Not long ago, I was playing the popular board game Snakes and Ladders (also known as Chutes and Ladders) with my son. Based on an ancient Indian board game, it has over the years become a worldwide classic. The game is rather simple to play: Two or more players place their tokens on a game board that has numbered, gridded squares. They take turns rolling a single die to move their tokens by the number indicated by the die, following a fixed route marked on the game board. A number of ladders and snakes (or chutes) are pictured on the board, each connecting two specific board squares.
The object of the game is to navigate your game piece from start to finish, helped or hindered by ladders and snakes, respectively. If, on completion of a move, you land on the lower-numbered square with a ladder, you can move their token up to the higher-numbered square. If you land on the higher-numbered square with a snake (or chute), you must move your token down to the lower-numbered square. The winner is the player whose token first reaches the last square of the track.
Like most board games, the historic version of Snakes and Ladders has roots in morality lessons. A player’s progression up the board represents a life journey affected by virtues (ladders) and vices (“snakes”). The game of Snakes and Ladders captures the eternal truth that for every “ladder” you hope to climb, a “snake” may be waiting just around the corner. Conversely, for every “snake” a “ladder” will compensate.
As I played the game with my son, I kept thinking about how today’s biotechnology industry, perhaps more so than ever before, can be like a game of Snakes and Ladders. The “snakes” on this game board include the ever increasing costs of development, exceedingly high cost of active pharmaceutical ingredients, and ever more rigorous oversight by regulatory agencies.
For unprepared or underfunded companies, those “snakes” may be lying in wait on every square of the biotechnology game board and looking to put a company back numerous spaces. In the worst of circumstances, such peril could even lead to the very “death” of a company. To avoid those “snakes” demands that companies within the biopharmaceutical world play the game ever more carefully, being especially time-efficient and judicious with capital expenditures. This is especially true for smaller biotechnology companies that often face limited financial resources, expertise, people, and equipment. For them, the “snakes” on the game board take on a greater level of risk. They cannot play the “game” alone. So finding the right partners is critical. A careful screening process should help reduce the risk of choosing the wrong ones.Ready to Play?
When partnering is in your company’s future, the following suggestions may help you navigate the biotechnology game board. These suggestions will help you avoid the “snakes” that will almost certainly result in sending your company back in the game. In many circumstances they may provide you with some ladders to save you time and valuable resources.
Your first move on the game board is critical. You must decide whether to partner with several companies that can help you achieve early goals through a step-by-step process or partner with a full-service contract development and manufacturing organization (CDMO) that can help your drug progress from clinical development into commercial manufacturing. Developing and manufacturing innovative drugs involves considerable risk, particularly financial ones. Finding a suitable partner can free up the company to concentrate its efforts and resources on core competencies such as research and development. If out-licensing is part of the overall strategy of a company, a CDMO that has already positioned itself as a preferred partner for biotechnology companies can add a significant degree of perceived and real value. That applies not only to a company’s compound (by helping to raise investment capital) but also to a company itself. Such efforts will help attract future investors and licensing opportunities.
Thus, selecting the right CDMO as your company’s partner will be critical to moving forward and may even help you to “charm the snakes” you encounter. The right CDMO can also act as a “ladder” — helping you move your token up to a higher numbered square of success.Ladders That Lead to Success
To assist you in selecting a CDMO suitable for your business, determine key attributes of the CDMO candidate. Some are described below.
Level of Experience: CDMOs with a high level of expertise and experience in development and manufacture of complex biotechnology compounds provide “ladders” that assist you and help you achieve success. Be diligent and persistent in your selection. Once you have identified a candidate, you must be assertive and ask questions that help you determine how long the company has been in business and what kinds of work it has undertaken.
Determine whether the company has experience in supporting your drug development steps, including clinical filling and possible later commercial manufacturing and market supply. Extensive knowledge of and experience in navigating domestic and international regulations will also be the ladders that help move your drug ahead in the development process.
Experience and expertise provide a greater likelihood of success and help ease the collaboration process. Well trained teams of scientists and engineers will support a competent and creative approach to your program and help solve problems that might arise. That helps speed time to clinic. Teams that are well versed in this “game” can work more efficiently because they will have comprehensive expertise about possible process-related challenges and support the organization at each step. So they make optimal use of budget, time, and human resources.
Finally, determine how well positioned a CDMO is internationally. Most countries have their own regulatory systems and national specifications. A CDMO that has already supported companies in international product approvals has likely developed significant experience that has been integrated into its processes. Having an established, solid working relationship with regulatory agencies such as the US Food and Drug Administration and the European Medicines Agency will act as a supportive “ladder” to move you ahead.
Agility and Flexibility: Encountering a “snake” is never a good thing. But early drug development by its very nature will present surprises. Be ready for them by engaging a CDMO that can act quickly and make adjustments.
Experienced Project Managers: Find a CDMO outfitted with “ladders” in the form of experienced project managers who understand your business. Doing so ensures that each project is handled properly and communication channels remain open. Regular team meetings should involve individuals from all technical areas and be a part of every relationship. This helps ensure that each party is fully informed of potential “snakes” or roadblocks in the process. Proper documentation of processes and the establishment of joint performance measures that can be easily quantified using objective dating is critical to success. p>
Because small biotechnology companies often have less experience in assembling their own project management teams, a CDMO will be essential in helping to create a team that meets the needs of a small company’s project. That allows the company’s staff to focus their efforts where their expertise is required. Confidence that your partner is sharing the right information and knowledge will result in a trusting partnership, which is the true core of a successful relationship.Creative Moves
A “nose to the grindstone” approach to your business goes a long way. But a CDMO should offer a range of services that demonstrate creativity and solutions that actually address the changing needs of the market.
Lifecycle management is an important consideration. Usually, if a drug is to hit the clinic fast in a first cycle, it will most likely be in a vial. For later clinical phases, a syringe may be the desired delivery mechanism. A viable CDMO will have capabilities that offer proactive approaches to the various challenges at each stage. Lifecycle management, if planned early enough, can make all the difference in the real success of a drug in the face of upcoming competition.Services That Consistently Meet International Quality Standards
Because aseptic manufacturing is becoming increasingly more rigorous and demanding, regulatory agencies in the United States, Europe, and Japan are demanding that CDMOs stay abreast of new and emerging rules and regulations. And because rigorous standards are being enforced, the technology for a facility itself must remain cutting edge. Providing high quality yield of valuable product is a must.Financial Stability Makes for a Strong Partner
Manufacturing biotechnology compounds is a long process. A drug product can take an extended period from process development to manufacturing. So the relationship you develop with a CDMO is a long-term one. Be certain that your partner can demonstrate that it has independent financial standing. A CDMO with a history of organic, consistent growth will prove to be a strong ally. If you encounter a “snake” — and you most likely will — you want to know your CDMO has the financial strength to deal with it.Ensure That Everyone Is On the Same Game Board
Developing a solid working relationship with the right CDMO can help you avoid or possibly “charm” the “snakes” on the board. They will also help you find as many “ladders” as possible. But like any game, it requires investment by both parties, particularly in the area of communications.
Factors that can affect good communication among team members and peers include differences in corporate cultures and business models and varying levels of knowledge and experience throughout the organization. Here, I’ve discussed a few issues that can make communication among parties more difficult.The Right Partner
If you have decided that a partnership with a CDMO is in your company’s future, my suggestions should help get you started. Remember that with whom you partner is a fundamental business decision that is best made in the early phases of biopharmaceutical product development. The development of biotechnology drugs is a difficult game, and the right selection of one or several partners to help increase your chance of success is critical to the future of your company.
Peter Soelkner is managing director of Vetter Pharma International GmbH, Eywiesenstraße 5, 88212 Ravensburg, Germany; 49-751-3700-3729;