Pharmaceuticals

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Update on COVID-19 Treatment around the Globe

 

Demand for repurposed drugs to continue even after launch of COVID-19 vaccines: Experts

Experts says that the demand of repurposed drugs are important to continue even after the COVID 19 vaccines come to the Indian markets. The founder of the Pronto Consult, Dr. Hari Natarajan & Dr. Karishma Shah commented that ‘use of repurposed drugs is likely to be continued until the entire population is vaccinated or there is some other drug that would take care of it’.
https://www.expresspharma.in/covid19-updates/demand-for-repurposed-drugs-to-continue-even-after-launch-of-covid-19-vaccines-experts/

FDA Approves First Treatment for COVID-19

Veklury is the first treatment for COVID-19 to receive FDA approval. Only in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care should Veklury be given.
https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19

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Post COVID-19 era in Pharmaceutical Industry

A whole new challenge has been posed by Coronavirus; the industry is at a standing start in terms of a vaccine and needs to prepare more efficiently than ever, against particular constraints and obstacles. The capacity of the industry to articulate the innovations, challenges and opportunities it poses in multiple languages is almost as difficult as developing a vaccine itself. Yet pharmaceutical firms are working hard to find how they can partner successfully with each other and continue to create market momentum well into the future, as well as educating the media and public about how viable a vaccine is and when it may be available.

The pharmaceutical industry landscape looks very different than how it did at the beginning of the year, whether it is postponed conferences, simulated gatherings, distribution reps unable to visit their clients, or analysts needing to focus on tech to communicate with their team and other associations and institutes. Pharmaceutical firms are adapting to the rapid changes that emerge from changes in supply chains and the need to adapt business procedures during these extraordinary times.
Healthcare services have experienced convulsive changes and are now undergoing them. Let me focus on how the pharmaceutical industry has evolved and will evolve.

  • Research & Development:
    Projects such as the EU-EFPIA public-private alliance with the IMI (Innovative Medicines Initiative) have paved the foundations for what we are seeing now: the old business model of the industry is being changed. Where there was once a cut-throat struggle to find, create and sell drugs, former competitors, such as vaccine manufacturers GlaxoSmithKline and Sanofi, who have joined forces to develop a safe and efficient coronavirus vaccine partnering through IMI ventures in this current scenario. This extraordinary focus on teamwork and cooperation goes straight around the board. From exchanging databases of validated therapies with researchers and others and seeing if the worst consequences of the current coronavirus can be mitigated, to having access to expertise, research results, development capacities and embracing risk sharing with the public sector.
  • Clinical Trials & Regulations:
    The focus must change to decentralized / near-patient / site-less-trials on sites and investigators. We need patients not only to stop attending hospitals where they may be infected or where they “steal” services from those in need, we really need to catapult to a paradigm focused on demographic data to classify and attract patients. Recruitment may no longer rely on the capacity of doctors to remember and locate qualifying patients. There is a chance to change health science, then. Similarly, in an outbreak situation and when businesses have to collaborate on master protocols and platform trial designs, this pandemic will force a new approach to vaccine trials.
  • Supply Chain & Resources:
    In the current situation, the Government of India should take crucial measures to eliminate the technological and financial obstacles that will spur the pharmaceutical industry to increase the production of APIs, thus reducing the pharmaceutical industry as a whole’s reliance on the Chinese market, which is heavily affected. Recently, the Indian government has taken applaudable measures by introducing an incentive package of 13.76 billion Indian Rupees (approximately $181 million) to encourage domestic production of essential starting materials, drug intermediates, APIs & medical devices.
  • Shift to consumer centric:
    In this covid 19 scenario, consumer has become very sensitive to information. There is a need to serve the demand of information through digital tools. The increased use of digital technologies, telehealth, and app-based environments makes patient-level data more available. Hence, it important that patient-centered supply chains should understand how this need can be met. Major improvements in telemedicine, video conferencing, remote-working software, and clinical-decision-support tools have helped doctors to cope up with the fast spaced transformed evolution in the field of medical technology. Increased supply chain transparency and information will be required by consumers and patients, and this transition to telehealth and app-based environments will require a tech-enabled distribution model.

Therefore, we can say that the COVID-19 pandemic is transforming the nature of world order and control, forcing leaders around the world to rethink their strategies for business and development. India certainly stands to benefit from such a restructuring with its deep expertise in the manufacturing of medicines, highly trained scientists and technological advancement.

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Financial Perspective Beyond COVID-19

In this pandemic period, managing cash flow and strategizing growth factors is crucial. Here are few tips that I learnt from my experience and can help you in addressing covid19 financial issues.

Managing cash flow: The corporate world is in the grip of panic mode in the wake of deadly COVID19 outbreak and it has hampered the functioning of several sectors, including pharmaceuticals. Faced with uncertainty around when the pandemic will end, the pace of recovery is expected to be a long and painful one. This pandemic has made the entire world realize the need to reimagine their supply chains. The union government has already announced investments to incentivize production of APIs in India with a clarion call for “Atmanirbhar Bharat”. The rapidly spreading Corona virus has compelled companies to re-strategize their methodology of work by adopting innovative methods to keep the business going effectively and profitably.

The normal business jargon “cash is king” is just correct in the current scenario. Management of cash flow is the essence for company survival in this liquidity crisis time and the strategies are:

  • Prioritise crucial payments such as salaries and contractual obligations and avoid statutory defaults and penalties.
  • Focus on the cash-to-cash conversion cycle.
  • Review debt retirement schedule and covenants.
  • Incentivise debtors by offering discounts for earlier settlement of receivables.
  • Revisit variable costs.
  • Revisit capital investment plans and ensure your internal earnings are adequate to finance the CAPEX.
  • Focus on inventory management.
  • Review Forex exposure.
  • Ensure that there is a robust review process of calculating financial loss due to supply chain risks.
  • Ensure statutory dues and taxes payables are adhered to.
  • Periodically checking the feasibility of the business model.
  • Plan policies for next 3 months/ 9 months/ 18 months.

If we consider it as a 3-month problem, an instant halt on variable expenditures like hiring, marketing, travel, etc. can help. However, if the crisis continues for more than 9 months, company will have to reconfigure its business strategy to reduce the variable expenses, renegotiate fixed expenses (rent, salaries, equipment lease payments, etc.), and focus only on the crucial essentials for survival. It may be a good idea to revisit sales strategy – selling online versus in-person. Some serious reconsiderations would be required if the effect of the pandemic continues for 18 months or beyond. Businesses will need to strategize, communicate, and act with compassion. They would require a revision of sales revenue goals and product timelines along with a new operating plan.

Management will have to keep the communication transparent as much as possible with its investors and employees.
Few tips to stay connected and afloat during the shutdown:

1. Communicate transparently with your customers: Customers can empathize with companies facing a crisis, as long as the communication is transparent. Communicate with customers to understand their perception of the product/solution offered by you.

2. Maintaining healthy relationship with contracted parties: It would be helpful to give your vendors, suppliers, landlords’ etc. sufficient notice in case there is going to be any delay in payments so that they can also be prepared and there is no bitterness in this already difficult time.

3. Managing employees & related optimization: For large companies considering layoffs, the primary option should be to cut the salaries of the higher paid exec/employees and to retain people who can’t afford to lose their jobs.

4. Keep your team engaged: The team relies on the team leader to keep them updated about every development and it is the responsibility of the Team Leader to keep the team members engaged and stay connected with them through video conferencing tools like Zoom and Google Hangouts. It is very important to maintain high spirits within the team and understand the general mood within your remote workforce.

5. Communication to stakeholders: The Leader to have an honest conversation on the situation and its impact on your business with the entire leadership team. Any negative message should be delivered with utmost empathy along with transparent reasons. Entire world is coping up to this challenge so why can’t we? Let’s address impact of covid19 positively by applying our basic principles and execution by new digital ways. Stay safe!

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Reshaping and propelling business

A new-normal is gradually moulding our way of leading life. Considering impact of pandemic, though it has affected the profits across value chains, we should glance at positive things. I think entire world has realized that human life is a prestigious life and we are accountable to keep “Our earth a great place to live”. So, henceforth our equation should be 3P’s; People, Planet and Profits. This article briefly explains the impact of pandemic on Pharma and Nutra value chain and way ahead for chief executives to think on.

Since the past few years, 2020 was touted to be a revolutionary year with terms such as 2020 Vision marking its presence in most corporate and industry plans. Surely, the year is turning out to be revolutionary but in a way that no one imagined.
Even with a plethora of research going into development of vaccines and curative treatments, we have been made aware of the strong mutation capabilities of the virus. It is now clear that the virus is here to stay and we must be the ones adapting to a change in our lifestyles, both on a micro and a macro level to be a ‘new-normal’.
Weneed to quickly, but rigorously, assess our current relevance to our customers, understand our competitive exposures, and re-tool our offerings and go-to-market strategies to get back on track, and capture new ground, in a landscape rich with potential new opportunities for our businesses, employees and communities.

Disruption in Pharma and Nutra value chains:
Drug discovery & Clinical trials
As we are aware that entire world is focused on discovering treatment for Covid19. As of now 200 drugs and vaccines are under development with almost 80% in pre-clinical and phase 1 of clinical trials. It has been observed that pandemic has halted almost 1300+ US-based clinical trails. On the contrary, 1800+ covid19 related trials that are focused on observational and interventional studies are in process. Thus, this has directly affected the discovery of new molecules which were in pipeline.
If we talk about Nutraceuticals, trials for ingredients exhibiting anti-viral, immunity boosting as well as symptomatic relief are ongoing. More than 18 such trials had been undertaken till the month of April and more in the pipeline.

Drug Launches

There has been no major impact on drug approval process. The number of FDA approvals has increased by 50% in 2020 as compared to last year. Some companies like Bristol-Meyers Squibb and Acacia Pharma has postponed their launches. A chance of drug launches in 2Q & 3Q is likely to be affected.
Nutraceutical industry has witnessed a spike in the market demand for its products. It is predicted that the industry will grow rapidly in the initial quarter and gradually lessen through the year. The ingredients such as vitamins, omega-3 and minerals have seen an impetus.

Raw materials

US and Europe are heavily dependent on China and India for bulk drugs like KSMs, APIs and intermediates. US imports around 80% of APIs, major chunk from China and India, whereas Europe’s imports around 50% of APIs from China and India. The pandemic has severely affected the generic drug producers in US and Europe. Mobius Capital Partners foresee that many buyers depending on China will try to stay less dependent on China and hence alter their supply chains. Atleast 57 APIs that are required in production of crucial antibiotics, vitamins, and hormones or steroids can go out of stock in case of prolonged disturbed supply chain in China.

With a steep rise in demand for Nutraceutical ingredients, availability and price has been a hurdle. Although, India is a biodiverse region with 4 out of 25 biodiversity zones, thus giving an edge to manufacturing and sourcing of ingredients from within the country without having to rely on imports.

Finished products and supply chain

Medicines being part of essential commodities, local government has supported the Pharmaceutical industry and has allowed working with minimal restrictions following proper precautions. As logistics and distribution is hampered, the industry is running on low production capacity that would affect the availability in coming months. In the month of April, at Baddi in Himachal Pradesh, where major production is carried out,Dr. Reddy’s Laboratories operated at 15% of capacity at its two units there, Abbott at 25-30% and Cadila was running at 35%, among others hindered by the lockdown.

The supply chain has been one of the worst affected links in the value chain of the industry. As the lockdown is being lifted and operations resuming with higher capacity, it is expected that these sections will continue to normalize.
Marketing

Doctors call visits play a crucial role in pharmaceutical sales and marketing. Sales team are the game changer in Pharma industry. But because of risk of infection, their work has been suspended. Many companies have adopted online sales channel, like emails, virtual and digital communication to interact with physicians and even with team. However, in near future digitization is going to be applied for doctor visit, now it is done by means of virtual communication. Even personalized messages or customized videos explaining product can be shared with Doctor, which they can observe in their spare team and can lead to effective value adding calls.

The road taken by Nutraceuticals on the other hand, is slightly different. Owing to the surge in awareness amongst consumers, we can expect a shift in the marketing model from doctor/influencer based to a more direct marketing style. We can already see advertisements incorporating buzzwords such as ‘immunity’ in their products. Online marketing is also a major tool that should be incorporated by these companies.

Leading our way via consumers:

Having an experience of more than 50 years in Wellness industry, my ways and methods always drill down to consumer level. We are living in consumer era, no doubt that my 3P’s strategy that prioritizes first people, followed by planet and then profits will work out towards a better world.
Here are few key points that arise from consumer survey done by Mckinsey India in April 2020. These points can help us in strategizing our ways to deal with current pandemic situation.

Following percentage is of respondents who were doing the activities as mentioned but after pandemic has started to do more. So, to retain our consumers we need to tap these points.

  1. More than 50% of consumers are thinking more wisely than usual while spending money.
  2. 45% are considering cheaper products to save money.
  3. 40% are making wise decisions by researching the brands and products before buying.
  4. Word of mouth or reference through family and friends are acting as powerful tool for marketing.

 

 

 

  1. Drug discovery & Clinical trialsAutomation has increased in Pharma industry to accelerate R&D, data entry and analysis which suggests an upward future trend in automation. Looking at the impact of covid19, regulatory authorities should incorporate digitalise clinical trials in the testing. Well, digitalising the clinical trials is already started by few companies, now at this stage it is need of the world to apply technology widely. The UK National Institute for Health Research has also released a framework to resume clinical trials.
  2. Product Launches

With time the industry will stabilise and as unlocking is already in process, both the industries will resume its activities and probably by 2021 product launches will peak up depending upon the market needs.

  1. Raw materials/ ingredients

Opportunity is knocking at the door and government has already taken steps to grab the chance. The PLI Scheme – Production Linked Incentive Scheme for manufacturing of KSMs, APIs and drug intermediates has already been rolled out. The decision maker has to realign priorities and focus on manufacturing the raw materials. This will help in reducing the imports from China.

Sanofi a leading Pharmaceutical MNC, is planning to become 2nd largest API manufacturer in world by 2022, with projected revenues of €1 billion by 2022. The strategy of CEO Paul Hudson’s plan is to simplify the global drug giant and focus on growth products, one of them is atopic dermatitis star Dupixent. As per his statement, the drug can generate €10 billion in peak sales.

  1. Finished products and supply chain

The disruption caused in the section has paved way for a more streamlined system. Incorporation of technology in terms of digitisation in logistics and supply chain as well as use of Blockchain technology would be beneficial in managing the entire supply chain system and would improve performance.

  1. Marketing

Marketing is also one of the areas that is likely to see a complete transformation. As few top companies have already started digitizing the way of communication with doctors, I feel companies should take advantage and check their performance using virtual communications system. As looking at benefits, interaction with physicians at their convenient time, physicians may love digital channels or choose a hybrid model of communication whereby face to face visits can be planned once in a month.

Bain research shows that more than 70% of B2B buyers—and a growing number of sellers— feel that virtual sales calls are as effective as in-person calls for complex products, even those involving a high degree of customization or configuration. This conclusion only proves the necessity of having a robust and functional digital infrastructure which can become the key in determining success of the company.

Further looking at current consumer behaviour we need to plan our marketing strategy accordingly. Considering availability, affordability and accessibility and streamlining logistics to resume the supply chain is crucial. Simultaneously, keeping brand value and products in list of consumers is required, so use of online marketing tools like advertising in journals, magazines can be preferred. Sending personalised messages to customers telling them how your services are responding to pandemic and about CSR activities will help in spreading word of mouth.

What’s next?

Unlike many industries struggling to identify a suitable response to the COVID-19 impact, the healthcare sector has infrastructure in place, with technologies such as remote patient monitoring, automated manufacturing facilities, and AI in drug discovery. The pandemic has resulted in very heavy lifting by healthcare workers, but the sector as a whole is somewhat immune to effects of a downturn. The crisis has largely acted as catalyst for transforming the sector, making it more sustainable and better prepared for future exigencies.

References:

  1. https://www.mckinsey.com/in/our-insights/survey-indian-consumer-sentiment-during-the-coronavirus-crisis
  2. https://www.bain.com/insights/the-new-normal-is-a-myth-the-future-wont-be-normal-at-all/
  3. https://www.bain.com/insights/tracking-the-global-impact-of-the-coronavirus-outbreak-snap-chart/
  4. https://www.fiercepharma.com/pharma/sanofi-to-move-forward-complex-api-spin-off-despite-covid-19-reuters
  5. https://fortune.com/2020/07/07/pharmaceutical-industry-collaboration-novartis-bristol-myers-squibb-big-pharma/

 

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Disruption in people’s habits, healthcare business practices will take place in Corona Times

The Covid 19 (ARV- Acute Respiratory Virus) situation is disrupting and challenging the entire world like never before. I believe, it will help in making companies the world over more humane than alone profit oriented. The social distancing will in fact help in bringing the people more closer.

The present crisis will make a new difference in the human kind’s equation to 3ps i.e. People, Planet and Profits. It will help in making each of us more humble, caring, empathetic and self sufficient; create more awareness about the importance of preserving and protecting our planet and its air, water and food resources; there will be a corporate behavioural shift where more importance will be given to people and planet over profits.

Profits need to be earned, as profit has five vital functions to play in business. Business should be sustained for future, so it should be useful to readily available for 1) Any sudden changes in technology and disruption and business becomes vulnerable 2) any calamity like Covid 19; and people ,products and planet needs to be supported 3) Any sudden economic requirements are increased due to amendments in corporate laws 4) yearly welfare of people through increments 5) Reward of risk taken by owners or investors ..It is vital for any living company to make profits, but not to have a profit ring attitude!

Throughout the world, the global pharma industry (including India, US, and Europe) depended on China for the raw materials and active pharma ingredients (APIs) needed to make the final products. Many of these economies faced severe issues in securing ingredients on time during the present crisis. From now on, the governments of these countries will not allow them to be over dependent on China. India is no exception.

I see Indian government encouraging more start-ups to manufacture many of these raw materials and APIs to make the economy self-reliant. Also, multiple non-pharma and non-healthcare players would enter the sector and invest in manufacturing of APIs (Active Pharmaceutical Ingredients), generics, medical equipments and wearables. It is the right time for Indian medical start-ups to make wonders in the global healthcare arena.

The global pharma industry will move from a product-centric approach to a people’s need – centric one. Till now it used to be purely product centric, meaning first the product was launched taking into consideration the market benefits, before taking it to patients. However, I believe, the situation would change after the present crisis. There would be many industry leaders, whom I believe, would plan, design, research on new pharma molecules based on what the society’s healthcare and medical priorities are. Profits will come on its accord.

There will be an increased adoption of data analysis to understand disease patterns, patient responses, drug development would be based on that. More plans and methods will be developed for better patient engagement, better accessibility to doctors and medicines, and increased patient adherence. There would be more evidence based therapeutic tools. I would say, all of this would make the industry more socialist.

The ongoing situation will accelerate the Digital Transformation of Healthcare or e-healthcare. It will lead to more e-health usage and accessibility in the country – be it in the area of telemedicine, electronic health records, medical billing software, hospital management systems, telemedicine, patient management programmes, healthcare wearables. There will be more usage of video-conferencing through zoom and skype calls.

Jugaad will work hand-in-hand with innovation. During the present crisis, we have converted train coaches into ICU centres and isolation wards. Likewise, our labs have been able to develop low-cost ventilators during this time of need. Why cannot our-start-ups continue to do the same even after the crisis.

Staying at home, people would realise the importance of balanced nutrition, sanitation and sanitisation. Even after Corona leaves the earth, we are going to move forward with our newly acquired habits. In effect we are becoming an inclusive healthy society in the challenging time. New family bondings will be created. This is the perfect time to go higher into spirituality. The new moment is inspiring healthcare and scientific research institutions in the world to leverage all their might to find new solutions towards bacterial and viral resistance.

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Health insurance:

Health insurance is an important aspect whereby pear like patient get subsidised and his affordability increases. Ministry of health, NITI Aayog, ayushman and their imperative should be given importance from implementation point of view.

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Regulatory:

In case of Regulation and competition as there are different bodies governing in different states integrating all these licenses could be great, imperative methods could be many in this process as digitization has made it transparent there could be supervision from the regulatory sight which can look at the anomalies and correct them.

Major issues today is, shortage of HCP which could be resolved by more than available 6000 pharmacists in India even in rural India’s. This learned population of pharmacist can be upgraded to take care of primary healthcare even in rural area with adequate certification or participation.

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New hospital policy:

In case of vertical arrangements in Healthcare services, providing an option to buy medications from outside for prescription generated in hospital could be additional boon to patient, however there should be no substitution on generic or branded generic name which is mentioned on prescription. There is a clinical experience with generic or branded generic medicines with healthcare providers hence that professional sanctity should be followed.

Portability of Patient Data is really marvellous thought and should be deployed so that multiple costs are saved from patient point of view.

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Perception of quality:

In case of quality perception behind proliferation of branded generics, as explained earlier will be injustice to those whom permission to manufacture and market generics is already given. Branded generics might be useful tool if there is process patent with the company to manufacture that particular generic which we used to have earlier in India before WTO stipulated increase on branded generics and can be permitted but no one drug one company one brand name could be insisted.

Another though of providing one generic name could be a good idea but definitely not one company and one drug.

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Online pharmacy:

e-pharmacy if properly regulated the special mention of trade margins from patient point of view will be already taken care off. They would charge but they won’t be equivalent to services charges as much as trade margins. This particular mode of delivery will also obviate trade association self-regulation.

The entire drug distribution and availability is already at reduced price and will be available at door steps if digital mode is followed, obviously with regulation.

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