Gene therapies offer incredible promise for treating diseases, but bringing these complex therapies to market comes with unique challenges. As a leading consulting firm focused on the gene therapy space, Bothwell Engineering frequently receives questions about what our gene therapy consultants do to support clients. This post will answer some of the most common inquiries we get.
What experience and expertise do your consultants have?
Our multidisciplinary team includes experts from the biotech, pharmaceutical, and cell/gene therapy industries. Consultants have decades of experience in R&D, manufacturing, quality, regulatory, and program management specific to gene therapies. Bothwell only staffs senior-level consultants with deep technical knowledge and hands-on expertise. This high caliber talent provides immense value to our partners.
When should a company engage a gene therapy consultant?
Consulting support can benefit companies throughout the gene therapy pipeline. During early-stage R&D, consultants assist with technology evaluation, proof-of-concept testing, and development of manufacturing processes. In later phases, consultants guide IND submissions, clinical trial execution, and developing cGMP manufacturing and control strategies. We also assist with BLA submissions, facility design, and commercialization.
What are the benefits of gene therapy consulting?
Top consultants offer external insights and specialized expertise that complements your internal team. They identify development hurdles early on and propose proven solutions. Consultants promote innovation, knowledge sharing, and adoption of cutting-edge technologies. This accelerates development timelines. Experienced consultants also have extensive networks across the industry to leverage.
How can consultants support preclinical development?
Preclinical phases have complex challenges like vector selection, analytical comparability, and demonstrating proof-of-concept. Consultants perform technology evaluations, identify best vector platforms, and establish analytical tests for potency, purity and identity. We also design compliant manufacturing processes, including disposables selection, USP/DSP integration, and facility fit assessments.
What about clinical phase consulting support?
During clinical development, consultants provide regulatory strategy and IND filing support, including drafting documents and liaising with agencies. We assist with clinical protocol development, focusing on unique gene therapy considerations. Consultants also develop cGMP manufacturing and control strategies aligned to late-phase and commercial needs. Critical quality systems are implemented under expert guidance.
Why is consulting important for commercialization?
Bringing gene therapies to market requires optimized commercial manufacturing, multidisciplinary facilities, and watertight quality systems. Consultants have launched numerous commercial gene therapy programs. We provide comprehensive commercialization strategies covering scale-up, tech transfer, facility design, supply chain establishment, distribution logistics, and pharmacy workflows.
How can consultants enhance a company’s capabilities?
Beyond adding niche expertise, consultants improve R&D productivity, accelerate timelines, and enhance your quality and regulatory compliance. Establishing best practice workflows under expert guidance instills long-term capabilities. Consultants also implement new technologies and drive innovation adoption across your technical operations. The objective is building competitive advantages through optimized bioprocessing.
How can consultants support talent recruitment?
Recruiting top gene therapy talent is challenging in this niche field. Experienced consultants leverage extensive networks to identify and recruit specialized researchers, clinicians, technical experts, and operational leaders tailored to your hiring needs. We understand the competencies and mindsets needed to build high-performing gene therapy teams.
Bringing a transformative gene therapy from concept to patients requires diverse expertise. Gene therapy consultants fill capability gaps and provide practical guidance across the development journey, from R&D to securing approval to scaled commercial manufacturing. Consultants identify process improvements, accelerate timelines, implement innovative technologies, and establish operational excellence through best practices. They also assist with targeted talent recruitment in a highly competitive hiring environment.
In summary, partnering with specialized gene therapy consultants enables companies to overcome hurdles, establish robust technical operations and quality systems, achieve faster market access, and ultimately deliver life-changing therapies to patients. To learn more about Bothwell Engineering’s consulting support, please contact us.
