Phase I specialists

Phase I specialists

In an industry teeming with clinical research organisations (CROs) of all shapes and sizes, what does it take to stand apart? Veeda Clinical Research does it by specialising in Phase I clinical studies. Dr Maurice Cross, Group Medical Director, Apurva Shah, Group Managing Director and Binoy Gardi, Managing Director are very clear that this will remain their forte in future as well. Viveka Roychowdhury analyses the growth path of this transnational tiger

Considering that Veeda Clinical Research came into existence just two years ago, one would be tempted to call them the ‘new kids on the block’. However, the company’s promoters bring with them over two decades of Phase I (PI) expertise in regulated markets. This expertise is crucial to the Indian pharma industry at this stage, as many domestic players aim to take their own research molecules from lab into the clinic. PI trials, also known as First-In-Man (FIM) studies, is the first time a new molecule or procedure is used in human subjects, after in vitro and/or mathematical modelling.

While other promoters might shy away from the risks of PI trials, one gets the feeling that this is exactly why the promoters decided to specialise in this field. Higher risks mean less players and consequently lesser competition. This is also the phase with the highest dropout rate, a whopping 70 percent. But it is also the phase with the highest growth rate, as more drugs move from lab to clinic. Emphasising this niche positioning, Binoy Gardi, Group Managing Director, Veeda says, “We differentiate ourselves because we are very focused on what we do, we are specialists in phase I trials.”

Dr Maurice Cross, Group Medical Director, Veeda, is a veteran of experimental medicine and began his tryst with PI trials way back in 1986, when he started Phase I CTU, a PI testing facility in UK. In November 2005, the three-way amalgamation of Phase I CTU, ClinSearch Labs of Ahmedabad and Plymouth-based Triphasic Clinical Trials Laboratories gave birth to Veeda Clinical Research.

“I think aggressive CROs are going to become drug developers in their own right….Our job is to take molecules and turn them into racehorses”

– Dr Maurice Cross Group Medical Director

Veeda

“We differentiate ourselves because we are very focused on what we do, we are specialists in Phase I trials”

-Binoy Gardi

Group Managing Director

Veeda

Tiger on the prowl

The rationale of the three-way merger was simple to leverage the specialised high-quality clinical pharmacology units in Plymouth with the vast populations, excellent turnaround times and considerable economies of the Ahmedabad facility. The promoters chose to accentuate their Indian connection with both name and visual. ‘Veeda’, an anglicised version of the Sanskrit, vidya, meaning knowledge, was chosen no doubt to emphasise the fact that PI trials are more about knowledge and science, rather than the number crunching of the later phases. Veeda adopted the icon of a powerful prowling Bengal tiger, a visual representation of the potential role of India in global clinical trials.

In January 2007, Veeda acquired DICE, a CRO based in Brussels, Belgium. The DICE acquisition gave Veeda expertise in data management, biostatistics, medical writing and statistical analysis, and gave an edge to Veeda’s plans for its clinical data management (CDM) business. Five months later, Veeda took over a P1 clinical research unit in Gorlitz, Germany. Strategically located near the border of Germany, Poland and the Czech Republic, the Gorlitz facility allows Veeda to tap facilities, as well as doctor and patient pools in three countries at one stroke. The same month, Veeda also gained a foothold in the Chinese market, with a strategic alliance with Shanghai-based Novamed. Novamed’s business model is to facilitate clinical development of multinational clients based out of Japan, US and Europe, who want to do trials in geographies like India, China and South Africa but do not have a presence here.

Part of Veeda’s agenda for 2008 is to complete two more overseas acquisitions. As Cross points out, with an established presence in UK, Europe and a partner in China, the next obvious stop would be the US market. The promoters have aggressive organic growth plans as well. Citing the advantages India offers to clinical researchers like himself, Cross says, “The great thing is that most Indian physicians have had a Western style education in the US or UK, so culturally it is very easy to transform Western style clinical trials to India. China, however poses huge problems. We have to have an interpreter at all times, and this person has to be medically qualified as well. The trend seems to be that China becomes the pre-clinical centre, India becomes the clinical centre.”

“We have invested a lot in IT
infrastructure, which also helps us to be US FDA-complaint. Like every scientific company, you have to share that scientific information to come to more conclusions”

– Apurva Shah Group Managing Director

Veeda

These days, Cross finds himself jetting across continents, supervising PI clinical trials of various global clients. He estimates he spends, “physically two months and mentally six months” of his time in India, as “the results are all that matter and these days you can get the results anywhere.” Cross relates how he recently watched volunteers being dosed in Plymouth, while sitting in the lobby of New Delhi’s Radisson Hotel, hooked into their WiFi. He was simultaneously on Skype, talking to a roomful of people in Osaka, who were also watching the same heart monitor screens.

As Apurva Shah, Group Managing Director, Veeda, points out, “We have invested a lot in IT infrastructure, which also helps us to be US FDA-compliant. Like every scientific company, you have to share that scientific information to come to more conclusions.” Implicit in that statement is the fact that real-time results translate into quick turnarounds.

… but also on leash?

As far as the bottom line is concerned, Veeda is in expansion mode. “We want to have a global position in this area. We expect to touch Rs 100 crore in revenues this year and aim to be a Rs 300 crore company by 2010,” states Gardi. To achieve this growth, the company is planning to triple capacity in its Ahmedabad clinical facility and has just opened a new Clinical Pharmacology Unit (CPU) at Muljibhai Patel Urological Hospital (MPUH), Nadiad, Gujarat. This becomes the first specialised renal CPU in India and Veeda becomes the first Indian CRO to conduct phase I /II clinical studies in renal impaired patients, at the unit. Veeda would also utilise this unit for carrying out trials related to urology like Ca Prostate and Ca Bladder which may necessitate admission in the ward, which is immediately adjacent to the Intensive Care Unit. The unit has six fully monitored beds and all supporting facilities necessary for safe conduct of trials. Veeda will also have access to the experienced manpower of the hospital as well as facilities available like kidney dialysis machines, pathology laboratory, X-rays and CT scan.

A few areas of concern remain, not least the fact that PI trials of molecules developed out of India are not permitted within the country. The reasoning of Indian regulators is that subjects might be exploited, given the high levels of poverty and illiteracy. Thus India has remained a phase II/III market, except for FIM studies of drugs discovered in India. Mincing no words, Cross calls it case of “bureaucratic mumbo-jumbo”, while Gardi opines that the process needs to be streamlined. Previously, Indian companies themselves were not confident of PI units based in India and preferred to take their molecules for FIM studies abroad. However as more researchers like Cross and entrepreneurs like Shah and Gardi, bring global expertise and promote transnational facilities like that of Veeda in India, this perception is slowly changing.

In its own way, Veeda is working at changing this perception and raising awareness and skill levels by organising workshops and seminars. At the first such workshop conducted last December, participants got an idea of the realities of glucose clamping for evaluation of novel insulins. The highlight of the two-day workshop was the practical sessions on cardiovascular toxicity and glucose clamp studies, conducted in Veeda’s PI unit. They also practiced using the MUSE cardiac data analysis system and learned first-hand how thorough QT studies are performed to FDA standards. Veeda plans to organise more such workshops focusing on delivering practical know-how on PI trials to clinical research professionals. This will help clients at the study design stage.

Another pain point concerns the non-availability of human resources (HR). Today, demand for skilled, trained clinical research professionals outstrips supply. Forced to choose from a relatively small talent pool, poaching is rampant and rising compensations are now threatening to erode India’s oft-cited economical edge. As Cross puts it, “Your big enemy is internal inflation in salaries. If Indian salaries rise at the current rate, you will soon lose your competitive advantage.”

Shah highlights another aspect of the HR challenge. He says, “Besides salary compensation, another concern is job-hopping. So you job-hop, double your salary but don’t pick up any skills or learn anything. Your knowledge is not developing at all.” At the lower rungs, clinical research professionals are typically young graduates, most susceptible to the lure of Mammon. Rising up the ladder thanks to job-hops, some may reach senior levels with none of the breadth of knowledge expected. According to Cross, Veeda has a lower than industry average turnover but most major pharma clients are worried about salary projections in India.

Clinical facilities at Veeda Clinical Research UK, include:

  • 63-bed capacity
  • 21 monitored beds including an experimental medicine unit (three beds) equipped for invasive studies and intensive physiological studies such as first-into-man intravenous anaesthetic studies.
  • MAC 5000 ECG machines, GE wall-mounted monitors
  • Capability to store ECG data in FDA format via a GE MUSE system
  • GMP accredited pharmacy and drug preparation area with a laminar flow cabinet, air conditioning and centrally monitored/alarmed drug storage facilities.
  • QP services
  • In-house catering allowing the unit to provide for specific dietary requirements.
  • Archive facilities both on and off site

    PI and bioavailability/bioequivalence at Ahmedabad include:

  • 116-beds in four temperature controlled clinical investigation areas
  • 12 monitored beds plus two specialist units with two beds and one bed for intensive monitoring
  • Experienced GCP trained staff
  • Two well-equipped, controlled-access, on-site pharmacies
  • MAC 5000 ECG machines, GE wall-mounted monitors
  • Capability to store ECG data in FDA format via a GE MUSE system
  • In-house catering allowing the unit to provide for specific dietary requirements.
  • Temperature and humidity controlled archive facilities both on and off site.

    Clinical facilities at Germany PI include:

  • 40 bed capacity
  • 6 fully monitored beds – GE Dash 4000 monitoring system
  • 32 non monitored beds – allowing for long residential stays
  • MAC 1200 ECG machines, GE wall mounted monitors
  • Capability to store ECG data in FDA format via a GE muse system
  • In-house catering allowing the unit to provide for specific dietary requirements

Source: Company website

Hybrid CRO model

Where will Veeda be in five years? “I think the aggressive CROs are going to become drug developers in their own right,” predicts Cross. Drawing a parallel to the world of race horses, Cross likens a pharma company to a breeder/owner and a CRO to that of a trainer saying, “Our job is to take the molecules and turn them into racehorses. I think a model that could exist in five years is that pharma companies form a relationship with people like us to search/research new targets, which we will develop until they reach a particular stage. Our tie-up with Bangalore-based Advinus Therapeutics is one of the places we hope to get our leads from. Advinus is already a hybrid, part CRO and part drug developer, because of their Merck relationship.”

“From a business perspective,” Gardi predicts that they “could also be the number one PI CRO in India – not just in terms of revenues, but in terms of reputation and quality. We are positioning ourselves at the top end of PI units.”

Will Veeda expand its services to the later phases? Not likely, because “the later stages are more about number crunching”, points out Gardi. Veeda would have to compete with biggies like Quintiles, Covance, etc and the company sees no strategic value in trying to be everything to every client. The company would rather aim to be specialists and earn a global position in PI studies.

Cross points out that in spite of the pain points, niche players like Veeda have a bright future as Big Pharma downsizes, outsourcing internal drug development to players who are agile enough to turn around trials quickly and move the Go/No Go decisions earlier in the development path. Veeda sure seems to have the vidya to do just that.

viveka.r@expressindia.com