Formulation Development & Drug Delivery Conference: Wrapping Up Our 60th Successful Year
The June Land O’Lakes conference celebrated its 60th year in 2018. We sat down with speakers and attendees to learn more about the success and longevity of this conference. For a brief recap of what its like to attend this conference, take look at our recap blog.
Behind the Scenes: How are the Topics and Speakers Selected
The makings of the Land O’Lakes conferences begin with a knowledgeable planning committee. The June Land O’Lakes planning committee was composed of a wide variety of experienced professionals in the pharmaceutical industry. Ahmad Almaya, PhD, from Eli Lilly & Company was a Conference Planning Committee Co-Chair and has been working in continuous manufacturing(CM) for about seven years. The committee also included Co-Chair Luke Schenck, Principal Scientist of Particle Engineering at Merck & Company.
From experience, the committee members understand the considerations and challenges that go into implementing continuous manufacturing and incorporated them into the conference. These topics include material sciences, drug substance, drug properties, formulation development, process development, Process Analytical Technology (PAT), release strategies, regulatory strategies, and issues with engaging with regulators. Taking their industry experience and using it to identify experts in the field allowed them to put together a comprehensive conference.
A successful conference needs a cohesive goal to be productive. The committee had a specific objective in designing this conference.
“What makes this conference stand out is that it really focused on applicability and covered a lot of different aspects. We did not go too heavy on one topic versus the other but rather we carefully selected areas that we thought are very important.” Ahmad Almaya, PhD, Eli Lilly & Company
They sought to give attendees information that would be useful for the problems they are currently facing. Covering all aspects of continuous manufacturing was most beneficial because each step of the process is significantly influenced by the others. This view point lends to better problem solving when implementing CM.
The committee knows that attendee participation is also a key element, besides pertinent content. Their goal was not only to present relevant and comprehensive material but also to have in-depth discussions on all aspects of continuous manufacturing. They achieved this by choosing material that the attendees would find both exciting and applicable to their own work.
Once this concept was devised, the committee contacted speakers who would engage attendees. They chose speakers that aligned with their goals for the conference:
“We look at recent publications and really survey the industry and academia for who are the subject matter experts working at the cutting edge of the field and worked to present it in a way that stimulates dialogue amongst the attendees.” Luke Schenck, Merck & Company
Continuous Manufacturing: An In-depth Coverage
Continuous manufacturing has many benefits from improving drug quality to preventing shortages but its implementation also has numerous challenges. For an in depth comparison of batch vs. continuous manufacture (CM), take a look at our blog.
Switching to CM presents new challenges in all steps in the drug development process. The first hurdle in the process that the conference covered was active pharmaceutical ingredient (API). Our session on API in CM looked at how the properties of an API are different for continuous vs batch manufacture.
“There is a lot of work going on on the manufacturing side or formulation side but there is also the impact of the input API on the process itself and I wanted to highlight that point” Deniz Erdemir, PhD, from Bristol-Myers Squibb pointed out.
After API, naturally we covered material science: the interface between drug substance and drug product. This topic delighted many attendees.
“I really enjoyed hearing both about the drug product and drug substance. I thought we were going to focus on the formulations side but I was pleasantly surprised that there was a lot of emphasis on the drug substance continuous manufacturing” said Deniz Erdemir, PhD
Material science with continuous manufacture can be tricky.
“It is important because a lot of drugs don’t have these perfect properties so they need to be improved through this particle engineering approach to make continuous manufacture possible.” Calvin Sun, PhD, University of Minnesota
This session jointly focused on drug product and looked at different particle engineering approaches to enable CM. This segued nicely into discussion of drug product.
The Formulation Development for CM session covered both direct compression and wet granulation featuring several case studies. Topics included how to know if a formulation is suitable for PCMM and how to optimize manufacturing.
CM allows for better quality control of drug products compared to batch manufacture. The Process Development, Unit Operation Integration and Control with DP CM covered the integration of PAT development and RTRT for CM. There were examples of hot-melt extrusion with CM and process development and control with direct compression CM.
The session on Regulatory Aspects of CM aimed to be a supportive resource for developing and implementing CM. The FDA strongly supports the use of CM for its quality assurance capabilities. As such, the session was centered around appropriate control strategies, methods of detection and control such as RTRT, and process performance qualification. When considering the implementation of CM, engaging with the FDA early on is critical for success. The Emerging Technology Team is a resource at the FDA for companies developing new CM technologies in order to further support CM.
The conference truly highlighted how continuous manufacturing needs to be implemented with a holistic view because, as the name suggests, each step in the process significantly affects the overall success. Attendees gained various perspectives from this conference inviting new avenues of problem solving to the challenges they face with CM.
“The conference is very well designed starting from API, to process, to regulatory aspects with both theory and philosophical discussion and examples/case studies” Calvin Sun, PhD, University of Minnesota
June Land O’Lakes Conference: A Cut Above the Rest
Land O’ Lakes conferences stand alone in their ability to provoke productive discussion on the current issues in industry. Attendees enjoy the unique opportunity to have in-depth discussions about their work with other genuinely interested attendees. Several aspects of the conference facilitate this positive learning environment:
“This is a really excellent forum for presenting work because attendees all share the same interest and you can really have very high quality discussion.”noted Calvin Sun, PhD, University of Minnesota
Not only does the conference bring together a group with very focused interests, it provides differing view points. Tying together innovation from academia, current examples from industry and guidance from regulators, this conference gives the most informative look at all fronts of a topic in pharmaceutical science. Gaining new perspective can provide valuable insight to an issue.
The word “conference” means “a meeting for discussion” which our conference coordinators have not forgotten as some of the large conference planners have. Our coordinators specifically planned ample discussion and networking time into the schedule. Attendees enjoyed the, half hour long, panel discussions that followed each plenary session which allowed them to ask detailed questions or share personal experiences. Many attendees remarked that there is rarely time for this at larger conferences and found it to be extremely valuable. Our planners consider the importance of dialogue and do not overload the schedule.
The size of the Land O’Lakes conferences is an additional benefit. Attendees found it much easier to network in the smaller conference environment. Many breaks and reception dinners were scheduled specifically for attendees to socialize and make new connections. And not just formal receptions, the coordinators planned an activity to help attendees relax and enjoy themselves while making connections with other attendees. Attendees took a trolley tour of Madison and the UW-campus which helped them feel refreshed and ready to return to work.
We pride ourselves on creating this learning opportunity in support of innovation across the field. These conferences would be nothing without the speakers and attendees who come willing to share and debate ideas. After our 60th year, the Land O’Lakes Formulation Development & Drug Delivery Conference reflects on a successful past and looks forward to a future of continued innovation.
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