In the previous article, we delved into a unique approval pathway offering smaller industry players the chance to enter the market by innovating older pharmaceutical products to improve outcomes and satisfy market needs.  The journey from identifying market needs to turning ideas into reality is not only complex and multifaceted but also a cornerstone of entrepreneurial success. In this installment, we delve into the key challenges and offer personal insights to inspire and guide aspiring entrepreneurs toward navigating the marathon of entrepreneurial success by bringing new products to market.

Skills

What do you bring to the table?

Smaller entrepreneurs who have a product idea and therapeutic category in mind must identify what value they bring to addressing the market opportunity.  Skill sets are critical in this industry, so the people making up your team are critically important.  What skills do you bring to the team?  Are you clinically minded, an operations expert, possess analytic savvy, strong sales talent, reimbursement expert, a combination of many skills?  Funding the project through all phases is another challenge.  Are you a leader and can you bring the right team together?  It is that team who must coordinate a very intricate dance of participants, generate confidence, and fund, or obtain funding along the way to product approval and launch. 

It’s Decision Time

Stay or Leave?

In my experience, the piece meal approach rarely works as intended and it is the worst way to go.  However, leaving the security of corporate life is horrifying.  The time to piecemeal is during the idea forming and validating phases, not during the execution phase.  Aligning yourself with the right people before jumping outside the “protective” corporate bubble is also a good idea.  One of the worst mistakes I ever made was leaving corporate life too soon, having only validated the idea, not the team!

Assembling the Team

How do you assemble the team?

Once you’ve decided to go for it, success hinges on the right team.  It is time to begin assembling a small team with people who have, or can access, the skills listed above.  Analytic, strategic planning, and strong communication skills are part of the operational necessities that cannot wait.  Certain roles can be contracted.  For example, clinical advisors, formulation expertise, and manufacturing all can be outsourced. 

The leadership roles and primary operational positions need to be full-time focused on the new business opportunity.  The management team of a small startup in this sector carries the greatest weight with lenders, investors and potential strategic partners.[1]  Details about the education, qualifications, and experience that you and your management team bring to “the table” will be intensively scrutinized and used as the foundation for evaluating your business.

Size Matters

As each lifecycle phase is completed, the size and composition of the team evolve.  Different talent must be added to the organization.  In my experience, stressful situations reveal the true capabilities of team members, highlighting the need for strong leaders who can anticipate and manage challenges. 

There will be many stress-filled situations and you will learn a lot about your team.  Those who were skillful and dependable in the corporate world may be much the same in a startup, becoming more resilient and dependable.  Others might surprise you in their inability to stand the pressure.  They might behave in ways you could not have imagined.  At best they become useless to the operation.  At worst, they go into self-protection mode and harm the business.  Strong leaders will see this coming and often can mitigate these negative situations. 

Many entrepreneurial leaders become successful because of how they address early personnel, environmental, and market challenges.  They are generally comfortable and competent managing product assets of varying values.  I have witnessed that continued growth and success will eventually push entrepreneurial leaders past their competency and comfort zones.  At that point it is common to see an acquisition, or leadership change, because the challenges are different and must be managed accordingly compared those in the beginning.

In the pharmaceutical entrepreneurial landscape, addressing market needs and pursuing innovation requires a strategic approach.  Success hinges on assembling the right team, validating ideas before making significant career moves, and adapting leadership styles to evolving challenges.  While the journey may push leaders out of their comfort zones, effective management of personnel, environmental, and market challenges can lead to continued growth and success in a business sector that is ever-changing.

[1] Wroblewski, M.  (2019).  How to Write the Management Team Section of a Business Plan.  Retrieved from  https://smallbusiness.chron.com/4-important-parts-business-plan-2669.html