Hybrid Concepts International
Accelerating The Development of New Therapies

A new generation of therapeutic innovation is afoot with cell & gene therapies redefining the traditional approach to disease treatment. Unlike classical drugs that focus on symptomatic treatments for diseases, cell & gene therapies seek to address the underlying problem that led to the disease or condition at the outset. This has the potential to pave the way for development of cures.

As a relatively new industry, less than 30 cell & gene therapies are approved by the FDA out of over 800 active clinical trials. Many development programs often can remain trapped in in either preclinical or early clinical development. Liberating preclinical assets past early-stage development to initial clinical trials, and early clinical assets to pivotal clinical trials, with the ultimate goal of marketing authorization and commercialization, are significant and challenging tasks.

This is where Hybrid Concepts International (HCI), a niche consulting and advisory firm focused on the cell & gene, and related advanced therapies space (inclusive of gene editing, tissue engineering, and regenerative medicine), helps chart the complex regulatory territory of commercializing innovative therapies. HCI brings its specialization in a wide range of cell & gene therapy disciplines to guide clients through all aspects of complex development lifecycles to market.

“We enable the development of potential one-time cures with our Team of deep subject-matter expert professionals in cell & gene therapy,” says Dr. Michael Mendicino, President, and Chief Consultant and Advisor at HCI.

The Team’s multidisciplinary expertise enables HCI to provide the best-suited experts for clients’ specific project needs in an incredibly challenging space.

At the heart of HCI’s robust team are its senior-level professionals with deep subject matter expertise across the cell & gene space, including regulatory strategy and submissions, CMC, manufacturing technologies and sourcing, quality assurance, quality control, good manufacturing practice and other good practices (GxP), preclinical strategy and operations, clinical strategy and operations, technical, scientific and medical writing, and due diligence.

HCI offers clients the convenience of solving all their regulatory burdens under a single roof with its one-stop shop approach of delivering consulting and advisory services that cover multiple cell & gene therapy disciplines. It assists clients with activities in the research and discovery phase, and the more definitive preclinical stage and associated development. HCI’s multi-disciplinary expertise also enables it to assist clients in moving their therapy from the preclinical to the clinical setting, and the clinical setting to the commercial setting. During the journey, HCI helps to ensure all its clients’ submissions satisfy FDA regulatory standards when treating human subjects. This is made possible by the expertise of its professionals across relevant therapeutics, platforms, tools, and technologies in the cell & gene space.

Akin to a Swiss Army Knife

Along its impressive timeline, HCI has grown its capabilities by adding more relevant disciplinary areas, such as the complementary work often needed to work on a project. For instance, HCI offers guidance in IND filing, covering each of the regulatory, CMC, preclinical (Pharmacology/ Toxicology), clinical, professional writing, and associated publishing to plan for, draft, polish, publish and submit an IND to the FDA.

During the preclinical to clinical stage, it is common for product developers to face setbacks because of their inexperience in filing FDA IND applications to start a clinical trial. There are instances where the IND application is placed on clinical hold after the client has attempted to file an IND themselves. HCI’s experts help clients prepare for FDA initial targeted engagement for regulatory advice meetings such as INTERACT and pre- IND meetings, and IND submissions. They also help clients prepare for associated expedited program applications such as regenerative medicine advanced therapy (RMAT) designation, and rare disease applications, such as orphan drug designation.

While helping clients advance from earlier to later stages of clinical development, HCI addresses specific FDA challenges like potency, comparability, and related manufacturing issues. Dr. Mendicino’s experience working at the FDA and consulting for FDA-facing clients ever since (over 125 clients in the cell & gene space at the time of this publication) has helped him tackle the common (and not so common), challenging areas of potency and comparability in the field. He and the HCI Team have handled numerous regulatory, IND enabling, CMC regulatory, technical, and other key challenges.

Through its unmatched competencies, HCI has assisted numerous clients to take their products into clinical trials by ensuring the proper execution of FDA and IND-related processes. Even when a client’s IND is placed on a clinical hold prior to retaining HCI, HCI works through the many regulatory challenges to lift the hold, helping clients proceed with their clinical trials.

Before filing for marketing authorization requiring a biologics license application (BLA) in the cell & gene space, HCI walks clients through the preparatory process. These include pre-BLA meetings, and pre-license inspections, ensuring they are comprehensive in all disciplinary areas for the BLA to be successful.

HCI is able to show far more flexibility in serving clients compared to larger consulting firms. It can tailor its services to meet the needs of any client. This includes compensation mechanisms, types of projects it can work on, and flexibility pertaining to the time zone and number of hours, in addition to executive titled positions, or numerous departmental leadership and support roles, as needed. HCI’s organizational structure enables its experienced Team to fully collaborate with clients and offer the finest expertise possible. In many cases, clients that have initially benefitted from HCI’s expert counsel and services in a particular discipline, have quickly realized the utility and need for additional disciplinary expertise from the firm.

We enable the development of potential one-time cures with our expert team of high-level professionals offering research assistance and regulatory guidance in all the disciplines of cell and gene therapy

Going above and beyond its services, HCI helps clients find the right manufacturer for their products and related components. HCI also helps them with vendor selection for procuring necessary materials and reagents for manufacturing, and contract organizations for supporting preclinical and clinical research needs.

Building on a Foundation of Wins

Continued success has led HCI on a path of exponential growth in both revenue and size. HCI aims to build on its capabilities to scale further and deliver even greater results to its clients, and is actively seeking investment to accelerate capital. As one of its many notable accomplishments, HCI has assisted companies in making the transition from private to public.

HCI also plays a vital role in the due diligence processes for venture capital and other relevant firms and interested parties looking to invest in, merge with or acquire players in the cell & gene space. HCI performs due diligence to provide investors with information on the technical, CMC, quality and compliance, regulatory, preclinical, clinical, and commercial aspects of innovative potential or investigational medical products.

The increasing number of experimental therapies awaiting approval in the cell & gene therapy space makes HCI, with its unique combination of FDA and industry expertise and consulting experience, the go-to partner for companies trying to develop and deliver cell & gene and other revolutionary therapies, tools, and platforms to the market.