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About Us
What we offer:
• Exceptional team of pharmaceutical development and global regulatory experts
with significant prior experience from major and small pharmaceutical companies.
• Significant hands-on experience in problem-solving for small and large companies.
• Significant scientific background.
• Timely and detailed attention to project needs and objectives.
• Confidentiality
EXECUTIVE STATEMENT
DeGraft-Johnson & Associates (DJA) is focused on bridging the complex areas of pharmaceutical development and global regulatory science. DJA was founded to provide sound, practical guidance to the pharmaceutical, device, and biotechnology industries. DJA is composed of highly technical and experienced consultants that are dedicated to applying the highest standards of regulatory rigor, ethics, and professionalism. These consultants have significant industry and global regulatory expertise to resolve challenging issues.
Based on our proven track record of success we believe the key factors to successful product development and commercialization include the following:
• Understanding customer project needs and objectives.
• Proactive integration of strategic regulatory direction to your project objectives
right from the beginning.
• Providing sound, strategic solutions to meet the challenges that are typical of
development and global regulatory affairs.
• Providing timely, cost-effective services based on real-life experiences.
We accomplish this by assisting our clients in meeting project objectives and deadlines without sacrificing integrity, innovation, or excellence.
We also offer various in-house and off-site training to meet the needs of our clients.
By choosing DJA to fulfill your development and global regulatory needs, you will be selecting a company with a combined experience of well over 100 years that will effectively manage your project with success!
Damaris DeGraft-Johnson, RPh, MSc. Med. Chem.
Founder and President
GLOBAL EXPERIENCE
Damaris DeGraft-Johnson, RPh, MSc. Med. Chem.
Founder and Principal Consultant
Damaris DeGraft-Johnson, RPh, is currently a Global Regulatory Consultant for the Pharmaceutical and Biotechnology Industry. Damaris is 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 CMC group at DuPont Pharmaceuticals for about 3 years. Damaris was also head of the Worldwide Regulatory Affairs CMC department at Rhone-Poulenc Rorer (currently Aventis Pharma). Before joining Rhone Poulenc-Rorer, Damaris worked at Merck and held several positions with increasing responsibilities in pharmaceutical development in the areas of preformulation, spectroscopy, stability optimization, scale-up, manufacturing problem-solving, as well as International Regulatory Affairs (over 30 countries including EU/Japan/Canada/Eastern Europe, etc.). Her background also includes hospital and retail pharmacy, as well as quality assurance and control.
Her 15 years of 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:
SUSTIVA® - Tablets, capsules and Liquid dosage form 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
CANADA:
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. Peters’ 30 years 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.
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 Pharma as 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.
EUROPE:
Monica Löfgren 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 to the industry and has now 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).
Marjorie Taylor BSc Ph.D Dip Reg Affairs MRPharmS
Regulatory Services
Dr. Marjorie Taylor is a pharmacist and partner with The Medical and Regulatory Partnership Ltd., a UK-based consultancy specialising in clinical and regulatory consulting. With substantial regulatory experience in the pharmaceutical industry gained with Wyeth, Smith Kline Beecham (now GlaxoSmithKline), Fisons, Rhône Poulenc Rorer (now Aventis), Marjorie has a strong pedigree in European regulatory affairs.
Marjorie has worked in a number of therapeutic areas including CNS, CVS, Oncology and Respiratory. Her regulatory expertise spans product development through to in-market product launch and support covering markets in Europe (including the Mutual Recognition Procedure) and the Asia-Pacific region. Within global regulatory affairs she has managed projects both in the CMC and Clinical areas.
Recent assignments include UK Product Licence Transfers, EU Accession market support, the MR Repeat Use Procedure and worldwide regulatory defense for a major anti-migraine product for a UK-based major multi-national pharmaceutical company.
Marjorie holds the UK Diploma in Regulatory Affairs.
Richard Taylor BPharm Ph.D MRPharmS
Clinical and Regulatory Services
Dr. Richard J Taylor is a pharmacist and a partner with The Medical and Regulatory Partnership Ltd., a UK-based consultancy specialising in clinical and regulatory consulting. With substantial experience in both public and private sectors, he has held senior medical and regulatory positions in the pharmaceutical industry and is widely published on pharmaceutical matters.
Richards’ expertise is in assisting developing organisations to build medical, clinical and regulatory affairs capability. His experience extends to a number of therapeutic areas and areas of interest are e-projects, prescription to OTC switch and medical and regulatory due-diligence for product in-licensing evaluations. Recent assignments include e-business consulting for a major multi-national Pharmaceutical company.
Richard is the former Head of International Clinical & Regulatory Affairs of Zeneca Pharma International (ZPI), the business unit of Zeneca Pharmaceuticals (now AstraZeneca plc) responsible for emerging markets, where he was responsible, among other things, for the strategic development of clinical trials capability. He also has pharma merger experience in clinical integration and change management.
At Fisons Pharmaceuticals he had responsibility for UK Medical Services, including medical information and pharmacovigilance and prior to this was Senior Clinical Research Scientist and subsequently Head of OTC medicines in International Medical Affairs at The Wellcome Research Laboratories (now part of GlaxoSmithKline plc).
Richard is a member of the Professional Executive Committee (PEC) of a UK National Health Service Primary Care Trust (PCT) and an assessor for The Royal College of General Practitioners Primary Care Research Team, which assists UK physicians’ practices gain accreditation to conduct clinical studies. He is a recipient of a Medical Research Council Scholarship at The Institute of Psychiatry and Kings College Hospital Medical School, London, UK; and holder of the first UK College of Pharmacy Practice Research Fellowship.
UNITED STATES:
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.
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 as a Microbiologist in a GMP facility in Hatboro, Pennsylvania. Here 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. Here 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. 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. Currently, as a consultant, Peggy offers GMP, GLP, and GCP Quality Assurance services in the areas of process assessment/improvement, SOP development, employee training, auditing and corrective action programs.
Prafull Shiromani, M.Pharm., Ph.D, CPhT.
Prafull Shiromani has 30 years supervisory experience in Pharm. R.& D., including 23 years at Merck in ‘solids (tablets)’ formulation and six years with Novartis in parenteral, liquid and semi-solids formulations. He received his Ph.D. in Pharmaceutics from Rutgers University-College of Pharmacy and his M. Pharm. from the University of Wales, Cardiff, U.K. He has actively managed top priority projects for Merck and Novartis, involving formulation development and commercial introduction of antihypertensives – Vasotec and Prinivil, cholesterol reducers – Mevacor and Zocor, histamine-2 receptor blocker – Pepcid , HIV Reverse Transcriptase Inhibitors, Lyophilized Parenterals, Desferal, etc. He was involved in initiating the manufacturing of these products in France, England, Holland and Germany. He has developed novel dosage forms of these products, such as chewable tablets, effervescent tablets, lyophilized tablets (Zydis), etc.
He was actively involved with JJMCP (Johnson & Johnson-Merck Consumer Products Co.) from 1989 to 2004 and succeeded in switching Pepcid Rx to Pepcid AC-OTC. He also worked on several other switch compounds, such as Mevacor OTC, Flexeril OTC, etc. He has extensive experience in Technical Writing (NDAs, INDs, Validation Reports, Development Reports, Biobatch Reports, Expert Opinion Reports for EMEA), providing assistance to the CMC, Regulatory, Quality Assurance Departments, participating in FDA Pre-Approval Inspections, cGMPs, working in Drug Development Teams, etc.
He has published and presented (incl. to FDA-CDER) extensively on ‘Statistical Optimization of Pharmaceutical Formulations’. He has performed factory audit as per 21 CFR Parts 210 and 211 and also participated in training of FDA Field Inspectors. He has been an adjunct professor at the Colleges of Pharmacy at University of Missouri and Temple University, Pa., and he has been a Ph.D. External Advisor at these schools. He was awarded Merck’s Vice-President Award for development of Vasotec and Prinivil. He has successfully completed four Aventis corporate courses on Clinical Study Site Monitoring and recently became certified as a Pharmacy Technician through the National Pharmacy Technician Certification Board.
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