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...says Atulya Nath, CEO, Global Institute of Intellectual Property (GSIP). He discusses importance of patents and policy framework in the life sciences vertical, which is favoured towards domestic companies. Arshia Khan What is the importance of Intellectual Property (IP) in pharma and healthcare? IP protection boosts innovation. It goes without saying that a strong enforceable IP regime fosters research and encourages inventors to produce technology, which is both beneficial to the society at large and has commercial value for the innovator. With the coming-in of the TRIPS compliant product patent regime in India, effective 2005, India has come a long way in the field of establishing a patent system, which can boast to be at par with the rest of the world. IP protection for the pharma and healthcare sector in India assumes a great significance, since apart from the considerable size of our generic industry, innovator companies are also gaining a solid footing and recent market analysis indicates that many such companies are investing more and more into their R&D divisions. What kinds of training services do you provide? Which are the other institutes that provide such trainings? GIIP provides basic and advanced training   services   in   the   field of    IP    generation,    protection, commercialization and management. GIIP, a pioneer in IP education, has been involved in capacity building for IP & patent professionals since the past four years and has trained more than 200 professionals in the PG Diploma and certificate courses and over 2000 corporate employees. GIIP offers diploma (full-time), certificate (full-time & part-time). executive and corporate (customized' programmes to hone skills of pharma. biotech, science,  engineering,  law graduates,    post-graduates,    PhDs in the field of Intellectual Property Rights (IPR) with focus on patents and patent process of US, European and Indian jurisdictions. Some of the other institutes that provide training in field of IPR are National Law School University Bengaluru, National Academy of Legal Studies and Research (NALSAR) University   of Law,   Hyderabad, Indira   Gandhi   National   Open University (IGNOU) Delhi, Institute of Intellectual Property Research & Development   (IIPRD) NCR, The Academy of Intellectual Property Studies (AIPS) Mumbai, Institute Of Intellectual Property Studies (UPS) Mumbai, etc. What is the need of the hour in the Indian IP scenario with regard to the life sciences vertical? The life sciences vertical is predominantly revolving around the pharma and the, biotech sectors, which are seeing a flurry of IP activity, especially with patent oppositions and litigations on the rise. An increase in patent- related issues has thus created a great demand   for   skilled   professionals having sound technical knowledge clubbed with patent skills. Trained  Personnel having key patent skills such as searching, drafting of patent specifications, filing, prosecution and other pre and post grant issues, are the need of the hour. The Indian Patent law being very complex, especially with respect to pharma and biotech, the industry is always on the lookout for professionally qualified   and   skilled people   in this sector. How are we placed in terms of IP services over other highly regulated Western more...

The Alien Institute for Brain Science  has   recently  released  the  world's anatomically   and   genomically comprehensive human brain map. The mappings are the foundation for the Alien Human Brain Atlas, which is an online public resource, developed to advance the Institute's goal to accelerate understanding of how the human brain works and fuel new discovery among the global research community. While developing the Alien Human Brain Atlas, the Alien Institute characterized and mapped the biochemistry of two normal adult human brains. This has provided opportunities for scientists to study the brain with new detail and accuracy. The data reveals a remarkable 94 per cent similarity between human brains, establishing strong foundation for translational and clinical research. The data analysis from the two human brains also indicates that at least 82 per cent of all human genes are expressed in the brain. This highlights the great complexity of the human brain while also providing an essential genetic blueprint to understand brain functionality better and fuel research in neurologic disease and other brain disorders.

 Controlled-dose nebulizers are more expensive than jet nebulizers and may require supervision of a clinician. However, they have the added advantage that the quantity of drug received by the patient can be accurately controlled and measured.  Therefore, for small-scale trials they offer significant advantages. Nebulizers allow formulation in solution and so overcome some of the challenges of stabilizing the drug. However, fragile Active Pharmaceutical Ingredients (APIs) cab be denatured by conventional jet nebulizers. The drug is delivered as an aerosol created by a compressor blowing air through the solution or suspension at high speed. In contrast, a controlled-dose nebulizer uses vibrating mesh technology that is much gentler, and therefore less likely to damage the drug. New study trials have shown that controlled- close nebulizers might reduce formulation costs and facilitate early-stage efficacy trials.  Melbourn Scientific, a contract analysis and formulation company, has developed A rapid formulation screening service for poorly soluble drugs. It has been working with its clients to develop formulations that can be used in first-in-human trials.  

A new Clinical Research Management System (CRMS) helps in improving the efficiency and efficacy of clinical research studies, enterprise-wide, by driving better management of treatment   plans, processes and protocols while also supporting research- billing compliance.                                        Centricity Research, developed by GE Healthcare, is the industry's first-enterprise- class CRMS. Centricity Research helps institutions conducting clinical or translational research manage the growing complexity of research processes and compliance requirements. Centricity Research has robust functionality, built on the foundation of the currently available Centricity Patient Protocol Management (CPPM) solution, to support both the institutions' and researchers' efforts in achieving compliance, enhancing safety, increasing subject recruitment and facilitating agency audits. Moreover, GE Healthcare has developed a strategic partnership with mdlogix (Medical Decision Logic, Inc), which developed its CRMS in collaboration with the Johns Hopkins University School of Medicine and other leading clinical research institutions.  

The capsule checkweigher by Bosch, KKE 3800, sets the   standard in the field of 100 per cent capsule weighing. Its precise gravimetric weighing technology and ergonomic design make them the ideal weigher choice tor capsule check weighing needs. The ultra high-speed capacity of the KKE 3800 is ideally suited for application with more than one capsule filler or for batch work. The checkweigher has an output of up to 230,000 capsules/hour. The Bosch KKE 3800 sets the standard in the capsule weighing field with 100 per cent accuracy and high output. The integrated current Good Manufacturing Practices (cGMP) and ASB technology 3 guarantees extremely high productivity   and the permanent positive guidance of the capsules guarantees maximum pharmaceutical security. Other highlights include easy accessibility, comprehensive production documentation and ease of cleaning. It has comprehensive production documentation and is controlled by industrial PC and 21 Code of Federal Regulations  (CFR)  Part 11-compliant software.

Today, a pharma company's strategy towards becoming a diversified global healthcare leader involves increasing innovation in R&D. However, with the large spent seen in the marketing segment, a question that looms is whether the spending in marketing more than R&D? Chandreyee Bhaumik A recent study by two York University researchers estimate that the US pharma industry spends almost twice as much on promotion as it does on R&D. The researchers' estimate is based on the systematic collection of data directly from the industry and doctors, which shows that the US pharma industry has spent 24.4 per cent of the sales dollar on promotion, versus 13.4 per cent for R&D, as a percentage of US domestic sales of $235.4 billion. IMS Health (IMS) and CAM Group (CAM), two international market research companies that provide the pharma industry with sales/marketing data and consulting services, aided the researchers in their estimate. Further, the Pharmaceutical Research and Manufacturers of America (PhRMA) concluded that pharma companies spend $29.6 billion on R&D and $27.7 billion for all the promotional activities. Thus, it is indeed a matter of discussion whether the pharma companies are spending more on marketing than on R&D.  Experts try to discern the situation.   R&D and marketing are both distinct yet essential aspects of the pharma industry. While R&D ensures that therapeutic solutions are made available, the marketing department makes the end users - doctors and patients - aware of these therapeutic solutions. In fact, to be precise, pharma companies spends are decided based on its priorities and capabilities. Sanofi has always been known for its rich R&D heritage. Further, the mission of Sanofi R&D is to address patients' real needs - those that are either poorly covered or completely ignored - and provide appropriate therapeutic solutions. For achieving the desired goal, innovation is the integral part of any pharma company. Innovation is the heart of our research model, as it is being conducted internally, and also through acquisitions, partnerships and close scientific collaboration with academia and biotechnology research institutions. Further, Sanofi Pasteur, the vaccines division of Sanofi Group, is at the forefront of developing immunological solutions to prevent diseases for every stage of life, and devotes more than^ €l million to R&D every year. Again, the Group also launched a transformation programme in 2009 to make R&D an innovation driver operating in a new environment that would stimulate creativity, openness and higher performance. Further progress was made during 2010 with the appointment of Dr Elias Zerhouni - world renowned leader in the scientific community - as President, Global Research & Development, covering medicines and vaccines. And closer home, the Group has appointed Dr Raman Govindarajan as Head - R&D for India. Clearly, R&D continues to be a key I focus area for Sanofi. By focusing on patients' needs, the company intends to become the most productive R&D organization in the healthcare sector. Aparna Thomas Senior director-communications and public affairs Sanofi-india   The two separate departments, R&D and marketing, are extremely relevant for more...

...says Angelos Orfanos, President, Life Sciences and Healthcare, DHL and Global Customer Solutions (GCS). A member of the GCS Global Senior Management Team leading the DHL Life Science Steering Committee, he discusses the importance of warehousing management in the pharma supply chain in light with the one that DHL has. chandreyee Bhaumik   What is your business mantra? We have undertaken a lot of commercial responsibilities. We take care of warehousing, express and freight that are considered to be the pillars of logistics. Thus, we offer customized solutions for logistics along with the required training and best access. We have always been following the 'Strategy 2015' that encompasses our approach in its entirety. Further, for the last few years since the pharma industry has shown stable growth, we have been inclined to make considerable investment in this sector. We hope that this will help us in accelerating the success of both the industry and company. How have you customized your offerings for the life sciences space? DHL globally partners with the top 20 leading pharma companies. • An investment in a 7,000 sq. ft. facility at the Free Trade Zone (FTZ) in Chennai with plans to add more facilities across India • All sites will be certified with our global internal standards and local certifications that are required by state/country • DHL has a unique end-to-end offering across business units and will continue to provide customers with the possibility to manage their entire logistics and supply chain for life sciences products with a broad footprint and standardized processes across the region. Warehouse is an essential component of an efficient supply chain. How important is it to provide an optimal warehousing facility? DHL takes pride in bringing forth the Good Manufacturing Practices (GMP) certified pharma warehouses. This is indeed the brainchild of true innovation. We have multi-use warehouses in Mexico, Brazil, the US and many other countries. In these warehouses, not only pharma companies can avail opportunities but also other segments can leverage on it. It makes the entire process much cost-effective. While discussing warehouse in the pharma logistics, it is essential to discuss the temperature controlling aspect of the said facility. To be precise, while dealing with clinical trials and stem cell research ingredients,   pharma   warehouses serve fruitful purpose. There are also customer service centers that monitor the logistics pattern of the supply chain from the beginning to the end. To cite an example, in Europe, there is a dedicated tracking system, cold chain transport solutions. Nowadays, customers want more visibility and transparency. This is applicable more in case of clinical trial materials. Thus, warehouse management system is important. Further, it can be said that tracking and tracing is a vital component, and here the relevance of 2D bar coding comes into picture. Further, global organizations are also into organizing IT platforms that try to take care of most of the problems.   How important are regulations in this market? Temperature variation between different countries makes the relevance of the more...

...says Dr K V Krishnan, Practice Head, Life Sciences, Mindteck. With a doctoral degree in Analytical Spectroscopy and an experience of over 29 years in the life sciences vertical, one of the leaders at Mindteck shares his expertise on the present and future industrial scenario. Parita Dholakia   Tell us how Mindteck helps a pharma company in achieving performance optimization along with cost reduction. Mindteck works in all areas of life sciences, with a strong focus on pharma industry. We provide a strong set of product engineering and IT service offerings to our clients in pharma business. Our offerings are comprehensive and cover software development, electronic design and independent verification & validation apart from other support services. Our technical solutions help life science companies to: • Reduce product development cycle time and quicker time to market • Increase productivity by enhancing the engineering bandwidth within the organization • Meet the regulatory/compliance requirements IT has become an indispensible factor for almost all sectors. How important is it for the healthcare industry? IT covers all aspects of requirements of hospital, pharmacy, clinic and health insurance units. Drug development, clinical trials data management, Electronic Medical Records (EMRs), Electronic Health Records (EHRs) are the major areas where IT plays a dominant role in healthcare. Patients are able to identify the best healthcare personnel and doctors are able to gain comprehensive patient view with the help of healthcare IT. Labs and hospitals are able to integrate the data with medical equipments, enable token issue system, display boards, etc, using today's IT services available for the healthcare industry. Hospital management    solutions    provide multiple functionalities for patient care, clinical lab management, hospital administration and other ancillary services such as financial management, human resource management and supply chain management. Over a period of time, has the approach of pharma companies changed for IT-based solutions? Pharma industry is loaded with a huge volume of information, and inefficiencies do exist in searching and retrieving data. So, issues related to information sharing and management of knowledge assets require IT-based solutions. Better utilization of data and shortened time to market can lead to time saving up to 1 year per drug. Due to these factors, the global approach of pharma companies has rapidly changed for IT-based solutions. Today, IT investments are widely spread across various functions of the pharmaceuticals industry such as R&D, clinical development, manufacturing/ supply chain, sales, marketing and corporate management. How has Mindteck kept pace with the technological revolution? The life sciences segment encompass companies in the fields of scientific instruments pharmaceuticals, medical devices, biotechnology, food processing,  environmental and organizations and institutions that devote a majority of their efforts in the various stages of research, development, technology transfer and commercialization.  In all these segments, global players are witnessing number of key technology trends such as convergence and mobility, cloud computing, adoption of energy efficient  technologies, enterprise adoption of Web 2.0 etc, that are impacting their business. Hence, it is essential for any vendor to keep pace with these technologies. more...