The chemistry, manufacturing and controls (CMC) path to a successful investigational new drug (IND) submission and biologics license application (BLA) for therapeutic biologics is both an exercise in strategy deployment and a race against the clock. Drug developers and consultants that facilitate their path to regulatory filing must execute robust CMC development strategies while simultaneously assembling documentation that will hold up to the scrutiny of jurisdictional regulatory authorities.
As most CMC consultants are fully aware, consultants and service providers alike should jointly operate in the client’s best interest. Rarely, the three-way relationship between the contract development and manufacturing organization (CDMO), the client organization is as complementary as it should be.
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In this webinar, the expert panel will discuss key considerations for CDMO selection to ensure a seamless integration of service provider and consultant, including process and data transparency, facility design and person-in-plant accommodations. They will also discuss how the Portable CMC® platform provides a focused, streamlined approach to CMC development and clinical manufacturing through modular work packages, structured documentation support and flexible workflows that align priorities in favor of client success.
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Register for this webinar today to gain critical insights into optimizing CMC development for biologics programs and ensuring successful IND and BLA submissions.
Speakers
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 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.
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Jesse McCool, PhD, CEO/Founder, Wheeler Bio
Jesse McCool is a seasoned leader in the biopharmaceutical development field with over a two decades of experience. Jesse co-founded Wheeler Bio in 2021, focusing on clinical-scale manufacturing, a testament to his commitment to advancing the industry.
Jess is a scientist by training, holding a PhD in Microbiology from the University of Massachusetts and completed his postdoctoral work at Darthmouth.
Message Presenter
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.
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Ali Siahpush, President & Owner, Pharmefex Consulting
Dr. Ali Siahpush has over 29 years of experience in cell therapy and biologics development and commercialization. Since founding Pharmefex in 2014, Dr. Siahpush has advised numerous cell and gene therapy clients on a vast array of CMC topics, including development, technology transfer, CMO selection, validation, comparability, regulatory submissions and interactions and CMC strategy.
Prior to creating Pharmefex, Dr. Siahpush was Vice President of Product Development and Manufacturing Science at Dendreon, a pioneer in cell therapy development and commercialization, where he was responsible for early- and late-stage product development and supported Dendreon’s commercial manufacturing for Provenge®.
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Dr. Siahpush also has hands-on experience in protein formulation and fill/finish, lyophilization, downstream development, protein derivatization, quality investigations, NC/CAPA’s and risk analysis. He has presided over transfer, validation and approval of numerous products both within and outside of the contiguous United States. He holds a PhD in Biochemical Engineering from University of Michigan, Ann Arbor.
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Libby Russell, PhD, Vice President, Syner-G
Libby Russell brings over 20 years of experience in the bio/pharma industry with a focus on product and process development, commercialization and regulatory strategy.
Her work experiences in the biotech industry at Amgen, Inc. and Ophthotech had her leading product commercialization efforts overseeing analytical, tech transfer, validation, regulatory and process development activities. She has experience in working on a range of products and modalities for both drug substance and drug product GMP manufacturing, including monoclonal antibodies, oligomers, glyco-proteins and vaccines.
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Her additional responsibilities included process validation support, regulatory document authoring, technology transfer documentation and commercial support. Then, during her time at Ophthotech, she started up a contract analytical lab, Neva Analytics, where she now remains on the Board of Directors. She received her PhD in Chemical Engineering from the University of Colorado-Boulder by studying protein aggregation in cell culture.
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Stephen Monks, Principal, GSL CMC Consulting
Steve Monks leverages over 25 years of technical management experience at startup and mid-sized biotech companies to help navigate the development pathway for complex biologics within quality and regulatory frameworks.
He is a data-driven and hands-on professional with extensive expertise in CMC strategy and guiding projects seamlessly from research phases to formal development. He is skilled in all aspects of cGMP manufacturing, including warehousing and distribution, and can ensure compliance and efficiency at every stage.
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He has a broad background in a variety of product types, including autologous therapeutics, cellular products, recombinant therapeutics such as virus like particles (VLPs), bioconjugates, ADCs, heat shock proteins (HSPs), monoclonal antibodies (mAbs), scFvs and Fc fusions, as well as peptides, natural products and small molecule Intermediates/API. Read Less...
Who Should Attend?
This webinar will appeal to professionals with the following job titles or those in the following fields:
- Biopharma
- Biotech
- Pharmaceutical
- Drug development
- CDMO/CMO
- CMC/Regulatory Consultants
- CEO/COO/CSO
- Head of Program Outsourcing
What You Will Learn
Attendees will learn about:
- The fundamental misalignment between legacy CDMOs, CMC consultants and drug developers
- Methods CDMOs can utilize to ease the CMC development pathway
- Key considerations for CDMO selection to ensure a seamless integration of service provider and consultant
Xtalks Partner
Wheeler Bio
Wheeler Bio is a biomanufacturing pioneer founded by industry experts and strategic investors who believe a different CDMO model is needed for innovators to bring new therapeutic leads to the clinic faster, without the risk and cost associated with traditional outsourcing models. Our novel hub-and-spoke concept, centered in Oklahoma City with satellite labs embedded in discovery centers on the coasts, will revolutionize the translational path from discovery to CMC development and first-in-human. Wheeler’s pioneering, highly-accessible, open-source development platform – Portable CMC® – delivers speed to clinic and uniquely-affordable workflows by integrating discovery CROs and CDMOs. Portable CMC® is a suite-ready drug substance manufacturing platform that customers can transfer to any CDMO in the world with no royalties, licensing fees or penalties. By overlapping with the discovery workflow, Portable CMC® reduces timelines and regulatory risks through the introduction of QbD principles earlier in the drug development cycle, increasing the opportunity for clinical success.
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