Cell Therapy Group - Brief

www.celltherapygroup.com

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 for business-focused services by those with expertise in regenerative medicine and cell therapy industries as well as the use of cells in traditional drug development. Clients: therapeutic, device, service, tools, and reagent companies, pharmaceutical companies, investors, publishers, other consultants, etc Services: 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 scientific services such as basic research design, process & product development, cell expansion and differentiation protocols, modeling for stem cells in drug discovery and testing, etc. The Group Cell Therapy Group prides itself in an unparalleled breadth of knowledge of the cell therapy and regenmed industries with scientific, technical, and commercial expertise CTG has works for a wide range of clientele from very early-stage start-ups to some of the largest life science 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.


SERVICES CTG works for a wide range of clientele from very early-stage start-ups to some of the largest life science companies 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 we're involved in it.

Service Strengths

Technical & Scientific

Basic research design. Cell expansion and differentiation protocols. Device (therapeutic & processing) design, development, market research, marketing, etc. Designing and 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.

Business Development Sales lead & strategic partner identification, negotiations, deal management, licensing, contracting, and transition management

Market Research & Analysis Competitor analysis, market size evaluations, sales lead identification, development of market strategies

Project Management Project implementation, management, and/or supervision

Marketing

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, conference presentations, industry organization participation, and strategies around utilizing digital marketing (e.g., video, digital business cards, websites), search engine optimization, etc

Communications

Press releases, websites, and strategies around utilizing traditional and digital communications (e.g., email, newsletters, video, blogs, podcasts), presentations (scientific, corporate, and financial audiences), media management, story pitches & integration strategies, etc

Advertising Print (e.g., journals, magazines, conference documents) & digital (e.g., e-newsletters, digital ads, cross-posting, podcasts, conference campaigns) media campaign development, negotiating, placements, and management

Operations Budgeting, IT, recruitment, intranets, employee evaluations

Business Plans Business plan writing, strategies, SWOT analysis

Financing Strategies Identification of primary targets for fundraising, assistance with developing presentations, collateral, etc

Human Resources Recruitment, career fairs, HR profiling, employee evaluation programs

Legal Affairs Negotiations, contracting, & legal affairs management

Outsourcing Selection & Management

Development of requests for proposals, vendor identification & selection, outsourcing management


Team Cell Therapy Group prides itself in an unparalleled breadth of knowledge of the cell therapy and regenmed industries with scientific, technical, and commercial expertise CTG 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


Core Team Member - R. Lee Buckler Founder. Managing Director. Director, Cell Therapy Business Lee works primarily with clients of all sizes in helping position them in the regenerative medicine space. This is typically focused on business development in the broad sense from developing strategy, market research and analysis, deal-making, marketing and communications, profile-building, sale-lead generation, etc.

Lee has worked in the cell therapy – regenerative medicine industry since April 2000. He has significant experience in both for-profit companies and non-profit organizations including Progenitor Cell Therapy, Malachite Management, 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 entire spectrum of the cell therapy and regenmed industries primarily around who is doing what with whom. This knowledge of the industry players, what they have, and with whom they are working is both driven by and drives his proprietary industry database. Additionally, Lee leverages for his clients the relationships he has with executives in many of those companies.

His clientele range from tools and services companies selling into the sector to companies (including large pharma and other lifescience companies) developing strategies around how to invest in the space.

Lee founded Cell Therapy News, created Cell Therapy Blog where he continues to blog, and serves on the Editorial Board of the journals BioProcess International and Regenerative Medicine.

Lee served as Chair of ISCT's Cell Therapy Commercialization Committee (2006-9), founded and administers the LinkedIn Cell Therapy Industry Group, and has served as an advisor to dozens of groups and projects in the regenerative medicine space. He is a frequently invited speaker and moderator at conferences in the industry.

Lee recently co-authored a chapter entitled, “State of the Regenerative Medicine Industry” in the book, The Delivery of Regenerative Medicines and Their Impact on Healthcare (CRC Press).


Core Team Member – William L. Fodor Director, Translational Sciences Bill has over 20 years of research, management and training experience in both academia and the biotechnology industry. An experience leader and team builder, Dr. Fodor has a proven track record of developing novel genetically engineered cells, both stem cells and differentiated cells, genetically engineered tissues and organs designed for regenerative medicine applications. Dr. Fodor’s experience as an Associate Professor, as a member of Executive Management Teams in the biotechnology industry, with grant and venture capital fund raising efforts, as well as participation in business development activities has gained Dr Fodor a broad range of core competencies in multiple 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 cardiac repair, cartilage and bone tissue engineering, whole organ transplantation, and genetic engineering of recombinant molecules. Bill’s thorough understanding of regenerative medicine, cell therapy, tissue engineering, molecular biology, manufacturing and translational product development, provides his clients with a unique combination of technical and development skills that can be directed at all aspects of the biotechnology business. Previously, Dr. Fodor was Senior Director of Product Development for ViaCell, Inc., where he oversaw basic stem cell research, the hematopoietic stem cell Process Development Group and the stem cell Clinical Manufacturing Team. Prior to joining ViaCell, Dr. Fodor was an Associate Professor at the University of Connecticut in the Center for Regenerative Biology and the Department of Molecular Cell Biology, where he taught genetics and conducted research in stem cell engineering, transgenic animal production, cell replacement therapies for diabetes and transplant immune rejection. Dr. Fodor initiated his professional career as a founding scientist at Alexion Pharmaceuticals where he directed the transgenic animal program focused on cell and tissue engineering for regenerative medicine applications and through his efforts earned a position on the Executive Management Team.


Core Team Member – John E. Hambor Director, Stem Cell-based Drug Discovery Dr. John Hambor has over 20 years of research, management and training experience in both the pharmaceutical and biotechnology industries. A results-driven executive leader, Dr. Hambor has a proven ability to apply breakthrough science to the discovery and development of novel small molecules and biological therapies. As a skilled hands-on scientist, executive and new business architect, Dr. Hambor has core competencies 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 cell technologies across the entire drug discovery process. With a deep understanding of regenerative medicine, cell therapy, tissue engineering, and classic pharmaceutical drug development, he provides his clients with a unique combination of technical and business knowledge that can be directed at business development, strategic planning, product development, market analysis, licensing, patent protection of intellectual property, and partnering & coalition building. Dr. Hambor was formerly the Chief Executive Officer of CellDesign, Inc., a global research and development company that specializes in the development of customizable stem cell tools, primary cells, and reagents for applications in drug discovery & research. Previously, Dr. Hambor was an Associate Research Fellow at Pfizer Global Research and Development. Dr. Hambor joined Pfizer in 1990 in Groton, Connecticut and has worked in several areas of increasing responsibilities. He spent his early years as a cellular and molecular biologist in the Inflammation and Immunology therapeutic areas. In 1998, Dr. Hambor joined the Genetic Technologies Department where he formed a stem cell research unit, eventually overseeing global efforts in stem cell technologies as part of the Genetically Modified Models Center of Emphasis.


Core Team Member – Daniel A. Segal Director, Stem Cell & Medical Devices Business Dan brings over 25 years of experience in the medical device industry with more than 12 of those years focused in the area of emerging stem cell therapies where he held various senior and executive management 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 distribution channels, and identifying and establishing relationships with strategic partners. As a former VP Sales and Marketing, Dan launched two new technology platforms into the cord blood market and drove adoption through launching a technical consulting service which established the company 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 cell products, as well as national and global business development, precipitating two new regenerative medicine programs; use of a new device for processing bone marrow in an ongoing European Phase II clinical trial and a second initiative involving the use of the same technology to perform clinical research on bone marrow stem cell separation in point-of-care orthopedic procedures Most recently as President/CEO of a start-up family cord blood bank, Dan was responsible for building the organization, gaining state licensure, developing the company’s strategic positioning, launching of commercial services and oversight of daily operations.


Project Consultants A sampling of our project consultants include: Consultant A Technical 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 reporting Business 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 B Expertise and experience in regenerative medicine, particularly conversant with the following: • Business planning, due diligence, technical and commercial analyses, go/no-go decision-making, market research, 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 C Extensive experience and expertise in stem cell biology, managing both discovery and R&D programs, neural stem/progenitor cells, islet cells, cardiomyocytes, hepatocytes, hESC-based ADMEtox platforms, differentiation of hESCs into cells for potential therapeutic use, etc


Case Studies Client#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 the contract manufacturer. § Contract renegotiation (and exit) with the existing contract manufacturer. § Global analysis (SWOT) of contract manufacturers with cell therapy product manufacturing and development experience and expertise. Client#2: Multinational pharmaceutical company headquartered in Europe. €900M+ annual revenue. Need: Understand the global cell therapy (particularly stem cell) industry and particular opportunities available to them through a written report covering specific assessments and recommendations Services: 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 the specific 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 of primary risks, and o identification of cell therapy products worldwide which are currently on the market or in development in [client’s] three primary clinical 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 had any 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 for positioning 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.


§ Competitive analysis. § Industry intelligence. § Development of marketing, communication, business development and sales strategies for penetrating market and establishing a leadership 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 in the 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.

Cell Therapy Group - Brief

Business

Transcript of Cell Therapy Group - Brief