As one of the world’s largest independent financial groups, with more than 200 years of global expertise, how important a market is India to Rothschild & Co’s overall business, in terms of revenue share (or percentage growth in revenue share)?

Rothschild & Co is one of the largest independent financial advisory firms globally with over 1,500 professionals on the ground in 58 locations across 42 countries. During 2021 and 2022, the firm successfully advised on over 1,000 M&A deals globally, which makes us the most active global advisor by volume of transactions. India has been essential to the firm’s global strategy for over 20 years. With a team of 25+ bankers and advising on an average of 12-14 transactions every year, we are one of the country’s largest pure play global M&A and financial advisory firms.

Our business in India has grown significantly over the last five years, both in terms of banker strength and revenues. Our focus on pure-play M&A and financial advisory service offering, strong global sector expertise coupled with experienced local bankers, and longevity of senior bankers within the firm in India is certainly paying off, evidenced by the rising share of repeat business from our existing clients. Given how our business in India has shaped over the last five years, we are highly confident to grow meaningfully in the next two to three years.

What’s been the engagement levels with India’s healthcare and pharma sectors, in terms of growth in value/volume of deals transacted as a percentage of Rothschild & Co’s global business?

Healthcare is an important and growing market at a global level. With a global team of c.100 bankers dedicated to the sector, Rothschild & Co has advised on over 170 transactions in the healthcare sector globally in the last three years. It is also a globally interconnected sector, especially in pharma and medical devices, which leads to a large volume of cross-border activity for us.

We have scaled up our healthcare sector franchise in India over the last few years and are now regarded as among the top two global firms in the healthcare sector in India, having advised on over 15 transactions in the last seven years. Some of the healthcare sector transactions we have advised in India include the sale of 20 per cent stake in Piramal Pharma to Carlyle, sale of Medreich to Meiji Seika Pharma, Intas Pharma’s acquisition of Actavis UK & Ireland, fund raise from Temasek by Integrace Health, sale of Oaknet Healthcare to Eris Lifesciences, TPG Growth’s investment in Solara Active Pharma and sale of majority stake in Symbiotec Pharmalab.

We continue to be busy in the sector, advising currently on multiple transactions across pharma, MedTech and healthcare services. We have advised a diversified set of clients in the healthcare sector in India, with our client base comprising large Indian generics majors, private equity (PE) funds and family-owned firms. In general, across sectors, we have had extensive experience in advising family owned/founded firms, which comes naturally to us, given our own heritage as a family-owned firm.

Quite a few pharma promoters in India are divesting stakes, as the next generation is not interested in taking forward their legacy in the same sector. As an investment banking and advisory firm, which are the segments most attractive for such deals and strategic investors like PE/VCs?

We have seen strong deal activity across multiple segments within the healthcare sector in India.

Not surprisingly, a lot of activity has been in the pharma sector, across multiple sub segments including domestic formulations, API/CDMO and nutraceutical ingredients. In the domestic formulations segment, we have seen a healthy level of activity from strategics as well as PE funds. Trade activity has been driven by a desire to enhance market share, plug specific whitespaces from a therapy area standpoint and accelerate beyond organic growth. Pharma B2B has witnessed consistent M&A activity, especially in the Active Pharmaceutical Ingredient (API) segment. The industry continues to be fragmented, providing the opportunity for consolidation. PE activity has been led by funds seeking platform investments and subsequent bolt-on acquisitions to acquire capabilities and scale up. Trade activity has been primarily driven by a desire to expand in high growth segments such as HPAPI, oncology, peptides and injectables.

Nutraceutical ingredient segment has also had recent deal activity, such as Novozymes’ acquisition of a majority stake in Synergia Life Sciences and TA Associates’ investment in OmniActive Health Technologies. The space is witnessing interest from global strategics as well as PE funds on the back of strong growth driven by rising consumer awareness and a shift towards preventive care. This segment is also witnessing strong inbound interest with overseas companies looking to acquire assets in India to access niche/high growth product portfolios, expand their manufacturing base and benefit from revenue synergies.

We have seen quite a few M&As/deals centered around Active Pharmaceuticals Ingredients (APIs) manufacturers as investors look to secure the global pharma chain to avoid the disruptions seen during the Covid pandemic. By when will we see the results of such moves? 

There is more focus on APIs now post-Covid. Several regions/countries have historically relied on China for bulk drugs/APIs. Given the supply chain disruptions faced during Covid, there is a greater realisation of the need to diversify the supply chain and avoid over reliance on one country/source. In certain product categories, China is likely to continue to be the major source/supplier, given the vast capacities (and consequently cost efficiency) built over time. This would be especially relevant in high volume intermediates/APIs, where cost is a key consideration and having large scale capacities helps drive costs of production down (i.e., benefit from economies of scale).

However, in categories which are either high value/niche or considered critical, we are witnessing a desire on the part of customers to diversify the supply chain outside of China i.e., China + 1 strategy. Outside of China, India and Italy are two of the major API manufacturing hubs, which are expected to further fuel the demand for APIs from India. We expect such supply chain diversification moves to take time to show results, given the gestation period involved in setting up large capacities and building/developing the eco-system required to have local production at a meaningful scale.

What are the trends driving M&As in the domestic formulations space in India and how is it likely to evolve going forward?

There has been a strong wave of M&A activity in the Indian domestic formulations space. Large Indian domestic companies are doubling down on the Indian market driven by a desire to enhance presence, plug specific whitespaces from a therapy area standpoint and accelerate beyond organic growth. Some key deals include Torrent Pharma’s acquisition of Curatio Healthcare, Eris Lifesciences’ acquisition of Oaknet Healthcare and Mankind Pharma’s acquisition of Panacea Biotech’s domestic formulation brands. Several strategic transactions have been in the form of brand acquisitions to fill specific portfolio gaps and strengthen specific divisions. Most large Indian pharma companies enjoy a healthy balance sheet, providing the ammunition to fund inorganic growth. This coupled with the fact that there are limited avenues for inorganic capital deployment (with similar risk-reward dynamics) implies that domestic M&A activity is expected to continue going forward.

Several larger domestic companies are looking to focus on core portfolios and sharpen capital/resource allocation decisions. This in turn has also resulted in companies divesting select non-core brands, a trend that is likely to continue.

There has also been a fair amount of PE activity in the Indian domestic formulations space, including Advent’s acquisition of Bharat Serums and Vaccines, KKR’s acquisition of a controlling stake in JB Chemicals & Pharmaceuticals and True North’s acquisition of Glenmark Pharmaceuticals’ orthopaedic and pain management business. This trend is expected to continue as some local companies look to sell, driven by a lack of succession considerations or as some of the larger companies look to restructure/shed non-core portfolios.

Given uncertain macroeconomic trends, increasing pricing pressures, escalating regulatory overhang due to quality concerns shadowing even the bigger Indian pharma companies, what’s been the track record of M&A in the healthcare/pharma ingredients sector (globally versus India) and how do we expect it to evolve over the next few years?

Pharma B2B has been an area with consistent M&A activity, especially in the API segment driven by PE funds and corporates. The industry has been and continues to be fragmented, providing consolidation opportunities. The industry continues to benefit from a structural move from customers to increasingly outsource manufacturing activities and shift towards an asset-light business model driven by cost pressure, the desire to migrate from a fixed to a variable cost structure and supply chain complexity.

In addition, there has been a growing share of mid and small pharma companies in the late-stage pipeline, which bodes well for continued growth in outsourcing, as several mid and small pharma companies rely on outsourcing to meet their manufacturing requirements. Also, there seems to be rising demand from customers for integrated service offerings, which would further drive consolidators to fill gaps in service offerings through acquisitions. China + 1 strategy could also drive inbound activity with overseas companies looking to acquire assets, especially those with strong regulatory track record, meaningful regulated markets exposure and presence in high-growth and niche areas.

As you rightly said, there is clearly a greater focus on compliance and regulatory track record. Given the increase in regulatory scrutiny and the spate of OAIs (Official Action Indicated) issued by USFDA over the last few years, investors and acquirers are increasingly emphasizing regulatory compliance/track record. Based on our experience, we believe a strong regulatory/compliance track record, especially with US and European regulators has clearly evolved into a “must have” for most investors.  

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Has Covid increased or decreased access and equity of healthcare and treatment?

There’s a panel discussion in MSF’s upcoming inaugural Health and Humanity Conference (August 17, New Delhi) on “How COVID has shaped justice and equity for access to treatment”. The focus is on looking at how COVID has shaped justice and equity in access to treatment.

So has COVID improved the status quo on access to treatment or is its impact more negative?

Its both. The positive is that the scientific community worked together to achieve breakthroughs to diagnose, treat and prevent COVID. Within months, we had a test, within a year, we had a vaccine, and within two years, we had started to see some very effective therapeutics. So you can see that if the right resources are available, mainly backed by governments, you can quickly have scientific breakthroughs.

In that sense, MSF has been highlighting how the pace of scientific progress is glacially slow in neglected diseases or populations. TB is a classic example. It took over four decades before new drugs became available for drug-resistant TB. One of the positives of COVID was that it brought collaboration of the scientific community across borders, and governments provided the resources needed to back these scientific advances. Clinical trials were conducted across countries, regulatory pathways were set up, and data was reviewed by national drug regulatory authorities to quickly make tests, vaccines and therapeutics available in the health system.

Yet, in access to these, a lack of global solidarity became evident despite early promises by world leaders. Technology and production capacity are concentrated in high-income countries and in the hands of a few pharmaceutical corporations. Monopolies on reagents affected the ability of local manufacturers in many countries to supply more tests to their health systems. High-income countries (HICs), including the US, UK, Switzerland, and many EU countries, tied up most of the global supply of vaccine doses early on in the epidemic. By the end of 2021, deadly pandemic waves swept across regions. Yet, many healthcare workers and vulnerable people in low and middle-income countries did not receive their first dose of approved vaccines.

So my point is, you could see public and private research institutions and collaboration among the scientific community to provide the breakthroughs that we needed, from the genomic sequence to the test to the vaccines to the drugs.

But in terms of equity, the high-income countries tied up all the supplies at the pandemic’s peak, so nothing changed for low and middle-income countries. So that came out and should shape the negotiations for the pandemic treaty.

What came out, particularly for regional multilateral forums like the African Union, was that it was not sufficient to depend on imports, donations and the leftovers from high-income countries.

African leaders are now committing to policies that recognise that production capabilities are essential for the continent in the future. They now face the challenge of providing their manufacturers with the policy framework and long-term financial support needed to develop technology and survive. These include investments but also the introduction of time-tested policies that have worked in countries like India, Bangladesh, Egypt and Argentina with developed manufacturing capacities, such as limiting intellectual property barriers that have a chilling effect on local production and giving preference to local manufacturers in public procurement.

So that’s a very positive (result) that you see. Other regions know the value of doing something India has done for the last five decades. India has sustained, both in terms of public investments in technology, giving incentives for technology development, developing pharmaceuticals, biotechnology, biologic drugs, tests, and of course, vaccines.

While India was criticised for blocking supplies by some for reserving supplies for itself, at the same time, it was evident that countries like India benefited from local production at the peak of the pandemic. So you can see the impact of that on the political thinking of the African Union and others that we need to invest in technology and manufacturing So that’s one of the positives.

Pre-pandemic policy efforts to encourage API production did not succeed as well as hoped. Post pandemic, the PLI scheme has received a different kind of policy push. So do you see this as another positive?

Yes. I think two very clear things came out of the pandemic. One, was the policies needed for India to bring back API manufacturing. It was there before the pandemic.

But what you also see is the issue of local production becoming important in the area of diagnostics. Shortages in the supply of reagents – the raw materials –going into making (diagnostic kits) tests. It’s something that India has to invest in and develop the capacity to address as there is heavy dependence on corporations for the reagents and the raw materials that go into diagnostics.

Second are the policies on encouraging local production of diagnostics. It took over a decade for the indigenous PCR machines and the PCR kits for DR-TB, which had been being developed but were not being procured despite meeting quality assurance standards from the WHO. Then because of COVID, policymakers in the health ministry recognised the importance, and you saw the very rapid expansion of PCR testing capacity in the health system across the country due to the pandemic.

The uptake (of PCR technology) by the public sector is what is subsidising the diagnostic manufacturers as the government expanded PCR testing capacity during COVID. This is a very big positive.

India because of its manufacturing capacity, but also the kind of support India gave from a regulatory point of view, from ICMR, the Department of Biotechnology, and the regulatory authority led to a lot of these breakthroughs for India on vaccine production, tests, and, of course, the drugs as well, because there is much political will in India to get these things done.

So, the industry also knew that the government of India was very interested in them producing the tests, vaccines, and drugs. So that’s a positive.

What about vaccines? How will COVID impact policies around vaccines?

For the limited supplies of vaccines and medical products made available to LMICs during the pandemic, pre-conditions were imposed on governments and the central global mechanism Accelerator – A (ACT-A) for COVID-19 vaccines, tests and medicines supply.

Among the most egregious clauses inserted by multinational pharmaceutical corporations in purchase agreements for COVID vaccines was to pass on the legal liabilities for severe injuries resulting from these new vaccines (indemnity clauses) to purchasers like governments and non-governmental organisations (NGOs) procuring vaccines and set a worrying precedent for the future. These clauses from Big Pharma undermine rights in case of severe injuries and transparency of pricing and supply terms and will continue to haunt us.

But there are some positive aspects.

There is now a recognition among some policy makers in Inda that adult vaccination is very important, mainly to provide another tool to address the rise of antibiotic resistance. New vaccines, like the pneumonia vaccine typhoid vaccines, are all essential vaccines that could offset the use of antibiotics at the community level.

We need the ICMR and NCDC to take up the importance of vaccines with the MoHFW to address AMR.

And what about the lessons for India?

It’s very clear that the Indian model of producing generics, vaccines and other medical supplies is an important tool and valuable in a pandemic or health emergencies. India was able to meet its own needs, for over a billion people.

There is a significant lesson for India which was among the few middle-income countries self-reliant in developing and producing tests, vaccines, equipment and medicines. India’s manufacturing might was not developed in a policy vacuum.

Underlying its success in meeting the national need for these medical products is the public sector investment and incentives for the development of technology and the absence of intellectual property barriers in its drug registration laws and health safeguards against frivolous monopolies in its patent system that enable its manufacturers to introduce competition that secures supplies and lowers the prices of vaccines and medicines significantly. Trading away this advantage in the current free trade agreements negotiations with the UK, Switzerland, and the European Union can be counter-productive in addressing health emergencies and future pandemics.

And, of course, the most important thing is that in India, whatever manufacturing happens, it’s tied to public procurement. India is one of the biggest markets for its own industry. So, in that sense, it also gives preference to its manufacturers, and that has sustained the Indian generic industry’s survival for decades.

That’s something that the African Union and others need to think about.

We are seeing a whole discourse on quality issues linked to substandard medicines from India in the global supply chain. Do you feel that that is a push back to this manufacturing might?

The important thing is that India does need to look at how they can continue the reforms on quality. There have been a number of reforms on quality, and I’ll give you some of them.

What’s been done on the quality assurance of antiretrovirals, TB drugs or antimalarials is historic, saves millions of lives across the world, and that model of ensuring that medicines produced in India have the same quality across all countries needs to be replicated in other essential medicines.

It’s very, very important to recognise that civil society fought not only for affordable generics in the HIV/AIDS movement, but for quality assurance as well. The Global Fund today buys millions of dollars worth of drugs from India for TB, malaria and HIV. And that model holds immense value for essential drugs.

The kind of quality assurance we need is not just for specific therapeutic areas, but we need to start thinking about what we want to do across the board for essential medicines and what resources India’s regulatory authority needs to ensure quality from its state licensing authorities.

India doesn’t have one FDA, which is the CDSCO. It has more than 20 FDAs, particularly if you look at the states which have manufacturing capacity, with SEZs.

CDSCO regulates medicines, which are newly introduced, whether it’s a new formulation, an FDC, or a new molecule compound. But CDSCO doesn’t regulate the quality of drugs that are older than four years old.

For example, HIV medicines today, which are more than four years old, go to the state FDAs for licensing. Currently, if you are bidding for a ARV tender in India, you don’t need to do the stability or bioequivalence tests. Because the state licensing authorities do not require that test.

So, It’s not just about testing the drug for contamination at the end, when the product is finally ready. Part of drug regulation is also the process of quality assurance at the time of licensing and after licensing. For example, to ensure that if a manufacturer changes the API source, they inform the FDA about it and ensure that the API manufacturer also complies with WHO GMP standards.

So these are some of the reforms that are much needed in India on quality.

If we do not discuss and debate quality seriously and the kind of reforms needed to consolidate quality work, the chances are that there will be an attack on generic competition from India.

It’s precisely for this reason that we need to consolidate the work on quality that India has done, particularly if you look at the areas of HIV and hepatitis and TB and malaria, where Indian manufacturers have been delivering millions of treatments of quality across the world and saving millions of lives.

I think this consolidation is very important at this point of time if we are not to have the kinds of attacks that we’ve seen in the past from Big Pharma – calling Indian generics counterfeits and trying to block legitimate trade in affordable medicines between countries.

viveka.r@expressindia.com

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As this will be your first official visit to India following your appointment as the Asia Area Vice President, AstraZeneca what are your plans to grow the India market share?

AstraZeneca is committed to transform healthcare for billions of people. Pioneering science is accelerating our understanding of disease, helping us better predict clinical success, develop and deliver life changing medicines and increase engagement in the clinic and beyond.

We’re building success across our markets and our therapy areas by creating innovative medicines and improving access to them, with the aim of transforming the lives of the greatest number of patients with improved outcomes and a better quality of life. The pandemic showed the power of science, technology and public-private partnerships in driving innovation and we are applying the lessons learned to address future challenges.

India is unique and presents exciting opportunities. We recognise the opportunity to serve growing patient population and contribute to improving healthcare outcomes especially in the non-communicable disease areas. With a high prevalence of conditions like cancer, diabetes, respiratory problems cardiovascular ailments and rare diseases, we are working with the ecosystem to ensure that we are able to deliver most effective medicines to patients in need. We are building strategic alliances with government bodies, local healthcare institutions and diagnostic organisations which can help co-create tailored healthcare solutions and improve the overall access to care.

In terms of therapeutic focus areas, what will be the growth drivers for AstraZeneca in a post pandemic world, as revenues from COVID-19 medicines reduce?

COVID-19 has exposed the vulnerabilities of health systems across the world. It has nudged us to adopt more resilient healthcare systems that can help address the underlying challenges such as the rise of non-communicable diseases. While COVID-19 has been a significant focus for us during the pandemic, we are invested in bringing down the burden of some of the biggest healthcare challenges today. Our strategy involves a balanced approach across all therapeutic areas we are present in to address unmet medical needs and deliver value to patients.

AstraZeneca continues to place a high priority on cancer. We continue to invest in research and development to advance therapies for conditions like lung, breast, and ovarian cancers. We have a solid portfolio of cutting-edge oncology medications. We expect considerable growth prospects in this therapeutic field as a result of the rising prevalence of certain diseases and the demand for personalised medical techniques.

Cardiovascular and respiratory diseases continue to constitute significant worldwide health burdens. Asthma, chronic obstructive pulmonary disease (COPD), and heart failure are a few of the ailments for which AstraZeneca has a long-standing commitment to finding novel solutions. We expect sustainable growth by addressing the unmet requirements of people and healthcare systems in these areas.

Furthermore, globally we are actively pursuing advancements in the fields of immunology, neuroscience, and rare diseases. These areas present opportunities for AstraZeneca to leverage our scientific expertise and develop innovative therapies that can make a meaningful impact on patients’ lives.

Additionally, our commitment to people and sustainability and addressing environmental, social, and governance (ESG) issues aligns with the growing focus on holistic patient care. We will continue to integrate inclusive & sustainable practices into our operations and leverage our capabilities to contribute to the overall well-being of patients and communities.

Most of India’s population pays for healthcare out of pocket. What are the company’s plans to make healthcare more affordable, accessible, and equitable, especially for families impacted by rare diseases?

We understand the importance of making healthcare more affordable, accessible, and equitable for the Indian population. AstraZeneca is committed to addressing these challenges through a multi-faceted approach. We strive to enhance accessibility by expanding our patient assistance programs and leveraging partnerships with local healthcare organisations. These initiatives seek to close the accessibility gap between patients and the medicines they require, particularly for individuals impacted from uncommon diseases.

We continuously invest in research and development to advance scientific knowledge and develop innovative therapies for rare diseases. By expanding our portfolio in this area, we aim to address unmet medical needs and provide new treatment options for patients.

We actively collaborate with healthcare professionals, researchers, and academic institutions in India to drive clinical trials and research activities with a focus on rare diseases. In addition to these efforts we recognise the importance of digital health technologies in improving healthcare access, particularly in remote areas. AstraZeneca is exploring partnerships and initiatives that leverage technology to enhance patient monitoring, remote consultations, and access to medical information, ultimately making healthcare more accessible and convenient for all.

Ultimately, we want to make sure that every patient can get the healthcare they require, regardless of socioeconomic status or the rarity of their illness.We remain committed to working with important stakeholders, funding research, and implementing initiatives that drive affordability, accessibility, and equity in healthcare for the Indian population.

How does the company plan to partner with the Government of India to tackle public health pain points?

AstraZeneca is committed to working closely with the Government of India to address issues related to public health and improve access to care. We recognise the importance of public-private partnerships in achieving sustainable healthcare solutions and building resilient healthcare systems and actively seek opportunities to collaborate on various initiatives related to access to care, innovation, upskilling and environment sustainability. Our collaborations with ISHIC (India-Sweden Healthcare Innovation Centre), ‘Skill For Scale’, an e-learning initiative that focused on upskilling primary care providers to equip them with hands on practical training to bridge the knowledge gap that exists in the management of NCDs.

At the community level, we have designed programmes that complement government agenda of building mass scale awareness on diseases especially cancer. Through our Ganga Godavari Programme, we have thus far touched more than 12,000 women and tested them for oral, breast and cervical cancer in many states of the country. Once identified at-risk or positive, beneficiaries are directed to nearest government facilities for further analysis and treatment direction.

AstraZeneca recognises the importance of empowering youth with disease knowledge so that they can make informed decisions about their health. Through our Youth Health Programme (YHP), we are working with adolescents to guide them about the ill-effects of tobacco and alcohol so that we can raise awareness about various health issues affecting youth and provide them with the necessary support and resources to lead healthier lives. By engaging with the government and right stakeholders, we strive to create a positive impact on youth.

These programmes represent a fraction of our broader commitment to collaborating with the Indian government to address pressing public health issues. AstraZeneca is dedicated to advancing healthcare in India and enhancing the general health and wellbeing of its people by utilising our knowledge, resources, and international network.

As part of a small but growing cohort of women leaders in the pharma sector, what are the initiatives you have implemented to support gender diversity?

I believe it’s important to have a strong support system, at AstraZeneca our employees are valued for their diverse experience and thinking as we are committed to creating a diverse and inclusive workplace where all employees can thrive. We empower our people to reach their full potential in a dynamic, inclusive and high performing working environment

The company’s initiatives and policies are helping to create a more equitable environment for women, and they are helping to attract and retain top talent.

Network of Women- AstraZeneca is passionate about developing a diverse and inclusive workforce, including a commitment to increase the presence of women in our leadership teams. One of the ways we to do this is through our Employee Resource Group (ERG) such as the NOW.

Women as Leaders – The programme has been designed to help women  in AstraZeneca develop to their  full potential in leadership roles. The programme  empowers  women  within  the corporate  environment  to  build their own  personal brand through increased confidence, develop their  ability to identify big picture opportunities,  seek advancement  by taking on  more  responsibilities and ultimately accelerate careers.

Project iDEA encapsulates our commitment to helping gender diverse talent across STEM (Science, Technological, Engineering, Mathematical) to prepare for employment by bridging and engaging with students from various backgrounds; giving them a glimpse of what we do with science in delivering life changing medicines for patients. This provides a structured development series for their first career, engage to know the career possibilities and exposure to the pharma industry, thereby attaining experience through a case study-based competition to gain mentorship and internship in AstraZeneca.

Viveka.r@expressindia.com

vivekaroy.3@gmail.com

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How has the role of decentralised clinical trials (DCTs) evolved in the clinical research industry?

The role of Decentralised Clinical Trials (DCTs) is rapidly evolving within the clinical research industry. While it initially focused on improving patient access to trials, they are now recognised for their immense potential to enhance the efficiency and effectiveness of the entire clinical trial process. This recognition has led to increased adoption and expanded utilisation of DCTs across a wide range of diseases and conditions. The transformation of DCTs within the clinical research industry can be observed through the following developments:

• Enhanced trial data quality: DCTs offer opportunities to collect more accurate and comprehensive data due to real-time, remote patient monitoring and electronic data capture. This improves the overall quality and reliability of the trial data
• Greater focus on patient engagement: DCTs enable greater patient engagement through remote visits, eConsent, and patient-centric technologies. This approach enhances patient participation and retention throughout the trial, leading to more representative and meaningful outcomes
• Broader application: DCTs are now being applied to a wider range of clinical trials, including studies involving rare diseases, complex conditions, and specialised populations. This expansion allows for more inclusive and diverse trial populations

What are the primary reasons behind the increasing traction of DCTs in recent years?

The field of clinical research is currently undergoing a profound transformation fueled by technological advancements, evolving patient expectations, regulatory changes, and lessons learned from the COVID-19 pandemic. These factors are driving key trends and shaping the industry in significant ways. From the integration of digital health technologies to the rise of decentralised trials, these developments are redefining the future of clinical research.

• Advancements in digital technologies: Rapid advancements in digital technologies, such as mobile devices, wearable sensors, electronic health records (EHRs), and telemedicine platforms, have made remote data collection and patient monitoring more feasible
• Patient-centric approach: DCTs prioritise the convenience and comfort of participants. By allowing them to participate in trials from their homes or local communities, DCTs remove geographical barriers and reduce the burden of travel and site visits
• Broader recruitment potential: Traditional clinical trials often face challenges in patient recruitment, leading to delays and increased costs. DCTs have the potential to overcome these challenges by expanding the recruitment pool beyond the limited geographic area close to trial sites. By including participants from remote areas, DCTs enhance diversity in study populations and improve the generalisability of results
• Regulatory acceptance and guidelines: Regulatory agencies, recognising the benefits of DCTs, have issued guidelines to support their implementation. For example, the FDA and the EMA have released instructions on decentralised trials, providing recommendations on data integrity, patient privacy, remote consent, and other considerations. These guidelines have fostered confidence among sponsors and investigators, facilitating the wider adoption of DCTs
• Learnings from the COVID-19 pandemic: The COVID-19 pandemic accelerated the adoption of remote approaches in clinical trials. With travel restrictions and safety concerns, traditional trial operations faced significant disruptions. DCTs emerged as a viable alternative, enabling researchers to continue studies remotely. The successful implementation of DCTs during the pandemic has highlighted their potential and paved the way for their continued use even beyond the pandemic

 What are the key benefits and advantages of conducting decentralised clinical trials compared to traditional site-based trials?

Revolutionising clinical research, DCTs have surfaced and presented unparalleled benefits that disrupt traditional approaches. It has demonstrated numerous advantages such as:

• Improved patient access and convenience: DCTs offer heightened accessibility and convenience by cutting down on the frequency of travel to clinical trial sites
• Enhanced patient retention: Maintaining patient retention in clinical trials is a frequent obstacle, often arising from demanding visit schedules, travel obligations, and logistical complexities. DCTs address these challenges by offering a patient-centric experience that alleviates these burdens
• Cost and time efficiency: DCTs achieve cost-minimisation in operations by doing away with the requirement for physical trial sites and decreasing on-site monitoring
• Real-time data collection and analysis: By enabling real-time data collection and prompt analysis, researchers are equipped to make informed decisions during the trial, leading to the development of more efficient and adaptive protocols
• Refined data quality and analysis: Enhanced data accuracy allows researchers to conclude the study findings with confidence, leading to the establishment of trust and credibility within the research community
• Driving flexibility and adaptability: Thanks to the remote nature of these trials, adjustments can be seamlessly implemented, encompassing the enlargement of the participant pool, modifications to study parameters, and timely responses to external factors like pandemics or natural disasters

 How does the use of technology enable remote patient monitoring and data collection in DCTs?

The use of technology plays a critical role in enabling remote patient monitoring and data collection in DCTs. Through digital health tools such as mobile applications, wearable devices, and connected sensors, participants can track and transmit real-time health data from their homes. EHRs facilitate securing the sharing of patient information between healthcare providers and trial sponsors.

Additionally, telemedicine platforms make it easier for people to have virtual consultations instead of in-person appointments. With remote data capture tools like electronic case report forms (eCRFs) and electronic patient-reported outcome (ePRO) systems, participants can directly enter their data and responses into digital forms. By integrating data from various sources like wearable devices and EHRs, valuable insights can be derived through real-time analysis. Measures are taken to ensure secure data transmission and maintain privacy to protect participants’ information. In essence, the integration of technology in DCTs enhances participant convenience, improves data quality, and optimises trial operations through remote monitoring and data collection.

 How do DCTs improve patient recruitment and retention compared to traditional trials?

DCTs expand participant accessibility by allowing individuals to engage in trials from their homes or local communities, eliminating geographical barriers. This broader reach increases the potential participant pool and enhances diversity in study populations. Additionally, the convenience of participating remotely reduces the burden on participants, resulting in higher engagement and improved retention rates. By minimising the need for frequent in-person visits and associated travel costs, DCTs enhance convenience and reduce the logistical challenges that often deter participation or lead to participant dropouts in traditional trials. The flexibility and patient-centric nature of DCTs contribute to increased recruitment rates and better participant retention throughout the trial, ultimately leading to more successful and efficient clinical research.

Additionally, the integration of applications with remote sensor devices allows subjects to virtually record trial-related details, eliminating the need for site visits. The ‘televisits’ feature enables subjects to conveniently engage in discussions with site clinicians, addressing their day-to-day questions and concerns. With the ‘caregiver concept’, patients can grant authorisation for a caregiver to provide their details when direct communication with the site is not feasible. In contrast, web portals provide a convenient solution, allowing patients to remotely log in, complete questionnaires, and record study-related information without the requirement of visiting the site in person. These features enhance accessibility and streamline the participation process in clinical trials.

 What are the future trends and potential advancements in decentralised clinical trials that are being explored?

The field of clinical trials is experiencing a paradigm shift with the emergence of DCTs. These trials leverage innovative technologies and approaches to enhance participant engagement, streamline data collection, and optimise trial design. As the industry progresses, several anticipated advancements will shape the future of DCTs.

• Decentralised trial designs: Further exploration of hybrid trial designs that combine aspects of traditional and decentralised models is anticipated. These designs can optimise the balance between in-person visits for specific procedures and remote data collection, tailoring the trial design to the specific needs of the study
• Virtual Health Assistants: VHAs play a vital role in DCTs by delivering personalised guidance, remotely monitoring participants’ health, ensuring medication adherence, facilitating communication, and enhancing participant engagement.  They educate participants on trial protocols, remotely collect real-time health data, promote medication adherence, address queries, offer emotional support, and maintain secure communication channels, contributing to the success of DCTs.
• Wearable and remote monitoring devices: Advancements in wearable technology, such as biosensors and remote monitoring devices, are expected to play a significant role in DCTs. These devices can collect real-time physiological data, allowing for continuous monitoring of participants’ health status and treatment response
• Generative AI: Generative AI has the potential to analyse large datasets generated by DCTs, identify patterns, predicted outcomes, and provide personalised insights. Furthermore, the technology can also assist in generating synthetic data to enhance datasets
• Blockchain technology: Blockchain technology holds promise for enhancing data security, privacy, and integrity in DCTs. It can enable secure data sharing, transparent consent management, and audit trails, ensuring trust and compliance in the trial process
• Regulatory advancements: Regulatory agencies are actively working on evolving guidelines and frameworks to support the implementation of DCTs. Continued collaboration and advancements in regulatory policies can further promote the adoption and acceptance of DCTs in the industry.

viveka.r@expressindia.com 

viveka.roy3@gmail.com

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Tell us about the growth opportunities opening up in the pharma sector, globally. How is Novo Nordisk poised to leverage them? What are your current and future areas of focus? Why?

The pharma sector continues to present significant growth opportunities globally. Several factors contribute to this positive outlook, including increasing global healthcare expenditure, population aging, rising chronic diseases, technological advancements, and expanding access to healthcare in emerging markets. Research and Development (R&D) Advancements in molecular biology, genomics, proteomics, and other fields are driving innovation in drug discovery and development. Targeted therapies, precision medicine, and personalised treatments are gaining prominence, presenting opportunities for pharma companies to develop novel and more effective drugs.

Today, chronic disorders have gained prominence. At Novo Nordisk, we are dedicated to tackling chronic diseases by driving change in diabetes, obesity, rare diseases- haemophilia, growth hormone deficiency, etc., cardiovascular diseases (CVDs), non-alcoholic steatohepatitis (NASH),and more. We are doing this by raising the innovation bar, harnessing the power of scientific excellence, and developing a leading portfolio of superior treatment solutions.

Can you tell us about Novo Nordisk’s priority areas of growth in India in the times to come?

Simplifying diabetes care, awareness around obesity and related complications, CVDs and rare diseases like haemophilia continue to be the focus areas for the Indian market. As a leading pharma company in India, Novo Nordisk India is dedicatedly working on three major aspects to shape a holistic healthcare ecosystem for the nation:

• Awareness (improved disease awareness and continuous dialogue with healthcare professionals and policymakers),
• Access (a bottom-up approach to enable early detection and a state-specific action-oriented approach starting at the grassroot level)
• Advancement (R&D and innovation for new and simplified product and therapy development addressing specific patient needs)

How important is India in the company’s global strategy? What are the growth plans of the company for the next three years? What is the roadmap to achieve them?

India is a key market for the company’s global plans. In terms of diabetes alone, India houses over 100 million people living with diabetes.[1] This is expected to grow to over 125 million by 2045.[2] Additionally, the number of people living with obesity in India is likely to be around 160 million by 2030.[3] These figures are alarming and underline the need for robust solutions, tailored to the needs of Indian population.

The company is planning on launching two important products in the coming years-

• potentially the world’s first once-weekly basal insulin icodec for type 2 diabetes care
• once-weekly injectable for obesity, Wegovy

How has diabetes care advanced? Can you share some key learnings from your expertise in diabetes drug discovery and development?
Over the last 100 years, Novo Nordisk has been part of an advancement journey for diabetes care. Ever since the discovery of insulin, there have been consistent efforts to bring insulin treatment as close to normal physiological levels as possible. Today, we can proudly say that new generation insulins mimic normal physiology to an extent that a person living with diabetes can live a diabetes-free life. Moreover, the introduction of GLP-1 RA in diabetes therapy has brought another significant development in diabetes care.

It is important to acknowledge some pressing unmet needs. These comprise adherence to treatment regimen, initiation of insulin therapy, regular monitoring of glucose levels, fear of needles, etc. At Novo Nordisk, we are working on developing solutions that cater to these needs and help simplify diabetes care for people, without disrupting their lifestyle.

In this direction, we are developing revolutionary solutions for type 2 diabetes care-

• Insulin Icodec: potentially the world’s first once-weekly basal insulin. It has the potential to reduce treatment burden and to improve adherence via the once-weekly administration.
• Cagrisema: a fixed-dose combination investigational drug that combines cagrilintide and semaglutide. In Phase 2 studies, it has shown greater HbA_1c reduction compared to semaglutide or cagrilintide alone.

References

[1]Metabolic non-communicable disease health report of India: the ICMR-INDIAB national cross-sectional study (ICMR-INDIAB-17) – The Lancet Diabetes & Endocrinology

[2]Facts & figures – International Diabetes Federation (idf.org)

[3]World Obesity Atlas 2023

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How do you see the global digital health scenario evolving in India, given the vulnerability of our health data, yet the promise of health insights to drive better health outcomes?

Digital Health is now being used at different levels in the value chain and across the continuum of care. For seeking healthcare-related information, seven out of 10 people will search the internet, similarly for medical information. With Instagram becoming an advertisement platform for healthcare products and services, patients know more about technology-based solutions than doctors. 

When it comes to providers, they are still to accept the reality, but now, technology-based solutions are there for all the challenges healthcare faces. While this means that we have achieved a high level of technical maturity, the care providers’ competence is not up to that level. Also, there is a fear of data loss and patient loss with tech systems being hacked, and these fears are genuine and should be addressed. 

By 2025, I believe one of the four healthcare providers including doctors will be using digital health actively, and patients’ needs will drive this change. 

What are the policy initiatives we need for India to reap the insights of digital health solutions available today?

The Government has already made its intent clear in the National Health Policy 2017 about creating the Digital Health Ecosystem and has moved to institutionalising technology adoption in healthcare through ABDM. The National Health Authority is doing an outstanding job. We need to invest more and enhance budgets for ABDM, make ABHA numbers mandatory for seeking healthcare in the country, and allocate one per cent of the digital health budget for data security solutions. 

Against this backdrop, what are the highlights of the Global Digital Health Summit (GDHS), Expo & Innovation Awards 2023 scheduled for September 1 and 2 at Mumbai’s Jio World Convention Center? 

We are aware of the fact that there is a lot of excitement about digital health and emerging technologies, but people need the right guidance to help them decide and embark on their digital transformation journey. Out of every four CEOs in pharma and healthcare organisations I spoke with, I could see the excitement but also the lack of the granular knowledge to implement digital health. This Summit is to help the healthcare and the life sciences industry to discuss the solutions they can implement to boost reach and revenues and have better clinical outcomes. We have got in top global digital health leaders, doctors and hospital administrators from India who are implementing digital health and have benefitted from IT. We hope to demystify that technology requires large investments and also, for doctors, technology takes away the personal touch, and how we can better manage chronic patients in the digital age. This is the first healthcare summit that hosts a session with patients on their expectations from digital health. 

How does it take forward the learnings from last year’s Summit?

Last year, we focussed on a few critical questions like return on investment (RoI) in digital health, leadership, and segments to focus. It was a policy and strategy summit, and this is the solutions and implementation summit. We are discussing solutions to implement. 

What is the audience mix for the GDHS 2023 and what can they expect in terms of speakers, topics, masterclasses, actionable insights etc?  

The audience of GDHS includes senior officials of the Government, global leaders in digital health, three Presidents of Global Digital Health Associations, Presidents of the doctor’s federations and clinical societies, pharma industry CEOs, IT solution providers, hospital CEOs, and medical device manufacturers. 

Attendees will get definitive answers about solutions that can help in managing chronic patients, tools doctors can use to become smart clinicians, how small hospitals can leverage technology to increase reach and revenues without increasing beds, how the pharmaceutical industry can leverage technology across the value chain, how the pharmaceutical industry can leverage digital therapeutics and why should medical devices manufacturers focus on software more than hardware. We are also discussing speciality care in the age of intelligent medicine, the use of big data, artificial intelligence, and the importance of data security and privacy.

We are launching the SMART Clinician’s Suite and SMART Hospital Suite to help doctors and hospitals choose the most appreciate technologies. Also, we are launching the Asia Pacific Digital Therapeutics Leadership Alliance to grow the DTx Ecosystem. It’s going to be a historic summit.

Can you give more information on the concurrent Expo and Innovation Awards?

Expo is an experience lab for attendees who come from different parts of the country and across the globe to meet the solution providers and learn first-hand from them. This expo will feature products and solutions that doctors and hospitals can use for digital transformation. 

The Awards are for recognising innovative and scalable solutions. They are judged by a global jury chaired by Brain O’Connor, Chairman of the European Connected Health Alliance, and Dr Michele Griffith, President of the International Society for Telemedicine and eHealth. Awards are objectively judged based on the data provided by the applicants, and the jury is global, so, it is tough to get this award, but those who get it will mean that have a product or service that is of a global standard. I am really excited to see how many Indian companies win this award. 

Charting a digital health roadmap is different for healthcare organisations of varying sizes, from doctor clinics to nursing homes, and multi-speciality hospitals. India also has a huge government-funded healthcare ecosystem. How does the Summit address this reality?

The summit deliberations are outcome driven, and based on the deliberations, we are drafting the ‘Digital Transformation Roadmap’ document and making it available to the healthcare providers giving them guidance on how to move ahead with their tech adoption journey. This digital transformation roadmap will be from a patient life cycle approach, and it will apply to doctors, hospitals, and pharma companies; be it micro, small, medium, or large in size or scope.

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How is the industry’s approach to drug development transforming? What are the imperatives that led to this change? How is Waters aiding advancements in drug development?

A central aim in drug development is to create new molecular entities into commercially viable drugs useful in managing diseases. While there are significant obstacles to marketing new drugs, the past 15 years have shown an increase in the number of drug approvals. The Food and Drug Administration (FDA) approved an average of 43 drugs in 2014-18, compared to an average of 23 in the first decade of the century. 

There is no doubt that cell and gene therapies present some of the most exciting opportunities for emerging drugs. The medical field is evolving fast and toward the direction of treating diseases previously incurable using genetic manipulations and genome editing. Super expensive solutions (up to $3 million per patient), albeit truly innovative in nature, make these treatments unavailable to most of the world’s population. 

Many millions of people are vaccinated against COVID-19, thanks to a messenger RNA (mRNA) encapsulated within a lipid nanoparticle. These novel drugs are impossible to develop, manufacture, and bring to market successfully without the use of analytical technologies, such as liquid chromatography (LC) and mass spectrometry (MS) instruments, chromatography columns and data capture, and analysis software offered by innovative companies, like Waters Corporation. For decades, Waters has been a trusted partner to many pharma and generics companies operating in India, particularly for small molecule QA/QC. 

As the demand for biologics and biosimilar drugs grows, an even greater degree of analytical data is sought, which is one reason for our recent acquisition of light-scattering leader, Wyatt Technology. When we pair Wyatt’s multi-angle and dynamic light scattering technologies with Waters’ LC instruments, size-exclusion chromatography columns, and data capture software, we can deliver to our customers a richer set of data for large molecule drug development and QA/QC. 

How is technology ushering in new paradigms in pharma R&D? How is Waters utilising technology to accelerate and enhance processes in the life sciences industry?

Drug company R&D is constantly pressured to improve productivity, provide support across geographies, and navigate complex regulatory environments. To manage these challenges, it becomes imperative for the pharmaceutical industry to keep pace with emerging technologies, and adopt efficient and agile operating models. Looming patent cliffs on blockbuster drugs, a constrained pricing environment, plus the prospect of pricing reform (especially in, but not limited to, the US) means many companies are prioritising R&D productivity improvement and pushing to get more out of every dollar invested in R&D. 

Waters, a global leader in analytical instruments and software for over 60 years, is focused on helping to solve problems that matter for customers in the life, materials, and food sciences. Leading pharma companies are already experiencing the benefits of our support in the reduction in errors, faster cycle times, enhanced innovation, higher productivity, and better compliance.

In October of 2021, Waters and Sartorius began a collaboration to help bioprocess scientists accelerate clone selection and process development with new tools for testing and measuring the product quality of recombinant drug products produced in a multi-parallel bioreactor.

This collaborative work facilitated the transfer of bioreactor sample data and analytical results between Sartorius Ambr multi-parallel bioreactor platforms and the Waters BioAccord LC-MS system. By co-locating these instruments in upstream bioprocessing labs, analytical turnaround times were significantly reduced as compared to the more traditional process of sending out samples to core analytical labs for the data needed for point-of-need decision-making. By empowering process development scientists to generate process quality attribute (PQA) data themselves, we enable them to make decisions about which molecules to advance into pre-clinical development more rapidly.

 With our joint announcement on June 4, 2023, Waters and Sartorius entered a new phase of our collaboration, this time to support downstream bioprocessing as well. By combining the Waters PATROL UPLC Process Analysis System as an at-line process analytical technology (PAT) tool with the intensified bioprocessing operations of the Sartorius Resolute BioSMB multi-column chromatography platform, we can help optimise continuous downstream operations to reduce production costs (e.g., resin consumption), and effectively monitor and manage product quality.

Waters and Sartorius are committed to supporting biologics manufacturers with the best upstream and downstream process development and drug product quality analytical tools to ensure the efficient manufacturing of safe and effective drug products. Our collaboration will continue with those objectives in mind.

Waters recently acquired Wyatt, a provider of light scattering and field-flow fractionation technologies. How will it enhance Waters’ capabilities to serve the life sciences market in India? 

By expanding our analytical capabilities beyond what LC-MS can provide alone, Wyatt brings new expertise and stronger data to novel modality applications which will improve our ability to help our customers solve some of the technical challenges in the development of biotherapies.

We know leading Indian companies are already using Wyatt light scattering technology, and the Waters-Wyatt portfolio will bring strong opportunities and leverage the existing direct and distributor presence. 

The biotechnology market in India has grown 14 per cent in the last year to more than $80 billion along with the offering of a strong CDMO presence. This aligns well with Waters and the expansion to customers with Wyatt’s light-scattering technologies. 

Any more interesting M&A in the offing? 

Waters is always looking at both organic and inorganic growth opportunities that can help us better serve our customers. We are excited by the recent acquisition of Wyatt Technology and the opportunities it can add to our portfolio. 

That said, Waters is investing to increase its technical expertise, capabilities, and reach into high-growth adjacent markets in areas that include bioprocessing, clinical diagnostics and early disease screening, sustainable polymers, and batteries.

What are the growth opportunities opening up in the pharma sector, globally and in India? How poised are you to leverage them?

India is known as the ‘Pharmacy of the World’, as the generic medicine supplier for over 200 countries, both developed and emerging markets. A large presence of local players producing branded generics, along with lower price levels, has provided India with a unique opportunity. Almost 50 per cent of drugs produced are exported and the remaining 50 per cent is consumed domestically. Pharma has learned to respond by producing large-scale drugs quickly compared to other countries. By the end of 2022, Indian pharma turned from volume to value creator. 

Waters has been a trusted partner to the Indian pharma industry during this time, providing liquid chromatography and mass spectrometry (LC-MS) technologies, and expertise that is vital to ensure quality and pre-release drug safety. Our instruments are widely deployed in pharma laboratories and contract manufacturers for QA/QC of small-molecule generic and large-molecule drugs. 

The biosimilar market in India is estimated to grow at 22 per cent CAGR to become $12 billion by 2025. The industry is looking for the identification of the right biologics or biosimilars to treat the next generation of auto-immune disorders, cancer, diabetes, rheumatoid arthritis, etc. In the coming years, approximately 10 biologic blockbusters will be released from the patent, creating enormous opportunities for Indian manufacturers of biosimilars to make the product most cost-effective.

With our acquisition of Wyatt Technologies, Waters India is well-aligned to support the industry as newer drugs and biosimilars are brought to market. When we combine Waters’ world-class LC instruments with Wyatt’s innovative light scattering technologies, we are positioned with vital products that biopharma companies use for discovery, product development, manufacturing, and QA/QC. Waters has an incredible opportunity as a strategic partner to the pharma industry to help India become a world leader in biosimilars. 

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What are the top three to five sustainability challenges in today’s pharma labs?

Several sustainability challenges must be addressed in today’s pharma laboratories to minimise environmental impacts and support a more sustainable future.

One of the most difficult challenges in pharma labs today is that they generate a significant amount of waste, which includes both hazardous and non-hazardous materials, which can have serious environmental consequences. Aside from this, improperly disposed of unused medications by consumers can contribute to environmental contamination and potentially harm wildlife. Whereas proper disposal of unused medications, as well as initiatives to reduce packaging waste, chemical waste, and improve recycling programmes, will aid in pro-actively addressing this challenge.

Like many other industries, pharma labs contribute to greenhouse gas emissions and carbon footprints through their energy use, transportation, and waste management practices. The day-to-day operation of these laboratories requires a substantial amount of energy and water, and many still rely on fossil fuels for energy. Overall, pharma labs must reduce their consumption of water and transition from fossil fuel-derived to renewable energy sources to mitigate significant environmental impacts.

According to one of our global customer surveys, 85 per cent of pharma labs and organisations already have sustainability goals in place, and 83 per cent of pharma lab leaders believe their current workflow needs to be optimised to meet their sustainability goals.

What are the quick ways to diagnose/find and address these sustainability issues? Especially those related to excessive water and energy consumption, waste generation by biopharma labs etc.?

To meet sustainability objectives and comply with regulations, biopharma laboratories can adopt sustainable practices such as waste reduction, energy-efficient processes, and environmentally friendly operations. The laboratories can utilise equipment and instruments designed to be environmentally friendly. This can include equipment with low energy consumption, energy-efficient HVAC systems, and eco-friendly materials. By monitoring these practices, they can identify areas for improvement and make timely adjustments.

In addition, these laboratories can create active pharma ingredients (APIs) and finished products that are designed to be more sustainable and environmentally friendly. This may involve the use of eco-friendly raw materials, green manufacturing processes, and eco-friendly packaging. Furthermore, they can reduce the pollution caused by their products and processes by maximising the use of raw materials and minimising waste production.

What have been the outcomes of Agilent’s commitment to sustainable lab practices? What did it cost to achieve these outcomes?

At Agilent, sustainability is a top priority for our product development and manufacturing processes. In 2020, we began partnering with My Green Lab to advance our sustainability efforts. This partnership started with select Agilent instruments being independently audited for the organisation’s Accountability, Consistency, and Transparency (ACT) Environmental Impact Factor Label. Since then, our collaboration has expanded to include participation in the My Green Lab Certification programme, and we are proud to have achieved the highest level of sponsorship, known as the “Angel” level. Our commitment to sustainability through collaboration with My Green Lab demonstrates our dedication to promoting environmentally responsible practices in the scientific community.

Can you give details about Agilent’s partnership with My Green Lab and ACT and the objectives?

Agilent is committed to promoting environmental sustainability and as a key example, has formed a partnership with My Green Lab to help accomplish this objective. Initially, we began by partnering with My Green Lab on the organisation’s ACT Environmental Impact Factor Label programme. The ACT label provides information about the environmental impact of manufacturing, using, and disposing of a product and its packaging, enabling purchasers to make better informed, sustainable choices.

In 2021, we became a proud sponsor of the My Green Lab Certification programme, the gold standard for best practices in laboratory sustainability. Our sites in Waldbronn, Germany, Cheadle, United Kingdom, and Santa Clara, California, have achieved the highest level of certification – ‘green’. This certification demonstrates our dedication to enhancing the environmental sustainability of our global internal laboratory operations.

What are some of the basic sustainable practices that can be adopted at pharma manufacturing plants?

Energy efficiency: Improving energy efficiency by using energy-saving equipment, optimising processes, and utilising renewable energy sources, such as solar power, can reduce carbon emissions and help lower energy costs.

Water conservation: Implementing water-efficient equipment and processes, and recycling and reusing water can help conserve water resources, reduce wastewater discharge, and lower water costs.

Waste reduction: Adopting a zero-waste approach by reducing, reusing, and recycling waste, and properly disposing of hazardous waste can significantly reduce the environmental impact of pharmaceutical manufacturing.

Sustainable sourcing: Choosing sustainable and environmentally friendly materials, ingredients, and suppliers can help promote sustainable practices and reduce the environmental impact of pharmaceutical manufacturing.

Green chemistry: Using green chemistry principles, which focus on reducing or eliminating the use and generation of hazardous substances, can help promote sustainable manufacturing practices.

Life cycle analysis: Conducting life cycle analyses to identify the environmental impact of a product throughout its life cycle can help pharma companies make informed decisions and promote sustainable practices.

Adopting sustainable practices at labs or manufacturing plants comes at a cost. How can pharma companies justify these costs as investments with ROI beyond it being the right thing to do for future generations on this planet?

Multiple reports suggest that research laboratories consume up to 10x more energy and 4x more water than office spaces, which can impact not only the efficiency but also the productivity of the laboratory. To combat the same, most pharma and life sciences companies have their own sustainability goals in motion. At Agilent, we believe that sustainability, productivity, and efficiency can co-exist in a lab without compromising on ROI.

In addition to basic cost-saving measures such as turning off lights and machinery when not in use, lab spaces can benefit from new energy and waste reduction methods and systems that are already available. Although adoption of these technologies can be slow in regulated industries such as pharmaceuticals, it is crucial for companies to transition as soon as possible to reduce the industry’s overall environmental impact.

One way for companies to address sustainability concerns is by conducting independent audits through external organisations, such as My Green Lab, to track and manage the environmental footprint of their labs. Such audits will encourage other labs to adopt more sustainable practices and promote the industry’s collective commitment to reducing its environmental impact.

Pharma companies can also choose to purchase more environmentally friendly instrumentation, which have been assessed for their environmental impact and do not compromise on quality results. Also, they can gain a better understanding of the utilisation of their instrument fleet with digital tools like asset management, advanced automation, and internet of things (IoT) technology in order to maximise efficiency without necessarily purchasing more instruments, reducing both cost and carbon footprint.

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As one of the top pharmerging markets, India’s growth potential in this sector is huge. How is BioAsia India transforming to help India Pharma Inc unleash its true potential and optimise its growth opportunities?

BioAsia is a cross-sectional forum and is a gateway for people from the life sciences, biotechnology, pharma, medtech and healthtech communities to come together, connect and contribute on a larger scale. Since our inception twenty years ago, we have seen a constant rise in the number of distinguished, world-class participants from more than 50 countries. In its 20th edition, BioAsia has now established itself as Asia’s largest life science conference, thanks to the polished record and reputation we have gained over the years.

In the prior editions, BioAsia has provided the Indian Pharma community with a platform for more than 20,000 B2B, B2R, and R2R meetings through our global delegates. It has provided the Indian Pharma community with a pathway to participate with luminaries from 95+ countries, sign 250+ Letter of Intents, Bilateral Cooperation Agreements, and MoUs, share 30+ knowledge papers and policy recommendations and witness a rise in Trade and Investment to upwards of $2.5 billion.

What are the highlights of BioAsia 2023? How will it differ from its previous editions? Can you enlarge on the three most important value additions for the participants?

Leveraging the success of the event over the years, the 20th edition is being planned on a grand scale. The event is scheduled between February 24 to 26, 2023 at HICC, Hyderabad with the theme of “Advancing for ONE: Shaping the next generation of humanised healthcare.” The COVID-19 pandemic has shown us the power of collaborative effort and its impact when the whole life sciences ecosystem came together to contain the virus. The ‘Advancing for One’ event celebrates the same spirit and asks the question of how this can be expanded to solve the future healthcare crisis.  

The last two editions of BioAsia were conducted in a virtual format due to the pandemic and now with spaces opening up, we are glad the forum will be in-person this year. The participation in the virtual editions was high, but we missed the physical connection and presence of the participants. With that in mind, BioAsia this year will feature insightful sessions and discussions on disruptive technologies in healthcare, accessibility, and affordability of healthcare for all, supply chain constraints with the current geopolitical uncertainties, R&D and technology, among others.

Over the course of the three days, prominent industry leaders, distinguished scientists, researchers, and entrepreneurs will come together to discuss humanising healthcare and will hold constructive discussions on how cross-sectional ecosystems can be integrated, how disruptive technologies can be best utilised, and how we can drive quality healthcare with accessibility and affordability at the forefront in the near future. Centered around these three questions, we are sure the 2023 BioAsia forum will generate meaningful value addition for all stakeholders and participants.

Elaborate on Bio Asia’s role and strategies to create and sustain an ecosystem conducive to driving innovation in the Indian pharma/biopharma industry.

BioAsia has consistently played a crucial role in the development of R&D in the Indian pharma/biopharma industry right from its inaugural edition in 2003. The forum was able to attract world-class players from the healthcare, pharma, and lifesciences industries and connect them with emerging leaders in the Indian community. With the recent editions of BioAsia, we have been taking a step further and have brought in prominent government dignitaries, industry leaders (pharma, healthcare, and lifesciences), researchers, entrepreneurs, and academicians with the aim of closing in on the intellectual and resource gap and increasing knowledge share in the Indian pharma community.

This year’s event will be centered around the ‘One Health Approach’ (nexus of science, indigenous knowledge, and policy) and the journey toward achieving universal healthcare. During BioAsia 2023, speakers will address key questions like what it means to strengthen healthcare infrastructure, how technology can be used to increase access to healthcare, how to increase prevention-based healthcare, and how to solve the problem of innovative and sustainable financing mechanisms to support the overall development of healthcare in India.

What does the future hold for this industry event? How is it poised to evolve with the shifts that the life sciences industry is undergoing?

With every edition, BioAsia has been steadfast in improving participation by key stakeholders including the number of countries, companies, luminaries, academicians, and research scholars who participate. BioAsia is expecting more than 2,000 global leaders and delegates from over 50 countries this year. The 2023 event is organised with an aim to problem-solve Healthcare for All and hold cross-sectional discussions between key stakeholders. We will also delve into conversations about the use of technology to provide telemedicine, wearables and Metaverse.

How should the stakeholders of the pharma/biopharma sector work towards streamlining the regulatory environment and sustaining cost competitiveness even as they build next-gen capabilities to leverage existing and emerging opportunities?

The pharma/biopharma sector is highly regulated, and navigating the regulatory environment is critical for the industry’s success. At the same time, the industry must also focus on sustaining cost competitiveness and building next-gen capabilities to remain competitive and leverage emerging opportunities. However, there are few strategies that the stakeholders in this sector can use including collaborating with regulatory agencies to streamline the regulatory environment. Government of Telangana has commenced Life Sciences Advisory Board comprising industry leaders, academia and Government Officials, the objective of the board is to advise on the overall development of sector in the state, including regulatory changes required. Apart from this, life sciences and pharma companies can adopt various strategies such as investing in next-generation capabilities, usage of digital technologies, investing in learning and development (L&D) and more. These actions will help the industry take advantage of emerging opportunities and deliver better healthcare outcomes for patients.

lakshmipriya.nair@expressindia.com

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How is pharma R&D in India transforming? What are the imperatives that led to this change?

The Indian pharma industry has emerged as a key provider of generic medications to both developing and developed countries. The transformation of India’s pharma business along the R&D value chain indicates a significant change from medication importer to drug inventor. The Indian government’s industrial and technological policies as well as improvements in intellectual property regulation were critical in this expansion of R&D competence. The industry has followed a trajectory from duplicative imitation to creative imitation to rise along the value chain of pharma R&D. Finally, as patent law evolves, the sector is learning to create capabilities in innovative R&D rapidly.

On the other hand, R&D in India for export-oriented items is gradually catching up with other global corporations. In addition to the numerous characteristics listed above, severe regulatory requirements for submission of product dossiers for approval by respective agencies such as the US FDA/EMA/ANVISA have also played a significant role. We have good talent in India, and a majority of Indian companies serving these regulated markets have adequate infrastructure to do research and development, particularly for the formulation of medicinal goods.

From an evolutionary point of view, how has COVID-19 impacted the pharma R&D sector?

The pandemic has had a huge impact on India’s R&D across industries, especially with the pharma sector striving to be strong in this area of critical need despite several issues impeding its growth. For instance, lockdowns and other restrictions enforced to prevent the spread of the virus forced many R&D facilities and labs to stop or significantly reduce their operations and divert their resources towards addressing the immediate needs caused by the outbreak. R&D leaders also saw productivity falling due to working from a distance.

However, the industry demonstrated remarkable resilience in creating solutions to keep operations running during times of uncertainty. There were pharma players who were already performing good research for vaccination, and they cracked the formulation for COVID-19 vaccines in a relatively short time. This rapid development, subsequent clinical testing, and approval by the Indian drug authority demonstrated our capability and intellect.

Can you share some key learnings from your vast expertise to improve the current R&D scenario in India and help advance potential treatments?

The Indian pharma industry has come a long way in R&D development, innovation and government policies to encourage new products in the market. However, to compete with the global market and sustain its title as the “Pharmacy of the world” post-pandemic, the sector must create an inclusive environment for industry leaders and scholars to discuss the current situation and create a path for R&D advancement in the pharma sector.

One such aspect that will fuel this growth is new chemical entities (NCEs). I believe that we have talent in India to crack NCEs, but we need the right infrastructure, investment planning, dedicated research centres, collaboration between universities and industry, and the patience to get success, since NCE development may take 10-15 years.

How is technology ushering new paradigms in pharma R&D? Tell us about the pivotal technologies empowering and enabling pharma companies to improve and accelerate their R&D outcomes. How is Amneal utilising technology to accelerate and enhance the life sciences R&D pipeline?

As per the GlobalData survey in 2022, 70 per cent of the industry respondents anticipate ‘drug development’ to be the most impacted area by implementation of smart technologies.

Because of the challenges and disruptions caused by the coronavirus pandemic, pharma businesses are increasingly adopting cutting-edge technologies such as AI, AR/VR, Big Data, and Quantum Computing to produce personalised solutions, speed up R&D efforts, and alter the user experience.

Most importantly, regulatory agencies are also keeping pace with the speed of industry. Clear guidelines and direction have helped to get faster approvals. For example, Modelling and Simulation for prediction in Bio Study, Stability prediction using software, Design of Experiments, and Quality Target Product Profile (QTPP) based development have expedited the overall development work.

Amneal makes significant investments in high-quality facilities, equipment, technology, and expertise. A few of our more complex capabilities include long-acting depot technology for injectable products and microsphere/multi-particulate-based development and scale-up. The company uses the latest technology in both lab and commercial sizes, and is constantly refining its procedures across its production activities.

Tell us about the growth opportunities opening up in the pharma sector, globally and in India? How is Amneal poised to leverage them? What are your current and future areas of focus? Why?

Globally, the pharma industry is quickly expanding, and India is experiencing tremendous growth in this field too. The worldwide pharma market is booming due to factors such as an ageing population, rising affluence, and more access to healthcare. In India, the government’s emphasis on expanding access to healthcare and the local market is also contributing to the growth of the pharma business. Furthermore, India’s enormous pool of skilled personnel and relatively inexpensive labour costs make it an appealing investment.

Our mission at Amneal is to make ‘healthy’ possible through increased access to the latest innovations in essential medicines, and we aim to leverage the country’s growing offerings in the sector by placing a specific emphasis on innovating products that address the market’s unmet needs. The company is also leveraging these opportunities by developing complex generics, different dosages by repurposing the existing molecules, and working to develop new molecules.

lakshmipriya.nair@expressindia.com

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