< PreviousTRAINING AND DEVELOPMENT10Pharma Business International www.pbiforum.netUniversity of Leicester has been awarded four ofthese studentships, allowing businesses to takeadvantage of burgeoning medical and biologicalresearch talent.The biggest problem comes as a result of a declinein many countries of graduates within fields applicableto the industry – or sciences in general. Within the UKthis is very pronounced, and other countries arefinding similar results. Initiative such as STEM areworking to make science subjects more appealing toyounger audiences, in hopes that this will create along term solution, but it does little to prop upproblems in the short term. Short-term solutions are limited to two realisticoptions. Firstly that companies invest more in theirrecruitment strategies, to attract the best talentavailable – limited as it may be. Headhunting andaggressive marketing campaigns might help to taketalent from rivals, but the risk is that such actions cancause rifts between companies who might havebefore had positive relations. Also there is the fact thatemployees who were tempted away by a companyhave already proven that they will move where thegrass is greenest, meaning that a counter-push byanother company might have them moving on oncemore. The other option is to invest more in developing theskills of existing or new employees to fill the gap inthe market. This is something of a medium-termapproach, as the training might take some time in itsown right, but it still should end in the same results. Inthese cases employees might be more willing to stayloyal to the company, as they have invested in helpingthe employee expand their skills. This can also boostmotivation and morale within the organisation. Thatsaid, it can be as expensive as recruitment itself,especially if it’s a large number of people beingtrained up. In addition, there is the risk of theemployees failing such programmes or struggling toabsorb material. In many cases this is something which can bemitigated with careful planning, however. Employeesshould be interviewed and selected based on theirmerits, including likeliness to stick to the course,invest their time in learning outside of work time – andoverall previous performance for the company.Employees who have proven their worth in the pastwill surely do so again in the future, so why not trainthem to take over more important roles?08-11_Layout 1 05/10/2017 09:20 Page 3Pharma Business International 11www.pbiforum.netTRAINING AND DEVELOPMENT© Shutterstock / Andrei_R08-11_Layout 1 05/10/2017 09:20 Page 4OUTSOURCING12Pharma Business International www.pbiforum.netHandled off-siteOutsourcing production, research or just about any aspect of a pharma business is nowcommonplace, but what are the risks involved?12-15_Layout 1 05/10/2017 09:21 Page 1Pharma Business International 13www.pbiforum.netOUTSOURCINGOutsourcing production used to be arisky prospect, something that was onlyconsidered as a last-minute resource in asituation where an influx of demand, or aproblem with your own production linehad taken place. Nowadays however,with the increased technologicaldevelopment – and as a result the moreaffordable access to technology –outsourcing pharma production is not asrisky a prospect as it once was.In fact it’s now a booming industry.Mostly handled by CMOs (ContractManufacturing Organisations), thehealthcare CMO market is boomingrapidly, and is anticipated to show aCAGR of 14.3 per cent leading up to2019. This has led to many majorpharmaceutical firms making the choiceto utilise CMOs for 100 per cent of theirproduction capabilities, greatly reducingstaff costs and other overheads.When it comes to the CMO industry,major plays are the US and Europe, whohave a large number of healthcare CMOswithin their territory. Germany, Italy andthe UK are particularly active in the EU –with Germany having a clear lead interms of the sheer number of CMOs thatspecialise in the pharmaceutical industry. The story is much the same in the restof the world. In 2012 the global pharmaCMO market stood at an estimated $97billion, while figures suggest that by theyear 2019, this will have ballooned to anincredible $246 billion. This is expectedto be a compound factor of pharma© Shutterstock / Matej Kastelic15 Á12-15_Layout 1 05/10/2017 09:21 Page 2OUTSOURCING14Pharma Business International www.pbiforum.net© Shutterstock / Dmitry Kalinovsky12-15_Layout 1 05/10/2017 09:21 Page 3Pharma Business International 15www.pbiforum.netOUTSOURCINGgiants making increased use of CMOs. But the figure isalso strengthened by the ending of a number of patentswhich will likely see a flurry of suppliers seeking toprovide now un-patented drugs at much lower rates. Of course there are risks associated with making use ofCMOs, with a major one being failure in on-timedeliveries, which can cost the original pharma company interms of both client confidence, and consumerconfidence. And of course there are also concerns to beraised on the quality of products, and compliance tocomplex hygiene regulations. In many cases CMOs riseabove such issues, as they are legitimate companies whoadhere to any and all legislation, but there will always bedangerous elements who are willing to take risks. Asalways, it’s best for contractors to look into CMOassociations, as membership of one of those often meansthe company has been made to pass some kind ofaccreditation check. The recent delay of a male pattern baldness drug fromGSK highlights the risks in selecting a CMO, after aproduction halt at their French CMO meant they could notmeet the launch date for Zagallo (dutasteride) in Japan.Of course there are other forms of outsourcing thatcompanies can consider, from contract researchorganisations (CROs) through to Contract Sales Offices orAgents. CROs are a popular choice due to the high levelsof expertise they can often secure in recruitment. Highquality scientists and researchers are always limited in theindustry, with many being quickly snapped up either bypharmaceutical giants or other CROs. It’s not uncommon for CROs to also work closely, ifthey don’t already offer, quality-control and testingservices for pharma products. This limits potential forcross-contamination or damage in shipments, and helpsto keep information protected from any possible rivals. Inan industry where intellectual property can be worth farmore than anything else, it’s certainly something toconsider.And IP has long been one of the reasons whyoutsourcing can be considered risky. While patents canhelp protect a company’s finished product from theft, thesame can’t be said for the research process – which isstill very much a race to the finish line. CROs are ofcourse dedicated to protecting the interest of their clients,as they have a legal and moral obligation to do, but therewill always be the associated risk where valuableinformation is sent from one location to another – andthat is just another aspect pharmaceutical companiesneed to keep in mind.12-15_Layout 1 05/10/2017 09:21 Page 4ADVANCED MANUFACTURING16Pharma Business International www.pbiforum.netDespite regulators only approving theUnited States’ first 3D printedprescription drug product in 2016, theproliferation of advanced and additivemanufacturing techniques have sincecome on in leaps and bounds. As withpersonalised medicine and artificialintelligence, additive manufacturing (or3D printing) offers a new productionavenue for drugmakers and a new meansof innovating for the healthcare sector.For example, the aforementionedprescription drug – ApreciaPharmaceuticals’ epilepsy treatmentSpritam – was purposefully formulated todisintegrate in the mouth with just a sipof water, making it an ideal option forpatients that struggle to take medicine. The precision of 3D printing offersmanufacturers absolute control over aproduct, from texture and ingredientbehaviour, to specific size and shapes.As drug makers realise the productionpossibilities of this technology, combiningmultiple treatments and doses into asingle pill is becoming a more tangiblereality. The process of 3D printing – inwhich a product is built up layer by layer– means producers can have completecontrol over structure, ingredients andFrom theground up With the 3D printing for the healthcare market expected to experience$1.5 billion in spending this year, the future really is now. 16-19_Layout 1 05/10/2017 09:22 Page 1Pharma Business International 17www.pbiforum.netADVANCED MANUFACTURINGcomponents. The impact this could haveon the healthcare sector and thepharmaceutical industry at large isnothing short of disruptive, somethingregulators have taken notice of. In order to eliminate drug fraud, makemedicines more efficient and meetincreasing demand, drug productionneeds to be brought into the modernepoch of manufacturing. This means thewidespread adoption of continuousmanufacturing, 3D printing and othermeans of automation. Now the US Foodand Drug Administration (FDA) isspearheading a push to update theindustry. Although it was formed back in2013, the regulator’s EmergingTechnology Team (ETT) has only recentlyfinalised instructing how pharmaceuticalcompanies can work with the group toassist in the development of advancedmanufacturing technologies involved in aregulatory submission. It is intended toserve as a centralised location providinga forum for firms to engage with the FDA.Companies have been urged to takeadvantage of the ETT even at an earlystage with advanced manufacturing19 Á16-19_Layout 1 05/10/2017 09:22 Page 2ADVANCED MANUFACTURING18Pharma Business International www.pbiforum.net© Shutterstock / Hurst Photo© Shutterstock / akank16-19_Layout 1 05/10/2017 09:22 Page 3Pharma Business International 19www.pbiforum.netADVANCED MANUFACTURINGtouted as a sword and shield forUS national security. Though drugmakersthemselves are inching alongthe capabilities of 3D printingand other advanced manufacturingtechniques, the biggestinnovations are to be found inacademia. One of the mostrecent, and indeedpromising, discoveriescomes from the Universityof Michigan in the USwhere a pioneering studypublished in NatureCommunicationscould give theindustry the jolt it needs. A technologydeveloped by researchers can print ultra-precise drug doses onto a slew of surfaces– such as a dissolvable strip ormicroneedle patch – which, they claim,could one day enable on-site printing ofcustom-dosed medications in pharmacies,hospitals and numerous other locations.Technologies such as these will be criticalin working alongside patients – such asthose who require multiple medicationsevery day – and realising the commercialpossibilities of personalised medicine.Alongside the security and safetyfears of printed medicines, the othermajor concern is their effectiveness.Studies conducted by Max Shtein,professor of materials science andengineering and the University ofMichigan, found that the pure printedmedication can destroy culturecancer cells in the lab as effectively asmedication delivered by traditionalmeans. The researchers adapted a technologyfrom electronics manufacturing calledorganic vapour-jet printing. One keyadvantage of this technique is that it canprint a very fine crystalline structure over alarge surface area. This helps printedmedications dissolve more easily, openingthe door to a variety of potential new drugsthat, at present, are shelved because theydon’t dissolve well when administered withconventional approaches.“Pharma companies have libraries ofmillions of compounds to evaluate, and oneof the first tests is solubility,” Shtein says.“About half of new compounds fail this testand are ruled out. Organic vapour jetprinting could make some of them moresoluble, putting them back into thepipeline.”And so we come full circle, with one ofthe latest innovations in this field echoingthe first 3D printed prescription drugproduct approved in the US. Advancedmanufacturing techniques aren’t just ameans of upscaling production, but rather aroad map to addressing the unmet needsof patients. If the notion of personalisedmedicine is to develop beyond industryrhetoric, than a support system to developand deploy additive manufacturing needsto be established. Efforts from the FDA andother regulators are encouraging, as indeedare signs from industry and academia,though challenges and dangers still persist.© Shutterstock / igorstevanovic16-19_Layout 1 05/10/2017 09:22 Page 4Next >