Industry Experts comingtogether for your success.

www.Klyo-Collaborative.com

For more information, please contact us at info@Klyo-Collaborative.com.

Biopharmaceutical Solutions

CBR International Corp.® is a global,full-service product, clinical, and regulatory compliance group dedicated to providing

comprehensive development services to the biotechnology, pharmaceutical, and device industries worldwide. Our expertise

in global Regulatory Affairs as well as years of cGMP Quality systems support makes us a leader in the industry.

What Makes Us Different. We are unique among consulting organizations in that we embrace a “team concept” that extends beyond

our US headquarters. For example, our team includes expertise in all of our disciplines as well as our global partner CBR Biotech Strategies GmbH. Most

importantly, CBR staff seamlessly integrate into client programs to become members of the development team and to drive programs to success. This approach has proven

successful for a broad diversity of clients, products, and indications.

Holtz Biopharma ConsultingBarry Holtz (holtzbiopharm@gmail.com) is a career biotech entrepreneur. Barry has a background in drug development with experience in bioreactor based cellular manufacturing systems and with plant-based biopharmaceutical systems. Barry has led the clinical development and manufacturing of cancer vaccines. He was one of the founders of Large Scale Biology, InterveXion Therapeutics, G-CON Manufacturing and Caliber Biotherapeutics.

McDay is a strategic marketing communications firm located in Philadelphia focused on marketing strategies for clients in pharmaceutical design and manufacturing. The company is led by president Susan Stipa (susanstipa@mc-day.com). Susan was Senior Vice President, Commercial Operations at Foster-Wheeler BioKinetics, a global engineering firm, before coming to lead operations and creative technical strategy at McDay. McDay brings a strategic methodology to client development for Klyo and a fresh view to technical marketing in the biopharma space.

Rockwell Automation has a broad suite of products and services for pharmaceutical development and manufacturing. Rockwell Automation provides control and automation solutions, services, and equipment for

manufacturing and provides extensive software tools for control of pharma manufacturing, automation management, and information management.

Rockwell worked with the Klyo Collaborative members on several projects including the Caliber Biotherapeutics automation system and the Pfizer

PCMM project with G-CON; Pfizer and GEA integrating a modular oral solid dosage system.

Rockwell Automation’s Solutions Group, with operations led by Wade Olson (wlolson@ra.rockwell.com), supports the Klyo

Collaborative. RA offers its solutions-based approach, which includes its validate ready modular control and

information software for maximized scalability and life-cycle management of pharma processes,

as well as automation tools that allow for efficient manufacturing process

flow development.

The Beck Group is an integrated design and construction firm headquartered in Dallas, has a very active life sciences team led by Steve Springer (SteveSpringer@beckgroup.com). Beck brings a wealth of experience in design/build projects. Beck was the design-builder on the Caliber project and is currently completing the Pandemic Influenza Project and Live Virus Vaccine Facility Project at Texas A & M for the CIADM initiative. Bryan Jones (BryanJones@beckarchitecture.com) is a principal architect at Beck and led the design on the Caliber project and both CIADM vaccine facilities. Jose Rivera (JoseRivera@beckgroup.com) is Beck’s life sciences project executive and brings an extensive background in the design and construction of pharma facilities around the country. Beck has been a true leader in the development and implementation of innovative advances within the design and building industries for over 100 years. In partnership with Beck Technology led by Stewart Carroll (stewartcarroll@beck-technology.com) Beck uses DProfiler, an advanced modeling software program developed by Beck Technology for predictive cost estimating and physical modeling of facilities at the very early stages of conceptual design. This allows Beck to increase the very early availability of information, reduce risk, clarify scope, improve quality and reduce cost for facility design and construction.

Laurus Bio - Dr. Phillip B. Maples (pbmaples@laurusbio.com) is a world recognized expert in the development

and manufacturing of cancer vaccines, gene and cell therapies and biologics manufacturing. Phil worked

for many years at Baxter Healthcare and developed several innovative manufacturing facilities and

products. Before initiating his consulting practice, Phil was EVP and Chief Technical

Officer at Gradalis, Inc. in Dallas, TX and led the development of the innovative

manufacturing facility to produce patient-specific medicines. Concepts developed

at Gradalis were the genesis for the G-CON POD flexible manufacturing

systems. Phil has a great depth of experience in regulatory

issues in drug development, clinical design and quality assurance and numerous

IND’s in his resume.

EEA is a well-known Austin, Texas based engineering company, founded in 1977, that

provides MEP design services. One of principal partners, Fritz Stinson (FritzStinson@EEAce.com)

led the facilities engineering effort for Caliber. Morgan Stinson (morganstinson@eeace.com) designed and executed the complex HVAC system for the Caliber

facility including the growing rooms and is now EEA’s lead for the Pandemic Influenza Facility; both were

accomplished as part of the Beck design / build team. EEA has provided design services throughout

the US and internationally and is licensed in all 50 states.

Klyo is an alliance of world renowned companies with multiple successes solving lifecycle problems in the biopharmaceutical industry. This collaboration has transformed the approach to address difficult problems in the industry by removing barriers that previously required companies to seek out and manage multiple partners to achieve desired outcomes.

Realizing that their collaboration was something unique in the industry, Rockwell Automation, The Beck Group, EEA Consulting Engineers, CBR International, Holtz Biopharma Consulting, McDay LLC, and Laurus Bio have voluntarily come together to offer their joint “A-team only” resources. This enables Klyo Collaborative to assist clients in understanding and resolving their most complex challenges.

With engineering resources at record lows, and pressure to deliver pipeline products at record highs, having the support of successful and experienced third parties has become a necessity. Klyo Collaborative provides an unparalleled full-service model, with the experience necessary to implement creative solutions.

Gradalis’ personalized medicine product development and GMP manufacturing facility in Carrollton, Texas designed and built (and further modified) by Barry Holtz, Phil Maples, and Fritz and Morgan Stinson (EEA)

“I’ve been really impressed with the quality of service provided by CBR International Corp.® CBR’s level of support, guidance and high standards were significant factors with regard to Piramal Imaging GmbH obtaining the unprecedented FDA approval for Neuraceq™. The dedicated efforts of the CBR Team made the approval process a more efficient and cost-effective one and I highly recommend CBR International Corp.® as the partner of choice.”~ Dr. Ludger Dinkelborg, Member of the Board, Piramal Imaging SA

“We had the opportunity to develop a Centre for Biotechnology which would make Swansea the center of biotech for the UK. Barry Holtz’s focus meant that we stayed on track and yet somehow had time to consider a wide variety of unique solutions to our design that truly garnered the attention of those at the highest levels of the UK government.” ~ Jim Abbey, Director Texas/UK Research Collaborative, Swansea University

FROM “CONCEPTS TO CONCRETE,” WE HEAR YOU*

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Product/Process Development and Manufacturing expertise:• Biologics, Biosimilars, MAb’s,

Vaccines, rProteins• Drugs: Oral Solid Dosage• Cell, Gene and DNA/RNA

therapies• Nanomedicines• Medical Devices /

Disposables

Lifecycle Continuum Strategies to reduce Time-to-Market

Strategic planning for Value Creation

Quality, Regulatory, Scientific, and Clinical development services for the US and global markets

Predictive Tools for Process Automation of Facility Estimating

Facility Design including Multi-variable Modeling

Scale-up at each stage of Biopharmaceutical Development

Optimization of Automation and Information Management Systems

Supply Chain, Inventory Control, and Logistics Strategies

Experience gained from numerous, successful INDs and product licensures in the US, EU, Japan and Australia: Four Continents (and counting)

Record of Success – INDs, NDAs, BLAs, 510(k)s and IDEs

cGMP Facility Design / Build with full Compliance and CommissioningEarly Product Development

Early Product Development

Pre-clinical Phase 1 Phase 2 Phase 3

Process Engineering

Regulatory Planning / QA

Process Experimentation / Development / Scaling / Supply Chain Mgmt / Quality Processes and Procedures

Design of Experiments / QbD / QA / Design History File

Cost Estimation / D Profiler Conceptual Design Schematic Design Design/Build

Early Process Engineering

MEP Engineering Process Automation Planning

Companion and Qualifying Assays Development / Verification / ValidationPre-Clinical Planning Clinical Planning / IND Clinical Monitoring BLA Development

Delivering Drug Development Solutions From Bench to Bedside

Caliber Biotherapeutics was built in response to a need for commercial scale, rapid response to biothreat and was funded in part by DARPA. The team was lead by Barry Holtz, founder of Caliber Biotherapeutics, Bryan Jones, Partner, Beck Architecture, Fritz Stinson, SVP EEA Consulting Engineers, and Jim Cornell, The Beck Group. This team designed and built and commissioned the multi-product capable facility in 18 months. The facility has the capacity to produce over 500 kg of biotherapeutic protein per year.

* klyo (verb): Greek word “to hear, or to listen”