Going for gold
The pharmaceuticals industry is changing rapidly and Penn Pharmaceuticals is expanding to exploit a whole new range of opportunities. Chief operating officer Darren Hassey talks to Gay Sutton about plans to treble capacity at the South Wales plant and make the company the gold standard for customer care.
Celebrating its 30th anniversary this year, Penn Pharmaceuticals began life at Penn in Buckinghamshire before moving to its current location in Tafarnaubach, Tredegar in 1986, where it has breathed life back into one of the depressed coal mining centres of South Wales. Today the company is not only a major employer in the area, but it has carved a reputation for excellence in the pharmaceuticals industry, particularly in areas such as paediatric medicine where it has special expertise in poorly soluble molecules, as well as working with potent and teratogenic materialsÔÇöthose that can cause birth defectsÔÇösemi solids, ointments and creams.
Unlike many pharmaceutical companies, Penn has established expertise across a wide range of disciplines. The company formulates medications, developing the active pharmaceutical ingredient of a drug into a tablet, capsule or liquid form, ensuring that it is stable, effective and safe, and then provides a range of analytical services from full stability testing to validating the content and quality of the medication. The company has a full scale manufacturing operation backed by packing, storage and logistics facilities and ships its products around the world. ÔÇ£The thing that makes us unparalleled is that we do all of these five things, and do them for both clinical and commercial products,ÔÇØ explains chief operating officer Darren Hassey.
PennÔÇÖs customers can require any number or combination of services. Virtual pharmaceuticals companies, for example, who merely hold the intellectual property on a single molecule or active ingredient, are likely to require the entire portfolio of services to bring that drug to market. At the other end of the spectrum, the large pharmaceutical giants may require just one of PennÔÇÖs highly specialised testing or formulating services, or may commission the manufacture of a special drugs trial kit.
ÔÇ£From my perspective, Penn is remaining a key service provider to a lot of the small and virtual pharmaceutical companies where we have roots and where we offer a continued strong service, especially in the areas where they only hold intellectual property and are truly virtual,ÔÇØ explains Hassey. ÔÇ£But as we grow and continue to develop, we are seeing and driving much more work with larger pharmaceutical companies who are seeing a need to work with highly specialised and often more focused companies, such as Penn.ÔÇØ
Another trend is that the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products (EMEA) are becoming more discerning about the necessity for pharmaceutical licence applications to pay attention to paediatric needs.
ÔÇ£ItÔÇÖs difficult to present paediatrics (and the same is true for geriatrics) with what we may consider conventional dosage forms, such as capsules and tablets,ÔÇØ explains Hassey. ÔÇ£ThatÔÇÖs where the more specialised dosage forms such as fast melts or dispersible drugs that are flavoured, have alcohol removed, etc, are often quite beneficial for those populations. Our ability and skill in delivering and formulating poorly soluble molecules therefore allows us to be very successful in that area.ÔÇØ
The company has also been expanding geographically and has invested in establishing sales channels into the US and Japan as well as Europe, which is also driving growth.
To support this multi-faceted expansion drive, Penn is one year into a £12 million, five year plan to treble capacity at the plant and upgrade the facilities, laboratories and systems. The first phase of the plan began last year with the construction of a large 25,000 square foot pharmaceutical grade warehouse some eight miles away at Oakdale, which has freed up space at the Tafarnaubach plant. Alongside this, Penn had been working in partnership with IT company Sage to develop a fully validated Code of Federal Regulations part 11 pharmaceutical materials management system. This too was implemented last year and is now fully up and running.
The next phase of investment will be to completely change the internal flow within the factory and upgrade the equipment and laboratories. The companyÔÇÖs challenge is to do this in such a way that the facility can continue operating, it being a matter of progressively moving areas of the factory into updated space until eventually the entire facility has been upgraded and optimised, and new equipment installed.
Last year was also significant from the operational perspectiveÔÇöthe decision was made that over the following three years, Penn would move from being average to being the gold standard in customer care in its industry. For the transition to this gold standard, the company has introduced what it calls the ÔÇÿGoing for GoldÔÇÖ programme. ÔÇ£The inspiration behind this programme was the Welsh Paralympics swimmer, David Roberts. At Athens in 2008 he equalled Tanni Grey-ThompsonÔÇÖs record of 11 gold medals, but he had no sponsor at the time,ÔÇØ says Hassey. ÔÇ£We now sponsor him, and as a business this has helped us to realise that you should always strive for greatness.ÔÇØ
The Going for Gold programme is organised into a series of projects that aim to improve all areas of the company. Each project begins with small achievements; the targets are then increasingly raised to bronze, silver and finally, gold standard. Meanwhile, the concept of the gold standard is visible all around the site, and reinforced through company sponsorship of sporting excellence such as the Lions tour of South AfricaÔÇöwith involvement in the Ryder Cup on the cards too.
To support all these improvements, as well as the implementation of the new IT system, an intensive programme of training has been rolled out across the companyÔÇösome 1,400 days of training have been provided for the 254 staff over the last 12 months alone.
The final area of strong growth in recent years has been in the so-called unlicensed medication market in the UK. This is where only a small batch of medication is required or an unusual method of delivery is sought. The medication or formulation is therefore not licensed. ÔÇ£One example of what we have developed is a new method of delivering Midazolam, a drug that is used for the long-term treatment of status epilepticus,ÔÇØ Hassey says. In hospital, licensed Midazolam is delivered by injection, but out of the hospital environment, this is often impractical. ÔÇ£So we have developed buccal Midazolam, which is applied into the buccal muscosa [a mucous membrane on the inside of the cheek]. ItÔÇÖs a thick viscous formulation which can be applied easily to the inside of the lip. ItÔÇÖs absorbed very rapidly and avoids first pass of the liver, so it has a very rapid effect.ÔÇØ Manufactured under the rigorous quality and safety standards at the Tafarnaubach plant, the buccal Midazolam is also completely safe.
The Medicines and Healthcare products Regulatory Agency is currently reviewing the quality and safety of unlicensed medicines, and Penn Pharmaceuticals has recently written a paper on the issue for the chief medical officer Liam Donaldson. If the regulations change, not only will the safety and quality of the unlicensed pharmaceutical products on the market improve, but Penn Pharmaceuticals, with its focus on quality and customer service, will be leading the way.
