Thoughtful planning and precise execution are becoming increasingly critical as the hurdles to drug approval continue to escalate. We believe that the amount of effort spent in planning a development program is directly related to its chance of success. At Therapeutics, we will clearly define a development strategy for your product and masterfully execute the program from concept to regulatory approval.

Market Assessment

To confirm the need for the envisioned product and its commercial viability, Therapeutics strongly recommends a proper market assessment prior to investment of significant product development resources. We can work with you and your commercial colleagues or one of our affiliates to develop the instruments needed to conduct primary qualitative and quantitative market research with physicians and targeted patients.

Often market assessment findings can reveal the product most appropriate to develop. To illustrate, one recent study executed by Therapeutics provided compelling evidence that the client had made an incorrect assumption about which product form target patients would prefer. Without those market research results the client would have proceeded with developing the less-desired product form, negatively affecting product success and ROI.

Technology

Understanding the features, benefits and limitations of a technology, from a safety and efficacy perspective, as well as its requirements from an analytic/formulation/manufacturing viewpoint are vital to the development of a successful strategy. Therapeutics focuses on helping its clients ensure they are developing the right technology for the right indication. We ensure that the product has a reason to be and a point of difference that is meaningful to patients, healthcare providers and, if appropriate, a strong rationale for reimbursement.

Regulatory

The regulatory hurdles for drugs, devices and biologics are dynamic but unlikely to decrease. Therefore, it is critical that your regulatory strategy be central to the development planning process. Our regulatory personnel have been in the game long enough to know that there are no successful shortcuts, yet are vigilant in the pursuit of alternate regulatory pathways and creative approaches to satisfy requirements without incurring unnecessary costs or delays. We prefer to prospectively engineer the regulatory requirements into the development plan, rather than depending on remedial, “bolted-on” solutions.

Clinical

Therapeutics’ clinical development capabilities are unsurpassed in the industry. Since dermatology is largely a descriptive science, it is absolutely critical that the clinical strategy and protocol design be founded upon hands-on experience to ensure that the protocol and program are not only ingeniously designed, but that they can actually be executed in the clinic. At Therapeutics, the dermatologist who develops your clinical strategy also sees patients on a regular basis, which is essential to conducting quality research according to your timeline.  This regular patient contact fosters continuous evaluation of the practicality of protocol execution.

Therapeutics also has a large network of experienced investigators and we constantly challenge our current investigator family and search for new members who can meet Therapeutics’ requirements.