Updated: Jun 20, 2022
In this blog, I will talk about consulting for small and big pharmaceutical companies. There are different challenges that consultants like me face when interacting with pharmaceutical companies and it is not only the size and available expertise at that company but also the interaction between the consultant and the project management team. There are advantages and disadvantages when working for different size organizations and it is the role of the consultant to overcome the hurdles and use their resources to accelerate the drug development cycle.
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Small pharmaceutical companies and even mid-size ones have limited resources for drug development. Their budget is usually small, the staff needs to wear multiple hats and often they have only one area of expertise they master. In addition, there are time constraints to meet the deadlines that are more aggressive than in large pharma. The deliverables need to meet the expectations of a highly competitive pharmaceutical industry.
Small pharma cannot afford mistakes
To stay ahead of your competition, small pharma cannot afford mistakes in choosing an expert to help them navigate through the drug development process. By choosing a well-established consulting firm or a CDMO (Contract Development and Manufacturing Organization) their cost goes to the roof. A small consulting company is always a risk because there is little information on their success stories and proven expertise. So, they reach out to someone they know, was recommended, or worked in the past.
Small pharma challenges for the consultant
Consultant (Principal) faces multiple challenges, and I am not talking about the scientific ones. The staff on the company’s side has limited time allocated to review and discuss the consultant’s work. Their busy schedule sometimes results in cancellation of (weekly) meetings, leaving unanswered questions necessary for the scope of work (SOW) and the follow ups sometimes are delayed. In this case it is the skill of the consultant to plan and factor in delays by gathering information that will allow the work to continue uninterrupted. Working on multiple tasks with close priorities, allows you deprioritize one for another until you get the information needed.
Sometimes you have limited impact from suggested experiments and recommendations and ultimately it relates to time and budget. In this case you need to look for alternative suggestions, and work with the company to achieve its goals. Always provide solutions they can chose from; you don’t know their internal constrains, they do.
One of the major challenges I faced was the access to the scientific literature needed for the SOW. Electronic journals are the bread and butter in the scientific world. The science and technology are moving in a fast pace, and you always need to be up to date in your field of expertise as it relates to the SOW.
Advantages working for Small Pharma
Having a small organization, small pharmaceutical companies need to move fast to stay ahead of the competition. Therefore, the decisions are made in a timely manner and there are not too many layers of approval. The CEO’s door is always open when it comes to a decision on the portfolio.
The consultant shouldn’t be worried about bureaucracy and multiple signatures or approval committees and meetings. This allows a better workflow and eliminates potential frustrations. The consultant provides services, and the work is compensated based on a signed contract. The compensation approval is always timely and there is a trust and respect between parties at multiple levels.
Big pharma can absorb mistakes
Although in large organizations there are multiple levels of strategy and data review, no organization is safe from mistakes in decisions and execution. A lesson I learned from my mentors was that you didn’t become at the present level of knowledge you are at now if you did not make mistakes, and you learned from them. Having an extensive portfolio, big pharmaceutical companies will not be significantly impacted by discontinuation of one or two projects. Some projects are discontinued due to toxicological issues in animal studies, and this is not in the mistake category. A lesser financial impact comes from unnecessary studies of SOW performed at CDMOs and is related to the lack of expertise they have on staff. Being a large pharma does not mean you can cover every aspect and intricacies of the science behind drug development (and/or discovery). And here comes the role of a highly seasoned consultant that can fill in the gaps. The consultant is always on their side and ready (sometimes 24/7) to solve ongoing or unexpected problems.
Big pharma challenges for the consultant
The major challenge for the consultant is how to convey your idea across the organization. With multiple expertise on staff, some ideas may seem like criticism. This is not personal because, when I worked in big pharma there were people who did not take criticism lightly. There are a lot of powerful people in high positions, and you should give them the proper respect.
One of the difficulties is that you cannot test your solutions in an experimental setting because you do not have direct reports and it is up to your primary contact in the company (who pays the bills) to assign the work as it fits with the project priorities. Sometimes you are passionate about your ideas, but never fall in love with your solutions.
Before being a consultant, many of us worked in big and small pharma in senior management positions. Now, you are not any more the person who calls the shots and assign tasks across the organization. How you manage to take a step back from the management hat and stay in the scientific field, it is a challenge; however, with years in your consulting business, this will become easier and easier.
Advantages working for Big Pharma
The main advantage of the big pharma is that there are a lot of smart people with years of pharmaceutical development expertise. You can test your idea by communicating with them in different set ups, and the best way is to be part of project teams. The video conferencing became more and more a norm although teleconferencing was always there. For multinational companies and for companies working with CDMOs across the globe, the time zone is a challenge. From the consultant point of view, working virtually is a plus; however, a face-to-face meeting occasionally is needed.
Consulting needs to have access to scientific literature. One of the major advantages for the big pharma is that they have access to electronic journals, and it is very easy to read them right away. In some case you need to submit a request if the access is through a different institution.
Several factors can affect the development
The consultant needs to provide good quality of work and in time, factoring in a safety margin. One general rule in the pharmaceutical industry (and probably in other industries too) is that timelines slip. Having safeguards and back-up strategies will assure the timely deliverables to the portfolio. To maintain a good reputation, a consultant cannot be part of timeline delays.
The recommendations should be sound and supported by scientific rational. If you think that the direction is correct but needs more data to support it, just say so. I saw bad advice given based on lack of expertise and as in any field, limited knowledge is dangerous when you are in a decision-making position.
More and more pharmaceutical companies relay on CDMOs for experimental work, including experimental design. The consultant is not part of the selection process but can, and it is recommended to be part of the weekly teleconference calls analyzing the data. In this case, the consultant is another layer of defense against bad execution or data interpretation.
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