"We act as a portal for the global players to enter Indian market and vice versa"

Emmanuelle M Voisin,
Founder and CEO,

Rajashree Devarakonda,
Vice President - India and Asia Pacific, VCLS
Voisin Consulting Life Sciences (VCLS), the global healthcare product development consultancy recently acquired B & H Consulting Services, Inc (B & H), an experienced regulatory firm helping pharma and biotech companies facilitate interactions with FDA and navigate the regulatory process, forming one of the World's Largest Independent Life Sciences Consulting Groups. In a tête-à-tête with Mahesh Kallayil, Emmanuelle M Voisin, Founder and CEO, VCLS deliberates on potential of the deal and her observations on Indian biopharma market, while Rajashree Devarakonda, Vice President - India and Asia Pacific, VCLS talks about Voisin's operations in India, challenges and opportunities for Indian biopharma companies and many more. Excerpts from the interview…

Congratulations on Voisin's recent acquisition of B & H Consulting Services. Could you please tell more on this?
Emmanuelle:Voisin Consulting Life Sciences (VCLS) was incepted in 1997 in order to assist the Pharma, Biotech and MedTech industry , especially the start-ups at that time, to place their products in the market. It is basically a product development and regulatory strategy consulting firm.

Over the years, the firm has evolved along two different areas. One, is we are regulatory driven, that is when a new regulation is been sought by the European Commission (EC) or United States Food and Drug Administration (US FDA) we are present and we try to understand the philosophy behind the regulations and prepare the services accordingly. So basically being regulatory driven means that when there is an orphan regulation in the air, be it orphan, pediatric etc., we know exactly what's going on and prepare the kind of services that our client will need. We once prepared for the geriatric regulation that never came up, but that's okay we are always prepared for everything and well ahead of time.

The number two is geography driven we really wanted to be an international firm and not just a network of consultants across the world. We are all employees in the different companies in different parts of the world. Europe is represented by France (Paris and Rennes), UK, and Switzerland. USA is represented by two main offices in Cambridge and San Francisco with more offices planed on the east coast, and of course Bangalore is our only and very important office in Asia Pacific (APAC).

Since we wanted to increase massively our presence in US, we recently made the decision to acquire B & H which is an experienced regulatory firm helping pharma and biotech companies facilitate interactions with FDA and navigate the regulatory process, adding man power to our current US operation. In addition to the regulatory, they also have very influential CMT competition so they can redefine lots of expertise in CMT.

Are you planning any such association with in India?
Emmanuelle: For now we don't have any such plan. But certainly it is in my mind. I want to develop the Indian operation under the leadership of Dr Rajashree.

Rajashree: It is not in plan right now. Our focus is right now on US and we are growing in a good pace. However, we as a company always keep our eyes open for good companies as well as good partners.

Please elaborate on Voisin's operations in India?
Rajashree: We started our Indian operations in 2008 and through this office we are operational in India and APAC. Our role goes two ways. On one hand, we assist Indian companies with their international development, to address the US and EU markets. On the other hand, we help foreign companies benefit from all that India offers - development capabilities in terms of manufacturing or clinical testing through our preferred local partners, as well as domestic market entry.

The services that we are providing from here are similar to our global counterpart but more so focused on the services related to Pharmacovigilance , clinical trial operations, clinical review of regulatory documents for Clinical Trial Applications/INDs, Clinical review of MAAs/NDAs/BLAs, clinical/regulatory strategy, Positioning of the product, Assistance with formal informal meetings with regulatory agencies, preparation of clinical development plans, risk analysis from pre-clinical development stage to market authorization stage, registration procedure and lifecycle management .

We have several Indian clients and our own projects coming from India and also from APAC. We also act as a portal for our global clients to enter India or APAC and help them register their product here. We have several local partners for our various services for example; clinical trials, pre -clinical studies etc. In addition, we also identify service partners for our global clients.

VCLS Indian team is also a hub for our clients to the ASEAN region.

In essence, VCLS assists Indian Biotech/Pharma companies with their novel product development and registration activities locally as well as in the global market.

As a bio medical consultant how you see biopharmaceutical market in India?
Emmanuelle: Indian Biopharmaceutical market is huge and growing. India is one of the big generic market. And now I can see that there is a trend towards more of innovations in biosimilar. In particular there is a trend towards bio similar. Biosimilar is much more difficult to develop as compared to generic.

Rajashree: India's biopharma segment is definitely showing growth. There is no shortage of technical competence for development and manufacturing. However, India has to work harder especially to meet product quality and GMP compliance to be in par with the developed countries. Biosimilars are also complex, large molecules. A small change in its structure during development can affect the quality of the final product and quality attributes leading to clinical safety and efficacy of the product. Hence, development of these products is difficult and has to be done very carefully. India is known for generics development it no ways guarantees that India will becomes a leader in the biopharmaceutical world. Industry really has to further invest in R & D, including in modern technology platform. Government has to tighten IP laws further. There should be a real collaboration with academics, scientists and industry. People working in this field from industry, academia, including regulators should receive basic training in areas such as GMP aspects, QBD, proper documentation, technology transfer, validation processes including scale ups. Regulation and approval process need to be streamlined including science based risk based analyses of the dossier should be made. Regulators also should receive training in this regard. Many companies in India have invested into the biosimilar domain without knowing the complexity in the field. It is key that companies like this partner with regulatory experts very early in their development.

Even though there has been a growth in the biopharma world with number of simple biotech products coming in to the market by Indian companies, we still have a long way to go in biologic sector especially for inovel molecules.

So, our main constrain is funding?
Rajashree: One of the major concerns for Indian biologic company is definitely funding. There is definitely private equity available however, venture capitalists are hesitant to invest in this sector and R & D investment is low. This can be addressed to certain extent by joint ventures . But it is not just that. Constraint is partially also in the mind set of people and Indian companies. It is key that companies and the staff need to be educated regarding the impact of minor changes to the molecule and its impact on safety and efficacy in the patient population. Hence the struggle to keep the quality of the standards is very high in this sector and safety and efficacy of the product in the end user. We should shed our 'chaltha hai' attitude. We should work with regulatory experts from early stage which ultimately makes the product development more robust. Experts involvement from the beginning and continuous dialogue with regulators, have transparency throughout the development of the product is really critical to bring out a successful product very early in to the market.

It is not that our regulations are not up to the global standard. In fact, our biopharma regulations are in par with European and US regulations. But, practical application of these regulations and adopting the review to the products and indications in a risk/benefit approach is something that we have to improve.

Why do you think India have not much indigenous vaccines to our credit?
Rajashree: Development of biologics is not same as other chemical drugs. Biologics need lot of investment from government. Indian government is investing lot on biologic research; no doubt. But it is not as much as how much it should be. For vaccine development we need to have favorable regulatory frame work, favorable environment to bring the product and you have to have sufficient fund you also have to have sufficient partnership - academic, industry and government body.

Nowadays there are capabilities in Indian company to use newer technology and equipment to bring product into the market. But, I personally think that many Indian companies are not ready to take the risk of investing in newer technology and still stick to old technology to develop biologics. Also, we need to revamp our regulatory framework and government bodies should come forward to incentivize and support investment in the biologic R & D. Conversations in this direction has started but it should still pick up the momentum.

What are the recent trends you observe in global life science market ?
Rajashree: Global life sciences companies are dealing with competition. Regulatory landscape is constantly and rapidly changing, while not always in the direction of harmonization. The rise of Health Technology Assessment poses a challenge to the industry for reaching a consensus across a myriad of agencies of often different viewpoints (eg, on choice of comparator for pivotal studies, clinical studies endpoints or health economics assessment methods). There are IP issues to contend with, inferior product quality issues, and issues with manufacturing practices, product recalls, and different regulatory data expectations from agencies across various geographic locations. There is high level of scrutiny from regulators especially for complex products like biologics and advanced therapy medicinal products. A lot of advancement has happened in this field. Now we have treatment available for number of life threatening diseases including number of cancers which were thought to be incurable before.

With price control regulations in many countries, margins for the drugs are also decreasing. This means, companies have to constantly work on reducing the cost of the drug but at the same time have to maintain product quality as well in order to meet stakeholder's value and expectation. Physicians are opting for personalized medicines as one drug that works in one patient may not work in the other due to biodiversity of patients and changing consumer demographics. Companies have to adapt their business models according to the changing environment by using innovative development strategies, different clinical data collection, high technology equipment's, innovative healthcare delivery strategies. Industry has a responsibility to bring the right product with proven efficacy and safety in to the market. So, the risk benefit analysis should be integrated in to the development and performed on a regular basis and risk monitoring should be performed continually including during post marketing period. The companies who are mulling to get into the biologic market or who are already developing products should take care of these things.

Involving experts very early on in the development of the product, as well as frequent interactions with regulators and payers throughout health product development are necessary to efficiently integrate the abundant mix of regulatory requirements, opinions, legal texts and regulatory guidelines may it be for Indian market or for global market.

A life science consulting company as Voisin Consulting Life Sciences (VCLS) can identify the gaps in the development, regulatory barriers, regulatory requirements and what the regulators are expecting to see in your applications well in advance due to our hands on experience from similar products the company has handled and from our constant formal and informal interactions with regulators. We provide actionable recommendations at every stage of development process, enabling clients to make informed decisions. We offer hands on assistance to develop briefing and submission packages as we lead communication with regulators and payers.

At VCLS, we anticipate and address challenges throughout health products life cycle. We identify and manage productrelated risks, from the early definition of the target product profile through nonclinical and clinical development, registration, launch, and commercialization. We also conduct due diligence to prepare for licensing, mergers and acquisitions. We provide actionable recommendations with essential information that enable clients to make strategic decisions. We help define the roadmap to the market, complete with situation audit, milestones, and the strategy needed to drive tangible results in line with corporate objectives. We also provide insights and course correction along the way.

We also communicate with Health Authorities on a regular basis and maintain established relationships with local health authorities and key opinion leaders in key geographic locations, facilitate formal and informal dialogue between the industry, regulatory agencies and payers.

We author and review submission packages, anticipate questions from health authorities, and provide a rationale to support our clients' position before regulatory and health technology assessment agencies. We often act as our clients' representative before health authorities.

We translate Quality, Safety, Efficacy and Cost-Effectiveness into Value. Health products' value is built during development, from the earliest stages . Supportive data needs to be gathered throughout, to demonstrate Quality, Safety and Efficacy/Performance in marketing applications and Cost -Effectiveness in value dossiers for payers. Value perception also varies across a number of stakeholders -regulators, payers, patients, healthcare professionals, and investors. Articulating various stakeholder expectations and translating Quality, Safety, Efficacy and Cost-Effectiveness into Value is our main commitment to clients.

What is your take on access to life saving medicines?
Rajashree: With the enactment of patent amendment act, 2005 , it is made end product also patentable along with processes.

But still, we don't have data exclusivity. In foreign countries, when a new product comes in to market, no other pharma companies have the right to copy it.

But in India, the generic companies have the freedom to bring out replica of the original drug. Big pharma and MNCs don't want to bring their products into Indian market because they have to compete with companies which sells generic version of same product for a low price. Indian government is to certain extent not doing a lot on the data exclusivity side because government wants to have competition in the market which in turn will help to bring down price of life saving drugs. Also, we have government agencies like NPPA to control the price of life saving drugs.

As a pharma consultant, we feel government has to choose a mid-way. Right now what is really happening is we are losing out many pharma MNCs. While keeping the price for life saving medicine lower, government needs to revise the laws on compulsory licensing and data exclusivity and patent acts making a better environment for R & D but at the same time ensuring patient protection and benefit. Once the patent regulatory frame work get tightened, more and more MNCs will invest in Indian market, more partnership will happen, R & D will cherish and more number of innovative products and life savings can come in to the local market.

What are your observations on ethicality of clinical trials conducted in India? How do you compare these with the ones carried out in developed countries?
Emmanuelle: There are a lot of CROs in India. Some of them are of extremely high quality and they do a great job. We have partnered with few of these CROs.

Once in a while you will hear that the trials are not done ethically. Problem is that the story is blown up. Unfortunately, media gave it a huge coverage. It will only going to damage the reputation of number of excellent CROs.

Rajashree: If we compare ourselves with the global market, we somewhat still lag behind even though there has been tremendous progress in the last couple of years. Some of our clinical trials regulations requirements are very good and progressive in comparison to the ROW and in fact are more protective of vulnerable populations and minorities, such as mandatory registration of all new clinical trials in the CTRI, registration of ethics committees, and use of language encouraging respect of participants' cultural, educational, and economic backgrounds etc which are addressing some of the grey areas in clinical research. We still have to further improve in aspects like documentation, transparency of the trial process including in the consenting process etc. in order to win back many of the MNC's and Indian companies and attract them to conduct clinical trials in India rather than in abroad. If we look into the amendment on clinical trial regulation that came on 2014 December, the amendment seems to be balanced between industry and patients protection. Regulation is changing for the better. But we have to still work on the transparency of the trials and integrity of the trials to be in par with the developed countries.

VCLS continues to assist its Global clients who wishes to enter Indian market in making an informal or strategic decision by keeping them informed of the local regulatory environment, provide advice on advantages and challenges of conducting clinical trials in India set up partnership to the clients as per their requirements, conduct due diligence and act as clients local representative, and assist in preparation of regulatory package and interact with regulators leading to successful approval for clinical trials or for marketing authorization.