The art of giving advice – why and how great consultants make a real difference!

by Timo Liebig

Biopharmaceuticals are special and very challenging to develop. A variety of interdisciplinary skills is required to successfully get a drug candidate from discovery through to approval and on the market. The odds that you have all the right skill sets in-house to endure that mission successfully on your own are close to zero. And the more complex the issue, the higher the need to engage multiple external experts with diverging subject matter skills. By doing so, (advice) seekers set the stage to create better solutions to problems than they would have concluded on their own.

Leading an open dialogue about challenges and show-stoppers during biopharmaceutical drug development is tricky and requires not only the right experience in the subject matter, but also a lot of openness, trust and careful listening (see Figure 1). Outside counsel is able to provide this unbiased view on the topic and is unprejudiced with the seekers. Competent advisors typically get engaged upon rather challenging situations and experience plenty of complex issues with a high frequency. Seekers can strongly benefit from this accumulation of manifold experiences on the advisors` side.

However, for a productive output you need advisors that are willing to tell you what you do not want to hear, rather than reassuring you in what you already said. In order to create a win-win for both seekers and advisors, either side should mind its biggest pitfalls. Seekers frequently tend to think they already have the answers and only plan to validate their strategy. The clear definition of the problem is also fundamental and seekers gathering and communicating incomplete or false facts – deliberately or accidentally – about the issue at hand inevitably invite critical situations. In addition, seekers should mind not to misjudge the advice, e.g. because the advisors` thinking is different to their own. Contrary perspectives to issues are vital to bring about fine-tuned, better solutions. In contrast, one of the biggest challenges for advisors can be that they overstep their boundaries. Communicating the advice imprecisely or overwhelming the seekers with too many options, which eventually leaves them with unrealizable advice, are other common flaws of advisors.

 
I’d like to give an example from my own experience where advisors had a great impact, from operational, strategic and financial perspective: A small biopharmaceutical company that was just founded – let´s call it Newco – works with several CMDOs to develop their products. About one year into development, Newco is not happy with the progress (quality of work, timelines) but doesn´t have resources nor facilities to develop the products on their own. Each CDMO is managed separately by Newco. The initial plan – without outside counsel – was to terminate the contract with at least 2 of the 3 CDMOs and find a new CDMO that offers fully-fledged services.

 
At this point, several consultants of diverse background were brought in. One was a process engineer, the other one was an analytical data specialist and the third one was an experienced regulatory professional. In the initial discussion, a lot of questions were asked by the consultants, most importantly what the end goal was. Then, step by step, the work and the data derived from each CDMO was accumulated and looked at, first in isolation, then all together. It turned out that most of the process and analytical data was comparable despite substantial differences in the equipment and analytical methods developed by each CDMO.

 
After this exercise, the consultants challenged the overall CMC development plan, helped amend the plan to fulfil regulatory acceptance and then supported Newco to define which data was crucial to move into the next development phase. Next, they suggested a short, simultaneous study using all three CDMOs in parallel to reproduce and finalize an important data set with pre-set acceptance criteria that triggered moving into the next development phase. With the fine-tuned, adapted CMC plan in hand, Newco could now narrow down and streamline the scope of work of each CDMO to make them work hand in hand rather than separately. The overall exercise took approximately 8 weeks, which were initially not planned for in the development timeline, with a price tag in the mid five-digit USD range. On the other hand, the revision of the overall development plan and the streamlining the CDMOs saved 5 months of time in total and lowered the budget for the CDMOs by several million USD.

 
In conclusion, giving advice is an art and requires a lot of skills and awareness from both seekers and advisors to create a mutually successful situation. As for any other element of your drug development, you should take the choice of your advisors very seriously and carefully select your advisors – ideally in advance of any arising issues. We at Biopharma Excellence not only ask the right questions but deliver value-creating solutions for your biopharmaceutical drug development. Contact us now and benefit from our experienced team of multidisciplinary experts for your products and programs!

 References 

1. Forbes online magazine, May 2018, „The subtle art of asking for and giving advice“ by Jull Griffin.

2. Harvard business review, Jan/Feb 2015 issue, „The art of giving and receiving advice“ by David A. Garvin and Joshua D. Margolis.