OUR PEOPLE:  GLOBAL EXPERIENCE

Damaris DeGraft-Johnson, RPh, MSc. Med. Chem.
Founder and President

Damaris DeGraft-Johnson, RPh, is currently a Global Regulatory Consultant for the Pharmaceutical and Biotechnology Industry. Damaris was also an adjunct assistant Professor at Temple University School of Pharmacy (Quality Assurance/Regulatory Affairs Program).

She received her B.S. in Pharmacy/Management from the University of Science & Technology, Ghana, West Africa, and a MSc. in Medicinal Chemistry from the Philadelphia College of Pharmacy & Science (currently University of the Sciences Philadelphia). Prior to her current position, Damaris was a Senior Director and head of the Worldwide Regulatory Affairs at DuPont Pharmaceuticals. Damaris was also head of the Worldwide Regulatory Affairs at Rhone-Poulenc Rorer (currently Sanofi-aventis Pharma). Before joining Rhone Poulenc-Rorer, Damaris worked at Merck and held several positions with increasing responsibilities in pharmaceutical development as well as International Regulatory Affairs (over 30 countries including EU/Japan/ Canada/Eastern Europe, etc.).

Her 20 years of global regulatory experience have afforded her with expertise in the areas of preparation and filing of INDs/CTAs/NDAs/NDS/MAAs, amendments/variations, global regulatory review/approval and global regulatory strategy and agency meetings. Her 20 years experience in drug development and manufacturing have enabled her to demonstrate significant expertise in various aspects of the field ranging from pre-formulation to commercialization of an array of products in all therapeutic areas. Some of the aforementioned products that bear her contribution in various stages of the regulatory process are:

Edluar® - Sublingual tablets for sleep disorders
SUSTIVA® - Tablets, capsules and Liquid dosage forms for Treatment of HIV
INNOHEP® - An IV Formulation used to treat blood clots and other related conditions
VIASPAN® - A Sterile Organ Preservation Solution
SINEMET CR® - A Tablet Formulation used for the Treatment of Parkinson's Disease
TAXOTERE® - An IV Formulation for Oncologic Indications
LOVENOX® - An IV Formulation for Cardiovascular Indications
RILUTEK® - A Tablet Formulation for ALS
SYNERCID® - An IV anti-Infective Product
EBASTINE® - A Tablet Formulation for Respiratory Indications NASACORT® & AZMACORT® - Inhalation Products
MENOREST & COMBI-PATCH®-Transdermal Patches with Estrogen/Progesterone for Various Menopausal Symptoms and Osteoporosis

UNITED STATES:

Kathleen Koons, MSc
Senior Regulatory Affairs Manager

Kathleen Koons is a Senior Regulatory Affairs Manager with DJA Global Pharmaceuticals, Inc. She received her Master of Science degree from West Chester University and her Bachelor of Science from the Pennsylvania State University. Her previous work experience comprises small and large pharma including Astra-Zeneca, Rhone-Poulenc Rorer and Sanofi-aventis.

Working within multi-disciplinary US/EU drug development teams, she has 20 years hands on experience with the evaluation and preparation of multiple INDs/NDAs, briefing packages, Investigator Brochures, etc. She has also conducted in-house and vendor audits, reviewed and approved batch records and corresponding support documentation. Kathleen coordinates with and assists clients in the development, management and creation of CMC regulatory submission documentation.

John Budzinski, Ph.D.
Contract Manufacture

Dr. Budzinski has over 28 years of management, technical and business experience in R&D in addition to administration and manufacturing experience. His recent focus is on all aspects of pharmaceutical manufacturing outsourcing. He received his B.A. in Chemistry and his Ph.D. in Organic Chemistry from Washington University, St. Louis, Missouri. Currently, Dr. Budzinski applies his expertise in the area of private consulting. John is also on the editorial board of Bio/Pharmaceutical Outsourcing Report. Some of the highlights of his career experience include pharmaceutical outsourcing, vendor identification/ selection, contract and price negotiations, demonstrated cost savings, international experience, cross functional management skills, auditing for manufacturing suitability and R&D Discovery and Process Development.

Julie Eble, Ph.D
Analytical Services

Dr. Julie Eble has 25 years of collective experience in regulatory sciences. She received her Ph.D. in Analytical Chemistry from Villanova University. Julie worked at Wyeth Laboratories where she developed methods and conducted stability and purity tests in the Production Development Section. Subsequent to this, she worked with DuPont's Biomedical Product Chromatography Application Group. Her career path next led her to DuPont Crop Protection where she managed a variety of projects, from planning and implementing phases of a business re-engineering to launching a worldwide program for project-management competency. While still at DuPont Crop Protection, Julie functioned as a Study Director, Sponsor Representative, and Analytical Coordinator for GLP studies. She also developed numerous analytical methods using HPLC and GC techniques. Currently, as a consultant, her experience affords her the ability to offer the skills of analytical consulting, project management, and technical writing.

Ronald J. Gerson, Ph.D., DABT
Preclinical Toxicology

Ron Gerson is President of Gerson Pharma Solutions, LLC, a consultancy with expertise in the design and execution of Preclinical Toxicology programs to support the human testing and successful registration of drug candidates.

Prior to Gerson Pharma Solutions Dr. Gerson was Vice President of Preclinical Research and Development and Vice President of Scientific Evaluation at Endo Pharmaceuticals. As Vice President of Preclinical Research and Development he was responsible for all preclinical activities supporting drug development and registration overseeing all activities in Toxicology, Drug Metabolism/Pharmacokinetics, Pharmacology and Pharmaceutics Development. Prior to his tenure at Endo Pharmaceuticals Dr Gerson held leadership positions in the Preclinical Toxicology Departments at Merck, Sterling-Winthrop, DuPont-Merck and DuPont Pharmaceuticals.

During his 25+ year tenure in the pharmaceutical industry, Dr. Gerson has been responsible for the preclinical development of a broad range of therapeutic classes of drugs including cardiovascular, antiviral, analgesic, CNS, cancer and imaging agents. He has written or directed the preparation of over twenty IND/FIM packages and four successful NDA/MAA submissions, including worldwide drug submissions for Zocor® and Sustiva®.

Dr. Gerson received his B.A. in Chemistry from the State University College of New York at Cortland, an M.S. in Pharmacology from the University of Maryland, his doctorate in Toxicology from the University of Rochester and pursued post-doctoral training in Biochemical Toxicology in the laboratory of John Farber at Hahnemann University.

Dr. Gerson is a member of the Society of Toxicology and the American Association of Pharmaceutical Scientists and is board certified in General Toxicology by the American Board of Toxicology.

Philip Ma, Ph.D., B.S.
Contract Manufacture

Dr. Ma has over 20 years of experience in pharmaceutical industry serving major pharmaceutical companies, consulting on process R&D and working in medicinal chemistry laboratories. He received his B.S. in Chemistry from University of Pennsylvania and his Ph.D. in Organic Chemistry from Massachusetts Institutes of Technology. Currently, Dr. Ma applies his expertise in the area of private consulting. Some of the highlights of his career experience include project management, drug development outsourcing, vendor selection for API, development of novel chemical structures and contribution to an array of scientific publications.

Peggy Schwartz, B.A. Microbiology
Quality Assurance

Peggy Schwartz has 25 years experience in Drug Development Quality Assurance including compliance with GMP, GLP, and GCP regulations. Peggy received her B.A. in Microbiology from Rutgers University in New Brunswick, New Jersey. She began her career in Quality Assurance working for Proctor & Gamble (P & G) as a Microbiologist in a GMP facility in Hatboro, Pennsylvania. She directed the Quality Assurance Department and hosted numerous FDA inspections. Through the transition of the plant to a Total Quality Management System, Peggy received valuable training and experience in applying the principles of Total Quality to all manufacturing processes, as well as the Microbiology and Analytical Laboratories. After 15 years at P&G, Peggy moved on to be the Director of Quality Assurance in a GLP facility where she was instrumental in improving laboratory processes, and led the Quality Assurance Department through GLP training, internal and external audits, corrective action systems, and calibration/validation programs.

Relocating to Chester County Pennsylvania to work for a Johnson & Johnson company, Peggy assumed responsibility for managing Clinical Operations and Regulatory Affairs. She was able to utilize her expertise in applying the principals of Total Quality to improve the Good Clinical Practices procedures in the office as well as at clinical sites.

Most recently, Peggy held the position of Director of Quality Assurance and Compliance for Vicuron Pharmaceuticals, a Biopharmaceutical company in King of Prussia, Pennsylvania. In this role, Peggy was responsible for all aspects of Quality Assurance for manufacturing and packaging of clinical supplies as well as compliance with GCP regulations at over 100 clinical sites worldwide.

CANADA:

Robert Sarrazin, MSc., B.S.
Canadian Regulatory Affairs

Robert Sarrazin has cumulative experience of more than 34 years in the world of regulatory affairs. He received his B.S. in Pharmacy and his MSc. in Immunology from the University of Montreal. He began his career as Associate Medical Director with Poulenc Limited where he assured the registration of many therapeutic drugs. In time, he became the Director of Regulatory Affairs for Rhone-Poulenc Rorer Canada Inc. For some time, he was on the faculty of the University of Montreal teaching regulatory affairs. Currently, he is the director of regulatory affairs for Applitox Bio Pharmaceuticalsas well as being a private consultant for brand name and generic companies. Some of the areas in which his regulatory experience excels are antipsychotics, antibacterials, antiparasitic agents, antidepressants, anticancer, non steroidal anti-inflammatory, antihypertensive, antiangina agents, antihistamines, vaccines and other biological products.

Peter Jeffs
Canadian Regulatory Affairs-Chemistry, Manufacturing, and Controls

Peter Jeffs and Associates Inc. (PJA) is a consulting business specializing in Canadian CMC. PJA was established in 1996 by Peter Jeffs after accumulating 30 years experience in the CMC area of drug approval with Health Canada. His role with Health Canada was director of the Bureau of Pharmaceutical Quality. PJA has been involved in numerous Canadian filings of New Drug Submissions (NDS), Supplemental New Drug Submissions (S/NDS), Notifiable Changes (NC) and Clinical Trial Applications (CTA) for both pharmaceuticals and biologics. PJA has also prepared several CTDs. In addition to the preparation of submissions, PJA provides strategic regulatory advice on CMC issues, expert reports, and detailed reviews of CMC data in submissions. Peter's experience with Health Canada gives PJA a unique knowledge of Canadian CMC requirements. The fact that Peter was a member on the ICH Quality Expert Working Group during the years that the Guidelines on Stability, Impurities, Method Validation, and Specifications were developed, gives PJA a special insight into ICH requirements.

Susanne Picard
Canadian Regulatory Affairs

In 2000, Susanne Picard, a pharmacist with a Master of Hospital Pharmacy, now having over 18 years of regulatory affairs experience, created the society SPharm Inc. Prior to becoming a consultant in Pharmaceutical/Medical Regulatory Affairs in 1997, Susanne held key regulatory and management positions in two multinational pharmaceutical companies and in a contract research organization. Susanne, supported by a team of specialists, brings her highly successful track record in regulatory affairs to SPharm, not to mention her extensive experience in all key regulatory product areas and in various therapeutic fields. This, along with her network of contacts that was built up and maintained for over a decade, brings to SPharm an excellent knowledge of the Canadian and foreign regulations and guidances; strategic business relationships with Health Authorities at all levels; strategic alliances with Contract Research Organizations (CROs), laboratories and other selected, high quality and efficient firms that can provide clients high quality and efficient regulatory and related services; efficient teamwork to respect timelines established with clients and by Health Authorities; a high level of client satisfaction resulting in business relationships that are maintained over time.

EUROPE:

Monica Lofgren M.Sc. (Pharm)
Regulatory Affairs Europe

Monica is a consultant for IPDC (International Pharmaceutical Development Consultants Inc.) working in the area of European Regulatory Affairs. Monica has her degree from the Pharmaceutical Institute in Stockholm, Sweden (now University of Uppsala, Sweden). She started her career working for the drug agency in Sweden reviewing drug applications, moved on in the industry and now has more than 30 years of regulatory experience; the last 24 years with Merck & Co (Merck Sharp & Dohme in Europe). In 1993 she moved from Merck in Sweden to join Merck's newly formed European Regulatory Affairs office in Brussels. During her period in Brussels she gained hands on experiences from all the new European procedures: centralized, mutual recognition, scientific advice, arbitration, variations, etc. and has taken Merck drugs from development through registration to maintenance. During the latter part of her career with Merck she formed a European regulatory policy group in Brussels and was very much involved in the new pharmaceutical legislation, which was finally published in April 2004. She has been chair of EFPIA's (European Federation of Pharmaceutical Industries and Associations) Regulatory Affairs ad hoc group and one of the Policy Committees: the Scientific Technical and Regulatory Policy Committee. In addition, Monica is co-author of the book, "New Drug Approval In the European Union: The EMEA" (Paraxel).