This is a list of consultants serving the cell therapy and regenerative medicine sector. The list is hosted by the Cell Therapy Group (www.celltherapygroup.com). For questions or to be added to this list contact Lee Buckler @ celltherapygroup.
Consultants in the Cell Therapy Sector Company Advanced Cell & Gene Therapy LLC Strength(s) Consulting in Cell, Gene & Tissue Therapies Services Principal or Contact Email firstname.lastname@example.org; email@example.com Website www.ac-gt.com Practical, experienced guidance in development, GMP/GTP Scott Burger or manufacturing, and regulatory compliance, as well as comprehensive Karen Edward scientific and technical strategic analysis of business opportunities in cell therapy, gene therapy and tissue therapies. These living biological therapies offer unprecedented opportunities, but are complicated by unique challenges in development and commercialization. ADVANCED CELL & GENE THERAPY provides assistance in key problem areas, including: * Evolving regulatory requirements * Commercialization strategy * Product and process definition * Biomaterials sourcing and control * Clinical-scale process development * product research and development strategy, planning, execution and management * product manufacturer selection and contract placement * pre-clinical toxicology and/or biodistribution study design and placement * clinical product development including programme design and placement * regulatory strategy including advice on regulatory authority meetings, clinical trial applications, orphan drug and fast-track applications * marketing authorisation applications including the writing of clinical expert reports and overviews * due diligence for licensing and investment purposes Alan Boyd Alan Boyd Consultants Ltd consultancy in relation to research and development projects for small to medium sized and large biotech, pharmaceutical, medical device and diagnostic companies alan.boyd@boydconsulta nts.com www.boydconsultants.com Biologics Consulting Group Regulatory consulting BCG consultants have extensive academic, industry and FDA Jim Kenimer experience in the areas of cellular therapy, tissue products, gene therapy and tissue engineering. This includes preclinical, clinical and product specific expertise with both biologic products and combination (biologic/medical device) products. Andra Miller, Ph.D. Cell & Gene Therapy Products Darin Weber, Ph.D. Cell, Tissue and Combination Products Ellen Areman, M.S., SBB Cell Therapy Product, Cord-Blood Banking, & Cell- Processing Devices Maritza McIntyre, Ph.D. Cell and Gene Therapy Products Stephen Litwin, M.D. Clinical Expertise – CTGT products for cancer and stem cell therapy Wilson Bryan, M.D. Clinical Expertise – CTGT products for neurological indications John Jessop, Ph.D. Preclinical experience with CTGT products David Pepperl, Ph.D. Preclinical experience with CTGT products Melanie Hartsough, Ph.D. Preclinical experience with CTGT products Stuart Portnoy, M.D. Combination Products (CTGT products + device) Angela Blackwell, M.S. Combination Products (CTGT products + device) firstname.lastname@example.org www.biologicsconsulting.com Bionest Partners Healthcare advisory services Consulting in operational, strategic, and financial solutions tailored for Nipon Das healthcare industries and financial institutions email@example.com www.bionest.com www.celltherapygroup.com 1 Consultants in the Cell Therapy Sector Principal or Contact Eric Atkinson Company Strength(s) Services Consulting services for cellular therapy and stem cell industry, including: * Commercialization strategy and business plan assistance and evaluation * Licensing and partnering strategy * Technology transfer * In/out licensing of IP * Distribution and OEM strategy and execution * Product and technology opportunity identification and evaluation * Assistance with due diligence of in-licensing opportunities * Contract drafting and negotiation * Identification, evaluation and/or management of outsourcing partners * Start-up and interim management * North American representation for foreign entities * Corporate and marketing communications Email eric.atkinson@broadreach bio.com Website www.broadreachbio.com BroadReach BioSystems, Commercialization strategy and assessment. Inc. Technology evaluation. Licensing and contract negotiation. Business development. Capgemeni International, large (strong esp in Germany) Commercial consulting & project management Ralf Emmerich ralf.emmerich@capgemini .com firstname.lastname@example.org www.gapgemini.com Carpenter Group Embryonic and adult stem cell research and preclinical development Experienced guidance in research and development strategies for stem cell therapies and drug discovery products, including: * Technical expertise in stem cell culture and differentiation * Evaluation of primary research data * Translation of research projects to preclinical development * Preclinical program design * Development of regulatory strategies Melissa Carpenter n/a [the] Cell Therapy Group Business consulting for the cell therapy and regenerative medicine industry Marketing, Communications, Business Development, Sales, R. Lee Buckler Advertising, Market Research & Analysis, Operations (soft-side - e.g., budgeting, IM, recruitment, human resources, intranets, employee evaluations), Business Plans, Financing Strategies, Project Management, Legal Affairs, Outsourcing Selection & Management lbuckler@celltherapygrou p.com www.celltherapygroup.com Compliance Consulting Quality assurance, compliance, and programs Lizabeth J. Cardwell DCi focuses exclusively on the commercialization of cell, gene and Dawn Driscoll tissue therapies, bringing global expertise and specificity to every project. Our custom services include: Business Strategy, Planning, & Implementation, Primary Market Research, Advisory Boards, Market, Sales & Manufacturing Capacity Forecasting, Financing & Development, and Project Management. Our Focus and Our Services - What DFM, Ltd. Can Do for You * Creating New Pathways For Growth * Penetrating / Creating New Markets * Aligning Commercial Activities with the Market * Balancing Risk, Value and Opportunity * Creating Medically Informed Market Assessments * Improving Sales Force Efficiency and Effectiveness * Unsticking Product Development * Optimizing Share of Research Voice Douglas F. Munch email@example.com n/a DCi Biotech Clinical, business & market analysis firstname.lastname@example.org www.dci-biotech.com DFM Ltd Strategic management consulting email@example.com www.dfmltd.com www.celltherapygroup.com 2 Consultants in the Cell Therapy Sector Principal or Contact Company Don Hill and Associates, Inc. Strength(s) Technical and regulatory consulting Services Email firstname.lastname@example.org Website www.donhillassociates.com We can help you achieve your objectives and needs for biotechnology Don Hill products, vaccines, cellular and gene therapy and more recently in traditional small molecule drugs. This experience includes: • Evaluation of manufacturing facility design, validation and process operations; • cGMP audits of API, clinical manufacturing and fill/finish facilities, manufacturing operations, quality systems and documentation; • Preparing clients for pre-approval, biennial and "for cause" cGMP inspections; • Providing technical assistance in the development and manufacture of monoclonal antibodies, vaccines, chemical synthesis and polymer products; • Assessment of and mitagation strategies for addressing the potential regulatory risks inherent in the manufacturing process, the scientific rationale for the development program and the strength of the validation approach. • Design and implementation of Quality systems for the development and manufacture of biologics and pharmaceuticals; • CMC strategies to ensure IND and CTA acceptance; • CMC filings for regulatory submissions; • Quality agreements for contract manufacture; • Meetings with regulators; • Responses to regulatory agency observations or questions; • Training ERA Consulting Group Specialist regulatory affairs and product development consulting to the biopharmaceutical industry The ERA Consulting Group provides regulatory affairs and product development consulting services to the biopharmaceutical industry. With offices in UK, Germany, USA and Australia, we have unrivalled expertise, a proven track record and over 20 years of experience, covering more than 300 biological/biotech products. Expertise in a wide range of biological products, ranging from classical blood products and vaccines to products of recombinant DNA and hybridoma technology, gene and somatic cell therapy products, as well as tissue engineered products Paul Cronin email@example.com www.eraconsulting.com Jain PharmaBiotech Research & market analysis consulting Jain PharmaBiotech was formed by Prof. Dr. K.K. Jain in 1996 to provide research and consulting services for the pharmaceutical and biotechnology industries. * Biodiscovery * Bioassay development * Human cell culture, banking and testing * Cell and tissue therapy * Stem cell biology and regulation * In vitro testing and validation * Biopharmaceuticals * Tissue engineering * Regenerative medicine * Biomaterials * Medical devices * Regulatory data development for new technologies Kewal K. Jain firstname.lastname@example.org www.pharmabiotech.ch Parenteau BioConsultants Technical, R&D, and IND related consulting Nancy L. Parenteau email@example.com www.parenteaubc.com/ www.celltherapygroup.com 3 Consultants in the Cell Therapy Sector Principal or Contact Joyce Lea FreyVasconcells Company PharmaNet Consulting Strength(s) Services Email firstname.lastname@example.org Website www.pharmanet.com/testing/html/c onsulting.shtml# Internatonal clinical and regulatory consulting & Therapeutic Expertise: Cell and gene therapies, tumor vaccines, and CRO tissues. Progenitor Consulting Translation of basic research into treatment Identification of new targets for research and development, confirming Alan Lesselyong alan@progenitorconsultin g.com strategies, evaluating the market potential for proof-of-concept experiments, scaling validated protocols, and the new technologies, and a strong connection with communication of technical information to a non-technical audience. the neuroscience community Product / process development, manufacturing, Consulting related to any aspect of process and product development, Robert Preti quality systems manufacturing, facility design, quality systems, cost-of-goods, regulatory affairs (esp CMC sections) bioprocessing rpreti@progenitorcellthera py.com www.progenitorconsulting.com Progenitor Cell Therapy www.progenitorcelltherapy.com Rainbow Biotechnologies SARL ReachBio SAB member for Sigma-Aldrich; formerly bioprocess tech dev director Avinoam Kadouri rainbow.biotech@bluewin. ch of Serono Biotech Center Contract laboratory services for: Emer Clarke * assessing potency of expanded, enriched and/or modified stem cell populations * efficacy of stem cell mobilization agents, novel cytokines or growth factor mimetics * efficacy or toxicity of hematopietic or mesenchymal modulatory agents, etc. Consulting and educational services in areas of: * hematopoietic and mesenchymal stem cell biology * cell therapy applications of hematopoitic and mesenchymal cells Assistance with due diligence and initial evaluation of in-licensing opportunities related to: * stem and progenitor cell biology * cellular therapies * therapeutic agents with the potential to affect hematopoietic or mesenchymal populations email@example.com m n/a Hematopoietic and mesenchymal stem cell biology and related cellular therapies. www.reachbio.com www.celltherapygroup.com 4 Consultants in the Cell Therapy Sector Principal or Contact Company Scintellix, LLC Strength(s) Special Domains of Expertise Include: Tissue Engineering/Regenerative Medicine Cell Therapy and Protein Therapeutics Biomaterials Development And Testing Hemostasis And Thrombosis Burns And Chronic Wounds Macroscopic and Microscopic Imaging Image Informatics Bioinformatics/Health Care Informatics Systems Biology/Genomics/Proteomics Small Molecule Therapeutics Process Planning and Management Services Access Opinion Leaders Assess Market Size And Readiness Plan Strategic Product Development - Product Design - Preclinical And Clinical Testing, including Clinical Trial design. - Regulatory Planning - Reimbursement Planning Recruit Management, Board and Other Essential Team Members Plan For Financing Business Development Planning Execute Licensing And Partnering Provide Intellectual Property Strategy And IP Asset Management Perform Technology Due Diligence For Corporations And Financial Institutions Email Website www.scintellix.com Peter C. Johnson firstname.lastname@example.org TotipotentSC Stem cell / cell therapy programs in South East Commercial, clinical, and other strategy consulting for stem cell Asia programs, products, technologies, etc Organizational, management, operational, and business development in cell therapy Process Optimization Business Development/New Products Market Entry Strategies Cell/Gene Therapy * Complete supply chain planning & development * Cell harvesting, manufacturing & infusion * Positioning for the next generation of blood products/services and/or transfusion medicine Cleanroom Consulting Production Planning and Inventory Management Regulatory Scientific/Medical Monitoring and Reviews Strategic Planning and Acquisition Analysis Interim Management Kenneth Harris email@example.com om firstname.lastname@example.org m www.totipotentsc.com Wells & Associates H. John Wells www.jwellsassociates.com www.celltherapygroup.com 5
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