The rapid changes occurring in the pharmaceutical industry are placing mounting pressures on (bio) pharmaceutical companies to accomplish more with less. Outsourcing to access unique technologies, lower costs and accelerate timelines is now the norm. The winners are service providers and pharma customers that form true partnerships based on trust and understanding. In this fourth edition of the Pharma’s Almanac, we explore different collaboration models and how both innovator firms and CDMOs are applying them while they navigate changing pharma industry dynamics and build strong foundations for future success.
Building a premier supplier of contract research, development and manufacturing services requires an understanding of the marketplace, a long-term strategy for both inorganic and organic growth and the ability to effectively integrate acquisitions, as described by Dawn Von Rohr, Senior Vice President, API Operations, and Steven Hagen, Senior Vice President, Technical Operations, Albany Molecular Research, Inc.
Ash Stevens’ Vice President of Operations, Vince Ammoscato, and Principal Scientist – Regulatory Affairs, Charles Stankovic, discuss how CDMOs that implement effective process qualification strategies help their pharma partners meet aggressive deadlines and regulatory requirements.
Nigel Walker, founder of That’s Nice LLC and Nice Insight, considers how evolving markets are prompting drug owners and developers to pursue new business models.
In a look at Pharma 3.0, Nice Insight editors explore how contract service providers are redefining their mission and reframing their strategic roles with customers.
Industry experts provide insights on the impact of FDA’s recent approval of a switch from batch to continuous manufacturing; analytical and processing equipment that will have the most impact on pharma processing in the next 10 years; and supplier-partner models.
Helmut Schneider, Manager, Biopharmaceutical Technology and Keith Webber, Investigator, Biopharmaceutical Technology, both in the Analytical group at GlaxoSmithKline Biopharmaceuticals, outline how collaborative interactions with an advanced analytical method development team can facilitate both process optimization and technology transfer.
Syed T. Husain, Chief Commercial Officer of Alcami, outlines why reformulation efforts supported by reliable CDMOs can significantly reduce the impact of the loss of patent protection.
Tim Tyson, Chairman and CEO of Avara Pharmaceutical Services, explains why CDMOs must be able to facilitate clinical trials and offer scalable processes to meet the needs of different patient populations and achieve regional supply and sustainable partnerships.
Philippe Mougin, President of Cenexi, details how partnering with CDMOs allows pharma companies to take advantage of manufacturing expertise and state-of-the-art facilities for the fill-finish and inspection of sterile pharmaceuticals.
The application of advanced protein engineering technologies to the development of novel biopharmaceuticals is outlined by Gjalt Huisman, Vice President of Pharmaceutical Technology & Innovation with Codexis.
The growing importance of secondary packaging for achieving unique solutions that improve patient adherence is the focus of Jason Lasicki, Vice President, Sales and Marketing for CWS Packaging Services.
John Moscariello, Vice President of Process Development for CMC Biologics, outlines his company’s application of quality-by-design principles for biologics process development.
Richard Snyder, CSO and Mark Bamforth, CEO, Brammer Bio discuss the unique challenges associated with the scale-up of cell and gene therapy manufacturing for late-stage clinical and commercial supply and existing technologies that can be applied to the problem.
The joint venture contract services model is presented by Stephen Ball, Director of Sales and Marketing with BioVectra.
Kimo Sanderson, Vice President of Marketing and Client Services at Asahi Kasei Bioprocess America, discusses the company’s innovative inline buffer dilution (IBD) technology.
Filipe Gaspar, Vice President, R&D, and Márcio Temtem, Associate Director Particle Design and Formulation Development with Hovione, explain the company’s development by design approach for reducing the cost and time for scale-up of spray drying processes.
The importance of real collaboration between service providers and their (bio)pharma partners is highlighted by Christian Sauveur, Industrial General Director with Servier Group.
The increasing need for dose form and delivery systems to support therapeutic compliance and value is reviewed by Kevin Haehl, General Manager, Unither Pharmaceuticals.
Nice Consulting highlights possible strategies that CDMOs can adopt in order to achieve sustained growth.
Pere Vilanova, Innovation Technology Manager, Grifols, reveals how the ability to accurately track and trace pharma products and manage the disposition of stock after sale can add business value beyond efficiently demonstrating regulatory compliance.
In the second of a two-part article, Matt Hicks, COO of Federal Equipment Company, discusses the unique strategies required to manage and recapture the value of equipment.
Key findings from the 2016 Nice Insight Pharmaceutical Equipment Survey are highlighted by Nice Insight researchers.
In an additional special feature, Nice Insight editors focus on novel equipment solutions that are leading to increased manufacturing efficiency and productivity.
About the author
Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes 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]