The Challenges - The Barriers to Success

1.       Not Thinking Strategically about IP – IP and licenses are at the core of everything. Establish clear Freedom to Operate, think globally and ensure owned IP is robust and be clear about what needs to be licensed from others

2.       Poor Planning - knowing in detail what you are going to do with investor funds and relying on CRO’s and CMO’s for advice – remember you can’t outsource the thinking on a programme that drives the plan.

3.       Relying Heavily on Third Parties, Especially CRO’s – although there needs to be a practical balance in what is outsourced and what is done in house the reality is that no third party will put the urgency and care in to product development process as you will.  Also recognise that with CRO’s the small company trials may be of a lower priority that for the big companies that are repeat clients. Tight engagement contracts are essential.

4.       Not Understanding the Target market – before investing funds it is imperative to direct the research programme towards a commercially viable end product addressing issues of novelty, meeting medical need and the likelihood of adequate reimbursement.

5.       Emotional attachment to a Medicinal Chemistry or Clinical Programme – the drug candidate doesn’t drive its own reverence. Get expert objective advice but stay candid.

6.       Lack of Strong Middle management – they connect the detail to the Company and investor aspirations. Get people who roll up their sleeves and communicate objectively.  Ensure someone knows who, what and how to do things consistently.

7.       Clinical trials with Too Many Objectives – avoid the kitchen sink. It complicates trials, obscures endpoints and slows down recruitment.  Many time Companies would have more objective data and saved money if they had done several less ambitious trials than a large complex trial with many objectives.

8.       Not Raising Enough Money – things always take longer and take more money than anticipated. Avoiding dilution by investors may mean that the company runs out of options half way through a programme.  Pick your VC or funder wisely; raise more than enough money to get to a sizeable value inflection point for the business.

9.       Not having a Regulatory Strategy and not Listening to the FDA – develop a regulatory strategy that has the highest chance of gaining product approval including considering other study designs, indications and endpoints that may accelerate approval. Treat the FDA as a discerning customer, take to heart what the Agency says and view suggestions as a mandate.

10.   Not knowing when to Partner- this is a strategic process that should dominate Board discussion.  Early validation of a technology needs to be balanced against potential value of going it alone or partnering late. Just remember that commercial partners are more risk adverse that they like to admit, as are funders and public markets.

11.   Not Being Ready for Success – sales, large scale manufacturing and commercial procurement are frequently afterthoughts to the drug approval process. In addition global roll out of a product is frequently slow.  Effective patent duration and valuable commercial sales are lost through this

12.   Lack of an Exit Plan – this needs to be embedded in the strategy of the Company

Let Jadara Pharma Ltd help you with these challenges