Leading Pharma Operations Executive Joins Company at Center of U.S. And Global COVID-19 Response

Actualizado el 11 de marzo, 2021 - 18.16hs.

Leading Pharma Operations Executive Joins Company at Center of U.S. And Global COVID-19 Response

ApiJect Systems, Corp., Appoints Ray Guidotti as Chief Operating Officer

PR Newswire

STAMFORD, Conn., March 11, 2021 /PRNewswire/ -- ApiJect Systems, Corp., a medical technology public-benefit corporation that revolutionizes how vaccines and injectable medicines are filled, finished, and delivered, announced today that Raymond J. Guidotti has joined the organization as its new Chief Operating Officer (COO), effective March 1, 2021.

Mr. Guidotti comes to ApiJect with more than 30 years of pharma experience in global business, operational strategy and execution, supply chain management, manufacturing network design, and capital project planning and execution. Since 2009, he has served in a variety of executive leadership roles with Patheon Pharmaceuticals and Thermo Fisher Scientific (which acquired Patheon in August 2017). Most recently he was Group Vice President of Global Engineering, Capacity Planning, and Technical/Operations Services for Pharma Services Group within Thermo Fisher Scientific, a global leader in serving science and an industry leader in contract pharmaceutical development and manufacturing services. 

­In his role as ApiJect's COO, Mr. Guidotti will work closely with CEO Franco Negron on realizing the company's growth strategy and continuing to build a world-class team in support of the delivery of the ApiJect platform. This will also include responsibility for the company's scheduled construction of the previously announced ApiJect Campus in Durham, North Carolina's Research Triangle Park that will have the capability to produce up to 3 billion doses of injectable medicines annually. The campus is being financed with a $590 million loan from the U.S. International Development Finance ­Corporation in addition to more than $200 million of privately raised capital.

In welcoming Mr. Guidotti to the ApiJect team, Mr. Negron, commented: "Ray Guidotti is the right person at the right time for ApiJect. He is a proven senior executive who will help drive our company's rapid emergence as a technology innovator and leader in the development and production of safe, effective, efficient, high volume injection devices. His deep technical and operational experience means he understands and has executed the technical and strategic aspects of successful pharmaceutical operations. His engineering expertise coupled with his executive leadership in the pharmaceutical industry is exactly what ApiJect needs in our COO. On a more personal note, Ray and I have a long history of professional collaboration dating back nearly 20 years which includes executive leadership roles at Patheon and Thermo Fisher Scientific. I couldn't be more excited to welcome him as a trusted member of our executive leadership team."

ApiJect Co-Founder and Chairman, Jay Walker, commented on Mr. Guidotti's hiring: "With Ray we have a real superstar in the pharmaceutical industry who has truly done it all. His experience in operations, business strategy, and execution complements our executive team as ApiJect's technology platform moves front and center to be a vital element in America's and the world's response to COVID-19. Ray is also among those few in corporate management who has the capacity and the interest in seeing and understanding what is around the corner in the next stages of industry innovation and change."

Mr. Guidotti commented: "As an engineer and pharmaceutical executive, I can say that I am thrilled to be joining ApiJect. Blow-Fill-Seal technology is safe, cost-effective and holds tremendous promise for rapidly transforming the speed and scale at which vaccines and other therapeutic medicines can be delivered. ApiJect is at the forefront of this work. I've been fortunate in my career to work with some of the most incredible leaders in Pharma and to be a part of teams that have achieved many firsts and improvements in the industry. With ApiJect, I have a chance again to work with a world class leadership team and to continue building out our organization with the kind of talent that will lead the way in expanding access, reducing cost, and revolutionizing the way vaccines and medicines are distributed to communities throughout the world. I couldn't be more excited to take on this challenge."

Mr. Negron concluded: "As a 24-year resident of the Raleigh-Durham area, Ray will also lead our company's integration in the area as an active corporate citizen. He has already put his hand into the ­­design and execution of our workforce recruitment, training, and retention efforts as our Research Triangle presence takes shape. When it comes to building a workforce of 650 from scratch, a plant from the ground up, and a company with world class operations, Ray knows what needs to be done and will guide our outstanding teams to ensure our company's success today and well into the future."

ABOUT APIJECT SYSTEMS, CORP.

ApiJect Systems, Corp. is a medical technology company that revolutionizes how the world manufactures and delivers injectable medicines and vaccines.

The ApiJect technology platform brings together simple, interconnectable components to create scalable drug delivery devices for U.S. and global markets. At the center of these devices is the aseptic and cost-effective Blow-Fill-Seal (BFS) fill-finish process. And, by using a modular manufacturing approach, these devices can be produced in clinical or commercial scale by ApiJect or the drug manufacturer.

Our first device, the single-dose ApiJect Prefilled Injector, allows a healthcare professional to twist a pen needle-style hub onto a BFS container — creating a simple, scalable prefilled syringe. ApiJect is working with several vaccine pharmaceutical companies to conduct the testing and regulatory reviews of COVID-19 vaccines in the ApiJect Prefilled Injector. ApiJect has submitted its needle hub device for a pre-submission FDA review and anticipates the filing of its drug container with COVID-19 vaccine as part of a review submission by each of ApiJect's COVID-19 vaccine partners. ApiJect's prefilled injector will be ready for patient distribution as soon as it receives FDA approval.

In 2020, ApiJect was awarded a $138 million contract from the U.S. Department of Defense, in cooperation with the U.S. Department of Health and Human Services, to create a high-volume domestic capacity to supply prefilled injectors. The U.S.-based facility that ApiJect has developed through this emergency program has the capacity to provide approximately 45 million prefilled injectors per month to America's population through 2021.

ApiJect has also recently been approved by the U.S. International Development Finance Corporation for a $590 million loan to construct a multi-facility campus enabling the U.S. to more quickly package high volumes of injectable medicines and vaccines in the event of a national emergency, beginning with COVID-19. Located in Research Triangle Park, North Carolina, this 1.2 million square foot campus will be home to the ApiJect Gigafactory, is one of the world's largest pharmaceutical fill-finish facilities. The campus is expected to have an annual production capacity of up to 3 billion single-dose prefilled injectors.

ApiJect, along with the U.S. Department of Health and Human Services, is a founding member of the RAPID Consortium, a public-private partnership dedicated to giving the U.S. and the world the surge capacity it needs for drug packaging to address future pandemics and bio-emergencies.

Learn more about ApiJect at www.apiject.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included in these materials that address activities, events or developments that ApiJect expects, believes or anticipates will or may occur in the future are forward-looking statements. The words "believe", "expect", "may", "estimates", "will", "anticipate", "plan", "intend", "foresee", "should", "would", "could", or other similar expressions are intended to identify forward-looking statements, which are generally not historical in nature. However, the absence of these words does not mean that the statements are not forward looking. Without limiting the generality of the foregoing, forward-looking statement contained in this press release specifically include the expectations of plans, strategies, and objectives of ApiJect. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of ApiJect, which may cause actual results to differ materially from those implied or expressed by the forward-looking statements.

 

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