·       Excellence in Pharma: API Development – Novel Synthesis of Dronedarone Intermediate, Cambrex

·       Excellence in Pharma: Formulation and Excipients

o    Parteck® SRP 80 Excipient, Merck* [*the life science business of Merck operates as MilliporeSigma in the United States and Canada] (Excipients)

o    Using Intrinsically Enteric Capsule Technology To Deliver Enteric Protection and Delayed Release Achieved Without Functional Coating, Capsugel (Formulation)

·       Excellence in Pharma: Packaging - PYCLEAR™ PROTECTION: Patient Protection & Cost-Efficiency, Pylote SA

·       Excellence in Pharma: Drug Delivery Devices - 3M™ Intelligent Control Inhaler – The new future for addressing patient adherence and competence in Asthma and COPD patients, 3M

·       Excellence in Pharma: Contract Services & Outsourcing - OptiForm Solution Suite and OptiForm Solution Suite Bio, Catalent Pharma Solutions

·       Excellence in Pharma: Regulatory Procedures and Compliance - Emprove® Program, Merck* [*the life science business of Merck operates as MilliporeSigma in the United States and Canada]

·       Excellence in Pharma: Supply Chain, Logistics & Distribution - MENA region, Raising Star with New Challenges, Pharma Venture Mena – FZC

·       Excellence in Pharma: Analysis, Testing, and Quality Control - NanoLIBS, B&W Tek

·       Excellence in Pharma: Bioprocessing - BioSC® Lab: DSP Purification Breakthrough for the Biopharma Industry, Novasep

·       Excellence in Pharma: Manufacturing Technology and Equipment - The Future of Continuous Pharmaceutical Manufacturing: ConsiGma™, GEA Group

·       Excellence in Pharma: Corporate Social Responsibility - Centella asiatica Project in Madagascar, Indena S.p.A.

·       Excellence in Pharma: CEO of the Year - Udit Batra, Ph.D., Member of the Executive Board of Merck and CEO, the life science business of Merck* [*the life science business of Merck operates as MilliporeSigma in the United States and Canada. Udit Batra is CEO of MilliporeSigma]

Barcelona, 5 October 2016: CPhI Worldwide, (#cphiww) organised by UBM EMEA, announce the winners of the distinguished 2016 CPhI Pharma Awards live at a dedicated gala dinner in the Fairmont Rey Juan Carlos I, Barcelona. The awards honour companies and individuals driving the pharma industry forward through innovations, new approaches, technologies and strategies.

The CPhI Pharma Awards, which received a record number of entries, launched four extra categories this year, covering: ‘Excellence in Pharma: Drug Delivery Devices’, ‘Excellence in Pharma: Regulatory Procedures and Compliance’, ‘Excellence in Pharma: Analysis, Testing and Quality Control’, and ‘Excellence in Pharma: Corporate Social Responsibility’.

Udit Batra, Ph.D., Member of the Executive Board of Merck and CEO, the life science business of Merck* [*known as MilliporeSigma in the United States and Canada] won the prestigious Excellence in Pharma: CEO of the Year award. This award is recognition of his work in leading the acquisition of technology company Sigma-Aldrich, to create a €4.7 billion business offering more than 300,000 products to help customers accelerate discovery, development and manufacturing of life science applications and diagnostic testing.

In the ‘API Development’ category, Cambrex’s Novel Synthesis of Dronedarone Intermediate provided a patentable, 4-step, convergent process that utilises standard plant equipment – removing all need for chlorinated solvents and minimising waste.

The ‘Excipients and Formulations’ category saw two triumphant companies. Parteck® SRP 80 Excipient by Merck* was recognised for sustained-release oral solid dose matrix tabletsin the excipients category. With Capsugel honoured for it’s formulation of and intrinsically enteric capsule technology to deliver enteric protection and delayed release, without functional coating - enabling the oral delivery of sensitive macromolecules.

Pylote’s PYCLEARTM PROTECTION Patient Protection & Cost-Efficiency received the ‘Excellence in Pharma: Packaging’ award for its breakthrough industrial innovation that replaces preservatives in consumer end products. PYCLEARTM PROTECTION solves the problem of the risk of contamination without any change to the primary packaging and no impact on the manufacturing process.

In the ‘Drug Delivery Devices’ category, the 3M™ Intelligent Control Inhaler was honoured for its approach to addressing patient adherence and competence in Asthma and COPD patients. This is an intuitive, fully integrated device delivering accurate doses to patients, whilst providing on-screen instructions for use and feedback to the patient and health care provider via an app.

The ‘Excellence in Pharma: Contract Services and Outsourcing’ award went to Catalent Pharma Solutions for its OptiForm Solution Suite and OptiForm Solution Suite Bio. These offer easy, simple, fast and cost effective approaches for both small and macromolecules in early development phases.

With its third award of the evening, Merck* Emprove® Program won in the ‘Regulatory Procedures and Compliance’ category. The programme facilitates risk assessment and supplier qualification by providing instant, online access to regulatory and technical information on hundreds of products used in pharmaceutical and biopharmaceutical manufacturing.

FZC targeted the ‘Supply Chain, Logistics and Distribution’ challenges for its exemplary work in the MENA region through its Pharma Venture MENA - winning an award in this category.

Within ‘Analysis, Testing and Quality Control’, B&W Tek’s NanoLIBS® was victorious. The handheld LIBS analyser helps companies comply with 21CFR Part 11, GMP, regional Pharmacopeias, and local policies based on PIC/S recommendations.

Novasep won the ‘Excellence in Pharma: Bioprocessing’ award with its BioSC® Lab – a DSP Purification Breakthrough for the Biopharma Industry. The BioSC® Lab chromatography is a flexible equipment that allows operations from 1 column up to 6 columns in batch, parallel batch or continuous processing with all media and membrane types.

Following the innovations in ‘Manufacturing Technology and Equipment’, winning GEA Group’s ConsiGma™ platform looks at the Future of Continuous Pharmaceutical Manufacturing. This continuous manufacturing platform is a cost-efficient technology with a very small environmental footprint,performing raw material dosing and mixing, wet or dry granulation, drying, tableting and quality control, all in one line.

Finally, the ‘ Excellence in Pharma: Corporate Social Responsibility’ award went to Indena S.p.A.’s Centella asiatica for its Project in Madagascar. Focused on improving the living conditions of the local communities involved in Centella asiatica harvesting, the project started in October 2015 and will last for three years.

Andreas Mavrommatis, Global Marketing Director at UBM EMEA, added: “The CPhI Pharma Awards celebrates the entire pharma industry, its unique achievements, key people and technological innovations – it's a celebration of everything that is best in our industry. In the last few years, we have seen an impressive increase in the number of entries, a growing appreciation of the overall value and prestige that winning an Award confers on a company, and, of course, a tremendous increase in the quality of emerging technologies submitted for consideration.

Feedback from our judges is that they have been simply blown away by the consistent quality of submissions – which makes their job of choosing a winner all the more difficult. On behalf of CPhI Worldwide and UBM EMEA, I would like to commend all of the finalists and offer my warmest congratulations to this year’s worthy winners.”

For more information on the CPhI Pharma Awards, please visit: http://awards.cphi.com/

*the life science business of Merck operates as MilliporeSigma in the United States and Canada

1. API Development - Novel Synthesis of Dronedarone Intermediate, Cambrex

The synthesis of the Dronedarone intermediate that Cambrex was approached to make involved a linear, five step process with large quantities of chlorinated solvent which was unsuitable for scale up if demand reached the projected peak. Cambrex developed a novel, patentable, 4 step, convergent process that utilises standard plant equipment and removed all need for chlorinated solvents, giving robust, reproducible results. Waste was minimised with the recycling and reuse of solvents, as well as a considerable reduction of the cost of goods, allowing the route to be scaled up efficiently to 1MT batches.

2. Formulation and Excipients

·       Parteck® SRP 80 Excipient, Merck* (Excipients)

Parteck® SRP 80 excipient for sustained-release oral solid dose formulations translates reliable performance profiles as well as cost efficient production processes, resulting in support for our customers to improve safety and compliance of patients. It is functionally designed for sustained release matrix tablets, fully synthetic for batch-to-batch and performance consistency and suitable for direct compression processes. Parteck® SRP 80 excipient can help accelerate formulation work, from simplified feasibility and development to rapid and cost-efficient manufacturing.

·       Using Intrinsically Enteric Capsule Technology To Deliver Enteric Protection and Delayed Release Achieved Without Functional Coating, Capsugel (Formulation)

Intrinsically enteric capsule technology is a new generation of functional capsules that provide the industry with the first viable alternative to enteric coating processes.  These two-piece capsules enable the oral delivery of sensitive macromolecules that require enteric protection but degrade under the high temperatures associated with coating application and drying.  These capsules offer product development tools that allow rapid feasibility assessments and product development of new compounds displaying acid-sensitivity or gastric irritation, or requiring delayed or targeted release.  Lastly, these capsules provide a differentiated approach for new products or repositioned existing products requiring enteric protection or delayed release.

3. Packaging - PYCLEAR™ PROTECTION: Patient Protection & Cost-Efficiency, Pylote SA

Pylote presents PYCLEAR™ PROTECTION, a major innovation that replaces preservatives in multi-doses products but still protects the patient both from the risk of external contamination of the solution, and removes the risk of local tolerance problems encountered with the preservatives used in drugs. PYCLEAR™ PROTECTION provides a comprehensive and integral answer to substitute the use of preservatives in products without any change to the primary packaging and no impact on the manufacturing process. PYCLEAR™ PROTECTION is a breakthrough answer for the pharmaceutical industry enabling it to solve the problem of the risk of contamination of solutions without use of preservatives.

4. Drug Delivery Devices - 3M™ Intelligent Control Inhaler – The new future for addressing patient adherence and competence in Asthma and COPD patients, 3M

An estimated 334 million people have asthma worldwide, and 65 million people have moderate to severe COPD - a number expected to rise.  Hospitals and care providers continue to see low levels of adherence and poor and inconsistent competence using current treatment devices. This has led to sub-optimal outcomes and higher rates of hospital admissions.  Answering the need for a solution to device misuse and adherence issues, the 3M Intelligent Control Inhaler, is an intuitive, fully-integrated device delivering accurate doses to patients, whilst providing on-screen instructions for use and feedback to the patient and health care provider via an app.

5. Contract Services and Outsourcing - OptiForm Solution Suite and OptiForm Solution Suite Bio, Catalent Pharma Solutions

The OptiForm Solution Suite platform offers easy, simple, fast and cost effective approaches for both small and macromolecules in early development phases. OptiForm Solution Suite addresses the bioavailability challenges of small molecules at an early phase of development. The platform is an integrated service using a unique toolkit of bioavailability enhancing technologies, including comprehensive molecule characterization and unique salt screening assessment, combined with parallel processing with four superior formulation technologies. Using a similar parallel screening concept, OptiForm Solution Suite expands the of the technology to macromolecules for biotherapy, and is targeted to their unique challenges with proprietary oral technologies.

6. Regulatory Procedures and Compliance - Emprove® Program, Merck*

The industry-leading Emprove® program from the life science business of Merck facilitates risk assessment and supplier qualification by providing instant, online access to regulatory and technical information on hundreds of products used in pharmaceutical and biopharmaceutical manufacturing. Recently, the program was expanded to include products for filtration and single-use processing. With an increasingly complex regulatory landscape, the Emprove® program is structured to address different levels of risk and the dossiers are organized to best meet the requirements of the latest regulations. The program has been providing efficient regulatory documentation to pharma and biopharma for over a decade.

7. Supply Chain, Logistic, and Distribution - MENA region, Raising Star with New Challenges, Pharma Venture Mena – FZC

MENA region is the 2nd world emerging market after M-BRIC. Yet not an easy market to penetrate and operate a smooth business because of the big difference in each local regulation and registration, supply chain challenge, custom, etc. We are presenting a cumulative approach and complete package with real life example and case model for consideration when thinking about such market . The whole process in place with success story implementation and  recognized ,awarded by local authorities and also abroad by Industry business groups.

8. Analysis, Testing, and Quality Control - NanoLIBS, B&W Tek

B&W Tek developed the NanoLIBS® handheld LIBS analyzer to help companies comply with 21CFR Part 11, GMP, regional Pharmacopeias, and local policies based on PIC/S recommendations. When a batch of salts is received, a sample less than a gram can be quickly taken in the receiving area and pressed into a tablet form on the spot. With the tableted salt, the NanoLIBS takes only seconds to give an identification result of the salt based on the elemental composition to notify the user whether the sampled drum is what it is supposed to be.

9. Bioprocessing - BioSC® Lab : DSP Purification Breakthrough for the Biopharma Industry, Novasep

Are you more Johann Sebastian BATCH or Wolfgang CONTINUOUS Mozart? No need to choose, you can have it all! BioSC® Lab chromatography is the most flexible equipment on the market allowing operations from 1 column up to 6 columns in batch, parallel batch or continuous processing with all media and membrane types.

10. Manufacturing Technology and Equipment - The Future of Continuous Pharmaceutical Manufacturing: ConsiGma™, GEA Group

The pharmaceutical industry, supported by FDA, is looking at continuous processing to improve production quality in an efficient, compliant and cost-effective way. GEA’s ConsiGma™ platform continuous manufacturing platform is a highly superior and cost-efficient technology with a very small environmental footprint.  The multipurpose platform can perform raw material dosing and mixing, wet or dry granulation, drying, tableting and quality control, all in one line, and has been designed to transfer powder into coated tablets in development, pilot, clinical and production volumes in a single compact unit. ConsiGma™ consistently delivers a higher quality product and considerably reduces time to market.

11. Corporate Social Responsibility - Centella asiatica Project in Madagascar, Indena S.p.A.

In 2013 Indena, leader in the production of botanical extracts for the pharma, health-food and personal care industries, launched its Sustainable Sourcing program with the aim to have a fully sustainable supply chain. One of the first goals of this program has been the Centella asiatica project in Madagascar. Focused on improving the living conditions of the local communities involved in Centella asiatica harvesting, the project started in October 2015 and will last for three years, with the specific objective to increase the quality of education and the school attendance of the children.

Distribution of educational materials, training for the teachers, and creation or renovation of infrastructures (libraries, restrooms, etc.) are the main actions; 5 schools, 30 teachers, and about 1500 children are the beneficiaries. To realize all this we have chosen two reliable partners: Reggio Terzo Mondo (an Italian NGO operating in Madagascar since 1973) and PRONAMA (our local supplier since 30 years).

12. CEO of the Year - Udit Batra, Ph.D., Member of the Executive Board of Merck KgAa and CEO, life science business of Merck

Udit Batra, Ph.D., CEO of the life science business of Merck, is a champion of innovation to improve health for people everywhere.  With more than 20 years in healthcare, he has a strong track record of results in business growth and turnarounds and is recognized as a life science industry leader and change agent. Over the past two years Batra has led the acquisition of technology leader Sigma-Aldrich to create a €4.7 billion business offering more than 300,000 products to help customers accelerate discovery, development and manufacturing of life science applications and diagnostic testing.

*the life science business of Merck operates as MilliporeSigma in the United States and Canada

About CPhI

CPhI drives growth and innovation at every step of the global pharmaceutical supply chain from drug discovery to finished dosage. Through exhibitions, conferences and online communities, CPhI brings together more than 100,000 pharmaceutical professionals each year to network, identify business opportunities and expand the global market. CPhI hosts events in Europe, Korea, China, India, Japan, Southeast Asia, Istanbul and Russia, and co-locates with ICSE for contract services, P-MEC for machinery, equipment & technology, InnoPack for pharmaceutical packaging and BioPh for biopharma. CPhI provides an online buyer & supplier directory at CPhI-Online.com.

For more information visit: www.cphi.com

The UBM EMEA annual schedule of Pharmaceutical events includes: CPhI, ICSE, P-MEC, FDF and InnoPack Worldwide (4-6 October, 2016, Fira de Barcelona Gran Via, Barcelona, Spain); CPhI & P-MEC India (21-23 November, 2016, BEC and BKC Exhibition and Convention Centres, Mumbai, India), Pharmapack Europe (01-02 February, 2017); CPhI Istanbul (8-10 March, 2017 at the IFC Istanbul Expo Center, Istanbul, Turkey); CPhI, P-MEC and Innopack South East Asia (22-24 March, 2017 at the Jakarta International Expo- Jakarta, Indonesia); CPhI Russia (28 March – 30 March, 2017 at JSC VDNH (VVC), Pavilion 75, Hall A, Moscow); CPhI, ICSE, P-MEC, BioPh and InnoPack Japan (19-21 April, 2017 at the Big Sight Exhibition Centre- Tokyo); CPhI North America and InformEx (16-18 May, 2017); CPhI China and P-MEC (20-22 June, 2017 at SNIEC, Shanghai, China); CPhI Korea (22-24 August, 2017)

About UBM EMEA

UBM EMEA connects people and creates opportunities for companies across five continents to develop new business, meet customers, launch new products, promote their brands, and expand their market. Through premier brands such as TFM&A, Internet World, IFSEC, MD&M, CPhI, Cruise Shipping Miami, the Concrete Show, and many others, UBM Live exhibitions, conferences, awards programs, publications, Websites, and training and certification programs are an integral part of the marketing plans of companies across more than 20 industry sectors.