Many  international companies seek to enter the U.S. generics market. Building a new pharmaceutical generics company from the ground up requires excellent project/timeline management and strong collaborations with the right partners.

Channeling Experience

In late 2014, when an international pharmaceutical company decided to serve the U.S. market directly, they recruited me for the task. I was intrigued by their wide range of dosage forms and manufacturing capacity, as well as their years of experience as a CDMO. 

Managing Timelines and Priorities is Key

Managing timelines for establishing a commercial platform, building a relationship with the FDA, engaging with distributors and suppliers and all of the other activities involved in building a company from scratch were crucial to achieving our goals. Like any startup, the team members all wore several different hats, constantly juggled multiple projects at once and worked to ensure that all projects came to fruition at the right time.

We were galvanized by achieving one milestone after another — from our first FDA submissions for a semisolid and a sterile product to passing our first FDA inspections — and we focused on building and implementing systems to accommodate the requirements of the U.S. regulators and market to align with the needs of U.S. consumers.

People are Paramount

The secret to success in any business is recruiting the right professionals, but having the right mindset is equally important.

Pitching a new company is challenging, but it is easy to identify candidates seeking a unique employment experience who are excited about tackling multiple types of challenges, can think outside the box and want to make a difference. Assembling a team of individuals who are hungry, want to be leaders and have years of experience and a vision on how things can run better will bring success.

Comprehensive Portfolio: The Sooner the Better

In generics, your portfolio is what will drive growth, and, given development and approval timelines, this should be a priority at all times.

After three and a half years, we had 12 products on the market, three of which were developed internally. Another five were approved and prepared for launch, two of which were developed internally. Given price erosion and increasing competition, the key to growth is to continue to launch new products and aim to be in the first wave for each.

Three times per year, our pipeline committee, comprising representatives from all departments, reviewed and deliberated possible candidates to develop as generic products and selected those to take forward. The goal was to identify products that will reduce costs for patients, address unmet needs, have a high likelihood of success and maximize the use of allocated resources and funding. This process enables all the key stakeholders to be engaged and aligned from formulation to commercial launch.

Forming the Right Partnerships: Turbocharging Growth

After understanding what you have in-house, you need to focus attention on what you lack. We worked with partners in the United States, India, Germany, Israel and Canada who develop and manufacture products. We also pursued business development and M&A deals in Latin America, Europe, India and the United Arab Emirates. These relationships enabled us to rapidly achieve FDA submissions and approvals and helped to accelerate growth. As one example, we acquired a portfolio for which we served as the contract manufacturer, providing us an established position in the U.S. market with nine commercial products. In the UAE, we partnered with a company that, with our support, was the first FDA-approved site in that region. I was able to collaborate with companies all over the world to co-develop products with unique delivery systems or other barriers of entry that can provide an advantage. 

My Take

The generics sector has been beaten down in the past four years and overall pharma is not the most popular space from a public perspective. However, I am still optimistic and I know that it is important that we are out there building the global supply chain and patient access.

Unlike coming into an already established organization, building a company from the ground up forces you to focus on the fundamentals of the business and provide a better understanding of all the parts that make this a success story.