Vice President, Sales & Business Development, Cambrex
SIMON EDWARDS has almost 30 years of experience in business development roles in pharmaceutical intermediate and API market. After graduating in chemistry, he spent three years in chemical development and clinical supply at GSK before moving into business development in 1989 with International BioSynthetics. He moved to the U.S. in 1997 and spent 16 years with Lonza prior to joining Cambrex in April 2013 as Vice President of Sales and Business Development.
How or why did you become a part of the specialty chemical industry?
After graduating university in the UK as an organic chemist, I spent three years in process development and clinical supply at GSK before joining International Biosynthetics as a business development manager. The driver for the move was to get into a business role while using my chemistry knowledge. That was all back in the 1980s, but that was when I became involved in fine chemicals, supplying not only the pharmaceutical industry but agrochemical, photographic and other less well-known industries such as u.v. curing. In the 1990s I started to specialize in pharma and moved to the U.S. in 1997 to work exclusively on custom development and manufacturing for the pharmaceutical industry.
What are the market drivers that make specialties attractive?
Cambrex is focused entirely on small molecules for the pharmaceutical industry. In 2017 the FDA approved the highest number of small molecule new molecular entities (34) in the last decade. There now exists the fastest growing and largest small molecule clinical pipeline in the last 20 years with more small molecules in clinical Phase I, II and III. We are also seeing the outsourcing trend of pharmaceutical companies continue to increase while also favoring well-established, high-quality western suppliers that can offer security of supply. This is particularly the case in the U.S. where the growing pipeline described above is increasingly dominated by small to mid-size pharma that do not manufacture in-house at all. These are some of the key drivers that make the market attractive today. The market does remain almost as fragmented, and competition is strong. The other thing that does not change is that the world population is always growing, and they all need medicine, so the growth in demand is always there.
What do you think are the most pressing challenges facing the industry and the pharma sector in particular?
Given these trends the major challenge facing the industry in the U.S. is having the right capacity to meet demands. Cambrex invested $260 million in facility expansions, equipment, technology and EHS upgrades to ensure these needs can be met while also ensuring standards in quality and customer service are enhanced. Perhaps the key challenge is characterized by the phrase, “the right capacity.” For example, to operate in highly potent technology one needs to be able to handle the ultra-potent that might require small scale, in the 20-150-liter range while others will require 500-gallon scale or even more. This same uncertainty in volume can also apply to any new product as forecast demand prior to launch very rarely matches the actual post launch. As a supplier you must have the flexibility to deal with either the disappointment of lower demand or an unexpected higher demand. Having capabilities across a range of scale and to have available capacity is always the challenge.
As a Vice President of Global Sales and Business Development, what are some of the historical trends you have seen during your time in the industry and how are they manifesting themselves today?
Cambrex presented the history of the contract manufacturing organization (CMO) industry from 1975 to date in a webinar back in 2016. After interviewing industry veterans, we came to view the history in four stages, which we referred to as the Early Years, Growth Years, Competitive Years and Resurgent years. The early years describe the birth of the industry, characterized by the beginning of the blockbuster drug era and the consequent need for pharmaceutical companies to outsource specifically difficult to handle reagents. The growth years describes the race-to-the-top as the blockbuster era got into full swing, R&D expenditure ballooned, and efficiencies resulted in a thriving rate of new chemical entities (NCEs). CMOs had to develop their GMP quality systems quickly and significantly to meet the demand and shift from single step, difficult reagent products to multi-step advanced intermediates or even API. The competitive years, the race-to-the-bottom, were characterized by the downturn in the number of NCEs, which coincided with major patent expiries and the drive for pharmaceutical companies to cut costs. The gold rush moved from the West to the East as Indian and later Chinese suppliers entered the market with excess capacity. Then came the resurgent years, the 2010s, which have seen us come almost full circle. NCEs are back to all-time highs and pharmaceutical companies looking to outsource not only to high quality suppliers but to those that can offer new technologies for which they have no desire to invest in inhouse facilities.
What’s one big trend you are watching?
As a supplier to the pharmaceutical industry you cannot get away from constant monitoring of the clinical pipeline. The need to introduce new technologies and capabilities to ensure innovative solutions is also important. There is also a trend towards smaller API volumes, so it is difficult to pick out one trend to follow because you must take all of these and more into account. One thing that is providing some interest, however, is the drift into the one-stop-shop approach of some suppliers. We are watching that to determine whether there is true value to the customers or not.