Growth in biosimilars, increased complexity of new oral solids, and cell and gene therapies are among the key drivers for sponsors seeking CDMO services. Leon Wyszkowski president, commercial operations at Thermo Fisher Scientific discusses the company’s recent investments, the challenges biopharma companies face, and future needs in the outsourcing space. –KB

Contract Pharma: In what area/s of Thermo Fisher’s Pharma Services business do you see the most growth?

Leon Wyszkowski: As a global provider of drug substance and drug product development and manufacturing services coupled with services for clinical trial optimization and logistics, we have a great vantage point into the pharmaceutical services space.

We see a number of trends currently driving the industry:

•    fast adoption and acceleration of biosimilars
•    increased complexity of new oral solids molecules
•    Shift to specialty drug: cell and gene therapy, orphan drugs (biologics and small molecule)
•    rapid growth in demand for biologics and vaccines and drug pipelines

As a result, we seek to invest in business areas that are impacted by these trends and would allow us to accelerate innovation, enhance productivity and assure operational excellence for our customers and the patients they serve.

CP: Please discuss the company’s recent investments in China and the new viral vector CDMO site in Lexington, MA.

LW: Thermo Fisher Scientific has invested in a new pharma and biotech customer center in Shanghai to accelerate development of new drug therapies. This follows the recent announcements of a Biosciences Customer Exploration Center in Shanghai and the expansion of our clinical trials facility in Suzhou.

The new Pharma and BioPharma Center will support the rapid delivery of novel and high-quality therapeutics by providing expertise in critical analytical processes and specialized workflows.

Thermo Fisher’s new Customer Solution Center in Shanghai is a hub of collaboration that will enable scientists across China to build new analytical workflows, enhance knowledge across our thriving pharmaceutical and biopharmaceutical sector, and help build capability and expertise in the region.

Last year Thermo Fisher opened its new $90 million viral vector CDMO (contract development and manufacturing organization) site in Lexington, MA. The 50,000-square-foot facility will add more than 200 jobs and support the development, testing and manufacture of viral vectors, which are critical to advancing new life-saving gene and cell therapies globally.

The new Lexington site provides much-needed capacity for viral vector development and manufacturing, which to date has been a bottleneck for biotech companies. This investment is part of a larger strategy to accelerate commercialization of new therapies by providing a range of services – from drug development through clinical trials to commercial manufacturing – to support pharma and biotech companies of all sizes. 

The demand for new gene therapies has outpaced capacity, and we’re in a unique position to partner with our customers to help them accelerate development and production of medicines that will ultimately benefit patients suffering from rare diseases.

The Lexington viral vector CDMO site will be supported by a diverse workforce of scientists, quality control specialists and production teams. These employees will use specialized, Good Manufacturing Practices (GMP) in a state-of-the-art laboratory to produce, test and manufacture viral vectors.

With the addition of the Lexington site, Thermo Fisher now has more than 2,500 employees at 15 facilities supporting various businesses in the Commonwealth.

CP: What are some of the challenges Biopharma companies face developing and manufacturing today’s biologics?

LW: The biologics pipeline is becoming more diverse and complex and companies can no longer rely on platform processes or on prior experience with in developing and manufacturing more straightforward biological drugs.

In addition, there is an ever-increasing pressure to bring drugs to market faster, at a much lower cost, while ensuring absolutely no compromise on quality, robustness or efficacy.

There have also been several recent technology advancements (such as 5KL SU bioreactor) and companies, especially emerging biotechs, need a guiding hand to ensure that they have a very clear understanding of the risks and consequences of committing to a certain approach in order to ensure successful and timely commercialization of their molecule.

CP: What do you anticipate for future needs in the outsourcing space?

LW: The advancing science in the area of biologics, cell and gene therapies will drive the need for access to specialized technologies and expertise to help speed medicines to market.  Pharma and biotech companies will need to rely on those with expertise and experience in these categories.

While a lot of attention is given to the trends in the biologic space, there is still a large percentage of the new molecule pipeline that is focused on oral solids. Going forward, more compounds in development will have solubility challenges. Today, approximately 70% of molecules in development have solubility issues, so we know customers will require those technologies and expertise to solve the solubility issues.

Because of the growth of biologics therapies there will be an increased need for high-quality sterile fill/finish services. Additionally, expanding capacity and capability in the development and commercial supply chain will continue to be key for China over the next few years.

Overall, advancing patient care, simplifying the supply chain, collaborating with regulators and delivering higher quality at a faster pace while increasing efficiencies will be the most pressing issues in the outsourcing space.
 

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Leon Wyszkowski is the President, Commercial Operations, Thermo Fisher Scientific Pharma Services. Leon has worked in drug development for more than 22 years, with extensive experience in operations, client services and supply chain logistics. He joined Thermo Fisher Scientific in 2006 as the General Manager of the Bristol facility in Clinical Trials. Promoted to VP and General Manager of the Allentown, PA site in 2009, Leon led contract negotiations to form a strategic partnership with Eli Lilly. In 2010, Leon was promoted to VP and General Manager of Clinical Services in North America and expanded his role in 2014 to VP of Clinical Services North America and Facility Network and then in 2017 he became the President of Clinical Trials. Prior to joining Thermo Fisher, Leon served as Director of Operations at Acculogix, and Associate Director of Clinical Supplies for Pfizer. He holds a Bachelor’s degree in biology from Brown University.