Outsourcing companies often leverage external support to guide their business development (BD) activities. To gain an advantage in a competitive and evolving market, it is advantageous to partner with a consulting group that brings both business and technical experience to the table.
21159Pharma formed as a response to an increasingly changing industry. With decades of experience working in pharma, I perceived a definitive need for outsourcing among companies of all levels. I saw an opportunity to put my technical and business acumen to use, helping companies looking to outsource operations.
When I was at pharmacy school, I never imagined what I would be doing at this stage in my career. Following a short career in retail pharmacy, work for Janssen as a drug representative, and an international job in Europe and Africa for Catalent, I ended up in the United States. For the next 20 years, I worked at a drug development CDMO, where I learned about both drug development and the outsourcing industry.
In 2017, I took some time off to consider gaps in the industry, before reimagining myself in a role where I could put my background to use and help companies gain and develop their business. By the end of the year, I founded 21159Pharma to leverage my skill set and help companies in this space to grow.
This has led to a lot of interesting assignments over the last year. A generics company was struggling to be competitive in the marketplace with their current CDMO, so I was able to work with the API supplier and another CDMO to provide a competitive cost. I was then involved in a launch planning chemistry and manufacturing controls (CMC) support, as well as the negotiation of CDMO contracts for manufacturing and packaging for an NDA launch for a pharma company.
21159Pharma works with a large team of experienced independent consultants that can support almost any CMC need, ranging from product development to supply chain, finance, regulatory and legal.
Following this, another small NDA company was in need of a head of CMC and BD, which involved licensing and finding CDMOs for API and drug product. In between this time, an overseas company was looking for a partner for their NDA product, and I was able to find the right partner through my net- work. There are many companies constantly seeking technical and business CMC support.
Range of Potential Projects
What type of projects are we looking to take on in 2019? The easy answer is any project involving CMC or BD related to outsourcing. This can range from finding an outsourcing provider for API, drug product manufacturing, packaging and/or clinical trials. It also involves preparing an RFP, selecting up to three vendors based on the needs of the project and reviewing the quotes — which are then provided to the sponsor for a final decision.
On the CMC side, this could be specialized technical help for the project or a CMC team to manage the development of a project. 21159Pharma works with a large team of experienced independent consultants that can support almost any CMC need, ranging from product development to supply chain, finance, regulatory and legal. One project in 2019 involved putting together a CMC to manage a product development pro- gram for a client. This team can also provide technical expertise and expert witness support for patent litigation. Another area of expertise has been finding partners for a range of assets, from products (NDA, ANDA, 505B2) to technologies, equipment and facilities. All this is made possible by possessing a large network of connections built over many years in the United States and Europe.
This leads into the story behind the company name: 21159Pharma. Over the past seven years, I have been active in CrossFit and have enjoyed the constantly varied workouts and tough challenges on the mind and body. 21–15–9 is a common rep scheme in CrossFit, which fittingly reflects the constant yet varied jobs that we take on and the thought and hard work required to complete each one.
My years of experience in different positions across the industry — from pharma to CDMOs to licensing — have given me deep understanding of both the business and technical issues pertinent to these companies. 21159Pharma can leverage the synergy between these types of expertise to help grow businesses within the pharma outsourcing space.