< PreviousOUTSOURCING 30 Pharma Business International www.pbiforum.net T here’s an age old saying that if you want something done properly you should do it yourself – and yet when there is just too much to be done in-house, it’s worth considering what tasks can be outsourced. Ongoing lifecycle maintenance of medium or large portfolios puts a tremendous resource strain on pharmaceutical companies. These activities are crucial to keeping your products on the market but can stretch teams thin, making it harder for companies to focus on new product development, line extensions and further global roll-out activities. At the same time, both product maintenance and product development are becoming more complex. Ever- changing regulations across global markets, specific CMC requirements for special product categories, a move toward innovative clinical approaches, and increased digitization of many regulatory processes all require specific expertise that might be unavailable in- house. Outsourcing can also free up in- house teams to regain time to focus on value-added tasks, while also removing the need for hiring of new staff – which is difficult in today’s economic climate and with a noted shortage of skilled recruitment targets. There are a number of core reasons Someone else’s business Outsourcing can be risky business, but it can also be good business – we explore why, and what to keep in mind. 32 Á 30-33.qxp_Layout 1 08/12/2022 11:12 Page 1Pharma Business International 31 www.pbiforum.net OUTSOURCING © stock.adobe.com/Kadmy 30-33.qxp_Layout 1 08/12/2022 11:12 Page 2OUTSOURCING 32 Pharma Business International www.pbiforum.net why mid to large sized pharmaceutical companies choose to outsource. One of the main focuses is to reduce complexity of tasks and strain on in-house teams saving on necessary training and recruitment of new staff members. The recruitment market is not what it could be and it feels as if every industry is facing the same problem. Still, shortages in students studying STEM subjects have taken its toll on the industry, making recruitment of skilled staff (and retaining them in the face of constant headhunting) difficult. Outsourcing allows a company to step away from recruitment and use the staff of another company, and in the same vein of thought use their technology and infrastructure as well – saving on costs associated with investing in said technology. Additionally, the ever-changing regulations and requirements of the industry may add an extra burden to house teams to have to come to grasp with, but which outsourcing partners might already have experience dealing with. The correct outsourcing partner is obviously one with topical experience in the field or medicines a company works in, and good scouting and research of outsourcing partners is required to make sure they fit a business’s needs. Whether a company is looking to outsource responsibility to take advantage of a company’s resources or 30-33.qxp_Layout 1 08/12/2022 11:12 Page 3Pharma Business International 33 www.pbiforum.net OUTSOURCING to free up their own staff to take on tasks more suited to adding value and earning profit is immaterial, however, as what is important is knowing how to manage outsourcing in an efficient and effective manner, as a piecemeal approach to outsourcing is likely to cause more problems than it solves. It’s important to select a partner that will take responsibility for any process or portfolios they are entrusted with, and preferably one with proven experience. This is obvious given that a new drug or portfolio is a company’s most important asset, and intellectual property is a tricky business at any stage – an outsourcing partner must therefore be prepared to take on responsibility as if it were their own. The important thing to remember is that even though duties are outsourced, they are still working for you and in your interests, which means KPIs and other targets do still hold. Accurate monitoring and analysis of how an outsourcing partner is performing should be performed at regular intervals. A good partner will provide that information when asked, and sometimes even when not. Outsourcing is both an opportunity and a risk, but it is one that is becoming more common across the pharma industry as employment opportunities outstrip employees. This challenge is unlikely to end any time soon, so it is best companies adapt sooner than later. © stock.adobe.com/Chopard Photography 30-33.qxp_Layout 1 08/12/2022 11:12 Page 415th Annual Pre-Filled Syringes and Injectable Drug Devices Conference 10 - 12 January London, UK The pre-filled syringes industry is growing at an exponential rate with innovations in parenteral delivery device development to increase patient centricity, aid self- administration and deliver biologics that have large-volumes and novel formulations. This year’s conference will explore the exciting advances in the combination product drug delivery space and a future outlook exploring how pharma, device developers and regulators can work together to encourage innovation. Transdermal and Microneedle Drug Delivery Conference 23 - 24 January London, UK The 2nd annual Transdermal and Microneedle Drug Delivery conference will explore advances in microneedle diagnostics through case studies and real-world examples, whilst engaging in modern strategies for topical and transdermal drug delivery. The two-day agenda offers you peer-to-peer networking with CEO’s, Senior Vice presidents, Directors of Pharma EVENTS © stock.adobe.com/ phonlamaiphoto 34 Pharma Business International www.pbiforum.net mRNA-Based Therapeutics Summit Europe 24 - 26 January Berlin, Germany Following the successful development of vaccines against COVID-19, biopharma hopes to deploy mRNA-based therapies to combat many other diseases in oncology, Delivery Technologies, Heads of Product Development and many more. Key considerations for the conference will be transdermal and microneedle systems as a mode of therapeutic drug delivery in combination with optimization of device design and development. Vaccine delivery will be a significant aspect of this year’s agenda with a focus on microneedle delivery technologies as a mode for vaccine delivery, in the pursuit to increase vaccine stability and accessibility. An outlook of the transdermal space will also be reviewed, including future directions and next steps required to advance the current field and accelerate access for patients and end users. Pharma and Biotech Patent Litigation Europe 24 - 25 January Amsterdam, Netherlands The European Summit on Pharma and Biotech Patent Litigation will be back in January 2023 for practical discussion around the leading industry topics. The internationally recognised summit will provide you with the necessary practical tools to both defend patent litigation challenges for your pharma and biotech product, whilst also maximising your litigation strategy to allow for successful IP protection. At this event, you will network with leading figures in the industry and gain unique insights on the latest regulatory changes and case-law updates. © stock.adobe.com/angellodeco 11th Annual Pharmaceutical Microbiology Conference 16 - 17 January London, UK Microbiology is an essential tool for the detection of microorganisms present in biopharmaceutical and drug product manufacture. The field of pharmaceutical microbiology has seen a rapid growth in recent years. This has been in part due to the introduction of alternative, rapid microbiological methods, and the application of automated approaches to microbiology. Together these have provided faster, clearer, and superior data, significantly improving the operational efficiency of laboratories. Alongside these new technologies ever changing regulations such as the impending release of Annex 1 and a globalised aseptic world have meant that the industry is having to re-think many of the most basic principles. This conference will explore the most pressing topics in this thriving field, from the movement toward process automation and reduction in operator-product interaction, to the latest technologies in rapid microbiological testing methods and data integrity. 34-35.qxp_Layout 1 08/12/2022 11:13 Page 1rare disorders, and beyond. The 2nd Annual mRNA-Based Therapeutics Summit Europe serves to do precisely this, returning as the only end-to-end industry-dedicated mRNA conference in Europe. Expect the freshest updates on mRNA-based vaccine development & future trajectories, emerging therapeutic approaches based on mRNA, and the route towards accelerated approval to bring about the next wave of mRNA vaccines and therapeutics that broaden the application of this disruptive technology. Viral Vector Process Development Summit 31 January - 2 February Boston, USA To replicate the success story of monoclonal antibodies, the next stage of evolution for viral vector-based therapies requires rapid expansion of manufacturing capabilities while minimizing cost and maintaining product quality. However, the incipient stage of the field and the complex manufacturing workflows involved also means that questions remain unanswered about optimizing upstream and downstream processes and defining robust CQAs to reduce impurity levels and achieve scalability. Here to bring these challenges to light is the Viral Vector Process Development Summit – a platform exploring the future of viral vector manufacturing that will push the industry ahead while gathering industry leaders to share their experiences, innovations, regulatory considerations, and challenges in this exciting area. www.pbiforum.net Pharma Business International 35 © stock.adobe.com/valiantsin Cloud Computing for Drug Development Congress 22 - 23 February San Diego, USA In today’s economy, it’s never been more important to elevate a data-driven culture. Cloud computing has opened doors that make this goal a real possibility. Biopharma, however, faces a multitude of big data challenges: the high cost of data ops; exponential growth of data filled with inconsistencies, and potential biases; and dependencies on centralized capabilities. The Cloud Computing for Drug Development Congress enables you to tackle these issues head-on. Connect in person with pioneers of this field who are driving the optimization of cloud strategies across their organizations and equip yourself with the tools needed to develop an interoperable data & analytics ecosystem. Precision Medicine in Inflammatory Bowel Disease Summit 30 January - 1 February Boston, USA Identifying biomarkers for inflammatory bowel disease is currently the greatest challenge limiting clinical efficacy in this field, resulting in relapses and increased cost of care. This is due to the incomplete understanding of the pathophysiology of diseases like Crohn’s and ulcerative colitis, which leads to a critical issue when effectively matching the right patient with the most effective treatment. Therefore, it is vital to unite at the inaugural Precision Medicine in Inflammatory Bowel Disease Summit to discuss with fellow IBD experts on strategies to move away from a one-size-fits-all treatment plan with trial-and-failure, and invest in precision medicine to make informed decisions across diagnosis, prognosis and clinical monitoring. 34-35.qxp_Layout 1 08/12/2022 11:13 Page 2FEATURES Laboratories Microbiology and R&D Pumps and Fluids Sorting and Weighing Health, Safety and Hygiene Next issue: Deadline - 1st February 2023 REGULARS News Events M&A Round-up Eye On Approvals Visit us at www.pbiforum.net where you’ll find the latest news as it breaks – and why not subscribe to our newsletters so you can have the latest news emailed to your inbox, in between digital issues? @pbiforumwww.pbiforum.netcompany/pbiforum 36.qxp_Layout 1 08/12/2022 11:15 Page 1Next >