In collaboration with Wyeth, MMI ran, for the third year, the highly popular course 'Molecules to Medicines: How Biopharma Delivers'. The two-day course was held at the TCD Institute of Molecular Medicine, St. James's Hospital on 15-16 October 2008.
This MMI/Wyeth course attracts a large audience of research students, academic staff and clinicians, including those contemplating a career in industry or doing translational research in academia. The lectures provide an overview of biopharmaceutical discovery, development and manufacturing, delivered by key staff from Wyeth, with a clinical perspective provided by a series of lectures from academic clinician scientists.
The first day of lectures drew an attendance of 62 from MMI parent institutions, as well as researchers from Dublin City University and Queen’s University Belfast. The following day’s workshop, limited to a group of 26, was designed to facilitate discussion of key issues arising during biopharmaceutical discovery, development, and manufacturing through breakout group discussion of specifically devised problem sets.
Molecules to Medicines Lectures – 15 October
The clinical perspective lectures, chaired by Professor Joseph Keane (TCD), concentrated on the use of biopharmaceuticals in three areas: breast cancer (Dr Dearbhaile Collins, RCSI), Intersitial Lung Disease (Professor Michael Keane, UCD), and rheumatoid arthritis (Dr Donough Howard, St. James’s Hospital). In highlighting successes and challenges in the development and use of biologic therapies, this session provided a foundation for the remainder of the course.
Two lectures on biopharmaceutical discovery were given by Dr Davinder Gill (Assistant Vice President, Biologic Therapeutics, Wyeth Pharmaceuticals). He described how the biotech industry has evolved over 25 years since the FDA approval of Humulin, a recombinant form of human insulin genetically-engineered to be produced in E. coli, to its current position with over 80 recombinant DNA products approved by the FDA to date. Today, the collection of biotech products includes secreted factors, fusion proteins, and monoclonal antibodies. Dr Gill outlined how the pharmaceutical industry has adapted molecular and cellular biology techniques, protein structure/function technologies, protein engineering, in vitro assays and animal models to enable the discovery of biotech drugs, how projects are shepherded through the complexity of pharmaceutical product development, how scientific innovation and creativity are utilized and how the risk of drug discovery is spread over multi-pronged strategies.
Dr Patrick Gammell (Scientist, Wyeth Biotech) described the major elements and considerations in the development of a typical manufacturing process and highlighted some of the current and future challenges. In the past 20 years, the change in the types of biotechnology products being made has led to considerable “industrialization” with a drive towards significantly improved expression levels, process yields and ease of product administration, with shorter process development timelines.
This was followed by two lectures on biopharmaceutical manufacturing given by Dr Paul Dillon (Senior Scientist, Wyeth Biotech), which included an overview of facility design and operation. Course attendees saw how the various technologies operate in the plant and heard a description of the interrelationships on a manufacturing site and how the process of manufacturing a batch involves a wide range of expertise. Natural variability can occur in biological systems and the investigative scientists who support the plant utilise a range of modern technologies to solve problems or to support planned changes.
The final presentation of the day by Dr Ken Seamon (University of Cambridge) offered a fascinating account of the origins of biological therapeutic regulation and presented a number of key examples that illustrate the complexities in regulating products developed with new technologies. Dr Seamon outlined how the regulatory system used for the evaluation of biotech products has continued to evolve along with the products and has always maintained a flexible approach that can accommodate novel therapies and technologies.
Molecules to Medicines Workshop – 16 October
26 of the day 1 attendees took part in discussion of key issues arising during biopharmaceutical discovery, development, and manufacturing. After setting the context for the problems, the instructors broke the audience into groups to discuss specially devised problem sets. For the discovery case study the groups were asked to devise an approach for the development of a biopharmaceutical drug which would neutralize an asthma-inducing cytokine. Each group then reported on their selected approach. For the development case studies, the group devised strategies to improve Phase 1 and late-stage cell lines, mindful of the challenges of improving productivity of the existing cell line while meeting a defined timeline. The manufacturing case studies required the groups to discuss how they would respond to a situation where routine batch analysis shows the distribution of charged sugars as close to the bottom limit of the specification. They each reported on how they would advise the manufacturing and quality groups in this situation.
The workshop also provided attendees with a very valuable opportunity to network with Wyeth scientists. Question and answer sessions on both days allowed participants to probe aspects of the biopharmaceutical industry and career options.
Tour of Wyeth campus in Grangecastle, Dublin
As a follow-on from the MMI/Wyeth course, a visit to the Grange Castle Wyeth campus will include a tour of the development lab, a video presentation about the site, and a round table discussion. The visit will be hosted by Dr Brendan Hughes (Senior Director, Development and Technical Services).
Feedback
As with all Molecular Medicine Ireland courses, feedback was gathered on all aspects of the course from the organisation and scheduling to the course content and delivery, and the responses were very positive:
“The information provided directly helps me in my work and has helped clear a few issues I myself have experienced.”
“This lecture series was exactly what I had hoped for. It gave a clear and in-depth explanation of industrial processes to produce a product. The course has opened my eyes on the processes involved in industry and I now have a better appreciation for the development of a drug from a concept to a finished product.”
“The workshop was well organised and a good effort to bridge the gap between academia and industry.”
“Both lectures and workshop were well organised. The speakers were all really good and of high standard. I’m looking forward to more lectures and workshops in the future.”
“After a brilliant day of lectures the workshop surpassed my expectations. Interacting with the staff of Wyeth has been a brilliant experience and I’m very glad I attended this course.”