Pharmanet

The dermatology team has experience in all stages of development, with the depth and breadth to conduct studies on any scale from regional to large, global programs. Medical professionals include dermatology-experienced clinicians, with operations expertise provided by clinical research associates, project managers, data management professionals, biostatisticians, and medical writers.

Leading the team is Karen Lewis, MS, Executive Director, Clinical Research.

Dermatology Study Experience

Regulatory experience includes NDA, ANDA, and 505(b)(2) NDA submissions; GMP, GLP, and cGCP audits; as well as regulatory liaison. Study experience includes topical, systemic, transdermal, transmucosal, and inhaled products, as well as devices, for:

Anti-acne	Anti-viral
Anti-bacterial	Dry skin
Anti-fungal	Wound care
Anti-inflammatory

Along with its expertise and experience, PharmaNet Dermatology also offers key competitive advantages:

	Strong relationships with many of the world’s leading medical centers and specialists, enabling access to a large network of investigators and patient populations.
	Senior-management oversight of all projects.
	A collaborative approach among team members and sponsor staff to share best practices and knowledge about the competitive landscape.

Karen Bean Lewis, MS

Executive Director, Clinical Research

Ms. Lewis has nearly 20 years of clinical-research experience. At PharmaNet, she oversees operational aspects of Phase II–III clinical studies in dermatology, and has directed or managed more than 25 studies in a wide range of indications. Prior to PharmaNet, she was Senior Manager, Clinical Research at Otsuka Maryland Research Institute. At Otsuka, Ms. Lewis planned and managed Phase I–III studies in neuroscience, cardiology, infectious diseases, and gastroenterology. She is a member of numerous professional societies, including the Association of Clinical Research Professionals and the American Chemical Society.

Patricia Milani, BSc

Senior Director, Quality Assurance

Ms. Milani manages quality systems on all Anapharm sites through a group of experienced auditors who cover clinical, bioanalytical, and scientific activities. The group also closely monitors supporting entities, including information technology, clinical laboratories, training, and any service providers that have a direct impact on Anapharm’s regulated activities. All audits are performed according to the standards of FDA, ICH EMEA, as well as Brazilian GLP, GCP, and GXP. Ms. Milani also manages compliance with Anapharm’s standard operating procedures, and has developed effective quality performance to ensure continual improvement in quality and compliance. She has hosted numerous positive regulatory inspections from FDA, HPFB, European agencies, ANVISA certifications (Brazil), and has participated in many positive GLP/GCP assessments from pharmaceutical companies worldwide. She previously worked for more than 7 years in an environment analysis laboratory, where she contributed to implementing and managing a GLP QA program.

Naim Zaki, MD, MS

Medical Director

Dr. Zaki has nearly 30 years of experience in medicine as well as the biopharmaceutical and contract research industries. At PharmaNet, he has served as the medical monitor on Phase II–IV clinical studies in infectious diseases, dermatology, urology, and endocrinology. Prior to PharmaNet, Dr. Zaki served in a variety of clinical research positions at companies including Genta Biopharmaceutical and Advanced Biologics. Prior to entering the biopharmaceutical industry, he served as a primary care physician, surgeon, and lecturer in biology, anatomy, and surgery.