DHC has encountered a variety of examples in which a client requires a temporary personnel solution, a sort of strategically savvy SME-on-demand, and the approach we take to those varying situations can differ.
Senior leaders at DHC have held leadership positions at numerous companies in the past. Because our experts continuously collaborate on projects for gene, gene-modified, and cell therapies across multiple modalities, encompassing all stages of development (nonclinical through to commercial), we’re uniquely equipped to provide as much or as little support as any given situation requires.
This support could be in the form of leadership (Chief Technology, Manufacturing, or Regulatory Officer) or technical expertise in the areas of CMC, manufacturing, quality, regulatory, analytical, non-clinical, project management, and/or regulatory writing.
DHC’s goal is to progress the field of CGT by assisting organizations get to their next step(s) in a timely and effective manner while planning for future growth. In any of these situations, the impact is to keep each client’s product or process on track and moving forward for as long as the client requires support (engagements have ranged from a few weeks to several years), stepping back and handing operations off to the client once they find themselves in a self-sufficient position. Embedding our experts can be extraordinarily helpful in minimizing disruption during change but these needs rarely, if ever, require a permanent DHC-based solution. Our emphasis is always on helping each client operate as efficiently, effectively, and independently as possible.
Our teams can take a hands-on, daily embedded approach or act as strategic advisors taking an outside-in approach. Occasionally our expert will bring in additional support from DHC colleagues to ensure top-tier coverage of multifaceted client needs.
Four examples of common reasons clients may be in need of interim leadership support are as follows:
a) Staffing vacancies. Occasionally organizations find themselves needing interim support to keep operations running while they hire a role internally, whether during the initial staffing ramp up for a young company, during an extended employee leave, or as a replacement for an employee who left the organization. With years of experience in leading departments, DHC SMEs get up to speed quickly, hit the ground running, and step in to seamlessly drive timelines to meet the company’s needs.
b) During acquisitions or mergers, it’s common for one or more site to be brought under the umbrella of their new parent company: in those instances, our experts can act as a Site Manager, COO or CTO to ensure momentum is maintained during the transition, while allowing time for the company to find the right permanent leader for the position. Alternatively, some companies reconsider staffing levels due to growth, technical changes or improvements, site redesign, etc., and need a consultant who can reallocate resources effectively while ensuring timelines remain on course.
c) In the event of a downsizing, DHC experts can step in to lend a hand in stabilizing operations while the company works to reposition itself for a more optimal future state.
d) Bringing top-tier expertise to particularly challenging situations: sometimes, a challenge emerges that is beyond the experience of current staff. Solving these issues may require the support of someone with either different or deeper technical expertise. The breadth and depth of DHC’s experience in working with 200+ clients a year enables us to bring unrivaled expertise to address even the most complex development challenges faced by our clients. In these cases, DHC can plug in to existing client teams to bring additional expertise to overcome complex technical, CMC, quality, regulatory, nonclinical, and/or clinical challenges.
