Foreword

CLINICAL TRIALS

Leveraging wearables effectively

An estimated million people use connected wearable devices according to IMARC

Digital Technologies and Pharma

Heading towards an effective transformation

Who would have imagined internetconnected medicine to be a reality until the FDA approved schizophrenia pill came into the market in late

Blockchain in Pharma

Patient safety and beyond

In the digital age where technology is leading the way blockchain has emerged as a disruptor in several industries from financial services to energy and life sciences Blockchain allows visibility and data integrity along with security against data hacking through decentralised blocks linked by the cryptography technique The pharma industry has f...

China\'s Regulatory Reforms

Promoting pharma innovations

In recent years Chinas investment in drug innovation has been on the rise The countrys pharmaceutical market is second only to the US at approximately US billion as of and is expected to increase at a CAGR of per cent to US billion by Interestingly China has become the leader in API manufacturing and exports Historically the pharmaceutical marke...

Pharma R&D Data

Integration and analytics

Despite years of efforts drug development continues to be challenging complex costintensive and timeconsuming The pharma RD process requires years of research and huge data gathering Through the whole process from discovery and development to clinical trial a drug developer would have gathered massive data on compounds diseases patient information...

Continuous Employee Screening in Pharma Industry

The new normal?

Continuous screening provides employers with a valuable tool to best evaluate their risks and ensure they place their employees in the most appropriate positions Lucia Bone Performing background verification or screening of new hires has been a practice the world over to ensure the organisation employs individuals that are talented and skilful a...

Human-Centred Design in Biopharma

Need of the hour

If we hope to create something of lasting value we need to start with what people want not just with whats technically possible IDEO a global design firm Innovation and technology advancements play a key role in product design and development but it is imperative that companies bring in a humancentred approach The advent of new technologies suc...

Modelling & Simulation in Drug Development

Modelling Simulation in Drug DevelopmentPharma companies look to improve experimental drug success rate and accelerate clinical development while striving to improve efficiency costeffectively It is imperative for companies to be cautious in decision making to increase the probability of commercial success for developing the drug Major pharmaceuti...

Reviving Pharma Productivity

Pharma industry has witnessed a staggering decline in RD productivity and is now a major cause of concern for the industry players This decline contributed to a downfall in the return on investments over the last two decades Interestingly there has been a trend reversal with increase in clinical trial success rate and drug development during Incre...

Patient Recruitment and Retention

Creating Effective Strategies

From initiation to marketing of the drug compounds face numerous challenges to become an approved drug Apart from preclinical financial and approval stages successful recruitment of patients for conducting clinical trials is one of the most challenging aspects Factors like lack of patient education about clinical trials and complex study designs ar...

Translational Medicine

Strengthening presence in Asia Pacific

Translational Medicine TM has redefined Pharma RD It has broken down the silos that existed between research drug development and clinical medicine and as a result presented a great promise At a time when the industry is struggling to keep up with rising costs thinning pipe lines and a high failure rate for drugs during trials a process like TM poi...

Electronic Document Management

Mandate from May 2017

Pharmaceutical regulators are becoming more cautious about approving innovative medicines for consumers safety The US Food and Drug Administration FDA has established many regulations that govern the development testing and production processes of drugs As part of streamlining these processes and addressing the cost trends FDASIA FDA Safety and Inn...

Current State of Regulatory Compliance in Pharma Industry

Current State of Regulatory Compliance in Pharma Industry

Pharmaceutical companies operate in one of the most dynamic environments Changes in regulations by leading bodies such as US Food and Drug Administration USFDA and the European Medicines Agency EMA have increased the significance of regulatory compliance management for drug manufacturers Pharma companies across the globe are compelled to alter thei...

R&D to Manufacturing

Evolution of disease treatments

As they target new types of diseases in specialistareas such as oncology and diabetes thepharma companies are investing in innovativetreatments to address these unmet clinicalneeds According to IMS health in the amountspent on innovating new medicines is more thatthe amount spent on brands associated withnew generic entrants The global

Tackling Antimicrobial Resistance

Bacterial resistance is developing quickly and many critically important drugs risk becoming obsolete warned the World Health Organization WHO in April Antimicrobial resistance AMR has emerged as a major threat for public health worldwide owing to ineffective use of antibiotics due to increasing patients demand

Gearing up for Post-Blockbuster Era

The golden era of blockbuster drugs is coming to an end but there are reasons to believe that new growth opportunities exist for pharma companies willing to adapt to the change The FDA approved New Molecular Entities NME in and this number came down from in and in Twentyeight firstofakind drugs were approved annually over the past five

Pharma Industry

Breaking new ground

New tools and innovative developments in technology have played a key role in the field of medicine One such technology that is enabling great amount of efficiencies in pharmaceutical development is mobile phones This technology which has revolutionised sharing of information digitally has wide applications in the pharmaceutical industry

Research & Development

Nanotechnology Promise

Investments in nanotechnology by governments and industries have been accelerating at a good pace globally However the pharmaceutical industry has been slow in investing and adopting the technology With the failure of the blockbuster model dwindling revenues pressure from generics patent losses declining product pipelines and ever rising RD cost...

Personalised Medicine-

What next?

While mergers and acquisitions partnerships and collaborations still offer avenues for growth for the pharma industry many feel that the concept of personalised medicine if used intelligently will set the industry on the right path By enabling highlycustomised therapies to treat diseases based on the patients genetic makeup personalised medicine...

Asia\'s two-fold opportunity

The global pharmaceutical industry today is severely affected by a combination of adverse factors fast depleting new drugs in the pipeline mounting costs of developing new drugs patent expiries of many a blockbuster of yesteryears intense competition from generics threat of counterfeits etc The tale of its woes is indeed endless

Biosimilars

A new era in biotech

The era of generics is all set to hit the biotech industry Not so long back the fledgling industry for biosimilars was threatening to not take off due to the lack of proper ground work of regulations But the strengthening regulatory framework for biosimilars especially in Europewith USA expected to follow suitmight have given biosimilars a fresh

Biobanking as an Enabling Technology for Biomarker Research

A Collaborative Approach in Translational Medicine

Rationale for pharma biobanking Despite significant advances there is still need for better highly effective and welltolerated therapies for many indications This requires the collaboration of scientists clinicians and basic researchers from academic as well as industrial research It is practically impossible to generate new kn

Reducing Post-Marketing Drug Withdrawals

Promise of new biomarkers

According to a Prospective Pilot Cohort study that was conducted for a week period in patients out of a total of were identified as having possible DILI and of these accepted to be included in the protocol During the oneweek proactive period seven patients out of a total of inpatients were identified with possible DILI

Drug Discovery

Back to Mother Nature

After more than a decade of showing disinterest the pharma industry is taking a relook at natural productsbased drug discovery Pharma companies had shifted their focus from natural products to combinatorial chemistry because of lower costs clarity on intellectual property and importantly because it could supply huge synthetic libraries in short per...

Pharma\\\'s Future

The pharma industry today operates in an uncertain environment Intensifying cost pressures declining revenue streams increasing latestage failures stringent price controls and an uncertain global economy add to its woes In the rapidly changing pharma landscape w

Drug Contamination

A serious threat

Contamination of drugs during manufacturing is not a new phenomenon In todays global manufacturing landscape it becomes even more imperative the manufacturers have processes in place to mitigate the risk of contamination Nevertheless drug contamination has emerged as a leading cause of recalls lately According to the Medici

Clinical Trials in Asia

Overcoming Regulatory Concerns

Asias clout in global clinical trials with these growth regions is expected to continue growing in the coming decade Global CROs are expanding their presence in Asia in line with market growth Given this potential the number of studies in the region has increased significantly and approvals have followed suit According to

Asia Goes Global

Welcome to the latest edition of Pharma Focus Asia The issue of outsourcing in the pharmaceutical sector has been a hot topic for discussion recently particularly now that the US Congress is considering reforming patent law The new legislation could have significant repercussions for firms that use the USA as part of their business strategy especia...

Kittens to Tigers

Kittens to Tigers

These are tough days for worlds Big Pharma Depleting pipelines patent expirations soaring RD costs and risks etc have all put the Big Pharma in rough weather Against this backdrop fast growing Asian economies notably China and India represent new horizons of opportunities The silver lining to this gloomy scenario is the fast transforming Indian ph...

Pharma Partnerships

The changing model

Multinational companies are looking eastward in their endeavor to create new therapeutics by partnering with emerging pharma companies from China India and other south east Asian economies Big pharma companies are also investing in large scale RD facilities a recent example of this being Novartis announcement to invest US billion in a RD facility i

New Pharma Business Models

Regaining power

Changing patterns of diseases ageing population price controls dry RD pipelines patent expirations for many blockbuster drugs and declining global generic market opportunities are a wakeup call for pharma Moreover the shift in focus to improved outcomes is pushing pharma companies to rethink on the existing business models for more productive RD so...

Partnerships

A pill for growth

The pharma industry is treading a new path for sustaining growthpartnerships Escalating RD costs tough regulations and price controls continue to trouble the industry Further a severe blockbuster drought patent expiries and anaemic drug pipelines have only added to the industrys woes Innovation did provide hope but even that has become a high

Clinical Trial Supply Chain

Key to success

The key to the success of a drug development programme is the effective management of clinical trials Clinical trials today are bigger more complex spread across multiple sites and conducted in evershrinking timelines making their management a daunting task However optimal management of Clinical Trials Supply Chain could play an important role in c...

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