In order to work as intended, this site stores cookies on your device. Accepting improves our site and provides you with personalized service.
Click here to learn more
Click here to learn more
I find building a company from the ground up very exciting, so that is always a leading factor behind starting a new business. Divesting is never the intention when building a business, it is more something that becomes clear over time. The motivation behind starting my businesses is to create value and deliver a meaningful impact into the pharmaceutical and life science space, in whatever shape that may take.
Take Sciformix, for example. As with my other businesses, Sciformix was created in the right place at the right time, offering our ability to combine science and process at a time when other outsourced businesses were only offering one or the other. When creating Sciformix, the intention was not to divest at a later stage, but to deliver value in what was, at the time, a new area in science.
CROs and regulatory consultants had been around for a long time when I founded Sciformix, but pharmacovigilance (PV) was a relatively new area in the industry. As regulations tightened on the reporting of adverse events within clinical trials, the pharmaceutical industry sprang into action, and it soon became clear that the new pharmacovigilance processes were too much, and too lengthy to all be completed in-house within the 15-day deadline for reporting serious reactions. These regulations were very new when we built Sciformix, and as a result we grew very quickly and worked through roughly one and a half million cases per year. When the time was right to divest, Sciformix was acquired by Covance, and it was time to move on to the next venture (Scitara).
When you are working on your business, there is not a conscious decision to divest. You know when the time has come to move on – it is like you flip a switch and realise it is time for something new, and you begin to ask yourself “why would I sell?”
Timing is critical when considering divesting. Is it the right time for your customers? Is it the right time for your employees? And is it the right time for your investors? If it is the right time for all three of these areas, then you can begin the transition fairly quickly. However, if only one or two of these areas are ready for this change, you need to step back and ask yourself “how can I make it the right time for all three?”. Thankfully, all of my exits have been at a point where the time has been right for all three parties, so I have left my businesses smoothly and on good terms.
Interestingly, a lot of our customers often prefer to work with smaller companies, such as those which I founded, over larger companies who offer similar services. The benefit of smaller outsourced companies – well, small in comparison to the customer – is that the culture is quite different. Smaller companies and agencies can offer a level of flexibility and innovation to customers that can be difficult to pass through larger organisations. In addition, there is a real sense of an “I have your back” attitude, as you are able to work closely with your customers. Culturally and contractually, my companies have been able to offer something different to larger companies, and we have been willing to do anything and everything our customers needed, which is why they would often choose to sign up with us.
However, as the business grows, those customers tend to stay. When customers become a part of your journey, your relationship with them evolves and your company becomes better equipped to protect their business. Because I aim to divest at a time when my customers are ready for it, there is generally a smooth transition.
As my previous three ventures were in tech, services, and global delivery, Scitara is the summation of all of my previous projects. As I mentioned in the last blog, Scitara aims to solve the major problem within the lab industry of data connectivity and is leading the digital revolution in labs to address this issue. To do this, we will require the cooperation of every connection we have made over the years, as by helping us, we can help them. If we can reach out to everyone in the ecosystem, we will be able to help companies take a huge leap into their digital transformation projects by creating a platform through which they can communicate their lab data through their digital systems, something which at present is proving a real hindrance to digital transformation projects.
This is why I believe Scitara is my finale. It is almost as if we have come full circle, as Scitara pulls together the skills and relationships I have built over my entire career – into creating a final solution. I intend to go out with a bang!
Industry leader interviews – Oscar Kox?My name is Jamie Portnoff, and I am the founder and principal consultant at JMP Consulting. JMP Consulting assists clients in the pharmaceutical industry to achieve and sustain compliance and improve overall performance in pharmacovigilance (PV) and related functions like quality, medical information and regulatory affairs. Before founding JMP Consulting, I worked in the pharmaceutical industry. Not many management consultants working in PV have hands-on, real-world PV experience; this experience means I understand the realities of day-to-day work in and around PV, and how challenging it can be to deliver against requirements and expectations. In my earliest days in industry, I especially enjoyed working with people and on projects, and I soon realised that I wanted to marry up my problem solving and analytical skills with my practical industry knowledge, and after a few years of working with big consultancy companies I decided to start JMP Consulting.
Let us look at the last three decades.
In the 1990’s there were basic PV safety database systems, such as ArisG, ArisLite and ClinTrace. Fax machines were a huge part of the tech that enabled PV processes, with a high volume of incoming and outgoing data by fax. Processes were extremely paper-intensive and were designed to accommodate transactional work, such as processing of cases and putting aggregate reports together; everything was very compliance-focused. Consequently, there was demand for full-time roles dedicated to paper management, typing up documents and data entry. Teams were typically regionalized, and everything was done “onshore”.
In the 2000’s, PV technology became more sophisticated, more globally oriented. There were advances in what the technology could do, and consolidation of major tech players due to M&A activity. Paper-based processes began to give way to more digitization and electronic workflow management. Analytics tools become more prevalent and more user-friendly. However, a typical PV department was still very paper-intensive. Some of the regionalized models began to consolidate to one system, one process, and one organization, particularly between US and Europe.
Throughout this decade, more stringent regulatory requirements were continually being introduced, such as the Risk Evaluation and Mitigation Strategy (REMS), as well as Volume 9a. Consequently the bar was being raised for the calibre of work, and quality management expectations were increasing. We saw more focused teams dedicated to signal detection and risk management, and specialized teams emerged to manage increasing business system needs as the regulatory requirements led to increasingly complex systems. Dedicated vendor oversight teams were also required as companies began to work offshore with vendors.
Over the last decade, good pharmacovigilance practices (GVP) were introduced in the European Union (EU). The Qualified Person for Pharmacovigilance (QPPV) is not a new requirement, but it became clear that this person needs a whole team around them to support them and help shoulder the workload.
Offshore work has grown in magnitude, partnerships between companies have become an integral part of how business is done, and next generation technology is rolling out to improve efficiency and consistency. Safety systems have become truly global, enabling a scalable end-to-end safety process within a single system.
Big changes are coming with PV technology, which will drive major shiftsin the way we think about how PV work gets done. We have seen evolution in PV technology before, but it seems this time around will be more impactful than anything from the past 20 years.
With the advent of next-generation technology, new hard skills will be required, such as understanding of machine learning, natural language processing and artificial intelligence. Organizations need to be able to manage transformation of the PV business effectively and regularly, and leverage advanced analytical tools to derive meaningful insights from various data sets. Additional ‘soft’ skills will also be needed, such as adaptability, flexibility, open-mindedness as well as the ability to ‘think outside the box’ to drive improvements through innovative thinking.
New roles within the organisation will emerge, with specific roles dedicated to:
Meanwhile, other roles will fade out and teams of people (in-house or outsourced) performing transactional activities will become a thing of the past.
From a process perspective – Processes must be highly scalable to accommodate growth in volume and complexity, and a blend of proven and cutting-edge technology is needed to support and enable this. A future-ready process has metrics to enable continuous improvement; it can efficiently evolve and adapt to simultaneously accommodate new regulations, innovative products and evolving stakeholder expectations.
From a technology perspective – Highly agile, flexible and robust, technology needs to be business-led with strong IS support and should be woven into an organisation’s processes, not vice versa.
From a people perspective – People in the organisation must accept increasing automation of processes – you can have the best technology in the world, but if the people in the team are rejecting it, it is not going to be successful. Well-managed resource models are also hugely important. The organisational structure must be designed around the business’ needs, not vice versa. Employees should offer more than one skillset and in return, they must have a pathway to develop professionally. It is critical that a team can approach things from different angles and can adapt to change – these days excelling in just one area is often not enough.