There are many changes on the horizon for the life sciences industry. To help pharmaceutical manufacturers navigate the changes ahead Clarkston Consulting has generated the report below to highlight some of the trends and changes that will have the greatest impact on the industry at large. Clarkston Consulting is a leading management, operations & implementation consultancy firm that specializes in the life sciences industry. The report outlines the current state of the industry by looking at the regulatory environment, changes brought on by mergers, acquisitions, and divestitures, serialization challenges and the state of high value biologics, specialty and orphan drugs. The whitepaper then examines factors that will have the greatest impact on the industry in the years to come and provides insights on how the industry will be able to successfully respond. Explore strategies to overcome the challenges and take advantage of the opportunities in internal manufacturing, external manufacturing, operational excellence, quality management and compliance at the American Biomanufacturing Summit 2016!
Read More →Infographic: Building a Culture of Quality in Biomanufacturing
Quality management is a key focus at the American Biomanufacturing Summit 2016. Manufacturers are facing increased pressure to reduce product costs while producing “bio-better” drugs that have a vastly improved pharmacological profile. By implementing a quality management system biomanufacturers will be able to build consistency into their processes, improve efficiency, ensure profitability and drive operational and competitive advantages. Implementing a quality management system is no easy feat, the process requires an organizational evolution and involves the optimization of procedures, processes and resource allocation. To enable these changes an organization must first work to build an organizational culture that focuses on quality. The first infographic in our quality series has been created from the information presented by Tony Mire-Sluis, Vice President, North America, Abingdon, Singapore, Contract and Product Quality, Amgen Inc., at the American Biomanufacturing Summit last year. Find out more about building a Culture focused on Quality at the American Biomanufacturing Summit 2016!
Read More →Younok Dumortier Shin: A speaker review of the American Biomanufacturing Summit 2015
We were fortunate enough to have Younok Dumortier, Director of Large Molecule Technology Platform at Janssen join us as a speaker at the American Biomanufacturing Summit last year. We caught up with Younok and asked her to share some of her opinions about the event and participating as a speaker. The American Biomanufacturing Summit is returning to San Diego in May 2016. Find out more about the American Biomanufacturing Summit 2016!
Read More →Addressing the Challenges in Biomanufacturing
The life sciences industry is evolving on a global scale. Shifting market demands, healthcare reforms and more stringent regulations are presenting new challenges to the industry at large. “It is particularly challenging to manage operations globally when dealing with vastly different regulatory review periods for new drug applications as well as making any significant changes to existing dossiers.” explains Ryan Cox, Director, Bulk Manufacturing at CSL Behring. Increased pressure to reduce the cost of healthcare in the US is pushing manufacturers to streamline processes while finding new ways to produce “bio-better” drugs that have a vastly improved pharmacological profile. To remain competitive “biomanufacturers must continue to focus on innovation in terms of making improvements to existing products” explains Ryan. As a result “the industry will need to become much more flexible and “lean” over the next 5-10 years.” Taking a holistic approach to the challenges and opportunities that biomanufacturers face, Generis’ American Biomanufacturing Summit 2016 will present attendees with first-hand case studies, strategies and best practices to advance manufacturing excellence, drive innovation and develop the necessary leadership strategies to ensure long-term success. Produced with the thoughtful input of some of the world’s leading organizations, this senior level program is designed to provide biomanufacturing executives with current trends and strategic insights on internal manufacturing, external manufacturing, operational excellence, quality management and compliance. Annually attracting 150 senior level delegates from across North America, this years program will provide delegates with strategies and insights to …
Read More →eBook: The Opportunities & Challenges in Biomanufacturing
With the American Biomanufacturing Summit 2016 only 9 weeks away, we took some time to sit down with Ryan Cox, Director, Bulk Manufacturing, CSL Behring to gather his thoughts on the challenges and opportunities in biomanufacturing. Check out the eBook below! eBook – Q&A with Ryan Cox To hear more from Ryan, join the discussion at the American Biomanufacturing Summit 2016 taking place on May 10 – 11, 2016 in San Diego.
Read More →The Future of the Life Sciences Industry
The life sciences industry is evolving on a global scale. Shifting market demands, healthcare reforms and more stringent regulations are presenting new challenges to the industry at large. “In this rapidly evolving landscape, how will you shape the future of your organization?” Clarkston Consulting is a leading management, operations & implementation consultancy firm that specializes in the life sciences industry. To find out more, visit the Clarkston Consulting website or join the conversation at the upcoming American Biomanufacturing Summit 2016 taking place in San Diego in May!
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