While the pharmaceutical contract services market is growing at a healthy rate, CROs and CDMOs are competing head-to-head to earn the right to be preferred providers, while other contract and specialty service providers are excelling to be top providers. Only organizations with specialized capabilities ranging from the technical to the strategic will be successful.
In this edition of the Pharma Almanac, you will find 17 articles that discuss aspects of pharmaceutical outsourcing for both small- and large-molecule drug substances and drug products across the value chain: development, process optimization and scale-up, formulation, technology transfer, and manufacturing of clinical and commercial materials. The authors share valuable insights on their areas of expertise and how to improve both existing processes and outsourcing partnerships – all learned firsthand. Enjoy the read!
[1] Nigel Walker, founder of life sciences marketing agency That’s Nice LLC and Nice Insight, the company’s research arm, outlines the trends driving growth in the pharmaceutical outsourcing market in 2016. Despite fierce competition in the market, there are opportunities for innovative and flexible CROs and CDMOs that can help their customers manage complexity, enhance efficiency and productivity, improve quality, and increase collaboration.
[2] The new 2016 Nice Insight CDMO Outsourcing Survey results suggest strong growth of the pharmaceutical contract manufacturing market, with more companies than ever spending over $50 million annually for outsourcing services.
[3] Rajesh Shenoy, Ph.D., VP of Global Chemical Development, and Christopher Conway, Senior VP of Discovery and Development Services, from AMRI, explores how the use of Good Laboratory Practices and thorough process development and optimization early on can fa-cilitate scaleup to commercial GMP manufacturing and speed time to market.
[4]Ash Stevens’ President & CEO, Dr. Stephen A. Munk, discusses the significant role that CDMOs with integrated service offerings, particularly those with excellent process optimization capabilities, are playing in the continued success of the small-molecule pharmaceutical market.
[5] New manufacturing strategies are needed to enable accelerated API and drug product development and commercialization. Continuous processing is an effective approach to increasing efficiency and quality and will be a key component of the manufacturing capabilities offered by the most innovative CDMOs, assert Hovione’s VP of R&D Filipe Gaspar, General Manager (NJ, USA) Marco Gil, and Head of Continuous Manufacturing R&D Nuno Matos.
[6] Syed T. Husain, Chief Commercial Officer of AAIPharma Services–Cambridge Major Laboratories, discusses the benefits to pharma companies of access to analytical, development, manufacturing, and oral solid dose and parenteral manufacturing / packaging from CDMOs that offer API and drug product development and manufacturing services.
[7] Kevin Haehl, General Manager of Unither Pharmaceuticals, discusses the importance of convenient dosing formats for improving the medication adherence of elderly patients. Single-dose options help reduce medication errors and can be designed for easy access, and blow-fill-seal and stick-pack products provide elderly patients with a means for keeping track of their medications.
[8] Greg Flyte, Director of Contract Manufacturing Organization (CMO) Alliance & Program Management at GlaxoSmithKline, highlights the importance of the ability of biopharmaceutical CDMOs to provide customized platforms to address specific customer needs, solve technical challenges, and bring products to market in the shortest possible time.
[9]CMC Biologics President and CEO Gustavo Mahler discusses how growth of the biologics market is creating demand for biopharmaceutical CDMOs with state-of-theart facilities, a broad array of expertise, and accelerated process and product development capabilities.
[10] The advantages of premixed parenteral delivery compared to other leading parenteral drug delivery options are outlined by Marga Viñes, Business Development Manager for Contract Manufacturing with Grifols Partnership. Specialized CDMOs with the right set of capabilities can help drug companies reap the benefits of manufacturing parenterals without assuming the majority of the risk when switching from in-vial admixtures to premixed IV bags.
[11] Guy Tiene, Director of Strategic Content and Robert Leeuwendal, Senior Consultant with Nice Consulting review alternative approaches that CDMOs can adopt for exceeding client expectations and improving the customer experience. Understanding customer expectations, aligning internal processes to support the desired customer experience, and demonstrating leadership are three key factors for success.
[12] Nice Insight discusses the top-line results of Nice Insight’s new 2016 CRO Outsourcing Survey. The level of CRO engagement at every clinical phase has increased prominently, and outsourcing expenditures will continue to increase in the next five years.
[13] The development of innovative, specialized technologies is crucial if clinical logistics organizations (CLOs) and others involved in clinical trial design and management are to meet the increasingly complex needs of the sector while simultaneously increasing study efficiency and reducing cost. CEO Wes Wheeler and CCO Ariette van Strien of Marken explore the growing need for CLOs that employ state-of-the-art information, inventory, temperature control, and other technological systems to provide patient-focused delivery of clinical trial materials anywhere in the world.
[14] Trends driving the pharmaceutical equipment market as revealed by Nice Insight’s 2015 Pharmaceutical Equipment Annual Study are discussed by Nice Insight. Equipment needs across the supply chain are changing, and suppliers are responding with innovative technologies.
[15] Matt Hicks, Chief Operating Officer, Federal Equipment Company, explains why managing surplus and idle equipment inventories without interrupting current development and manufacturing programs has become an increasingly complex task, and strategies to manage surplus equipment to reduce costs, eliminate redundant or idle manufacturing equipment and facilities and free valuable manufacturing space.
[16] The 2016 CDMO and CRO Industry Leaders results are in. Companies have been ranked according to CP score, a measurement of customer perception that averages six key drivers. These CDMOs/CROs are ranked to the nearest decimal, suggesting a competitive landscape in which consumers are attuned to individual service offerings and overall market trends.
[17] Aaron Mazze, Digital Director of That’s Nice, outlines the Power of “Inbound” for Digital Marketing and Sales Success. As a complement to traditional “outbound” marketing, inbound techniques emphasize content development to pull customers towards a company’s brand and value proposition, increasing both awareness and credibility.
About the author
Cynthia A. Challener, Ph.D.
Scientific Content Director
Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.
LinkedIn www.linkedin.com/in/cynthiachallener
Email [email protected]