A winning strategy is essential to reach or accomplish goals in pharmaceutical industry. However, maintaining the excellence of Strategic Drug Development Services is a necessary stipulation for the Strategic evolution for Pharma companies. The technologies leading to Pharmaceutical regulatory strategy and Pharmaceutical strategic developments are at the limits of human knowledge. The huge size of the companies, organizations and the complexities of their technologies and processes present many challenges. On the other hand, strategy development and distribution system is highly costly to implement. The effective Pharma strategies can help to generate business exposure, relationship building, and market research. Thus, they are important initiatives to boom overall business in the long term.



Personalised medicine is going to change the shape of the pharmaceutical market in the years to come


As per ICH QA guidelines impurity in a drug substance is any component of the drug substance that is not the chemical entity defined as the drug substance and as per ICH QB guidelines impurity in any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product

Is Blockchain the Right Technology for the Pharma Supply Chain?

A marriage between blockchain and the pharma supply chain is not preordained



In this highly competitive market quality has become the market differentiator for almost all products and services

Designing Sustainable High Performance in Business-to-Business Collaborations

With a cognitive systems engineering approach

In todays fast paced world of biopharmaceutical innovation no one individual or single organisation can really work alone

Today’s Line Managers

More of mentors and facilitators and much less of bosses

Gone are the days when line managers used to visit once in a while for joint working with their team members for a few days meet some important doctors and before leaving issue stern instructions to the team members that they should meet their targets without fail failing which they may not be in the team for long


Swiss government chooses the wrong medicine with reference price system for drugs

Since autumn the first package of costcutting measures in Switzerlands healthcare system is being reviewed One of the measures is the socalled reference price system for pharmaceutical whose patents have expired The Government Health Department has given two models to the consultation


Imagine you could genetically engineer your medical marketing team. You can

Allow yourself a moment to dream Imagine that you could give your medical marketing team superpowers What would they be Being invisible would allow your marketers to watch competitors as they work Being able to read the minds of key opinion leaders would make your medical affairs team incredibly insightful Time travelling market access teams could...


Use Cases in the Pharmaceutical Industry

What is Blockchain A Blockchain is a global distributed ledger or database running on millions of devices and open to anyone where information and particularly anything of value can be moved and stored securely and privately Tapscott et al On the Blockchain trust and integrity amongst strangers is established not by intermediaries but through mass...


Seventy years ago average life expectancy globally was today it is Seventy years ago million people worldwide were infected with smallpox today none The disease is eradicated Thanks to initiatives such as Gavi the Vaccine Alliance more than per cent of children now get early immunisation


In ethically promoting Pharma business field force are the resources who generate prescriptions for the products being promoted thus bring in revenue therefore the figures at the top of the line always depend upon their contribution However not all members of the field force are consistently hitting the numbers If we enable most of the field force...



The increasing cost of research in the west the ongoing tightening of regulations and pricing policies and major funding cuts for biomedical research have led to an increased interest in the outsourcing of clinical trials Not only is the APAC pharma market growing faster than the rest of the world it has a large treatment nave population and has sh...

Why Quality Standards of Drugs has to be the Primary Focus Area for Pharmaceutical Industry

Perhaps not as rampantly in the developed countries but definitely in the developing countries and especially in India access to medicines comes first even earlier than the access to healthcare facilities or doctors This essentially means that come illness most likely one would swallow a pill first and then visit a doctor if at all deemed neces...


How China is investing in its pharmaceutical market

Recent legislation has forced the Chinese regulatory environment to evolve establishing a friendlier environment for pharmaceutical development These changes may opendoors for pharmaceutical companies but they also create the need to adapt to the fastchanging regulatory requirements and the uncertainty that comes with legislative change The...

Advancing Production Capabilities to Boost China’s Pharmaceutical Market

The path forward is paved with Industry 4.0 and brand security solutions alongside regulatory change and new infrastructure

China is the second largest pharmaceutical market in the world according to a Top Markets Report on the countrys pharmaceutical industry by the International Trade Administration The same report also forecast the country to grow from US billion in to US billion by However despite the markets sheer size several hurdles line the path in moving

Integrated Drug Development Strategy

The nexus to value-based pricing

The burgeoning costs of healthcare globally are not sustainable The Tufts Center for the Study of Drug Development reports that it costs on average US million and years to develop and obtain regulatory approval for a new drug Driving up drug prices is the fact that only per cent of drug candidates entering clinical trials result in an approved dr...

Statin Drug Interactions and Related Adverse Reactions

Statins are a wellestablished class of drugs for the treatment of hypercholesterolemia with a proven longterm safety profile Statins have been shown to reduce the risk of cardiovascular morbidity and mortality in patients with or at risk for coronary heart disease Catapano et al Statin use is expanding and approximately per cent of the world popu...

The Evolution of Brand Strategy

As the pharmaceutical market transforms, so does the meaning of brand strategy

Imagine being a fly on the wall when I conduct one of my research interviews in a pharmaceutical medtech or diagnostic company Observe what happens when I ask one of my carefully worded questions Please describe your brand strategy Since I research across many countries and disease areas the answers vary in detail But witness enough interviews and...

The Importance of Post-Hire Screening in the Pharmaceutical Industry

Preemployment background checks are generally wellaccepted as part of the hiring process in highlyregulated sectors such as the pharmaceutical industry With patents and other valuable intellectual propertyoften worth millionsat risk the potential of sabotage from activist groups theft from industry rivals potential insider threats and not to forget...

Biosimilars Interchangeability

Regional views aren’t interchangeable

Around the world regulators view biosimilars rather differently in terms of designating them as interchangeable with the reference product To date the US has taken a conservative approach not with standing the experience Europe has gained in monitoring thousands of patients who have switched from originator to biosimilar products Meanwhile in Asia...

Setting up a Pharmacovigilance System

Pharmacovigilance PV is principally concerned with the identification of Adverse Drug Reactions ADRs and reduction of the associated risks Detection and reporting of ADRs can make prescription of medicinal products much safer and more effective This is possible only if pharmaceutical companies and patients report the ADRs as and when they occur...

Future Prospects of Biotherapeutics and Challenges

Biotherapeutics or biological products are generally produced using living cells or organisms recombinant DNA technology controlled gene expression and antibody technologies It may be manufactured using biotechnology derived from natural sources or produced synthetically Recombinant hormones vaccines monoclonal antibody based products growth factor...

The Human-Centred Biopharma Organisation

To maximise performance it is time to put the human in the centre of the complex multicultural and dispersed ecosystem of biopharma innovation The Challenge of Sustainable Growth The Current Scenario The pharmaceutical industry has changed dramatically over the past years Despite a range of merger and acquisitions within large companies the...


The right steps to successfully break into a new market

Driving Forces for Globalisation As the pharmaceutical industry squares off against the challenge of globalisation there is a greater need for content than ever Driven by forces from both the clinical and commercial sides pharmaceutical companies are experiencing rising costs and competitionwhen conducting clinical trials and commercialising existi...

Life Story

The idea of product life cycle is more useful that you realise

Although its ancestral ideas can be traced back to the late th and early th centuries the concept of PLC as not at a strategic marketing tool is really the child of two later schools of thought Rogers famous Diffusion of Innovation concept with its ideas of innovators early adopter s and laggards showed how and why the adoption of innovative new pr...

China Biopharma

Is a Wave of GMP Exports in Our Future?

Its been a long road beginning with Chinas opendoor policies in the s and membership in the WTO in but Chinas recent and rapid expansion into hightech biopharma manufacturing suggests a future that will involve exports of biologics to Western markets Even before it became the worlds source of toys and electronics China had been animportant exporte...

Failing Data Integrity Audit is not an Option

Asias pharmaceutical manufacturers have seen huge growth in recent years India for example is now the worlds third largest supplier of generic drugs by volume while its domestic market is expected to grow at per cent to per cent CAGR to reach US to US billion in the next decade according to PwC India currently supplies per cent of overthecounte...

Indian Pharma Companies Need Supply Chain Transformation

Unlocking growth

India has emerged as one of the worlds fastest growing pharmaceutical markets over the past decade The industry saw a growth of around per cent per annum between and and now stands at US billion The generic drug sector expanded at an even faster pace of per cent per annum during the same period and now accounts for per cent share of global exp...

Generics in Switzerland

The portrait

In the market reached million Francs US million seven per cent growth in value over but market penetration still lags considerably behind the OECD average The reason the generics market is not yet fully developed in Switzerland is in large part due to a lack of incentives for doctors and pharmacists when it comes to prescription The Swiss generi...

Plotting Efficient Paths for Clinical Development

Clinical development is a complex puzzle with regulatory requirements epidemiology technology and specific clinical expertise all involved in how efficiently a product is developed and ultimately brought to market Many elements of this puzzle are closely related to geography and vary from one region to another As a result thoughtfully considering t...

Trends in Pharma Export Industry in India

While talking about the beginning of Indian pharmaceutical industry it begun in the late s and early s out of the need to meet local shortages and bring down the cost At that time most medicines were imported into India and market was dominated by MNCs Once domestic market was conquered by local companies there was a need to spread their wings in i...

Four Switches of Success

Life science firms exist to meet the needs of patients whilst simultaneously creating value for their shareholders or owners That much is obvious It is also apparent that firms vary greatly in their ability to do these two things the different longevities of companies tell us that What is much less clear is why firms differ so much in their ability...

The Future of Pharma Regulations

The Pharma industry at large is faced with challenges due to fast changing global regulations and many countries moving towards adopting a tighter control over drugs The patent cliff has pushed the industry to maximise their revenue from the existing portfolio in the past few years and thus resulted in expanding their market in emerging markets Thi...

Rigour or Rigmarole

Life sciences companies vary enormously in their size structure and processes but almost every firm shares the annual ritual of the strategic plan Whatever the business the intended outcome of this nearuniversal process is an agreed view on how the firm intends to win in the market place As such it ought to be seen as the most important and fundame...

Analytical Characterisations of Bio-Similar Products and Peptide-based Drugs

Biopharmaceuticals such as monoclonal antibodies and recombinant proteins have emerged as important lifethreatening therapeutics for the treatment of diseases including cancer Recently products are approved for various human diseases in the United States of America and the European Union Moreover biopharmaceuticals are currently in various stages...

Decision-making in Vaccines

How the fusion of price with access risks a tragedy of the commons

In four global vaccine producersSanofi Pasteur Merck Pfizer and GSKinvested significantly over US m each in global vaccines RD each year This has shrunk from global RD vaccine producers in and in Today there are only two producers for each of the northern hemispheres principle infant adolescent and adult vaccines In the past these RD based pro...

State of Pharmacovigilance

Proposals for streamlining the system

In recent years pharmacovigilance has been recognised as being one of the most important sciences in the health sector and this has led to develop new regulations and guidelines not only in Europe but also in the developing countries around the world The only goal of pharmacovigilance is protecting safety and this of course is also the aim of new r...

Growing the Regenerative Medicine Industry in Asia-Pacific with Help from Regulatory Science

Despite the scientific advances and progress in medicine there are only a few effective ways to treat the root causes of many injuries and diseases especially agerelated diseases Regenerative Medicine RM has the ability to repair and regenerate tissues and organs damaged by injuries diseases or the natural progression of age These therapies have th...

The Genetically Modified Organisation

New research points to how leaders can accelerate their firm’s evolution

In a market characterised by change it is a truism that life science companies must adapt to survive Yet such change is notoriously difficult as the extinction of our industrys great names shows Between and for example the Pharmaceutical Research and Manufacturers of America PhRMA lost per cent of its members This attrition suggests that CEOs la...

Competing on Alignment

The most powerful strategic management tool is also the most misunderstood Consultants often use military analogies comparing competitors to enemies and strategies to battle plans This tradition arose in the early days of strategic planning in the s when many executives and writers had personal experience of military life But for the life scienc...

Sustainable Antibiotics

Evolving pharmaceutical supply chain to ensure effectiveness

Tackling the challenge of supply chain security in the face of antibiotic resistance Antibiotic resistance Antimicrobial Resistance AMR also called antibiotic resistance is a reality AMR renders antibiotics ineffective meaning they can no longer fight bacterial infections and ultimately become useless Every year AMR is responsible for nea

Prospects for Personalised Medicines in the Asia-Pacific Region

Personalised Medicine PM is the wave of the future but will the waves be bathing the shores of AsiaPacific with the same market force as they do on either side of the Atlantic Personalised medicine also called precision medicine encompasses treatment approaches that target the medicines used based on the characteristics of the individual patient ra...

Microfluidic Organs-on-a-Chip

The patent landscape

Traditional methods of drug discovery in particular the use of animal testing suffer from many limitations including a the length of time and high costs associated with animal trials b the loss of animal lives and c the failure of animal tests to accurately predict human responses Twodimensional D cell cultures have shown value in biomedical rese...

Regulatory Considerations for Forced Degradation Studies to Assess the Stability of Drugs

Quality safety and effectiveness are the most important attributes of drugs and pharmaceuticals Because of its key role in public health the pharmaceutical industry has always been a comparatively highly regulated industry Until the end of nd World War the quality of pharmaceutical products was determined mainly by assaying the content of their act...

What are the 10 Hot Topics in Pharmaceutical Operational Excellence for 2015?

Status Quo Analysis from an Operations Management Perspective

The competence centre for Operational Excellence OPEX at the Institute of Technology Management at the University of St Gallen Switzerland ITEMHSG has focused its research for more than ten years on the challenges faced by pharmaceutical companies in their pursuit of Operational Excellence Over time the researchers have been able to sustain a datab...

The Lasting Advantage

Why are some firms more competitive than others This is the central question of my research in the field of strategic management Decades of research in both the life sciences and other industries have converged to suggest there are perhaps three overarching reasons The first is the most obvious what academics call the ResourceBased View of the Firm...


The patent landscape

Additive manufacturing or D printing as known more widely is revolutionising the manufacture and distribution of products With the expirations of the basic additive manufacturing patents anyone can purchase an inexpensive printer and replicate products But these products are often protected by various forms of intellectual property laws

Creating and Sustaining Cultural Change by Focusing on Operational Excellence

Over the past decade the importance of Operational Excellence OPEX in the pharmaceutical industry has grown significantly A mere copy and paste from successful automotive excellence programmes does not work for the pharmaceutical structural requirements in the long run Friedli et al This has been realised by most of the pharma companies in the pas...

Contract Research organisations

An Outlook

Financial performance of large innovative pharmaceutical companies in indicated a gloomy prospect for these wellestablished leaders in their domain This trend is expected to grow as many drugs are going offpatent in time to come

The Six Great Shifts

Transforming the pharma industry

Many languages have an equivalent to the expression Seeing the forest for the trees meaning the ability to discern the big picture from little details That ability is important in life but especially true for leaders of life sciences sector Every day we are bombarded with news of innovative technology tighter regulation and new approaches to contro...

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