In the fast-paced world of drug development, bringing a new molecule from the preclinical stage to the clinic efficiently is crucial.
Companies face the challenge of finding specialized partners - such as Contract Development and Manufacturing Organizations (CDMOs), Contract Research Organizations (CROs), and regulatory consultants - to navigate the complex journey from discovery to First-In-Human (FIH) or Proof-of-Concept (POC) studies.
Additionally, smaller biotechnology firms often struggle with limited resources and the need for pipeline management support.
This article explores the key needs and challenges faced by biotechnology and pharmaceutical companies, and introduces innovative solutions like SGS PACE that can help streamline the drug development process.
Meeting diverse needs
For biotechnology and pharmaceutical companies, getting their new, innovative products to patients as quickly and efficiently as possible is their primary concern.
Many great medicines are used as a last resort treatment for patients, such as oncology products, and therefore must receive accelerated approval from the FDA. As a result, companies need to prioritize speed and accelerate their supply chain to commercialize their products sooner.
Alternatively, for other products with less critical associated timelines, the pace of the production process will depend on factors like funding availability.
Regardless of the approach, these companies must identify partners with specific expertise. They require a CDMO capable of developing formulations and manufacturing drugs within tight timelines.
A partner skilled in developing bioanalytical methods for preclinical and clinical testing that can be validated and operationalized on time is also essential.
Furthermore, they need to identify the right partner CRO with a Clinical Pharmacology Unit for executing FIH and POC studies.
Once biotechnology and pharmaceutical companies have identified the right partners to work with, they have to start putting together the puzzle.
One significant hurdle is managing multiple partners and coordinating communication and knowledge sharing between them.
Challenges faced in drug development
One significant hurdle for biotechnology and pharmaceutical companies is managing multiple partners, coordinating communication and knowledge sharing between them. This can lead to unforeseen issues and delays if not properly managed.
Conflicting timelines from different vendors often exacerbate the situation, causing cascading delays and disrupting the overall process. These challenges demand a more agile and resilient approach to ensure a streamlined and efficient drug development process.
Introducing SGS PACE
To address these needs and challenges, SGS PACE offers an innovative solution.
By providing consultancy services from the initial contact, SGS PACE leverages the input of developmental, preclinical and clinical experts to provide multidisciplinary advice throughout the drug development process.
Through a single partner, biotechnology and pharmaceutical companies gain access to one program manager and a dedicated point-of-contact, ensuring seamless support from early preclinical stages to commercialization.
By using SGS PACE to their advantage, biotechnology and pharmaceutical companies gain access to a dedicated program manager who works closely with their teams and SGS's experts. This collaboration results in custom strategies, knowledge sharing, efficient time frames and cost management tailored to clients' specific needs and budget.
Clear roadmap
The value of SGS PACE comes from tapping into SGS's considerable expertise, supporting successful project execution without the complexities of coordinating multiple partners.
At the onset of each project, SGS PACE sets up a customized program plan encompassing the proposed strategy for formulation, bioanalysis method development, manufacturing, and clinical development. This comprehensive plan includes different scenarios with estimated timelines and budgets, empowering clients with essential information to make well-informed decisions. Our team of experts evaluates available data and proposes the best approach, ensuring the most efficient and effective path towards achieving the client's drug development goals.
With this strategic consultancy aspect, SGS PACE offers clients a clear roadmap, allowing them to embark on their drug development journey with confidence.
Our SGS PACE program allows our clients to tap into our expertise to help them run successful projects, without the complexity of trying to coordinate all the moving parts.
Conclusion
Efficient and timely drug development is essential for biotechnology and pharmaceutical companies. By understanding their needs and challenges, as well as exploring innovative solutions like SGS PACE, these companies can optimize their development processes.
Streamlining partnerships, collaborating effectively with multiple vendors, and simplifying the process are crucial steps toward achieving success in the competitive landscape of drug development.
With the right support and efficient strategies, biotechnology and pharmaceutical companies can bring their innovative products to market faster, benefiting patients and advancing healthcare as a whole.
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