Cell Therapy Group - Brief

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  • 1. ABOUT US Cell Therapy Group (CTG) is the premier consultancy for the commercial side of the cell therapy and regenerative medicine sector.Cell Therapy Group (CTG) was founded in June 2008 by Lee Buckler to meet the demand forbusiness-focused services by those with expertise in regenerative medicine and cell therapy industriesas well as the use of cells in traditional drug development.Clients: therapeutic, device, service, tools, and reagent companies, pharmaceutical companies,investors, publishers, other consultants, etcServices: commercial-related services such as business development, market analysis & research,marketing, strategic planning, due diligence licensing, business planning, strategic alliances, sales &lead generation, advertising, project & interim management as well as more technical and scientificservices such as basic research design, process & product development, cell expansion anddifferentiation protocols, modeling for stem cells in drug discovery and testing, etc.The GroupCell Therapy Group prides itself in an unparalleled breadth of knowledge of the cell therapy andregenmed industries with scientific, technical, and commercial expertiseCTG has works for a wide range of clientele from very early-stage start-ups to some of the largest lifescience companies in the world.CTG has three categories of team members:  Core Consultants who are exclusive to CTG. All are senior consultants and project managers  Project Consultants who are under master services agreements and confidentiality agreements with CTG. They offer a wide variety of expertise and experience. They are brought in on projects as required.  A Consulting Network of other consultancies with which we work closely as client needs and projects dictate. www.celltherapygroup.com
  • 2. SERVICESCTG works for a wide range of clientele from very early-stage start-ups to some of the largest life sciencecompanies in the world. We are contracted to:  put together the right team for a project and be responsible for it,  manage a project whether or not our consultants are on the project,  provide a discrete set of services as part of a team contracted or managed by an outside party, and/or  simply assist in the selection of the right team for a project whether or not were involved in it.Service Strengths Basic research design. Cell expansion and differentiation protocols. Device (therapeutic & processing) design, development, market research, marketing, etc. Designing andTechnical & Scientific developing stem cells programs and/or lines for drug discovery and/or toxicity testing. Tissue engineering constructs, products, and modeling for therapeutic or non-therapeutic uses. Sales lead & strategic partner identification, negotiations, deal management, licensing,Business Development contracting, and transition management Competitor analysis, market size evaluations, sales lead identification, development ofMarket Research & Analysis market strategies Project implementation, management, and/or supervisionProject Management Primary message development, branding or re-branding, trade show management, website development & management, marketing collateral development (e.g., flyers, brochures, handouts, folders, presentation templates), soft marketing such as publications,Marketing conference presentations, industry organization participation, and strategies around utilizing digital marketing (e.g., video, digital business cards, websites), search engine optimization, etc Press releases, websites, and strategies around utilizing traditional and digitalCommunications communications (e.g., email, newsletters, video, blogs, podcasts), presentations (scientific, corporate, and financial audiences), media management, story pitches & integration strategies, etc Print (e.g., journals, magazines, conference documents) & digital (e.g., e-newsletters,Advertising digital ads, cross-posting, podcasts, conference campaigns) media campaign development, negotiating, placements, and management Budgeting, IT, recruitment, intranets, employee evaluationsOperations Business plan writing, strategies, SWOT analysisBusiness Plans Identification of primary targets for fundraising, assistance with developing presentations,Financing Strategies collateral, etc Recruitment, career fairs, HR profiling, employee evaluation programsHuman Resources Negotiations, contracting, & legal affairs managementLegal AffairsOutsourcing Selection & Development of requests for proposals, vendor identification & selection, outsourcingManagement management www.celltherapygroup.com
  • 3. TeamCell Therapy Group prides itself in an unparalleled breadth of knowledge of the cell therapy andregenmed industries with scientific, technical, and commercial expertiseCTG has three categories of team members: Core Consultants Consultants who are contracted to work exclusively through CTG. Each are senior consultants and project managers. Each are contracted "directors" to CTG and assist the Group with business development, services, and projects within their particular expertise.  Lee Buckler  Bill Fodor  John Hambor  Dan Segal Project Consultants Contractors who are under master services agreements and confidentiality agreements with CTG. They offer a wide variety of expertise and experience. They are brought in on projects as required. Consulting Network Other consultancies with which we work closely as client needs and projects dictate www.celltherapygroup.com
  • 4. Core Team Member - R. Lee BucklerFounder. Managing Director. Director, Cell Therapy BusinessLee works primarily with clients of all sizes in helping position them in theregenerative medicine space. This is typically focused on businessdevelopment in the broad sense from developing strategy, marketresearch and analysis, deal-making, marketing and communications,profile-building, sale-lead generation, etc.Lee has worked in the cell therapy – regenerative medicine industry sinceApril 2000. He has significant experience in both for-profit companiesand non-profit organizations including Progenitor Cell Therapy, MalachiteManagement, Stem Cell Technologies, and the International Society for Cellular Therapy.The core value Lee brings to CTG and its clients is a rare breadth of understanding of the entirespectrum of the cell therapy and regenmed industries primarily around who is doing what withwhom. This knowledge of the industry players, what they have, and with whom they are working isboth driven by and drives his proprietary industry database. Additionally, Lee leverages for his clientsthe relationships he has with executives in many of those companies.His clientele range from tools and services companies selling into the sector to companies (includinglarge pharma and other lifescience companies) developing strategies around how to invest in thespace.Lee founded Cell Therapy News, created Cell Therapy Blog where he continues to blog, and serveson the Editorial Board of the journals BioProcess International and Regenerative Medicine.Lee served as Chair of ISCTs Cell Therapy Commercialization Committee (2006-9), founded andadministers the LinkedIn Cell Therapy Industry Group, and has served as an advisor to dozens ofgroups and projects in the regenerative medicine space. He is a frequently invited speaker andmoderator at conferences in the industry.Lee recently co-authored a chapter entitled, “State of the Regenerative Medicine Industry” in thebook, The Delivery of Regenerative Medicines and Their Impact on Healthcare (CRC Press). www.celltherapygroup.com
  • 5. Core Team Member – William L. FodorDirector, Translational SciencesBill has over 20 years of research, management and training experience in both academia and thebiotechnology industry. An experience leader and team builder, Dr. Fodor has a proven track recordof developing novel genetically engineered cells, both stem cells and differentiated cells, geneticallyengineered tissues and organs designed for regenerative medicine applications.Dr. Fodor’s experience as an Associate Professor, as a member of Executive Management Teams inthe biotechnology industry, with grant and venture capital fund raising efforts, as well as participationin business development activities has gained Dr Fodor a broad range of core competencies inmultiple areas including: • Executive Management (team building, cross functional team development, budget management and organizational alignment) • Basic Research (cell and tissue engineering, cell, tissue and organ transplantation, stem cell biology, large and small animal transgenic engineering, novel bi-functional molecule engineering, immunology, molecular biology and genetics) • Translational Research (design and implementation of PoC pre-clinical animal models, biomarker assays, IND preparation) • Process Development (bench scale bioreactor process optimization, stem cell expansion & differentiation, RNAi screening, recombinant protein production and purification) • Clinical Manufacturing (cGMP training, SOPs, batch records, large-scale cell culture, cryopreservation, product specifications) • Project Management (project design & implementation, budget alignment, strategic planning) • Management of External Collaborations (corporate, academic)Bill broad experience within the regenerative medicine field spans many scientific disciplines,including immune responses to transplanted cells, neural repair, stem cell applications for cardiacrepair, cartilage and bone tissue engineering, whole organ transplantation, and genetic engineeringof recombinant molecules. Bill’s thorough understanding of regenerative medicine, cell therapy, tissueengineering, molecular biology, manufacturing and translational product development, provides hisclients with a unique combination of technical and development skills that can be directed at allaspects of the biotechnology business.Previously, Dr. Fodor was Senior Director of Product Development for ViaCell, Inc., where he oversawbasic stem cell research, the hematopoietic stem cell Process Development Group and the stem cellClinical Manufacturing Team. Prior to joining ViaCell, Dr. Fodor was an Associate Professor at theUniversity of Connecticut in the Center for Regenerative Biology and the Department of Molecular CellBiology, where he taught genetics and conducted research in stem cell engineering, transgenicanimal production, cell replacement therapies for diabetes and transplant immune rejection. Dr.Fodor initiated his professional career as a founding scientist at Alexion Pharmaceuticals where hedirected the transgenic animal program focused on cell and tissue engineering for regenerativemedicine applications and through his efforts earned a position on the Executive Management Team. www.celltherapygroup.com
  • 6. Core Team Member – John E. HamborDirector, Stem Cell-based Drug DiscoveryDr. John Hambor has over 20 years of research, management and training experience in both thepharmaceutical and biotechnology industries. A results-driven executive leader, Dr. Hambor has aproven ability to apply breakthrough science to the discovery and development of novel smallmolecules and biological therapies.As a skilled hands-on scientist, executive and new business architect, Dr. Hambor has corecompetencies in multiple areas including:  Basic Research (stem cell biology, drug discovery, transgenic animals, molecular biology and genetics)  Process Development (optimization of stem cell expansion & differentiation into multiple somatic cell types, RNAi & small molecule screening, recombinant protein production)  Clinical Manufacturing (SOPs, batch records, automated large-scale cell culture)  Project Management (project design & implementation, process reengineering, strategic planning)  Supervision (team building, talent development, team & organizational alignment)  External Collaboration (corporate, academic)The value John brings to CTG and its clients is his broad perspective of utilizing stem celltechnologies across the entire drug discovery process. With a deep understanding of regenerativemedicine, cell therapy, tissue engineering, and classic pharmaceutical drug development, he provideshis clients with a unique combination of technical and business knowledge that can be directed atbusiness development, strategic planning, product development, market analysis, licensing, patentprotection of intellectual property, and partnering & coalition building.Dr. Hambor was formerly the Chief Executive Officer of CellDesign, Inc., a global research anddevelopment company that specializes in the development of customizable stem cell tools, primarycells, and reagents for applications in drug discovery & research.Previously, Dr. Hambor was an Associate Research Fellow at Pfizer Global Research andDevelopment. Dr. Hambor joined Pfizer in 1990 in Groton, Connecticut and has worked in severalareas of increasing responsibilities. He spent his early years as a cellular and molecular biologist inthe Inflammation and Immunology therapeutic areas. In 1998, Dr. Hambor joined the GeneticTechnologies Department where he formed a stem cell research unit, eventually overseeing globalefforts in stem cell technologies as part of the Genetically Modified Models Center of Emphasis. www.celltherapygroup.com
  • 7. Core Team Member – Daniel A. SegalDirector, Stem Cell & Medical Devices BusinessDan brings over 25 years of experience in the medical device industry with more than 12 of thoseyears focused in the area of emerging stem cell therapies where he held various senior and executivemanagement positions in sales, marketing, business development, and operations, with start-up,small, medium and Fortune 500 companies.During the course of his career Dan has been responsible for strategic planning, business planning,launching new products into worldwide markets, building and managing international distributionchannels, and identifying and establishing relationships with strategic partners.As a former VP Sales and Marketing, Dan launched two new technology platforms into the cord bloodmarket and drove adoption through launching a technical consulting service which established thecompany as a worldwide leader in cord blood /stem cell processing and storage systems.As Vice President of Business Development, Dan managed the development of new stem cellproducts, as well as national and global business development, precipitating two new regenerativemedicine programs; use of a new device for processing bone marrow in an ongoing European PhaseII clinical trial and a second initiative involving the use of the same technology to perform clinicalresearch on bone marrow stem cell separation in point-of-care orthopedic proceduresMost recently as President/CEO of a start-up family cord blood bank, Dan was responsible for buildingthe organization, gaining state licensure, developing the company’s strategic positioning, launching ofcommercial services and oversight of daily operations. www.celltherapygroup.com
  • 8. Project ConsultantsA sampling of our project consultants include:Consultant ATechnical Expertise• Working knowledge of the pharma world from discovery to development, clinical trials to outcomes research• Toxicology/Preclinical Safety• GLP research for drug discovery assay development• Cell-based assays• Primary cell isolation & culture• cGMPs, product specifications, product development• Safety assessments for GMP cleaning limits and toxicological review of contaminant deviations• Scientific writing, regulatory guidelines & submission reportingBusiness Acumen• Market analysis• Consultative selling• Stem cell technologies & market• New product launch• Business Development• Trust-building & Teamwork• Creative problem-solving• Strategic Planning• Training development/instructional design & instructor led training• Effective communication/influence skills• Strong professional network built on collaborative partnerships and ability to sincerely connect with__________________________________________________________________________________Consultant BExpertise and experience in regenerative medicine, particularly conversant with the following:• Business planning, due diligence, technical and commercial analyses, go/no-go decision-making, marketresearch, risk analysis• KOL networking and facilitation towards scientific and business collaboration/partnership• R&D, preclinical and clinical pathway planning for cell therapy product commercializtion• Adipose stem cell product commercialization• International markets for regenmed & stem cell businesses, particularly China, Isreal, & Middle East• Medical tourism.__________________________________________________________________________________Consultant CExtensive experience and expertise in stem cell biology, managing both discovery and R&D programs, neuralstem/progenitor cells, islet cells, cardiomyocytes, hepatocytes, hESC-based ADMEtox platforms, differentiationof hESCs into cells for potential therapeutic use, etc www.celltherapygroup.com
  • 9. Case StudiesClient#1: Multinational division (€1B+ annual revenue) of a global healthcare company (€3B+annual revenue).Need: Develop a manufacturing strategy for a cell therapy product being brought into the US market.Services:§ External analysis of the value of current contractual obligations (for product & process development-related services) with thecontract manufacturer.§ Contract renegotiation (and exit) with the existing contract manufacturer.§ Global analysis (SWOT) of contract manufacturers with cell therapy product manufacturing and development experience andexpertise.Client#2: Multinational pharmaceutical company headquartered in Europe. €900M+ annualrevenue.Need: Understand the global cell therapy (particularly stem cell) industry and particular opportunities available to them through awritten report covering specific assessments and recommendationsServices: An analytic report including:o overview of the global status of the industry,o discussion and analysis of the different business models (and product types) in the cell therapy industry,o main risks, opportunities and threats presented by the different product types and business models (globally and considering thespecific characteristics of the client),o analysis (drawing on publicly information) regarding the technologies and commercial viability of 4 potential target companies(identified by client) including a SWOT of each and a discussion around the primary differences in business models,o specific recommendations and a potential roadmap for the client to enter the sector including some assessment and definition ofprimary risks, ando identification of cell therapy products worldwide which are currently on the market or in development in [client’s] three primaryclinical markets.Client #3: US-based, start-up, public company. $1M+ in annual revenue. $9M+ market cap.Need: Increased market penetration and profile. Establishing discussions with key potential clients with which they had not yet hadany successful contact.Services:§ Introduced discussions with several key potential clients and converted a high percentage of these into evaluation orders.§ Provided strategic advice on market positioning and a key marketing joint venture.Client #4: Multinational service division of a global, scientific product and services company.$10B+ annual revenue.Need: Better understand the cell therapy market and what opportunities exist for the company in the sector. Develop a strategy forpositioning the division as the market leader in the sector. Penetrate the market to build a competitive lead the industry.Services:§ In-person meeting to kick-off development of strategic planning. www.celltherapygroup.com
  • 10. § Competitive analysis.§ Industry intelligence.§ Development of marketing, communication, business development and sales strategies for penetrating market and establishing aleadership profile.Client #5: US-based, private, services company. $2M+ in annual revenue.Need: Understand the cell therapy market and what opportunities exist for the company in the sector. Understand where they fit inthe landscape of competing service providers in the sector and identification of specific opportunities and how they might be pursued.Develop a strategy for how the company might best penetrate the sector.Services:§ An overview of the cell therapy industry and market.§ A SWOT analysis of their primary and secondary competitors around the world.§ A roadmap for how they might proceed in establishing a presence in the cell therapy industry for their services. www.celltherapygroup.com