Without a coherent commercialization strategy and an integrated development plan, you’ll waste time and money.
Pharmaceutical Development Planning
It’s often said that failing to plan is planning to fail. I disagree. You can go on and on for years without a plan, burning money, wasting time, losing good staff and not actually “failing”. Obviously, this doesn’t help anyone, particularly shareholders and patients. A good plan will allow you to fail early or progress to your planned exit.
Commercialization strategy is vital to understanding your development priorities. For example, if your intention is to exit after Phase 2 Clinical, the aim will be to add as much value as possible, as quickly as possible to reach that milestone.
If you are focused solely on the US market during development through to approval but your next commercial target is Europe or Australia, there is a possibility that you’ll need to reinvent the wheel for other regions. If your development plan is aligned with the commercial strategy in the first instance, you will have an integrated development plan, saving both time and money.
But it’s not just “development” that needs a strategy and a plan, it’s also regulatory.
As a small-medium sized biotech company, you may want to consider quicker routes to market in other regions to get some cashflow into the business before completing clinical development. An example would be to use the provisional approval pathway in Australia to get your product to market while still progressing Phase 3 development and your US and EU filings.
Write your eCTD content to ensure minimal re-work when going into secondary or tertiary markets.
After 35 years in the industry, the most common mistake I’ve seen is failing to plan.
TudorRose Consulting and our sister company Adjutor Healthcare provide an integrated service to clients in need of a different perspective on commercialization, development and regulatory strategy and planning.
We help you define goals and priorities and what it will take to get there.
Contact us for more information.