Hello,

Grand Challenges in biological engineering in general can be formulated as follows

1. Develop carbon sequestration methods.

2. Manage the nitrogen cycle.

3. Provide access to clean water.

4. Advance health informatics.

5. Engineer better medicines.

6. Reverse-engineer the brain.

7. Engineer the tools of scientific discovery.

Partially in biopharmaceutical engineering are drug design and discovery, natural products, formulation design and pharmaceutical technology, alternatives to antibiotics and new approaches against antibiotic resistance etc.

Hello,

Grand Challenges in biological engineering in general can be formulated as follows

1. Develop carbon sequestration methods.

2. Manage the nitrogen cycle.

3. Provide access to clean water.

4. Advance health informatics.

5. Engineer better medicines.

6. Reverse-engineer the brain.

7. Engineer the tools of scientific discovery.

Partially in biopharmaceutical engineering are drug design and discovery, natural products, formulation design and pharmaceutical technology, alternatives to antibiotics and new approaches against antibiotic resistance etc.

Thanks Karen A. Darbinyan for your response. The grand challenges you listed are important research topics that the scientific community in biological engineering should definitively address. In the biopharmaceutical context, you also mentioned key points that might significantly influence the biopharma industry of tomorrow.

Actually, some researchers contacted me related to this post: most of them asked me to refine the question. My idea by launching this question was to have people (specifically the ones from academia) sharing their opinion about research transfer in biopharma industry and the key limitations they associated with it in order to identify what are the elements (e.g.,research areas, technologies, funding) influencing the continuous innovation in biopharma industry.

See below a non-exhaustive list of topics to feed this discussion. Feel free to tell me which of these is for you the most important to work on and/or to add new ones :

- research approach (e.g., funding of industrial research in academia, speed of research and implementation in industry vs in academia, legal aspects of collaboration with industry)

- process platforms (e.g., continuous manufacturing, cell-free systems)

- equipement and automation (e.g., robotic, single use, small scale production)

- analytics (e.g. measurement at the level of the raw material, process or product)

- research topics (e.g., cell-line engineering, systems biology, bioinformatics, data science, artificial intelligence)

Hello, I think all should be started from education - research and development approaches (e.g., funding of industrial research in academia, speed of research and implementation in industry vs in academia, legal aspects of collaboration with industry) as you mentioned. This area more preferable and more reliable and will have high impact to others which mentioned blow.

Dear Anne Richelle,

Thank you to open this discussion. It is so valuable for all researchers to share their experiences in this case.

In addition to topics that you mentioned, let me add two other things:

According to my experience, bridging academia and industry needs an interdisciplinary management that should understand both sides. Regarding to this issue, I can say that in interdisciplinary research area finding a “common language” is the main important thing.

“Intellectual property”, “data management and security” are other issues that should be considered. They are also so important for transferring knowledge/technology/data between two groups of industry and academia.

Seems that my question is still too vague to trigger responses from people ;)

If you were CEO of a biopharma company what would you change to improve the innovation strategy and on which research topics would you invest?

As someone who works at a smaller more R&D driven biotech company who has had to collaborate with larger biotech behemoths, to me there is one thing I would love to see change from an innovation strategy perspective. It is simply allowing for failure and for projects that may seem risky or have no immediate dividends within an R&D pipeline. Far too often I have seen very promising or otherwise scientifically exciting ideas and projects allowed to just disappears into the ether when they didn't fit someone internal bureaucratic parameter within a large biotech R&D group.

Thank you Aleksey Karpitskiy for your response. It is true that companies most often evaluate research projects in function of their potential outcomes and their alignment with some strategic global guidelines which is actually not really in line with the "innovation concept" itself. To my opinion, this enforces the gap between research in industry and in academia: the risky projects tends to belong to academia while the benefit of them (once clearly identified) will be collected afterward by companies...

For those interested in the biopharmaceutical market, G. Walsh recently released his last benchmarking study. A very interesting reading to give some perspectives to this discussion https://www.nature.com/articles/nbt.4305

Anne - this is a great question and one that is actively being pursued within NIIMBL - a public/private partnership to solve pre-competitive manufacturing or industrial barriers for biopharmaceuticals (https://niimbl.force.com/s/).

The topics I have seen come up are not brand new but have some barrier that prevents industry as a whole from leapfrogging over the current status quo - basically more process analytical technologies, quality by design, and sensors - seem to be the more universal "if we just had" buckets. The devil is in the details of what needs to be solved specifically, and that is where proprietary nature of development comes in to play.

My thoughts on your kickstart list:

- research approach - if this is meant to head towards development (a big if) we need academics to design for translation but the typical NIH funding system is designed to do ongoing research. If NIH is funding why would a researcher want to transition the research out? This doesn't apply to all but it certainly influences the robustness of transitioned technology because development thinking isn't necessarily baked in from the beginning. A few public/private partnerships are attempting to affect that.

- process platforms - the question isn't new ideas, the question is how will those ideas find their way into an ongoing commercial facility? New platform ideas are coming up all the time but how will that platform be received by the FDA and how much risk does it introduce to the commercial manufacturing? These concerns are not usually articulated well to the inventors so we are delayed in finding meaningful progress.

- analytics - top priority in my mind. The better you know your process and product, the better you can present novel technologies and change the way we experience medicine. Still, it is slow going because of similar reasons to the process platforms. The risks to change are high and standard creation is slow.

- research topics - seriously check out NIIMBL and a few other programs. The research topics are out there but it is difficult to know where to find things or for a single organization to qualify for all the areas.

In my mind, advanced manufacturing as it will be for biopharmaceuticals in 10-20 years is a lynchpin challenge. If we can evolve from manufacturing like we did in the 1990-2000s and invent and innovate the future of manufacturing, that would be the most important thing we can do for this industry. The new medicines are being invented now, we just can't scale properly.

Since your question is of a very general in nature. The best answer one can give is that the challenges are so many, that you may say the sky is the limit. It all depends on what you wish to channelize you knowledge.