June 6, 2016
By Alex Keown, BioSpace.com Breaking News Staff
Biologics Consulting, based in Alexandria, Virginia, launched a new division aimed at designing efficient preclinical and clinical programs to put pharma companies on the pathway to regulatory approval.
The new Clinical Trials Planning and Oversight Group is aimed at providing assistance to small and medium-sized biopharmaceutical companies as they develop and manage of efficient and cost-effective clinical trials.
Biologics Consulting has a long history of helping pharmaceutical companies with regulatory and product development issues. But, over time, company officials noticed there was a need from numerous client companies, particularly the smaller biotechs that may lack the internal infrastructure to develop and run their own clinical trials.
Steven Walker, Biologics Consulting’s chief business officer, said the role of the new division is to make sure the client company has the tools to be as “successful as possible” and as “time efficient and cost conscious as possible” when it comes to developing clinical trials.
Norman Baylor, president and chief executive officer of Biologics Consulting, said in a statement that the company has seen a “significant need” for the types of services the new division will provide and added the company has “the in-house experience and expertise necessary to fill the void that currently exists in the market.”
“Generally speaking, we’re able to not only provide comprehensive assistance to biotech and pharma companies, we’re looking at helping clients navigate the earlier stages from pre-IND stage to full licensure,” Walker told BioSpace in an exclusive interview ahead of BIO 2016. “We can go from animal models to human models to commercialization and then to FDA approval.”
The new division will be able to design a trial from the ground up, or assist a company in transitioning from a Phase I to a Phase II trial.
“The true benefit of having a full service consulting company is we can pull in many aspects of a clinical trial to interpret and implement data,” Walker said.
Biologics Consulting has worked with more than 3,500 companies in 53 countries, and in the past four years, has contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported), 80 510Ks, and 42 IDEs. Over that time frame, Walker said it became apparent there were areas where their clients needed assistance, such as how to read data, manufacture, and store and move the product.
Looking at the contract research organization (CRO) landscape, Walker said they expect to see growth of between 5 and 10 percent in the market between now and 2022, which is based on the increased expectations of companies outsourcing their CRO needs. Walker said it’s not only important for a company to vet the CRO, but also have an additional set of eyes to review clinical trial data to be sure the information is being viewed with an internal bias.
“We are not a CRO, but we can help identify and manage the relationship of the CRO interactions… There is a need for external expertise in managing these relationships,” Walker said. “One gap that was identified was clinical trial information in some cases may not have been as well prepared or executed as it could have been.”
With several clients already onboard the new division and more planning on using the company’s services, Walker said they are building up the new division with content experts and “integrating them into the broader organization.” Currently, Biologics Consulting has more than 60 employees and a network of about 100 consulting subject matter experts.
Walker said the primary milestone for the new division is ensuring they’re being customer centric. He said they have to make sure theirs is a model that is “responsive, flexible and meets the needs of the client.” Walker said there has been a complexity of requests from some companies, often due to support issues for combination products, companion diagnostics or orphan drugs with small testing populations.
“We have the breadth of experience to address any trial concerns and we’ll continue to grow the level of expertise… by understanding there’s this evolution of complexity to make sure we have backgrounds and experience to support it (the new division),” Walker said.
