GZP is announcing expansion of its longstanding capabilities in helping its clients develop biosimilars and drug or biologic/diagnostic device personalized medicine programs for FDA and EMA review.
New legislative initiatives in the US and subsequent regulations and guidelines have provided a number of pathways for development of biosimilars, with the associated requirements for intensive planning and execution of nonclinical and clinical programs.
GZP's CMC, pharmacology/ toxicology, clinical and regulatory experts are available to assist firms in navigating the complexities of such programs.
GZP has been working with firms in Australasia, the US and Europe to develop and test prognostic/diagnostic devices and test methodologies, including genetic testing and identification of biomarkers, for use during clinical trials and post approval therapy.
The selection of appropriate candidates for clinical trials, as well as for specific commercial treatments are important in the personalized medicine and reimbursement arenas.
Regulatory success can be enhanced by assuring that new clinical trial initiatives are carried through to the review and approval process and GZP works with clients to achieve this goal.
Dr. Evan B. Siegel, GZP's CEO, will be in Kuala Lumpur (November 17-22), and will be pleased to meet with interested parties by individual arrangement in Malaysia.
In 2012, GZP increased its global client base across therapeutic areas such as oncology, ophthalmology, and endocrine disease.
The firm created and submitted several INDs and facilitated many meetings and other communications with the FDA, leading to rapid movement of client programs.
GZP believes that early, frequent, targeted, and creative FDA communication leads to successful product development and attracts investors in today's financial climate.
According to Evan Siegel, "We are pleased that firms are still generating promising diagnostic and therapeutic products in the biotechnology and pharmaceutical spaces. Our clients believe that data speak strongly to regulators and we provide sophisticated and intensive help towards that end. The continued success of our business is attributable to our long-term clients, repeat business, and referrals, as well as the stability of our team. This provides an integrated and client-specific approach to delivering the highest quality regulatory and product development services."