Despite strong growth in the overall biopharmaceutical market and the biopharma contract services market, manufacturers of biologic APIs and drug products face innumerable challenges, from increasing cost pressures to expanding regulatory requirements and limited formularies. In this 3rd edition of the Pharma’s Almanac, we provide in-depth discussions of the trends — positive and negative — driving the biopharmaceutical market and the use of CROs/ CDMOs. Contract service providers representing the full value chain also offer their unique insights into the practices and strategies that are helping overcome the various challenges and enabling the accelerated development of novel medications.
Nigel Walker, founder of marketing firm That’s Nice LLC and Nice Insight, the company’s research arm, discusses how the biopharma industry is responding to both market drivers and constraints.
In a special focus on biologics, Nice Insight editors review the integral roles that CROs and CDMOs are playing in translating innovative technologies into highly successful treatments.
Brammer Bio CEO Mark Bamforth, along with Steve Kasok, CFO and Richard O. Snyder, CSO, explains why successful realization of commercial cell and gene therapies is predicated on the ability of big pharma and new biotech firms to establish partnerships with CDMOs with specialized expertise.
Rigorous integration is also essential within full-service CDMOs if they are to effectively support drug substance and drug product development, manufacturing, testing and packaging, reports Syed Husain Chief Commercial Officer of Alcami – the new alliance formed from the merger of AAIPharma Services and Cambridge Major Laboratories.
Advances in biotechnology are also impacting the production of small-molecule drugs, according to Rob Wilson, Senior Director of Business Operations for Codexis, Inc. The ability to rapidly develop specialized, engineered enzyme biocatalysts is improving efficiency and reducing costs in discovery, development and manufacturing.
The various facets of effective collaboration that differentiate ideal suppliers from qualified vendors are discussed by a virtual panel of top executives from contract providers Avara Pharmaceutical Services, Xcelience (a division of Capsugel Dosage Form Solutions), Vetter Pharma International and UPM Pharmaceuticals.
Oliver Technow, President, Scott Doncaster, Vice President of Manufacturing Technologies and Engineering, and Heather Delage, Vice President of Business Development for Biovectra, remind us that close relationships must be supported by the unique combination of specialized capabilities and demonstrated performance to achieve partnerships that can be competitive in the marketplace.
Cyrus K. Mirsaidi, President and CEO of BioDuro, outlines how integrated contract research and development organizations (CRDOs) with specialized expertise and innovative technologies can accelerate the biopharma drug development process and reduce overall costs.
Ash Stevens’ Vice President of Operations, Vince Ammoscato, and Senior Process Safety Engineer, Sean Lapekas, underscore the importance of conducting comprehensive process safety evaluations.
Bruce Miles, Lead, Mergers & Acquisitions Integration with Think Tank Partner, Nice Consulting, highlights factors driving the success of new organizations like Alcami that are formed via mergers and/or acquisitions.
The design of better packaging, administration devices and the use of advanced manufacturing technologies must be employed to allow production of the affordable, convenient and easy-to-use drug forms necessary for increasing patient adherence, according to Kevin Haehl, General Manager of Unither Pharmaceuticals.
Oriol Prat, Director of Contract Manufacturing with Grifols Partnership, outlines the challenges associated with the outsourcing of fill/finish activities and the importance of selecting a contract service provider with a clear track record of quality performance.
Trends in the pharmaceutical industry are changing equipment and technology needs and thus purchasing patterns. This is challenging manufacturers to rethink their equipment management strategies. Matt Hicks, Chief Operating Officer of Federal Equipment, discusses these key issues and a range of potential solutions.
GlaxoSmithKline Biopharmaceuticals’ Process Development Head, Erich Blatter, discusses why biopharma CDMOs must have the expertise to achieve efficient and effective upstream and downstream process development, enabling “right first time” technology transfer.
That’s Nice LLC and Nice Insight discuss how the adoption of single-use equipment is facilitating the implementation of flexible manufacturing solutions to achieve costeffective, aseptic production.
In three roundtable articles, industry leaders provide insights on enhancing bioavailability, the biosimilars landscape and antibody-drug conjugates.
Nice Insight researchers provide details about the recently completed 2016 Pharmaceutical Equipment Survey, including the demographics of respondents, types of equipment considered and the evaluation of company awareness and perception.
Guy Villax, CEO of Hovione, discusses the FDA’s shift from a focus on quality metrics to one that combines metrics with quality culture, and why leading CDMOs embrace innovative technologies and practices, including the introduction of Quality Culture into FDA’s lexicon.
Scale-down modeling is described by John Moscariello, Vice President of Process Development, and Gustavo Mahler, President and CEO of CMC Biologics, as an indispensible tool for biopharmaceutical process development, characterization, optimization and validation.
The list of top CDMOs and CROs are ranked according to customer perception as determined by The 2016 Nice Insight Contract Development & Manufacturing Survey and The 2016 Nice Insight Contract Research — Preclinical and Clinical Survey.
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]