Leadership

Consultants

Chemistry and Manufacturing: DeGraft-Johnson & Associates, LLC
DeGraft-Johnson & Associates has over 25 years combined global regulatory and hands-on experience in drug development and life-cycle management with DuPont Pharmaceuticals/Bristol Myers Squibb, Merck & Co and Rhone-Poulenc Rorer (now Sanofi-Aventis) Pharmaceuticals. Damaris has made significant contributions to the timely resolution of complex issues related to the development, manufacture and commercialization of over 200 products in the global markets. Damaris has been involved with all the European regulatory procedures for clinical trials and marketing authorizations. Damaris is also an adjunct Professor at Temple University School of Pharmacy (Quality Assurance/Regulatory Affairs Program). As Founder and Principal Consultant of DeGraft-Johnson & Associates LLC (www.degraftjohnsonassociates.com), Damaris also acts as a consultant for the Pharmaceutical and Biotechnology Industry.

Intellectual Property: Oblon Spivak
Founded in 1968, Oblon, Spivak, McClelland, Maier & Neustadt has grown to become one of the largest firms in the United States specializing exclusively in intellectual property law. They attribute our steady growth to their founders' passion for quality service and uncompromising scientific expertise.

They offer a team of internationally known experts in every field of intellectual property law, all enthusiastically committed to the goal of client service. Their accomplished professionals are experienced in every technical discipline and hold doctorates and other advanced degrees in biotechnology, computer and software engineering, physics, chemistry, and many other fields.

Regulatory and CRO: PharmNet Development Group
PharmNet Development Group, a drug development services company, provides a range of early and late stage clinical drug development services to branded pharmaceutical, biotechnology, generic drug, and medical device companies worldwide. In early clinical development services, PharmNet specializes primarily in the areas of Phase I and early Phase II clinical trials and bio-ana!ytical laboratory services, including early clinical pharmacology. The company also provides late stage clinical development services that focus on Phase II through Phase IV clinical trials. It also offers a range of complementary services, including data management and biostatistics, clinical laboratory services, medical and scientific affairs, regulatory affairs, submissions, and clinical IT solutions. The company has approximately 40 offices in North America, Europe, South America, Asia, and Australia.

API Supply: Interchem
Interchem Corporation prides itself on over 20 years of service in the pharamaceutical industry. Since its inception, Interchem has been successfully locating sources of fine chemicals, intermediates, bulk actives and sophisticated next generation compounds from all over the world. Interchem today represents some of the world's best manufacturers of fine chemicals and active pharmaceutical ingredients. By combining the expertise of their manufacturers and their in-house technical and regulatory team, they are able to handle even the most diverse customer requests in a quick and reliable manner.

PreClinical: Aspen Biomedical Consulting, Ltd.
Aspen Biomedical Consulting has provided a range of services related to regulatory strategies in pharmaceutical development and drug safety on a national and international level. Their services include high level strategic approaches for overall development, as well as specific approaches and solutions for clinical and nonclinical issues related to the research and development of all classes of drugs and biologics, from pre-IND through post-NDA.