Virtual Pharma Companies
Once considered a trend, virtual pharmaceutical companies have become a new way of life.
Given a number of continuing industry pressures — including greater diversity of pharma R&D sponsors, looming patent expirations and increased focus on outcomes-based patient care — the virtual pharmaceutical model is proving to be successful, says Tom Salus, director of sales at Metrics Contract Services.
“A number of these companies admittedly are putting all of their eggs in one pharmaceutical basket, but for investors, it’s often worth the risk,” Salus said. “Virtual companies often have minimal staff — sometimes no more than a CEO, an accountant and an attorney — so their operational costs are are focused on people and services with minimal fixed assets. The sole focus is getting their one drug into clinical trial.”
And for that, virtual pharma companies turn to consultants and outsourcing partners for help.
“With the downsizing Big Pharma has created in recent years, there are numerous experts in formulation development, analytical chemistry and quality assurance consulting with these virtual pharma companies,” Salus said. “They’re seasoned scientists who don’t get bogged down with internal operational matters; they care about the scientific challenge and getting the work done fast and right.”
Salus recently took a call from a consultant familiar with Metrics Contract Services. The consultant had begun working with a virtual company that had identified a contract pharma development and manufacturing organization (CDMO) as a partner. The consultant, a scientist, evaluated that company’s capabilities, services and regulatory history and decided to switch to a different CDMO.
“The consultant called us and said, ‘We need to be dosing clinical trial material (CTM) by the end of the year; can Metrics do it?’” Salus recalled. Metrics said that it could and would. Any CDMO working with virtual pharma companies needs to demonstrate the following characteristics, Salus said:
- First-time-in-man (FTIM) experience. For the record, Metrics has conducted more than 150 FTIM
projects for different chemical entities while developing hundreds of batches of CTM.
- A strong regulatory track record.
- Scientific excellence and integrity.
- Flexibility and a willingness to help, including guiding the project when appropriate.
- Transparent and honest communication.
“When it comes to working with virtual pharma companies and their consultants, the CDMO’s role is to augment the consultant’s technical expertise with scientists, facilities, and equipment that can get a compound into clinical trial quickly and safely,” Salus said. “At Metrics, we’re prepared to partner with virtual companies from concept to commercialization.”