Early-stage pharmaceutical product development is a pivotal stage of product development whose significance is often underestimated, seen merely as a checklist of tasks before clinical trials. However, early-stage development forms the bedrock for successful clinical trials and eventually regulatory approvals.
Preclinical activities for evaluating safety, toxicity, efficacy, PK/PD (pharmacokinetic/pharmacodynamic modeling), dose range and others are performed during this stage, leading to proof-of-concept studies in humans or clinical trials to demonstrate efficacy. These studies provide crucial data for determining dose ranges and initial efficacy beyond risk assessment.
Formulation development — including preformulation and analytical — is another crucial aspect of early-stage pharmaceutical product development, ensuring compatibility with manufacturing processes and scalability. For example, a poorly chosen excipient or process can pose significant hurdles to regulatory approval.
A well-structured regulatory strategy is essential, particularly for inexperienced organizations. It provides clarity on objectives, required resources and the intended regulatory pathway. Open communication with regulatory agencies throughout this phase facilitates a smoother proposal process and regulatory approval.
Early-stage pharmaceutical product development is iterative, involving continuous refinement based on emerging data and insights. It also requires adaptability to changing disease prevalence, treatment paradigms and patient needs.
For this reason, the selection of a contract development and manufacturing organization (CDMO) partner with expertise and experience in early-stage development is crucial for any sponsors hoping to reach the clinic faster. Collaboration among sponsors, CDMO and regulatory authorities is key to product development.
Join this webinar to gain insights into how early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals, and why collaboration with experienced partners like CDMOs is essential.
Speaker
Srinivasan Shanmugam, PhD, Executive Director, Pharmaceutical Sciences, Business Support, & New Technologies, Adare Pharma Solutions
In his current position, Dr. Srinivasan Shanmugam is involved in the development and expansion of Adare’s pharmaceutical technology portfolio and supports product development, co-development and tech transfer opportunities.
Dr. Shanmugam has a PhD, MS, and a BS in Pharmacy. Dr. Shanmugam has more than 20 years of experience in designing and developing conventional, NDDS/alternate, advanced/modified drug delivery systems and pharmaceutical platform technologies for oral and other routes of administration. His expertise includes enabling technologies for challenging drugs and developing platform technologies.
Additionally, his expertise includes patient-centric solutions focusing on pediatric and geriatric populations to achieve dose convenience, flexibility and precision. Dr. Shanmugam has published numerous research articles, holds multiple patents and is a reviewer/editorial member of various prestigious journals. Dr. Shanmugam’s recent work focuses on product development solutions for special patient populations like pediatric and geriatric populations.
Message PresenterWho Should Attend?
This webinar will appeal to:
- Anyone preparing to take a project to the clinic
- Anyone looking for a CDMO partnership
- Anyone involved in pharma outsourcing
- Outsourcing decision-makers
- Senior/Principal Scientists
- Formulation Directors/Managers
- R&D Scouting Technology Innovation Directors/Managers
- CMC Directors/Managers
- Outsourcing/procurement professionals
What You Will Learn
Attendees will learn:
- Early-stage pharmaceutical product development is foundational for successful clinical trials and regulatory approvals. Preformulation activities and formulation development ensure compatibility with manufacturing processes and scalability, impacting regulatory approval
- A well-structured regulatory strategy is essential, and open communication with regulatory authorities facilitates smoother processes and approval. Adaptability is vital, and a key aspect of this is a collaboration among sponsors, contract development and manufacturing organizations (CDMO) and regulatory authorities
- Early-stage development is iterative, involving continuous refinement based on emerging data and insights
- Expert collaboration in early-stage development is crucial for a strong foundation in pharmaceutical product development
Xtalks Partner
Adare Pharma Solutions
Adare Pharma Solutions is a global technology-driven CDMO providing end-to-end integrated services, from product development through commercial manufacturing and packaging, with small molecule expertise focusing on oral dosage forms. Our specialized technology platforms provide taste masking, controlled release, solubility enhancement, and patient-centric dosing solutions. We have developed and manufactured more than 65 products sold by customers worldwide.
We have the expertise and proven track record to guide projects from clinical research stages through optimization, validation, and approval. We operate seven facilities in the US and Europe, equipped to facilitate efficient drug product development and manufacturing, maintaining excellent environmental conditions compliant with US and EU cGMP regulations.
Adare has dedicated high potency GMP manufacturing and development areas. Our in-house regulatory and quality teams have a proven global track record, assuring our clients that products we manufacture are provided with the highest relevant standards for patient care.
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