Lead Partner

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Precision Medicine Group has brought together targeted expertise that can propel drug development and access. We apply relevant insights and specialized capabilities to unlock the potential of data—accelerating drug development, advancing manufacturing, and elevating engagement to deliver commercial success.

Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focuses on the complexities of clinical, regulatory, manufacturing and commercial needs to successfully bring a cell or gene therapy to market.

Expertise Partners

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BIA Separations

BIA Separations, a Sartorius company, develops and manufactures market-leading CIM® monolithic chromatographic columns for purification and analysis of large biomolecules, such as viruses, plasmids and mRNA, which are applied in cell and gene therapies.  BIA's technology for manufacturing-scale purification is already used in production of the first commercialized advanced therapeutics; BIA also has a keen presence with novel drug candidates in the clinical pipeline.  Expecting continued strong double-digit sales growth over the next few years, BIA earned sales revenue approx. 25 million Euros in 2020, contributing to Sartorius Bioprocess Solutions, part of the Sartorius Group.

www.biaseparations.com

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Azzur Group

Azzur Group partners with leading pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that help them start, scale, and sustain their GxP organizations. With experts at more than 15 locations throughout the United States, we take pride in our development and execution of phase-appropriate quality and compliance services to our clients From Discovery To DeliveryTM. Learn more at Azzur.com.

www.azzur.com

Andelyn

Andelyn Biosciences

www.andelynbio.com

Program Partners

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Precision for Medicine

Precision for Medicine is the first full-service, global clinical research organization purpose-built to accelerate precision medicine research and development. Our expertise in rare and orphan diseases includes 150+ projects in 80+ diseases. Precision converges the power of clinical operations excellence, deep laboratory expertise, and advanced data sciences to maximize insight into patient biology, deliver more predictable trial outcomes and speed clinical development.

Our gene therapy expertise is mobilized through Precision ADVANCE, a collection of interconnected services and complementary teams uniquely focused on the complexities of the clinical, regulatory, manufacturing and commercial requirements to successfully bring a gene therapy to market. With over 2100 people and 35 offices worldwide, we stand ready to help accelerate your life-changing treatments anywhere around the globe.

www.precisionformedicine.com

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Thermo Fisher Scientific

Thermo Fisher Scientific provides industry-leading solutions for drug development, clinical trial logistics and commercial manufacturing to customers through our Patheon brand. Our Patheon Viral Vector Services business (formerly Brammer Bio) specializes in CDMO services for companies developing gene-modified cell therapies and in vivo gene therapies.Our key offerings include process and analytical development, clinical and commercial supply of viral vector drug substance and drug product, and regulatory support, enabling our clients to bring novel medicines to market.We are flexible to support every client’s unique product needs, timelines and regulatory pathways. Through recent investments in our world-class facilities and planned expansions, we are strategically positioned to support your immediate and long-term viral vector manufacturing needs.

www.patheon.com/viral-vector-services/

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Cytovance Biologics

Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule APIs from both mammalian cell culture and microbial fermentation such as monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines and other biological products including plasmid DNA and cell-based therapeutics. In addition to our clinical and commercial cGMP API manufacturing services, Cytovance offers well integrated development services supporting the entire product lifecycle including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization.  A centralized, responsive program management team coordinates all critical CMC activities for each client program around raw materials management, QC testing, ICH stability studies, and regulatory support.  Our 140,000 sq. ft. state-of-the-art facilities in Oklahoma City are designed to meet U.S., EU, and other global regulatory standards.

www.cytovance.com

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Mix Talent 

Mix Talent is a talent acquisition and consulting firm that specializes in pharmaceutical, biotech and gene therapy. We partner with companies to plan for, identify, assess, and recruit the talent they need to make their business successful.

At Mix, we believe culture is the key to securing top talent and top talent is the key to building and growing a truly magnetic culture. And we know this is especially important for companies focused on rare disorders where the patient population is small and the stakes are high.

We will help to bring your company’s mission and story to life, and then find the right candidates who will make your story stronger. Our experience, knowledge, and network with R&D, clinical, and commercial hires help our clients go beyond hiring just headcount to truly creating dynamic organizations.

www.mix-talent.com

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ICON plc

www.iconplc.com

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Optum Frontier Therapies

Creating access to therapies at the frontier of health care, Optum Frontier Therapies reimagines the specialty pharmacy experience by delivering one-stop distribution, tailored services, and data-backed clinical care and research. Our offerings ensure holistic impact for patients and their families, and support commercialization for manufacturing partners – from expertise in deep cold chain to wholesale distribution. As an independent business leveraging the best of Optum, our team is dedicated to building new models for advanced therapeutics.

www.frontiertherapies.optum.com

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Veristat

Veristat is a CRO with a focus in accelerating clients’ rare disease therapies for unmet medical needs through the clinical development process. We've worked on more than 300 rare disease clinical projects and have prepared over 35 rare disease regulatory submissions. With experience in running trials for the first gene therapy approved in Europe, and over 20 gene therapy trials, Veristat is adept in providing comprehensive solutions for Advanced Therapies.

www.veristat.com/therapeutic-expertise/rare-diseases

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Halo Labs 

Halo Labs knows stability and particles. The Aura, our flagship product, can count and characterize subvisible particles - and tell you whether they are aggregated viral capsid, or external contaminants.  A simple, plate-based approach enables low-volume (5µL), high-throughput, fully automated particle imaging and analysis at any stage from developability assessment through quality control.

www.halolabs.com

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The Discovery Labs 

The Discovery Labs is located in the heart of the Cellicon Valley, where cell and gene therapy was invented. Our end-to-end service offering includes contract development and manufacturing services through the Center for Breakthrough Medicines and life science real estate at Innovation 411 and Innovation Renaissance, together a 1.6 million square foot campus consisting of 28 buildings on over 300 acres. Our biotech hub in King of Prussia is home to world-renowned life science institutions. With the capability of adding up to 4 million square feet of expansion space, we can accommodate companies from startup to large enterprise and enormous future flexibility to grow in place.

www.thediscoverylabs.com

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Certara

Certara accelerates medicines to patients using biosimulation software and technology to transform traditional drug discovery and development. Its clients include 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries.  Our unique and regulatory-ready models for immunogenicity, immune-oncology, rare disease, vaccines and gene therapy are used by major pharmaceutical and emerging biotech companies.

www.certara.com

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Parexel

www.parexel.com

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Polyplus Transfection

Polyplus-transfection applies its 15+ year expertise to the development of novel transfection solutions up to GMP grade for high yield transient protein and antibody production in CHO and HEK-293 cells, as well as for viral vector production for Gene and Cell Therapy (PEIpro product range).

www.polyplus-transfection.com

Panel Partners

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FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is an industry leading cGMP Contract Development and Manufacturing Organization supporting our partners in the biopharmaceutical industry with the development and production of their biologic, vaccines and gene therapies.

www.fujifilmdiosynth.com 

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Deallus

Deallus is a unique strategic intelligence consultancy operating across the global life sciences sector. Our mission is simple: to prepare you for the future by delivering the forward-thinking assurance you need in an uncertain and highly competitive world. The knowledge and clarity we provide helps life sciences companies shape future markets by making the right strategic decisions with confidence.

www.deallus.com

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AGC Biologics

AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial production, using mammalian and microbial production systems.

Our integrated service offerings include cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression — including our proprietary CHEF1® Expression System for efficient protein production with CHO cells.

Our company DNA drives us to provide innovative solutions for clients to reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle.

We forge exceptionally strong partnerships with our clients and we never lose sight of our commitment to deliver reliable and compliant drug substance. Right. On Time.

www.agcbio.com

Exhibition Partners

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VGXI

VGXI, Inc. is a leading plasmid DNA CDMO with nearly 20 years of experience providing exceptional quality products to clinical trials worldwide. The company's continuous, low-shear AIRMIX® lysis technology and optimized purification process provide highly supercoiled plasmid with exceptional purity across all manufacturing scales. Production services include high purity plasmid for preclinical research, Highly Documented (HD) plasmid for GMP viral vector production or pharm/tox studies, and cGMP plasmid DNA for clinical through commercial supply.

www.vgxii.com

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Trinity

Originally founded in 1996 as Trinity Partners, Trinity has since grown to comprise a global team of advisors, technical experts, data integrators, and technology innovators. Our track record of consistent growth for over two decades has been fueled by our commitment to our clients, our passion for the life sciences, and our depth of expertise in the industry. Since the beginning, we have been evidence-forward in all our analyses and recommendations, focused on quality and accuracy first and foremost. Today, having leveraged our thoughtful approach and dedication into a global organization, we have the client footprint, deep experience, and technology solutions to have a powerful impact on our clients’ business, and on the industry.

Trinity’s approach is focused on our foundation of three: advisory services, insights & analytics, and technology. By seamlessly integrating each of these solutions, we can meet the distinct needs of both emerging biotech firms and established pharmaceutical companies. We can provide comprehensive end-to-end analytical and strategic support to early-stage companies as well as tools and solutions for larger, more established life sciences clients. Our deep industry expertise, powerful tools, and focus on evidence-based insights have enabled us to drive commercialization forward for some of the most innovative therapies and devices in the industry.

www.trinitylifesciences.com

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Emotive Agency

emotive is multi-award winning, global healthcare communications agency with offices across the EU and US. Our highly skilled, experienced team is already a trusted partner for many leading biopharma companies in ATMP and rare disorders in the pre, peri and post launch stages of the product lifecycle.

We use our strategic scientific, creative and technical expertise to engage with HCPs, those living with a disorder and other stakeholders in the care pathway to stimulate advocacy and uptake of novel and innovative products.

www.thinkemotive.com

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Premier Research

Premier Research, a clinical research company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.

As a global company, Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Whether it's developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions.

www.premier-research.com

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Delphi Genetics

Delphi Genetics is a private biotech company with proven track record in genetic engineering and bioproduction. The company provides one-stop-shop service from development to GMP manufacturing of plasmid DNA for Cell & Gene Therapy applications, with a focus on DNA for viral vectors. Delphi Genetics has developed an innovative antibiotic-free technology (Staby®). Staby technology meets regulatory guidelines and drives a better plasmid DNA stabilization, and has been non-exclusively licensed to several big pharmaceutical companies.

www.delphigenetics.com

Diamond Pharma Services

Diamond Pharma Services

Diamond are a leading European technical and regulatory affairs consultancy with extensive experience in the development of advanced therapies including supporting the development & marketing authorisation for both the first gene therapy (Glybera) and CAR-T (Yescarta) to be approved in Europe. Overall we have supported more than 40 gene, and gene modified cell therapy programmes. Our specialised team has broad and varied industry experience offering both breadth and depth of expertise, from which our clients can benefit. Diamond offers a comprehensive service including regulatory affairs, product development (nonclinical, CMC and clinical), pharmacovigilance and quality & compliance.

www.diamondpharmaservices.com