The Data Generation

The pharmaceutical market landscape remains tremendously dynamic in 2017. Outsourcing practices for drug discovery, product and process development, clinical trials and manufacturing continue to evolve as well. Data — ‘Big Data’ in particular — is facilitating much of the changes, from the effectiveness of outsourcing to paradigm shifts in manufacturing. The first issue of Pharma’s Almanac in 2017 explores the current market landscape and the impact of Big Data and covers a whole host of other topics:

The Industry Leader Insight article by Don Barbieri, Technical Products Manager for Excipient and Drug Delivery Systems with SPI Pharma, touches on the importance of patient-friendly formulations in addressing patient noncompliance.

The pharma industry needs to address poor patient adherence with improved user experiences to help patients and improve public perception, according to Kevin Haehl, General Manager of Unither Pharmaceuticals.

Nigel Walker, Founder of That’s Nice LLC/Nice Insight, looks at the impact Big Data is having on the life science industry.

Our feature story highlights preliminary results from Nice Insight’s seven industry surveys on CDMOs, CROs, intermediates, excipients, equipment, the clinical supply chain & logistics and life sciences private equity/venture capital investments.

Our Roundtable discussion encompasses new regulatory requirements impacting the excipient supply chain, the evolving role of cloud computing in pharma, and what service providers need to do to provide global yet local support.

The concept of enhancing CDMO responsiveness through embedded flexibility is explored by Gwenaël Servant, Managing Director of Servier CDMO.

Virtual Panelists explore the potential of continuous manufacturing as reported by Nice Insight’s Executive Content Director Andrew Warmington.

Stephen Sirabian, Executive Vice President, E/E Division and Ed Godek, Manager, Process Technology for Glatt Air Techniques, Inc. describe the pharma industry’s growing capabilities for continuous solid dose manufacturing.

Ronak Savla, Ph.D., Scientific Affairs Manager and Stephen Tindal, Director of Scientific Affairs from Catalent Pharma Solutions discuss bioavailability and particle engineering in oral solid dose formulation.

Márcio Temtem, Associate Director for Particle Design and Formulation Development and João Vicente, Team Leader for Particle Engineering & Solubility Enhancement with Hovione, discuss alternatives to amorphous solid dispersions (spray drying and hot-melt extrusion), including an effective coprecipitation technology.

The importance of operational excellence and the ability to deliver high-performing, variation-free processes in achieving successful production of oral solid dosage forms is discussed by Adam Covitt, VP of Federal Equipment Company.

Arne Grumann, VP of R&D at Fermion, reviews the increasing role that CDMOs with knowledge and experience in optimizing crystallization and particle engineering are playing in solid dosage drug development and formulation.

Marga Viñes, Business Development Manager with Grifols Partnership, outlines the requirements for successful tech transfer of sterile injectable fill-finish projects to CDMOs.

Christa Myers, Senior Pharmaceutical Engineering Specialist and Todd Vaughn, Senior Process Specialist & OSD Expert with CRB discuss the need for introducing new processing concepts, analytics and control in OSD facilities of the future.

Catherine Hanley, Director of Marketing and Syed T. Husain, Chief Commercial Officer with Alcami outline their company’s strategy for supporting small and medium-sized pharma and biotech innovators.

Drivers for growth of the sterile injectibles market and the opportunities for CDMOs with the right tools, skills and experience are explored by Nick Bykerk, Director of Finance, Supply Chain and Business Development and Val Dittrich, Business Development Manager with Grand River Aseptic Manufacturing.

In an Executive Q&A piece, Catherine Hanley, Director of Marketing for Alcami, highlights the keys to achieving successful cultural integration following a merger or acquisition.

The “Quarterly Review” covers notable news, while “Trends Trading” by Emilie Branch, Nice Insight’s Strategic Content Manager, looks at investments in companies leveraging the microbiome.

The key attributes of CDMOs providing high-quality support for the manufacture and distribution of controlled substances are reviewed by Patrick Hatem, VP of Manufacturing and Kim Noll, Commercial Project Manager and DEA Liaison with UPM Pharmaceuticals.

Ariette van Strien, Chief Commercial Officer and Daniel Bell, VP of Regulatory Compliance and Technical Affairs at Marken discuss the importance of offering personalized services when supplying logistics solutions to the pharma industry.

The importance of considering the design intent, necessary single-use systems, and acceptable risk when designing single-use facilities is reviewed by Carl Carlson, Director, Bioprocess Design and Technology with M+W U.S., Inc.

Tim Tyson, Chairman and CEO of Avara Pharmaceutical Services, discusses building a quality CDMO through the acquisition of human and physical capital.

Icagen VPs Anil C. Nair, Kenneth F. Wertman, Marcel Patek and Paul R. August explore the ‘growth pharma’ model in which drug discovery programs are obtained via acquisitions.

Steve Kuehn, Executive Content Director at Nice Insight, introduces the latest offering at www.Pharmasalmanac.com — Pharma’s Almanac TV — another channel providing valuable insights from thought leaders in the industry.

In this issue’s In Conversation piece, Oskar Gold, Sr. VP Key Account Management and Marketing/Corporation Communications at Vetter Pharma International, discusses how outsourcing the fill-finish of aseptically prefilled syringe systems can help companies of all sizes.

Mark R. Bamforth, President and CEO and Richard O. Snyder, Chief Scientific Officer with Brammer Bio outline the significant investments their company is making to support the commercial manufacture of viral vectors.

Finally, we say thank you to the sponsors of our first Nice Symposium OSD and outline two symposia planned for 2018. This issue of Pharma’s Almanac is packed full of valuable information, but there are endless topics to explore. Let us know what interests you!

 

Cynthia A. Challener, Ph.D.

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.