Question: Vaccine and Co . is a medium sized ( 2 5 0 employees ) innovative biotechnology firm that produces vaccines for healthcare providers, usually at
Vaccine and Co is a medium sized employees innovative biotechnology firm that produces vaccines for healthcare providers, usually at a national level, across the globe. Vaccine development for a totally new virus and indication eg the HPV vaccine for girls can take years the more innovative the longer and can only be shortened to a point even if there is huge demand. They can all be shortened if the state prioritises it eg for Covid the Government supported developing a database of volunteers for the trials so trials got off the ground faster. They also asked the Medical and Healthcare products Regulatory Agency MHRA to prioritise the review and do it all in parallel, as data came along rather than at the end when all the data was complete. Contracts are usually not negotiated until the clinical development is almost finished. Covid is an unusual one, but even there, the trials were running before the contracts were signed. The companys Business Development Partner BDP will stay involved with the ultimate client and the Program Leaders PLs as it is very much a team effort.
The principal tasks of the BDP and the PLs at Vaccine and Co are to plan and run the program, from the lab to the market, and to build a relationship of trust with the relevant drug approval agencies to ensure the development program is likely to gain approval across as many markets as possible. The companys leaders must also develop a good working relationship with the healthcare providers in the key markets, keeping them informed regarding development progress and on results, as they become publicly available. Not until the final results are available will the risk benefit profile be clear, leading to crucial discussions with the regulators as well as the healthcare providers. Any delays in vaccine roll out can result in significantly increased patient mortality if the disease is severe, in addition to loss of revenue, possibly irreversible damage to the companys reputation and cash flow. The key post incumbents must have the skills to develop a strong network of relationships with everyone involved in completing these essential orders. Although a Drug Development Plan will contain the key details and requirements for completion, it is up to the PLs to track performance, often in parallel streams so that any disconnections can be prevented or dealt with, as necessary.
The skills and abilities required of the PLs have evolved over the last few years and now more than ever before needed to have alongside their excellent technical skills, superior communication, teamworking, organisational and influencing, time management and problemsolving skills so that they can identify any potential progress delays and come up with safe, innovative, creative, and costeffective solutions. Vaccine and Co employs two PLs who can between them be responsible for several vaccine developments at a time, usually at different stages of completion. During a period when four vaccines were in progress, it became evident that some key stages were not being completed against schedule the companys key investors being alerted to the prospect of not meeting this urgent global need for these vaccines, on time, as planned upset them as they had a strong understanding and appreciation of the societal need for these products and the company were delivering it at cost price Further, evidence revealed that there were numerous tensions and pinch points between the PLs their clinical trial teams, and the production staff, particularly when they moved from pilot manufacturing to full scale production.
Two particular key investors of Vaccine and Co who previously worked themselves in the business, after some consideration and reflection, decided to take a closer look at what was happening within the business. It soon became clear that there were tensions between the PLs and the production staff which were not being delt with effectively. One senior production staff member stating he was being frustrated and having to work exceptional unpaid overtime due to the general technical incompetence of the two PLs He stated that neither of the PLs seemed to have the necessary talent or required attributes for the job and that both were associated with dissatisfied customers, delayed deadlines and a general lack of communication and crisis management approach to their general working lives, which impacted on everyone else in the workplace. It had become apparent that employees generally, particularly the experienced postdoctoral staff were already considering leaving and going to work elsewhere for better reward packages and now there was a general feeling across the staff of stress and anxiety Additionally, although the organisation had significant employee diversity on entry to the company across all employment areas, this was disappointingly not evident at the first and secondline management levels unlike the majority of
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