Sciformix Corporation Celebrates Company’s Founding Day by Volunteering at Local Charities in India and Philippines

Helping the communities where we live and work by leveraging the extraordinary abilities of our people, ideas and resources

7th May 2013 – Sciformix Corporation, a world leading Scientific Process Organization (SPO), announces the introduction of a Social Impact Initiative day taking place on 7 May 2013 to celebrate Sciformix’s 6th inception day. The day involves over 400 Sciformix employees moving away from their offices and volunteering their time to local charities to work at the ground level setting up medical camps, giving health awareness presentations and spending time with aged people and orphans in Pune and Mumbai, India and Manila, the Philippines.

During the Social Impact Initiative (SII) day all Sciformix employees will spend their time with various charities such as Tunga Gaon Charitable Trust, Mumbai, where qualified medical practitioner employees will open a clinic for slum dwellers. In Pune, Sciformix teams will support Maher Ashram, Non Government Organization (NGO) for destitute children, providing them with health and eye checkups. Additional teams will spend time distributing food and drink and taking part in social activities across various charities including Asha Daan, Dhanvantari Trust and Jhanvi Trust.

The Social Impact Initiative day was incepted by Manish Vinayak Soman, President and CEO of Sciformix.  He explains the rationale for its introduction, “While Sciformix is succeeding in our chosen area of expertise it is equally important for us, as an individual and as an organization, to grow and succeed from within. In the present connected and global world, success is defined not only by our business achievements but also how well we serve our communities and enrich our ecosystem and together, our employees can experience the happiness of giving through our Social Impact Initiative day.”

Sciformix, recent winner of Frost & Sullivan’s Pharmaceutical Knowledge Process Outsourcing Entrepreneurial Company of the Year award, has experienced remarkable growth and is looking to give back to local communities. “We live our mission of helping people live healthier lives; and our values of integrity, commitment, focus, innovation, diversity, excellence and teamwork every day, in everything we do. Giving, volunteering and business innovations are the ways in which we live our mission and respond to the needs of our communities. Each is important; together they become a powerful commitment to improving health, people’s lives and communities” says Soman.

Sciformix, headquartered in the USA, with operations in India and the Philippines, partners with clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Clinical Research & Post Approval Support Services, Medical Affairs, Scientific Writing and Regulatory Affairs.

To find out more about the charities involved and a full schedule of activities for the Social Impact Initiative day please visit http://www.sciformix.com/about-us/corporate-responsibility. To learn more about Sciformix visit www.sciformix.com, email us at ask@sciformix.com, or call us at +1.877.576.5005.

ENDS

For further press information please contact: Gemma Clulow, The Scott Partnership: + 44 1477 539539 mail to sciformix@scottpr.com or Susan Najjar, Director of Marketing, Sciformix Corporation: + 1 617-264-0339 mail to susan.najjar@sciformix.com. 

About Sciformix

Sciformix Corporation is a world leading Scientific Process Organization (SPO), providing scientific knowledge-based services to pharmaceutical and biopharmaceutical, generics, consumer products, medical devices and other healthcare companies - in the areas of Safety and Risk Management, Clinical Research & Post-Approval Services and Regulatory Affairs. Our mission is to partner with global life science companies to provide high quality scientific knowledge-based expertise that deliver better quality outcomes and improved efficiencies across the entire product lifecycle with the ultimate objective of improving quality of healthcare for patients worldwide. Corporate headquarters is located in Westborough, MA with operations in USA, India and the Philippines.

We create value for our clients through our singular focus on the life sciences industry, strong pharmaceutical domain competency, exceptional subject matter expertise, industry reputed scientific advisory board, uncompromising focus on quality, process rigor, predictable results, and ability to scale. Our portfolio of services spans the full spectrum of product lifecycle from pre-clinical and clinical to post marketing activities to help our customers solve complex analytical challenges, improve the quality of patient healthcare and increase client productivity.

Sciformix is dedicated to providing our clients outstanding services and solutions, fueled by an unrivalled commitment to quality. We share the same level of involvement, dedication and passion as our clients by becoming an integral part of their team. Our distinct combination of scientific expertise, process rigor and technology innovation delivers consistent, reliable and insightful results. Our ability to scale and grow to meet your evolving needs means we are flexible and dedicated to your success in delivering safe products with more efficiency and greater speed. We help you make the right decisions at the right time by providing Trusted Services Built on Science.

 

PRECOS Launches Portfolio of Techniques and Models of Acquired Resistance to Targeted Agents and Standards of Care used in Oncology at AACR Annual Meeting 2013

WASHINGTON D.C April 6^th 2013 - Preclinical Oncology Services Limited (PRECOS), a leading pre-clinical research and development service provider with a specific focus on oncology, today launches PRECOS Unique Models of Acquired resistance (PUMA) at the AACR annual meeting (Washington DC, April 6^th – 10^th). Derived from cell lines and proprietary PDX (Patient-Derived Xenograft) models, PUMA models provide a unique bespoke collection of clinically relevant and validated models of resistance, as well as the techniques and expertise to develop client specific models of acquired resistance to chemotherapeutics and targeted agents. Such models are a major advancement for pharmaceutical and biotech companies running oncology R&D programmes and will enhance success rates during the critical phase of transitioning from pre-clinical to clinical evaluation of new drug candidates.

 

 

The first available examples of PUMA models are in specific lung cancer subsets where PRECOS has previously developed and characterized a focused panel of PDX lung cancer models derived directly from Caucasian patient tumour material – PRECOS’ unique model atlas LION (Lung In ONcology). By repeatedly challenging relatively homogeneous cell line populations (CTX models) and heterogeneous tumours from PDX models across several passages, PRECOS is able to compare and contrast behaviour such as growth characteristics with gene expression and pathway analysis, response to chemotherapeutics and targeted agents. It is also possible to assess the effect of varying treatment regimens and dosing strategies including drug holidays or combination therapies. This allows panels of tumour subset specific models to be built which are able to mimic patients and their responses to treatment regimes in the clinic.

 

 

PRECOS is committed to further developing PUMA and is continuing to progress the techniques to provide customised services. This will enable its clients to build models based on the characteristics of diverse cancer cell types which can offer insights for designing optimal treatment strategies around their pre-clinical candidates prior to product development and clinical trials.

 

 

“As oncology R&D progresses, there is an increasingly critical need for more clinically-relevant predictive pre-clinical models in order to overcome the high attrition rates of agents entering clinical trials,” said Dr Martin Page, Scientific Consultant, PRECOS. “All new agents entering phase 1 clinical trials will be tested in cancer patients that have likely become resistant to a range of targeted and chemotherapeutic agents. PUMA is part of our PREdict platform, and offers PRECOS’ clients pre-clinical models that are authentic counterparts of the drug-resistant tumour subsets seen in the clinic, rather than drug-naive models. PRECOS’ latest portfolio offers specialist drug resistant pre-clinical models with responses of higher predictability with outcomes that can be seen during clinical testing.”

Scientific consultants will be on hand at AACR to discuss strategic needs, whether you want to access our unique collection of clinically relevant lung oncology models, discuss specific project needs or the relevance of specific models with our experts, or develop a bespoke collection of validated assays or models, please call +44 0870 166 6234 or e-mail enquiries@precos.co.uk to book an appointment at AACR. Alternatively please visit ww.precos.co.uk for further information.

For further information please call +44 (0)870 166 6234, email enquiries@precs.co.uk or visit www.precos.co.uk

Sciformix Executives Drive Agenda on Achieving Drug Safety Excellence as Premium Sponsor of 5th Annual World Drug Safety Congress

26^th March 2013 – Sciformix Corporation, a world leading Scientific Process Organization (SPO), has announced its premium sponsorship of the 5th annual World Drug Safety Congress, taking place from April 24 - 25, 2013 at the Revere Hotel Boston Common, Boston, USA. The World Drug Safety Congress addresses strategic and crucial issues in the development and execution of drug safety programs. Senior executives of Sciformix, will be chairing the opening session and setting the stage on how organizations can stay on top of international regulatory requirements and streamline their drug safety programs. 

Sciformix, premium sponsors of the event for the third year in a row, continues its success in its global delivery of services and solutions in Safety and Risk Management. Their scientific and safety experts work closely with the top global pharmaceutical and biopharmaceutical, generics, consumer product and medical devices organizations to support their safety needs throughout the entire product lifecycle.  With substantial growth in business year on year, Sciformix is taking its position as a leader in drug safety services.  

The World Drug Safety Congress aims to present innovative solutions to the key safety challenges facing both pharmaceutical industry and pharmacovigilance professionals worldwide. It brings together senior personnel from a range of global pharmaceutical companies, regulatory agencies and academic institutions to share their expertise in the drug safety arena.  The conference provides an excellent opportunity for attendees to discuss diverse issues related to drug safety with specialists and practitioners.  At the conference, Sciformix will be demonstrating its expertise by engaging with the speakers and delegates, sharing their knowledge of key developments in the global drug safety market, and demonstrating solutions that provide competitive advantage to participating companies.  

Manish Soman, President and CEO comments “We are delighted to be a part of the World Drug Safety Congress. Our support of the event is part of our ongoing investment in the field of drug safety. We want to share the knowledge we have gained while working with clients over the years, which has been incorporated into our innovative methodology and approaches to the problems of drug safety and risk management”.

To help drug safety professionals achieve excellence, world renowned expert Sidney Kahn, Senior Principal Pharmacovigilance Practice at Sciformix, will be addressing the audience with his keynote presentation on “The challenges in achieving excellence in the rapidly evolving global drug safety environment”.  On the second day of the conference, Chitra Lele, Chief Scientific Officer and co-founder at Sciformix will host an in-depth presentation and panellist discussion on “Taking the noise out of signal detection”. Experts including Ram Tiwari, Ph.D., Associate Director, Office of Biostatistics, Center for Drug Evaluation & Research, US FDA and Michael Sprafka, Executive Director of Observation Research, Head of Pharmacovigilance-Epidemiology, Amgen, will provide practical solutions to the problems of inadequacies of available quantitative measures and indicate possible enhancements of the method during an informative and thought provoking presentation and panel discussion.

Sciformix partners with their clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Clinical Research & Post Approval Services, Medical Affairs, Scientific Writing and Regulatory Affairs.

Copies of presentations from Sciformix are available by emailing ask@sciformix.com. To learn more about Sciformix visit www.sciformix.com, email us at ask@sciformix.com, or call us at +1.877.576.5005.

ENDS

For further press information please contact: Gemma Clulow, The Scott Partnership: + 44 1477 539539 mail to sciformix@scottpr.com or Susan Najjar, Director of Marketing, Sciformix Corporation: + 1 617-264-0339 mail to susan.najjar@sciformix.com.

About Sciformix

Sciformix Corporation is a world leading Scientific Process Organization (SPO), providing scientific knowledge-based services to pharmaceutical and biopharmaceutical, generics, consumer products, medical devices and other healthcare companies - in the areas of Safety and Risk Management, Clinical Research & Post-Approval Services and Regulatory Affairs.  Our mission is to partner with global life science companies to provide high quality scientific knowledge-based expertise that deliver better quality outcomes and improved efficiencies across the entire product lifecycle with the ultimate objective of improving quality of healthcare for patients worldwide. Corporate headquarters is located in Westborough, MA with operations in USA, India and the Philippines.  

We create value for our clients through our singular focus on the life sciences industry, strong pharmaceutical domain competency, exceptional subject matter expertise, industry reputed scientific advisory board, uncompromising focus on quality, process rigor, predictable results, and ability to scale. Our portfolio of services spans the full spectrum of product lifecycle from pre-clinical and clinical to post marketing activities to help our customers solve complex analytical challenges, improve the quality of patient healthcare and increase client productivity.

Sciformix is dedicated to providing our clients outstanding services and solutions, fueled by an unrivaled commitment to quality. We share the same level of involvement, dedication and passion as our clients by becoming an integral part of their team.  Our distinct combination of scientific expertise, process rigor and technology innovation delivers consistent, reliable and insightful results.  Our ability to scale and grow to meet your evolving needs means we are flexible and dedicated to your success in delivering safe products with more efficiency and greater speed. We help you make the right decisions at the right time by providing Trusted Services Built on Science.

 

PRECOS to Showcase Preclinical Oncology Service Portfolio at the AACR Annual Meeting 2013

NOTTINGHAM, UK, 18^th March 2013 - Preclinical Oncology Services Limited (PRECOS), a leading pre-clinical research and development service provider with a specific focus on oncology, will be attending the AACR (American Association of Cancer Research) Annual Meeting, taking place April 6^th – 10^th 2013, at the Walter E. Washington Convention Center in Washington DC.

At the show PRECOS will be unveiling its new PUMA platform for preclinical oncology research, in addition to running four poster presentations covering a range of preclinical research studies. This year’s meeting has the theme of “Personalized Cancer Care Through Discovery Science” and will bring the finest minds in cancer research to the American capital. Senior scientific staff from PRECOS will be available to discuss the company’s expanding portfolio of cancer models in relation to scientists’ specific oncology drug discovery and biomarker study requirements.

PRECOS leads the way in providing robust models, validated against today’s Standard of Care agents to enable pre-clinical in vitro and in vivo testing of the next generation of oncology drug candidates. PRECOS will be launching a new cutting-edge service and portfolio of models at the North American show which may help in the development of drugs used to prevent or overcome resistance to treatment in cancer patients. The company provides expertise, specialism and innovation to small to medium biotechnology companies and the new platforms will support new and existing projects going forward.

The following posters will be presented, and reprints are available from enquiries@precos.co.uk:

• In vivo generation of EGFR-TKI resistance in a patient-derived xenograft (PDX) with an activating EGFR mutation (L858R), and molecular characterisation of the resistance mechanisms

 
At the show PRECOS will highlight how using a novel patient-derived NSCLC xenograft model, driven by the L858R EGFR mutation, PRECOS set out to recapitulate the reported clinical routes of resistance to EGFR inhibitors and to evaluate if additional mechanism could also be identified.

• In vivo response and molecular characterisation of a NSCLC squamous cell carcinoma PDX model exhibiting reproducible sensitivity to FGFR inhibitors

PRECOS will address LION137 which is a novel patient-derived NSCLC SCC xenograft model with reproducible FGFRi-sensitivity which is directly relevant to the clinical setting. This model could be invaluable in assessing novel agents targeting the FGFR pathway and in the development of new combination strategies which may prevent or overcome resistance.

 

• Patient-derived xenograft models reveal a subset of clinically relevant squamous non-small cell lung cancers that respond to targeted EGFR inhibition

PRECOS will shed light on the proposition that a significant subset of NSCLC patients with squamous histology may benefit from treatment with targeted EGFR inhibitors. It claims that its LION SCC models could be valuable for biomarker studies to identify the basis of the EGFR inhibitor responder subset and for evaluating new agents in a more clinically relevant setting.

• In vivo oncology target screening using a lentiviral inducible- shRNA knockdown system

PRECOS will provide an insight on how to optimise a lentiviral inducible-knockdown small hairpin RNA (shRNA) system for efficient in vivo cancer target validation, using polo-like kinase 1 (PLK1), an essential cell-cycle protein, as a proof-of-concept target.

Dr Neil Rotherham, chairman of the PRECOS board comments, “We are committed to developing novel panels of models, including resistance models to support drug discovery and the development of the next generation of therapeutic agents to treat resistance. AACR is a great platform to showcase our expanding portfolio of solutions designed to meet oncology research and development needs.”

The AACR Annual Meeting 2013 examines the latest and most exciting discoveries in every area of cancer research and provides a unique opportunity for investigators from all over the world to meet and forge collaborations. Speakers at the event provide case studies of emerging targets in order to address some of the issues surrounding target-based drug discovery and development. PRECOS’ full service offering will be highlighted at AACR 2013, including its in vitro, in vivo and ex vivo services that are matched by advanced model development and imaging services to enable PRECOS to provide a uniquely comprehensive and custom service to its clients, from concept to final result.

Details of the new platform are currently top secret, but all will be revealed in Washington. If you would like to book a meeting to learn about PUMA as well as our other platforms and models first hand from our scientific team, or are unable to make the show but still want to learn more, please contact us through enquires@precos.co.uk.

For further information please call +44 (0)870 166 6234, email enquiries@precos.co.uk  or visit www.precos.co.uk

The Royal Mint Achieves New Level of Trade Effluent Monitoring with Analytical Technology Instrumentation

The Royal Mint has selected Analytical Technology to equip its new effluent treatment plant.

The Royal Mint is one of the world’s leading export mints, making coins and medals for an average of 60 countries every year. Located in Llanstrisant, South Wales, the headquarters were opened in 1968 by the Queen in readiness for the introduction of decimal coinage. With a first responsibility to make and distribute United Kingdom coins, the company employs more than 700 people and operates round-the-clock for 50 weeks a year.

With the treatment of trade effluent increasingly coming under the spotlight, The Royal Mint recently embarked on a multi-million pound project to build a new effluent treatment plant to replace two existing treatment lines and support increased production capacity from two new nickel plating lines. The new plant would need to monitor hydrogen peroxide levels, pH and turbidity to ensure the safety of the effluent being discharged.

The new effluent treatment plant aimed to allow the business to discharge 100% of its trade effluents into the sewer, requiring first class monitoring instrumentation to ensure water quality. If trade effluents are not safe to be released into a sewer , there is a requirement for companies to either change their process to no longer produce the effluent, treat the effluent before discharging to the sewer or pay for it to be taken off site, each option both time consuming and costly.

The Royal Mint selected Analytical Technology’s pH, hydrogen peroxide and turbidity sensors for its water monitoring needs. The Q45P AutoClean pH monitor with MCERTS classification will be used to control pH levels throughout the nickel-plating process and the pH correction process in the new treatment plant, while the Q45H/84 hydrogen peroxide sensors would monitor the effluent to ensure peroxide levels remained low enough to allow efficient effluent treatment. A minimal maintenance instrument, the ATI d15/76 AutoClean turbidity monitors were chosen to determine water quality by measuring the degree to which the water has lost its transparency due to the presence of suspended solids. ATi’s F12 gas detection system was also implemented to protect employees from harmful exposure.

Graham Hartry, Environmental Manager, Blank Processing, The Royal Mint explains: “Our new effluent treatment plant has been built using the Best Available Technology (BAT) and will significantly reduce the amount of effluent discharged, allowing us to recycle wherever possible. The use of Analytical Technology’s pH, hydrogen peroxide and turbidity monitors has allowed us to regulate the levels of chemicals and suspended solids within our effluent discharge, ensuring that we comply with stringent regulations and do our utmost to protect the environment.”

As a result of the new effluent treatment plant incorporating Analytical Technology instrumentation, The Royal Mint discharge 100 per cent of its trade effluents into the sewer, without damaging the sewer infrastructure or the environment. Key benefits include the instruments being easy to set-up and maintain, delivering reliable and compliant results as well as delivering high levels of customer support to keep the plant running.

For more information on Analytical Technology’s range of water and gas monitoring instrumentation, please call +44(0)1457 873 318, e-mail sales@atiuk.com or visit www.analyticaltechnology.com.

Analytical Technology Helps Britannia Food Ingredients Ensure Safe Wastewater Disposal

Specialist electrochemical sensor manufacturer Analytical Technology selected by Britannia Food Ingredients Ltd to ensure safe wastewater disposal.

 

Located in Goole, England, Britannia Foods Ingredients formed in 1966 produces a range of speciality fats for the chocolate, confectionery, biscuit and snack food industries. Like all manufacturing companies, Britannia Foods must comply with strict regulations to ensure that trade effluent entering the public sewerage system is pre monitored to ensure it does not contain any harmful chemical levels.

Britannia Foods Ingredients trade effluent is handled by Yorkshire Water, who issue trade effluent consents relating to factors including the rate and maximum volume of the discharge, the temperature of the discharge and where the discharge may be made. The conditions of a trade effluent consent are set for a number of reasons including preventing the corrosion of sewer fabric, overloading of sewers and possible flooding of properties, blockage of sewers and hazardous situations involving employees conducting maintenance within the sewerage system.

In order to comply with its trade effluent consent and ensure protection of human health, Britannia Food Ingredients selected Analytical Technology’s Q45P AutoClean pH monitors and D15-76 monitor with an Air Blast AutoClean system to indicate water quality and the presence of suspended solids in its waste water stream. The D15-76 monitor has enabled Britannia Food Ingredients to realise turbidity measurements down to 0.001 Nephlometric turbidity units (NTU) and as high as 4000 NTU, eliminating the need for separate high and low ranges.

Britannia Foods Ingredients have found the pH and turbidity monitors to have overcome challenges associated with sensor fouling and are reliable, accurate and low maintenance. Richard Stockdale, Operations Manager at Britannia Food Ingredients explains: “Both monitors have enabled us to comply wit the stringent trade effluent consent criteria outlined by Yorkshire Water, providing reliability and giving us peace of mind that our effluent will not negatively impact upon the environment or the sewerage system. In addition to this, we have found the Analytical Technology instruments and controllers to be extremely easy to programme and set-up, with the whole implementation process taking less than two days.”

For more information on Analytical Technology’s range of water and gas-monitoring instrumentation, please call 0800 8046 062, e-mail sales@atiuk.com or visit www.atiuk.com.

 

Novozymes Biopharma’s rAlbumin approved in Japan as MAQUET expands into new market

 

 

Recombumin® Alpha used by MAQUET CARDIOPULMONARY

in a version of the company’s proprietary BIOLINE Coating

 

NOTTINGHAM, UK – February 27, 2013 – Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has announced that one of its leading customers has achieved approval of a medical device in Japan using Recombumin^® Alpha - formerly Albucult^®, a recombinant human albumin (rAlbumin) product. Recombumin Alpha is used by MAQUET in a version of the company’s proprietary BIOLINE Coating, which has already received regulatory approval and is being used successfully in many countries around the world. This approval represents yet another landmark registration for Novozymes Biopharma’s Recombumin portfolio and the first for a medical device product in Japan. The use of Recombumin Alpha in MAQUET’s BIOLINE Coating confers a range of unique advantages due to its stable, pure and safe composition, meaning that it can enable manufacturers to streamline their regulatory approval processes and accelerate a product’s time-to-market.

 

Novozymes’ rAlbumins have been assisting MAQUET in developing safe, regulatory compliant products for over 10 years as part of an ongoing strategic partnership between the two companies. The BIOLINE Coating has been developed by MAQUET to improve the biocompatibility of extracorporeal circulation system devices, such as oxygenators, which come into contact with blood during heart surgery. Whether for oxygenators, centrifugal pumps, filters, reservoirs, venous bubble traps, catheters and cannulae, tubes or tubing set accessories, a consistent quality of BIOLINE Coating is supplied for all applications. The use of Recombumin Alpha contained in the version of BIOLINE Coating approved for the Japanese market helps to improve the biocompatibility of these devices, while its unmatched safety and purity profile minimizes the risk of contamination and impurities.

 

Dr. Wolgang Rencken, President and CEO at MAQUET Cardiopulmonary AG comments: “With Novozymes’ rAlbumin, MAQUET is now able to offer our highly biocompatible BIOLINE Coating in Japan. Reducing negative side effects on blood when it comes into contact with foreign surfaces, such as polycarbonates or tubings, has always been one of MAQUET’s focus areas in extracorporeal circulation. We are very happy to offer this advantage to our customers and especially their patients in Japan. ”

 

Dermot Pearson, Marketing Director at Novozymes Biopharma comments, “We are delighted that Recombumin Alpha is a component of a medical device product now approved for the Japanese market. As a business, Novozymes is conscious of the rapidly changing regulatory landscape with regulations becoming increasingly tighter. As a result, we are committed to assisting our partners in developing safe, stable and highly pure products using ingredients which are Q7 compliant.” Dermot continues, “Our long-term relationship as a strategic partner to MAQUET has worked through mutual understanding of the company’s goals and Novozymes’ deep knowledge of the regulatory processes involved in taking product to market.”

 

Novozymes’ rAlbumins are compliant with the National Formulary (NF) rAlbumin human monograph published by the United States Pharmacopeia (USP). The use of Recombumin Alpha offers a range of performance and quality benefits for these applications, including sustainability of supply, improved biocompatibility and GMP compliance. Novozymes’ also ensures batch-to-batch consistency to reduce processing and testing times to drive product efficiency for customers looking for a compliant albumin alternative.

 

For further information on Novozymes Biopharma’s Recombumin portfolio please visit www.biopharma.novozymes.com