Stempeutics Research: An Leading Name in Stem Cell Therapeutics

 

Founded on the vision of ethically and scientifically exploring the full potential of stem cells for transforming medicine and offering new hope to millions of people, Stempeutics Research Pvt. Ltd. is striving ceaselessly on its path towards developing innovative stem cell products that address prominent unmet medical needs with an ‘India first, global next’ approach.

Stempeutics, founded by the Manipal Group in 2006, is a late-stage life science company focused on developing and commercializing novel therapeutics based on adult stem cells. Stempeutics’ strength lies in developing innovative stem cell-based products by nurturing cutting-edge research and clinical applications through the dedicated efforts of its highly qualified team. Scientists working at Stempeutics have filed over 65 patents and have published over 75 peer-reviewed international publications.

The company’s flagship product, Stempeucel^® drug, is an on-demand, off-the-shelf product based on pooled, allogeneic Mesenchymal Stromal Cells (MSC) derived from the bone marrow of healthy, adult volunteers.

Research conducted at Stempeutics has shown that pooling technology balances out variations observed with individual donor cells, resulting in a product with strong immune-modulatory properties, broader cytokine/growth factors array, longer lifespan, and consistent clinical outcomes.

Stempeucel^® is being developed for the treatment of Critical Limb Ischemia (CLI), Osteoarthritis (OA), Diabetic Foot Ulcer (DFU), Perianal Fistula (PAF), and Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 pneumonia.

In August 2020, the Drug Controller General of India (DCGI) granted the manufacturing and marketing approval of Stempeucel^® product for the treatment of CLI. Stempeucel^® thus became the first allogeneic cell therapy product to be approved for commercial use in India and the first stem cell product to be approved globally for CLI indication.

Stempeucel^® has been licensed to Cipla for CLI & DFU indication and to Alkem Labs for OA indication for the India territory. Stempeucel^® has strong patent protection with 18 patent applications filed across the globe out of which 16 have been granted.

The core Stempeucel^® patent has been granted in the USA, Australia, New Zealand, South Africa, Japan, China, Singapore, UK, France, Germany, Italy, and the Philippines. Stempeucel^® has been classified as an ATMP product by EMA and designated as an Orphan Drug for the treatment of CLI due to Buerger’s Disease.

Stempeutics’ proprietary pooling approach provides for an efficient manufacturing process thereby enabling the products to be made accessible to patients at an affordable cost. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent products to patients. The proprietary technology also helps Stempeucel^® extend the therapeutic potential of the drug across multiple disease categories.

In Critical Limb Ischemia, Stempeucel^® directly addresses the root cause of the disease by reducing inflammation, stimulating the growth of collateral blood vessels, and repairing damaged muscle, thereby reducing the pain, healing the ulcers, and salvaging the affected limb.

“Our company strongly believes in ‘Science Driving the Business’. While there are many companies around the world focusing on ‘Mesenchymal Stromal Cells’, the stem-cell technology platform what we have adopted is unique and novel for the development of treatment for immune-mediated and inflammatory diseases,” says Mr. BN Manohar – the MD and CEO of Stempeutics Research.

Mr. Manohar has transformed Stempeutics – a life science start-up from R&D to commercialization stage with Global recognition. Under Manohar’s leadership, Stempeutics has been recognized as India’s hottest startup by Business Today in 2008 and Karnataka Government bestowed the “Emerging Company of the Year Award” in 2011 and 2013.

In 2017 Manohar was awarded the “Biotechnologist of the Year” award by the Wockhardt Foundation, India. He raised US$ 10M in 2009 by establishing a strategic alliance with Cipla and US$ 13M in 2019 by establishing a strategic alliance with Kemwell Biopharma.

Stempeutics Research believes that India is already seen as the world’s low-cost pharmacy as far as conventional therapies are concerned, and the recent economic and epidemiological changes present a lucrative opportunity for the Indian biotechnology industry to replicate this success in the field of novel and innovative healthcare therapies that include biopharmaceuticals, vaccines, and regenerative medicine, etc.

“In 2021 Union Budget, Kiran Mazumdar-Shaw is seeking measures that can help India transition from being a volume player to being a substantial value player in the global market. She has also sought ways to incentivize investments for start-ups and to support risk capital,” comments Mr. Manohar.

To catch up to these significant opportunities, Stempeutics’ growth objectives for the next few years include:

• Revenue generation in India and Exports: Commercialization of Stempeucel^® cell therapy product for three key indications – Critical Limb Ischemia in 2021, Knee Osteoarthritis in 2021, and non-healing Diabetic Foot Ulcer in 2022
• Expansion to other countries where Indian regulatory approval is accepted.
• Globalizing Stempeucel^® product for a select indication. Cross key regulatory milestones in Japan (PMDA), EU (EMA) & US (FDA) for commercializing Stempeucel^® product for the select indication.
• Scaling Commercial manufacturing with 3D technology and make the product affordable in India.

Source: https://insightscare.com/stempeutics-research-an-leading-name-in-stem-cell-therapeutics/

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Advancells: A Pioneer at the Forefront of the Healthcare Revolution

Healthcare and medicine have been of prime significance to mankind with the intent of sustaining our lifespans and keeping them free of any ailments. Healthcare facilities and services in India have been evolving with time and in recent years have been on a path of continuous development.

Companies across this spectrum are ceaselessly striving to deliver the best of their potential in order to cater to the ever-increasing demands of the healthcare industry. This edition, Best of 5 Regenerative Medicine Companies, places a spotlight on those companies that are bringing about profound changes and innovations in the sphere of regenerative medicine.

One prominent name among these companies is Advancells, an India-based research-oriented company focused on regenerative medicine and its therapeutic applications.

In the following interview with Insights Care, Vipul Jain, the CEO and Founder of Advancells Group shares with us in detail about the current landscape of the healthcare sector and how his company has gained a strong foothold within the same.

Below are the highlights of the interview:

Brief our readers about Advancells, its vision, and the key aspects of its strong position in the healthcare industry.

Advancells Group is a multifaceted organization that focuses on cell culture research and stem cell therapeutics to encourage academic and industrial innovations in the healthcare domain. An offshoot of the same, Advancells strongly believes that stem cell therapy and regenerative medicine can change the global viewpoint of medical healthcare in the years to come.

Humankind is looking towards an era where personalized medicine will replace drugs, organ transplantation will be based on 3D printed organs, and aging will be a reversible process. These miraculous statements will no longer be mere words upon the progression of stem cell therapy into translation and Advancells will play a major role in realizing such biomedical applications. With an expert research and clinical consultation team, we harbour the potential to hold an eminent position as a premier regenerative therapy-based global organization.

What makes your company a preferred choice among your clientele over your competitors?

Currently, stem cell banking and research have gained prominence in India, but therapy is still a neglected perspective. Advancells bridges this gap by creating regenerative therapy awareness and encouraging stem cell therapies.

When it comes to our USPs, Advancells harbors cGMP certified cell culture laboratories and expert research personnel to ensure that our clients get the best quality of stem cells for therapy and research, besides other bioproducts like tissue-specific and disease-specific primary cells.

When it comes to patient treatment and policies, with a gross 70% therapeutic success rate, many patients have found significant relief from disorders of osteoarthritis, diabetes, and ALS with stem cell therapy.

The credit of Advancells being a preferred choice for stem cell therapy goes to our medical experts who play a major role in helping doctors, patients and caregivers in understanding the clinical potential of stem cell therapy. Besides that, low-cost and quality healthcare assurance makes more patients take up our value-added services as compared to our competitors.

From a business leadership perspective, what is your opinion on the impact of the current pandemic on the healthcare industry and the related market for regenerative medicines?

In all practicality, every industry has been financially affected by the COVID-19 pandemic and a lot of predicted CAGR percentages for biomedical trends will have to be recalculated before understanding the forecast, due to the pandemic setback.

But research-wise, the COVID-19 duration has been the most hard-working time for several healthcare and related companies. Besides spending resources and time on vaccines and alternative therapies, many big firms have pushed a lot of effort into drug designing and repurposing. Scientifically speaking, such a research pace has not been seen prior to the pandemic crisis.

Other than that, in my opinion, another major change for the companies was the transition into digital marketing for business survival. While many companies ceased to exist, and many stood strong through the storm of the pandemic, this period also laid the ground for some entrepreneurs to build up their company in healthcare-related fields. To sum it up, the pandemic was a survival life lesson for every industry out there.

Share with us your opinion on the necessity for businesses to align their offerings with newer technological developments, especially when it comes to changing industry trends and customer preferences?

Business and marketing strategies have evolved in the current times to customer-based engagement-oriented marketing and the major survival criteria are to adapt. It is quite necessary for business ventures to align their services with the recently available technologies so that they can provide optimum timely and useful value-based products.

The best example to put forward is the adapting of telemedicine and telehealth technologies by the healthcare business. While visiting a clinic or a doctor was regarded as ‘should be avoided due to social distancing norms during the COVID-19 pandemic, telehealth apps and technologies kept the healthcare business afloat. So yes, every day sees business entities molding their ways and adapting to modern technologies to innovate themselves. That is the way it should be!

In your opinion, what could be the future of the healthcare industry post the COVID-19 pandemic? And how are you strategizing your company’s operations for that future?

As far as the healthcare industry is concerned, it is inevitable that the post-COVID-19 period is going to see a boom in business.

Regarding the operations of Advancells, we have always been a step ahead in organizing and strategizing the market demands to maintain an optimum balance between business profits and social welfare through healthcare, even in times of a crisis. During the pandemic, Advancells started producing DRDO-certified Personal Protection Equipment (PPE) kits, to help the frontline healthcare warriors, and ICMR-certified Viral transport Medium (VTM) kits, to accentuate COVID-19 sample collection for faster diagnosis. Advancells has always believed in helping people and even after the COVID-19 pandemic, we will continue following our passion, sticking to govt. healthcare guidelines.

If given a chance, what is the one thing that you would change about the business ecosystem in your respective market?

In the Indian healthcare scenario, there are very few doctors who practice regenerative medicine, and patients looking for an alternative treatment are not much aware of regenerative medicine or stem cell therapy too. This is a major problem in our business market as most medical personnel are themselves hesitant of prioritizing stem cell therapies.

But with advancements in stem cell research and translation, we believe that this equation will slowly get better as more doctors witness the positive patient outcomes upon the use of regenerative medicine treatment.

As an established business leader, what would be your advice to the budding entrepreneurs aspiring to venture into the healthcare industry?

The first step of any entrepreneurship venture is to have a good plan and the second step is to believe in it all the way towards success. Failure is a part of taking the entrepreneurial leap, but no success comes without it. If you have a plan, and you think you bear the potential to go along, never hesitate to work towards it.

If I have to advise regarding the entrepreneurial journey in the healthcare domain, always know the trend! Do not hesitate to work towards it. It is always better to try and fail, rather than lying around and hoping for a miracle to happen. Failure has always been considered the pillar of success and you should not let your fear or insecurities get the best of you.

If you have what it takes to be an entrepreneur, you should take the risk. For a passionate entrepreneur, every day is an experience and a lesson to learn for the company’s growth. The more you learn, the more successful will be your vision.

How do you envision sustaining your company’s competency in a cutthroat and volatile world of business? Where do you see your company in the next five years?

Not many companies can take up the challenge of promoting stem cell therapy and encourage people to witness the positive application of regenerative medicine. In that respect, we hardly look at any company as a competitor.

We believe in working towards establishing goodwill and good health among the patients with the best quality of technology and patient care. The world needs more people who can vouch for the therapeutic benefit of stem cell therapy and that will require more industries practicing stem cell therapy awareness along ethical lines with no false promises.

Source: https://insightscare.com/advancells-a-pioneer-at-the-forefront-of-the-healthcare-revolution/

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Isolation & loneliness - the ignored epidemics ravaging the lives of older adults

Shainoor Khoja, CEO, and founder of Thrive-Community outlines the role technology can play in overcoming this growing problem, if it’s built right

Loneliness and isolation are taking their toll on people of all ages right now with older people being impacted the most. Life was hard enough for many of them in a pre-Covid-19 world given limited support from friends and relatives, housebound challenges due to diminishing health or other mobility issues, NHS (National Health Services) staff shortages, or the accessibility and affordability of adequate care in the first place.

The pandemic has only exacerbated an already dire situation. Almost 12 months on and older adults living independently are still being advised to minimize contact outside their respective support bubbles. Those living in residential care are only permitted virtual contact with close relatives. When they are allowed real-world visitors, it’s behind Perspex screens with friends and family members obliged to wear PPE so they look like spacemen. Such foreboding conditions can be intimidating at best, for some older adults it can be very frightening indeed. Research is showing that reduced social contact is detrimental to the physical and mental wellbeing of many, and the continued virtual appointments/checkups combined with constantly changing social distancing guidelines (intended to keep them safe), are exacerbating the problem further.

The digital divide is not acceptable in a modern world

Considering we live in a digital world, it begs the question as to why do older adults feel lonely, isolated, and removed from society? After all, PCs, laptops, smartphones, and tablets are widely available, most areas of the UK have adequate broadband and 4G coverage, and platforms like Zoom, Skype, FaceTime are providing some semblance of normality by allowing us to see the people we’re talking to. Sadly, many older people lack the skills, confidence, and motivation to take advantage of these platforms and another digitized service due to digital poverty and/or poor system design. Such a state of affairs is not really acceptable for a country aspiring to eradicate digital poverty and for an NHS wanting to implement a long -term digital transformation plan with a mobile-first strategy and connectivity at its core. There is an international shortage of technology built specifically for older adults which is a concern as this demographic is growing faster than any other.

The lack of intuitive technology for this age group makes it all the more difficult for overstretched healthcare professionals to benefit from the value that well-designed technology could bring. In many instances, digital devices and the services they support are hindering rather than helping overburdened social workers and other outreach teams. Smartphones should be serving as a “go-to” communications and patient management tool, but this isn’t happening in reality and older people are becoming more and more isolated as a result.

Tech can only solve problems if the adoption barriers are properly understood

The downfall of many handsets and other consumer electronic devices, along with the health and wellbeing services they power, is that a certain amount of know-how is needed to get them up and running in the first place. There are browser issues and settings menus to contend with, seamless experiences are not always that seamless because you’re obliged to juggle between services and platforms, depending on what you’re trying to do. Grappling with tech, remembering the multiple steps needed to join a Zoom call, for example, can be overwhelming for some older adults, especially if there’s no one close by to help them get started in the first place. Small displays don’t make things any easier either, especially for those who are short-sighted or arthritic.

Switching between different technologies is just as frustrating for professional carers. They have no control over what systems or device type their patients are using. Some may have Zoom set up, others may prefer Skype or Facetime. Chances are that their patients don’t have anything at all which makes virtual caring impossible. As a result, social services and community care workers are losing contact with those who are reliant on these services the most because they’ve given up trying to engage with tech.

New players are taking the time to gain a better understanding of the situation

Covid-19 has caused anguish across the board, but a positive outcome has been an advancement in the usability of many healthcare systems/technologies/platforms. This holds particularly true for the newer players who are taking the time to better understand the requirements of the different user groups, with more intuitive applications coming online as a result. Many of these services are leveraging capabilities such as machine identification, facial recognition, and sound recognition to overcome accessibility challenges by streamlining processes and removing the need for usernames and passwords.

The key failing of all digitized healthcare systems, old and new, however, is not understanding the importance of mood. Erratic mood changes provide a pretty reliable indication that something is amiss among older adults. Equally as important, a subtle change in mood over time can indicate the onset of different medical conditions. Staying on top of these early warning signals makes diagnosis and treatment easier, which in turn improves the overall quality of life and helps to combat feelings of loneliness and isolation.

There is no going back to a pre-Covid world. Even with the development of breakthrough medicines and nationwide vaccination projects, there is still a long way to go before everyone is inoculated and protected. We also live in a digital age and whilst we have to adhere to social distancing and other safety measures, the different technologies needed to facilitate digitized healthcare must be accessible and available to all, especially to those isolated and lonely older adults who need them the most.

About Shainoor Khoja

Shainoor Khoja is passionate about utilizing technology, building partnerships, raising funds, and fostering talent to drive social impact in critical fields, particularly healthcare and education, in some of the world’s most challenging environments. She is a fierce advocate for youth, female empowerment, and improving the lives of the most vulnerable in society. As a serial entrepreneur with private equity experience, Shainoor has built businesses from the ground up, from a successful chain of physiotherapy clinics in developed markets to social enterprises and small businesses in fragile, conflict states. Shainoor is currently developing Thrive Community, a digital platform that will keep older adults in the UK connected and engaged with their families, friends, and care providers.

Source: https://insightscare.com/isolation-and-loneliness-the-ignored-epidemics-ravaging-the-lives-of-older-adults/