Interview: A licence to think

Published: 20-Mar-2013

Stephen Munk has never wanted to be a cog in a wheel and as President and CEO of Ash Stevens he feels he has been able to make a difference. He talks to Jane Ellis about chemistry, the pharmaceutical industry, and cars.

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Fast cars, food and wine, music and the arts – and chemistry – are Stephen Munk’s passions. To feed one of these passions he has been President and CEO of Ash Stevens, headquartered in the US automobile and Motown city of Detroit, Michigan for the past 15 years.

Under his direction, the company has become a leading provider of high-calibre chemical development research for drug substances.

Ash Stevens has more than 50 years of experience developing and manufacturing active pharmaceutical ingredients (APIs) for new cancer drugs and other therapeutic agents and is a long-time provider of contract research services to several Institutes within the US National Institutes of Health, including the National Cancer Institute and the Walter Reed Army Institute of Research.

When Munk joined the firm in 1997 there were 35 staff and it had received two FDA manufacturing approvals. He became President in 1998, adding the title of CEO in 2001. Ash Stevens has since taken its FDA approvals to 12 and staffing levels have more than doubled to nearly 80 people, with new positions available.

‘Since I joined we have been investing and growing and my proudest achievement has been to move an outstanding but academic chemistry laboratory into a functional API manufacturing organisation,’ he says.

The most recent development has been completing the installation of 4000L reaction vessels for large-scale manufacture of APIs at Ash Stevens’ Riverview facility in Michigan. Validation is underway and they will be operational by April.

My proudest achievement has been to move an outstanding but academic chemistry laboratory into a functional API manufacturing organisation

The installation is part of a five-year, US$20m expansion project announced in 2010 to boost productivity and nearly double jobs at the plant. The first phase involved the construction of a 920m2 cGMP storage and materials handling facility. Other phases of construction include a new 9000L reactor bay with 2000L, 3000L and 4000L vessels for the large-scale manufacture of APIs. The company also aims to consolidate its Detroit laboratories to a single site at the Riverview location.

Ash Stevens was founded in 1962 by Professor Calvin (Cal) Stevens and Dr Art Ash as a chemistry research group, which started to provide contract research services to the Federal Government. While the company still provides these services, its core business today is the development and cGMP manufacture of APIs.

Munk’s love of chemistry grew under the guidance of ‘two brilliant mentors’, Henry Rapoport and Dale Boger. Rapoport, who died in 2002, was Professor of Chemistry at the University of California, Berkeley, with whom Munk studied for his PhD in Organic Chemistry (1979–1985). Rapoport is widely recognised for his work in the development of the chemical synthesis of biologically important compounds and pharmaceuticals.

Those mentors gave me the tools to solve problems – a licence to think

Boger was Professor of Chemistry at Purdue University, West Lafayette, IN when Munk was an American Cancer Society Postdoctoral Fellow from 1988–1991. Boger is currently Richard and Alice Cramer Professor of Chemistry at The Scripps Research Institute in La Jolla, CA. He is active in the field of organic chemistry and has research interests in natural product synthesis, synthetic methodology, medicinal chemistry, and combinatorial chemistry.

‘Those mentors gave me the tools to solve problems – a licence to think,’ says Munk.

After a long period of study, in 1991 Munk began his commercial career by joining Allergan, a global specialist pharmaceutical company with 5,000 employees. Its product range includes ophthalmic pharmaceuticals, plus dermatology and neurological products and, most notably perhaps, Botox.

Joining the company as a Medicinal Chemistry Scientist, Munk rose through the ranks to become Co-Team Leader of the alpha-2-Adrenergic Discovery Team and participated in the development and launch of glaucoma drug Alphagan (brimonidine).

He also introduced novel alpha-2 pharmacology assay protocols and prepared novel α2-adrenergic agonists and new reagents for their synthesis.

Munk’s transition to Ash Stevens became more one of management than working at the laboratory bench and so to help with the change, he went to a local college and took an accountancy course, as well as ‘lots of short courses on GMP topics; I’m a voracious reader’.

Professor Stevens approached him to join Ash Stevens in 1997 as VP of Research. Stevens knew Munk had been at Berkeley with Rapoport and had been involved with brimonidine, which Ash Stevens manufactured, and hired him, ‘without giving a thought to how he would take the company to the next level’.

I’ve always been interested in being early into a research programme – it’s an opportunity to make a difference

‘I think he hired the right person, but for the wrong reasons,’ says Munk. ‘I was really more a pharmacologist than a chemist. The first two years were a tremendous learning curve. I never thought I’d be a CEO – perhaps I had more ambition than good sense. But when you’re given an opportunity it gives you pause.

‘I’ve always preferred to be an agent of change and take risks,’ he says. ‘I’ve always been interested in being early into a research programme – it’s an opportunity to make a difference. I don’t want to be a cog in a wheel. It was a wonderful opportunity to join Ash Stevens, which was smaller than Allergan and open to innovation.’

But times have changed, and today Munk says there is a tremendous focus on the cost of drug development, rather than the novel science employed in that discovery. ‘It’s a major challenge, especially in the innovator side of the business. Most people don’t have an appreciation of what it costs to develop a drug or where it starts – and it is becoming increasingly challenging to find good drug candidates.

‘I would hope that the NIH will continue to fund basic research. But the industry is having a difficult time and investors require a return on investment – not just for the cost of the ingredients, but also for the cost of the research. It’s a tough societal challenge.’

And there are dangers in looking to Asia for cheaper manufacturing of drugs; Munk quotes the example of glass shards being found in Ranbaxy’s generic Lipitor (atorvastatin) last year. This was the second time that the FDA had investigated Ranbaxy – the first was in 2008 – for improper manufacturing practices at its plants in India and the US.

I don’t think we need more regulation, but what there is certainly needs to be applied more fairly

Munk believes there are double standards in the regulatory process in different countries across the world for innovator drug manufacturers and generics producers. ‘The playing field should be level across all countries worldwide, but there aren’t so many inspections in Asia. The same standards should be applied to all pharmaceutical manufacturers – as a businessman and a patient I would like to see that.

‘I don’t think we need more regulation, but what there is certainly needs to be applied more fairly. I’m not advocating more, but even application of the regulations. We don’t always appreciate that regulation can be a good thing when it is properly applied, but it costs money.’

Biologics are the way of the future, according to Munk, particularly antibody drug conjugates (ADCs), even though Ash Stevens doesn’t produce them.

There are signs that these next-generation products are gaining acceptance with Seattle Genetics’ Adcetris (brentuximab vedotin) being the first to receive FDA approval in 2011.

Munk believes it is a pioneering product that paves the way for personalised medicines. It harnesses the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells.

‘As we learn more about the fundamental biology of cancer there is the opportunity to do good science, improve human health and grow a viable business,’ he says.

But there are fewer opportunities in research these days. In the 1980s, Big Pharma was hiring a number of chemists every year, but now it is a very tough business.

‘When Merck, Pfizer and AstraZeneca are cutting jobs, chemistry doesn’t appear to offer good employment prospects, but if you don’t have a chemical, you don’t have a drug,’ he points out.

Chemistry doesn’t appear to offer good employment prospects, but if you don’t have a chemical, you don’t have a drug

Munk says he would be happy if his career could emulate that of John Topliss, the inventor of the Topliss Tree – an operational scheme used in medicinal chemistry – and Senior Director of Chemical Research at Schering-Plough and subsequently Vice President of Chemistry at Warner Lambert. Like Munk, as his career advanced Dr Topliss became progressively more involved with management responsibilities, but he continued to be enthusiastic about chemistry and pioneer new techniques.

Munk has always followed a job or educational opportunity, which has also taken him across the US.

For the past 15 years he has been working in Detroit, ‘which doesn’t deserve its reputation’, where he has been able to feed his passion for chemistry, as well as for fast cars by joining other petrolheads at the annual Detroit Motor Show, which he says is spectacular again after being in the doldrums for a few years, with Porsche, Ferrari and Nissan returning to exhibit this year. Munk avidly watches BBC2’s Top Gear and plans to buy a new BMW 320 all-wheel drive.

Stephen Munk has no regrets about his career and says Ash Stevens is a great place to work and staffed by ‘bright, enthusiastic people’, many of whom he inherited when he joined the company. He jokes that he needs to work for another 10–15 years ‘as I need to save for my retirement’, but before then he has an ambition to take Ash Stevens’ sales to US$100m.

After that he would be happy to go back to his academic roots and spend the last years of his career at Wayne State University, in Detroit, where he is currently Adjunct Professor of Chemistry.

Curriculum Vitae
Career
1997 to presentCEO and President, Ash Stevens
Adjunct Professor of Chemistry, Wayne State University, Michigan
1991-1997Drug Discovery, Allergan, Irvine, CA
Co-Team Leader, alpha-2-Adrenergic Discovery Team
1988-1991Purdue University, West Lafayette, IN
American Cancer Society, Postdoctoral Fellow (with D. Boger)
1985-1988Chem. Products and Biotechnology, Allied-Signal EMRC, Des Plaines, IL
Senior Research Chemist
Education
1988-1991American Cancer Society Postdoctoral Fellow (D. Boger)
Purdue University, West Lafayette, IN
1979-1985PhD, Organic Chemistry (H. Rapoport). Thesis Title: “Tetrahydropurines”
University of California at Berkeley, Berkeley, CA
1976-1979BSc, Chemistry, cum laude, Undergraduate Research Participant (G. Yuen)
Arizona State University, Tempe, AZ

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