Seven Partners “Hear” Pharmaceutical Lifecycle Challenges Together
MARCH 20, 2015 (Austin, TX) - Seven companies have voluntarily come together to form a new collaborative problem-solving group, aimed at assisting biopharmaceutical companies solve their most pressing lifecycle pipeline problems.
Rockwell Automation, The Beck Group, EEA Consulting Engineers, CBR International, McDAy LLC, Holtz Biopharma Consulting and Laurus Bio have joined to form the Klyo Collaborative, named for the Greek word “to hear, to listen.” They will hold a press conference on:
Date: Tuesday April 21st, 2015
Location: Interphex 2015, New York City, NY, Jacob Javits Convention Center, Room 2D14/2D15
Time: 11:00 am
This new alliance has already demonstrated a number of successes solving lifecycle problems for the biopharmaceutical industry. Realizing that their previous successful collaborations were something unique in the industry, these seven companies have come together and are offering their joint “A-team only” resources to clients, through the Klyo Collaborative. They offer innovative solutions for early stage biotech firms looking to accelerate development timelines, as well as all-inclusive approaches for larger pharmaceutical companies experiencing a decline in internal resources with mounting pressure to deliver an increasingly diverse global supply of safe pharmaceutical products.
Dr. Barry Holtz, the group’s founder, says “Pharmaceutical companies, both large and small are stretched for resources. Smaller companies may not have the tools to plan for scale-up, clinical paths, and commercialization. Large pharma is now incorporating many new technologies through acquisition and cannot staff adequately for this wider scope of activity “This is a world-renowned group of successful and smart people, with experience on both the owner side and the delivery side of the development equation, who represent the perfect team to listen for the problems, and offer credible solutions.”
Dr. Phil Maples, a Ph.D molecular biologist and Managing Director of Laurus Bio agrees, and adds that the group’s members are “non-competing, and cover every discipline - regulatory, quality, scientific, clinical, process development, architecture and construction, engineering, and automation. Not all of our partners will be involved in every project; but it was important for us to have the resources for all the critical disciplines at our fingertips, and besides, this group wanted to find reasons to work together, after the multiple successes that we’ve had.”
Dr. Jeanne Novak, a former FDA reviewer and the founder of CBR International, adds that the Collaborative is “a unique opportunity to work with successful, motivated professionals to provide the full-spectrum of program development services necessary to deliver products from bench-top to bed-side.”
The strengths of the Klyo Collaborative include:
- CPC and cGMP Facility Design/Build with full compliance
- Quality, regulatory, scientific, and clinical development services for the US and global markets
- Optimization of automation and information management systems
- Multi-variable modeling of facility designs
- Numerous successful IND’s and product licensures in the US, EU, Japan, and Australia
- Optimization of early stage biotech opportunities for acquisition
- Product expertise includes drugs, oral solid dosage forms, biologics, vaccines, medical devices, combination products, autologous therapies, as well as cell and gene therapies
- Supply Chain and Inventory Control
- Scale-up at each stage of biopharmaceutical development
- Global Supply Chain Strategies -Bulk medicines delivered globally for local fill/finish
- Lifecycle Continuum Strategies - specific experience for reduced time-to-market
- Predictive tools for automation and facility estimating
With development resources at record lows, and pressure to deliver pipelines at record highs, having the support of successful and experienced third-parties has become a necessity. Klyo Collaborative has the capability to take ideas “all the way to the pipe, brick and mortar of the solution, or anywhere in between, with regulatory confidence and documentation” says Dr. Holtz.
ABOUT KLYO Collaborative
Klyo Collaborative, headquartered in Austin, TX, one of the fastest[1] growing biotechnology states in the US, offers the resources of Rockwell Automation, The Beck Group, CBR International, EEA Consulting Engineers, Laurus Bio, McDay, and Holtz Biopharma Consulting, to solve lifecycle problems in the biopharmaceutical industry.
BACKGROUNDER
Rockwell Automation – Rockwell Automation has a broad suite of products and services for pharmaceutical development and manufacturing. Rockwell produces control and automation 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 very large oral solid dosage system. Rockwell Automation’s Systems and Solutions group, led by Wade Olsen (wlolson@ra.rockwell.com), supports the Klyo Collaborative and offers its solutions-based approach, which includes tools like Arena.
Arena utilizes a methodology that enables you to build a manufacturing process flow in a fast, intuitive and easy-to-learn manner. Arena’s drag and drop elements and structures allow you to build simulations and visualize results with engaging 2D and 3D animation capabilities that do not require programming assistance.
The Beck Group– 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 was one of the architects on the Caliber project and on the Pandemic Influenza Facility. Jose Rivera , JoseRivera@beckgroup.com has an extensive background in the design and construction of pharma facilities and is a life sciences market leader at Beck. Beck brings a century of construction experience and an extremely collaborative approach to pharma projects. Beck leads the design and building industry in innovation by developing and advancing technology. Working in partnership with Beck Technology led by Stewart Carroll stewartcarroll@beck-technology.com, the use of technology helps Beck increase the availability of information, reduce risk, clarify scope, improve quality and reduce cost for design and construction projects. 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.
CBR International- CBR International, founded in 2002 is headquartered in Boulder, Colorado and is led by CEO and owner, Dr. Jeanne Novak (jnovak@cbrintl.com) . Dr. Novak, formerly of FDA and Fort Detrick, has a rich background in quality assurance and regulatory affairs and leads a company with substantial resources in both of these areas, including clinical development. Jeanne has worked with members of the Klyo Collaborative on a lymphoma cancer drug development program at Large Scale Biology and is active in the Ebola effort globally. Dr. Novak is recognized as a world expert in vaccine development and is well published.
EAA Consulting Engineers – EEA is a well known Austin, Texas based engineering company, founded in 1977, that provides MEP design services. One of principal partners, Fritz Stinson (fritzs@auseea.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 involved with the Pandemic Influenza Facility. EEA has provided design services in the US and internationally and has worked extensively in the design of high containment environments. EEA is licensed in all 50 states.
McDay – 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.
Laurus Bio - Dr. Phil Maples (pbmaples@gmail.com) is a world recognized expert in the development and manufacturing of cancer vaccines, cell therapies and biologics manufacturing. Phil worked for many years at Baxter and developed several innovative manufacturing facilities and products. Before initiating his consulting practice, Phil was Senior Vice President of Manufacturing at Gradalis, Inc. in Dallas, TX and led the development of the innovative manufacturing facility to produce patient specific medicines. The 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 has a number of IND’s and drug licensures in his resume.
Holtz Biopharma Consulting- Dr. Barry 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.
KLYO CONTACT:
Barry Holtz
Klyo Collaborative
Tel.281.794.1436
rbholtz@gmail.com