Together on the trail to the summit
We, at Drug Development Consultants, believe that bringing a drug to market is a noble pursuit. The discovery of one drug, producing a generic version of another or approving a third for new application are rooted in the desire to improve health and find affordable ways to benefit the many.
HOW DID WE GET HERE?
This thinking is embedded in the broad background of Ron Filler, PhD, the Founder and President/CEO of Drug Development Consultants. Ron multi-faceted experience as a Basic researcher in some of the most well-known scientific institutions led him to applied science and to directorial positions in various contract labs and Pharma.
But not until 17 years ago, with the founding of DDC, could he implement a consistent high level quality control and a combination of hands-on and out-of-the-box global thinking.
PERSONAL AND EFFECTIVE
As a boutique company by-design, DDC is a consulting company tailored to the specific needs and structure of each client. Kept intentionally small, DDC develops a close team-relationship with the client and makes itself available as part of the client’s team. This approach is invaluable to small and medium size companies that are limited in their resources. DDC’s mission is to optimize a client’s ability to reach the marketplace with minimal costs and in the shortest time possible.
For that purpose, we maintain the highest level of current scientific capability in pharmaceutical development. DDC’s senior staff scientists have over 30 years of individual experience in pharmaceutical regulatory and scientific services. These experts cover a comprehensive list of therapeutic indications, nonclinical safety assessment approaches that include in silico Quantitative Structure Analysis Relationship (QSAR) analysis, external peer review of toxicological pathology findings, pharmacokinetic evaluations of Phase 1 trials, and CMC/formulation development.
Ron is the main point of contact for each project. He plans and oversees nonclinical and clinical phases, provides regulatory guidance for meeting FDA’s safety and efficacy requirements and advocates for the company as needed. Guided by “Do No Harm”, DDC strategy has been to maintain a balance between efficacy and toxicity according to the prevailing thinking of the FDA.
THE WORLD WITHIN REACH
The advocacy role of DDC is particularly crucial for foreign drug companies that are looking to enter the US market. In our capacity as a registered US agent, DDC represents foreign companies to the FDA, and when the situation arises, we provide due diligence capability to facilitate licensing partnerships with other drug companies.
DDC has successfully acted as US agent for companies from Denmark, Italy, England, Japan, and Israel. DDC developed a close regulatory partnership with CoreMed Corporation of Japan. Together, they look to expand the options of their clients to become a global success.