Supporting Biopharmaceutical Companies to Effectively Manage Process Development and Biomanufacturing Using External Resources
An Interview with David Jackson by Sherry Stone
SS: Why have you decided to join BioMed Transition Partners?
DJ: Following the successful conclusion of BioMed's project to restart a dormant biomanufacturing company, we determined that the challenges are far greater and the hurdles higher than they have ever been for success in the development and manufacture of biopharmaceuticals. It is our observation that many companies in our industry lack significant expertise or capacity in process development and manufacturing disciplines to meet these challenges. When those companies turn to outsource suppliers without sufficient internal knowledge to make the best decisions and the right "choices," they often fall short of reaching their goals and frequently put their entire organization at risk of failure. The Partners of BioMed invited me to join them in an initiative directed at helping such companies.
SS: Is BioMed an outsource supplier or contract manufacturer? Does BioMed maintain facilities to produce product for others?
DJ: BioMed in not a biomanufacturing company. Our team is an extension of our clients' manufacturing team; we assist them in establishing the technical requirements, the compliance needs, and the cost and schedule criteria necessary for their project. In the areas where outsourcing is required, we provide guidance and critical resources in the selection of contractors and service providers. The BioMed team enables our clients to make independent informed choices that fits the needs of their projects.
Our initial work focuses on understanding product/project dynamics and its current status. We help the team identify those issues that represent challenges and risk factors at all stages of product development and GMP manufacturing 'life cycle" including the regulatory hurdles. The goal here is to decide what must be outsourced to accomplish the project goals.
The outcome of this initial effort enables the team to assemble the detailed specifications of what must be done and the acceptance or performance criteria that contractors must meet in performing the work. These initial efforts form the basis of creating a knowledge-based plan for moving the project forward as well as assembling the information required for the preparation of the proposals that will be issued to potential contractors for the project.
SS: There are many suppliers currently available that focus on outsourced manufacturing services. How do you select the right supplier?
DJ: Indeed, today there are many biomanufacturing and development service contractors to choose from and several that offer a broad range of services. Using the strategy of creating a knowledge-based plan, prior to discussions with contract organizations our clients have a clearer view of exactly what services and support they require. This approach better enables the client's management team to match the company's resources with its goals and objectives, make good choices and good decisions without being unduly influenced by the sales and marketing efforts of contractors bidding on the proposals. In addition, this approach clarifies any challenges or risks the team may face as the project moves forward.
The selection of a specific supplier/contractor is a multifactor based decision that includes project cost and schedule requirements as the critical technical and GMP compliance issues. By bringing the appropriate experience and expertise into the selection process the best choices can be made.
The Partners of BioMed have experience in operating and managing biopharmaceutical contract manufacturing companies as well as operating and managing product companies securing such services and suppliers. In short, we have been on both sides of the table and clearly understand the business.
SS: After the selection process how can your clients be sure that they will receive the level of performance that they should expect?
DJ: As part of the range of services we offer we are able to support/complement a company's internal capabilities by taking on the role of our clients' internal development/ manufacturing team on an extended basis for a particular project. This service includes coordination of internal efforts, and the management of contractors' performance, as well as controlling cost and schedule.
SS: What benefits are realized by clients from these BioMed services?
DJ: Clearly, on time and successful execution of process development and manufacturing at all stages of development are critical to the costs and ultimate success of companies in the life science sector. Our goal is to help in every step of the process and serve as a collaborative team to help assure that performance criteria are met.
SS: What problems do life science companies often face when working with outsourcing suppliers?
DJ: Unless the management team of a life science company is well versed in the requirements of process development, scale up and GMP manufacturing, its expectations may not be in line with the suppliers' ability or capacity to deliver the necessary results. Delays and cost overruns often have a devastating effect on a company's ability to raise funds and continue their development program. Internal expectations must be in line with the outsourcing supplier's ability to deliver.
Intimately related to the ability of the supplier to perform is the level of detail and quality of information provided in the scope of work and tech transfer package issued with the contract. Historically, contractors are poor mind readers and can not be expected to know exactly what a client needs or wants and can not be expected to know or understand the important details of the project. If the mission critical information or details are not in the technology transfer package, and part of the contract, the project may be seriously at risk.
SS: What is it that you find so stimulating about working on bio-manufacturing projects?
DJ: Over the years that I have been in this business I have had the privilege to work with some of the best people in the industry. I have helped solve a number of very difficult problems that resulted in the successful development of products.
For me, it's all about working with dedicated teams of people and organizations on a global basis, helping them address the unmet medical and healthcare needs of people everywhere through the manufacture of biopharmaceutical products. There is no better reward, and nothing more exciting than making a difference in the lives of people and families facing challenges of healthcare issues around the world.