Speed-to-Market and Accuracy: Challenges of the New Pharmaceutical/Biotech Market
By Jayme Norrie
MasterControl Document Control and Management Software facilitates Quality and Speed-to-Market Objectives.
Speed-to-market objectives have long driven project management milestones in pharmaceutical/biotech companies. Today, with patent life seemingly shorter, a robust competitive environment, and stricter regulatory reviews, the concept of speed-to-market is being redefined. It’s no longer just about getting new medical technologies to the waiting healthcare community faster. It’s also about accuracy in terms of how products are defined to regulatory agencies.
Challenges that companies face today include:
- Investors who want the fast track to profitability;
- A more competitive marketplace;
- Pricing controls and reimbursement hurdles;
- Stiffer FDA compliance regulations and a demand for improved safety and efficacy;
- Increased fees and costs in the development of products, increasing burn rates;
- New patent legislation that could effectively shorten the life of new patents; and,
- In midsized companies, building out infrastructure while moving new innovations forward.
Internal teams are being squeezed between two masters: doing things right and doing them quickly. Failure on either side can have serious implications. In addition, the stakes are getting higher. As regulatory approval becomes more difficult to achieve, the cash to keep companies moving forward is becoming harder to come by. The amount of paperwork is also escalating. The documents required for submission, the interim documents required during the development phases, and the planning and legal documents can feel like a confusing labyrinth.
In large industry settings, workflows and processes are well-established as a result of decades of experience and large teams of experts carefully siloed to focus on one specific aspect of the product. The resources in both manpower and funding to get the work effectively and efficiently completed are not without their challenges, but they are considerably less difficult than what midsize companies face.
Midsize pharmaceutical companies need their personnel to wear more than one hat and to work as a finely-tuned machine that can quickly learn and adapt to new processes. The cross-functional teams are expected to understand processes, documents, and work environments outside of their specific functional domains, which makes their work much more challenging and requires solid time management skills, exceptional team communication and collaboration, and the ability to prioritize tasks.
Most midsize pharmaceutical and biotech companies are developing innovations that may be untested. Companies that produce biologics are probably the best example of this. Team members working on product innovations are extremely busy during the development phase. The single most crucial element for regulatory approval is the end result, i.e., whether the result has medical relevance and is safe for the patients who are expected to benefit from it. If companies don’t recognize shortcomings very early in the process, or if they have potentially unrealistic goals regarding endpoints and timelines, they can move all the way through the process only to find out at the end that FDA approval won’t be forthcoming. Ensuring regulatory approval in the pharmaceutical and biotech space entails well-crafted protocols, in-depth understanding of clinical trials, and the ability to provide a cogent, meaningful submission narrative when developing the NDA.
During early stage development collaboration is critical; direction comes from many sources. Much of the early work drives not only product strategy but corporate as well. Strategic decisions not to move forward with a product are often due, not to a product’s merit, but to the limited resources of the company to move everything forward. Thus, early work on worthy products often gets shelved so that companies can focus on other projects. As a result, information about early stage discoveries frequently gets recorded in lab notebooks and sequestered in a fire-proof vault, where it can be easily forgotten. This is unfortunate, not only because information from early stage discoveries is important to possible future projects, but because of the potential insight early stage information can provide into the development of current product candidates.
Today’s most effective companies use electronic Document Management Systems (eDMS) to support workflow and processes, and to facilitate team collaboration. Changing the way that teams communicate and share documents, of course, requires an initial transition. However, in an age of rapid technological advancement, workers quickly adapt and even evolve the uses of electronic tools to further increase speed-to-market activities and regulatory compliance.
The advantages eDMS systems offer midsize life science companies include:
- Improved corporate strategy development and execution: eDMS systems provide senior management with ready access to documents for investor and business development presentations. They also enable the scientific, medical, engineering, and marketing teams to share knowledge and work together to develop strong medical products.
- Vastly improved internal and external collaboration: Cross-functional teams need documents and information outside of their specific domain in order to collaborate effectively. Examples of teams that need to view one another’s documents to facilitate collaboration include: the team designing the product and the team marketing the product; the regulatory department and quality department (which together develop templates for use by internal as well as external teams); research and all other departments, which must quickly respond to new information that affects the status of the product. In addition, suppliers working on product testing and support collaborate with several functional areas in a process that presents additional challenges, given that these external team members are not part of the day-to-day operations and culture.
- Reduced time required to manage workflow: Face-to-face meetings are critical at times and can improve the working relationship and mutual respect among cross-functional team members. When too much time is spent in meetings, however, they can be detrimental to achieving goals and meeting deadlines. The ability to manage the workflow electronically enhances productivity by eliminating unnecessary face-to-face meetings.
- Enhanced SOX compliance: Senior managers and corporate boards are now mandated by what have become very expensive processes to assure corporate responsibility. Although the overall fiscal management lies with the CFO, budgets and approvals for work are usually prepared at the functional level. The ability to maintain documents and allow department managers and accounting to audit them—preferably without stopping the workflow— can greatly enhance SOX compliance.
- Vastly improved ability to manage the labyrinth of documents required to keep the company and product profitable: FDA submissions documents are critical and can be time consuming, as they must be routed through various departments for review, revision, and ultimate signoff. However, they are only one of many types of documents that must be collaborated on, revised, and approved. Other types of documents include formulation studies, statistical analyses, market analyses, in vivo study data, corporate communications and investment presentations, revenue and patent forecasts, clinical trial results, quality SOPs, etc.— the list goes on and on. The ability to electronically route, review, revise, and signoff on documents vastly improves the ability to manage all the documents that are involved in the process of developing and bringing a product to market.
- Reduced bottlenecks: In paper-based environments, most documents are Word or PDF driven. Some documents (such as the promotional or press documents that come out of marketing) are even put into binders or folders and passed around with signoff sheets. Many of these critical documents wind up accumulating on someone’s desk. The ability to send documents electronically, and escalate them when necessary to the next level of responsibility, can help reduce bottlenecks and keep the workflow moving.
- Improved product and process knowledge: As companies build out infrastructure, add new systems, such as manufacturing, and bring in external suppliers and experts, the learning curve and training involved can impede processes and slow down team performance. In the area of manufacturing, the consequences can be disastrous if line managers and workers aren’t properly trained to meet FDA compliance regulations. Keeping personnel trained on new product information, processes, components, and SOPs is critical both to the timely delivery of products and to successful agency audits. The ability to evenly disseminate new information about products throughout the organization keeps everyone on the same page and decreases errors.
- Greater likelihood of product approval: In the pharmaceutical and biotechnology industries, where huge amounts of data from a variety of sources flow into a company at the end of a clinical trial, the first priority is to cull through and organize all the information. Often this means dividing the data among teams and regulatory managers to be reviewed, revised, and re-circulated. Bottlenecks frequently result, endpoints may not be totally achieved, and clinician paperwork may be poorly completed. The task of defining the submission strategy, of necessity left for the end, is often accomplished hurriedly and in a frantic state of mind.
Contrast this scenario with information coming back into the same electronic file it left, and teams being able to collaborate on study results that can be easily accessed by Principal Investigators for completing forms. Contrast this scenario with a setting in which there is a greater opportunity to “see” the regulatory strategy and related issues in order to fully prepare for the submission, and—more importantly—in which there are efficient processes in place for assuring a complete regulatory submission.
Ultimately, what separates products that get approved from those that don’t are:
- The quality, clarity, and comprehensiveness of regulatory filings that demonstrate medical viability and product safety.
- The ability for the cross-functional teams to prioritize and agree on the regulatory strategy and incorporate important product attributes into the submission for strong label outcomes.
- The team’s ability to generate a high level of detail and scientific / medical focus, and their readiness to defend their submission quickly and accurately.
- Enhanced FDA compliance: Companies that don’t think an audit will happen to them are like drivers who think they’ll never have a fender bender. It’s an unrealistic and potentially costly mistake. Likewise, companies that manage processes without audits can be surprised to learn, when it’s time to file a submission, that not all of the FDA’s requirements have been properly documented and maintained. To see how much an eDMS can save you, divide the annual income of a product by the number of the days it will be generating revenue. That’s how much each day that goes by without a product approval, or because of a manufacturing delay, costs you— and, conversely, how much an eDMS system can save you.
New electronic document management systems offer companies more than FDA compliance. They provide workflow processes that enhance collaboration and communication, as well as the ability to meet critical milestones, enabling companies to create well run, finely tuned organizations capable of extraordinary flexibility and focus.
Jayme Norrie is the Chief Strategic Officer of Incite World, a company that provides consultants from the pharmaceutical, biologic, medical device, and diagnostics industries to help life science companies achieve their goals. For more information, please see www.inciteworld.com.
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