The Science Collective: Accelerating Drug Development Through Integrated Expertise

Introduction

Drug development is increasingly complex, requiring rapid, informed decision-making throughout the product life cycle and across manufacturing sites. Access to a broad, deep scientific pool of pharmaceutical development expertise is especially critical when developing novel therapies, formulating for targeted patient groups, and dealing with technical challenges that can arise without warning. Companies need to coordinate diverse capabilities to manage complexities and ensure programs are fast and efficient.

Piramal Pharma Solutions responded to these needs by creating the Science Collective, a team of six experts with over a century of combined experience who serve as internal consultants and client advocates within Piramal's global operations. In effect, they are a seamless, no-cost extension of the client's CMC team. Members of the Science Collective are highly regarded as leaders in their respective fields, known for their ability to overcome scientific challenges and accelerate compounds through every phase, from development and manufacturing to commercialization and life cycle management.

With a perspective that spans Piramal's global operations, the Science Collective provides input on site selection, shares technical recommendations, and develops project strategy. These specialists bring vital technical communication skills, an extensive understanding of Chemistry, Manufacturing, and Controls (CMC), and an in-depth knowledge of project needs and execution directly to the client.

As a cross-functional technical leadership team, the Science Collective works in close collaboration with site heads, technical staff, operations, quality, regulatory affairs, and other functions across Piramal's global network, pairing company-wide resources with deep local knowledge to add value at every step of a project. Backed by a robust integrated project management strategy, the Science Collective assures that even the most complex, multi-site programs run with clarity and precision.

De-risking Projects via Early Expert Input

The Science Collective engages at the very start of a project to assess feasibility, safety, and operational strategy. By involving the experts from day one, the Science Collective, in collaboration with Piramal EHS and client toxicology data, verifies that the molecule can be safely handled at its sites based on its therapeutic class and Occupational Exposure Band (OEB) requirements.

For example, Piramal may assign the development and/or scale-up of a highly potent API to its Riverview, Michigan drug substance site, which is capable of handling materials in OEB Bands 5/6. Similarly, the Science Collective may determine that the same highly potent molecule would best be placed at its drug product facility in Ahmedabad, India, since the site is equipped to handle compounds with Occupational Exposure Limits (OELs) as low as 1 μg/m³. If confronted with an even lower OEL or commercial-scale drug product manufacturing, Piramal may select its Morpeth, U.K., site as the most appropriate facility for the project. Insights from Science Collective specialists in drug substance and drug product inform these decisions and preserve alignment as projects move across global formulation sites.

Another early-stage task the Science Collective manages is verifying technical requirements for the dosage form and manufacturing process. The early technical verification includes collaborating with the client on a Target Product Profile (applicable to both drug substance and drug product programs) and an internal cross-functional assessment of the capabilities needed to develop, manufacture, and test the respective product. For drug product programs, unique unit operations such as tablet imprinting, hot melt extrusion, extrusion/spheronization, and over-encapsulation represent just a few of the specialized capabilities Piramal brings to clients.

For drug substance programs, API development requirements, containment procedures, and supply chain considerations including coordination between Piramal's Eastern and Western facilities are evaluated with equal rigor. For complex modalities like antibody-drug conjugates (ADCs), this early integrated technical planning spans multiple disciplines simultaneously, encompassing specialties such as proteins, high potency compounds, bioconjugations, and lyophilized drug products. Piramal's ADCelerateTM program was created specifically for this purpose. By integrating all aspects of ADC development, we can take clients from R&D to GMP production in as fast as twelve months with guaranteed delivery at a fixed price.

Across all programs, Piramal's experts perform an early review of regulatory requirements at each development stage to ensure projects maintain compliance with strict quality standards throughout execution.

Dr. Gold is one of the Science Collective members who provides critical input at the early stages of a project. Combining his intricate knowledge of Piramal's global capabilities with his specialized drug product expertise, he carefully evaluates each project to ensure it is matched to the facility best suited to its requirements. With a proven track record in pharmaceutical development, operations leadership, containment design, and continuous improvement, Dr. Gold ensures Piramal's site-specific development teams remain in lock-step with customers and their projects.

As an expert in biosimilars, monoclonal antibodies, vaccines, and gene therapy, Dr. Desai is a key voice in the planning stages of clients' biologics projects. With a brief spanning from proof of concept through commercialization, Dr. Desai draws on his robust experience to ensure customers' early decisions about complex therapies are informed by project needs as they advance and scale.

Complementing that biologics expertise is Dr. Barry, who oversees CMC deliverables across the development spectrum from preclinical to commercial and steers bioconjugate initiatives through complex challenges. By engaging Dr. Barry early in a project, Piramal lays the groundwork for the successful orchestration of its bioconjugate and large molecule capabilities. He works across internal functions and client teams to align on technical strategy, anticipate and mitigate risks, and ensure that programs are set up for regulatory success from day one.

Harnessing Expertise for Efficient Execution

The Science Collective provides ongoing technical input, oversight, and troubleshooting once the project is active. By serving as the central technical bridge connecting the customer, business development, site heads, proposal teams, and global functions, these experts help translate meticulous planning into efficient execution.

Dr. Carniaux is central to that process, leveraging his advanced expertise to lead Piramal's global API development initiatives and provide the scientific leadership and input required to align R&D with overarching strategies. With responsibility for internal tech transfers, Dr. Carniaux works with the Technology Transfer, Quality, and Manufacturing teams to achieve smooth transitions as projects scale up and move between Piramal facilities. Leveraging his extensive knowledge, he helps Piramal's clients ensure the right balance between science, compliance, and their timelines, establish streamlined approaches, and tackle complex challenges in their drug substance programs.

Dr. Neelakantan is also vital to tech transfers in his capacity as Director of Development at Piramal's Lexington, U.S., facility, which specializes in the development and production of sterile liquid and lyophilized parenterals and injectables from early clinical trials to commercial scale. Dr. Neelakantan has been a key member of the Lexington site for more than a decade, applying his extensive sterile injectables experience to projects that leverage the facility's advanced capabilities, which include automated filling lines, lyophilization cycle development, and large-scale liposomal batches.

Piramal's injectable capabilities extend beyond sterile formulations into the specialized, fast-growing world of peptide therapeutics, a modality that demands its own distinct expertise in API synthesis, characterization, and formulation. That expertise is embodied in Dr. Bacardit, who works closely with clients across their peptide programs. From early development through regulatory submission, he provides technical guidance that helps clients navigate the unique challenges of peptide therapeutics while ensuring manufacturing processes are designed for long-term success.

Integration and Program Management: The Backbone of the Science Collective

The Science Collective's value lies not only in the depth of its members' individual expertise but in how successfully that expertise is integrated across sites, modalities, and functions. While each member is a recognized specialist in their respective field, they have extensive knowledge of their colleagues' functions, enabling them to speak each other's technical languages and translate the needs of one discipline into another.

An example of how this concept is put into action is the previously mentioned ADCelerate program. This unique, integrated bioconjugate development and manufacturing offering bundles together all the elements required to take an antibody-drug conjugate from R&D to GMP production. Peptide fragments, mAbs, payload-linkers, conjugations, and sterile fill/finish services are all aligned and integrated into a single, fixed-price offer that compresses timelines. It's the expertise of the Science Collective and their close working relationship with integrated program managers that makes this possible.

This cross-functional fluency, combined with Piramal's integrated global network, allows the Science Collective to approach even the most complex multi-site, multi-modality programs with a level of cohesion that is rarely found within a single organization.

What turns this cohesion into execution is Piramal's integrated project management strategy. Comprising both site-based Project Managers and Integrated Program Managers, this approach is the glue that holds a complex program together ensuring consistent communication and continuous alignment between Piramal's global teams and the client, from kick-off through delivery. This integrated model reinforces the Science Collective's strength and capabilities, helping Piramal's clients move programs forward with technical confidence and operational clarity.

Conclusion

By embedding world-class, modality-specific expertise directly into the planning and execution phases of every project, the Science Collective provides Piramal's customers and internal teams with ready access to insights that support efficient delivery. The experts' decades of experience equip Piramal to proactively mitigate risks and quickly address unexpected problems, keeping projects on time and on budget.

The need for the Science Collective's expertise is greater than ever. As drug development becomes more complex and competition over the most promising targets intensifies, biopharma companies require CMC expertise to smoothly advance programs and gain an edge over rivals.

The Science Collective's integrated expertise spanning multiple modalities, global sites, and development stages combined with Piramal's integrated project management strategy, meets that need. By uniting deep scientific specialization, cross-functional capabilities, and disciplined program oversight, Piramal helps clients advance their complex programs with efficiency, quality, and speed, ultimately delivering life-changing treatments to patients in need worldwide.

For more information contact the Science Collective at sciencecollective@piramal.com

Further Reading

Meet Our Science Collective

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/ finish, peptide products and services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines and gene therapies, made possible through Piramal Pharma Limited's associate company, Yapan Bio Private Limited.