Category Archives: Consumer Health

Six new startups win funding and expert support from Bayer

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Changing the experience of health: that’s the focus of the six startups which the Bayer G4A team has included in the Accelerator program this year.

The young companies came out ahead of more than 1,800 competitors from 100 countries.

They now have 100 days in which to intensively drive the further development of their products and solutions with expertise and investment from Bayer. The company will provide them with offices in Berlin, pharmaceutical executives and industry experts as mentors and EUR 50,000 in funding for each project.

The startups that have applied are developing digital solutions that cover the entire value chain within healthcare. Also this year, a patient jury was asked to rank startups according to the impact that their solutions would have on patient experience.

This year’s winners are:
• Agamon (Israel, GB): A healthcare intelligence platform that can be used to compile and structure health-related data from various sources in order to derive new information. www.agamon.io
• Cyclica (Canada): A cloud platform that aims to use artificial intelligence and biophysics to accelerate drug development. www.cyclicarx.com
• KinAptic (USA): An accelerated learning system for VR stroke rehabilitation using electric stimulation that analyses and detects neural signals to stimulate nerves in stroke patients. www.kinaptic.com
• OME (GB): Personalised health coaching that uses extensive data analyses to compile individualized health programs (nutrition, sleep, physical activity) in order to prevent disease. www.ome.health
• S-There Technologies (Spain): A smart device that analyses health data through urine in the toilet and gives patients insights into their health. https://s-there.com/
• Zencorlabs (Germany): A smartphone software and device that uses artificial intelligence to warn patients of heart failure.

Six years ago, Bayer started cooperating with startups in the healthcare sector through the G4A program headed by Eugene Borukhovich, he said, “It’s incredible to see the tremendous impact that some of our startups have had in the industry. I’m impressed to see the maturity and significance of their innovative solutions. Through the Accelerator program, I’m convinced we will be able to make a significant contribution to truly change the experience of health as we know it. We will continue to put people at the centre of their health and care every single day.”

Dieter Weinand, Member of the Board of Management of Bayer AG and head of the Pharmaceuticals Division commented, “Digital solutions are essential to driving innovation in an evolving healthcare environment. Bayer is seeking to apply them across the pharmaceutical value chain in order to detect diseases at an earlier stage, to develop medicines faster, and to deliver individual treatments with a meaningful outcome for patients. In this endeavour, we benefit immensely from collaborations and the exchange of knowledge and skills with innovative startups.”

SOURCE: www.pharmafield.co.uk/pharma_news

Can pharma halt the world’s obesity crisis?

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Major research published in the Lancet this week comes as no surprise, but the findings are still sobering: across the world there are too many people who are not doing enough exercise, putting themselves at risk of diseases such as obesity and type 2 diabetes.

The research published in Lancet Global Health showed that more than a quarter (1.4 billion) adults are at risk from not doing enough physical activity – these diseases are hugely costly to society and to individuals affected.

The levels of insufficient physical activity varied widely across income groups – 16% in low-income countries, compared with 37% in high-income countries.

And in 55 (33%) of 168 countries, more than a third of the population was insufficiently active according to the figures collated in 2016.

In four countries more than half of adults were insufficiently active – Kuwait (67%), American Samoa (53%), Saudi Arabia (53%) and Iraq (52%).

But the regions with the highest increase in insufficient activity over time were high-income Western countries (from 31% in 2001 to 37% in 2016), and Latin America and the Caribbean (33% to 39%).

Countries from these regions driving this trend include Germany, New Zealand, the USA, Argentina, and Brazil.

Authors also identified several socioeconomic forces at work behind the problem – including urbanisation, sedentary occupations, and motorised transport in the richer countries where lack of exercise is most prevalent.

This research will be of interest to the pharma companies that are attempting to tackle diabetes and obesity related diseases, not just with medications but by working with governments to try and influence policy to reduce incidence of the disease.

Leaders in the field such as Novo Nordisk and AstraZeneca are actively campaigning to try and encourage governments to think about how they can encourage people to become more active, and reducing the levels of obesity in society.

With networks of experts in diabetes in countries across the world big pharma companies have realised that there is a huge opportunity to reach out to health systems using corporate social responsibility programmes that aim to tackle the issues outlined in the Lancet research.

For instance Novo has created an initiative entitled “Cities Changing Diabetes” that specifically aims to tackle the problem of “urban diabetes”.

The project involves collecting qualitative and quantitative evidence that could lead to better understanding of the problem and the contributing factors.

It has built up a network of partners across the world, including city leads, city administrations, academia, diabetes associations, health insurances, community centres and business corporations.

So far it has built relations with 16 cities across the world, representing 100 million citizens, including Beirut, Copenhagen, Leicester and Shanghai.

The project is driven by the recognition that the problem with diabetes is only going to get worse unless immediate action is taken.

According to modelling from Novo Nordisk, in order to hold the rise in prevalence at 10%, the world must set itself a target of reducing obesity by 25% by 2045.

Novo organised a Cities Changing Diabetes Summit last year, where it made the call for joint working across sectors and disciplines in order to unite them behind the cause.

Novo has launched an Urban Diabetes Toolbox that gives policy makers tools on how to tackle the problem, including diabetes vulnerability assessment tools, and tips about how to promote healthy living.

AstraZeneca has also been active in this regard, taking part in the multi-year Action in Diabetes initiative and participating in the Global Diabetes Policy Forum in Rome last October.

Now in its third year, the event brought together more than 100 leading global experts in type 2 diabetes care to discuss best practice in policy-making.

Inspired and funded by AstraZeneca, the initiative operates in partnership with the Internatioinal Diabetes Federation, the World Heart Federation, and Primary Care Diabetes Europe, among other organisations.

AstraZeneca’s work aims to demonstrate the interconnectivity between metabolic, cardiovascular, and renal diseases and foster policies that deal with these diseases in an holistic manner.

Eli Lilly is also known for its work in diabetes, and has launched its non-communicable disease partnership with a similar aim.

It has three aims  – piloting new approaches to strengthen diabetes care, advocating to governments for better disease management, and increasing appropriate use of and compliance with medicines to improve outcomes.

The scale of the problem is daunting, but pharma’s focus on raising awareness about the issue, and bringing different stakeholders together towards the common goal of reducing obesity is an example of how industry can help to tackle one of the major social problems of our times.

SOURCE: www.pharmaphorum.com/views-and-analysis

Patient centricity: a winning formula

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Industry has taken a collective pause in an effort to re-evaluate and rethink longstanding approaches to drug development and commercialisation.

There has been considerable discussion about the concept of patient centricity in the pharmaceutical community, with attention being recalibrated on the ultimate goal — making it easier for the patient to reach improved health outcomes. This perspective is underpinned by the recognition that what is best for the patient will lead to beneficial outcomes for all stakeholders, including the drug company, the healthcare provider and the supporting community of associated service providers.

There is a famous quote from former United States Surgeon General, C. Everett Koop: “Drugs don’t work in people who don’t take them.” It is estimated that less than one third of all prescriptions written are actually filled at the pharmacy by patients. Wide-ranging studies have shown medication adherence rates for life-threatening diseases — including diabetes, heart disease and oncology — can be as low as 30–40%. With the benefit of interventional techniques and developing technologies, adherence rates have been shown to improve; however, these programmes are not broadly adopted within industry at scale and have neither significantly reduced the overall cost of healthcare nor benefitted large populations.

Patients may be non-adherent for a variety of reasons, some conscious and some unconscious. Certainly, we are all admittedly forgetful when it comes to taking our medicine on time or being diligent about timely refills of those prescriptions. Cost can also be a significant factor whereby patients will consciously stretch their medication supply or simply go off therapy. In either instance, doing so will hamper the health impact of their prescribed therapy or worse; taking a drug holiday while prescribed an anticoagulant could potentially put their life in jeopardy.

Other considerations may be unwanted side-effects or a lack of understanding about how to optimally take the medication, such as taking with food or alternatively avoiding food for some period of time, resulting in reduced effectiveness. Fear or general lack of understanding can also inhibit the path to improved health by affecting the patient’s perception of the medication and their willingness to be compliant.

Likewise, the patient may not physically experience the benefit of the drug and, in some instances, may have a negative perception owing to the unwanted side-effects. Hypertension is the classic example; the patient may have high blood pressure but generally not feel the effects of their disease. However, they may experience considerably unpleasant side-effects as a result of their course of treatment.

Likewise, a similar scenario plays out in popular cholesterol lowering medications. By scale, these two examples are noteworthy; in the US, with a population of more than 300 million people, of which 75% are adults, it is estimated that one in every three adults has hypertension, whereas 10–20% of adults have high cholesterol. A large-scale patient-centric approach to benefit medication adherence would have significant positive health and economic impacts.

Focusing patient centricity in clinical trials

In addition to challenges with patient adherence to medication in clinical trials, sponsors and study organisers are also constantly faced with hurdles such as patient recruitment and patient retention. As the industry is tasked with further expediting drug development and decreasing clinical study duration, FDA is increasingly requiring additional studies and further data to prove long-term safety and comparative effectiveness, including post-marketing studies once the drug is commercially available in the market.

This trend is coupled with an increasing percentage of drugs being brought to market for very specialised disease states and narrow therapeutic indications. This wave of specialised medicines and the ongoing need for treatment-naïve candidates, paired with cost pressures in the R&D sector, has increased the use of multinational studies. These complex studies in turn create the requirement for multilingual labelling. This can result in the creation of investigational medicinal product (IMP) study materials that may contain upwards of 16–20 languages on a single label.

Clinical trial professionals are left to balance all of these demands and creatively identify initiatives to keep the focus on the patient. At a surface level, these competing priorities may seem to be in direct conflict. However, when one looks at the situation from a broader perspective, the focus on patient centricity clearly generates tangible value and outweighs the short-term inefficiencies created by opting for a solution solely based on speed or cost.

Patient centricity in package design

A practical example of patient centricity in action can be found in package selection for investigational studies. When looking to initiate a clinical study, a sponsor company may be evaluating whether to choose a bottle or a unit dose blister in a calendarised format for their clinical study material.

Looking simply at the short-term criteria of expediting material for study initiation, when a difference of weeks or days can be considerable, the path of selecting a bottle would be a logical solution. It is a cost-effective packaging option, it is relatively “off the shelf” in its availability, it can be hand filled by a clinical packager with minimal start-up costs, has an acceptable stability profile for barrier properties and is child resistant.

Conversely, when evaluating the development of a unit dose adherence package, the company might find that it may involve a longer lead time for development and be more costly to produce. Looking from a short-term perspective and the immediate pressures of cost and expediting, the choice leaves little room for debate. However, if the sponsor company is taking a holistic approach with a focus on patient centricity, the broader economics absolutely point to the use of a patient-centric package.

Using a calendarised unit dose blister format or compliance/adherence packaging enables sponsor companies to both address the needs of the patient as well as positively impact the desire for better data, more efficient studies and lower total delivered cost. The use of this style of package allows patients to take medication exactly as prescribed and track their usage, rather than a bulk approach in a bottle format. Physicians can capture vital information on the package, including the specific date to start the therapy and any other pertinent notes for the patient. With the returned package, the patient can physically demonstrate to clinical providers that they have taken the product as prescribed. Furthermore, technologies are available that can provide real-time tracking of patient dosing, allowing for clinical interventions to ensure proper adherence while the study is in progress.

These technologies and principles extend to other delivery forms such as injectables. The ability to prompt, monitor and even track real-time information is a powerful tool. Likewise, with the advent of Bluetooth and nearfield communication technologies, packages with integrated technology can capture real-time information about side-effects or other vital information as patients take the medication during the course of treatment. Better adherence leads to healthier patients and more valuable study data.

Poor adherence can be rectified and corrected as it happens. Better information gathering can lead to improved patient retention, a significant cost in clinical trial administration and a persistent challenge in study duration. It is estimated that, in the industry, clinical studies on average have a 30% drop out rate. With more adherent investigational study patients, health outcomes are improved and better retention is realised, translating into reduced total delivered cost, more valuable data generated and studies executed more efficiently.

Patient centricity in clinical supply chain logistics

Another focus point for realising patient centricity in clinical trials is in the area of study design and administration. Considerable interest is being focused on Direct-to-Patient models, in which patients may minimise or in some instances avoid the need to come to a hospital or clinic to receive the study drug, as well as provide critical health feedback. In this scenario, patients are engaged by clinical trial or healthcare professionals in a home setting and the study drug is physically delivered to their home by a trained specialist. Clearly, this model is not applicable for all studies and disease states, but for certain programmes there can be considerable benefit to the patient and the study.

In certain geographies, patients in a traditional clinical study may have to travel significant distances to participate, which can considerably hamper patient recruitment and retention. In a Direct-to-Patient model, the study effectively comes to them. This model may increase the cost of study administration for the sponsor company; however, by executing the study in a more patient-focused approach, the sponsor company can realise significant benefit through patient recruitment and retention, again translating into better data, more efficient studies and a faster path to completion.

Patient centricity in a global world

One of the increasing challenges in taking a patient-centric approach to clinical study execution is the growth in multinational study execution. Often, supplies are designed to pool, so that multiple languages are provided and materials can be directed to individual countries as needed.

This scenario forces sponsor companies to either manage a multitude of language-specific supplies or focus on common supplies — whereby they condense information owing to the shear amount of text being added, often squeezed into a multi-page booklet.

Careful consideration must be paid to graphics that are common to all languages and cultures to ensure patients can clearly comprehend considerably distilled opening instructions, dosing regimens and other key information. Rather than a traditional pooled supply approach, some companies have developed newer strategies for just-in-time (JIT) labelling or late stage customisation logistics, whereby they label study materials according to country specific requirements at the time of drug dispatch.

This can reduce the complexity of a scenario in which they would be trying to accommodate 16 different languages on the same label in a multi-page booklet approach. This JIT strategy might decentralise supplies but may bring other benefits, such as meeting the language and cultural needs of patients in their geography, as well as those of the study administration.

Patient focus yields powerful results

The industry is only in the infancy of its journey towards patient centricity; but, it is clear that with a focus on the patient, many tangible benefits can be realised by drug companies in the development and commercialisation of life-saving medicines.

With so many significant breakthroughs during the past decade, it is exciting to see where this patient focused journey will lead as new patient breakthroughs are happening every day.

SOURCE: www.manufacturingchemist.com/news

Merck KGaA finds consumer health buyer in P&G for €3.4bn

Wax Selection – Leaders in Pharma, Biotech & MedTech Recruitment

Merck KGaA has successfully found a buyer for its healthcare unit, after Proctor & Gamble announced that it was prepared to part with €3.4 billion to gain the rights to a portfolio that includes Seven Seas and Bion3 supplements.

To push the deal through, it is assumed that Merck had to climb down slightly on its valuation of the business, which it had initially pegged at around €4 billion. However, now that the deal has gone through, the company will be able to focus on its pharmaceutical business and potentially use the extra cash to grow its pipeline.

The company’s decision not to play hardball on price may well have been influenced by watching Pfizer’s failure to offload its on healthcare business.

Pfizer had a firm valuation of the business at $20 billion, a figure that all of the companies interested in taking on the business were disinclined to match.

GSK, for instance, took a look at the possibility before deciding to spend $13 billion buying Novartis out of their joint healthcare venture.

While P&G had actually previously shown interest in Pfizer’s unit, which is three times the size of Merck’s, but did not want to pay more than $15 billion for it.

All of which meant that Pfizer has been unable to find a buyer and has spent a large amount of time for no productive end – clearly Merck did not want this to be the case in its own sale.

“We like the steady, broad-based growth of the OTC Health Care market and are pleased to add the Consumer Health portfolio and people of Merck KGaA, Darmstadt, Germany, to the P&G family,” said David Taylor, Chairman of the Board, President and Chief Executive Officer.

P&G’s acquisition will see 3,300 Merck employees move over as part of the transaction, which is expected to close during the 2018/2019 financial year.

The steady growth Taylor references is the fact that Merck has achieved 6% growth for the last two years. However, Merck wants to pull away from this sector because pharmaceuticals can offer for greater return – though with an equivalent risk of any potential drug failures, as it is has found after being stung by trial failures with Bavencio.

SOURCE: www.pharmafile.com/news/517106