The drug development terrain can be rocky, particularly for academics. Here are four tips that might help the startup process run more smoothly.

Setting up a biotechnology company with the view to develop a drug compound and bring it to market can be a very complex and intimidating prospect. In addition to employing a multitude of skill sets, embarking on an entrepreneurial venture can be daunting.

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There are some basic fundamentals that can help you along the path of starting a company, irrespective of the therapeutic area, such as cardiovascular, metabolic diseases or oncology, my research specialty. Having been involved in a number of start-up companies and routinely mentor early stage start-ups, here are some key pointers to help navigate your way. These main concepts are essential to bring your compound through all the various stages of pre-clinical development and translation to a clinical setting.

Do your homework: Making the jump from academia to a bio-technology company is a major step. Before embarking on a start-up venture it is first essential to ask, and positively answer, the following questions:

  • Is there a market for the idea/compound?
  • What’s the profit potential of this business?
  • What are the obstacles to my business plan?
  • Are the goals of the business achievable?
  • What resources do I need to make this business a success?

Get connected: Founding and running a bio-technology company utilizes a completely different skill set to that of a bench scientist, so having access to experts in the required fields is essential. Towards this end, it is necessary to get connected to the biomedical ecosystem that help start-ups get off the ground. These include grant awarding bodies, intellectual property lawyers, marketing experts, and entrepreneurs who have founded and managed companies. For example, Massachusetts has a vast network of leading teaching hospitals, universities, entrepreneur communities, venture capitalists (VCs) and biotech companies within 30 miles of each other. This ecosystem is home to more than 400 biotech companies that employs more than 65,000 people. The central framework relies upon the synergy between problem identification, discovery innovation, and the ultimate commercialization by industry. The focal point for all these components is MassBio-Mass Connect that marshals this expertise and experience in a mentoring program to help companies write business plans to pitch to potential investors.

Target appropriate funding bodies: Utilize the funding bodies available. An example of this within the US is the Small Business Innovation Research (SBIR) fund. SBIR aims to stimulate technological innovation that meets federal research and development needs, while fostering and encouraging participation in innovation to increase private-sector commercialization. It is important to create a thorough inventory of all those available, and target accordingly. Avoid limiting yourself to the most obvious funding bodies; there may be networks or private funding mechanisms available. Aim to pitch your technology and company to as many audiences as possible.

Partner with a Contract Research Organization (CRO): Given the number of moving parts involved in starting up a company, it is worthwhile to partner with a CRO that has the expertise and experience to bring the compound to market. This option is preferred to starting from scratch. The CRO and client, in this case an emerging start-up, work as a team from the very beginning. Some of the principal advantages are:

  • Quality: Standard of execution and low error rate.
  • Expertise: Scientific and technical knowledge spanning entire project.
  • Experience: Number of times a particular assay has been run.
  • Capability: Equipment, personnel and other given elements even if it hasn’t been run before.
  • Capacity: Staffing, space and access to study materials.
  • Pricing: Easier to maintain competitive-market-aligned pricing.

Conclusion

The overarching objective of any start-up biotech company is to move the product through the pre-clinical pipeline and into a clinical setting in the fastest and most and cost-effective manner, without compromising integrity or quality. Utilizing the expertise and experience of professionals in their respective fields is an invaluable resource, and will be instrumental in realizing this goal.