Pharmacovigilance Growth Trends : Global Industry Analysis, Size, Share, Growth,and Forecast, 2013 – 2019

According to the World Health Organization (WHO), pharmacovigilance is defined as a series of actions performed to assess, detect and prevent any possible adverse effects of pharmaceutical products, and minimize the medication risks. It majorly focuses on the assessment of adverse drug reactions, which are lethal responses to drugs that occur at the doses used for treatment of a disease or used in the modification of physiological functioning. Medication issues such as drug overdose and drug abuse are also checked for, as they too may lead to some adverse drug reactions. Pharmacovigilance aims at ensuring optimum patient care and safety with respect to the usage of medications and also provides reliable information about efficient evaluation of the possible hazard and benefit profile of drugs.

The market for pharmacovigilance has a huge demand as all pharmaceutical license holders need to understand and comply with its guidelines. This market can be segmented based on the different technologies including drug safety database systems, signal detection systems and others. Regulatory guidelines for the same are stated by the U.S. FDA, EMA and other regulatory bodies. These regulations and guidelines provide a framework for the companies to follow in order to carry out pharmacovigilance activities.The major factors driving growth of this market are need for efficient drugs, continuous technological upgradations, increased focus on patient care and patient safety, and intensification of safety regulations by various regulatory bodies. These factors boost the uptake of pharmacovigilance systems by pharmaceutical companies. Reluctance of companies towards adoption of new technologies, lack of proper education and training to the resources, and lack of awareness about prevailing pharmacovigilance systems might hamper the growth of the market. Currently, majority of the companies are outsourcing their pharmacovigilance operations for the purpose of cost effectiveness. The scope of these systems can be further enhanced by integrating them with other data sources such as clinical databases and medical records. These advanced and novel approaches further enhance the decision making on safety and efficacy of drugs, and provide relevant and reliable information.

Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019," the global pharmacovigilance market was valued at USD 2,147.3 million in 2012 and is estimated to reach a market worth USD 5,008.2 million in 2019 at a CAGR of 12.9% from 2013 to 2019. A rising tide of regulatory expectations, tougher inspection regime and instant need of patient reporting has provided the much needed impetus for the growth of the pharmacovigilance market. An upsurge in number of acute and chronic diseases has consequently led to a rise in number of drug consumption, which has also elicited a growth in the number of adverse drug events and drug toxicity cases. Moreover, several high-profile safety issues, regulatory warnings, large volume of events to be reviewed along with negative media coverage have compelled the pharmaceutical players to take support of various outsourcing services. There are two major outsourcing services opted by these pharmaceutical players i.e. traditional CROs and BPOs. These outsourcing services not only provide cost savings but also help in bringing process efficiency. Pharmaceutical companies are now forming long term partnership with the CROs and BPOs to share the costs involved in PV process right from drug discovery to post marketing approvals. In addition, PV requires skilled resources with excellent language skills and strong knowledge pertaining to case reporting. 

The research report on pharmacovigilance provides detailed analysis of the global market and helps in understanding the driving forces responsible for the growth of this market. The report discusses the market of pharmacovigilance market on the bases of clinical trials phases i.e. Phase I to III and post marketing surveillance (PMS). We have also mapped the trend for preference of the pharmaceutical players for in-house and outsourcing in our chapter by type of service.The global pharmacovigilance market has been segmented based on all the above mentioned parameters and market size estimates and forecasts for the period of 2011 to 2019 have been provided for each of the segments, in term of USD million, considering 2012 as the base year for calculations and 2011 representing as the historical year. The CAGR (%) of each market segment for the forecast period 2013 to 2019 has also been provided along with market size estimations. The report exclusively studies the aforementioned segments with respect to geography. Under geographic section we have covered four regions, namely, North America, Europe, Asia-Pacific and Rest of the World (ROW). 

The market overview section gives a detailed qualitative analysis of the factors responsible for driving and restraining the growth of the global pharmacovigilance market. The section also covers opportunities and market attractiveness analysis of the geographical regions.The report concludes with the competitive landscape and company profiles of major market players. These market players have been profiled on the basis of various attributes such as company overview, financial overview, business strategies, product portfolio and recent developments. Some of the major players profiled in this report include PRA International Inc., Covance Inc., Synowledge LLC, OptumInsight Inc., iMedGlobal, TCS, iGATE Corporation, Cognizant Technology Solutions, Quintiles and others.

Pharmacovigilance Trends: Getting to Know the DSUR

In 2010, the International Conference on Harmonization (ICH) rolled out its E2F Development Safety Update Report (DSUR) guideline. The DSUR is similar to the US’s Investigational New Drug Annual Report (IND-AR) and the EU’s Annual Safety Report (ASR) in that its purpose is to provide a brief overview of safety for a project on an annual basis. Although both the Food & Drug Administration (FDA) and EU Clinical Trial Directive required what is termed as IND AR and ASR, respectively, the content, format and timings differed between the US and EU reports. Considering that most contemporary trials are multinational, a need was felt towards harmonizing these requirements and to provide a uniform standard acceptable to all regulatory agencies across the world. The concept of a DSUR was first introduced by the CIOMS VI working group and taken forward by the CIOMS VII working group. In 2008, the ICH published a draft guideline E2F on DSUR, which has been updated in August, 2010, incorporating background, objective and scope of DSUR and providing guidance on DSUR contents.Major features of the DSUR are that it covers an entire Investigational Medicinal Product (IMP) rather than just an indication, and that much of its information is cumulative from inception of the project.     

FDA’s planned updates for Module 1

Among these is a new Section 1.13.15, for the DSUR, but FDA’s Module 1 update is not expected to be implemented until early 2013.  As per Connie Robinson (FDA personnel), “Currently for an IND, it would be acceptable to place the DSUR as a single document in Section 1.13.3 Summary of Safety Information. You should state that the DSUR is being submitted in place of the IND annual report in the cover letter and provide a link to the document if possible. If information (other than the granular annual report information) is expected as a part of the DSUR, but the information should be placed in its own designated e-CTD location.”

Usefulness of DSUR

DSURs, which are an enhanced report over the previous required reports, contain not only an evaluation of safety information collected in the past year but also includes a cumulative review of existing safety information. This evaluation allows the sponsors the ability to identify and evaluate potential risks with the drug and make appropriate adjustments to their clinical development program.The DSUR expects more information than its predecessors (IND-ARs and ASRs) including patient data from the inception of a project, and could thus take more time for a company to prepare. As with most things, once a process is put in place and becomes familiar, subsequent reports will become smoother to produce.

Points to Remember

1.      A DSUR should be submitted until the last visit of the last patient in the Member States concerned, as specified within the protocol.

2.      The data lock point (DLP) for a DSUR reporting period is the last day (or the last day of the month, ICH E2F section 2.2) before the anniversary of the DIBD (Development International Birth Date), the date on which the product was first authorized for testing in humans anywhere in the world. IBD (International Birth Date), the date on which the product was first approved for market anywhere in the world can also be acceptable.

3.      The first DSUR period should not be longer than 1 year. The DSUR is always submitted on a yearly basis.

4.      For transitional period: The DIBD and the European Birth Date (EBD) of the previous

5.      ASR should be aligned in such a way that DSUR periods that are substantially longer than 12 month as well as overlapping DUSR periods are avoided.

6.      A DSUR is required for Phase IV clinical trials, if only such trials are conducted.

7.      Submission of one single DSUR is strongly recommended if the same IMP is used in the clinical trials.

8.      A separate DSUR for a comparator, placebo or non-IMP is not required. However, relevant safety information of the above mentioned drug types should be addressed in the DSURs of the investigational drugs.

9.      The Investigator Brochure (IB) or Summary of Product Characteristics (SmPC) can be updated during the DSUR reporting period.

Since CDSCO does not require DSUR, for Indian pharmaceutical companies undertaking a global trial for a locally developed drug, Indian regulators will not have real-time update of the drug's developing safety profile, while foreign regulators (such as tripartite countries) having requirement of DSURs will have this information. With the global focus on DSUR, Schedule Y needs to be revised incorporating similar provision of providing cumulative safety updates to the regulators during clinical development phase.

India: Robin Hood of the Pharma World

India’s pro-consumer patent regime is an exciting alternative to the dominant IP model pushed by the US

Gilead’s Sovaldi is a wonder drug sold at a shocker price. It is the most effective cure for Hepatitis C, and is in high demand. But the drug has caused an outrage in the US where patients, healthcare providers and insurers have questioned its exorbitant price tag. For a a 12-week course, Sovaldi costs $84,000 (₹50,00,000).Sovaldi was also in the news for an entirely different set of reasons. Earlier this month, an Indian generic firm, Natco, filed a ‘pre-grant opposition’ to Gilead’s patent covering Sovaldi. The move could result in the Indian Patent Office rejecting Gilead’s patent, bringing down the price to a fraction of its current price.This is not a one-off incident. India has tackled the issue of unaffordable prices of drugs protected by patents by incorporating a remarkable array of provisions into its intellectual property (IP) law.

These provisions qualify as ‘legitimate flexibilities’ allowed under the WTO’s Trade Related aspects of Intellectual Property Rights (TRIPS) Agreement.

And they fall under three heads: provisions for curbing the grant of patents for new forms of known substances (known as ‘evergreening’); allowing third-party competitors to question a patent application before its grant; and introducing provisions for compulsory licensing, including the grant of compulsory licence for not working the patent locally.On the one hand, incorporating these flexibilities have resulted in the revocation of patents covering drugs of leading pharmaceutical companies, such as Merck, Pfizer, Eli Lilly, GlaxoSmithKline, Novartis and Roche. This has allowed Indian generic companies to produce those drugs, leading to allegations of IP ‘theft’.

On the other, Indian generics makers were able to provide generic versions of these drugs to other markets at a fraction of their cost, earning India the title of ‘pharmacy of the developing world’.If there is an idea that captures the outcome of the last six decades of patent law reform in India, it is the legend of the heroic outlaw, Robin Hood. India is the Robin Hood country.

Rob the rich, give the poor

Often accused of tolerating and even promoting roguish behaviour — of robbing the intellectual property of the rich and giving it to the poor — the accusations against India reached an all-time high recently. The US Chamber of Commerce made strong requests to the US Trade Representative (USTR) to categorise India as a “Priority Foreign Country”, a status reserved for the worst offenders of intellectual property rights.In its formative years, Indian IP law did not grant patents for pharmaceutical products; this contributed to the creation of a vibrant generics industry supplying cheaper drugs both nationally and internationally.

In its post-TRIPS form, the law now requires a higher standard of patentability for improvement patents covering existing drugs.India, therefore, maintains two positions in tandem: as a safe haven for ‘patent busters’ by providing a legal framework that has exceptionally denied the maximum number of patents on medicines in the last decade; and as the pharmacy of the developing world.

The ‘roguishness’ of states

Intellectual property debates often revolve around the metaphor of property. The law ascribes property status to intangible things, such as ideas. One of the advantages of using the language of property is to ensure that, like real property, IP too can be stolen.

An entire array of terms has been used to define what an act of IP infringement is legally: stealing, copying, counterfeiting, theft, etc., and the persons who participate in these activities have been called ‘thieves’ or ‘pirates’. There is little tolerance for roguish behaviour under IP law. Not only persons, even countries are sometimes classified as ‘rogues’ if they fail to offer proper protection for IP.

The USTR meticulously publishes the IP compliance data sheet of all the countries that matter and takes care to classify nations on the level of protection offered for IP.The roguishness of states can be understood by the tag ascribed to them: ‘Watch List’ or the ‘Priority Watch List’ refers to countries with particular problems when it comes to IP protection and enforcement; ‘Priority Foreign Country’ refers to countries with the worst IP policies and practices. The US has put India on the Watch List ever since it became a member of the WTO.

But now, with severe pressure from the US Chamber of Commerce, India could be designated “Priority Foreign Country”.India introduced pre-grant opposition of patents as a means of checking the validity of patents before their grant, a provision that has resulted in the rejection of many drug patents for minor improvements including Novartis’ controversial anti-cancer drug Glivec.

India’s grant of compulsory licence to Bayer’s Nexavar is yet another instance of tweaking the law to suit public interest.This is the first non-essential compulsory license issued in the absence of a medical emergency at the instance of a generic manufacturer.India’s patent law also requires proof of enhanced efficacy for patents on new forms of known substances, another provision that has resulted in a heightened standard of patentability that patentees have not been able to meet in this market.

The cost of being Robin Hood

Being Robin Hood comes at a cost. Persecution and emulation are the two inevitable consequences. On the one hand, India’s efforts to redefine and redesign patent laws met with strict opposition from the US and the European Union.On the other hand, countries such as Brazil, the Philippines, Brazil and South Africa have either emulated or strongly favoured following India’s path. India’s patent reforms have a remarkable extraterritorial impact.

The strict opposition to India’s patent laws comes from the fact that it provides an alternative model of compliance with the TRIPS Agreement vis-à-vis the dominant model propagated by the US.Understandably, India’s alternative model of law has seen stiff resistance in the form of counter-provisions in Free Trade Agreements (FTAs) entered by the US and other countries.As in most cases involving the clash of ideologies, both the law and its applications are areas of contention.

Tamarind, anti-depressants may lead to toxicity in body: Study

Previous studies have shown that garcinia cambogia may, in fact, increase the levels of serotonin -- a neurotransmitter. New research found that taking the supplement in combination with anti-depressants known as selective serotonin reuptake inhibitors (SSRIs), which also cause serotonin levels to rise, could lead to serotonin toxicity."People who are taking SSRIs should not use garcinia cambogia at least until further research is done," said D Robert Hendrickson, a toxicologist at Oregon Health and Sciences University.

In India, garcinia cambogia is better known as Malabar tamarind. This fruit originated in Indonesia, but is grown and cultivated along the western ghats of Kerala. Sri Lanka and Malaysia are also well acquainted with the garcinia cambogia. The hydroxycitric acid (HCA) compound in the fruit is touted as a fat-burning, metabolism-boosting, appetite-suppressing weight-loss product.

Jubilant gets nod for generic drug

Drug major Jubilant Life Sciences has received a nod from the US Food and Drugs Administration (FDA) to market a generic diuretic medicine, the company said on Friday.The Spironolactone tablets (25 mg, 50 mg and 100 mg), which received the abbreviated new drug application approval, is the generic version of GD Searle’s Aldactone. It is used to treat fluid retention in the body caused by conditions such as congestive heart failure and cirrhosis of the liver.Jubilant said it will launch this product, which has a market size of $87 million a year, in the first quarter of the fiscal year 2015-16.

Strides Arcolab gets USFDA nod for Bangalore facility

Drug firm Strides Arcolab's manufacturing facility in Bangalore has been approved by the US health regulator after a successful audit of the plant, the company said on Friday.

"Oral Dosage Forms manufacturing site (KRS Gardens) in Bangalore was recently inspected by the US Food and Drug Administration (USFDA) as part of GMP compliance audit and the facility continues to be approved," Strides Arcolab said in a statement.

The last USFDA inspection and approval for this facility was in the year 2011, it added.

The KRS Gardens facility in Bangalore manufactures oral dosage forms such as tablets, capsules (both hard gelatine and soft gelatine) and sachets.

The manufacturing plant supports important current and future submissions for the US market, the company said.

Strides Arcolab shares were trading at Rs 505.35 apiece on the BSE in late afternoon trade, up 8.44 per cent from its previous close. 

 

Sun Pharma drug facility banned after FDA found data flaws, rat traps

Testing flaws, a garbage pileup, and a ‘un-cleanable’ laboratory led to the FDA ban, according to an inspection report

According to the FDA’s November report, the inspectors reviewed Sun Pharma’s recordkeeping and the integrity of its data at the plant, which makes cephalosporin antibiotics as well as bulk ingredients for the medication.

US regulators who visited a Sun Pharmaceutical Industries Ltd drug plant in India before the facility was banned last month from exporting to the US saw testing flaws, a garbage pileup, and a laboratory they called un-cleanable. The Food and Drug Administration (FDA) inspectors observed that some workers misrepresented test data and deleted undesirable results, according to an inspection report known as Form 483 that Bloombergobtained via a Freedom of Information Act request. There were rodent traps and a strong smell of urine in a quality-control lab area and bathrooms were in total disrepair, with what appeared to be human waste on a wall, the report said.

On 12 March, the agency barred the antibiotics plant in Karkhadi from exporting to the US, the factory’s primary market. The findings of the November inspection haven’t previously been reported, and the FDA didn’t disclose specific reasons when announcing the ban.

“We have sent our response to the FDA and given that the facility now has an import alert, it’s clear that the FDA does not agree with our view,” Sun Pharma said in an emailed response to questions from Bloomberg News. “In this process, we have learnt and have resolved to work on further strengthening our systems and controls.”Sun Pharma this month agreed to buy Ranbaxy Laboratories Ltd, which has four factories banned by the FDA. Last year, Ranbaxy agreed to pay $500 million to settle a whistleblower lawsuit and federal criminal charges that the company sold adulterated drugs while lying about it to the regulator.

Generics demand

Indian drug makers have become major sellers to the US as demand for cheaper generics rises. The industry is also an essential provider of affordable medicines at home and in other parts of the developing world such as Africa.Drug factories in India are coming under greater scrutiny after the FDA imposed restrictions on several suppliers of generic medicines to the US for failing to meet manufacturing standards. Sun hasn’t faced FDA curbs in the past five years even as the regulator barred some factories from Indian rivals including Ranbaxy and Wockhardt Ltd over the last year.

Spokesmen at Ranbaxy and Wockhardt didn’t immediately respond to calls and emails seeking comment for this article.Founded by Indian billionaire Dilip Shanghvi in 1983 with five psychiatry products and a single manufacturing facility, Sun has grown into a company with net sales of Rs.11,240 crore in the year ended March 2013, with production sites in other parts of India and several countries including the US, Bangladesh, Hungary and Israel.

Negligible contribution

While Sun’s banned facility contributed less than 1% of revenue in 2013, the stock could be affected if operational risks become repetitive, Balaji Prasad, an analyst at Barclays Plc in Mumbai, wrote in a 13 March note to clients. The facility has a negligible contribution to Sun’s revenue, the company said when the FDA issued the import ban.Sun Pharma rose to close at Rs.625.60 in Mumbai trading on 23 April. The stock has advanced about 10% this year, outpacing the 8.1% increase in the benchmark S&P BSE Sensex.

Corrective steps

According to the FDA’s November report, the inspectors reviewed Sun’s recordkeeping and the integrity of its data at the plant, which makes cephalosporin antibiotics as well as bulk ingredients for the medication.The inspectors observed that analysts regularly delete undesirable chromatographic results, and products are retested without initiating an investigation. Manufacturing waste, old equipment and other garbage was seen in the facility’s perimeter manufacturing areas making them susceptible to pests, the report said.Sun Pharma has implemented corrective measures on cleanliness at the plant, and where testing procedures weren’t properly followed, it has taken the necessary disciplinary action and replaced equipment, according to the email to Bloomberg News. The drug maker said some of the FDA’s observations were related to the surrounding areas of the buildings, and it hasn’t made a final decision on whether to shut the facility.

The FDA in an e-mailed statement to Bloomberg News declined to comment further.

In 2009, the FDA ordered manufacturing to be halted at Sun’s Detroit-based unit after a string of recalls over manufacturing defects. Three years later, the FDA cleared the subsidiary to resume operations with two products, according to a company statement at the time. Sun Pharma didn’t immediately respond to an e-mail requesting an update on that unit.

Data integrity

The FDA last year banned about 20 plants in India from exporting drugs to the US and warned several others.The latest ban on Ranbaxy occurred in January, when the FDA barred one of its plants from exporting to the US after finding workers there overwrote raw data collected on samples over five months until they got acceptable results.“It’s not like our quality expectations are that radically different from the US,” said Ajit Mahadevan, Mumbai-based leader of the life sciences consulting group at Ernst and Young, referring to the Indian drug industry. “It’s just that in its execution, there’s a lot less intensity perhaps, and people get away with a lot more.

FDA keeps close watch on pharmacies

AURANGABAD: Following restrictions implemented by the Food and Drug Administration from March 1, 2014 for the sale of 46 drugs off-the-counter (OTC), FDA inspectors from the Aurangabad division had launched a weeklong inspection drive on March 27.

The inspectors had monitored around 150 medical stores over the week and found that pharmacies have started maintaining a register of supply and sale of these 46 drugs under the notification.

"Around 80% of medical stores sell medicines under this schedule in the city. Hence the department had taken up the inspection drive to check whether they were maintaining proper records," said Viraj Paunikar, the Aurangabad division joint commissioner, drugs. "The inspectors are also making sure that these medicines will be dispensed by a pharmacist only on the prescription of a registered medical practitioner as defined under the Drugs and Cosmetics Act," he said.

"Chemists will have to keep a record, with the name and address of the prescriber, the name of the patient, the name and the quantity of the drugs supplied that have been brought under the newly-inserted Schedule H1 in the Drugs and Cosmetic Rules," Paunikar said.

"Such records shall be maintained for three years and be open for inspection by the Drug and Controller General of India (DCGI). Violation can result in cancellation or suspension of licence and even prosecution. The state drug inspectors or FDA inspectors are authorized to conduct surprise inspection at any retail medicine shop and check the register," he said.

Paunikar said some of the retail pharmacists - there are 8,000 total in the Aurangabad division - equipped with logistics like computers are maintaining the records online, while others are keeping separate registers with columns marked with the patient's name and address, the doctor's name and address, invoice number, date, the drug and the quantity supplied.

"The notification aims to regulate the sale of the antibiotics that are being presently sold over-the-counter (OTC) without any check and mandatory prescriptions from doctors," the official said.

If a specific medicine contains a drug substance specified in Schedule H1, the drug formulation shall be labelled with the symbol Rx in red and conspicuously displayed on the left top corner of the label, the notification states.

Posted by: Indian Biological Sciences and Research Institute, NOIDA

World Malaria Day 25th April 2014

World Malaria Day is a chance to shine a spotlight on the global effort to control malaria. Each year, Roll Back Malaria (RBM) partner organisations unite around a common World Malaria Day theme. Invest in the future: defeat malaria is a three-year theme partners chose for the period of 2013-2015 to call attention to the need to reach the 2015 Millennium Development Goals and defeat malaria in the future.

Malaria Worldwide

·         3.3 billion people - half the world's population - are at risk of malaria

·         One million people die each year from malaria

·         Every 30 seconds a child dies from malaria

Malaria in Africa          

·         90% of all malaria deaths occur in sub-Saharan Africa

·         1 in 5 childhood deaths are caused by malaria

·         Malaria is responsible for a 1.3% growth penalty per year in some African countries

·         10,000 pregnant women and 200,000 infants die from malaria in Africa

·         Malaria costs Africa more than $12 billion in lost GDP every year

Malaria remains one of the world's biggest health challenges, with efforts across the world to eliminate the mosquito-borne disease failing so far.April 25 has been named as World Malaria Day, to remind the public and the world that malaria is both preventable and curable

Mortality rates falling

Malaria mortality rates have fallen by 42 per cent globally since 2000, but still approximately half of the world's population is at risk from the disease. The World Health Organization says it killed around 627,000 people in 2012.Most of the malaria cases and deaths occur in sub-Saharan Africa. In Asia, the greater Mekong sub region countries of Cambodia, Thailand, Vietnam and Myanmar, are showing parasite resistance to artemisinin, the major component in anti malarial drugs.With three out of four people being at risk of malaria in South-East Asia region, World Health Organization today called for greater investment in the battle against malaria on the occasion of World Malaria Day. Even though the number of confirmed malaria cases in the Region, which is home to a quarter of the world’s population decreased from 2.9 million in 2000 to 2 million in 2012, the disease remains a significant threat to the lives of people.

’1.4 billion people continue to be at risk of malaria in South-East Asia. They are often the poorest, including workers in hilly or forested areas, in development projects such as mining, agroforestry, road and dam constructions, and upland subsistence farming in rural and urban areas,’ said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia. Stressing that the funding needs to be increased for diagnostics, drugs, insecticide-treated mosquito nets, and research and response to drug and insecticide resistance, Singh said, ‘We need to empower communities to protect themselves. Eliminating malaria will take greater political will.

India is expected to decrease malaria case incidence by 50?75 per cent by 2015. Sri Lanka is in the elimination phase with no indigenous case reported since November 2012. Maldives has been malaria-free since 1984. Bangladesh, Bhutan, Democratic People’s Republic of Korea, Nepal, and Sri Lanka reduced the incidence of malaria cases by more than 75 per cent from 2000 to 2012. Thailand and Timor-Leste are on track to achieve a decrease of over 75 per cent.

Artemisinin-based combination treatment (ACT) is currently the first line treatment for the most lethal type of malaria, Plasmodium falciparum. Resistance to this drug would compromise the lives of hundreds of thousands of people affected with malaria, and there is an urgent need to invest in ways to contain the spread of resistance to these drugs, said Singh.
‘Another danger lies in the fact that the Anopheles mosquitoes, which carry malaria parasites, are increasingly become resistant to insecticides. ‘Investments are needed to develop new tools, to conduct operational research to address bottlenecks in malaria control programmes, and to scale-up and ensure rational use of existing interventions,’ said Singh.

Skill Requirements for the Regulatory Affairs Function

In an ongoing effort to keep our clients and candidates informed of job market trends specific to their function, we have highlighted 5 areas where this demand for skills and experience is most acute, giving companies recruitment challenges and candidates opportunities.

1 – Emerging Markets skills still in demand

The emerging markets of the BRICS and the Next 11 emerging economies have created new commercial priorities for pharmaceutical companies. While macro-economic have created some recent economic weakness in these markets, the long term trend is towards considerable growth. This new commercial importance has placed considerable emphasis on ensuring the right regulatory leadership is in place to drive optimal drug approvals in emerging markets. Equally, companies are adapting to new operational models with more expertise being placed closer to the markets themselves. Finally, the global leadership of a regulatory function in coming years will almost certainly demand emerging markets experience in the experience profile of the appointee, placing a strategic incentive on acquiring that experience if you are ambitious for future leadership roles.

2 – Orphan Drug experience valuable

Orphan Drugs and Rare diseases were the story of 2013. Quite simply this sector is hot, and whether it is rare cancers or other rare genetic disorders, the orphan drug sector is experiencing considerable innovation and investment. With a rapidly developing global pipeline of new innovative therapies aimed at the 7000+ rare diseases, experienced regulatory professionals who understand the orphan drug designation process and perhaps have already assimilated the knowledge around recent initiatives like the FDA’s breakthrough therapy, PDUFA derived from FDASIA, suddenly find themselves in considerable demand. These people are experienced in conducting constructive dialogue with agencies to look for effective pathways for approval of new and innovative therapies for treating rare and ultra-rare diseases.

3 – Biosimilars sees promise of investment  

Biosimilars has seen considerable investment in recent years. While the biosimilars story is nothing new, the focus it is now receiving in multiple large innovative pharma companies is placing greater and greater emphasis on surrounding these investments and business units with the qualified expertise required to carry out effective biosimilar development. Liftstream forecasts that in 2014/15, the market will see an inflection in biosimilars recruitment and the global innovator companies are to lead this growth. In particular, companies with considerable experience in biologics drug development and manufacturing will be most visible. Regulatory Affairs professionals with specific expertise and experience of the biosimilars regulations and the manufacturing challenges will be in increasing demand for both their conceptual and practical knowledge.

4 – Disease specificity drives suitability

There are several underlying reasons for the increase in skill specificity. Liftstream would be pleased to talk you through those reasons if you have a genuine interest. The most simple to convey though is that in general terms companies need people to bring very specific capabilities which can be applied almost instantly to the projects or tasks to be delivered. This does not afford the degree of cross-training or ‘development’ that is often thought of when considering to apply for new jobs. Employers are also responding to a need to see the value of employees returning sooner, as employee retention is on a long-term declining average and the market becomes more competitive as the economy improves. One of the outcomes of this is simply that regulatory affairs professionals are being recruited increasingly to have disease area specificity. This is particularly true in areas like oncology, CNS, immunology and many rare metabolic disorders. This trend is set to continue and disease experts will be highly sought after.

5 – Market Access collaboration growing feature

Successful clinical and regulatory affairs strategies are only part of the story these days. The third and increasingly high-hurdle is the payer challenge. Getting pricing and reimbursement for new therapeutic products is proving very difficult, especially in Europe, and only highly innovative therapies with are first in class and best in class are commanding their prices and achieving access. Liftstream believes that the increasing convergence of the world of regulatory with market access is set to continue. Multi-stakeholder dialogue is a new imperative in planning clinical development. These new and critical strategies must be integrated and so regulatory affairs professionals are going to be increasing exposed to market access responsibilities. The next 5-10 years provides an excellent opportunity for regulatory professionals to use this momentum in market access to create a new career pathway for themselves as either responsibilities morph together or you acquire skills which open new avenues.

If you would like to conduct a review of your regulatory affairs recruiting strategy or would be interested in discussing your career plan, please contact Liftstream here for a confidential consultation.

     Pharmacy, Life Sciences, Biotech, Medical Professionals can update their knowledge to enter into world of Regulatory Affairs by joining course at IBRI,Noida  www.ibri.org.in

Weekly Training Programs for Lifesciences Professionals

IBRI has introduced One Week Workshops for students to utilize their summer vacations in order to gear /train themselves for 21^st Century Knowledge-Led-Economy. The Workshops are on the topics/domains which will Increase Excellence for Breakthrough In Career Competency            Earning Value.

       The aim of the workshops is to endow the participants Practical Hands-On-Experience Apart From Theoretical Knowledge For Total Expertise On The Subject.

S.No	Workshop On	Duration	Eligilibility
1	Genomics & Proteomics	1 Week	Graduate/PG /Professional
2	Next Generation Sequencing	1 Week	Graduate/PG /Professional
3	Computer Aided Drug Designing & Cheminformatics	1 Week	Graduate/ PG/Professional
4	Human Genetics; Concepts, Methodology & Applications	1 Week	Graduate/PG /Professional
5	Clinical Trials	1 Week	Graduate/PG/ Professional
6	Biostatistics & Research Methodology	1 Week	Graduate/PG /Professional
7	Database Management Systems & Biological Database	1 Week	Graduate/PG /Professional
	Computer Sciences Workshops	1 Week	Graduate/ PG/Professional
1	Information Technology: Basics	1 Week	Graduate /PG/Professional
2	Database Management Systems	1 Week	Graduate /PG/Professional
3	E- Commerce	1 Week	Graduate /PG/Professional
4	C,C++,asp.net,Php,and more	1 Week	Graduate /PG/Professional

           

Posted by:Indian Biological Sciences and Research Institute, NOIDA