Speciality Chemicals Magazine was delighted to attend DCAT Week ’17. We met with a number of key decision makers, such as Dr Rudolf Henko, CEO of Siegfried, Steven Klosk, CEO of Cambrex, James Mish, CEO of Noramco, Stephen Lam and Patrick Glaser, both Senior Vice Presidents at Patheon, and other leaders of industry from Flamma, Isochem, Jiuzhou Pharmaceutical, Neuland, Pfizer, STA Pharmaceutical, Zymtronix and others, to discuss global issues in pharmaceutical development and manufacturing. Sarah Harding reports.
The Drug, Chemical and Associated Technologies Association (DCAT) held its flagship event, DCAT Week ‘17, in New York City from 20th to 23rd March. This is a key global event for the pharmaceutical sector. The Association added four venues to this year’s DCAT Week to accommodate the significant growth in attendance and the need for additional meeting space.
In the words of Stephen Lam, Senior Vice President and Head of Biologics at Patheon, “DCAT Week is very much about bringing suppliers and buyers together, and the focus is on the one-to-one interactions.” Lam’s view was echoed by his colleague, Patrick Glaser, Senior Vice President – Small Molecule API at Patheon, who added, “DCAT Week is the most fruitful meeting – people come here with negotiations in mind.”
“DCAT is unique in that it is truly a meetings-oriented event that provides the opportunity to talk to many customers about specific business opportunities,” said Steven Klosk, CEO of Cambrex.
Indeed, there is an air of ‘ready to do business’ here, as noted by Dr Rudolf Hanko, CEO of Siegfried, who has “always liked DCAT for its efficiency.” Similarly, James Mish, President and CEO Noramco said, “Companies come to DCAT with decision makers. For this reason, it is a very effective and efficient venue to conduct business.”
GianPaolo Negresoli, Managing Director of Flamma, has been coming to DCAT for a number of years now and he is convinced, “DCAT has become the most important event. It’s less commercial than the trade shows, and you meet the people you need to meet in order to get business done.”
“No matter how much technology advances, it can’t beat the face-to-face aspect of meetings like this,” said John Fulmer, Associate Director of Neuland (North America).
DCAT is also an ideal venue to gather experts for top-tier discussions of important topics. DSM Sinochem Pharmaceuticals, a global leader in sustainable antibiotics produced using its proprietary patented enzymatic biotechnology, hosted an industry dialogue on combating Antimicrobial Resistance (AMR). The 13 signatory companies of the Industry Roadmap for Progress on Combating AMR, which was signed in September 2016, were invited to participate. A distinguished line-up of keynote speakers included Ambassador Juan José Gómez-Camacho, Permanent Representative of Mexico to the United Nations (UN), Jayasree K Iyer, Executive Director of Access to Medicine Foundation, Steve Brooks, Vice President EHS at Pfizer, Ramanan Laxminarayan, Director at CDDEP, and Dr Nata Menabde, Executive Director of the UN’s WHO Office.
Dr Stephane Corgié, Founder and CEO of Zymtronix was at DCAT to talk to people about next wave biocatalysis. There is little doubt that this up and coming company is destined for an impressive future, with its ‘enzyme immobilization’ technology poised to take on the pharmaceutical, food and agrochemical sectors. Zymtronix’s novel technology entraps any enzyme (mostly using resins), enabling controlled mobilization that makes the enzyme usable, stable and more economical. Moreover, Corgié uses nanotechnology to make the enzymes magnetic, so they can be easily recovered and re-used. “Our goal was to make a universal platform,” explained Corgié. “If you have an enzyme that works, we can make it work better.”
DCAT also provides a unique platform for companies to share their views on the industry and their strategies for the future. For example, Dr Rudolf Hanko provided a recap of the past 6 years, through which Siegfried followed its ‘Transform’ strategy, and he explained how the company is now entering a new phase, ‘Evolve’, which will drive it forward to 2020.
Stephen Lam and Patrick Glaser of Patheon also provided Speciality Chemicals Magazine with an update. The recent acquisition of Roche's API manufacturing facility in South Carolina reflects Patheon’s plan to expand its footprint in the US, which is in response to a strategic decision to increase manufacturing in North America. The company is working to secure a business model focused around integrated supply chain solutions, from early development through to final dosage forms. Glaser also highlighted Patheon’s niche offering for polymers, which can be difficult to produce but are well represented at the company. Lam added that Patheon’s offerings in small molecules and biologics frequently cross over, and the fact that the company has both capabilities in its pipeline is particularly useful for a number of larger clients.
James Mish signed on as President and CEO of Noramco in July 2016 to transform the now independent specialty API company into a business that delivers extra value. Specifically, he has enacted a plan that covers three transformative pillars – operational excellence, commercial excellence and strategic growth. Since taking the helm of Noramco, Mish has accelerated Noramco’s API innovation pipeline, moving five products forward in just 5 months. At the DCAT meeting in New York, Mish outlined three ways Noramco will better serve customers: through geographic expansion, continuing with global API registrations that began ten years ago; by expanding API product offerings, including cannabinoid-based APIs; and by a ‘solutions’ approach. By solutions, Mish means the information and product knowledge formulators require to utilize Noramco’s API in products and solve formulation challenges. They include formulation-friendly particle sizes and API characterization studies that assist in resolving stability and bioavailability problems. These and other solutions are designed to reduce customers’ time to market.
Simon Edwards, Vice President, Global Sales and Business Development at Cambrex believes that demand for small molecule APIs is strong, and that it will remain so for the foreseeable future. Furthermore, as pharma companies continue their shift towards discovery and marketing, he believes that manufacturing of small molecule drugs will be increasingly outsourced to service partners such as Cambrex. Edwards said, “By researching the needs of the small molecule market, we have made investments to expand our capacity with the ‘right’ assets to match the demands and current shortages, providing access to capacity when needed and the flexibility to meet small volumes and surges in demand.”
Dr Amelie Abore, Vice President of Isochem, is focusing on custom manufacturing, and the company has made a number of recent investments in upgrading its manufacturing and analytical equipment. Abore also explained that the company is placing a major focus on data integrity, especially following recent problems in this area in some world region. This, Abore explained, is driving many customers to return to Western countries for their manufacturing needs. There is an increasing demand, she said, for US and European CMOs.
Coming to America…
This view was echoed by John Fulmer, Associate Director of Neuland (North America), who declared an increasing demand from big pharma, especially in the US. Fulmer pointed out a trend for European companies consolidating their footprint, and repatriating to Europe, and then outsourcing to US CMO service providers. In his view, this is driving much of the demand for US CMO partners.
Simon Edwards of Cambrex thinks there iscontinued worldwide growth in API consumption and increased outsourcing requirements by large innovator companies. Coupled with the increasing use of generics, with additional opportunities for further penetration in developing markets, the industry continues to experience strong growth. According to Edwards, “This growth, over the past few years, has resulted in some capacity constraints in the industry at critical volumes, particularly in the US. Overall, there is a high demand, driven by the innovative pharmaceutical companies in the US and to some extent the EU, for reliable US and European suppliers with flexible, large, mid and small scale cGMP capacity such as Cambrex.”
James Mish of Noramco thinks the current political climates in the US and Europe are favourable for pharmaceutical development and manufacturing at the moment. He added, “Accessing high-quality APIs is a priority in the pharmaceutical industry. Companies with FDA-inspected facilities in the United States tend to have an advantage in quality. Noramco is fortunate to operate facilities in Wilmington, Delaware and Athens, Georgia.”
Steven Mentzer, Senior Director - Global Supply Business Development at Pfizer, is in charge of divestments following M&As. Slightly different to most people attending DCAT Week ’17, who were there to discuss manufacturing and supply deals, Mentzer was seeking possible partners for his divestitures. And where is it easiest to sell those assets? According to Mentzer, “There is definitely a demand for plants in the US now. Even companies in Europe or China want to be in the US – it’s a business trend.”
… or heading east?
However, after talking to STA Pharmaceutical CEO Minzhang Chen, and Yu Lu, Senior Director – Business Development at STA, I wondered if the situation is as simple as that. The Shanghai-based company has five sites – four in China and one in San Diego, California. While this might seem to support suggestions that companies headquartered in Asia are seeking to expand into the US, in fact it’s clear that STA’s focus is firmly on the homeland. Already employing more than 950 R&D scientists in two Shanghai sites alone, and with that number set to increase to 1250 within the next 2 years, the sheer scale of their endeavour is breath-taking. Chen simply smiles and points out that this is the Chinese way. “We are always like this,” he laughs, “Remember, when we build a wall, we build a great wall!”
Their latest development – when finished in 2018 – will be home to 500 scientists and nine manufacturing plants. “This is only possible in China, where we have a huge population of college graduates, giving us a large pool of skilled people to choose from,” explained Chen. STA is managing to deliver up to 700 development programs a year for a customer base from all over the world, 90% of whom Chen says are based in the US and Europe. STA has passed three FDA inspections in the past 3 years (two with ‘zero observations’). “People are happy with what they are seeing and what we deliver,” Chen asserted.
GianPaolo Negresoli, Managing Director of Flamma, has faith in the future of Chinese industry. The family company, which has two well established sites in Italy, is in the process of building a GMP laboratory in China. Negrosoli explains, “Our driving strategy is to integrate the same quality in Italy and China. It’s most important to offer the same profile, and the same products.” His new site in China will be headed by a long-stranding member of his team who is fully prepared and equipped to ensure that this is achieved.
Perhaps, though, Tony Jones, Global Head of Business Development – CDMO Division at Jiuzhou Pharmaceutical, best summed up the situation. “It’s not about west versus east,” he counselled. “It’s about being an international organization.”
And maybe the huge demand seen in the US, Europe and China is simply a reflection of a turn-up in the industry globally. Certainly, Mert Alver, Vice General Manager of the Turkish Atabay Group appears to believe the trend is there. “We focus on generic APIs and finished dose forms,” he explained, “including HPAPIs, and we are definitely seeing a growing industry in Turkey.”
DCAT Weeks ’18 and ’19 are already scheduled to take place in the weeks beginning the 19th and 18th March in 2018 and 2019, respectively. We look forward to seeing you there!
For more information about DCAT and the Association’s future events, visit https://www.dcat.org.