Tag Archives: Collaborative

Accelerating Footfalls In Less Charted Pharma Marketing Frontiers

Posted on by
Reply

Having experienced unprecedented disruptions, especially in the pharmaceutical and biopharmaceutical business, many global and local drug majors, are rethinking their marketing strategies. These have, no doubt, been prompted by the challenges of change, which are sometimes stark, but more often than not - nuanced.

Many of them are now, therefore, charting into less charted or even uncharted frontiers of pharma marketing warfare. Most companies had no choice, though, but to embrace new approaches, at least as a stopgap, to reach their target audience – hoping to revert to pre-pandemic practices, ultimately.

Interestingly, some pharma majors could envisage that long-term focus on many of these new and innovative areas – more effectively than even the pandemic lockdown time, could be a game-changer in the business. Accordingly, they tried to adapt, several of these approaches, quickly and effectively – for sustained excellence in the post-COVID paradigm.

In this article, I shall focus with several global and local, publicly available examples, of innovative pharma marketing approaches that are now being tried by several top drug companies in the post-COVID period.

I. Continuation of pandemic induced innovative approaches – global examples: 

  • Virtual Conferences and Events: Experiencing success with virtual events and conferences during the COVID-19 pandemic, many pharma companies are leveraging this digital space to reach out to healthcare professionals and patients. These events now include webinars, selected virtual conferences, and online workshops.

Pfizer, reportedly, held its first virtual investor day in September 2020, which was attended by thousands of participants from around the world. The company also organized several virtual events to educate healthcare professionals about its vaccine.

  • Social Media Marketing: The use of social media marketing is also increasing in the pharmaceutical industry. Companies are using platforms such as Facebook, Twitter, and LinkedIn to reach out to their customers and engage with them on a regular basis to build long-term relationships.

For example, Novartis, among a few others, is using social media to promote core values of its products and engage with customers. The company has built a strong presence on social media platforms where it shares news and updates about its products and research, as well.

  • Influencer Marketing: Many companies are partnering with influencers in the healthcare industry to promote their products. These influencers can be doctors, nurses, patient advocates, or even celebrities who are passionate about health and wellness. Influencer marketing can help companies reach a wider audience and build trust with their customers.

The French pharma major – Sanofi, has partnered with celebrity chef and diabetes advocate Charles Mattocks who was diagnosed with type 2 diabetes in 2011. The objective is to raise awareness about diabetes and promote the company’s diabetes products through social media and other channels.

  • Patient Education Programs: Companies are investing more on patient education programs to educate patients about their health conditions and treatment options. These programs can include online resources, mobile apps, and support groups. By providing patients with accurate and reliable information, companies can improve patient outcomes and build brand loyalty.

Merck, another global player, developed an online resource called MerckEngage to educate patients about their health conditions and treatment options. The platform provides patients with information about various health topics, including diabetes, cancer, and heart disease.

II. Continuation of pandemic induced innovative approaches – Indian examples: 

Some Indian pharma players are also not far behind in several innovative areas for business excellence in the post pandemic paradigm. Following are some of those examples from Indian pharma companies, as available in the public domains. These seem to have attracted greater focus in the pandemic period, and are continuing even today, with undiluted focus:

Virtual Conferences and Events: Illustratively, Lupin has been using virtual events to promote its products in the post-COVID period. The company is organizing virtual conferences and webinars to reach out to healthcare professionals and other customers. Similarly, Sun Pharma launched a virtual conference for healthcare professionals to discuss the latest developments in the field of dermatology.

Digital and Social Media Marketing:  Several Indian pharma companies are increasingly adopting digital marketing “strategies to reach out to their customers. Companies are using social media, online ads, email marketing, and other digital channels to promote their products and services.

For example, Dr. Reddy’s Laboratories continue using social media platforms like LinkedIn, Twitter, and Facebook to engage with healthcare professionals and consumers. Even, Cadila Healthcare, reportedly, has been using search engine optimization (SEO), pay-per-click (PPC) advertising, and social media marketing to reach out to its customers.

Telemedicine: With the rise of telemedicine during the pandemic, pharma companies are partnering with Telehealth/Telemedicine platforms to reach out to patients. Companies like Cipla have partnered with telemedicine platforms to offer online consultations and delivery of medicines to patients’ doorsteps. Sun Pharma has also been using telemedicine to reach out to its customers and has partnered with telemedicine providers to offer its products to patients who cannot visit a doctor in person.

  • Direct-to-Consumer (DTC) advertising: DTC advertising is gaining popularity among Indian pharma companies. With the rise of online pharmacies, companies like Abbott and Pfizer are launching DTC campaigns to increase disease and treatment awareness programs directly to consumers.
  • Collaborations and partnerships: Indian pharma companies are increasingly collaborating with other players in the healthcare ecosystem to provide integrated solutions. For example, as mentioned above, Lupin has partnered with a health-tech firm to offer a platform for online consultations and home delivery of medicines.
  • Greater patient-centric approaches: Some Indian pharma companies are adopting more patient-centric approaches for more effective omnichannel patient engagement initiatives. For example, Dr. Reddy’s Laboratories have launched an initiative to educate patients on the proper use of medicines and the importance of adherence to treatment.

As the industry continues to evolve, we can expect to see more companies adopting newer and more innovative marketing strategies to engage with their customers.

Summary:

Many of the above examples are pandemic triggered innovative approaches to keep the neck above water during unprecedented business disruptions in the pharma industry. Interestingly, some companies are not just continuing but further sharpening these initiatives in the post pandemic days. Moreover, it’s good to note that these are now being implemented by the concerned sales and marketing teams with greater gusto and zeal.

The point to ponder, therefore, is pharma industry ready now to excel amid start and more often nuanced – the challenge of change? To respond to these challenges effectively, more companies now need to seriously evaluate and consider adapting such strategic footsteps, first as pilot studies and then gradually scale up, for business excellence in the contemporary period.

Let me hasten to add, in this ball game pharma leadership mindset change to act decisively, after accurately studying – based on data-science, to ascertain where and how to change could well be a win-lose situation. However, the good news is, recent data vindicate the accelerating footfalls in many these less or even un- charted pharma marketing frontiers, both globally and locally.

By: Tapan J. Ray        

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Covid Prompts Pharma To Move Away From Competition Driven Business Model

Posted on by
Reply

As deliberated in my just previous article in this blog, Covid has been a watershed in several areas of pharma business. One such key area is its competition driven strategic business model. It aims to deliver significant value for a longer time than the competition, protected by a patent thicket driven TINA factor – and only for those who can afford such patented drugs. It didn’t matter, if a vast majority of patients are denied access to these medicines, with a dangerous pricing trend acting as an insurmountable barrier. Flying solo has been the motto of most players in this ball game, to delight the stock markets.

Interestingly, Covid pandemic seems to be changing this model. Pharma industry, by and large, is now trying to demonstrate its core value for the society – moving away from displaying competition driven one-upmanship. In this article, I shall deliberate on this area.

Covid poses both – a humongous challenge and a great opportunity:

As the article, published in the MIT Sloan Management Review on April 16, 2020 highlights: ‘The COVID-19 pandemic may well prove to be the biggest challenge for humankind since World War II.’ The same holds good for the pharma industry, as well. The drug companies are now expected by all, to play a pivotal role in the fight against the pandemic ‘that is bringing health care systems to their knees and sending shock waves through economies across the globe.’

This is generally because, pharma industry possesses wherewithal to develop effective drugs and vaccines to combat this health crisis – if not alone, but certainly collectively. It also offers a great opportunity for pharma to ‘walk the talk,’ by demonstrating upfront that meeting all patients’ unmet needs lie at the core of the pharma business. As I quoted a global CEO in one of my articles articulating, this crisis also comes as ‘a Shot at Redemption in Pharma Industry.’

Thus, if the industry reacts quickly and responsibly, it may have the chance to also redeem a reputation that’s been tarnished for years. Some of these instances are, illegal marketing practices, corruption scandals, and obscene pricing of vital drugs, the MIT Sloan article underscored. Flying solo in this situation may not be just enough, if not foolhardy.

Flying solo in this situation may not be enough:

Taking this initiative won’t be a piece of cake, either, if pharma companies prefer to do it alone during this unprecedented health crisis.  The drug players will need to be willing and able to successfully collaborate with other players in the race to develop treatments and vaccines. Otherwise, their legitimacy will be fundamentally questioned, especially when the entire world is running against time.

The rationale of two top drug companies entering into collaborative arrangements is obvious – the realization that pooling of all resources together is the best way of delivering effective Covid related solutions to the society at the shortest possible time. The good news is, pharma has already taken the first step in this direction, even when some of them are competitors, in several areas – moving away from their competition driven business models, as of now.

Once strange bedfellows – now partners:

The article published in the Bloomberg Law on June 05, 2020 very aptly observed: ‘The race to address the pandemic has brought together strange bedfellows as big-name companies’ partner with their rivals.’ The Scientist also wrote on July 13, 2020: ‘The urgent need for tests and therapeutics has brought companies together and pushed researchers to work at breakneck speeds.’

One can find this happening on the  ground now, as some major pharma and biotech companies, including Eli Lilly, Novartis, Gilead, and AstraZeneca, formed a group called COVID R&D to share resources and expertise to try to accelerate the development of effective therapies and vaccines for COVID-19. Besides, Roche Holding AG and Gilead Sciences Inc. have teamed up on trials for a drug combination to treat Covid-19.

There are several instances of such collaboration also in the Covid vaccine area. For example, GlaxoSmithKline plc struck a deal with Sanofi to produce 1 billion doses of a coronavirus vaccine booster. Besides, Pfizer from the US and BioNTech from Germany are joining hands to co-develop and distribute a potential Coronavirus vaccine, aimed at preventing COVID-19 infection.

It’s a reality today that Covid-19 has brought not just the strange bedfellows within pharma and biotech companies together. Academia and governments have also moved on to the same collaborative platforms, to save people from a deadly and super contagious infection, in the shortest possible time. We have witnessed this

in India, as well. For example, the Council of Scientific and Industrial Research (CSIR) and Aurobindo Pharma Limited have also announced a collaboration to develop vaccines to protect against SARS-CoV-2 or COVID-19.

The rationale and some possible issues: 

Each of these players is bringing some expertise and intellectual property to the table. “As they work together, they’re going to create more, so you have the ‘yours,’ the ‘mine,’ and the ‘ours’ of collaboration,” as the Bloomberg Law points out. That said, any collaboration of such nature and scale will have its own share of legal issues, such as, patents, trademarks, trade secrets, revenue sharing models, and more.

The collaborators, in pursuit of saving mankind from Covid-19, are expected to find enough alternatives to resolve these glitches for a win-win outcome – not just for now, but much beyond – with the dawn of a new collaborative model. The rapid general acceptance of this collaborative model by more and more drug companies to meet unmet medical needs in many other areas – much faster, in all probability, will delight the health care consumers and also be appropriately rewarded.

Leveraging the collaborative business model beyond pandemic:

E that as it may, it still remains an open question to many, whether such collaborative model will be leveraged for an accelerated rate of drug, vaccine and diagnostics development beyond the pandemic.

The good news is, as The Scientist article reported, some pharma players are seriously pondering how to continue working in this new way – with the same sense of urgency and purpose, for other disease areas too. They believe, the lessons being learned with the collaborative models, may help expedite development of therapeutics in other serious conditions, such as, Alzheimer’s, intractable cancers and autoimmune diseases.

If and when it happens as a predominant business model, suffering patients and the society, in general, would lap it up and the innovators would be suitably rewarded. However, the paper also says, there are still some drug companies who prefer to continue working in a more insular fashion, as was happening in the old normal. But, experts also feel, that should not cause any worry, as long as majority prefers to continue following the collaborative models, in the new normal, as well.

Pharma would make a good profit from collaborative business models too:

For those who say that drug companies won’t make good profit from Covid drugs and vaccines, Pfizer CEO has an answer. Albert Bourla, Pfizer’s CEO, reportedly, has no patience for the argument that pharmaceutical companies should not be making a profit on the drugs and vaccines they introduce to fight Covid-19. This article highlights, at $19.50 per dose, the 1.3 billion doses of Pfizer BioNTech Covid vaccine that the Pfizer plans to make by the end of next year, could translate to nearly $13 billion in sales, after the company splits its revenue with its partner BioNTech. It is roughly the same as Pfizer’s all-time best-selling drug Lipitor sold in its best year.

Adding to it, another article on the same issue, published by Fierce Pharma on August 13, 2020, further reinforced the above expectation. It wrote, the longtime Evercore ISI pharma analyst haspredicted the total market for COVID-19 vaccines would be worth $100 billion in sales and $40 billion in post-tax profits. It assumed frontrunner Moderna would supply about 40 percent of the market, Novavax would take 20 percent and the other vaccine developers would split the rest. “One could look at the field under this base scenario and conclude it is reasonably valued in total,” the analyst concluded.

Nonetheless, there could still be several points that remained unanswered in this analysis. But the bottom line is, the collaborative model is not just profitable, it starts generating profit earlier and faster – virtually eliminating the cost of possible delays when a company flies solo.

Conclusion:

With a seemingly flattening curve, the Covid pandemic still continues, alarmingly. As of October 25, 2020 morning, India recorded a staggering figure of 7,864,811 of Coronavirus cases with 118,567 deaths.

With this backdrop, COVID-19 has provided the pharma industry a new opportunity to demonstrate its true value to the society – not the self-serving ones. It’s now clear that no one can rule out, there won’t be a similar unprecedented health catastrophe in the future too. It may come in various different forms, or may even be from a rapid and complex mutation of the same lethal virus.

Moreover, such crisis may not come and go in just a few months – may even linger for a long time. In any case, these may again be equally disruptive – or even more disruptive to lives, livelihoods and the economic growth engine. In such a scenario, putting the brightest scientific brains of the world together will be critical, and adding top speed to the process being the essence to come out of the crisis with least possible damages.

Covid pandemic has also demonstrated that the competition-based model of the drug could be a serious retarding force in that endeavor. What will matter, is a well-structured collaborative model that can create a win-win situation – both for patients and the business. I reckon, it’s about time to move into this model to find most effective drugs and treatment solutions for many other unmet needs related to a host of intractable diseases, much sooner.

There could, of course, be some business issues with this model. But those can be resolved amicably for an all-weather greater success in business, along with protecting the society – for all. From this overall perspective, it appears, Covid pandemic now sends a strong signal to pharma companies to move away from predominantly competition driven business models, expanding more into collaborative ones.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Covid Propels Healthcare Into A Virtual World: A New Growth Driver For Pharma?

Posted on by
Reply

Amid ongoing Covid pandemic, most discussions on pharma specific ‘digitalization’ initiatives continue to predominantly hover around its traditional business growth drivers. In fact, even before the Covid time, it was no different, in a smaller scale and with a lesser intensity, though.

Incidentally, since quite some time, with the explosion of different types of web-based businesses, offering opportunities to buy and receive, virtually everything, at one’s doorstep, many things started changing rapidly. Almost all businesses started offering the state of the art, easy to use smartphone app-based e-commerce solutions, in different formats, to grow their businesses. Alongside, more and more people started managing their daily needs and wants online, even in India. Intriguingly, despite the availability of telemedicine, telehealth and e-pharmacies, even in the old normal, most people continue to prefer in-person health care solutions, including buying medicines.

Then came a bolt from the blue – the unprecedented global health crisis, caused by Covid-19. Almost overnight, amid requirements of maintaining stringent personal measures to keep Covid at bay, making in-person doctor-calls for brand demand generation activities, posed a great challenge. Doctors, too, became hesitant to meet general patients and medical representatives, in that situation. Thus, to keep the business up and running, most pharma companies gave top priority in finding out a digital solution for the brand demand generation processes. Interestingly, this was happening, when many patients, especially those with non-Covid ailments, also faced a similar situation to meet their health care needs.

Finding no other viable alternatives, many patients were pushed to search for a robust digital solution for health care needs, as well – just as they were already meeting their other regular needs – online. In that sense, Covid propelled many patients to step into a new virtual world of healthcare - telehealth or telemedicine. As mentioned above, although, these services were up there in pre-Covid days, many patients, apparently rediscovered them, in a new Avatar, to get relief from ailments and also save their lives.

On a hindsight, it appears, why the need to leverage telehealth or telemedicine in that crisis, did not appear to be a priority for most pharma companies to foster patient-centric growth of the business. Thus, continuing with the core concept of my previous article, – this article, will focus on the possibility of pharma spearheading the process, aiming for a win-win outcome – boosting access to high quality affordable care for all, on the one hand. And simultaneously, harnessing this new growth driver to excel in the business, on the other.  

Telehealth or e-health will grow just as other e-businesses, unhindered: 

With the Government of India issuing guideline for telemedicine practices on March 25, 2020 and later, on May 12, 2020, publishing those guidelines in the gazette, ‘Telemedicine’ has been made a high priority health care enabler. The notified guidelines also make telemedicine consultation provided by a Registered Medical Practitioner (RMP) under the Indian Medical Council Act, 1956, legally permissible. In addition, effective October 01, 2020, Telemedicine costs will be covered under medical insurance in accordance with the Insurance Regulatory and Development Authority of India’s (IRDAI) new guidelines.

The net effect of these measures will not just help reduce pressure on the fragile public healthcare infrastructure of the country, but will also expand access to lower cost and high-quality private care to a large number of people.  

Telemedicine is here to stay and be a key pharma growth driver:

With Covid propelling health care into virtual platforms, providing and receiving medical care through telehealth has become a necessity for many people, for different reasons. However, the question that surfaces, will patients return to the old normal, if and when the pandemic ends?

The article – ‘3 reasons telehealth is here to stay,’ published by the MedCity News on October 09, 2020, presents a practicing physician’s perspective on this issue. The author envisages, ‘telemedicine will continue to gain traction with my colleagues and most likely, become a permanent clinical option for patient care.’ Going by such hands-on experience, I reckon, telemedicine will continue to grow for several important reasons, such as:

  • Technology to make telehealth increasingly user friendly: Ongoing IT innovation is making telehealth platforms simple and more effective for doctors and a large number of patients belonging to all age groups. “All they have to do is click a link on their smartphones, which is sent to them via text automatically.” Thus, these tools will increasingly become the best option for treating a broad range of conditions, long after the pandemic subsides.
  • Telemedicine costs are covered under medical insurance, now: Effective October 01, 2020,Telemedicine costs will be covered under medical insurance, even in India. Moreover,‘Telemedicine’ has now been made a high priority health care enabler, carrying a permanent legal status in India. 
  • Health Equity and affordable care: Access to affordable health care is not evenly distributed across the India. Telehealth can help fill these gaps, with increased affordable access for all, even in rural India, as patient location won’t be a problem in getting prompt and quality care at a low cost.

From the above perspective, it appears, it’s high time for pharma to leverage Telemedicine and Telehealth as a major growth driver, powered by innovative business strategies.

Is there any difference between Telemedicine and Telehealth?

Very often these two words are used interchangeably. Mostly because, both telemedicine and telehealth are the practice of medicine using technology to deliver care at a distance.

Telemedicine offers remote clinical services, such as, virtual consultations, diagnosis, prescriptions, preventative care, monitoring via telecommunication platforms, including text, video chat, wearable devices or even phone calls. Whereas, telehealth, in addition, can include remote non-clinical services, such as health care training, administrations and continuing medical education.

Reasons for pharma’s cashing on this new growth driver at a low cost:

Besides Government’s support to telehealth and telemedicine, growing health care consumer demand and user-friendly technologies, are catapulting virtual care to the mainstream health care delivery systems. In tandem, driven by unique and long-term value offerings, telemedicine is being increasingly recognized as a critical means to get prompt care for minor but urgent ailments. Consequently, moreusers are getting attracted to its convenience and benefits, which may have a snowballing effect. Some of which are as follows:

  • Prompt access to disease treatment services, as and when needed by patients, without any long waiting time, for any reason.
  • Significant health care cost saving for all – more for rural population who will be able to avoid long distance travel, involving both time and money, besides associating hassles.
  • Prompt follow-up consultation facilities, will help avoid disease complications, reducing the burden to hospitals for secondary or tertiary care.
  • Further, pharma can offer even greater patient satisfaction by leveraging virtual healthcare platforms, as these will help ensure more effective follow-up and enhanced treatment convenience than traditional in-person visits. Several studies, such as the article, published in ‘The American Journal of Managed Care,’ on January 15, 2020, vindicate this point.

In short, accelerating rate of use – with the increasing need for prompt, easy and affordable access to care, are driving telemedicine to be an integral part of healthcare service delivery system. Which is why, expansion of pharma business in this new virtual space, with well-integrated collaborative strategies, could prove to be a key growth driver – over a long period of time.

Moreover, there doesn’t seem to be any need to deploy a large and cost-intensive field force, as is usually followed for expansion of pharma business in newer areas. This is because, ‘telemedicine requires a different approach to promotion.’

Telemedicine requires a different approach to promotion

That telehealth requires a different approach to marketing and promotion from traditional pharma marketing, was deliberated by ZS in the article -‘Four telemedicine myths for pharma to avoid,’ published on July 05, 2020. The paper underscored, ‘instead of building brand awareness and engaging patients in education and information, telehealth promotion needs to drive patients to take one specific action: call today!’ It further elaborated:

  • Brands that bury the telehealth link on page 8 of their website or make linking to a physician one of more than 20 different calls to action, will find low patient engagement and low pull through.
  • As virtual health care is here to stay, telehealth itself should be a strategy for active promotion, by optimizing the steps to get patients connected to a physician in the shortest and the easiest way possible.

From this perspective, brands that will find the right pathway for engaging in telehealth, will reap the benefits of increased engagement with patients and telehealth physicians. To achieve this objective, with a robust, commercial strategy, the first step for each brand will start with understanding the needs of patients and physicians that needs to be addressed on priority. Then comes, mapping out how the brand will get used to meet those needs.

Conclusion:

We are still in the midst of an unprecedented new Coronavirus pandemic. As of October 18, 2020 morning, India recorded a staggering figure of 7,494,551 of Coronavirus cases with 114,064 deaths.

With the pandemic severely curbing most patients’ access to care – following the traditional process, Covid propelled health care into a virtual world, almost in no time. Telemedicine brought to the fore, its game changing potential to provide expanded access to high quality and affordable health care, through multiple channels, sans physical presence. Location of a patient or of a competent physician isn’t an issue, any longer, in the disease treatment process. With telemedicine patients will be able to get treated as and when they will want.

The future of Telehealth or telemedicine appears to be promising even beyond Covid time, with more people preferring digital platforms for affordable and more convenient medical care than in-person visits. With virtual care getting integrated into traditional health care delivery systems, pharma players will need to explore this space, as a new growth driver – for wider reach, and greater share of mind of customers for their respective brands.

For Telemedicine to be successful – benefitting a vast majority of both urban and rural populations, country’s health policy makers and, especially the pharma industry should work in unison. Only then, the net outcome will offer a win-win situation – both for the Government and also for the drug industry. It will help expand access to high quality and affordable care to all – seamlessly, irrespective of location. Consequently, pharma marketers will get access to another powerful business growth driver – in telemedicine. Its time about time for all to act – sooner the better.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

A Potential Game Changer For Pharma R&D

Posted on by
Reply

The ghost of ‘Patent Cliff’ has been haunting the ‘Big Pharma’ since quite some time. This situation has been further aggravated by cost containment pressures of various Governments both in the developed and the emerging markets together with contentious issues on Intellectual Property Rights (IPR).

The ‘dream run’ that the innovator companies enjoyed in launching patented products so frequently and making many those blockbuster drugs of billions of dollars, is no longer a reality.

According to the findings of ‘Pharmaceutical R&D returns performance’ by Deloitte and Thomson Reuters of December 2012, the R&D Internal Rate of Return (IRR) of leading pharmaceutical companies had fallen to 7.2 percent in 2012 from 7.7 percent in 2011.

Many would, therefore, tend to believe that the paradigm is changing significantly. The new paradigm in the brand new millennium throws some obnoxious challenges, including some related to IPR, triggering a process of churning in the global pharma industry. Some astute CEOs of ‘Big Pharma’, having a deep introspection, are bracing for restructuring, not just in the business processes, but also in the process of organizational behavior, mindset, ethics and values. Unfortunately, there are many who seem to believe that this giant wheel of change can be put on the reverse gear again with might.

A new PPP initiative in pharma research:

This trying situation calls for collaborative initiatives to achieve both knowledge and cost synergies for a quantum leap in harnessing R&D output.

One such big laudable initiative has come to the fore recently in this arena. Having experienced something like the ‘law of diminishing return’ in pursuit of high resource intensive R&D projects aimed at critical disease areas such as Alzheimer’s, 10 big global pharma majors reportedly decided in February 2014 to team up with the National Institutes of Health (NIH) of the United States in a ‘game changing’ initiative to identify disease-related molecules and biological processes that could lead to future medicines.

This Public Private Partnership (PPP) for a five-year period has been named as “Accelerating Medicines Partnership (AMP)”. According to the report, this US federal government-backed initiative would hasten the discovery of new drugs in cost effective manner focusing first on Alzheimer’s disease, Type 2 diabetes, and two autoimmune disorders: rheumatoid arthritis and lupus. The group considered these four disease areas among the largest public-health threats, although the span of the project would gradually expand to other diseases depending on the initial outcome of this project.

Not the first of its kind:

AMP is not the first PPP initiative of its kind. The Biomarkers Consortium was also another initiative, not quite the same though, of a major public-private biomedical research partnership managed by the Foundation for the NIH with broad participation from a variety of stakeholders, including government, industry, academia, patient advocacy groups and other not-for-profit private sector organizations.

Open innovation strategy of GlaxoSmithKline (GSK) to discover innovative drugs for malaria is yet another example, where GSK collaborated with the European Bioinformatics Institute and U.S. National Library of Medicine to make details of the molecule available to the researchers free of cost with an initial investment of US$ 8 million to set up the research facility in Spain, involving around 60 scientists from across the world to work in this facility. 

Nearer home, ‘Open Source Drug Discovery (OSDD)’ project of the Council of Scientific and Industrial Research (CSIR) is a now a global platform to address the neglected tropical diseases like, tuberculosis, malaria, leishmaniasis by the best research brains of the world working together for a common cause.

Challenges in going solo:

In this context, it is worth mentioning that the CEO of Sanofi, Chris Viehbacher reportedly said in an interview on April 15, 2013 that his company “Won’t push hard to find an Alzheimer’s treatment because the science isn’t advanced enough to justify the costs to develop a drug. Therefore, Sanofi definitely won’t commit major resources seeking to discover an Alzheimer’s therapy.” He further stated, “I think we have to do a lot more basic science work to understand what’s going on. We really, at best, partially understand the cause of the disease. It’s hard to come up with meaningful targets.”

The above report also mentioned that the first Alzheimer’s drugs, should they prove successful, would lead to a market worth US$ 20 billion as estimated in 2012.

Long desired OSDD model:

The new AMP R&D model in the United States seems to have derived its impetus from the “open-source” wave that has swept the software industry. Keeping that spirit unchanged, in this particular ‘open source’ model too, the participants would share all scientific findings with the public and anyone would be able to use these results freely for their own research initiatives.

The collaborators of this PPP project are expected to gain a better understanding of how each disease type works, and thereafter could make use of that collaborative knowledge to discover appropriate new molecules for the target disease areas.

AMP is also expected to arrive at methods to measure a disease progression and its response to treatment much more precisely. This will enable the pharma participants getting more targets right and early, thereby reducing the high cost of failures. Just to cite an example, there have been reportedly 101 failures since 1998 in late-stage clinical trials by Pfizer, J&J and Elan Corp.

Commendable initiative in the uncharted frontier:

The ‘open source’ AMP initiative of ‘Big Pharma’ in the uncharted frontier is indeed very unusual, as the innovative drug companies are believed to be not just quite secretive about the science that they are engaged in, but also near obsessive in pursuing and clinging-on to the Intellectual Property Rights (IPR) through patents for each innovative steps related to potential new drugs.

It is worth noting that like any OSDD model, this PPP agreement also denies the participating players from using any discovery for their own drug research up until the project makes all data public on that discovery.

However, as soon as the project results will be made public, fierce competition is expected all around to develop money-spinning winning drugs.

Participating companies:

Ten pharma companies participating in AMP are reportedly, AbbVie, Biogen Idec, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Merck & Co., Pfizer, Sanofi and Takeda. It is good to find within the participants some staunch business rivals. According to a report, a number of foundations, including the American Diabetes Association and the Alzheimer’s Association have also agreed to get involved in the project.

Some key non-participants:

For various different reasons some key pharma majors, such as, Amgen, Roche and AstraZeneca have decided not to participate in AMP.

AMP project and cost:

AMP reportedly has reportedly articulated its intent to: “Map molecular paths that each disease follows and to identify key points that could be targets for treatment. In Type 2 diabetes, for instance, researchers hope to catalog the genetic changes that raise or lower a person’s risk for developing the disease. It also will seek novel methods to measure each disease’s course while assessing if a potential drug is working. Being able to measure a disease’s progress in that way, could speed drug development by raising a company’s confidence that an experimental drug is working, or let it more quickly end a project if a drug isn’t working.”

The participating companies and the NIH have jointly agreed that the AMP would put together a research system on cost sharing basis by pooling the brightest minds who are experts on each disease, along with the best drug discovery laboratories, relevant data and samples from clinical trials to decipher the diseases in ways, which none of these pharma players has been able to achieve just yet on its own.

To achieve all these, the total cost has been estimated at roughly just US$ 230 million, as compared to US$135 billion that the global drug industry claims to spend in a year on R&D.

This should also be seen in context of a study of December 2012 carried out by the Office of Health Economics (OHE), UK with a grant from AstraZeneca, which estimated that the cost of developing new medicine has risen by ten times from US$100 million in the 1970s to as high as US$ 1.9 billion in 2011.

As a head honcho of a global pharma biggie had put it earlier, a large part of these R&D expenses are the costs of failure, as stated above.

Criticism:

As usual, criticism followed even for this path-breaking project. Critics have already started questioning the rationale of the choice of the above four disease areas, with an exception perhaps for Alzheimer’s and wondered whether the participating players are making use of the federal fund to push hard the envelope of their respective commercial intents.

Another new collaborative approach: 

In another recently announced collaborative initiative, though not of the same kind, where Merck & Co has reportedly entered three separate collaboration agreements to evaluate an immunotherapy cancer treatment that is part of a promising new class of experimental drugs that unleash the body’s immune system to target cancer cells.

Conclusion:

There could still be some hiccups in the process of effective implementation of the AMP project. Hope, all these, if any, will be amicably sorted out by the participants of stature for the benefits of all.

Be that as it may, ‘open source’ model of drug discovery, as believed by many, would be most appropriate in the current scenario to improve not only profit, but also to promote more innovative approaches in the drug discovery process.

On May 12, 2011, in an International Seminar held in New Delhi, the former President of India Dr. A.P.J. Abdul Kalam highlighted the need for the scientists, researchers and academics to get effectively engaged in ‘open source’ philosophy by pooling talent, patents, knowledge and resources for specific R&D initiatives from across the world for newer and innovative drugs.

According to available reports, one of the key advantages of the ‘open source’ model would be substantial reduction in the high cost of failures of R&D projects, which coupled with significant saving in time would immensely reduce ‘mind-to-market’ span of innovative drugs in various disease areas, making these medicines affordable to many more patients.

Thus, PPP initiatives in pharmaceutical R&D, such as AMP, are expected to have immense potential to create a win-win situation for all stakeholders, harvesting substantial benefits both for the pharmaceutical innovators and the patients, across the world.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

 

 

 

Collaborative commercialization of inexpensive smaller incremental innovation in Chemistry will play an important role in bringing affordable new drugs or new drug delivery systems

Posted on by
Reply

It started in the 17th century:

Alchemy, a medieval chemical science and speculative philosophy aiming to achieve the transmutation of the base metals into gold, searching for a universal cure for disease and indefinitely prolonging life, not considered a science by many, gradually became the basis for the development of chemistry into the 17th century. However, perceivable impact of chemistry on humanity, through its smaller incremental innovation, started being felt only in the second half of the 19th century.

Chemistry – an interface between the physical world and humanity:

Experts in this field often opine that the current form of human civilization has been made possible, to a great extent, through significant advancement of such innovation in chemistry and its role in modern technology. Chemistry is indeed an interface between the physical world on the one hand and the humanity on the other.

Getting a perspective of resource and time requirements for such initiatives:

Is there any similarity between development of pharmaceutical chemistry and IT software?

Now a days, one finds a striking similarity between small incremental innovation in IT software and the same in pharmaceutical chemistry. Both are creative and belong to the knowledge economy. Scientists in both the communities try to generate innovative ideas, which can lead to their effective commercialization.

Resource requirements for these two are strikingly different:

However, the nature of the commercialization process of these two sciences, though seemingly similar in terms of innovativeness, is indeed quite different. In the software community, two people can implement an idea with minimal resource requirement and could end up with a profitable commercialized product, without much difficulty. In contrast, two chemists may come up with a brilliant idea, which in many cases, may require significant investment of resources much before to even think to get the initial product commercialized. Subsequent steps of scaling up will be a separate issue altogether, with more resource commitment.

The process of commercialization of smaller incremental innovation in pharmaceutical chemistry is much longer:

As we all know, the process of commercialization of incremental innovation in chemistry takes a much longer time scale, as these are not usually spare time projects, unlike computer softwares. The cost involved in testing out and implementing a new idea in chemistry is very high and may not even be possible without any robust institutional backing.

Target inexpensive smaller incremental innovation in pharmaceutical chemistry:

Some illustrative examples of such smaller incremental innovation in chemistry are as follows:

1. Development of pharmaceutical co-crystals

2. Merger of chemistry of traditional and modern medicines for synergy in both efficacy and safety

3. Chemical technology switch: taking technology of one field and transferring it to a different field to get a new drug substance

4. Application of polymorphic chemistry in drug discovery.

The process has begun:

International experience:

The chemistry department of Oxford University, U.K, which is incidentally the biggest chemistry department of the western world, has made significant advances in commercializing incremental innovation in chemistry. Among many, they created and commercialized the following three entities through such incremental innovation:

• Medisense

• Oxford Molecular

• Oxford Assymetry

The Indian experience:

Despite all challenges, in India, as well, the commercialization process of smaller incremental innovation in chemistry has already begun. The Chemistry Department of the University of Delhi has developed 11 patentable technologies for improved drug delivery system using nano-particles. One of such technologies was development of ‘smart’ hydrogel nano-particles for encapsulating water-soluble drugs. This technology was sold to Dabur Research Foundation in 1999.

Another nano-particle drug delivery technology in opthalmogy area was also commercialized by transferring it to Chandigarh based Panacea Biotech Ltd.

Conclusion:

This process is expected to gain momentum in our country too, contributing significantly to the progress of the healthcare sector of the nation. “Commercializing smaller incremental innovation in Pharmaceutical Chemistry”, I reckon, will play a key role in providing affordable modern medicines to a vast majority of the population, as India transforms itself into a knowledge superpower.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.