OUTSOURCING - The Power of Partnerships Fueling Biopharma Progress With Advanced Tools & Expert Support

INTRODUCTION

Whether they were working 20 years ago or are shaping the most innovative therapies and diagnostics entering the clinic today, scientists at every phase of the research and development pipeline continue to need robust and reliable tools to work effec­tively and efficiently. But while today’s biopharma stakeholders face many of the same challenges they have for decades, much has changed about how we work in the space, as well as the range of tools and solutions at our disposal. Advances in research tools and critical components have kept pace with the growing number of novel drug modalities and precision medicines.

As biopharma moves faster and new drug approvals reach an all-time high, relationships with critical component suppliers and expert development and manufacturing partners cannot be an afterthought. By supporting biopharma companies with reli­able, cutting-edge tools and services and reshaping the drug de­velopment process, these organizations will play a critical role in helping biopharma reach its full potential.

A CHANGING LANDSCAPE

One of the most significant recent shifts in the pharma space is a growing reliance on collaboration and outsourcing to develop increasingly complex therapeutics. Early in my career as a chemist, when small-molecule drugs dominated the landscape, drug development efforts were largely managed internally with minimal external support. Groups within pharma companies were directed at designated topical focuses in discovery and de­velopment, with research infrastructure maintained in-house.

As more complex small-molecule drugs and biopharmaceu­ticals have emerged, pharma organizations are seeing the ad­vantage of working with expert development and manufacturing partners for specialized chemistry and biology needs. Rather than building an internal “linker chemistry group” to support an ex­panding antibody-drug conjugate (ADC) pipeline, for example, a growing number of organizations are instead turning to part­ners with specialized chemical and biological expertise and linker design capabilities. In doing so, they can access specialized pro­duction infrastructure as well as deep knowledge in linker chem­istry, de-risking their development process.

This shift has fundamentally changed the way companies work, especially for biotech organizations developing advanced biopharmaceutical modalities. Development partnerships give companies the flexibility to leverage established expertise and in­frastructure and focus their resources elsewhere, a vital advan­tage for early stage organizations with limited capital. The cell therapy field has highlighted the advantages of collaborative de­velopment and manufacturing partnerships for driving progress and maximizing resource efficiency. In this nascent industry, there are a limited number of experienced personnel with the specialized skills necessary to support cell therapy development and production, leading to persistent challenges in finding and main­taining talent. Additionally, building the in­ternal infrastructure required to produce cell therapy products for clinical or com­mercial use is a massive investment for any organization. Simply put, it’s not real­istic or resource-efficient for every com­pany to build in-house capabilities from the ground up.

COLLABORATION, CAPABILITIES & COST EFFICIENCY

The benefits of collaborative, special­ized partnerships are also true for vital re­search tools and product development capabilities. Working with established ex­ternal partners can help drug developers gain reliable, cost-efficient access to the most advanced techniques and tools and the expertise to best apply them. When it comes to innovative therapies and diag­nostics, outsourcing doesn’t have to come at the cost of IP ownership — biotech com­panies can still develop the IP for a product and outsource the process or “recipe” to an external partnership. By emphasizing collaboration and breaking silos, bio­pharma players big and small can en­hance their research capabilities and ac­celerate product development, getting groundbreaking therapies to patients faster.

The explosion of scientific innovation that has empowered biopharma’s biggest milestones over the past 2 decades has now created a new challenge – an over­whelming number of options. Faced with a seemingly infinite range of new choices for tools, techniques, and suppliers, re­searchers struggle to navigate these op­tions and ensure they’re selecting providers with reliable, validated, and cost-effective solutions. It’s a similarly daunting task to shopping on Amazon as a consumer today. With virtually countless options for even a single product at our fingertips, it can be hard to sift through these choices to find what we need and know it’s coming from a reputable, trust­worthy supplier. While biopharma re­searchers may not be bombarded with a curated social media feed of potentially dubious products, it’s not uncommon to rely on a simple internet search to serve up exactly what you need, when you need it. But for something as important as drug or diagnostic development, working with re­liable, high-quality tools from the begin­ning is vital to long-term success. Partnering with reputable, established crit­ical component suppliers can connect drug developers with the tools and reagents they need at every step, from R&D to the clinic.

UNLOCKING NEW POSSIBILITIES

In addition to expanding the global catalog of tools and reagents, innovation in research methodology has transformed the scope of research and made complex techniques more accessible. Technical ad­vances have empowered a deeper under­standing of disease etiology than ever before, helping drug and diagnostic de­velopers to identify novel drug targets and mechanisms. We can now probe biologi­cal systems at a previously unattainable resolution with a growing range of ad­vanced research techniques and tools available to scientists at every level. Inno­vations in spatial biology techniques have helped researchers visualize proteomic and transcriptomic data within the context of tissue, opening doors to promising di­agnostic and translational applications across cancer, immunology, and more. Re­cent research has also fostered an appre­ciation for the role of previously “niche” topics, such as glycobiology, in health and disease. In turn, advances in chemical bi­ology are enabling researchers and drug developers to apply this deeper biological knowledge to work in a therapeutic con­text. Due to the increase of available tools and expert supplier support, approaches such as click chemistry are now accessible for biopharma players big and small to use successfully.

Artificial intelligence (AI) and high-throughput technologies are further sup­plementing these advances, helping biopharma companies to deliver on the potential of promising biomarkers and mechanisms with faster, more efficient re­search. Sophisticated robotics systems can now support automation in high-through­put screening and experimentation, en­abling more efficient selection of candidate compounds to guide drug de­velopment. While it seems like we’re just scratching the surface thus far with AI and machine learning (ML) in biotech, some exciting applications have highlighted the power of these technologies. In this space, collaborating with specialized partners can also help biotech and biopharma compa­nies gain access to the most advanced tools without investing internal time or re­sources to build capabilities.

Companies such as Etcembly and Alloy Therapeutics are uniting deep im­munology expertise with powerful AI/ML approaches to engineer better im­munotherapies. Etcembly, for example, has built a massive and growing database mapping the human immune repertoire, from which it conducts in silico T-cell re­ceptor (TCR) engineering for novel thera­pies. Rather than relying on manual screening of lead candidates, companies working with Etcembly can leverage AI-based engineering of novel TCR candi­dates. These can then be applied in new biologics or used to re-engineer and im­prove existing biotherapeutics. AI/ML guided techniques like these can help speed the path of novel, groundbreaking drugs to the clinic, potentially cutting de­velopment timelines in half.

GOING FARTHER TOGETHER

While AI holds undeniably exciting possibilities for advancing medicine, it won’t be completely replacing scientists anytime soon. We can’t lose sight of the value of deep experience, expertise, and collaboration between researchers. AI of­fers so much, but what it still cannot re­place is the wealth of information an experienced scientist holds about their failed experiments and missteps in execu­tion. That still resides in the experience of research and translates to the valuable tal­ent of experts across the field. Lessons about failure are just as valuable as in­sights on success, and sharing both through collaborative relationships can take biopharma further.

There’s work to be done yet, and drug and diagnostic developers can continue to advance and fine-tune innovative tools and techniques, including the use of AI, alongside expert development partners and critical component suppliers. As re­search tools continue to evolve and ex­pand, partnerships between biopharma and specialized providers will play a fun­damental role in accelerating the develop­ment of new drugs and diagnostics. There is simply too much for pharma to bear alone, and we can all go farther and faster together.

Dr. Lisa V. Sellers is the CEO of Vector Laboratories. She is an accomplished leader and mentor in life sciences with more than 20 years of experience in the industry. As a top innovator in immunohistochemistry, immunofluorescence, and glycobiology products used for scientific discovery, she drives the company’s expansion and business strategies. She earned her PhD in Chemistry from the University of Colorado Boulder and her BS in Chemistry, ACS Certified from Santa Clara University.