As the resilience of life sciences companies continues to be tested, there is no dearth of technologies to strengthen the ecosystem. But do pharma honchos see enough value and ROI to onboard such systems? In the first of a series of thought leadership round tables, hosted by Express Pharma, as part of SAP India’s Industry Knowledge Exchange (IKEX) Series, in partnership with the Indian Pharmaceutical Alliance (IPA), life sciences leaders share insights on major pain points and some solutions

With a perfect storm of virus variants, geopolitical instability and stagflation, and much more, brewing, how do life sciences leaders transform their enterprises into more resilient and flexible entities?

Continuing the partnership with the Industry Knowledge Exchange (IKEX) Series, in association with the Indian Pharmaceutical Alliance (IPA) and SAP India, Express Pharma is organising a series of Thought Leadership Round Tables for pharma leadership across key functional areas. The aim is to understand their concerns and search for collective learnings and synergies.

Focusing on the theme, Driving Business Innovation in Life Sciences, the consensus at two recent engagements, (Bengaluru, May 11, 2022, followed by Mumbai, May 19) was that though the sector is faced with a plethora of opportunities, the challenge is to choose the right one, and the right path, to maximise chances of success.

Leaders at the Bengaluru round table spanned contract research (Dr Mahesh Bhalgat, COO, Syngene), big biopharma (Krishna Sai T, Head IT, Biocon), contract biopharma manufacturing (Sanjay Lodha, VP – Operations, Kemwell Biopharma), as well as supply chain and operational heads from pharma (Rajesh Kshirsagar, COO, and Jitendra Patel, Supply Chain Head, Micro Labs and Shailesh Siroya – Managing Director, and Bharath Bhushan D V – M&A and Investor Relations, Bal Pharma).

Round 2 in Mumbai had a similar mix, with stalwarts like Arvind Agarwal, CFO, Ajanta Pharma; Nihar Medh, Sr VP SCM, Global Head of Procurement, Cipla; Rohit Chugh, Head -Digital Transformation, Sun Pharma; Manish Kishore, Global Head – IT, Wockhardt; and Pankaj Agarwal, Operational Excellence, Lupin with Sudarshan Jain, Secretary-General, IPA giving an industry overview on recent policy interventions.

From challenges …

Supply chain and operational heads like Lodha of Kemwell Biopharma spoke about the disruptions of the COVID-19 pandemic, when India’s dependence on consumables like filters and raw materials crucial to the production of COVID-19 vaccines and other bio-therapeutics, created a backlog in production schedules and increased costs. The uncertainty of supplies and increase in freight surcharges, sometimes upto 12 per cent of the value of the consignment, led to the realisation that manufacturing of these inputs, be it equipment or ingredients, needed to shift to India.

However, this is easier said than done. Veterans like Agarwal of Lupin pointed how setting up API plants in the country has been next to impossible, resulting in India’s dependence on imports.

Micro Labs’ Kshirsagar spoke of how lead times increased, as pharma companies cannot change vendors as easily as other manufacturing sectors, due to regulations. The shortage of shipping containers continues even today, with delays of 45-60 days. His colleague Patel recalled how input costs increased prices while Bal Pharma’s Siroya commented on how the volatility impacted the ability to quote rates in tenders.

All spokespersons agreed that the regulatory diktat to trace the route of synthesis of each ingredient, after the nitrosamines linked to cancer were found in some input ingredients, added another layer of challenge. Supply chain disruptions constrained pharma companies to search and switch vendors.

Talking about the challenges of using digitisation strategies to meet these challenges, Biocon’s Krishna Sai pointed out that this magnified the need for documentation especially when companies change vendors due to scarcity. In the same vein, Wockhardt’s Manish Kishore highlighted the impact of dead inventory in the supply chain and the need to connect 3PLs across the chain.

… to innovative collaborations

But these constraints led companies to dig deeper for insights to find a way around these blocks. For instance, Dr Bhalgat spoke about how technology can be used to understand which ports are less congested than others so that supplies can be re-routed. He also commented about how technology is also being used for looking at equipment efficiency and making equipment monitoring automated and round-the-clock therefore permitting early interventions.

As companies chase limited input ingredients and the like, Medh pointed out that while companies continue to compete, the benefits of collaborating to sort out supply chain issues could perhaps be one of the biggest learnings of the pandemic.

Chugh highlighted that achieving scale, compared to peers in countries like China, was another big challenge. He also emphasised on the use of new technology- blockchain which holds a lot of promise in the pharma value chain to address the issues of counterfeit medicine and provenance. The overall thought process of implementing ‘digital transformation’ and how to bring about cultural change was debated.

Agreeing with this analysis, Ajanta Pharma’s Arvind Agarwal opined that unless large pharma companies collaborated with smaller ones, they would not be able to achieve scale. In the same vein, Kishore pointed out how collaborations with start-ups and smaller players could help India meet global pharma requirements.

From his perch as IPA Secretary-General, Jain highlighted that coordination and collaboration between companies and associations have been the hallmark for ensuring a consistent supply of medicine during the COVID-19 pandemic. Although all the companies aggressively compete in the marketplace, they have been sharing the learnings in terms of the safety of employees, digitalisation, common supply chain issues encountered during the pandemic and the situation in different parts of the country. They have been also coordinating closely with the ancillary industries and channel partners. The government has been a great support during this unprecedented time. All issues related to availability have been dealt with at high speed. This has been transcribed as a case study with IIM Ahmedabad.

Jain reiterated that we should leverage the learning going forward in the interest of public healthcare. Initiatives to supply medicines to Sri Lanka, Ukraine and Russia, is a great example of Indian pharma companies playing an important role in access to medicines. India can bring savings to healthcare systems across the world through the supply of affordable quality medicines. Recent FTAs with Australia and UAE are steps in the right direction. Going forward, he opines that digitalisation will play an important role in building productivity and efficiency in the supply chain and overall company operations.

Tech as an enabler

Commenting on the role of technologies, Lodha conceded that there were many technologies – both software and hardware- available, but obsolescence was a major problem. Replacing tech every 4-5 years made them prohibitively expensive. Krishna Sai too agreed with this assessment, that most tech needed to be replaced every 3-5 years but spoke of the benefits of harnessing the data for predictive analysis.

In the battle for resource allocation, justifying the value of technology to finance heads /CFOs is a tough sell. While leaders can sell on compliance, Dr Bhalgat pointed out that making a business case for tech spend should ideally package the cost as a value, which is possible if the benefits are clearly quantifiable.

While Kshirsagar threw up the need to integrate data across all manufacturing systems through Electronic Batch Records (EBRs), Siroya spoke on how high attrition meant that companies had to constantly train new recruits.

The threat of a limited talent pool was discussed at the Mumbai round table too, leading Medh to predict that companies which have been able to deploy technology, will be able to retain talent better.

The subtext of many conversations at both round tables was maintaining the delicate balance achieved during the pandemic, when companies pooled resources, whether it was to meet surging demand for COVID therapeutics or liaise with policymakers. And companies are aware that they need to continue to look for synergies. For instance, Medh suggested further areas of collaboration like using common vendor audits.

Companies like Sun Pharma are already harnessing technology, and Chugh gave an overview of how his company has digitised secondary sales data to gain visibility of stock beyond the factory gate.

Show RoI and benefits

Giving a CFO’s perspective, Agarwal of Ajanta Pharma referred to the benefits of digitization of inventories, suggesting that the pharma sector can learn from other sectors, especially FMCG, one of the first sectors to embrace this approach.

Given the stress on margins and the inability to pass on costs to the end-user/patient, many participants wondered if India could afford to continue to be the low-cost pharma manufacturing destination of the world. The answer would be to scale up fast, using smart technologies to do more with less.

Given the theme was Driving Business Innovation in Life Science, tech experts from SAP India like Sudakshina Ghosh, Industry Business Architect, Team Lead, Industry & Customer Advisory Practice, SAP India, Rajesh Kuppuswamy, Life Sciences and Health Care Industry Advisor, SAP India and the team from Tenthpin Management Consultants gave an overview of how pharma companies can transform their organizations into intelligent enterprise by achieving value with intelligent ERP systems

SAP’s Kuppuswamy gave examples of how SAP is incorporating user feedback to build India-centric solutions using the SAP global ecosystem, co-developing solutions with strategic partners like Tenthpin Management Consultants who have complementary expertise in niche areas.

Further expanding on this partnership, Raghuram Janapareddy, Partner & Managing Director India, Tenthpin Management Consultants who moderated both engagements, supported by team members Rama Rao Jupelli and Vishal Pratapwar, explained how SAP along with Tenthpin is building a comprehensive life sciences eco-system for collaborative innovation, wherein they invite pharma companies to be part of an advisory council to identify common business requirements and build them in a collaborative manner.

Tech solution providers like SAP and their partners like Tenthpin Management Consultants are building robust cloud-based business solutions needed by pharma companies, hoping to get more companies on board and help them find ways of harnessing their strengths.

But given the constraints, will more pharma companies invest deeper in such technologies, with an eye on future gains? And do they have a choice, if they want to not just survive, but thrive and move to the next level?

Express Pharma, SAP India, and IPA look forward to continuing this dialogue with pharma leaders at forthcoming round tables. Watch this space for more insights!

Siesmic shifts in life sciences

Resilience of the Supply Chains are being stretched to the boundaries, with multiple external factors, which are changing dynamically every day. Shorter delivery time lines, varying demand for new drugs, Expiration of stocks, theft & counterfeits, loss of potency due to failures in expected controlled environment, geo-political situations, natural calamities, etc. are impacting the supply-chains.

Inbound Logistics: The recent Pandemic has exposed the inbound supply chain challenges extensively. Shortage of APIs, extensive delays in shipments, numerous quality check for onboarding new vendors, ever-changing prices for the raw materials, raising costs etc. are impacting the supply of raw materials and intermediates for manufacturing.

Production (Manufacturing): The manufacturing process is becoming more and more complex. Distributed Manufacturing, Customized batch sizes, complexities in labelling requirements, batch traceability, cold chain monitoring are some of the challenges that pharma companies must handle. The manufacturing lines are not geared up for varying batch sizes. Capital investments are a deterrent for investing in flexible manufacturing machinery.

Marketing, Sales and Distribution (Outbound Logistics): With extreme competition and growing demand for generics, economic crisis in few countries and inflation effecting the consumer buying behaviour etc. are putting extreme pressure on the pharma companies for the growth, and sometimes their sustenance. Spurious and counterfeit drugs are compounding these woes. Due to these dynamics, it takes a lot of time to recover the investments into the R&D, which impacts the profitability and cash flow.

In addition, the involvement of multiple external players such as, Third-party Packing Agents, Logistics depots, Cold Chains service providers, 3PL, Export agencies, Airports, Ports, Customs, Marketing Agencies bring their own complexities to the outbound supply chain.

Quality and GXP: With intense scrutiny from the regulatory, changing international regulatory compliance requirements, constant surprise inspections, need for submission of enormous amount of documentation and data, expiring IP timelines are some of the macro challenges that Pharma companies are facing. In addition, there are also need for maintaining the books and records for the internal quality processes, need to prove the compliance to the SoPs and Quality Management System, managing the quality compliance by the external partners such as CROs, ensuring constant quality surveillance to avoid DS/DP expiry, managing the batch genealogy, proactive quality surveillance are some of the challenges the companies face.

(Source: Tenthpin Management Consultants)

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Take us through your journey in the Indian as well as the global pharma industry.

My journey in the Indian pharma industry started with Ranbaxy Laboratories. After completing my PhD from the National Institute of Immunology, I wanted to be in academics and research. However, life had something else in store for me. I reluctantly joined Ranbaxy, but ended up spending more than 20 years in the industry, of which 12 years were at Ranbaxy and 11 years were at Dr Reddy’s Labs. At Ranbaxy, I was one of the few who started the NDDS team and initiated 505b(2) development for the first time in India. Later on, I took an internal transfer to the conventional generics team.

After 12 years at Ranbaxy, I switched to Dr Reddy’s Labs in Hyderabad. The first eight years at Dr Reddy’s were with Proprietary Products BU and we were mandated for pharma product innovation. Products were being developed for the US market. In a short time of eight years, the team developed, filed and got approval for seven innovative pharma products through 505b(2) regulatory path, not an easy achievement for a company of our size and resources. All the seven products got approval in the first cycle of review with the US FDA. Later, we also worked on multiple innovative products for India and EM. During this period, I had an opportunity of multiple F2F meetings with global regulatory agencies like the US FDA and MHRA.

While at Dr Reddy’s, I also got an opportunity to attend and complete ISB-Kellogg Global Advanced Management Programme and multiple DRL’s signature “Annual Leadership Summit” at Boston where we were taught by HBS professors in classroom settings. The later part of my work with DRL was spent in establishing a dedicated R&D team for Emerging and India markets called BRaIN (Branded and Innovation).

Both Ranbaxy and DRL provided me with extensive global exposure. I got the opportunity to travel and work with partners and teams in the US, France, the UK, South Korea, China, Russia, Japan, South Africa, Netherlands, Romania and Sweden. This helped me develop a global perspective on the pharma business.

Experience with Ranbaxy gave me the opportunity to build strong technical competence with great execution skills. It taught us to hold the bull by the horn and not run away from problems and looking for long-lasting solutions. Stay and training at DRL helped me become a mature leader with a global perspective. I could develop great soft skills, essential for leadership roles.

After having spent more than 10 years with DRL, and more than 20 years in corporate pharma, I was looking for a more impactful role where you have the opportunity to contribute to activities which can create a long-lasting impact on society. The current role as Secretary-cum-Scientific Director of the Indian Pharmacopoeia Commission (IPC) gives me that opportunity. Our interventions help improve and maintain quality of medicines being sold in the country. It directly touches millions of lives on a daily basis.

It’s been over a year now since you joined IPC. Tell us about all that you have achieved during this stint.

A lot has been achieved in the last one year. First and foremost has been the change in mindset. The organisation has become more receptive and open to stakeholders. Customer-centricity has improved. We created a platform on Telegram – IP Discussion Forum, with a current membership of 850 members, mostly from industry and majorly from MSMEs. Members are resolving their issues and doubts instantaneously. The best part is that solutions are coming from members only. IPC is facilitating the discussion on the platform. Accountability has increased at every level, team members are answerable, and decision making is data-driven and faster.

On the pharmacopoeia side, the inventory of Impurity Reference Standards has grown by 70 per cent, 165 to 277, the highest increase in any single year since IPC’s inception. Multiple awareness programmes, some of them in collaboration with organisations like USP, SMPIC on pharma quality are being conducted for customers. On an average, once a month, I am personally speaking on one or the other platform on pharma quality, issues and probable solutions for India. Offtake of IPRS is improving, which is an indicator of increasing quality cautiousness among manufacturers.

IP is on its way to becoming at par with other leading global pharmacopoeias. We are introducing dissolution specifications in the Prolonged Release Formulation monographs, which was not there till now. For the first time, we are implementing “Flexible Monograph” policy in IP. There is an increased focus on the veterinary part of IP. We have a new Veterinary Expert Committee working, that is aligned with IPC’s methodology and frameworks. We are initiating the development of digital IP. If everything works as per plan, we should be able to launch digital IP during the current year, 2022.

On the pharmacovigilance side, we have demonstrated significant growth on all the growth indicators. The number of AMCs has increased from 346 to 530+, the highest increase in any single year since the start of PvPI. The number of adverse event reporting has grown. We initiated the celebration of the National Pharmacovigilance Week (17th to 23rd September) for the first time, and it is going to be an annual phenomenon from now onwards. The number of centres for MvPI has grown three times, and so has the adverse event reporting in the medical device domain. There is a new energy in the system. It is just the beginning of IPC phase-II.

What are the major targets that you wish to achieve during your tenure here?

During my tenure, I wish to bring IP at par with leading pharmacopoeias of the world like USP, BP and EP. We want to start few applied educational programmes which will supplement our quality improvement goal. We also want to become source of trained manpower for the pharma industry, especially in analytical and quality domains. We want to initiate structured research programmes in the quality and regulatory domain. We would like to start PhD programme in these areas. If you search for an institute which can be identified with their contribution in the pharma quality domain, it is difficult to find. Whereas, for other specialisations like dosage form development, pharmacology, medicinal chemistry, phytochemistry, etc, you can easily find researchers and institutes both. We have to fill this gap if we have to address the problem of medicine quality in this country.

On the pharmacovigilance/materiovigilance side, we want to graduate from a data collection and regulatory recommending agency to larger healthcare data analytics centre. We want to use the adverse event data for more use and benefit of the society. We want to increase public awareness about the pharmacovigilance programme whereby patients and their family members start reporting the adverse events on their own and not get influenced by practitioners. There is a lot to be done.

Since you have been a corporate leader for years, and now you are on the other side of the fence as a policymaker. Do you see yourself as a bridge between the pharma industry leaders and the policymakers? Since you might be aware of the challenges faced by both the sides, is it going to help in designing better policies for the pharma sector?

The answer is yes. My experience and exposure is already being used in multiple policy initiatives. My presence in the government system is helping by presenting the customer’s perspective.

What have been your key learnings in the past one year? Any change that you wish to bring in IPC as an organisation?

The past one year has validated many management and leadership concepts. Irrespective of corporate or government, these concepts work everywhere. Some of them being: it is important to ask the right questions in any system; to work with “keep it simple” approach; delegation; lead by example, if we demonstrate then only we can demand, etc.

At IPC, there was a strong foundation built in the last 10 years. We are trying to build next-level IPC over this strong foundation. The IPC of the future will be more open and collaborative — a knowledge-generating centre, place to look towards for “quality and regulatory” advisery and a partner in improving pharma quality in this country and beyond.

Apart from the pharma domain, what other areas interest you?

Spirituality, leadership development and organisational building.

What is the one thing that always motivates you to keep following your goals – be it professional or personal?

“You are here to support life.”

akanki.sharma@expressindia.com
journoakanki@gmail.com

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We are observing a paradigm shift in the pharma/healthcare sector. Being on Abbott’s board, did you witness any positive disruption in the company/industry due to the pandemic?

Yes, absolutely! Pharma and healthcare as a sector was put on spot due to the ongoing pandemic and I foresee at least for another decade or so that this sector is going to get unprecedented focus. The COVID-19 pandemic has changed the way we used to live. Healthcare has become the centre of our lives because of the dependency the pandemic has created. We are now dependent on the pharma industry for our day-to-day well-being. Every company had to reinvent itself overnight to be able to manage the pandemic. Being part of the essential services, the pharma companies had to ensure that their manufacturing facilities were operational as was the supply chain, to ensure continuous access to medication. While the government was asking the masses to lock themselves and the people were fearful of getting infected, pharma companies had to address their employees and ensure that they remain motivated to come to work and deliver.

Abbott took good care of its people in providing them a healthy environment, good hygiene, testing, kits and anything else their employees needed to be able to come to work to keep the manufacturing and operations going. There were other challenges too – field operators not being able to have physical meetings with the doctors and many non-critical illnesses requiring surgeries being postponed, in turn, affecting the normal course of business. Abbott used this time to bring in digitisation, streamline and become an even more robust company and be future-ready. The Managing Director steered the company well with the support of its people and Board through the pandemic. This was a true test of the leadership skills of the management team and they excelled.

You had a long stint in Africa in the beginning of your career and you worked with the government on several projects. Did that background help you to shape your career later?

I started working when I was 21 and I began my career in Africa. Twelve years of these foundation years of my career spent in a different continent influenced me tremendously as a professional. I became a mature adult during this phase of my life. It helped me to understand and appreciate different cultures, different ways of life, different belief systems and different thought processes, and I realised that there is nothing good or bad, it’s just different.

 I learnt the true meaning of equality when my first official dinner at the only five-star hotel then had the company driver and the receptionist on the same table as the CEO and the senior management team.

Africa gets a large number of volunteers/expatriates from different nationalities to come and work there. I worked and socialised with this diverse set of people, apart from the locals – Germans, Swedish, Brits, Americans, Chinese, Sri Lankans….the list is endless. Working with this diverse set of people taught me different work styles and varied cultures. I was also exposed to the diversity of India in Africa. The Indian community was a small closely-knit group of people from Gujarat, Kerala, Tamil Nadu, Punjab, Uttar Pradesh and a few other states, and while we had many similarities, we had many differences too.

Botswana is a matriarchal society. A large part of the senior staff were women there. All my bosses were strong women.

Women held top-notch positions across industry, government and social enterprises. There were women all around – strong educated women – who were part of policy formulation, decision making and implementation. On my return to India in the late 90s, I was surprised to see that we hardly had any female representation among the corporates and a handful of women were in leadership positions.

I had a personal tragedy, and I had no family around me to support me. I learnt that no matter what we say or think, no matter which part of the world we are in, human behaviour, at its base, is intrinsically similar. The compassion, care, empathy and support that I got was from across all these nationalities. I learnt that the basic goodness of human being has nothing to do with race, caste, colour or creed.

You have worked with government and corporates, and now you are an entrepreneur. How would you categorise your experience for each of them?

All three roles are very different and you realise it only when you are a part of it. The government gives you a large canvas and scale at a very different level. The work one does, impacts a large segment of the society. The decisions taken have a long-term effect on its population. Hence, things move slow. Pros and cons are discussed, large committees are set up and everything is looked at minutely from various angles and perspectives. Fortunately, I worked with the government of a rich country, and, therefore, didn’t have to face the challenge of delivering services with limited resources, which the governments of many developing and under-developed countries face.

In organisations, you realise, in comparison, how fast things move. It’s a contained environment. You can witness the effects of your decision-making within a few years, sometimes on a quarter-by-quarter basis. You witness the impact of your work every year in the company’s results. In my corporate life, I had to reframe my thinking from looking at the company and its employees first, and then, the larger community and other stakeholders.

Then, when you start your entrepreneurial journey, you realise, despite the success and despite being known, you have to begin all over again. You lose a chair and everything goes with it. You don’t have the large ecosystem to support you. It’s stressful. Suddenly, everything is dependent upon one individual, i.e. you. So, that’s when the realisation kicks in on how difficult it is to be an entrepreneur. Getting good talent and skills becomes challenging as you cannot pay them that much when you are starting on your own. It is a difficult journey, but a beautiful one as you get to do what you want to do. You can create and draw the picture you want. That has a different high.

You are a distinguished woman leader. You serve on the Boards of various reputable companies and work with various reputed companies on transformation projects. How did you utilise the challenges/opportunities to your advantage?

I work on change and transformation projects and because change takes time and doesn’t happen instantly, most of my projects run from anywhere between a few months to a few years. When you need to move a group of people from their existing state to the desired state, they will only do so if they find value in it for themselves or if they fear they will be left behind if they don’t change. It requires working at the individual level as well as at the company’s level. One needs to look at culture, structures, systems, processes, the changing market dynamics, the existing skills and gaps, and be prepared to alter approaches as he/she navigates through the maze. I strongly believe that the solutions lie within the companies that I work with.

My role is that of a catalyst to help them find these and understand the need to change. I have been successful in making people move towards the desired state. I thoroughly enjoy my work as there are always challenges. When you say something needs to be changed, that has been working fine for the organisation, your decision gets challenged and you have to justify, why? Over the years, I have realised that if you have good and sustained communication, provide simple logical reasons, can show the direction and the end objective or purpose, change happens.

You are an advocate of gender parity at workplace. What is your perspective on the best practices for a diverse board composition? 

For me, a diverse board is the one that has all the components of diversity – gender, skills, knowledge, age, thought processes, personalities, etc. In my view, when a company makes board selection, it should consider all these. A board should be a culmination of various functions like marketing, human resources, legal, finance and subject matter experts to supplement and compliment the experiences and skills that the company management possess. In terms of gender diversity, a Board will be truly diverse if it has 50 per cent women as that is representative of the society. Companies are built from the society and are there for the larger good of the society. As organisations, we have failed if we are unable to groom and bring up women that have leadership positions. We can move the women percentage up in the boardrooms and at the senior leadership levels only if there is true intent. I strongly believe that the women are Board-ready, but not all Boards are women-ready and the same goes with the leadership positions.

Sebi mandated to have at least one woman in the board panel. Do you think this regulatory nudge has sincerely changed the mindset of male-dominated corporates?

The government intended to promote gender diversity because the organisations themselves were not doing that. Government can help you nudge in that direction, but, finally, the ownership has to be taken by the corporates. The good news is that many organisations picked the “one woman director” based on merit and skills rather than infuse a family member. The sad news is that not many companies have gone beyond what is statutory and have more than one women board members. There are few progressive companies that have gone beyond, Abbott is one of them. It changes the Board dynamics and perspectives – you are seen as someone who has that seat basis your skills and the value add you bring to the table, and not a plug in because of a statutory requirement.

The lone woman Director needs to prove herself doubly and triply to be accepted at par with the other Board members. That apart, women and men look at issues differently. Having more women on the board helps bring in these diverse perspectives and not just a male viewpoint. Lastly, it brings some amount of discipline and decorum in the boardrooms and does not remain an old boys’ club. Irrespective of the gender, the biggest quality in a Board member should be to have the courage of conviction.

Being a Chairperson at the FICCI Women on Corporate Boards Mentorship Program, what was your vision and modus operandi?

The FICCI Women on Corporate Boards was started by Arun Duggal and Anjali Bansal and I was fortunate to have been given the opportunity to lead it. It was a beautifully-designed programme with a large number of promoters and CEOs as mentors. These mentors committed their time to mentor women for Board positions. The second piece focussed on inducting senior women leaders from various industries and functions as mentees. These women leaders were matched with the mentors who shared their Board experiences and prepared them for Board positions. There were various learning sessions conducted periodically to equip the women with all the technical, statutory and soft skills required to be an outstanding Board member. The biggest challenge was to help them find Board positions and I bridged this through my network and through FICCI.

Which women leaders’ work and contribution to the corporate world do you admire the most?

I respect Indira Nooyi for her work professionally and personally. She is on another level. We can learn so much from her the way she managed her personal and professional lives at the global level, keeping her values and humility intact. I also admire Kiran Majumdar-Shaw. I find her to be honest and speak up for things that are challenging, no matter what the repercussions. She does the right thing and not be always diplomatic. Another person I really admire is Renuka Ramnath as I have seen her journey from ICICI to being an entrepreneur. To be able to build an ecosystem, finding the right talent, being able to raise funds, being able to deliver and generate good returns year-on-year shows her capability that how brilliantly she has managed in a male-dominated environment.

There are many such professional women that I have deep respect for. Somehow, I may be a little biased towards the professional women who have done exceedingly well rather than the daughters/wives from family businesses. There is no doubt that these women too are doing exceptionally good work, but I feel they get a headstart as they have a platform to start with, whereas, professional women have to empower themselves to create the platform on their own, which is a treacherous journey.

You have co-authored a book and you are a coveted speaker. What do you enjoy more – writing or speaking?

I am a social person and I like speaking. I love to interact with people as you learn from the person you are interacting with and there is two-way learning.

Is there anything people don’t know about Shalini Kamath that you would like to convey through us?

The girls of my generation were taught to be good wives. We were trained on all housekeeping needs from cooking, cleaning, knitting, embroidery, stitching, etc. etc. etc…. I am proud that I also chose to build a strong career. I am grateful to all those who have played an important part in helping me build my career. I will always remain indebted to them.

Besides, the two creative pursuits for me are singing and cooking. I enjoy both tremendously.

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As sectors, pharma, lifesciences and healthcare are poised for major disruption and transformation. In your opinion, how have the Boards equipped themselves to help organisations navigate through this journey?

Indeed, pharma is undergoing a drastic transformation. Times like these have made us realise that the board of pharma companies are operating in a high-risk environment. Board is not just being a kind of steward where statutory and compliance is concerned, but also having an oversight on the overall business of the organisation. During the current pandemic, what became apparent is that two factors are critical – patient safety and employee safety.

Talking about employee safety, pharma was one industry that was at the frontline of all the crisis and making sure that you know you are not just taking care of your stakeholders, but you are also looking after yourself and your families. Many employees needed counselling, mental strength and perseverance, and the board of directors had to make sure that the organisations are doing that in the right earnest, taking care of their employees and their well-being. For me, this was an important thing that we observed, and pharma boards did it very well.

Coming to patient safety, pharma is a research-focussed industry. It is not that today you can do disruptive innovation just by sitting and coming up with ideas in a boardroom and expect to hit the ground running on execution. It requires years and years of research to come up with something that can be certified as patient safety measure, be it India or abroad, every country goes through its own regulations and norms. The kind of agility that was demonstrated by pharma companies was unprecedented. What used to take many years of deep research, was achieved in a short span of 12 months with cross-border knowledge collaboration. When I look at it, I think patient safety with the added advantage of speed and agility has been the benefit of pandemic and we saw different companies took on different responsibilities identifying their strength and core DNA of their business to deliver solutions i.e., the company on whose board I sit on, was very clear that they were focussing on testing kits and not so much on vaccine or any other thing.

So, coming back to the board responsibility, I think two things we had to ensure were employee safety and patient safety and motivate the organisations to intelligently use technology with science to deliver on both the aspects.

What is your idea of Diverse Board room composition?

Gender diversity has become mandatory by law, and it can be debated that we needed a law to enable this. For me, it’s a good first step and I am quite appreciative of the fact that at least something needed to be enforced for them to become a rule rather than an exception. But for me, diversity goes beyond just gender. Skill diversity is important to me. The kind of new skills that are emerging makes it important to have multi-skilled diverse board to be ready to face new challenges. Boards also have a stakeholder relationship committee, but it is restricted more towards the investors. In my view, inducting stakeholders on to the board, not in every meeting per se, but occasionally having a customer voicing, their perspective in the board meeting, will help the board to take an informed decision. Today, your customer is your stakeholder. So, having a customer’s voice on the board is going to become crucial.

Another important aspect is demographic diversity of the board. There used to be this myth that you need to have a mature, grey-haired profile to be worthy of the board because wisdom only comes with age. But, today, with a new whole start-up ecosystem and the entrepreneurial ecosystem, we are realising that it has its own strengths. The young-age leaders today keep themselves abreast with the current digital advancements and they have showed that age has got nothing to do with the wisdom. It has everything to do with the spirit of entrepreneurship that they bring to the table. So, for me, the demographic diversity is also important. I haven’t seen a lot of change happening by choice that you are not going out and seeking the demographic diversity, rather it’s happening subconsciously. I guess, over the period of time, it is going to happen. In many new-age companies, the shareholders and promoters themselves are, in any case, much younger than the board profile. So, it balances out.

You serve on various prestigious Boards like Abbot Healthcare, L&T and Welspun. Has Diversity, Equity and Inclusion (DE&I) become part of board culture? If yes, what kind of conversations happen around this subject?

Different companies have evolved at different levels, it’s not one formula. Family-run boards are different from global boards, and the global boards are different from entrepreneurial company’s board. So, this is a journey that, I am happy to say, has begun for everybody. They might be at different levels of maturity, but they have all started the discussion around the topic. We are seeing a lot of diversity mandates going to professional search organisations, where they curate and find the right profile with the right skills, which is a good evidence that at least on the skill diversity front, there is some action happening.

Inclusion and equity is a journey. Some boards are ahead of the others. So, currently, it might not be a proactive conversation that would be happening in many boards amongst other business-related conversations and challenges that board is grappling with because of the pandemic. But, if the topic of DE&I comes up for the conversation, there is a lot of positive intent to move in this direction and to do the right thing.

Besides DE&I, what are you most passionate about?

I am very passionate about brand and digital. I left corporate six years back when I started my journey of building my organisation “Storm the Norm.” It started with the book I had written by the same name. I have always lived by the principal that if you always go by the norm, you will only make incremental changes to your life, or to your business, or to your work or to anything you are doing. However, if you take a contrarian view and if you challenge the norms and the stereotypes, only then, you will do something disruptive.

Today, the work I am doing in the diversity space also comes from the same principal – that women lived with so many societal norms, like women are not meant for corner office, marriage comes before work, women are not supposed to demonstrate anger, etc., there are like hundred norms that women have lived with and some of them are self-inflicted. All my work in diversity is pushing women to challenge these norms. Why do you take it as given? Family before self, we have been living with these cliches and stereotypical premises which can’t be changed overnight, but at least start facing and changing them one at a time.

I think women feel guilty if they don’t attend to their family. I had quit my job to help my daughter with her studies and later, it took me almost one year to get back at one level lower. Mine is a very average girl life and people relate to it and think that if she could do it, why not us. Having said that, today’s environment is much tougher and if you give up, it’s not easy to come back. In today’s context, when I speak of my personal experience of 30 years in corporate world, dealing with the professionals and being the only woman in the leadership team in General Motors and Max Life Insurance for several years, I emphasise on what that means and how one makes his/her presence felt. So, all my talks on diversity come from my personal experience and people are able to resonate with it as it is real.

What helped you to land your first board role? How did you decide what’s the right board to join and what was your learning?

There wasn’t a plan like this, but I was keen to get on the boards when this whole thing started. I felt myself worthy enough to be on the board and that is very important. This is the first step that in your mind, you must know that you are ready for the board. First board for me was through the reference, that got validated and endorsed through what perception the larger world had about me and who had known and respected me for my work and skills. This demonstrated that, you can only expect the references to come through if you have invested in creating a personal brand for yourself. Even if a referral puts your name up, the company will do its due diligence in public domains and if you have not invested in creating personal brand in your domain area and you do not have a certain reputation, then the referral may not work in your favour.

Coming to deciding on which board to join, I only apply two filters – compliance and governance. I look for whether the company is well-governed and strong on compliances. I don’t look at the size of the organisation. I serve on the boards of mid-sized companies as well as the large-sized ones. I am also very diverse in industries because for me, my kind of skill is challenging the norms and I can apply it to domains and industries. I have never been choosy that I want to be on tech board or pharma board. Other important factors that I consider are, can I leave value on the table if I join the company? Is it a strategic board or is it a normal statutory tick mark board? For me, being on strategic board where you can add value and where there is a respect for the value that you add is of prime importance.

In retrospect, what would you have done differently in your corporate career?

I think I like speaking. I would have been a good professor. Even now, I like speaking, talking and I do host my own conferences and sessions and masterclasses. So, I would have been happy hosting my own classes, having my own academy. Even today, I feel that I can have my storm the norm academy and ask people how to think disruptively and out of the box.

What advice do you have for the next generation of board aspirants who are starting fresh on their board assignments?

Be a master of your skill – that’s very important. Today, you need to stand out, you need to be a stormer to get noticed. You might be good at your skill but are you standing out? You need to have something that differentiates you. Being the domain expert and continuously investing in staying relevant in your domain is a necessity now. You have to identify what your call is. Your call could be human relations, public policy, finance, etc., and within that call, what is your unique differentiator that the world needs to see. It is important that we are seen and heard today. If you have aspiration and ambition to go out in the public world, then you need to do something about it. You can’t just be doing great work with your head in computer all the time. Also, having some kind of inspiration and having a role model always helps because it propels your own ambitions.

Lastly, the most important thing that I want to tell the aspiring women is – women come with an expiry date syndrome on their career. It is something that I feel very passionate about and I talk a lot about. So, what I mean by expiry date is, even before you have started your first job, you put an expiry date on it thinking when I get married, my job expires. When my husband gets transferred, my job expires. When my child is born, my job expires. So, the job will expire, but the career will stay. So, if you are a job-oriented person, you will put an expiry date in your head but if you are a career-oriented person, the job can stall or end, but your career will continue. So, be career-minded, not job-oriented.

How would you describe your typical day? Outside work, what excites you the most?

First of all, I am a big TV buff. I do watch TV couple of hours every day that just numbs my mind from all the chaos. Otherwise, I have a very active mind. I am constantly thinking, writing, researching and reading. So, some hours of being passive where my mind is at rest helps me to work better.

Secondly, I like travelling – I am constantly planning trips.

Third thing which I like is being in awe of little things. I don’t look for big choice. If I see good weather and I see birds chirping, I do want to stand there for 15 minutes and do nothing and just be with myself. Even when I take holidays, I just sit by myself and gaze at the nature’s beauty. I like absorbing these little joys of life. These little joys give me big sense of gratitude to how much one has gotten in their life. I am an ISHA volunteer and follower, so, I have a huge impact of Sadhguru and his teachings on my life. Those things, I really value now.

The post Inclusion and equity is a journey appeared first on Express Pharma.

You are leading Cipla from the front, was joining the family business always a plan?

Before joining Cipla, I worked at Goldman Sachs as an investment banker for almost five years across their London and New York offices. I joined the firm right after completing my Masters at the London School of Economics.

My entry into Cipla in 2011 was at a time when the company was on the cusp of change. I took a call to switch over from my career as an investment banker in London to my family business here in India. Given that I had practically no experience in the pharmaceutical sector and that Cipla was also at a critical turning point, it was a big leap to take and a massive responsibility. But I saw it differently. For me, it was an opportunity to infuse fresh thinking into the organisation and refresh the existing mindset to lead it towards future growth. In hindsight, I couldn’t have asked for a more opportune time than that.

Coming from the founding family, did you face any stereotype challenges? What was your go-to strategy? 

While I was very happy to join the family business, I had apprehensions about foraying into a new domain. My first challenge was to develop a solid understanding of how pharma functioned as an industry. Consequently, I spent a lot of time with strong mentors to understand how the generics business runs.

When you are working for a company that has eight decades of legacy behind it, it is imperative to drive the organisation with a humanitarian approach to healthcare, keeping up with its legacy of caring for life and fast-forwarding its journey into the future. While I was empowered to transform the company through my position on the Board, keeping the purpose of Cipla, on which it was founded by my late grandfather Dr KA, intact, was also my priority. As a leader, having a clear-cut vision is essential. The bets that I undertook at the time may have been new to many within the system, however with conviction and a well thought through strategy it has today, led Cipla onto a new path of becoming a holistic healthcare solutions provider focused on wellness, instead of limiting ourselves to manufacturing medicines alone.

What disruptions do you foresee in Indian pharma, healthcare and life sciences sector? How is Cipla poised to ride the wave? 

The pharma industry has started evolving from its current role of being seen as traditional drug manufacturers, to an industry that is focusing on being holistic healthcare providers. Going forward, one of the disruptions we see is the shift from illness to wellness wherein patients are empowered about their health needs and are transitioning to a more preventive, and curative behavioural change. Pharma companies will have to re-imagine their roles in the lives of patients and play a larger part in their lives. At Cipla, we took major steps towards growing Cipla Health into a holistic wellness player. This business has achieved an all-around play across multiple, large OTC categories. Cipla Health launched an entire range of products including hand sanitisers, surface disinfectants, face masks, etc. to cater to the increasing market demand for hygiene essentials due to the ongoing COVID-19 pandemic.

The second disruption is embracing digitisation. In pharma, digitisation has not only played a crucial role in bringing about operational efficiencies and managing supplies but has also enabled more meaningful and convenient engagements with stakeholders. For instance, today pharma companies are able to reach a much wider base of doctors and patients beyond cities alone through the use of virtual engagement platforms. From a value-add point of view, we see digital as a tool that will empower each and every stakeholder in the healthcare ecosystem to actively participate along the care continuum. We recently launched an initiative ‘Healthcare Superstars’ that provides a unique virtual learning experience comprising of LIVE interactive sessions, global collaborations of, world-renowned speakers, interview and case-based learning for medical professionals.

Last but not least is access through collaborations. This pandemic is a great example of how the power of the collective has worked towards combating this crisis. Governments, public and private institutions and individuals came together and pooled in their strengths to strengthen the response to COVID-19. The pharma industry, in particular, came together in solidarity by forging global partnerships to make drugs accessible, some lending their innovations and others their manufacturing capacities and distribution networks. Cipla has been the partner of choice given our large portfolio of COVID-19 treatments through our multiple strategic partnerships with innovators such as Gilead, Roche, MSD, Eli Lilly and CSIR-IICT to provide access to life-saving treatments.

Building an inclusive, diverse and equitable workplace is on top of the agenda for most corporates today. Where do you position Cipla on this maturity curve?

Companies have a lot of scope to embrace a workplace that is not just diverse but inclusive. And this starts with inculcating a mindset shift, i.e., going beyond numbers play to bring about true equality. Gender equality and inclusiveness cannot be ensured by enhancing women representation alone but also introducing policies and initiatives that empower them within the system to effectively contribute to their roles. The right approach is to take steps towards inclusiveness. Additionally, it is equally important to nurture and chart out development for diverse talent at all levels within the organisation that will equip them to become leaders in the future. Gender diversity and inclusiveness should not be limited to the Board alone.

At Cipla, we strive to ensure that our people practices and systems are gender-inclusive. In FY 2019-20, we set up an Inclusion & Diversity Council, led by me, to give additional support to our efforts to build a truly diverse and inclusive workforce. It acts as an advisory body on all matters related to diversity and inclusion such as recruitment, leadership development, the launch of new initiatives, building a healthy work-life balance, and so forth. Maternity Leave, Paternity Leave, Adoption leave, Creche facilities, institutionalisation of POSH, initiatives like Meri Saheli (Women employees-only forum to share women related issues at the workplace), are some examples of the policies that we have in Cipla to build a more inclusive culture. We also recently extended our group Mediclaim policy to cover LGBTQ and live-in partners.

Building a diverse culture gives a competitive advantage? Your take on it, please.

An organisation with a diverse talent pool not only makes for good social sense but also makes for perfect business sense. Welcoming new thinking and developing a culture of looking at things from a fresh perspective and a refreshed lens definitely gives a competitive advantage to the company. With diverse mindsets at the table, the company can operate in an all-encompassing way rather than adopting a traditional approach to their decisions; which is necessary with the evolving times. For example, at Cipla, we are not just looking at the industry from a typical lens of how a pharma company exists. And one of the major benefits that we have seen by bringing in diverse talents, is that we have been able to evolve in our role beyond traditional notions of being a drug manufacturer.

In today’s world, talent is attracted to companies that are not just diverse but inclusive too, making these companies the ‘employer of choice’. Organisations that take that on the front foot in being inclusive and diverse are companies where employees have a sense of belonging, making them want to be a part of a company that is future-focused while having a strong sense of purpose.

What does future-ready organisation mean to you?

In my experience, a company that is ready to re-imagine their businesses to stay relevant in the evolving times, while staying true to their core purpose is a future-ready organisation. Cipla, being a part of an industry that is at the forefront of fighting the pandemic, we had to ensure an uninterrupted supply of medicines for COVID-19 and other illnesses despite the industry-wide challenges in raw material procurement, operations and logistics and subsequent nation-wide lockdown in India. Given the nature of the pandemic, we had to also ensure that employee health and wellbeing was not compromised in the bargain.

What helped us successfully overcome these roadblocks was the business-wide ‘Re-imagination’ exercise that was already underway at Cipla towards making our business future-ready and resilient on all fronts. As a business leader, making your core business growth drivers resilient to these changes, addressing and smoothly working past the changes while keeping the big picture in mind to secure the next leg of growth are questions we grapple with every day. For me, the answer lies in changing with the times. And therefore, the last few years at Cipla has been about embracing change, expanding and consolidating strategically, innovating, diversifying, finding the right partners, and staying alert to the latest business trends. These approaches have held us in good stead and will help us sustain our growth through the pandemic and beyond.

On the talent front, we have always welcomed individuals from diverse backgrounds with new thinking and developed a culture of looking at things beyond the traditional approach. This too adds to what forms the basis of a truly solid yet agile and future-focused organisation.

Given the tight work schedule, how do you maintain a work-life balance?

I try to allocate an equal amount of time to my family and work and treat both as equally important. It also helps me a great deal to have a strong support system both professionally and at home to help me do justice to both my roles. It is not easy to have a work-life balance when you are bearing responsibilities as a mother and as a professional. That said, maintaining a balance between work and personal life needs to happen on a daily basis. While there are some days that work takes the front foot, there are also days wherein our personal lives must be given priority. As a leader, it is imperative to understand how the two must be balanced and a conscious call needs to be taken on a day to day basis.

One should try and reach out for help whenever required. Fortunately for me, I don’t have inhibitions in asking people for help. My family and friends have always supported me by weighing in on various occasions and that has made the journey easier.

Personally, what are you passionate about and how do you pursue your interest? 

I am extremely passionate about fitness. I love running as it refreshes my mind and helps me focus better, while also ensuring physical fitness. I usually aim to run at least three to four half-marathons every year. In order to gear up for these marathons. During the pandemic, I have been particular about my fitness regime as it boosts immunity. I ensure a regular exercise schedule and running on the treadmill.

What message do you have for professionals with diverse backgrounds venturing into the pharma and healthcare industry?

Drawing from my personal experience, while the industry I came from was completely different from the role and space I currently am in, it is the fresh perspective that worked in favour. What people could think is a drawback, may actually be the greatest advantage, if leveraged correctly.

To those with diverse backgrounds venturing into the pharma and healthcare industry, I’d say never be afraid to take the leap and try something new or pursue your passion. And I see a lot of young professionals doing so, which is great. Also, always be game to learn and unlearn throughout your life. An open mind will help you grow not just professionally but also personally as opposed to rigidity.

The post An organisation with a diverse talent pool not only makes for good social sense but also makes for perfect business sense appeared first on Express Pharma.

The Indian pharma industry has recorded tremendous growth over the decades, more so during the pandemic. The Indian pharma sector has continued to be one of the key stakeholders in the pharma supply chain, providing access to affordable and quality medicines. Even at a time when COVID-19 posed several challenges to manufacturing and transport, the Indian pharma industry was driven to meet domestic and export needs while ensuring the safety and quality of medicines. Companies toiled relentlessly to ramp-up production and ease out disruptions to ensure uninterrupted supply of medicines.

Considering the production capacity that the country enjoys, several countries across the world export from India. The US imports close to one-third of generics used, from India. This is due to the availability of a high volume of quality drugs at cost-efficient prices compared to other manufacturing hubs in the world. While volume is certainly key, quality is of equal importance and cannot be comprised with as patient-centricity is one of the key tenets of the pharma ecosystem. This is the main reason why the USFDA established stringent guidelines which ensure that quality manufacturing standards for products are maintained by every pharma company.

Considering India’s expertise in manufacturing and exporting high-quality generics, diligent adherence to the USFDA guidelines is evident. A recent study published by the Centre for Drug Evaluation and Research (CDER) and the USFDA concluded the high-standards of Indian drugs. The study, conducted between February to November 2019, assesses the quality of imported drugs from outside the US. The sample size included 252 difficult-to-make drug products, of which 36 per cent of sampled products and nine per cent of finished dosages were from India. 

Researchers stated these products met the US market standards for dosage unit uniformity and dissolution, indicating acceptability for use by patients regardless of manufacturer or region.

What could this mean for the Indian pharma industry?

It is evident that the stringent regulations set forth by the USFDA and Indian companies’ compliance of the same imply that the quality of drugs is assured. Furthermore, the lure of Indian generics in the international community is undeniable. While Trump’s recent call to ‘Buy American’ – a means for the American pharma industry to move towards self-reliance prompted countries across the world to delve into the larger implications this move would have on the global pharma ecosystem, such a shift is easier said than done. The high costs incurred in manufacturing drugs in the US coupled with the low-profit margins the companies would face, given the drug prices in the country, would make importing drugs from countries like India an attractive option.

Having said that, there is scope to further strengthen the Indian regulatory system. The Indian pharma sector must become more stringent when it comes to the quality of drugs and the manufacturing process. The Indian drug regulatory system is complex. To meet the global standards of manufacturing and quality assurance, the institution of a regulatory authority independent of bureaucracy is imperative. This will ensure transparency in the entire manufacturing ecosystem. Providing impetus to pharma companies which, over the course of COVID, have forayed into new drug discovery is also essential. Driving innovation through a single window, fast-track approvals without compromising on quality will be crucial, going forward. 

To surmise, the guidelines set out by the USFDA, along with the industry’s commitment to provide high-quality, affordable generics to the country and the world are evidenced by both the CDER study and India’s position as the leader in the generics space, specifically in the exports market. However, there is further scope in the regulatory ecosystem to be further strengthened. Companies complying with the guidelines following safe manufacturing practices which in turn ensure the export of high-quality, safe and efficacious therapeutics should be incentivised. In doing so, India will certainly cement its position as the ‘Pharmacy of the World’.

The post Indian pharma: Driving excellence in quality and patient centricity appeared first on Express Pharma.

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

The post How the AMR Action Fund intends to support antibiotic-focused biotechs appeared first on Express Pharma.

Nationwide, most industries are guilty of having skewed gender equality ratios and the Indian pharmaceutical industry is no exception. According to a report published by Mercer India, female representation in the pharma industry is just 11 per cent — of the 49.5-million-plus strong. The statistics vary across sectors. While female representation in the manufacturing function stands at 12 per cent, 17 per cent in R&D and 21 per cent in corporate functions, it slopes down to a mere 5 per cent in the sales and marketing function.

The figures are even more dismal when it comes to the percentage of women in top leadership roles. Yes, the industry can boast of a few women leaders — like Biocon’s Kiran Mazumdar-Shaw. But the truth is that a lot more numbers need to be added up before the Indian pharma industry can fix the gender gap in its top leadership.

Unfortunately, it is nothing less than ironical that while traditionally, women are the main healthcare providers at homes, their representation in an industry that is the backbone of the country’s healthcare system is completely disproportionate, especially in top leadership roles. However, interestingly, it could very well be that pharma companies could actually gain by improving their workforce’s gender diversity.

According to a 2018 report by McKinsey Global Institute, India could add up to $0.7 trillion — more than 18 per cent — to its GDP by 2025, simply by paying attention to the slanting balance of its gender equality scales. Also, it is only fair that companies should represent and reflect their customers and their end-users. But, what are the challenges that limit women from scaling the ladder to the top in the pharma sector?

Stuck with stereotypes?
As Archana Bhaskar, Chief Human Resource Officer, Dr Reddy’s Laboratories points out, the Indian pharma industry has been relatively more traditional and conservative with its practices. Dr Gagandeep Kang, Executive Director, Translational Health Science and Technology Institute, talks on similar lines, “Traditionally, male-dominated workplaces are not willing to make accommodation for women — whether it is flexibility in working hours, safety or child care in the workplace. Women are not supported, or encouraged, or made to believe that they are capable of handling important, complex responsibilities — that goes against all that we know women can do.”

Limitations for many women (to scale up) often begin at home, and from within. Sandhya Shenoy, Associate Vice President, FDC, points out, “Women have to shake off the mindset that they are less deserving. Society has conditioned us to be content and less ambitious. However, the larger problem exists within. Women have an inherent urge and take it as a moral responsibility to excel at the roles of a daughter, sister, wife and mother. Anything outside these roles does not matter and this includes their careers as well. This has resulted in women paying scant attention to self-development.” Furthermore, biases and gender stereotyping in manufacturing industries can lead to a lack of confidence in women, acting as a barrier to their dreams of being in leadership positions.

These biases may even worsen the operational difficulties that women face due to the nature of their jobs. Tripti Nakhare, Senior General Manager – Regulatory Affairs, FDC, points out that as production activities usually span over irregular shifts, social norms may restrict ladies from working beyond certain hours. “Moreover, Indian law used to prohibit working of female employees beyond permissible hours, i.e. after 7:00 pm/8:30 pm/9:30 pm/10:00 pm in factories and establishments. However, the Act has been amended so we may see a rise in the number as some women may prefer to work in the second shift so as to balance work and home. Sales entails touring which keeps women away from home where they definitely shoulder a larger share of responsibility. Not all families adapt to this. Also, not every place in India is safe for a woman travelling alone,” Nakhare points out.

Women leaders may also face resistance more than their male counterparts. Sharing her thoughts on the matter, Antoinette Gawin, President & CEO, Terumo BCT says, “I have not experienced this (resistance by men over women leadership). But, early in my career, there were some touchy situations, driven in part by my age vs my gender. I had my first Executive role at GE when I was 27 and became a VP at 29. That created questions and natural concern. I also went through two pregnancies in that period. Very frightening for those who grew up in an environment where pregnant women ‘absented themselves’ from the public eye.”

In the end, competence always wins. Dr Renu Swarup, Secretary, Department of Biotechnology, Ministry of Science and Technology affirms the notion that a strong leader will be able to successfully lead their team, irrespective of their gender. She adds, “Those team members who are resistant to hard work and change would probably have the same attitude irrespective of the gender of the leader. If you have the confidence, you can deliver.”

Dearth of role models
Ask any women leader in the pharma industry and they will agree that having a female role model, or mentor, can have a significant impact on a youngster’s career. But with such debilitated numbers of successful women leaders in the industry, the industry could well be in quite a serious dearth of role models for its young and upcoming. Talking about how role models can influence a young woman by expanding their exposure, Mary Rodgers, ‘virus hunter’, Principal Scientist and Head, Abbott Global Surveillance Center, says, “In general, I think exposure is a big hurdle because girls don’t always have role models who will plant an idea in their heads, whether it’s a subject to take in school, a summer class or internship to explore, or having confidence in their own skills, they may not be thinking in the right direction. I was really fortunate to have strong female mentors and role models at every stage of my career, and they each had a major impact on the path I took. From seeking work in a lab as my first job during college to balancing motherhood with the demands of lab work, I have really benefited from seeing how other women have succeeded when faced with these same choices and challenges.”

In this direction, Suman Sharma, Director – Sustainable Antibiotics, Centrient Pharmaceuticals, feels that companies should work on mentoring programmes to facilitate interaction between the veterans and the newcomers.

However, there is a severe lack of female role models/mentors and this may reflect on how poorly the industry is able to retain its female workforce, even at the entry-level. Smita Holey, Associate Vice President – International Business, Cadila Pharmaceuticals notes that fewer women in managerial positions may result in lack of strong network, ultimately causing drop-out of accomplished women professionals from their roles. She explains, “Having more women in the leadership position will create a safe platform for women professionals, reducing the number of dropouts of accomplished women from the chain. When the change is slow, women feel unheard and undervalued and hence they seek other opportunities. Working on the societal construct as well as grooming the women workforce can help put more women leaders in the pharma industry ultimately leading to more pharma women leaders. Companies nowadays are making conscious efforts to highlight their women leaders on platforms such as in media, conferences, business meetings etc. providing a platform for their growth. Such initiatives act as a strong communication point in encouraging future generations.” She further pointed out that women are not represented at higher levels and hence, their competencies and strengths go largely unrecognised. Also, she feels that the kind of value that can be added to teams due to the presence of women is undervalued.

All in all, the presence of women leaders as role models can act as a direct intervention to develop future women leaders. This directly affects ladies joining the industry at the entry-level and helps them prepare for the trek up the ladder.

Recognise, recruit and retain
Responsibilities at home can easily clash with work, and more than often, women are compelled to give up the latter. Organisations need to recognise these factors and customise strategies, developing benefits and programmes that help women manage their family and professional responsibilities by offering flexibility. Companies can experiment with different work models like having a contingent workforce, hiring part-time workers and consultant contracts.

Resuming work after childbirth is another factor that puts women in a fix. “Most women give up work at some point of time due inability to cope with the situation of dual responsibility,” Nakhare observes. Extension of maternity leaves from three months to six months, she believes, may have helped women to better adjust to motherhood. However, organisations can go a little more steps further to help a female employee resume career after childbirth. Talking about how something as simple as opening up a crèche can help tremendously, Nakhare recollects about her time at Lupin and says, “The biggest boon in Lupin was the crèche facility. These were the years when we started our family. I could take my child with me to work. Having my child close to me was the priority and I was the first staff member to begin using the crèche. I availed of this facility for both my children till they turned three.”

Evolving with time
In order to bridge the gender gap that exists in the pharma industry, companies need to actively create a culture that actively advocates diversity and inclusion. A few organisations have already stepped up, showing initiative to address the issue. Recently, Dr Reddy’s Laboratories was in news for retaining its spot for the third consecutive year in Bloomberg’s Gender-Equality Index (GEI). The GEI tracks the financial performance of public companies committed to supporting gender equality through policy development, representation, and transparency. The reference index measures gender equality across five pillars: female leadership and talent pipeline, equal pay and gender pay parity, inclusive culture, sexual harassment policies, and pro-women brand.

Dr Reddy’s Laboratories launched the ‘SHE story – Increasing women in sales’ as a part which 50 women returning from career breaks were given part-time contract roles as Special Hospital Executives (SHE’s). They focussed on building relationships with junior doctors while covering one major hospital/ medical institute. Today, Dr Reddy’s Laboratories has more than 100 SHE team members. “Despite challenges, they delivered on their targets and expanded our customer base pan India,” Bhaskar informs. To increase the number of women in manufacturing, the company became legally compliant to deploy women in API production as well as in night shifts in plants and redesigned the shifts to make it a five-day work week in our Biosimilar plant.

Dr Reddy’s Laboratories also hosts a ‘Post Maternity Buddy Program’ – under which maternity counselling services are provided to all women employees along with access to a ‘buddy mothers’ programme wherein mothers can reach out to ‘buddies’ within the company that can help them with their doubts and queries around pregnancy. The
company has also launched a mid-management leaders programme called Chrysalis, to strengthen the pipeline of women leaders.

Cadila Pharmaceuticals also has taken positive steps to promote more gender diversity among its ranks. Believing that one of the best ways to develop women leaders from a young age is to expose them to various aspects of the pharma industry and help them explore opportunities within the organisations, the administration at Cadila has come up with a variety of policies like flexible work timings and highlighting women role models. In the year 2019, for its young leaders’ programme, Cadila maintained the gender diversity by hiring 50 per cent women professionals for roles in management, research and engineering. “We also focus on hiring women for higher positions. Selected women employees in the organisation are put on an accelerated growth path to help them assume leadership positions in the near future,” a company administration representative states. The company also maintains a blog which features its women leaders frequently as a mode of inspiration for the young and upcoming.

Even government scientific bodies are shifting gears to boost gender equality among their workforce. Dr Swarup shares, “Department of Biotechnology (DBT) has made a concerted effort to encourage the participation of Young Women in Science and Technology. There are numerous opportunities for young women. BioCARE is one such scheme which allows women researchers both employed and unemployed to take up research. We also have special awards to recognise the excellence in research and innovation by women scientists – Janaki Ammal-National Women Bioscientist Award. DBT through its Public Sector Enterprise Biotechnology Industry Research Assistance Council (BIRAC) also supports women entrepreneurs. We have three incubators which specially focus on women entrepreneurs and nearly 10 per cent – 15 per cent startups supporting are women. We also have a WiNER a special Startup Challenge for women entrepreneurs to help them to take entrepreneurship research forward and create enterprises.”

Knocking on the glass ceiling
“There is no reason to believe that pharma is not suitable for women. It might be the case that when the industry was established, women didn’t have the opportunity to work in otherwise stereotyped industries such as pharma. Today, I see more and more women making their mark in these industries and breaking the conventional norms. With continued efforts, there will come a time when women will have equal representation in the workforce in pharma,” says Holey, identifying the positive transformations happening in the Indian pharma industry. It looks like the Indian pharma industry is gearing up to transform into a more gender-neutral sector with more and more women taking up leadership roles. And as Shenoy points out, “There is plenty of room on the top!”

tarannum.rana@expressindia.com

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Mary Rodgers, virus hunter, principal scientist and head, Abbott Global Surveillance Center explains to Viveka Roychowdhury how strong female mentors and role models encouraged her during her journey from her first job during college to balancing motherhood with the demands of lab work

As a leading scientist and as a role model for women in STEM, do you find more women in STEM today than when you took it up?
Yes, I see more girls opting for careers in science, but we have a long way to go. I was lucky that I received the right encouragement, exposure and access to some wonderful mentors early on in life. I knew that I wanted to be a scientist from a very young age. But what I couldn’t decide at first was what kind of scientist I wanted to be — it turned out that my father-in-law (to be) was helpful. We were discussing my plans and I shared that I was majoring in chemical engineering. He said to me, “I don’t know, I just don’t see you as a chemistry person, you seem more like a biology person.” And I said, “Well maybe I’ll take a biology class.” And he was right, I am a biology person – I’m fascinated by molecular biology. I graduated with a bachelor’s in biochemistry from University Wisconsin-Madison and eventually earned my Ph.D. from Harvard in biological and biomedical science. I was in Mumbai recently for a transfusion conference and met many women who were at the helm of scientific institutions. I found this to be very impressive and encouraging.

What were the hurdles and how did you deal with them?
In general, I think exposure is a big hurdle because girls don’t always have role models who will plant an idea in their heads, whether it’s a subject to take in school, a summer class or internship to explore, or having confidence in their own skills, they may not be thinking in the STEM direction. I was really fortunate to have strong female mentors and role models at every stage of my career, and they each had a major impact on the path I took. From seeking work in a lab as my first job during college to balancing motherhood with the demands of lab work, I have really benefited from seeing other women have succeeded when faced with these same choices and challenges.

Are society’s attitudes evolving so that less women give up a STEM career than before?
I think the stereotype that STEM careers are only for men is changing, and it’s encouraging to see that a record number of women are getting PhDs in STEM fields. My own son even told me that he “wants to be a boy scientist”, which I think means that he thinks most scientists are women, although I’m sure there’s some bias there because of his mom. We need to keep this momentum going – for women to choose, strive and thrive in STEM, they need the right exposure in school, right encouragement as they choose their education pathway, and access to additional information as they select their career options.

You have the opportunity to observe women in STEM across countries and cultures. Which countries have you seen the most change in this aspect?
I’ve been working in research related to Abbott’s Global Viral Surveillance programme for five years now, and I haven’t seen many changes during that time – I find that amongst our global collaborators, women are present similarly to men.

What is your advice to policy makers, corporate boards and the scientific community at large, to improve contributions from women in STEM careers?
It’s important for parents, educators and others to expose girls to STEM, and encourage them in every way possible to pursue science and related fields. At home, it’s important for parents to gauge their girls’ interest and introduce the right reading materials and hobbies to nurture their aspirations. I always tell kids that if they like asking questions, then they might want to consider becoming a scientist – asking questions is fundamentally what we do. At the community level, recognising girls for academic achievements is important. Also, Abbott offers internships giving both girl and boy students the opportunity to contribute to our life-changing technologies alongside engineers and scientists who look like them.
For more information on Abbott’s STEM activities, parents and teachers can visit – http://www.abbott.com/women-in-stem/stem-resource-library.html

viveka.r@expressindia.com

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On a recent visit to Mumbai, Dr Ian Hudson, CEO, Medicines and Healthcare products Regulatory Agency (MHRA) spoke with Viveka Roychowdhury on how the Agency is working with pharmaceutical companies to increase compliance with Good Manufacturing Practices (GMP) as well as preparing for Brexit and beyond

We have seen quite a few lapses in pharma Good Manufacturing Practices (GMP) in terms of inspection outcomes. What are MHRA’s insights on this issue, with respect to inspections conducted by the Agency’s staff at pharma manufacturing sites in India? What is the progress made? What are the suggestions for the way forward?
We’ve been inspecting a number of manufacturing sites here in India. These include both manufacturing as well as clinical trial sites. From time to time, yes, there are problems with manufacturing sites here (in India), just as there are with other sites all over the world in other places that we inspect.

What is important is that we work with the company to address any findings there are, to make sure the company gets back in compliance as soon as possible, that the impact on any medicines is assessed as quickly as possible and appropriate action is taken. We always focus on a public health point of view, in terms of what are the impact of any findings on public health.

So yes, from time to time there are manufacturing issues, whether it’s here in India, or in the UK, Europe or the US or where ever they (the sites) are. But most of the time, things are fine.

Are there any specific repeat observations that keep coming up, recurrent challenges that the MHRA observes? For instance, the US FDA has found recurrent data integrity issues and pharma companies in India are addressing those issues. What are the trends in observations from MHRA inspections?

I think it is important that if any data integrity issues are raised, that the company fundamentally addresses what had gone wrong in their process to make sure it’s addressed. I do not want to talk about individual companies but it is absolutely critical that companies look at what has gone wrong and if there is an issue, to address it.

Clearly, India has a critical role in the production of (medicinal) products across the world. Something like 28 per cent of medicines in the UK market are made in India, either the active ingredient or the final product. It is absolutely important that wherever medicines are manufactured, they are manufactured appropriately standards, that there are no data integrity issues, and the data and results are reliable. Fortunately, the results are fine most of the time but on occasion there are issues. Then the challenge is (to find out) why, what when wrong, and making sure that the company addresses it at the highest level in the company and action is taken accordingly.

What are the other issues besides data integrity that come up when there is GMP non-compliance?
From time to time, issues do arise in the manufacturing process but that is the same where ever the manufacturing occurs. Manufacturing is a complicated business. Sites are fine most of the time but occasionally there are problems and things need to be addressed.
As I mentioned, we would take a risk-based approach to decide if there are risks to the public as a consequence of this, and the company must get into compliance but in the meanwhile, (we ask) do we need to take any action on the product or on the manufacturer to ensure that they get back into compliance.

And on the clinical research and trials sites?
Most clinical trial sites around the world are fine but issues do arise sometimes. Some are relatively minor and of little consequence. Occasionally, we find issues which are of more significance, in which case we need to work through what’s going on. Is it simply a mistake or is it something more serious than that? At the end of the day, fundamentally, is the data reliable and are those subjects appropriately protected in the clinical research? That’s what we aim for in our inspections.

Major violations on the manufacturing or clinical research side need be taken very seriously and addressed at the highest level of the companies. There cannot be a tolerance of anything else other than compliance with the regulations. They must absolutely weed out any problems with data integrity, etc. That is a message I would like to send out loud and clear.

But what I would not like to say is that the rest of the world is fine and India isn’t. That is not what I am saying at all. We can sometimes see problems wherever the trial is conducted or manufacture takes place, whether India or elsewhere.

It is particularly critical for India given that it is a source country for manufacturing for much of the world’s pharma products as India is described as the pharmacy of the world.

How can companies prepare before interactions with the MHRA?
In a recent presentation in Mumbai, I described some of what’s happening in the MHRA, in the supporting innovation, pharmacovigilance, and some ways companies could prepare before interactions with MHRA. My advice is that they should be transparent and upfront, and discuss problems with us rather than hiding them. We are going to find about about them sooner or later. We may have seen them before and can suggest ways to help out. We both have the same goal to provide safe medicines to patients.

What have been the changes in the MHRA to deal with Brexit and beyond?
A lot of the work at MHRA is independent of Brexit. We see that we have a clear responsibility to support innovation. We have all sorts of mechanisms to do that. Innovation has a very broad definition. It can mean new ways of manufacturing, new ways of doing things. We have an innovation office, who would be happy to talk to companies to advise them. We’ve got help lines and scientific advice provisions as well. Basically, we want to have an open door policy.
We want to see products developed safely for the benefit of public health. To ensure that at the end of the day, the public can derive the benefit from well-made medicines. We put a lot of effort into the innovation space.

We also have a pharmacovigilance programme, with the Yellow Card Scheme, which is the scheme for reporting adverse drug reactions or medical device alerts. In the yellow card system, we are looking at a number of things to increase reporting by promoting the scheme to healthcare professionals. We expanded the scheme to not only include adverse drug reations but medical device adverse incidents, defective medicines, potential counterfeit medicines,. All of these can be reported through the yellow card scheme.

We are also looking to get the yellow card integrated into the healthcare systems to ensure that healthcare professionals have easy access to it as well. We are also looking to see how we can evaluate signals from the yellow card scheme rapidly by using large data sets. For example, we’ve got the clinical practice research data link covering a large anonymised healthcare records data bank of 35 million patients, so we can very quickly take a potential signalling issue through the yellow card scheme to then look to see if it is a genuine issue, if so at the size of the issue, so that we can very quickly refute or confirm the issue from the signal and do the linkage that way. We are also looking to see how we can collaborate with others in the outside world in terms of best use of this data from a safety point of view.

We’ve also developed a Yellow Card app, which can be downloaded from the Apple App Store or the Google Play Store. This is useful for healthcare professionals or anyone to report safety issues to us.

We also feed safety information down the Yellow Card app, so you can follow a particular drug to see if there were any safety alerts or what’s been reported about it. This technology has been made available for others to potentially use. Other countries are potentially using that for their safety reporting. Companies can potentially use it, for example, for their sales rep to report to the database etc.

On the inspection side, we are looking at other models. For example, how far can we go in terms of desktop inspections for sites that have a good history of compliance, taking into account results from other regulators. This helps us prioritise our work by considering if we can do a desktop inspection to assure ourselves that things are fine. They will never fully replace site inspections but they might help us decide that we do not need to go this year to a particular site. We would ask the manufacturer for information on the site, whether there were issues, any out-of-specifications, etc. So if they’ve got a good track record of compliance, and there is nothing to report, then we may put our resources to another site where there has been more problems.

We are also looking to see how much we can rely on other regulators’ inspections in our own decision making. For instance, we can consider if there is a need for us to go and inspect if other stringent regulators, for instance, like the US FDA or Health Canada or Australian Therapeutic Goods Administration (TGA) has been to a site. If the site was good, can we rely on this and factor it into our own decision making. We are moving in this direction.
Another thing that the inspectorate is looking at is having compliance teams to assist companies where there are problems to help get back into compliance as soon as possible, to be producing compliant products as soon as possible.

We are also looking at what we can do to be fully prepared for new approaches in the future. Whether it’s bedside manufacture or the use of artificial intelligence in manufacturing, we’re making sure we’re gearing up for that side of things. We also work very closely with inspectorates around the world.

The UK government also supports innovation in the life sciences sector, including the generics part of the sector. This is an important priority for the UK government. We have things like the accelerated access review, which looks at not just how products are brought to patients, not just the regulatory piece but also the HTA, etc.

The responsibilities of the MHRA are actually quite broad. We have the regulatory centre within the agency, which is responsible for medicines, medical devices, blood components, herbals, homeopathic medicines. We have an enforcement as well policy function. British Pharmacopoeia is part of the agency as well.

But we have two other centres within the agency. One is the the Clinical Practice Research Datalink (CPRD), with anonymised healthcare records with over 35 million patient lives in the database for research purposes.

This is a fantastic tool for observational-type research like on safety of statins in the market place, safety of pertussis vaccine in pregnancy, refuting the link between MMR and autism, etc. These studies can be done on a large size population database. We are also using this database to see how this can support clinical trials going forward. The MHRA approves in the order of 1000 clinical trials a year. 25 per cent of all European clinical trials are done in the UK or involve the UK. We’ve got a very progressive environment for clinical trials in the UK, with a lot of investments in the clinical research networks. We are very keen to support new ways of doing clinical trials like adaptive trials, etc. We are very supportive of these new ways.

In addition, we are looking at using the electronic health records (EHRS) through CPRD to support clinical trials, so you can screen for the inclusion and exclusion criteria of a clinical trial to see if it is viable or not. We can come up with a list of patient records and doctors can approach these patients who might be eligible for a particular trial, to ask them if they’d like to participate in the trial or not or when a patient visits a doctor, a message flashes on the doctor’s screen that this patient is eligible for this trial, do you want to enroll them or consent them? The EHR can then be used to randomise patients as well as follow patients.

The third centre is the agency is the National Institute for Biological Standards and Control (NIBSC). Here, we produce biological standards, these are physical standards in a vial. We produce 90 per cent of the world’s biological standards.

October 30 is a milestone for the Brexit process. What is the MHRA doing to assure pharma companies and investors that the UK is open for business given the Brexit context, in both scenarios of a ‘soft’ and ‘hard/no deal’ Brexit?

UK will remain a member of the EU until the end of October, unless an implementation period is ratified through Parliament earlier. If it is agreed, then we enter the implementation period, where we will be subjected to the same regulation. We will be doing the same in terms of regulation of medicines and medical devices at least until October. After October, we are either in the implementation period or we are a standalone regulator, so the agency is currently planning for both, either an implementation period or we would leave (the EU) without a deal.
Over the longer term, the UK government’s preferred position is to negotiate continued participation in the European medicines and medical devices systems. We would still be working with the medicines and medical devices network across Europe. But that requires negotiation and it may or may not come to be. We then prepared extensively, for the end of March and now it carries over to the end of October, for the possibility of no deal, wanting an implementation period and wanting a future relationship with Europe. We’ve issued extensive guidance to industry to help them prepare for a no deal Brexit. We’ve prepared draft legislation, as well as extensive guidance to let companies know what they would need to do. If we ended up in a no-deal situation as a standalone regulator, we also looked as some additional options like rolling reviews, accelerated assessment of new applications or targetted review based on existing European review, etc.

Our approach in all of this has been to be as pragmatic and helpful as possible, to be as open and supportive to industry as possible. But commensurate with our role of protecting public health. We must make sure, first and foremost, that we do that. We did not want to introduce any unnecessary burdens. For example, we said we’d take the same dossiers as the European authority; we would not ask for anything more. The feedback has generally been that companies have appreciated our open, flexible and helpful approach.

We see we have an important role to play internationally. We are very keen to help and support and collaborate with other regulators internationally and that is not going to change post-Brexit. We will still interact with our counterparts in Delhi and in other places across the world as well as through the International Coalition of Medicines Regulatory Authorities, which we currently chair. We are also doing work to help to support developing regulators. We will still be part of the international regulatory community wanting to help because its for the benefit of public health for all.

viveka.r@expressindia.com

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