As biopharmaceutical development grows more complex, the importance of aligning innovation with manufacturing strategy has never been greater. This webinar explores how reshoring biologics manufacturing to the US is emerging as a practical solution to accelerate tech transfer, streamline timelines and ensure greater operational control — especially for early-stage innovators navigating today’s development pressures.
Through a candid, podcast-style conversation, the featured speakers will examine the factors prompting biopharma teams to build or shift capabilities to the US. With increasing demands for IP alignment, regulatory clarity and supply chain integration, US-based manufacturing offers opportunities to simplify development logistics and reduce delays that can arise from fragmented global operations.
Attendees will gain a grounded perspective on how perceived barriers — such as tech transfer complexity, infrastructure limitations and cost concerns — can be addressed when manufacturing is designed to be agile, scalable and cGMP-compliant from the outset. Rather than adapting legacy platforms, what does it take to reimagine the discovery-to-clinic pathway using high-science/high-touch principles and a modular development model?
This session will explore critical questions for early-stage biopharma leaders:
- Can US-based biologics manufacturing match or exceed the agility and timelines of global alternatives?
- How does a domestic strategy support early innovation, IP management and long-term development continuity?
- What does a successful multi-stage tech transfer look like when supported by the right infrastructure and expertise?
This webinar will help attendees evaluate current strategies, challenge assumptions and gain actionable insights to inform decision-making and reduce risk across the biologic’s development lifecycle.
Register for this webinar to learn how biologics manufacturing strategies support innovation, agility and early development success.
- Biologics ,
- Biologics Development ,
- Biologics Manufacturing ,
- CDMO/CMO ,
- cGMP ,
- CMC ,
- Commercial Manufacturing ,
- Drug Development ,
- Drug Discovery ,
- Drug Manufacturing ,
- GMP ,
- Location/FDI ,
- Pharma Manufacturing and Supply Chain ,
- Pharmaceutical Manufacturing ,
- Pharmaceutical Regulation ,
- Regulatory ,
- Regulatory Compliance
Speakers
Aaron Pilling, PhD, Director of Business Development, Wheeler Bio
Aaron Pilling enjoys the responsibilities of moving biotechnology products through stages of CMC process design, clinical supply and commercialization. For nearly 20 years, Aaron has provided expert CMC leadership over a wide range of biologics molecule types and through multiple stages of development and commercialization.
Always underpinning CMC development with sound scientific approaches, rigorous data and statistical analysis and careful documentation strategies, Aaron thrives on leading CMC projects and defining clear visions for programs and molecules while also empowering and mentoring team members to achieve their — and the project’s — full potential.
Message Presenter
Brian R. Berquist, PhD, Chief Development Officer, Wheeler Bio
Brian R. Berquist has over 20 years of industry, government and academic research and development experience. Brian serves as the Chief Development Officer for Wheeler Bio, overseeing cell line, process, analytical and formulation development.
Prior to joining Wheeler, Brian was in positions of increasing responsibility at iBio and commenced his tenure there as the VP of Process Development and Head of Platform and Technology Development. Brian was responsible for building the Process Development teams as well as the Analytical Development and Characterization groups for IND.
He enabled the early clinical development of therapeutics and vaccines for both internal programs and CDMO services clients. Dr. Berquist received his PhD in Molecular Medicine from the University of Maryland School of Medicine, where he graduated summa cum laude. He followed with a post-doctoral fellowship in the Laboratory of Molecular Gerontology at the National Institute on Aging, a part of the National Institutes of Health.
Message Presenter
Rajesh G. Beri, PhD, Principal Consultant, Pharmefex Consulting
Dr. Beri has over 30 years of experience in the Biotech Industry, starting as a Bench Scientist with Lonza Biologics in 1996 and progressing to executive-level leadership positions at Senda Biosciences and Goodwin Biotech, prior to launching his consulting career. During his career, Rajesh has managed over 70 biologics projects from pre-clinical through commercial approval. He has played a key role in the approval and life cycle management of leading biologics products such as YERVOY®, ORENCIA®, OPDIVO®, ARZERRA®, BENLYSTA®, SOLIRIS® and StrenSIQ®. He has established and led development, manufacturing sciences, technical operations and CMC functions at several organizations while promoting a culture of technical excellence and quality compliance. His teams have supported manufacturing, supply chain, engineering, quality, regulatory and business development functions.
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Dr. Beri has a strong track record of active participation at industry events, with over 20 presentations, five publications, two granted patents and one patent pending approval. He has been a key steering committee member of the Biophorum Operations group (BPOG), contributing to the publication of white papers covering Characterization, Validation and Continued Monitoring of Biologics and a Technology Roadmap for Biomanufacturing.
Based on his experience, Dr. Beri is well-positioned to assist pharma and biotech companies with a broad range of technical, operational and strategic expertise in the development and manufacturing of multiple product modalities manufactured using both mammalian and microbial expression systems, such as recombinant proteins, monoclonal antibodies, ADCs, mRNA and Lipid nanoparticles. Rajesh’s expertise spans from cell line generation to drug product manufacturing and packaging, and from pre-clinical through post approval and the associated regulatory interactions. Dr. Beri received his Bachelor of Technology in Chemical Engineering from the Indian Institute of Technology, Mumbai, India and his Master’s and Doctorate degrees in Chemical Engineering from Worcester Polytechnic Institute.
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Who Should Attend?
This webinar will appeal to:
- Biopharmaceutical founders and innovative leaders seeking greater control over IP, timelines and manufacturing strategy in a reshoring-focused landscape
- Subject Matter Experts (SME’s) and CMC executives looking for scalable, US-based solutions to streamline complex tech transfers and accelerate development
- Venture capital and strategic investors evaluating infrastructure risk and timeline efficiency in biopharmaceutical portfolios
- Policy and national security stakeholders interested in the role of domestic biomanufacturing in protecting innovation and ensuring pharmaceutical national security
What You Will Learn
Attendees will:
- Understand why US-based biopharmaceutical manufacturing is strategically advantageous
- Learn how complicated tech-transfers are handled with precision, without sacrificing streamlined development
- Explore the connection between IP security, geopolitical risk and drug development timelines
- Discover how leading US-based platforms can streamline biopharmaceutical development, with immense quality and scalability
Xtalks Partner
Wheeler Bio
Wheeler Bio is a biomanufacturing pioneer, founded by a team of industry experts and strategic investors who believed a streamlined CMC CDMO model is needed to help innovators accelerate the process between discovery and clinical studies.
As a High Science/High Touch biologics CDMO, we leverage our team’s collective experience on over 1,400 unique molecules as well as years of internal research and development to develop our Modular CMC platform. This streamlined approach to antibody and antibody-like biologic CMC development provides our clients with the speed and scalability needed to get programs into the clinic and beyond with unmatched budget and timeline security. Whether developing innovative biologics, biosimilars, or onshoring existing programs, our Modular CMC platform serves biotechs and large pharma alike.
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