Research Development

Novel Genetic Vaccines

Rational design and standardised evaluation

Vaccines play a central role in health protection and advances in biotechnologies now offers numerous novel approaches for vaccine development. The goal of developing new vaccines to immunise people against infectious diseases has long been a key priority for the world's medical authorities.

Evaluating drug solubility in lipid-based delivery systems

Understanding the solubility behaviour of the drugexcipient complex in a lipid-based drug delivery system will help formulation scientists in rational selection of the appropriate excipients and in the determination of the optimum excipient levels to ensure drug remains solublised.

Can Genomics Provide

Blockbuster Drugs in Defiance of 'Personalised Medicine'?

It has become dogma that the era of genomics will require extensive genotyping of each patient 'personalised medicine', and that this will carve up the pharmaceutical marketplace, making blockbuster drugs a thing of the past. In the extreme, each patient will require their own unique, customdesigned drug. Put differently, every patient's disease will be an orphan disease. Let us use cancer genomics as an example, to refute this dogma.

Targeted Therapies

A sustainable business model?

Personalised medicine breaks the cycle of trial and error medicine and helps ineffectiveness rates of medicines to decrease dramatically. Orphan drugs, targeted therapies for rare diseases, with their innovative nature and improved efficacy, make it a precursor for personalised medicine therapies and can offer a viable business model to expand from. Society should develop consensus for such new models in multi-stakeholder partnerships which will also make it sustainable.

Personalised Medicine

Changing business models

Personalised medicine, in which sophisticated diagnostics guide drug choice, dosing, and patient appropriateness, challenges older business models for both pharma and diagnostic tests. In particular, the diagnostic tests are original inventions and often require substantial original clinical research, which may or may not be intermingled with development costs for the drug.

Personalised Medicine & Drug Development

Biomarkers leading the way

Applying biomarkers as part of drug development efforts only started to materialise a few years ago. Given the recent efforts by not only regulatory authorities but also pharmaceutical companies, several case studies are now available that suggest that biomarkers will become a more integral part of future drug development and commercialisation and, therefore, foster the "promise of personalised medicine" over the coming years.

Biosimilar Medicines

Understanding the challenges

"Follow-on" proteins pose complex questions for patients, biopharmaceutical companies, and regulators. Understanding the challenges in the development of biosimilars by the industry and regulators and addressing them could pave the way for delivering affordable and better biological medicines to patients throughout the world.

Drug Discovery in Academia

An evolving model

As economic pressures mount on the current industrial model of drug discovery and development, there is growing momentum in academic institutions to enter the fray of drug discovery and development. There has always been a symbiotic relationship between academia and industry in the discovery and elucidation of new biological targets; however, the delineation of the roles of academia and industry are beginning to blur.

Preclinical Research in Big Biotech

Vertical integration is the key

As companies transition from young, start-up phase organisations to a more mature and successful stage, the needs and demands placed on the management teams from both internal and external sources change. These changes can have long-term consequences, whether they happen by strategic design or circumstance. The key element for growing companies is vertical integration.

Computerised Cognitive Function Assessment

Coming of age

The role of automated cognitive function testing in contemporary drug development is assessed here, from the early stages as an aid to translational medicine, through pivotal trials of cognition enhancers to post-marketing studies. Properly automated cognitive function assessments have considerable benefits over traditional pencil and paper tests, and can bring additional value to all stages of drug development.

When medical need is not matched by market opportunity

Tropical parasitic diseases are major contributors to mortality and morbidity in the developing world, yet fail to offer a compelling market opportunity for new pharmaceutical development.

Oral Inhalation Technology

Impact of nanotechnology

Regulatory awareness has led to the need for new approaches when regulating nanotechnology in the inhaled area. Opportunities as well as challenges exist. If addressed, they can open the doors for new IP to be generated along with considerations that can be incorporated in Life Cycle Management.

New Drugs in Japan

Conditional authorisation

Conditional authorisation and early post-marketing phase vigilance systems constitute an integral part of new drug approval and risk management in Japan. They intend to ensure safe launch and early access to patients of new drugs.

Changing Face of GPCR Drug Discovery

Opportunistic future

Although GPCR drug hunters can boast of a successful and glorious past, the present and future challenges remain high. Some of the changing paradigms in GPCR research that may aid in confronting the challenging environment of GPCR drug discovery are discussed here.

Transforming Drug Development

A fully outsourced model

The pharmaceutical industry is not transforming fast enough to address the persistent decline in productivity. Alternative drug development models are being explored in an effort to jumpstart transformation.

Antibacterial Research

Bright future?

New antibacterial drugs have been few and far between due to a slump in the R&D activities and also due to many unique challenges in this area. However, of late, there is renewed interest in this field and many innovative concepts and targets are being looked into.

Targeted Delivery

Photosensitiser conjugated gold nanoparticles

Biocompatible gold nanoparticles have been explored as a new vehicle to deliver photosensitiser to tumour cells. The use of gold nanoparticles can significantly increase the accumulation of photosensitiser in tumour cells and lead to a high efficiency in destroying the tumour cells.

Adjuvant Systems

Next stage of rational vaccine design

Although vaccines helped in improving healthcare globally, significant disease challenges still remain. As such, new solutions are required where classical vaccine approaches are insufficient to provide optimal protection for specific populations and against certain diseases.

Early Formulation

Shortening the development timelines

Formulators are faced with an increasingly competitive industrial environment and very challenging compound properties. Smart development strategies, like frontloading are needed in order to increase the R&D productivity and to bring new chemical entities earlier onto the market. Key factor for success is the intensified cooperation between research and development.

Enhancing Antibody-based Cancer Therapy

Antibody combinations and dual-targeting bispecific antibodies

Monoclonal antibodies are becoming an important class of antitumour agents, as they have been shown to enhance the efficacy of various therapeutic regimens without significantly increasing systemic toxicity. Further, results from preclinical and early clinical studies suggest that combination of antibody-based therapeutics may be more efficacious than each individual antibody alone with still minimal and acceptable toxicity. Antibody combinations and dual-targeting bispecific antibodies represent promising approaches to more efficacious antitumour therapy.

Current Advances in Proteomics

Every single protein in the human body is a potential target for diagnosis and treatment of diseases. This article presents a brief description of biotechnology methods applied in proteomics that may help discovering new drugs.

Getting to the Bone

Fighting skeletal cancer metastases with specific T-lymphocytes

Breast, prostate and lung cancer most frequently metastasise to the skeleton Adoptive immunotherapy with antigen-specific T-lymphocytes may represent an alternative to  standard treatment modalities such as chemotherapy and radiation, which can only provide palliation.

Target Deconvolution in the Post-genomic Era

In times of reduced productivity coupled with increasing costs within the pharmaceutical industry, “reductionistic” target-based drug discovery has come under pressure and phenotype-based discovery has gained momentum. Target deconvolution is an important aspect for efficient progression of compounds towards development..

Sonication-Assisted Nanoencapsulation

Nanoencapsulation of low soluble cancer drugs has been elaborated through powerful ultrasonication of the drug powder and simultaneous sequential polyelectrolyte deposition. This is a novel approach that allows change in capsule wall thickness to adjust drug release rate, and to attach an antibody at the outer shell layer for targeted delivery.

Nanobiomechanics and Human Diseases

Insights into the pathophysiology

Nanobiomechanics research carried out on human diseases provides new and important insights into their pathophysiology and may suggest new methods for early detection and diagnosis.

Unconventional Micro and Nanofabrication

Biological tools and assays developed through unconventional nanofabrication techniques are proving to be inexpensive.

Improving Pharmaceutical R&D

Using Lean Sigma

Application of Lean Sigma to pharmaceutical research and development is a scientific process and requires high level of engagement from all key stakeholders.

Mitochondrial Nanomedicine

Tailored and efficient therapeutics

The ongoing merger of nanoscience with mitochondrial medicine gives rise to novel strategies for diagnosis and therapy of mitochondrial disorders.

Multi-functional Nanomedicine

Technology convergence in development of targeted therapeutics

The use of multi-functional nanosystems affords convergence of technologies for simultaneous or sequential target-specific delivery of multiple drugs or by combining drugs with different energy modalities.

Drug Discovery

A decentralised multi-polar model

Where the pharmaceutical industry is being unable to successfully translate core models of drug discovery from theory to practice, the two-pronged approach of Evolva Biotech in building a diversified and risk balanced compound pipeline stands as a case in overcoming the hurdles faced by the industry in the R&D paradigm.

The Asian Vaccine Industry

Opportunities and challenges

A roadmap for Asian vaccine research and development programmes can lead to a strong regional vaccine industry, self-sufficient healthcare policy and the possibility of economic growth through the manufacturing of valuable biological products.

Controlling Infectious Diseases

Evaluation of vaccines

Although vaccine evaluation differs in various aspects from that for therapeutic drugs, many procedures specific for therapeutic drugs have been applied to vaccine evaluation.

Developing Cancer Vaccines

Using tumour-associated peptides

Effective next-generation cancer vaccines have to include relevant and well characterised antigens known to be presented by real tumour tissue.

Getting to the Heart of a Tumor Cell

Targeting the nucleus

In combination with other agents, tumour cell-specific nuclear targeting approaches have great potential in developing truly tumour cell-specific therapeutic treatments.

The Next Generation of Recombinant Immunotoxins

Reducing immunogenicity of the cytotoxic part

Immunotoxins comprise cell-specific targeting components coupled to cytotoxic agents. Although clinical data are encouraging, the problem of immunogenicity remains unsolved. To allow repeated administration, human immunotoxins with greatly reduced immunogenicity need to be developed.

Assessing the Immunogenicity of Protein Therapeutics

Immunogenicity poses a risk that should be assessed during drug development, as it possibly compromises drug safety and alters drug characteristics including pharmacokinetics and bioavailability. Immunogenicity assessment strategies combine pre-clinical predictive methods with clinical stage measurement of anti-drug antibodies.

Automated Purification of Natural and Synthetic Compounds

The purification of naturally derived and synthesised compounds via automated flash chromatography allows unattended separation while reducing errors and re-purifications.

Biomedical Polymers

Drug delivery and molecular imaging

During the last two decades, significant advances have been made in the development of biocompatible polymers as the platform for drug delivery and molecular imaging.

Electronic Health Records and Clinical Research

Despite the value of combining EHR and EDC for multicentre trials, we are many years away from a standard, usable process for this.

Pharmacogenomics and Personalised Medicine

Synergy between the industry and academia

Despite the value of combining EHR and EDC for multicentre trials, we are many years away from a standard, usable process for this.

Biopharma Convergence

Heralding a new era

Biopharma convergence seems to be the panacea for pharma companies struggling with weak R&D productivity and biotech firms facing funding shortfalls.

Natural Products in Drug Discovery

Drug discovery from natural products has reclaimed the attention of the pharma industry and is on the verge of a comeback due to new technological inputs that promise better returns on investment.

Challenges for R&D success in China

Novo Nordisk’s experience

For pharma R&D success in China, the essence is to know how the local environment will support or pose challenges to the characteristics of an effective organisation.

Model Behaviour

The use of biological models to study the effects of gene mutations is a cost-effective alternative to an animal model. The yeast Schizosaccharomyces pombe is a particularly useful tool for this process.