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Pharma &Biotech PHARMA & BIOTECH 1/ 2016 I N Markets & Companies Innovation Manufacturing & Supply Chain Top 10 Brands in the Pharmaceuti- How the Pharma Industry Can Developing New Synthetic Routes, cal Industry, Pharma M&A Update, Bridge the Innovation Gap, Trends High-Potency Manufacturing, Drug Market Reports, Expert Opinions, and Success Factors in Chemical Shortage Prevention, Specialized Company News and Pharmaceutical Research Pharma Logistics Azelis Pharma 2016 advert 240x330_PRINT:Layout 1 02/09/2016 11:38 Page 1 Azelis Pharma – We’re here to add value to your business where it counts In a dynamic pharmaceutical market driven by constant development, changing regulations and evolving healthcare demands, you need a fully compliant partner with proven technical expertise, market knowledge and the capability to keep you more than one step ahead. Azelis serves the human, veterinary health and medical sectors across EMEA, Americas and Asia Pacifi c and represents many of the industry’s top API and excipient manufacturers. Our unrivalled product portfolio is supported by a full package of certifi cations and licenses. APIs – broad therapeutic range includes: cardiovascular, CNS, dermatology, diabetes, infections, nutrition, ophthalmology & pain Excipients – covering all functions: bases, binders, coatings, colours, diluents, fi llers, glidants, lubricants, sorbents, preservatives & sweeteners We work closely with customers to understand their formulation needs, identify new opportunities from patent and therapeutic targeting and proactively add value from product development through to manufacture. Contact us to fi nd out how Azelis can help with quality ingredient sourcing and supply. www.azelis.com · [email protected] Creating value, growing together E DITORIAL Diagnosis: Innovation Insufficiency – Treatment: Combination Therapy Since the beginning of the 21st century, pharma M&A activity has exploded. In addition to mergers and acquisitions, outsourcing of research and manufacturing has become common place.. Whether or not this will translate into a more viable industry, however, has yet to be determined. Many of the mergers and acquisitions The Art of the Alliance were predicated on increased effici- One trend that crystallizes from the ency in the discovery and development expert statements is related to the in- of new drugs and therapies as the lack creasing role of research collabora- of new products is a major threat to tions. Just two decades ago, many sci- many pharmaceuticals companies. entists worked isolated in their “silos.” The industry has focused on clo- Cooperation with companies and ins- sing the innovation gap for more than titutions was more the exception than two decades. No one solution can the rule. This has changed completely. bridge the R&D productivity gap. The Alliances between big pharma and future of pharma innovation de- academia, hospitals and biotech s are tract research/contract manufactu- nological processes. With many re- mands a holistic approach that common practice today. Dr. Magid ring organizations (CROs/CMOs). search-based products in the pipe- addresses every R&D dimension— Abou-Gharbia, author of our feature The outsourcing trends also poses line, the first batch of biosimilars is strategy, organization, funding, tech- article, is a living example of a scien- new challenges on the pharma supply approaching registration. nology and expertise. tist who has been an accelerator of chain including a strong increase in In pharma manufacturing we will collaboration in pharma research. the complexity of pharma logistics. see more modular concepts allowing Expert Insights a shorter change over time and a hig- For this first edition of CHEManager Staying Ahead In Outsourcing Biosimilars and her agility of a factory. This is of spe- International Pharma & Biotech we Outsourcing of research, develop- Modular Manufacturing cial importance for biopharmaceuti- asked R&D experts of chemical & ment and/or manufacturing activities Other trends in Pharma include the cal products and underlines the need pharmaceutical companies to share continues to be an important topic for upswing of biopharmaceuticals on for excellent engineering. As the im- their opinions on success factors and pharmaceutical companies of all si- the products side and the tendency portance of high-potency APIs is in- challenges in research and the role of zes as it enhances the overall perfor- away from big-volume products to creasing, CDMOs and CMOs boost in- IT tools and human ingenuity. More mance of companies by enabling small-volume products on the manu- vestments in dedicated high-potency than twenty opinion leaders ranging them to focus their resources on core facturing side. manufacturing lines. from CEOs to heads of research and activities. Accordingly, the contract The market for biopharma pro- process development have responded research, development and manufac- ducts is expected to boom over the Please take the time to study this is- to our questions. Their statements de- turing industry continues to grow, next two decades. Industry estimates sue, it will be time well invested. liver first-hand insight into innova- driven by an expanding array of cus- that 30% to 40% of all pharmaceuti- tion strategies and provide an outlook tomer requirements presenting new cal products in the next 10 to 15 Dr. Michael Reubold and Dr. Ralf Kempf on the future of pharma research. challenges for both, Pharma and con- years will be produced with biotech- Editors, CHEManager How we contribute to the success of cancer research. Recently we transported some 2°C to 8°C temperature-sensitive biotech products in special boxes from San Francisco to a Swiss laboratory where cancer drugs are prepared to improve patients’ quality of life worldwide. This is just one of the many success stories we share with our customers. swissworldcargo.com We care for your cargo. CHEManager | Pharma & Biotech 3 C ONT E NT © Paulista - Fotolia.com EDITORIAL 3 A New Pathway 24 Novel Metal-Free Nitro Reduction Method Developed by Academia-Industry Collaboration MARKETS & COMPANIES 6-9, 21 Martin Rahmel, DexLeChem Best Pharma Brands 6 Interbrand Health Ranks Pfizer, Roche and Merck on Top MANUFACTURING & SUPPLY CHAIN 26-33 Thorsten Schüller, CHEManager Opportunities in Drug Development Big Pharma Targets Aspiring Biotechs 8 and Manufacturing 26 ONTENT Pharmaceutical M&A Activity Remains Buoyant Despite High-potency Manufacturing Continues to a Decline in Landmark Deals Attract Investment of CDMOs and CMOs Vir Lakshman, KPMG Patricia Van Arnum, DCAT Pharma Facility Awards 29 RESEARCH & DEVELOPmeNT 10-20 ISPE Recognizes Leaders in Drug Shortage Prevention Serialization – The Bigger Picture 30 C Bridging The Innovation Gap 10 Pharmaceutical Research in a Changing Environment Preparing for All Requirements with a Scalable Machine Dr. Magid Abou-Gharbia, Moulder Center for and Software Concept Drug Discovery Research Jörg Willburger, Bosch Packaging Technology The Winning Formula 12 Pharmaceutical Logistics as a Brand 32 Chemists Who Can Collaborate Will Thrive in Specialization in the Logistics Sector: Pharmaserv Pharmaceutical Research, Experts Predict Established a Separate Logistics Segment Industry professionals ranging from CEOs to heads of R&D Interview with Thomas Janssen, Pharmaserv and Dr. Martin Egger, and process development share their opinions Pharmaserv Logistics CHemICALS & APPLICATIONS 22-25 EVENTS INDEX IMPRINT 34 The Possibilities Of Peptides 22 Small Proteins Open Window to Better Treatments Thorsten Schüller, CHEManager 4 CHEManager | Pharma & Biotech Consistency. Proven Increase viable CHO cell density by supplementation with recombinant Insulin Human AF CHO cells are one of the most widely used platforms for the production of biopharmaceuticals. Increased demand for safety and reliability has moved the standard for CHO cell culture media from Serum to Serum free and further on to chemically defi ned media. UAB in collaboration with Novo Nordisk Pharmatech (world’s largest supplier of recombinant insulin) has shown that addition of animal origin free insulin to three leading commercially available off-the-shelf chemically defi ned media resulted in signifi cant increases in viable cell density. In addition to this benefi t insulin has been proven to aid in the expression of diffi cult to express proteins. To learn more visit www.novonordiskpharmatech.com CHO-S cell growth in ActiCHO media CHO-S cell growth in ActiCHO media CHO-S cell growth in CD CHO media CHO-S cell growth in FortiCHO media 8 100 8 100 15.0 100 15.0 100 7 7 12.5 12.5 Viability (%) Viability (%) 6 6 Viability (%) 10.0 10.0 5 5 4 50 7.5 50 7.5 50 4 50 3 5.0 5.0 3 2 2.5 2.5 1 2 0 0 0.0 0 0.0 1 0 Viable cell density (10^6 cell/mL) Viable cell density (10^6 cell/mL) 50 h 100 h 150 h 50 h 100 h 150 h Viable cell density (10^6 cell/mL) 50 h 100 h 150 h iable cell density (10^6 cell/mL) 0 0 V 0 mg/L Insulin 1 mg/L Insulin 5 mg/L Insulin 0 mg/L Insulin 1 mg/L Insulin 5 mg/L Insulin CD CHO and CD FortiCHO are trademarks of Thermo Fisher Scientifi c and ActiCHO are trademarks of GE Healthcare Biosciences AB. M ARK E TS & C O M PANI E S Best Pharma Brands Interbrand Health Ranks Pfizer, Roche and Merck on Top Global brand agency Interbrand has identified the top 10 phar- maceutical brands among the top 25 global pharmaceutical companies. Besides the finan- cial value of the brand, its influ- ence on health-care professio- nals played an essential role in the selection. The world’s largest pharmaceutical company, Pfizer, is also the company with the best and most valuable brand. This is the result of a global study by Interbrand, a New York specialist in evaluating brands. Interbrand prized the value of the Pfizer brand at about $20 billion and thus sees the US group at the top of the pharmaceutical giants. Next are the big players Roche — with a brand value of $15.5 billion — and © gustavofrazao - Fotolia.com Merck & Co.
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