Lonza

Lonza

Lead Partner

We want to be your partner and drive pioneering therapies to the market. We invest in enabling technologies and build expertise to support the development and commercialization of your new innovative therapy. Our scientists and engineers bring decade-long development experience across a broad spectrum of cell types and technologies. This builds the backbone of an extensive service offering, providing you with tailored process and analytical development, manufacturing and regulatory services.

www.pharma.lonza.com

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Covance

Expertise Partner

Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp) headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®. Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions.

www.covance.com

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BIA Separations

Expertise Partner

BIA Separations has 20 years’ experience in chromatographic purification. Our products, CIM monoliths, were designed with unique operating properties that make them ideally suited to the challenging requirements of purifying biomolecules such as virus particles, vesicles, proteins, RNA’s, plasmids and other forms of DNA. We provide products that range from small analytical columns to large industrial prep-scale columns (including cGMP and disposable units) as well as method development services.

www.biaseparations.com

Project Farma

Project Farma

Program Partner

Project Farma is an industry leader in providing project management, validation, engineering and consulting services with a proven track record in gene and cell therapy. We partner with cell and gene therapy organizations in addition to healthcare, pharmaceutical, bio-pharmaceutical companies to support finding ground-breaking treatments and solutions. Our clients include startups, small and large pharmaceutical and biotech companies and CMOs/ CROs. We are committed to helping advance cuttingedge medicines by leveraging our deep knowledge and broad experience in cell and gene therapy to meet any new challenges. With over 200 employees, our business infrastructure enables robust scalability to ensure that the proper resources are available to support the project.

www.projectfarma.com

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Thermo Fisher Scientific

Program Partner

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.thermofisher.com

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Polyplus Transfection

Program Partner

Polyplus-transfection applies its 18+ year expertise to the development of novel transfection solutions. Polyplus-transfection is the leading supplier of a key critical component for viral vectors manufacturing for Gene & Cell Therapy. We are proud to provide qualified and GMP-grade transfection reagents suitable from R&D to clinical trial and commercial scale, accompanied by a strong scientific and regulatory support. In addition, we provide a range of effective transfection reagents to deliver most nucleic acids, including DNA and siRNA in vitro and in vivo.

www.polyplus-transfection.com

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CareMetx

Program Partner

Patients First – it’s in our DNA. At CareMetx, we fight for every patient “from intake to outcomes” by providing Hub/reimbursement services, leading-class technology and strategic consulting to accelerate access to lifesaving treatments. Speed and efficiency – is why we’re different. CareMetx leverages our expertise and innovative patient eAccess technology to revolutionize the patient experience. We partner with our clients to launch or transition pharmaceutical programs in record time with significant cost savings.

www.caremetx.com

Trinity Partners

Trinity

Program Partner

Trinity is a global life sciences strategy consulting company. We partner with leading pharmaceutical, biotech, and medical device / diagnostic companies to provide best-in-class strategic support and evidencebased insights. Our support spans the lifecycle of development from early stage pipeline assets to life cycle management across a diverse type of business questions. Trinity’s experience touches all types of markets, with orphan/rare diseases being one of our top markets of focus. Our expertise in gene and cell therapy is driven by our commercial understanding of the markets and our scientific background, coupled with deep experience supporting many clients at the forefront of these therapies.

www.trinitylifesciences.com

invitae

Invitae

Program Partner

Invitae Corporation (NYSE: NVTA) is a leading medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices.

www.invitae.com/partners

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Bio-Rad

Program Partner

Bio-Rad designs, manufactures, and distributes a broad range of innovative tools and services to the life science research and clinical diagnostics markets. Founded in 1952, Bio-Rad has a global team of more than 7,750 employees and serves more than 100,000 research and industry customers worldwide through the company’s global network of operations.

www.bio-rad.com

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MilliporeSigma

Program Partner

MilliporeSigma, a life science leader, is a business of Merck KGaA, Darmstadt, Germany is skilled in the art of GMP viral vector production and technology innovation, having manufactured viral vectors for over 20 years and producing more than 500 lots of drug substance from preclinical through commercial production. Our comprehensive portfolio of best-in-class bioprocessing products and technologies combined with our application expertise can help you quickly scale up to reach your process goals.

www.milliporesigma.com

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PRA Health Sciences

Program Partner

PRA Health Sciences delivers innovative drug development solutions that improve patients’ lives. Our people are passionate about clinical research, working tirelessly to provide quality results. We offer exceptional experience across all phases and therapeutic areas and a broad spectrum of solutions, ranging from full-service clinical development to a pioneering embedded model.

With 16,000+ employees covering 90+ countries, we bolster an impressive global presence with keen local insights. Our project teams harness their understanding of local regulations, standards of care and cultural customs to effectively align our approaches with each study’s unique goals.

At PRA, we love what do because we are making a difference in the lives of patients and their family members worldwide. Over the years, we have contributed to the development of numerous drugs now available to countless patients. From our scientific and medical experts to therapeutically aligned project managers and monitors, we provide the commitment and expertise needed for today’s complex studies.

www.prahs.com  

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Pall Biotech

Program Partner

Pall supports clients discovering, developing and producing pharmaceuticals, vaccines, cell and gene therapy products. Pall is the leading provider of bioprocessing, integrated automated systems and single-use solutions - from suspension and adherent cell bioreactors, through downstream purification, to formulation and filling. Process and product contract development services from cell culture through purification are offered, with extensive expertise in viral vector product development.

www.biotech.pall.com

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The Jackson Laboratory

Program Partner

The Jackson Laboratory is the definitive resource for uncovering the genetic and molecular causes of genetic diseases. With ever-increasing precision, JAX® Mice, Clinical & Research Services provides the most innovative and unparalleled mouse models and research services, supporting the transition from discovery to application, resulting in individualized treatments and therapies.

www.jax.org

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Veristat

Program Partner

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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MolMed

Hosting Partner

MolMed is a biotech company focused on innovative cell and gene therapies that can meet the therapeutic needs in the treatment of tumors and rare diseases, by combining scientific and research excellence with clear and strong industrial projects. With two approved manufacturing facilities (about 4.800 SQM) and top level expertise, MolMed offers platforms of lentiviral and retroviral vector manufacturing with different scales and a consolidated processes in cells engineering (Hematopoietic Stem cells and T-cells).

www.molmed.com

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Repligen

Hosting Partner

Inspiring advances in bioprocessing, Repligen is a technology leader in bioprocess filtration, pre-packed chromatography and Protein A ligands development. Propelled by a culture of innovation and collaboration, and with a focus on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide.  Named one of the fastest growing biotech companies in the USA, Repligen is headquartered in Boston, MA with major manufacturing sites in Massachusetts, California, Sweden, and Germany.

www.repligen.com

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Fujifilm Diosynth

Panel Partner

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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VGXI

Exhibition Partner

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

Beacon Hill

Beacon Hill Pharma

Exhibition Partner

Beacon Hill Pharma, Beacon Hill’s Life Sciences specialty division, partners with Gene Therapy, Pharmaceutical, Biotech, Medical Device, Diagnostics, Clinical Research Outsourcing, and other corporations delivering the most qualified Life Sciences resourcing solutions in the market today. Committed to identifying and delivering qualified candidates that fit your objectives and company culture, we place Life Sciences contractors in all 50 states, seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharma’s National Recruiting & Delivery.

www.beaconhillgenetherapy.com

Vigene

Vigene Biosciences

Exhibition Partner

Vigene Biosciences’ mission is to Make Gene Therapy Affordable. Headquartered in Rockville, MD, Vigene offers FDA and EMA compliant cGMP production for AAV, lentivirus, adenovirus. With a proven record of cGMP grade AAV, lentivirus and adenovirus production, Vigene is combining the proven production technologies with rigorous regulatory compliant cGMP production to meet the needs and expectations of clinical material clients. Globally Vigene is proud to serve over 1000 academic, biotech and pharmaceutical labs.

www.vigenebio.com

RHO

Rho

Exhibition Partner

Rho, a contract research organization (CRO) located in Chapel Hill, NC, provides a full range of services across the entire drug development process. For more than 30 years, Rho has been a trusted partner to leading pharmaceutical, biotechnology, and medical device companies as well as academic and government organizations. Our commitment to excellence, innovative technologies, and therapeutic expertise accelerate time to market, maximize returns on investment, and lead to an exceptional customer experience.

www.rhoworld.com

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QPS

Exhibition Partner

QPS is a global, science driven, customer-focused CRO that provides preclinical studies and clinical trials to the biotech and pharmaceutical industries. Our 1100+ person organization has expertise in nearly all drug modalities including small molecules, proteins, and other biotherapeutics. We have supported gene therapy since 2002: ASOs, siRNAs, miRNA through mRNAs and viral vectors. Our bioanalytical technologies include LC-HRMS, hybridization-LC, and qPCR; while our full spectrum DMPK services covers PK, DDI, biodistribution, and radiolabel studies.

www.qps.com

Paragon Bioservices

Paragaon Bioservices

Exhibition Partner

Paragon Gene Therapy, a unit of Catalent Biologics, is an industry leader focusing on transformative technologies, including adeno-associated virus (AAV) gene therapies, next-generation vaccines, and oncology immunotherapies. Paragon Gene Therapy has five facilities across Maryland dedicated to process development through commercial manufacturing of most scalable AAV platforms across multiple serotypes. Since 2016, Paragon Gene Therapy has completed over 100 clinical GMP AAV batches across 60 programs.

www.paragonbioservices.com

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AnovoRx

Exhibition Partner

An independent pharmacy and services provider, Anovo is dedicated to rare disease therapies and the people who rely upon them. Anovo provides specialty pharmacy, Hub, 3PL/Title model and distribution services all under one roof.
Therapy-dedicated teams offer reimbursement support, therapy education, and delivery services to enable quick, convenient and courteous access to therapy along with a positive therapy journey.
Our success is due to the time we invest in listening and collaborating with our manufacturer partners to develop custom programs that align with your goals and patient needs.

www.anovorx.com

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Delphi Genetics

Exhibition Partner

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

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Ology Bio

Exhibition Partner

Ology Bioservices, Inc. (Ology Bio) is a biologics-focused CDMO serving both government and commercial clients from its three US locations: Alachua, FL; Alameda, CA; & Frederick, MD. Ology Bio’s capabilities include cell & virus banking, process development/optimization, cGMP manufacturing, analytical & bioanalytical development and testing, and full regulatory support of antibodies, cell & gene therapies, proteins, and viral vaccines. Ology Bio provides expertise from preclinical stage through FDA licensure, and offers licensing of proprietary cell lines.

www.ologybio.com

cytovance

Cytovance Biologics

Exhibition Partner

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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Premier Research

Exhibition Partner

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

emotive

emotive

Exhibition Partner

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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PerkinElmer Genomics

Exhibition Partner

PerkinElmer Genomics is a clinical molecular and biochemical laboratory offering an unmatched continuum of screening and diagnostic testing options, from newborn screening to whole genome sequencing. Our lab leverages PerkinElmer’s work-flow solutions to create unmatched efficiency and sustainability, enabling us to accelerate report delivery and increase affordability, empowering clinicians to utilize genetic testing earlier in the diagnostic process. Our team of experts takes pride in turning complexity into meaning.

www.perkinelmergenomics.com

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Biocair

Exhibition Partner

Biocair is a global specialist courier with over 30 years of dedicated experience in the pharmaceutical, biotechnology and life science sectors. Biocair focuses on providing the most comprehensive time-sensitive and temperature-controlled logistics services available whilst delivering flexible, tailored, cost effective solutions to all clients. The Biocair network spans more than 850 locations in over 160 countries across Europe, Africa, Asia and the Americas.

www.biocair.com  

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DPS

Exhibition Partner

DPS is a global, 45+-year-old, full-service engineering firm with      in-house CM and CQV expertise, offered in an EPCMV model or in part, to meet client preferences. With a core business focus in the Life Sciences sector, DPS has 1,900+ highly specialized personnel worldwide that design and engineer sophisticated facilities to the highest safety standards. Our reputation of delivering innovative designs, cost-effective solutions, sound judgment, strong management, and technical excellence, results in 85% repeat client business.

www.dpsgroupglobal.com

  

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PSI

Exhibition Partner

PSI is a privately-owned, full-service clinical research organization (CRO) operating globally. PSI’s global reach supports clinical trials across multiple countries and continents, and is known to be highly selective about the work that they pursue. With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers and its employees.

www.psi-cro.com

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Vironova

Exhibition Partner

Vironova is a Swedish biotechnology company providing comprehensive, hardware, software, and services for the analysis of nanoparticles. Vironova revolutionizes access to transmission electron microscopy–based image analysis in biopharmaceutical development. Our solution enables automated analyses for faster and better informed decisions to secure robust bioprocessing and final product quality.

www.vironova.com

PPD Biotech

PPD Biotech

Exhibition Partner

PPD® Biotech is devoted to finding the right Phase I-IV clinical development solutions for biotech and small to midsize pharma. With dedicated teams, PPD Biotech combines the global resource scalability and full-service offerings of PPD with personal attention, flexibility and a shared mindset that enables us to find the optimal solutions for your study, no matter the size.

www.ppdi.com/Services/PPD-Biotech

Diamond Pharma Services

Diamond Pharma Services

Exhibition Partner

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