of these principles as we move forward in partnership to improve patient access to quality medicines.

Support Fight the Fakes on Thunderclap!

In a month we will celebrate “World Malaria Day” (25 April)! The Fight the Fakes campaign would like to mark the progress made in the control and elimination of malaria with a ringing Thunderclap!

Malaria is a disease that can be prevented, diagnosed and treated when using the right medicines. The past decade has seen an impressive mobilization of resources and political will to reduce worldwide suffering from this sickness:

50 COUNTRIES are on track to reduce malaria cases by 75% in 2015!

The strides achieved so far have in large part rested on raising awareness and community-level actions to provide treatment and nets for prevention.

Let’s keep fake

medicines from undermining these efforts!

Fact: 30% of the drugs used to treat malaria worldwide are fake medicines.

So what does this mean for you and me? When pills of chalk, salt or even poisons are given in the place of lifesaving medicines, the consequences are devastating for individuals and their communities.

Fact: Every 5 minutes a child dies of malaria because of taking fake medicines.

Please join us in adding to the awareness by letting the people know about the dangers of fake medicines. It only takes a minute to sign up and support our Thunderclap!

Chasing away the Monday morning blues


Life just always seems a bit tougher on Mondays. One good way to blow away the blues is to concentrate on projects that reward you with quick wins followed by the reward of some “me time”. That’s why, when I can, I try to fit in an hour of sport instead of grabbing a longer lunch. It breaks the day and gives me a boost… and keeps the doctor away!

I was thinking about this when last week I was invited to speak at the launch of a new study on corporate healthy lifestyle programs in Moscow. Research has shown that in Russia, people place great value in their health but few take action (you might be able to apply that to many countries), with the resulting health problems that come from smoking, unhealthy diets and lack of physical activity. But there is some good news. This new study showed that employees want their companies to help them be healthy and two in three Russian companies appear to be up for the challenge, not least because a healthy workforce is a more productive one.

First study of its kind in Russia explores corporate wellness programs

The study assesses the experience in setting up and implementing corporate healthy lifestyle programs in Russian companies, identifies employee attitudes and their preferences for the programs implemented. The study was commissioned by our Russian colleagues at AIPM and ourselves at IFPMA and prepared with support of the National Research and Development Center for Preventive Medicine and the Russian Union of Industrialists and Entrepreneurs (RSPP), in partnership with the Ministry of Health of the Russian Federation.

46 state-owned and private companies representative of a range of the sectors participated, including Gazprom, Lukoil, United Breweries Heineken, IKEA, Russian Railways, Megafon, Rostelecom, to name a few.

Top line findings show employers and employees are ready to get healthy

The survey determines that two out of three employers were ready to support their employees’ health. The most common types of programs employers currently provide their employees include arranging for sports events, vaccination and hot meals. Employees unanimously welcome company programs that support sports activities, subsidies and discounts for health nutrition and health screening.

The study shows that there is significant scope to expand healthy lifestyle programs in the workplace to fully reap the benefits of a healthy workforce. It also provides a blueprint for successful programs and encourages other employers in Russia to put in place healthy lifestyle programs. After all, these programs are not only beneficial for employees; they are also in the interest of employers and have been publicly supported by World Health Organization (WHO) and International Labour Organization (ILO).

Multiplier effect as employees bring the health messages into their homes

Workers that commit to a healthy lifestyle will likely influence their families and friends and will be more receptive to government prevention campaigns, which may be the key to helping tip the balance and lead to healthier reflexes among all of us.

We have witnessed this spill over effect within the pharmaceutical industry, where more than half of the prevention programs that our companies carry out for their 1.1 million employees reach wider network of relatives.

Health across all government policy making is a force for good

Government actions in support of corporate healthy lifestyle programs can make a dent in the tragic and escalating trend of deaths and disability through NCDs. Even in the case of workplace wellness policies, a “whole-of-government” approach encompassing coordinated actions in areas other than health and at different geographical level is needed

Prevention, even through physical activity, is the best value for money in curbing NCDs. Corporate healthy lifestyle programs are yet another way to empower and help us turn the tide of apathy and change behaviours.

We all know, at a personal level that it is difficult, but if we all get behind it, there is a chance we will succeed in ultimately saving and have better lives. If you are not convinced, you can still see it as a nice escape to the Mondays’ blues!

World Cancer Day 2014: Hand in hand to debunk cancer myths


Today, February 4th is World Cancer Day. This annual event is the ideal opportunity for millions of people to raise the profile of cancer around the world. The Union for International Cancer Control (UICC) and its 800 member organisations across 155 countries seek to press the world’s media to place cancer on their agendas and across their global news networks.

UICC, its members and partners such as IFPMA use World Cancer Day to present the facts about a disease which many people do not know about and to dispel the many myths and misconceptions around cancer. As CEO, I have seen first hand how misinformation or lack of information about cancer can make detection and treatment even more challenging for people. That is why, this year we seek to “debunk” four myths, following the success we had addressing four other myths in 2013:

  1. We don’t need to talk about cancer
    The truth is that whilst cancer can be a difficult topic to address, particularly in some cultures and settings, dealing with the disease openly can improve outcomes at an individual, community and policy level.
  2. There are no signs or symptoms of cancer
    In fact, for many cancers, there are warning signs and symptoms and the benefits of early detection are indisputable.
  3. There is nothing I can do about cancer
    The truth is that there is a lot that can be done at an individual, community and policy level, and with the right strategies, a third of the most common cancers can be prevented.
  4. I don’t have the right to cancer care
    We believe that everyone should have the right to access proven and effective cancer treatments and services on equal terms without having to suffer hardship as a consequence.

A lack of knowledge in the general public is a key indicator of the difficulty we face in addressing cancer today. It results in individuals exposing themselves to risk factors which they are unaware of. It causes people to view cancer as simply fate. It encourages people to assume that a diagnosis of cancer will always lead to death. All of these myths and misconceptions limit our ability to tackle cancer effectively.

World Cancer Day is our annual opportunity to improve the world’s general knowledge of cancer and challenge misconceptions about the disease at an international level.

What are the facts?

  • In the next twenty years the real growth in cancer deaths will take place in low- and middle-income countries – in countries which are least equipped to cope with such an increase in cancer cases.
  • Cancer kills more people prematurely than any other non communicable disease.
  • Globally, more people die from cancer than from AIDS, malaria and tuberculosis combined.
  • Approximately one in three individuals will develop cancer in their lifetime.
  • In 2010, 14.1 million people were diagnosed with cancer and 8.2 million people died from the disease worldwide.

Cancer is already a significant challenge for our generation and it is set to become even more impactful in the next 20 years. New data from the International Agency on Cancer Research (IARC) suggests that cancer cases will rise by 75% to close to 25 million new cases per year over the next two decades.

Please visit to see what you can do to share information about World Cancer Day, and be aware of the events and activities being run around the world by the member organisations and partners of UICC (

UICC, its members, partners and other globally respected organisations like the IFPMA, work together to reduce the burden of cancer globally on a day-to-day basis. On World Cancer Day we stand together to bring focus to a disease which many people do not want to talk about. Cancer affects everyone in some way and the UICC welcomes all organisations which recognise that they can contribute to improving the situation globally. In this respect, the UICC applauds IFPMA for their stated ambition to improve “health around the world by contributing expertise, building trust, and establishing solutions for global health”. Together we are stronger.

Cary Adams is Chief Executive Officer, Union for International Cancer Control (UICC). He is also Chair of the NCD Alliance, a coalition of around 2,000 NGOs working on Non-Communicable Diseases, which includes cancer, diabetes, heart and respiratory diseases.

Sharing biotherapeutic best practices: a win-win for all

Fermin Ruiz De Erenchun

In November, I returned from a very productive and interesting trip to Peru, where we hosted a regulatory workshop focused on biotherapeutic medicines. The reason for my enthusiasm is the very high level of commitment and engagement among health authorities and other experts to cooperate in overcoming national obstacles to medicines access.

At this workshop, the medicines we focused on were biotherapeutics, a class of therapies that offer patients new hope for a variety of common and rare diseases. These medicines are “manufactured” using naturally-occurring microorganisms rather than by traditional use of chemical synthesis. This makes biotherapeutics much more complicated to produce– and to regulate! In many cases, the old rules don’t work well for these medicines, which is why our South America-wide workshop, called Biotherapeutic medicines: sharing experiences and best practices, was of such interest to so many experts.

As Chair of IFPMA’s Biotherapeutics Group and a physician, I know the value of these medicines to patients. This class includes synthetic insulin for diabetes, innovative anti-inflammatories for arthritis, and treatments for hepatitis. In fact, there are currently more than 200 biotherapeutic medicines available for patients and many more in the pipeline, but until now health authorities have slowly developed new rules for reviewing the regulatory dossiers of these medicines. This conference was a forum for regulators from around South America, along with experts from the World Health Organisation and Health Canada, to bring their experiences, their lessons in reviewing biotherapeutics before and after approval, and their best practices.

Our hope is that health regulators in South America and beyond will adopt and apply the best practices that make sense to their individual countries. Much has been said about globalization in recent years – positive and negative – but this event, where countries can learn from one another on what to apply and what to avoid, is certainly a very positive example. It is a win-win for all involved, especially patients.

To find out more, click here.