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
celltherapy@ac-gt.com; kedward@ac-gt.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)
jkenimer@bcg-usa.com
www.biologicsconsulting.com
Bionest Partners
Healthcare advisory services
Consulting in operational, strategic, and financial solutions tailored for Nipon Das healthcare industries and financial institutions
ndas@bionest.com
www.bionest.com
www.celltherapygroup.com
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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 m_carpenter@mac.com
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
lcardwell5@comcast.net
n/a
DCi Biotech
Clinical, business & market analysis
ddriscoll@dci-biotech.com
www.dci-biotech.com
DFM Ltd
Strategic management consulting
dfmunch@dfmltd.com
www.dfmltd.com
www.celltherapygroup.com
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Consultants in the Cell Therapy Sector
Principal or Contact
Company
Don Hill and Associates, Inc.
Strength(s)
Technical and regulatory consulting
Services
Email
dhai@msn.com
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
info@eraconsulting.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
jain@pharmabiotech.ch
www.pharmabiotech.ch
Parenteau BioConsultants Technical, R&D, and IND related consulting
Nancy L. Parenteau
info@parenteaubc.com
www.parenteaubc.com/
www.celltherapygroup.com
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Consultants in the Cell Therapy Sector
Principal or Contact
Joyce Lea FreyVasconcells
Company
PharmaNet Consulting
Strength(s)
Services
Email
jfrey@pharmanet.com
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
emer.clarke@reachbio.co m
n/a
Hematopoietic and mesenchymal stem cell biology and related cellular therapies.
www.reachbio.com
www.celltherapygroup.com
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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 pjohnson@scintellix.com
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
ken.harris@totipotentsc.c om info@jwellsassociates.co m
www.totipotentsc.com
Wells & Associates
H. John Wells
www.jwellsassociates.com
www.celltherapygroup.com
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