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Nick brings over 30 years of experience in the pharmaceutical and biotechnology industry to his role as Managing Partner of Verta Life Sciences. He has helped numerous clients; develop, manufacture, register, launch and supply new products around the world. His expertise lies in manufacturing strategy and has been responsible for the annual supply of over $5 billion worth of pharmaceutical products globally.
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Ian leverages over 30 years of experience in the Pharmaceutical and Medical Device sector. With a proven track record in consulting for almost three decades, Ian has extensive knowledge in all areas of product development, manufacturing processes, business development and worldwide regulatory requirements that supports his focused insight and leadership for multi-disciplinary teams of Health Care Projects.
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Beth has over 30 years of experience in the pharmaceutical and biotechnology industry helping clients overcome challenges in the areas of business development, product launch, manufacturing supply chain optimization, strategic sourcing, and contract negotiation. Her 30 years in the industry has given her a deep knowledge of contract manufacturing offerings resulting in her ability to pinpoint the right manufacture for a client’s specific needs.
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Dr. Denis Boyle is an internationally recognized bioprocess expert with more than 30 years of experience in the development and validation of technologies to produce biopharmaceuticals. Denis has led protein therapeutic development teams for Pfizer and other companies spanning nearly 20 years, including 4 years leading the successful introduction of several validated GMP animal health vaccines.
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Sam has deep technical expertise in all aspects of upstream bioprocessing for monoclonal antibody and cell and gene therapy products. Sam has helped companies transition from research to development; established, validated, scaled up and technology transferred manufacturing processes; provided industry and technical insight to the development of business strategy.
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Doug has over 25 years of clinical and commerical biologics experience. He is worked at the world’s largest independent biotech company, with additional experience at CDMO operations, and consulting work. He has worked directly in multiple clinical and commercial bulk drug substance manufacturing facilities holding technical and management roles. Extensive experience in mammalian and microbial upstream and downstream processes, operations management, new product introductions, changeover, tech transfer, process scale-ups, manufacturing investigations andCAPAs, continuous improvement / lean manufacturing, FMEA / risk assessments, and change control.
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Leo is a global regulatory CMC expert with more than 30 years of experience leading teams of regulatory, development, and manufacturing staff as well as providing individual contributions at the senior level at several pharma companies. Leo's expertise ranges from strategic (developing regulatory strategies for product approval, market launch and supply continuity; leading global teams to author and submit more than 150 regulatory submissions); to reactive (directing regulatory activities for the in-licensing and divestment of multiple approved products; interfacing with regulatory bodies during inspections and for continuity of supply issues).
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Liz is an ex-MHRA assessor with has over 17 years experience in regulatory affairs for biological and biotechnological products. Before moving to consultancy, she was a Senior Pharmaceutical Assessor at the MHRA, where she assessed all types of biological products including monoclonal antibodies, peptides, vaccines, blood products and gene therapy products, presenting to CHMP and BWP at the EMA and to MHRA expert groups. Liz’s expertise in quality/CMC aspects of biological and biosimilar products for IND/CTA andBLA/MAA has resulted in the approval of multiple BLA/MAA applications, as well as clinical trials and line extensions/sBLA.
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Jim Zisek has nearly 30 years of CMC Regulatory expertise across both pre and post approval global CMC Regulatory Affairs. He is an experienced regulatory affairs professional with a long history of ensuring high scientific quality global CMC regulatory submissions and managing expectations of regulators. He has led company teams of scientists at pre-NDA and Scientific Advice meetings at both FDA and EMA, respectively, and has been directly involved in agency inspections at global company sites.
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John is a Regulatory Consultant with over 20 years of experience in achieving corporate objectives for a wide range of pharmaceutical companies around the globe. John’s expertise lies in assessing, developing and implementing successful regulatory strategies for regional or global development plans of innovative small molecule and biologic therapeutics. He has helped clients assess potential assets by conducting thorough due diligence reviews, providing innovative regulatory strategies that utilize expedited regulatory pathways, strategic guidance for correspondence with or meeting preparation for Health Authorities,
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Lauren is a Global CMC regulatory affairs consultant with over 10 years experience in biopharmaceutical industry. Lauren specializes in regulatory strategy, CMC change management, compliance gap analyses, and risk mitigation for small molecule and biologic drug products. She has experience authoringIND/NDA applications and post-approval variations for global health authorities and acting as a CMC representative in cross-functional meetings with project teams, contract manufacturing sites, and other key stakeholders.
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Su has over 20 years of experience in global CMC regulatory affairs and drug development and manufacturing. Her expertise lies in developing global regulatory CMC strategies in biologics, small molecules, gene therapyATMPs and combination products with successful submissions across development stages including BLA/NDA, MAA, IND and IMPD, post-approval supplements and other global submissions. She has extensive experience in developing regulatory strategies for challenging CMC situations and create high quality, compliantCMC regulatory documents. She has experience in therapeutical areas of oncology, immunology, CNS, chronic kidney disease and infectious disease.
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Joy has 26 years experience in Technical and Regulatory support for US, EU, China, and ROW. She brings a strong 10+ years CMC background from product research and development to manufacturing operations with an additional 16 years regulatory CMC biologics experience in mAbs, ADCs, biological products, and Cell Gene therapy products. Before moving to consultancy, Dr Gao was the Regulatory CMC Executive Director at Sanofi leading biological clinical programs, including development of regulatory CMC strategy for early phase Cell/Gene therapy pipeline projects and two Phase 3 program with Orphan/Breakthrough therapy designation.
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Rob is a Senior Consultant and Subject Matter Expert across several biological science domains, including development of molecular diagnostics, characterization of new and emerging threats, molecular virology and bacteriology, vaccinology, artificial intelligence& machine learning, and regulatory affairs. He consults to the Department of Defense, Biomedical Advanced Research and Development Authority, industry and academia for 15+ years.
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Andy’s primary expertise lies in the analytical development and testing of inhalation, dermatology, sterile and oral solid dosage products where he has over 29 years of experience developing products through early phase to commercialization. Andy has experience in developing metered dose inhalers, dry powder inhalers, semi solid topical products for the pharmaceutical andOTC markets in the US, Europe and emerging markets.
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Susan Long is a Senior Consultant and Senior Analytical Chemist in Pharmaceutical Methodology, Stability Program Design and Data Visualization with 30 years of experience in the CMC sector with GlaxoSmithKline, GlaxoWellcome, and Burroughs Wellcome Co. Susan is an expert in both ICH andEmerging Markets including market-specific CMC requirements for global markets. Her primary expertise lies in the analytical deliverables needed to support drug product registration in the US, EU, and EMAP markets.
Noreen is a pharmaceutical development consultant with over 30 years analytical testing and quality assurance experience. Noreen has led teams of scientists in QC testing support of R&D clinical trial manufacturing of drug substance and solid dosage, topical, biopharmaceutical and sterile formulations. Her extensive analytical sciences knowledge and experience with global regulatory requirements has led to a long history of approvals to progress new product formulations from clinical trial phase through successful commercial approval.
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Kirk’s expertise lies in pharmaceutical analytical chemistry. He has a track record of global project and organizational leadership in R&D, delivered during the course of a 30 year career at GSK. He has broad experience with a focus on Stability; Method Development, Validation and Transfer; and Laboratory management and Quality. leader with broad experience who delivers results with pragmatism, scientific acumen, and contextual awareness to support the development, registration, and launch of products.
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Jeff is a highly experienced product development scientist focusing on analytical CMC, and physical and structural characterization supporting both drug substance and drug product. Jeff’s expertise is in CMC analytical and physical and structural characterization of drug substances and drug products, supporting all phases of development including registration and commercialization. Jeff focuses on integrated approaches to complex development problems to provide a fundamental understanding to underpin robust CMC analytical control strategies.
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Graham is a Senior Consultant with30 years of pharmaceutical development experience in managing CMC early development and physicochemical characterizationAn experienced scientific leader with a proven track record for understanding and resolving complex technical issues throughout the product life-cycle for both drug substance and drug product including inhaled, semi-solid, liquid and solid dosage forms.
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Kailas has over 40 years of experience in pharmaceutical development. Kailas’s expertise lies in developing and validating appropriate in vitro methods for topical products. She has developed InVito Release Test (IVRT) for many of the products currently in the market.Kailas was the pioneer in developing the In vitro release test using first principles and with her experience with compendial methods, she set out to establish appropriate validation protocols.
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Wes has over 37 years of leading global analytical teams with a variety of biological product types. Wes have provided technical support to the introduction, analytical validation, technology transfer, and ongoing manufacture of several commercial biotechnology and natural products. Wes has led groups providing process, formulation, and protein characterization analytical support. Commercial biological products Wes has supported include proteins, oligonucleotides, heparin, vaccines, blood products, and antibody drug conjugates.
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Anh is a Senior Consultant with 30+years of delivering pharmaceutical products to market with global manufacturing leaders such as GlaxoSmithKline and virtual companies. Anh’s broad development experience includes the develop ability of drug candidates, drug delivery design for early clinical phase through marketed products, clinical supply manufacture, process development, scale-up, technology transfer, research alliances, development and manufacturing through CMOs, due diligence evaluations, and leadership/management of projects from candidate selection through commercial launch.
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David is a Senior Pharmaceutical Formulation and Process Development Consultant with 34+ years experience in development and commercialization of sterile injectables and oral solids with GlaxoSmithKline and Pfizer.He has developed novel formulations for NCE’s, managed product life cycles through line extensions and product improvements, extensive production support/troubleshooting experience and international project team leadership.
Ann has over 30 years experience within the pharmaceutical industry within larger pharma companies, smaller biotech’s and CDMO’s. Ann’s expertise lies in pharmaceutical development – analytical development and formulation selection, through process manufacturing strategy, outsourcing, new product introduction, technology transfer, and complex global program leadership. She has helped clients deliver clinical supplies, launch new products, establish internal systems, rationalize global analytical operations, and close out contracts.
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Kathy is a experienced Quality consultant skilled in Quality Assurance, Quality systems, Compliance, GMP manufacturing, compounding pharmacy, medical device, and continuous improvement. She has over 35 years of global technical and managerial experience in Pharmaceutical Production and Quality Assurance with a broad range of pharmaceutical products/dosage forms such as: solid dose; sterile products (lyophilized, terminally sterilized, and aseptically filled); APIs; medical devices; biological products; vaccines; and radio pharmaceuticals.
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Lydia is a Senior Quality Assurance professional with 30 years experience in the pharmaceutical industry. Lydia’s expertise lies in her ability to create Quality Management Systems in accordance with FDA and international health agency requirements. She brings leadership and expertise in resolving start-up and ongoing quality issues, as well as overseeing the quality systems. Lydia’s knowledge of start-to-end commercial manufacture and supply expanded through various managerial positions, including Microbiology, Analytical, supply chain, warehousing, and leading cross-functional project teams to transfer drug products, and Active Pharmaceutical Ingredients successfully.
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David has over 33 years of experience in the pharmaceutical industry with extensive experience in cGMP compliance related to the manufacture of Pharmaceutical products. This includes solid dose, aerosol, dermatological, liquid and encapsulated product types. His areas of expertise include Process/Product Validation, Quality oversight of Contract Manufacturers and cGMP compliance related to CAPA implementation and many other areas of pharmaceutical manufacture.
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Cynthia is a Quality professional with demonstrated experience in global GXP (GMP/GCP/GLP) regulated environments and management of FDA Consent Decree activities. She has over twenty years of quality/compliance expertise and management experience primarily in the Pharmaceutical and Biotech industry. Experience includes quality assurance (GMP - FDA 210, 211, 820, Part 4; ISO 13485; ICH Q7-11 and EU Requirements; GCP – FDA 312,50, 54-56, ICH E6 (R2); GLP – FDA 58), regulatory compliance/labeling, project management, clinical & commercial manufacturing, third-party contract manufacturing, team building & leadership, & training & development.
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Karen is a highly experienced pharmaceutical consultant with domestic and international expertise in the areas of manufacturing, packaging, logistics, project management and contract negotiation. Her expertise lies in product outsourcing, manufacturing/packaging transfers, new product introductions, supply chain management and contract negotiations. She has been a project team leader for product launches and technical transfers for pharmaceutical products marketed globally.
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Andy is a senior Pharma/Biopharma Operations Professional with 30+ years experience in leading pharmaceutical manufacturing sites, capital programmes, business transformation, manufacturing strategy and new product acquisition due diligence. Andy thrives in leading cross functional teams involving Commercial, R&D, Manufacturing and Corporate functions, utilising a collaborative and inclusive leadership style. He demonstrates the ability to ‘join the dots’ from development of strategic options, preparation of business cases, securing endorsement from C-Suite Stakeholders through to implementing the full business transformation.
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Laura is a project management consultant with a strong background in successfully coordinating large and small project teams and overseeing the launch and operation of pharmaceutical and biotech products. She has experience managing projects, ensuring they were effectively planned, executed, and monitored according to established timelines and deliverables. She has provided Project Management for CMC development and manufacturing activities for a potential COVID-19 treatment, including drug substance development, drug product manufacturing, and packaging at seven CMOs around the world.
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Russell is a Business Development and Procurement leader with a wealth of experience in developing contract manufacturing pipelines and sourcing multiple direct and indirect categories. He has gained extensive experience in pharmaceutical B2B sales. He has also been instrumental in delivering robust sourcing strategies on a global level. He has developed and implemented commercial strategies as well as launched and delivered multiple outsourcing strategic programs to support the profitability of multiple organizations including, GSK, Abbott and a stand alone CDMO, Avara Pharmaceuticals.
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Ken have over 30 years of experience in Business Development, Strategy, B2B Sales,Global Planning and Technical. Kens’ expertise lies in BusinessDevelopment Transactions (Acquisitions', Divestments, Licensing and DueDiligence) , Network Strategy & Sourcing (setting up and optimizing existing Supply Chains), Supply Chain Operations (Operational Excellence, Leadership and Coaching) and B2B sales (Strategy, Marketing, Contracting and Key AccountManagement). He has helped launch new products, rationalize global manufacturing operations, close and sell manufacturing facilities.
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Betty is a experienced Pharmaceutical Supply Chain expert with over 35 years of experience in the supply chain in business. Betty brings experience across the supply chain including direct and indirect procurement, distribution and logistics. She has a proven track record in delivering benefits in terms of cost savings and improved processes through collaboration and use of lean tools and practices.
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Mike has over 40 years experience working across all aspects of the supply chain. He has successfully delivered global projects in trade compliance, end to end supply chain, import / export control towers, broker management and shared service operations. Mike has led the strategic design of global supply chain and trade compliance solutions; draws on deep expertise in global trade management, compliance, production planning, distribution planning, S&OP development, sales forecasting and international trade.
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George has over 30 years of success in building and running supply chain organizations across a range of industries. He has built a broad supply chain expertise by developing and leading a variety of operational teams and global organizations, building supply chain networks, executing new product introductions, mergers, acquisitions and divestment and ERP implementations. He has delivered +50 new product launches globally supporting over $5.5B in sales growth for both large and small pharma companies.
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Jim is a Packaging Consultant with 40 years of delivering results globally supporting pharmaceuticals, OTC’s &biologic projects. He has extensive knowledge of packaging materials, processes, graphics development, and standardization. This includes sustainable packaging design, cost savings, ant-counterfeiting strategies and process improvements. His expertise lies in packaging engineering including the design, development, and qualification of all types of primary and secondary packaging components. This expertise also includes supporting manufacturing start-ups, new product introduction, technology transfer, and technical problem-solving.
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Diana is a Graphic Designer specializing in logo and packaging development for pharmaceutical products. She has over 25 years of experience in packaging design and print development for pharmaceutical products. A solution-driven, customer-focused team member with a broad understanding of pharmaceutical packaging requirements, she has managed project timelines, communications, and resources from inception through launch.
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Ian is a Senior Consultant having worked in Pharmaceutical, Healthcare and Pharmaceutical Consultancy Organizations. He is a proactive leader that will utilize extensive technical expertise and LEAN principals to reduce process and procedural complexities that will result is higher quality and more affordable medicines. This has involved training, writing key policy protocols to realize compliant process validation, sampling strategies and annual product reviews.
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Martin is a seasoned CMC leader and innovator for conception, realization of small molecule drug development strategies and registration of drug candidates. Martin’s’ expertise is focused on the development and implementation of short-, mid-, and long-range small molecule drug product development strategies that ensure scientific best practices in the understanding and overall scope/vision of registering and approval of a drug candidate. He has provided development strategy for both small molecule assets including driving decisions on intravenous drug product development for a diabetes drug candidate.
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Ravinder is an experienced synthetic organic chemist with over 23 years of experience in process research & development in API drug substance manufacture. He has a proven track record of originating synthetic ideas, developing and successful implementation of synthetic processes to API manufacture from pre-clinical to commercial supplies. Ravinder has extensive experience in working with the most of API CROs and CMOs in Asia, Europe and US. His experience covers the identification and development of synthetic routes for rapid scale-up for laboratory-based manufacture of API for clinical supplies, and development of cost-effective final manufacturing processes, and through validation of processes in commercial manufacturing equipment.
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John is a Drug Discovery andMedicinal Chemistry Consultant with over 30 years of preclinical therapeutics discovery in large pharma and small biotech John’s experience and expertise lies primarily in medicinal chemistry and small-molecule drug discovery. He is a chemistry and discovery operations leader across multiple therapeutic areas with >25 years of experience managing teams of scientists of widely varying professional levels and experience, and extensive experience directing CRO research. He brings experience with overall site management and building up groups. John’s medicinal chemistry expertise extends from early lead discovery to clinical drug candidate development.