What was the full measure of the disruption caused in the market for pharma lab equipment and instruments industry in India due to the COVID-19 pandemic?

At the beginning of the pandemic, many industries shared a growing concern around service deliveries due to scheduling and planning capacities,as well as logistical capabilities. While the situation brought in challenges for businesses, it also enabled companies to accelerate in areas ofemerging technologies and capabilities.

Agilent started to adopt digital tools to support customers and ensure business continuity with minimal service disruptions. Additionally, regular communication updates on turnaround times of shipment deliveries and other logistic issues were shared with the customers. Agilent supported its healthcare, pharma, and other partners by catering to essential services with installation, maintenance services, and repairs at their site locations.

At Agilent and businesses everywhere, the pandemic has increased the need for – and the acceptance of – digital tools to support business continuity. Agilent has been working on augmented reality to support remote services, and with the evolving situation, it gave us the opportunity to deploy these capabilities. One such solution is the AgilentCrossLab Virtual Assist, which is used extensively to service customers directly for troubleshooting and repairs. This tool also enables service teams to interact and access specialised knowledge.

Collaborations and consolidation are being touted as a way forward for strengthening this industry in India. What are your views on this strategy? Any significant tie-ups, partnerships in the offing for Agilent?

Collaboration between academia and technology providers is key to strengthening and accelerating research. Agilent has been partnering with key institutes to develop new solutions and innovation with purpose. Agilent India collaborated with researchers at IIT Bombay (India) and the QIMR Berghofer Medical Research Institute (Australia) to develop a rapid method for differentiating COVID-19-positive patients expected to show severe symptoms from those likely to experience only mild symptoms.

Furthermore, in March this year, Agilent India collaborated with Gujarat Technological University (GTU) to establish a Center of Excellence (CoE) lab facility at their Ahmedabad premises. This facility will enable the faculty members, students, and Agilent team to study and develop novel applicational workflows in the areas of analytical chemistry, biopharma, and life sciences research. The spirit of collaboration goes beyond just a few projectshere at Agilent; we work closely with our customers in partnership across different industries.

How has this segment shaped over the years, and what are the challenges that it has faced? Please also tell us about how these got amplified by the COVID crisis.

Pharma is a high growth segment for Agilent. Pharma and biotech represented 35 per cent of our overall revenues in FY21, and it kept growing in FY22. When we look at the past years, we made great progress. In Q2 2019, one year before the COVID pandemic started, pharma represented just 30 per cent of our business. It highlights the strength and resilience of this market even with COVID, but it also demonstrates how our innovation and investments in higher growth markets continue to pay off.

We see a great opportunity in the pharma segment. There is a growing demand for biopharma research & development (R&D) and manufacturing worldwide. Rapid growth in nucleic acidbased therapeutics attracted much investment. Where Agilent has had a huge install base in pharma labs in the past years, the small molecule pharma replacement cycle will bring more needs from the segment.

What would be an ideal disaster management framework to protect this segment, if the industry faces similar adverse circumstances in the times to come?

Agilent adjusted quickly to address changing circumstances in the COVID era, not only in the pharma segment but also in other major segments where we are leading. Our resiliency driven by Agilent’s business model and portfolio helped us tremendously and is significantly different from our peers.

For example, we have our service business under a service contract, our whole consumables business, and our Nucleic Acid Solutions Division (NASD) business. These are key highlights of what we’ve been focusing on to transform the nature of our business and deepen market penetration in areas such as pharma, biopharma, which tend not to be as affected by a recessionary pressure if that was to occur.

If we went back to probably 2008-2009, during the great financial crisis, our business was much more capital-intense, much more instrumentoriented than it is today. It was probably in the mid-30s in terms of services and consumables. And today, it’s closer to 60 per cent.

The pharma business is probably more resistant to recession. If we look at what happened during 2020, it’s important to note that Agilent still grew one per cent. We’ve got a much more resilient business model because of the higher concentration, not only in faster and more resilient markets like the pharma business. Additionally, when we look at our portfolio of products and services, our areas of consumables and services area greater proportion of the business than we had before.

However, our team of people are at the forefront of all our hard work. With our ‘One Agilent’ culture, we were able to display our resiliency by implementing our key strategies. With this in mind, we are confident that we can face future challenges and meet them successfully.

What are some short-term and long-term measures that can be adopted to boost the growth of this industry, in the present and the post COVID era?

The pharma industry is growing for Agilent now. In our FY22 Q2 that just finished, pharma represented 37 per cent of our overall revenues this quarter and grew 13 per cent during the quarter YoY, on top of 29 per cent growth last year. For the long-term, we have several strategies to further strengthen our segment:

◆We are continuing to lead the transformation of the analytical lab. We believe customers need to have both: world class scientific outcomes, and efficient and effective management of the lab environment– what we call, “improving the economics of the lab.” At the core of our efforts is our “integrated platform” strategy, where in the labs we will offer intelligent instruments, new customer business models like subscription services, and integrated workflows all in an integrated digital ecosystem.

◆We have built a growing “Double Digit” biopharma business, which focuses on:
● Developing leading analytical tools and workflows
● Building market leadership in oligo-based active pharmaceutical ingredients (APIs) for RNA-based therapeutics
● Integrating Cell Analysis solutions for immunotherapy, biologics research, and cell and gene therapy
◆In the long run, I believe we have a few critical, strategic enablers for the growth of the whole company. These include:
● Our focus on innovation, we keep R&D investment higher than the industry
● Our ability to expand globally
● A successful merger & acquisition (M&A) track record
● Our growing digital capability

All above are built on the foundation of a unique One Agilent culture where we emphasise collaboration, people, and results. I can’t emphasise enough that the Agilent culture is our key winning factor – it makes high performance possible and sustainable over a long period of time.

Can you elaborate on the opportunities in India’s pharma lab instruments market?

India’s healthcare sector has shown tremendous resilience and risen to challenges during the pandemic. India is hailed as the pharmacy of the world and the government has also reoriented its policies towards making the country self-reliant in terms of vaccines, medical drugs, medical devices, and equipment. India’s pharma manufacturing and export markets are poised to further strengthen this position.

Various policies and incentives such as a production-linked incentive scheme for APIs/ key starting materials (KSMs) and medical devices, a scheme for pharmaceuticals, and promotion of bulk drug parks are also being introduced by the government.

These opportunities and growth in the end market will open new doors for lab instrument manufacturers. Focus on drug discovery, R&D, and new international regulations present the need for workflow-based solutions that can deliver unprecedented sensitivity and repeatability while offering ease of use.

Agilent has been at the forefront of providing tailored solutions and workflows for new and emerging application challenges in pharma and biopharma – an example of this is the analysis of mutagenic impurities in recent times. The topic of optimising laboratory efficiencies while keeping costs down is at the forefront of discussions, which presents tremendous opportunities for smart instruments and digitally connected labs.

What will be the key drivers and trends that will shape this market?

Pharma companies are dealing with many changes when it comes to monitoring drug safety and ensuring regulatory compliance. Artificial intelligence and machine learning will fuel an increase in automation in every part of the value chain. We live in a data-driven world, so scientific laboratories must fundamentally transform how they create, manage, and effectively use all the data that is generated in their lab ecosystem.

Achieving and sustaining a competitive edge in a world of constant change will require the continual transformation of lab operations and scientific data management. These are the foundation blocks of the “lab of the future.” It encompasses smart technological workflow systems that are connected and capable of collecting vast amounts of data via integrated automation.

How is Agilent poised to leverage the emerging opportunities in India’s life sciences sector? What are Agilent’s plans for this market in the next three to five years?

Agilent has developed an array of technologies and platforms that have pushed the boundaries in providing solutions that support the needs of our customers. We continue to do this by enhancing the interconnectivity of our solutions, services, and workflow systems. This initiative has already brought certain technologies to life that will play a key role in the next three to five years.

For example: ◆ Asset Monitoring – Agilent CrossLab Asset Monitoring combines advanced IoT sensor technology and data analytics to enable lab-wide visibility
◆ Smart Alerts – Monitors instrument health and provides email-based alerts, notifying lab operators when to consider replacing key consumables, when to perform preventive maintenance, and when an Agilent instrument stops running anywhere in the lab. Digital lab-wide connectivity lets users remotely monitor all their Agilent instruments
◆ SLIMS (Laboratory Workflow Software) – End users can effectively track samples as they progress through the laboratory from sample receipt to automated result reporting
◆ OpenLab Software/Cloud Storage – This has become a viable option for virtually every computing workload in the laboratory, from sample management to complex analytics, to secure data storage and data integrity We have also been working to enable faster, customer-preferred online interactions that improve the ease of doing business and offer alternative buying models, such as flexible payment plans to help our customers acquire the latest technologies while preserving their capital budgets. This suite of future-ready, smart solutions, and customer-centric advanced capabilities will form the core of our strategies going forward as we continue to focus on growth within the pharma and biopharma markets. Inherently, Agilent continues to keep its people and shared knowledge at the center of every strategy.

lakshmipriya.nair@expressindia.com
laxmipriyanair@gmailcom

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The International Society of Pharmacovigilance (ISoP) South Asian Chapter was officially flagged off during the 20^th ISoP Assembly held in Oman recently. The initiative will provide a great boost to PV and drug safety not only in India, but the four other South Asian countries namely Bangladesh, Sri Lanka, Nepal and Bhutan, which are part of this chapter, ISoP notified in a statement.

Speaking in this regard, Moin Don, Lead, South Asia Chapter, said, “As a Chapter Lead, I sincerely appeal to all to actively participate by getting involved in this Chapter activities and getting enrolled themselves at the earliest. We have a great vision in front of us and a clearly charted out road map to have a governance structure, a team of executives and working policies, which will ensure that we organise PV awareness/education programmes in collaboration with academia, industry, regulatory authorities and other important international stakeholders such as WHO, DIA, UMC, PVPI, etc.”

The statement further said, “In order to understand the roadmap, here are some indicators:

• Initiate, encourage and support the Pharmacovigilance education and research in all health profession courses
• Support the existing Pharmacovigilance Programme of India (PvPI)
• Establish or strengthen the Pharmacovigilance systems in South Asian countries
• Bringing together the Pharmacovigilance systems in South Asian countries to cooperate and collaborate in identifying the safety signals of medications, in particular, in these countries
• Improve the industry, academia and regulatory collaboration for monitoring the safety of medications and vaccines, in particular
• Percolate the activities of ISoP in South Asian countries by means of meetings, symposia, workshops, conferences and training programmes
• Publish the scientific papers and periodicals on important aspects of Pharmacovigilance activities in South Asian countries”

India, as one of the most desirable destination/hub for outsourced PV activities with more than 7000 PV professionals working as SMEs in PV domain, can take the lead role to be the torch-bearer and mentor to the other four countries in this chapter, Don added.

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We can agree on two things. Biocon is a superstar. And so is SII. 

Biocon is a poster child of biotech innovation in India. Decades of unwavering passion, commitment to a science that India has no skill in, and enduring financial patience, has brought it in the league of a big few, like Amgen. While it is nowhere near inventing new drugs, it is possibly halfway there. What’s important is that its science has received validation from regulatory agencies that matter. Its ability to manufacture new forms of insulin at global standards and scale is remarkable. This is one of the world’s oldest drugs but has remained a monopoly of two or three big companies for nearly a century. Biocon is busting that and how – with nearly three billion does already dispensed globally. 

Serum Institute of India (SII) is already the world’s largest manufacturer of vaccines and by some reports, accounts for nearly two-thirds of the world’s vaccine use. A private company, it kept a low profile, maintaining a tight focus on child immunisation the world over – working closely with GAVI, UNICEF and the health ministries of the world. Until Covid stuck, who outside the industry would have heard of SII? It perhaps is a household name today, or nearly getting there. What remains vastly unacknowledged is the serious global impact that one organisation can have on the health of the world. That SII has remained fiercely independent is perhaps the biggest contributor to affordability and accessibility of essential vaccines in the southern hemisphere. 

That two global superstars are coming together is a milestone event in the evolution of Indian biotech. What’s interesting about this alliance?

Let’s not invade each other’s spaces

SII has been working to get into biosimilars, novel antibodies and proteins on its own. It has not seen much progress despite having technical collaborations in these areas. Biocon is light years ahead, as we know. By taking a stake in the latter, SII gets a meaningful share of the value of a pipeline it aspired for but is late to the party. Similarly, for Biocon, vaccines would have been the logical expansion opportunity, given its scientific ability. It now gets access to a commercial portfolio and can bring immediate revenues.

A joint future pipeline

Biotechnology based sciences have many new frontiers that are opening to therapeutics and prophylactics – mRNA, CAR-T, fusion antibodies, novel conjugations, stem cells etc. – to name a few. There is merit in pooling together resources to explore this. Much of the raw materials used in biologically derived products are import intensive – media, bags, reagents. There is also merit in collaborating to indigenize this – as considerable global scale is available in both companies to back this. This “Atmanirbhar” theme is timely. 

Devil is in the details

• Will Biocon be successful in commercialising the 100 million doses per annum it has access to? Most of the developing world depends on GAVI, UNICEF and national level health bodies to make these available and SII already services these channels successfully. It will also service the Covid vaccine alliance once exports are allowed to open up. It leaves the private trade channels available for Biocon to participate in – where opportunity exists mostly in the US and Europe. The more modern polyvalent and pneumococcal vaccine should be considerable scope here, however lengthy regulatory hurdles will not be insignificant even for the joint might of these two companies. 
• No details of the proposed joint pipeline are available. One assumes that it may be a conceptual understanding presently. Who will invest how much, how will synergies be leveraged, which synergies will be leveraged – are currently unknown? Arguably the most exciting part of the collaboration remains a mystery

Managing perceptions and egos

Optically, without details of future pipeline and investments, it does appear that the alliance is a short-term fix to “revenue gaps” for Biocon. At the price of some “loss of control”. The companies should disclose more granular plans in the near term to prevent this perception from cementing. It’s also unclear why Biocon hasn’t taken a commensurate reciprocal stake in SII, which would have eased even remote “conflicts of interest” in future. Could that be a possible next step?

Both companies are professionally managed, founder driven organisations. They are run by flamboyant founders, who not only enjoy being in the limelight but are also known to speak their minds. Will they be able to strike the right relationship and governance that deals with issues objectively and proactively? The track record of Indian companies collaborating (other than outright M&A) is woefully inadequate to form a view. 

The success of this alliance may depend as much on Founder Chemistry as it does on the science of Biology. 

(Note: Chandru Chawla is Executive VP, Cipla and writes on management, leadership, environment conservation and human rights. The views expressed above are personal)

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The International Society for Pharmaceutical Engineering (ISPE) has released its latest ISPE APQ Guide: Management Responsibilities and Management Review. This is the second publication in the APQ Guide series that seeks to improve the state of pharmaceutical quality and ensure sustainable compliance.

The Guide Series is a part of the ISPE’s initiative, Advancing Pharmaceutical Quality (APQ), a comprehensive programme for assessing and improving an organisation’s quality management maturity. The Guide was developed by members of the APQ Program which evolved from the ISPE Quality Metrics Initiative, representing extensive industry engagement, collaboration with academia and other associations and knowledge sharing with regulatory agencies.

ICH Q10 sets a clear expectation regarding the role of strong leadership in terms of demonstrating and communicating “strong and visible support for the pharmaceutical quality system.” The ISPE APQ Guide: Management Responsibilities and Management Review provides a systematic and proactive approach to evaluate the management responsibilities highlighted in ICH Q10 as well as other key leadership components like patient/consumer focus, management commitment, quality planning, internal communication, management of outsourced activities and purchased materials, management of change in product ownership, and regulatory and industry awareness.

Guide Co-Lead Steven A Greer, Executive Coach, Speaker and Consultant, Genesis Assist, LLC and ESi, Inc, said, “This Guide provides a practical tool for organisations that want to assess and strengthen their leadership systems to support their pursuit of cultural excellence and ultimately create more value for their patients, shareholders and employees.”

Adding to it, Michael Grischeau, Guide Co-Lead and Director, Data Analytics and Management Review, AbbVie Inc, said, “Most scorecards do not include metrics focussed on leadership effectiveness. So, drift can occur without warning signs and the results can be significant: drug shortages, enforcement actions, recalls, dissatisfied patients/consumers and disengaged organisations. The APQ MRR Guide builds upon the framework of ICH Q10 with insights from industry leaders on what strong and effective leadership looks like.”

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What are the learnings from this pandemic that can be used to serve heretofore unmet needs?

COVID-19 pandemic is one of the greatest humanitarian challenges. The pharma and biotech industry has received this challenge with unprecedented courage and creativity. While we are all aware of the accelerated vaccine development efforts across the world, innovations around drug repurposing, immunity modulation, novel diagnostics, hospital-specific patient care-pathways, large scale disinfection methods, etc., have received tremendous investment and are being used as mainstream practices.

One of the biggest learnings from the pandemic has been that the realisation that the drug development regulations and the approval pathways need a complete overhaul. Response-time needed to tackle such exigencies is exponentially shorter than the typical drug approval pathway. We might need to redefine our approach to drug discovery and approval to be prepared for the future.

How is Windlas Biotech contributing to the fight against COVID-19?

Realising the urgency of the pandemic, Windlas introduced several adjunct products like – safe-to-use-sanitisers, novel germicidal mouthwash and nasal sprays, convenience packs for complicated multiday multi-drug therapies, etc., for the benefit of patients in India.

We also realised early on that scientists will need rapid prototyping and clinical trial competencies to bring new ideas to market. Therefore, we partnered with Oncotelic, a US-based biotechnology company, to develop an ayurvedic/nutraceutical drug against COVID-19 in India. The product known as ‘PulmoHeal’ is a formulated plant extract of the indigenous plant Artemisia. It is the first herbal drug showing promise against COVID-19 through TGF-ß inhibition and is expected to be effective through the entire infection cycle. Our open-label, randomised, multicentre, placebo-controlled clinical trial is nearing completion and we are observing highly promising and statistically significant impact on patient recovery.

Encouraged by the interim data, we are adding additional sites (including AIIMS Delhi) and extending the including criteria to sicker patients. The active component of ‘PulmoHeal’ is a highly pure and special form of artemisinin.

What is in store for India’s biotech sector in the coming year and the next decade?

In my view, our vast and rich heritage of Ayurveda – which is a rich resource of drug development using ethnobiological approaches, our modern scientific and highly competent clinical research ecosystem and the fact that we can accomplish all of this at a fraction of the cost compared to the developed nations, will place Indian biopharma sector in a leadership position in the world in the coming decade. Like in our partnership with Oncotelic, US, we have seen that modern scientific rigour when combined with the age-old traditional knowledge has the power to unleash potentially game-changing health solutions for the world.

In the past two decades, India has been a pharmacy to the world with its focus on generic and affordable medicines. The next decade will be about India’s emergence as a pharmacy to the world for research-based innovative medicines as well. PM Narendra Modi has repeatedly stressed the need for building a self-reliant India, asking us to be vocal for local. I think that the government’s administrative reforms coupled with market opportunity will unleash leap-frog thinking in the biopharma sector and bring creative, affordable and disruptive ideas to the forefront. Almost every company in the sector is thinking of multiplying their R&D investments manifold. This will inevitably result in new employment, new intellectual property creation and affordable health solutions for India and the rest of the world.

What are the new business models in biotech for emerging markets, including India?

Delivering drug therapies to patients in the near future world will require new skills, technologies and channels. Some of these technologies like artificial intelligence-based bioinformatics, novel protein synthesis, rapid development of bio-assay techniques of key target proteins are exciting, however, need to be supplemented with the required skill set to be widely adopted by the biopharma companies.

Once a drug is developed – it is still only half the battle won. Manufacturing it at a large scale while maintaining quality standards is critically important and requires special skills and capabilities.

We believe that Indian companies will come up with new business models to leverage opportunities across the spectrum. Playing a role in the early-stage research, technology scale-up and high volume manufacturing are all critical enablers and are need of the hour for research-based biopharma ecosystem. Indian companies will also take significant share in the bulk drugs industry and even intermediates industry to truly become the ‘Pharmacy of the World’. There is a significant opportunity for growing companies like Windlas to play the role of enablers while accelerating the search for new drugs for better health.

How is Windlas Biotech poised to leverage the opportunities in this sector?

Windlas Biotech has a strong Innovation Board with leading clinicians and academicians in the drug development field working on several short, medium and long-term projects. We have partnered with large multinationals and Indian pharma companies across the world to bring innovative products to market. These innovations are focused on three themes – improving patient compliance, novel drug delivery systems and reducing the cost of therapy.

What are your plans for the recent future?

Windlas is one of the leading CDMOs in India. We employ about 1500 people and ship around two billion dosages a year to various companies and patients.

We are evaluating expansion in terms of our manufacturing footprint in different dosage forms as well as our R&D infrastructure. We are backed by private equity investor Tano Capital and are looking at acquisition opportunities that help us further our mission. We plan to emerge as a leader in ethnobiology drug development, leveraging on the rich ayurvedic/homoeopathic knowledge coupled with cutting-edge clinical research and rigorous modern manufacturing practices. Our initial foray in pulmonary health will be further expanded into other areas where together with our partners, we have established first-mover advantage i.e. TGF-ß targeted therapies in collaboration with Oncotelic. The imminent launch of PulmoHeal together with a respiratory mobile app developed by Oncotelic using its AI/cluster computing platform with IBM provides personalised care that is consistent with Ayurvedic philosophies.

lakshmipriya.nair@expressindia.com

laxmipriyanair@gmail.com

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The COVID-19 pandemic has left its mark on the clinical research and trials sector, but disruptions have only served to temper the steel of long-timers. Clinical research organisations (CROs) are helping pharma companies roll out the COVID-19 trials and while this is a huge business opportunity, it is also fraught with risk. Besides the usual risks associated with testing new products, is the fact that the trials had to be run under severe logistical constraints.

In September, an analysis by Frost & Sullivan informed that with the increased threat of COVID-19 and worldwide lockdowns in effect, the CRO market is experiencing interruptions in ongoing clinical trials and delays in new trials. Recovery is expected to commence from 2023; although it will be staggered, it will take revenue to the original growth trajectory by 2024–2025. As per the revised forecast after the impact of the COVID-19 pandemic, the CRO market is estimated to garner revenue of $63.83 billion by 2024 from $43.03 billion in 2019, at a compound annual growth rate (CAGR) of 8.2 per cent.

The report titled, Hybridisation of Clinical Trial Designs Reviving Global CRO Market Post-pandemic; 2019-2024, reveals that hybrid clinical trials and remote patient monitoring are key trends driving the global CRO market. Hybrid clinical trials leveraging safety-focused, direct-to-consumer logistical solutions are taking centre stage, ensuring research continuity.

Surviving testing times

But disruption is not new to the global CRO sector. India’s CRO sector went through one such upheaval when new clinical trial guidelines were released in 2013-14 but the revised regulations of 2019 have steadied the sector. One of the CROs which seem to have survived this testing time is SIRO Clinpharm (SIRO).

Founded in 1996 by Dr Gautam Daftary, initially as a subsidiary of Bharat Serums and Vaccines, a company set by his father, SIRO is one of India’s earliest CROs.

The company enjoyed a good run, growing as the sector matured in the country, notching up 250+ clinical trials spanning the pharma, medical devices and FMCG sectors.

Regulatory speed breaker

The company took on private equity investors (PEs) in 2007 to scale up but a fresh set of guidelines for clinical trials in 2013-2014 halted not just SIRO but the entire sector.

Meanwhile, the second generation was ready to join SIRO. Post an undergraduate degree from Emory University in Economics and Mathematics, Dr Daftary’s elder son, Akshay started his career at Bharat Serums and Vaccines in 2014, moving to SIRO in 2018. He now serves as a Director, in charge of global business development activities and client management.

Post an undergraduate degree from Babson College with a focus on finance and entrepreneurship, his younger sibling Karan worked at the Puma Group for a while before joining SIRO in 2018. He is now Global VP, SIRO Clinpharm and is in charge of ancillary services including finance, human resources, quality assurance, IT, legal and corporate marketing.

As the second generation at the helm, Karan and Akshay witnessed how the stringent clinical trial regulations of 2013-2014 caused many large global companies to leave India, resulting in a large reduction in clinical trials in India. They narrate this had a sizeable impact on SIRO’s operations as well, which was dependent on winning complex studies from global pharma companies.

According to them, SIRO was slightly better placed to weather the turbulence as before this regulatory downturn, the company grew its medical writing vertical extensively to ensure stability and holistic growth of the organisation. This service offering brought “great stability” to SIRO’s operations with standalone and annuity clients in alternative geographies.

Survival, not revival

Both siblings agree that the new Drugs and Clinical Trial Rules launched in 2019 created a very positive shift in sponsor sentiment and a willingness to return to India for their global clinical trials. This has revived an industry that was undergoing a significant downturn.

The company underwent a brand refresh in 2018 and re-established its core mission of Helping Lifesavers Save Lives. They feel that SIRO has been a perseverant organisation that saw an opportunity in the downturn and hence their success story has been that of “survival, and not revival.”

Charting the way forward, the siblings reflect that there was no one single way of continuing their growth, but a series of factors that helped them maintain their strong position in the clinical research segment.

While growing the India operational team, the duo also has their sights set strongly on establishing an operational presence in the US in medical writing and biometrics.

Meanwhile, Dr Daftary bought back stakes from investors and other shareholders in 2017 to once again become 100 per cent owner, resulting in “simpler decision-making processes, lofty growth ambitions and supply of ample capital” to achieve their growth plans.

Impact of COVID-19 on clinical trials

The importance of clinical research has increased as we grapple with the COVID-19 pandemic and the possibility of more such pandemics sweeping our planet. But out of the disruptions due to COVID-19, came swift changes in regulations, to cope with logistical nightmares posed by lockdowns, heightened fear of transmission of infection, etc. In hindsight, these changes will be for the better.

Akshay and Karan speak about the limited access to healthcare facilities, state-wise regulations in India as well as resource constraints during the lockdowns. While there was an obvious challenge in opening new sites for trials, even running existing ones was a challenge based on strict controls that had been swept into place in the light of the dangerous nature of the pandemic. To ensure the safety of personnel, clinical trials were stopped at several sites.

On the other hand, recruitment challenges were amplified with participants in clinical trials finding it difficult to visit sites as often as required by several stringent clinical trials. Although this impacted SIRO as a CRO, sponsor companies were greatly affected as well due to delay in timelines which in turn impacted their stringently planned clinical pipelines.

The short term impact of COVID-19 was the need to handle many aspects of the trial remotely. To overcome this hurdle, while maintaining strict adherence to clinical guidelines, SIRO decided to initiate remote monitoring which enabled them to continue with sponsors’ clinical trials in the middle of the pandemic. This initiative was greatly appreciated as it enabled studies to continue.

SIRO also took many precautions while sending their employees to offices or sites as and when needed. The Daftary siblings narrate how technology has been a great enabler in transitioning many activities to a virtual activity – as has happened in the past, while technology has been available for long, its adaptation and penetration into specific aspects of business process is greatly facilitated by challenging times like the COVID-19.

They feel that the potential long term impact of COVID-19 would be the continued use of technology to bring about a paradigm shift in how clinical trials are executed, with virtual clinical trials with real-time monitoring through wearables connected to the cloud.

The duo reflect that while the regulations for clinical trials will continue to evolve, one of the main drivers for change shall be the situation that we have seen due to COVID-19.

The pandemic has thrown several challenges to the regulators. Firstly, in terms of fast-tracking a vaccine or a drug for a COVID-19 kind of situation and second, ways and means to overcome the constraints of lockdown like situation on the clinical research.

They anticipate significant changes in regulations to provide for/govern virtual clinical trials/decentralised clinical trials and the increased use of technology in the conduct of clinical trials.

The ‘Good to Great’ approach

When asked about their strategy for the future, the second generation at the helm quote from Jim Collins’ book, ‘Good to Great’, “Greatness is not a function of circumstance. Greatness, it turns out, is largely a matter of conscious choice.” This dictum inspired them to believe that the future lay in their hands and they would need to confront the brutal facts to ensure future growth.

As firm believers of the additive impact of several small and well thought of initiatives, the SIRO team has apparently already laid out the focus areas, dubbed the Five pillars of SIRO, and shared their vision with all employees of the organisation through a virtual meeting labelled ‘SIRO Vision Series’.

The core aim of these initiatives was to build on SIRO’s core competencies in end-to-end clinical service provider space by leveraging innovative technologies, redefining internal processes, building stronger employee engagement, and expanding in alternative geographies.

They narrate how they have seen a stark shift in the industry towards automation of documents and artificial intelligence (AI) which led them to automate some processes and offerings, and documents using AI to ensure the benefits extend to our clients. They also created an Innovation Hub internally, focussed on leveraging technologies to help achieve their innate belief of Helping Lifesavers Save Lives.

Three-pronged approach in the coming year

Scanning the horizon for new growth opportunities, the duo reveal that they are looking at a three-pronged growth approach in the coming year. These include expanding in alternative geographies, adding more to service offerings, and automation of services.

In terms of geographies, SIRO is looking to expand its operational wing to alternative geographies like the US and South East Asia for their ancillary service offerings like clinical data management and biostatistics/programming.

They would be looking to do this through alliances/acquisitions based on compatibility with their current offerings. With the additional service offerings, SIRO took the time during COVID-19 to create a new and more targeted solutions approach for FMCG companies by amending their SOPs and strategy to cater to different requirements of these companies. They indicate that they would be looking to enter alternative segments with a similar focused and customised approach.

A recent example of SIRO’s approach to augmenting their service portfolio is their partnership with Azidus announced this September, to widen their service offerings with healthy volunteer BA/BE studies. It is early days yet, but the duo indicate that both the partners have been having very interesting discussions with their customers and if the early signs are an indication of the times to come, they see a very interesting partnership ahead.

In fact, this has propelled them to explore more such alliances with complimentary service providers which are the key to drug development activities.

Claim substantiation, a sweet spot for growth

The duo believe that India is now emerging once again as a global hub for clinical research. Once seen more as a cost arbitrage, the quality and expertise that comes out of the Indian clinical research sector is clearly evident for the healthcare world to see. From niche to large CRO, India has become a destination for end to end clinical services, aided by its diverse population and favourable regulatory landscape. This potential has led to the mushrooming of CROs as business continues to be outsourced to India from Europe and the US.

In Akshay and Karan’s assessment, one of the areas where the clinical sector is going to play an important part is the consumer health sector. With increased regulation pertaining to claims and advertisements by food business operators with respect to their food products, along with heightened consumer awareness, they see demand for claim substantiation through a structured process as a focus area. We see a similar opportunity in the AYUSH segment. The irony is that while COVID-19 bought the CRO sector to a standstill for some time, it has today created more revenue opportunities.

The duo point out that during COVID, several consumer products claimed to prevent COVID, and the substantiation of their claims has become extremely important. This is where SIRO has come in with prompt professional services and helped design trials to prove the efficacy and safety of new products.

With the easing and streamlining of regulatory guidelines, a large influx of clinical research studies and trials are pouring in India with large global companies considering Indian patients for their global studies. The siblings also see that the sector is now creating more jobs and attracting students to explore this field for potential study and future career.

Current projects of interest and revenue mix

Of the three industry segments that SIRO currently supports, the pharma industry remains, by far, the dominant stream of revenue. In this space, the company is working on a few trials wherein the drugs are being tested in a specific set of COVID patients. They have been a part of initial discussions for conducting full or some parts of Phase III for an Indian company and for an international company.

In medical devices, SIRO is supporting a company extensively for their claim substantiation regarding the virucidal activity of the COVID-19 virus in the environment and helping them with their global regulatory and marketing strategy.

The FMCG sector makes up the third segment, with SIRO reportedly receiving several requests in this space in the last few months to help FMCG companies to substantiate their claims for products that they have made related to the ongoing pandemic. Citing a Gazette notification regarding advertising claims which clearly stated the importance for clinical validation and scientific backing of claims, the SIRO Next Gen indicate they are working with consumer health/FMCG companies to substantiate their claims regarding immunity enhancements in their products and are also in discussions with consumer health and Ayurvedic companies to clinically test products on immunity parameters.

Akshay and Karan anticipate that though the latter two segments presently form a smaller proportion of revenues, with renewed focus and the streamlining of their approach to the FMCG sector, this proportion will grow exponentially over the next few years through increased clientele and geographic reach.

Challenges to COVID-19 vaccination campaigns

India has earned her stripes as the largest global vaccine manufacturing hub, with a fair number of COVID-19 vaccines being researched, trialled and manufactured in the country, and Akshay and Karan have no doubts that India has always been a country to rise up to challenges and pass them with flying colours – and they believe a similar result would be possible when it comes to the COVID-19 pandemic and getting it under control.

But while there is an urgent need to get the vaccine for COVID-19 into the market, they raise concerns about the potential storage and supply issues that would come with it.

They point out that with Phase 2 and 3 clinical trials going on for a wide array of vaccines (40+ global candidates currently), it is important to note that storage conditions for different vaccines would vary based on their chemical composition. In India, there are 3-4 large scale trials going on, and it is believed their temperature requirements would be in line with SIRO service offerings that are offered at their clinical trials supplies warehouse in Mumbai.

For example, they mention that the Johnson & Johnson vaccine is a single shot (dose) vaccine compared to most of its competitors, while also not requiring extremely cold temperatures for storage. Some other vaccines, like Pfizer, require temperatures between -20 and -70 degrees Celsius which require its own cold chain management system. Additionally, during transportation, simple cold refrigerated vehicles would not be feasible to maintain the quality of the vaccine prior to administration.

Another unique challenge they raise is the facility for storage of vaccines at hospitals prior to the administration which needs to be addressed by the governing bodies at a state and central level. However, given India’s large vaccination programme in place, they remain confident that the relevant regulatory and governing bodies would take swift action in these areas prior to large scale commercialisation.

With GenNext firmly at the helm, SIRO seems all set to come out stronger after this disruption as well.

viveka.r@expressindia.com

viveka.roy3@gmail.com

The post GenNext at SIRO Clinpharm appeared first on Express Pharma.

Considering the need to provide overall health awareness and education to the masses, professionals and industry experts, HEAL Health Connect Solutions has been organising online series of webinars for the last five months. These educative series of webinars consist of various healthcare topics, including pharma.

This time, in collaboration with Express Pharma, HEAL Health Connect Solutions is organising ‘Emerging Dimensions in Pharma Excellence e-Summit’ followed by Pharma Excellence Award on August 20. With an aim to throw light on different aspects of the pharma industry, the e-Summit is split into four sessions, consisting of the following topics.

Challenges faced by pharma industries during COVID-19 times: This topic calls for in-depth discussion and insights to come up with solutions. The pharma industry has a direct connection with any disease, epidemic or pandemic because it comes up with solutions in the form of vaccines or medicines, eventually. Therefore, it is essential to discuss and deliberate on how pharma companies are responding to the rapid challenges arising from the disruption in supply chains and the need for change in existing business processes.

Digital adoption – How much have we been successful? : With everything going digital, it is extremely important for doctors to be well versed with e-consultations and digital presence. Similarly, pharma companies also have to adapt to the new normal and work closely with doctors to bring out a comprehensive healthcare delivery system in these tough times.  So, in this discussion, experts will analyse whether pharma and healthcare sectors have been successful in digital adoption.

The new decade of Indian pharma industry post-COVID-19: This topic will examine how prudent and important it is for pharma firms to deploy market intelligence to understand market dynamics and shifts in customer behaviour to understand customer needs, expectations, readiness, accessibility etc. while chalking out their market re-entry and customer re-engagement plans. It will also analyse how the new decade post-COVID-19 could play out for the Indian pharma industry.

The challenges of pharma MSME and solutions: The Indian MSME sector comprises around 64 million enterprises and employs close to 120 million people. It contributes 30 per cent of India’s GDP and constitutes 45 per cent of exports. But, the COVID-19 outbreak and subsequent lockdown affected it adversely and its collective production decreased by more than 90 per cent. Therefore, it is important to discuss the challenges of pharma MSMEs and figure out solutions for their growth.

The HEAL Health Connect Solutions has been proactively highlighting such issues since the outbreak of COVID-19. Extensive discussions on the above topics during the e-SUMMIT are expected to streamline operations and help redefine the pharma industry post-COVID-19.

Register @ https://hhconnect.in/pharmaexcellenceesummit/

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How does C2FO work as a financial technology/service? 

C2FO is the first and largest working capital marketplace in the world and is working to deliver a future where every company has the capital it needs to grow.

Financial tools on the C2FO platform provide better, faster, and more flexible financing solutions, enabling enterprises (of all sizes) to manage their working capital needs. Our ability to create a seamless match between Accounts Receivable (A/R) and Accounts Payable (A/P) has enabled efficiency in cash flow between trading partners. While suppliers can take control of their cash flow, companies can increase EBITDA and gross margin and earn a better return on short-term cash, which improves the financial health of their supply chains.

C2FO’s strategy is clear: eliminate or greatly reduce credit risk and make capital available on tap. Our tactics are equally simple and clear: match accounts payable and accounts receivable from the world’s companies on a platform that is fast, affordable and easy for all to access. 

How can C2FO as a financial technology/service help provide liquidity to pharma companies in particular, as they have to scale up rapidly to meet COVID-19 driven demand while being hamstrung by price caps and other regulatory issues?

In India, C2FO works with more than 100 leading corporates, including some of India’s top pharma companies. These corporates are using the C2FO platform to improve their own and their vendor partners’ access to liquidity. At the same time, C2FO solutions bring efficiencies in a company’s treasury and payment processes to drive cost optimisation and improved operating margins.

In recent times, the rise in demand has put pressure on pharma companies’ faster turn-around of raw material, increasing their need for more capital. C2FO offers a single front-end technology platform backed by balance sheet-friendly financing options like accelerating cash flow (from global pharma buyers) and financing from C2FO’s multiple funding partners. The programme does not require KYC or other documentation while it addresses the cash flow needs of the pharma company and their diversified vendor base in India and across the globe!

Given the rapid scale that the pharma companies are trying to achieve, capital requirement remains a critical aspect. C2FO has brought in a combination of Dynamic Discounting (DD) and Dynamic Supplier Finance (DSF) to enable these companies to support their own or their suppliers’ need for affordable capital.

What have been the major challenges and learnings while adopting C2FO in the sector in India?

The Indian pharma sector is expected to grow to $100 billion by 2025 and there is an immense opportunity to leverage on its low-price, high-volume factor. The high growth of the Indian pharma industry requires companies to adopt financing strategies that will support the dynamic financing needs of their supply chains. While traditional financing channels like banks provide some liquidity support to the pharma supply chains, they are usually limited by their credit appetite and regulatory requirements of KYC and documentations. A high growth industry like pharma requires newer technologies like C2FO to scale their financing strategy rapidly.  

What have been the savings after implementing C2FO? Any success stories? 

C2FO is one platform providing many working capital solutions. We work in synergy with the multiple departments within the company to help them achieve their business objectives. It strengthens the company’s finances and complements several ongoing initiatives in the areas like process improvements, supply chain health and working capital management. The solutions of C2FO are easy to implement with a secure file exchange that requires minimal ongoing support. It helps gain more control over the capital by providing the flexibility to either invest or preserve short-term cash. Every company can take control of its financing strategy without being overly dependent on external and often high-cost options like bank and credit insurance.

There are multiple success stories across pharma and several other industries. This is reflected by the frequent awards and recognitions won by many C2FO customers at regional/ global levels. For e.g.: CIPLA’s team won the Asia Pacific Award for ‘Best Treasury & Finance Strategy’ at a leading trade finance awards platform recently.

What could be the possible pitfalls of using this technology, on the data security and confidentiality side as well as other issues? And how can these be prevented?

As the world’s largest non-bank provider of working capital, working with Fortune 500 companies serving over one million businesses in more than 180 countries, C2FO takes data security and confidentiality extremely seriously. Globally, over 50 million invoices are uploaded daily and the C2FO platform has funded over $110 billion in working capital to date.

C2FO facilitates the price discovery for early payment on a highly secure platform which is compliant to international gold standards in data security (SOC 2 Compliant). All file exchanges for the system operations are encrypted. Companies’ accounts payable systems still make all the payments directly to suppliers. The programme is totally automated and each programme is customised to match the client’s financial workflow and control architecture.

How does the company see its future in India and specifically the pharma sector?

C2FO plans to develop newer markets including India, where it started operations five years ago. We are expanding business in India, as we continue to hire team members, build our product line and invest in future growth opportunities. While there are more than 150,0000 businesses in India on the C2FO platform, we want to provide easy access to affordable capital for many more businesses through our network. We are very passionate about driving capital access to the very far end of the supply chains thus supporting the financial well-being of many small and medium businesses – which are India’s backbone in many respects. 

India’s pharma market is the third-largest in the world in terms of volume, and it is the 13th largest in value. India is moving towards reducing dependency on the import of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Owing to this rebalancing of where drugs are made, the Indian pharma industry is expected to register a growth of 14.2 per cent in the second quarter, as per a study by Information and Credit Rating Agency (ICRA). This growth is expected to induce immediate liquidity requirements for both the pharma companies and their suppliers. While traditional financing providers are still waking up to this challenge, we have already created a digital-funding-network that will highly support the next phase of super-growth of the Indian pharma industry.

How many clients so far? What’s the target accounts receivable and accounts payable globally and in India for this FY? 

The Indian market currently accounts for a sizeable portion of C2FO’s total global business. Almost 50 per cent of the total client base and 33 per cent of the total employees are based in India. With our growth initiatives and continued product innovation, we expect to grow rapidly in the coming years. Our strategy continues to provide the most convenient and affordable source of capital in India. C2FO has enabled working capital flows of more than $110 billion through its digital network and works with more than 200 leading companies, including 25 of the Global Fortune 100. 

viveka.r@expressindia.com

viveka.roy3@gmail.com

The post Our digital-funding-network will support India pharma’s next phase of super-growth appeared first on Express Pharma.

Koki Sato, Country Head and GM, Takeda India talks about the company’s recent drug launch in India, its plans for the Indian market, the impact of COVID-19 on Takeda as well as the pharma sector and more, in interaction with Sanjiv Das

Takeda recently launched Kynteles for ulcerative colitis. How is the launch going to bring in a change in the gastrointestinal drug market?

With an estimated disease burden of 1.1 million Ulcerative Colitis (UC) patients and 0.3 million Crohn’s Disease (CD) patients in India, the market is in need of continuous innovation within therapies that help address inflammatory bowel disease (IBD). With the launch of Vedolizumab (Kynteles), we aim to address the treatment gap for IBD patients as it is the only gut-selective biologic available in the country.

The UC and CD adult patients who have had an inadequate response or were intolerant to either conventional therapy or were tumour necrosis factor-alpha (TNF-α) antagonist will potentially benefit from this new line of treatment. Its efficacy and integrated safety profile from clinical trials have been built based on more than 415,000 collective patient-years of exposure. Kynteles has a proven safety profile that makes it conducive for long- term treatment.

What will be your other growth plans for the Indian market?

We are building a robust product pipeline across therapeutic areas to strengthen Takeda’s commitment to patients for better health and a brighter future. We are committed to bringing our innovative therapies to patients, which will help them live a considerably improved quality of life. With the acquisition of Shire, Takeda has been able to augment this vision in India. We now have our patient offerings across portfolios like gastrointestinal (GI), rare diseases (haemophilia and lysosomal storage disorders), and plasma-derived therapies.

Understanding the unmet needs of patients in the country, we explore various possibilities of expanding our portfolio under the existing therapy areas while also bringing in newer portfolios. Over the next two to five years, we intend to bring innovative products under our haematology and immunology portfolios.

What has been the COVID-19 impact on Takeda’s business globally and in the Indian market?

Our response to the coronavirus outbreak is guided by our values of Takeda-ism and patient-trust-reputation-business. In short, we are doing everything we can to protect our employees and their families, while also working to best support our patients, communities, and importantly, the healthcare providers upon which so many rely. Due to the increasing burden on our healthcare system and providers as they cope with the evolving situation related to COVID-19, Takeda’s guidance for customer-facing employees is to step away from healthcare sites and provide support virtually. We believe that this is the best way to support our patients and staff, communities, and healthcare providers.

From a supply chain point of view, Takeda’s strategy is to secure product supply continuity for patients by managing adequate inventory levels and/or alternative suppliers to produce our medicines. Based on current assessments of our global supply chain, we anticipate minimal disruption for the near-term due to the coronavirus outbreak. Longer-term, it is not yet possible to predict precisely what the impact may be on individual products. We will continue to monitor the situation as it evolves and take all necessary actions to ensure supply continuity for the people we serve.

What major transformations do you foresee in the pharma sector post-pandemic?

As we emerge from this pandemic, the ‘new normal’ will become the way of operating businesses across industries. The use of technology and digital engagements will become furthermore prevalent to stay connected in the virtual world. I believe new ways of working are evolving, giving flexibility to employees while maximising productivity. Since the lockdown, nearly the whole world has been working from home. Post-COVID, there will be a healthy mix of various working models, and pharma companies will adapt to that.

What measures have the company taken to protect its employees from COVID-19 pandemic, and to keep up the supply of medicines?

We have adjusted our business approach as a result of this outbreak. Along with protecting our employees, we are taking conscious efforts to mitigate the spread of the virus and reduce the epidemic burden on the general healthcare system. As per Takeda’s global advisory, our telework guidance applies to all our colleagues, including our customer-facing employees– especially those who interact with healthcare professionals. Technology is critical now more than ever. Our employees are technologically savvy and able to stay connected and work productively from home or other locations. We are encouraging our people to conduct their meetings virtually using the array of technology tools we have available. We are taking additional measures in every market as per the local laws and directives to ensure our employees’ safety while maintaining business continuity and access to therapy for patients.

Do you plan to launch any new drugs to fight the COVID-19 pandemic?

Takeda and other world-leading plasma companies have come together to focus on developing a hyperimmune globulin in the global fight against COVID-19 through CoVIg-19 Plasma Alliance. The CoVIg-19 Plasma Alliance is an initiative to accelerate the development of a potential treatment for COVID-19.

Recently Takeda Pharma inked a research agreement with CARMINE Therapeutics. Tell us more about the deal.

This research collaboration seeks to discover, develop, and commercialise transformative non-viral gene therapies for two rare disease targets using Carmine’s REGENT technology that is based on red blood cell extracellular vesicles.

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While focus is on the global deaths from COVID-19 crossing the six lakh mark, we have lost seven lakh people to antimicrobial resistance (AMR) each year, which is why more than 20 biopharmaceutical companies recently announced the launch of the AMR Action Fund that aims to bring two to four new antibiotics to patients by 2030. Silas Holland, Interim Director – External Affairs, AMR Action Fund explains to Viveka Roychowdhury how the collaboration will support small biotech firms involved with promising antibiotic R&D as well as with governments, not lobbying for specific legislative changes but participating in the broader debate about AMR and the need to support sustainable investment in antibiotic R&D

Research on new antibiotics does not get funding as the market is limited due antibiotic stewardship programmes to prevent overuse as well as increasing patient awareness on the harms of self-medication. In fact, most of the 20 bio-pharma companies that are partnering with the AMR Action Fund to put up this new investment of $1 billion have abandoned or contracted out their antibiotic research programmes for this reason. How will the Fund address this issue?

We know that collaboration will be critical to address the global AMR crisis. The AMR Action Fund investors include both companies that continue to invest in antibiotic R&D (e.g., MSD, Pfizer, GSK) and those that do not – including some that were once active in this space but exited due to the market challenges (e.g., Lilly, Novartis).

Many of the exciting and innovative products in the antibiotic pipeline are being developed by small biotech companies. So, this is where the AMR Action Fund will focus its investment. However, because developing antibiotics is a long, complex and expensive process and there is no viable market for new antibiotics, many of those small companies struggle to secure the necessary funding to cover the challenging later stages of development. In recent years, a number of antibiotic-focused biotechs have declared bankruptcy or exited this space, despite having successfully developed new antibiotics, due to the lack of commercial sustainability.

With the AMR Action Fund, the pharma industry is stepping up to support these biotechs with funding and expertise to strengthen and accelerate antibiotic R&D. Nevertheless, in order to ensure that we have a sustainable market in the long-term, policymakers need to take action too, by enacting market-based reforms that create an environment where antibiotic R&D can flourish. We believe that by bringing together a broad alliance of industry and non-industry stakeholders, including philanthropies, development banks and multi-lateral organisations, the AMR Action Fund can help encourage governments to create market conditions that enable sustainable investment in the antibiotic pipeline. These policy reforms will address the underlying market challenges for antibiotics that led to the larger companies exiting antibiotic R&D and bankruptcies of the antibiotic-focused biotechs.

The AMR Action Fund aims to bring two to four new antibiotics to patients by 2030. The Fund is expected to be operational during the fourth quarter of 2020. What are the milestones to the 2030 goal? Does the Fund already have a few candidates, in terms of companies or investigational candidates, in their sights? What is the expected financial commitment per biopharma partner?

The AMR Action Fund is a true collective industry initiative, bringing together more than 20 innovative pharma companies of different sizes from around the world. Companies voluntarily set their investment level and committed up to $100 million. Beyond funding, the AMR Action Fund will also provide technical support to portfolio companies, giving them access to the deep expertise and resources of large pharma companies, to strengthen and accelerate antibiotic development. This “in-kind” support is in addition to the cash investments already raised.

The AMR Action Fund will invest in smaller biotech companies focused on developing novel antibiotics that address the highest priority public health needs (based on WHO and US CDC lists of priority pathogens), make a significant difference in clinical practice and save lives. Our investments will be guided by an independent Scientific Advisory Board, comprising world-class experts. More information on the investment process will be available once the Fund becomes operational during the fourth quarter of 2020 (expected).

You mentioned that the AMR Action Fund intends to work with governments to ensure there is a sustainable pipeline of new antibiotics. Could you give us more details on what will this possibly entail?

The AMR Action Fund will bring together a broad alliance of industry and non-industry stakeholders, including philanthropies, development banks and multi-lateral organisations, and help encourage governments to create market conditions that enable sustainable investment in the antibiotic pipeline. The AMR Fund will not lobby for specific legislative changes, but will participate in the broader debate about AMR and the need to support sustainable investment in antibiotic R&D.

What role does the new AMR Action Fund envisage for countries like India in terms of research and development of new antibiotics, and in terms of long-term policy solutions to build a sustainable antibiotic pipeline?

The AMR Action Fund is open to making investments in biotechs in any country, including India. If an India-based biotech has a product that meets the AMR Action Fund’s criteria and is recommended for investment by the Scientific Advisory Board, it will be considered for investment.

All countries have a role to play in supporting appropriate access and innovation for novel antibiotics – and there is no one-size-fits-all solution. The AMR Action Fund would be happy to work with all relevant stakeholders to determine the appropriate long-term policy solutions in India.

AMR levels are expected to rise due to over/misuse of antibiotics, both by doctors as well as potential patients during the COVID-19 pandemic. How will the launch of the AMR Action Fund address the issue that having new antibiotics may not be the only solutions to address future infections?

The AMR Action Fund takes the issue of responsible use seriously, and is committed to ensure that the novel antibiotics it invests in are used appropriately. Through its investments and capability platform, the AMR Action Fund will ensure that company activities are aligned with the appropriate use goals. However, even with appropriate use, bacteria will continue to evolve and develop resistance to antibiotics. Staying ahead of this growing threat requires ongoing innovation and a functioning innovation ecosystem. It is the focus of the AMR Action Fund to address this problem, beginning to rebuild the global antibiotic pipeline while working across the ecosystem to support long-lasting solutions.

viveka.r@expressindia.com

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