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With 20 years’ experience in the Biotech and Life Sciences industry, Micah Rimer’s success has been primarily due to his ability to read organisations, frame the problems and identify the best path to bring people together to achieve the desired goals. During Micah’s time working in Biotech and at big pharma he has successfully deployed consultancy groups within lab informatics and clinical projects.
Scimcon has supported Micah and his teams extensively on high profile projects in big pharma and Biotech. In this blog, Micah draws on his valuable experience to provide insight and tips on how to best to engage and work with consultancy groups.
Deciding on the right Informatics Consultant for your pharma or Biotech company is not a simple task, despite the various vendors available. Informatics in the Life Sciences industry covers a wide scope, so it is unlikely you will find an appropriate consultant through Google’s search algorithms. To find the best fit, you should consider what the key priorities are for your engagement, find a partner that you can trust and work well with and one that can bring a unique perspective to your collaboration.
Starting out with the key skills and contributions that are needed, as in any selection process, is the first step in identifying the right Informatics Consultant.
While technology is constantly advancing, I would encourage you to think hard if the tech skills are really the most important aspect for a successful collaboration. From my experience, while an understanding of the underlying technology and what it is capable of is important (be that LIMS, ELN, eCOA, eDiaries, PV software etc), what is of more importance is someone who can both communicate and partner with the organisation. A successful computerised system consists not just of the software, but also the people that will use it and the processes they will follow. All of those components must be balanced for a successful implementation, so while the technology piece may feel like the most obvious area to address, do not underestimate the work with the people and processes.
For example, there was a point in my career where I was asked to implement a Pharmacovigilance (PV) signal detection system for an organisation I was employed by. This had been a critical gap in the organisation for a long period of time, and there were several options on how to proceed, but no easily defined right answer. We could look to either evaluate and buy something off the shelf, hire a company to build a custom-designed tool, or alternately we could try to finalise a prototype that a programmer in the department had been playing around with for a while. (His tool had nice features, but still some technical gaps and no clear path forward to make it robust enough to use in such a highly regulated environment). In looking for external help, some may have favoured looking to recruit Informatics Consultants with a background in Pharmacovigilance, or perhaps with the technology skills to leverage the drug safety system platform. But in choosing Scimcon, I went with the partner I trusted to help evaluate the options and lead a successful implementation in that particular organisation. A fantastic off-the-shelf tool would never have been a success if people did not want to use it because they preferred the home grown highly customized (but invalidated) prototype.
With Scimcon on board, we were able to evaluate the pharma and drug safety landscape and determined that there could be a good path forward with the prototype that had already been developed. We were able to establish an effective team, drawing upon the Pharmacovigilance expertise in the department to address business process and usage questions. The programmer who built the prototype had the vision for how the software should work and what needed to be done from a technical perspective. Scimcon was able provide the knowledge and experience of how to move a prototype to a production system and validate a custom-defined tool that had been built by a programmer who does not have expertise in documentation. The output was widely recognised as a huge success.
It is important to keep in mind what gaps you are trying to close and what capabilities are needed to fill them: – Maybe you need the knowhow to get a project completed in a challenging environment; the technical skills to do the programming; the expertise with documentation; or you need to access people who have exceptional attention to detail to make sure a system is appropriately qualified and works as intended.
Whatever your challenge, you should ensure that the skillsets available from your informatics consultancy match the challenges you are facing.
As with many relationships, the more time you work together, the more trust you build up. This just proves that the importance of having established relationships and ways of working cannot be understated. No one is perfect, but the devil you know may indeed be a better fit than someone new to you. Always think about building up relationships for the future; it is a small world.
With this in mind, when looking for life science Informatics Consultants to partner with, one key consideration is to determine how they will be able to deal with adversity. What are they prepared to do if they see that a project is starting to go sideways? When speaking with them, ask them about projects that did not go according to plan or did not work out, and how did they manage that situation? What did they learn from that? Do they do anything differently from those lessons learned? Consultants, and Informatics Consultants especially, have all been thrown into projects where the requirements and expectations were not appropriately set in the beginning, which lead to problems later. Good consultants always learn from these situations and avoid repeating the mistakes that led them down that path.
Another key consideration for the interviewing and recruitment process is the quality of the questions the consultants ask and how well they listen.
Before you speak with them, think about what questions you would ask if you were in their shoes, and not having access to all the internal information you have: – Do they ask the right questions? Maybe they ask some questions you had not thought of? And how well are they able to play back what you have told them?
Often sales or account managers are very focused on telling you how easy it is for their teams to deliver, and how they will be able to deliver no matter what restrictions and conditions you add into the situation. Are there any conditions of the setup that would prevent the consultants from accepting the assignment? If there is nothing you can state that would cause them to be concerned, then maybe they are too good to be true! Look for their understanding that implementing systems is not usually a walk in the park. A truthful consultant is extraordinarily valuable.
Of course, it is always good to check the references as well. Does the life science informatics consultant have customers that have worked with them over a long period of time at different companies?
Bringing in consultants is typically not so easy, so numerous long-term engagements at different stops can itself also be a sign of delivering quality.
You should also look for feedback on the work the consultants delivered. There is a huge business out there for the larger agencies which spend time and resources selling at the executive level, but then use more junior resources to do the work. Having senior people presenting and being able to provide a concise message is important, but by and large you typically want to find people who are getting the work done. You must never lose sight of the goals to deliver projects on time and the overall drive for results.
Consider all of these aspects and listen to your instincts. Typically, these are not small or unimportant investments in the first place. Taking time to ensure you have the right fit is important. At the end of the day, you need to feel comfortable and confident that the people you choose can be counted on to deliver for you.
To me, one of the most valuable skills I look for with Informatics Consultants is the ability to bring a unique perspective. In a management training course I once took, the advisor summed it up this way: “Look, you are all smart people. If you come to a situation where you do not see a solution, it is probably because there is not just one solution. When you arrive at a situation like that you will have to find some way to balance and continually adjust, as there is likely no one right answer.” When I am bringing people in to support me on projects, I am looking for that ability to connect the dots and leverage previous experiences to help find the best solution.
One of the valuable parts of working as a consultant is that you get to see a variety of companies, all with different setups. While some people find that lifestyle stressful or challenging, there is an inherent value in being exposed to so many alternative organisational environments. If you can synthesize new information and learn rapidly, all these experiences add up to quite some knowledge. The more you can see things repeated with modified parameters, the easier you can find what works and what does not work, which is why we look to simulations to find some solutions. Informatics Consultants that have worked in different Biotech and big pharma settings with a wide exposure to different projects can help bring that knowledge to your organisation.
Finding consultants who have worked in various parts of life sciences or in other fields can also help to provide a more well-rounded view. At times, that enables seeing solutions in places you might not expect. They can also recognise patterns in the organisation you may be too close to see. The combination of being able to share these insights, as well having seen so many challenges and varying situations, can allow consultants to provide services to you that you simply are not able to manage internally.
Finding the right Informatics Consultant for your life sciences organisation is not an easy task; you need to make sure that you are bringing in the right skillset to match your situation.
The priority is to find people you can trust and who you feel confident can work in your environment. While the technology of course plays a role, do not overstate the importance of it and dismiss the (not insignificant) people and the processes aspect to our work. The system in itself will not be considered successful if people are not comfortably using it. Look for companies that can adjust to your needs and find solutions to your challenges as the landscape continues to change. In the end, that is what counts, finding a way to get the job done.
Scimcon is proud to offer its consultancy services to Biotech and big pharma companies around the world. To find out how we can help you achieve success in your implementation project, contact us.
Ajit Nagral – Growing and divesting businesses in the life sciences and pharmaceutical industries?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!
The evolution of pharmacovigilance?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.
