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Murad Husain, RPh, MS
Murad Husain is a Regulatory affairs professional with more than 25 years of pharmaceutical industry experience, 20 years of which is in regulatory affairs.
Murad led numerous worldwide regulatory teams for drugs and biologics development and registration. He achieved approvals of original NDAs, BLA and new indications for drugs and biologics in pulmonary, oncology, CNS, rheumatology, anti-infective therapeutic areas while at Pfizer, Hoffman-La Roche, Serono, Astra, Forest and Savient. He led several FDA Advisory Committee meeting preparations, negotiated drug development and registration programs with FDA, MHRA, MPA, BfArM, HPB and EMA. Murad also achieved US FDA approvals of generic drugs while at Forest, Ben Venue and Astra. Regulatory strategy for drug development is Murad’s core competency. Murad worked with many small, medium and large international pharmaceutical companies for in- and out-licensing activities. Murad was a member of PhRMA’s Pharmacogenetic Task Force, Oncology Dialogue, and was actively involved with PDA’s Technical Committee. Murad’s recently held positions have been Vice President of Regulatory Affairs at Savient Pharmaceuticals, Worldwide Director of Regulatory Strategy at Pfizer, Director of Global Regulatory Affairs at Hoffman-La Roche, Associate Director of Regulatory Affairs at Serono and Astra (now Astra-Zeneca), Manager and Associate at Ben Venue (now Boehringer Ingelheim) and Forest. Murad holds a Master's degree in Pharmacy as well as a Master’s degree in Pharmaceutical Marketing. He is a Registered Pharmacist in New York.
Roberta Tucker, RPh
Roberta Tucker has 25 years of pharmaceutical experience, primarily in regulatory affairs. She worked at Parke-Davis/Warner-Lambert (Pfizer) for 4 years, 9 years at Hoechst-Roussel Pharmaceuticals (Sanofi-Aventis), 5 years at Astra Pharmaceuticals (Astra Zeneca), 4 years at Asta Medica/Muro Pharmaceuticals, Critical Therapeutics and is now a consultant. Her experience spans large international to small start up companies, dealing with multiple projects across most CDER Divisions. She has submitted multiple INDs, maintained INDS, served as the company liaison for many products, provided strategy for development and FDA meetings, prepared and lead company meetings at FDA, submitted numerous currently approved NDAs, and has extensive knowledge not only of development but of postmarketing activities such as product launches, review of advertising and promotion, corporate compliance, review of press releases and due diligence activities. Her broad based regulatory knowledge and experience has enabled her to guide start ups on corporate requirements and SOPs needed in order to commence clinical trials. She is a registered pharmacist in the PA.
Sharif Ahmed, MS
Sharif Ahmed is a Regulatory affairs professional with 25 years of pharmaceutical industry experience, 15 years of which is in regulatory affairs dealing primarily with FDA and Health Canada. His experience includes working for Fisons (now part of Aventis), ICI (now Astra Zeneca), Interpharm (now Amneal), Faulding (now part of Actavis), Barr and Teva. Most recently, he was a Director of Regulatory Affairs at Barr Laboratories, Inc. which became a subsidiary of Teva. He has worked in a wide variety of therapeutic areas, including reproductive health, analgesics, anesthetics, arthritis, cardiovascular, respiratory, anti-infectives, psychiatry, neurology and oncology. His expertise includes solid oral, semi-solids, liquids, injectables, ophthalmics, nasal sprays and transdermal drug delivery systems. At Barr, he worked with 5 development sites spread across US and Europe. He was also responsible for the US regulatory group based in Europe. In addition to getting hundreds of ANDA approved by the FDA, he managed the CMC submissions of the key Barr IND and NDAs. Sharif also worked and secured approval of a number of ANDS and NDS from Health Canada. He holds a Master's in pharmacy and a Master's in pharmaceutical marketing and health care administration.
Anastasia G Lolas, MS
Anastasia Lolas is a regulatory affairs professional and the owner of Visionary Pharma Consulting LLC. She provides consulting services to the pharmaceutical industry regarding regulatory and compliance issues related to product quality microbiology of small molecules and therapeutic proteins. Previously, she was a Microbiologist with the Biotech Manufacturing Team in the Division of Manufacturing and Product Quality at CDER/FDA and a Microbiology Reviewer with the New Drug Microbiology Staff in the Office of Pharmaceutical Science at CDER/FDA. In her 6 years at the FDA, Anastasia evaluated numerous new drug applications and biologics license applications and conducted pre-license and pre-approval inspections of therapeutic protein manufacturing facilities. Anastasia holds a B.S. in Biology from Virginia Polytechnic Institute and State University and a M.S. in Food Science from the University of Illinois at Urbana-Champaign. Prior to joining FDA in 2005, she was employed at Nestlé Waters North America. Anastasia is the Meeting Chair of the PDA Capital Area chapter and a member of the PDA Letter Editorial Committee.
Brian E Davies, MSc, DIC, FRSB, FCP
Brian Davis is a highly experienced Clinical Pharmacologist with many years of working experience in both animal and human studies. He has a solid background in the drug development process from pre-development/DMPK through regulatory approval. Brian's areas of expertise include protocol design for Phase I/II studies, study conduct, data analysis, and technical and medical writing. Therapeutic areas include oncology, anti-infectives, metabolic disease, virology, inflammation, CNS. Brian's current projects include consultation for Janssen Biologics Division and The Medicines Company. Brian's recently held positions include Director, Clinical Pharmacology at Hoffman-La Roche, Director, Clinical Pharmacology and Medical Writing at Advanced Biomedical Research, and Director, Clinical Pharmacokinetics at Bracco Diagnostics. Brian holds a BSc in applied biology, MSc in biomedical techniques, biomedical methodology and enzymology and a DIC from Imperial College of Science, Technology and Medicine. Brian is also a fellow of the Institute of Biology (CBiol), Royal Society of Biology (FRSB) and American College of Clinical Pharmacology (FCP).
Robert Bell, PhD
Dr Bell is a pharmaceutical executive with over 20 years of multidisciplinary experience in strategic global business development, product registration and commercialization of new drugs, biologics, devices and generic drug products. Dr Bell has extensive experience with global business collaborations and product development efforts resulting in product approvals and market opportunities. He provides active leadership and mentoring involvement with pharmaceutical trade associations and academic institutions. Dr Bell's employment history includes Vice President, New / Strategic Drug Development at Barr Laboratories, Inc., Vice President, Research, Development and Quality at Somerset Pharmaceuticals, Inc., Vice President, Research and Development at UDL Laboratories, Inc., Director, Research and Development at AL Pharma and Senior Chemist at Carter-Wallace, Inc. Bell's research interests include pharmaceutical, clinical and biomedical analysis, CMC, quality, vaccines, follow-on proteins/biologics, women's health and oncology therapeutics. Bell also serves as expert witness in pharmaceutical matters (e.g.GxPs, regulatory, product development, etc.). Dr Bell is an Affiliate Professor of Pharmacy at the College of Pharmacy at the Medical College of Virginia, Virginia Commonwealth University, an Adjunct Professor of Pharmaceutics, a member of the National Advisory Board and recipient of the Distinguished Alumnus Award from the College of Pharmacy, University of Florida. Bell is the Past Chair of the Analysis and Pharmaceutical Quality (APQ) section for the American Association of Pharmaceutical Scientists (AAPS) and serves in various leadership capacities for AAPS, including chair of the 2006 National Biotechnology Conference, Executive Council as Member-At-Large (2009) and Chair of the Americas for the 2010 PSWC/AAPS Meeting. Dr Bell is a member of the United States Pharmacopeia Council of Experts for the General Chapters for Biological Analysis (2010-15), Editorial Advisory Board for the Journal of Pharmaceutical and Biomedical Analysis, Editorial Advisory Board for the Journal of Chemical and Pharmaceutical Sciences and Expert Member, Board of Pharmaceutical Sciences, International Pharmaceutical Federation and reviewer for AAPS PharmSciTech. Bell is also a member of the American Society of Clinical Oncology, American Urology Association, International Society of Andrology, American College of Clinical Pharmacology and American Chemical Society.
Grier Harris, PhD
Dr Harris, has worked in clinical product development since 1986, focusing on clinical trial management and quality services since 1998. This work was conducted under the direction of several different companies, including Clinical Development Associates, Pharmaceutical Development Associates, ClinSites, SFBC Charlotte, and SFBC International. In 2004, Dr Harris left SFBC International and began working full-time for Appian Services, LLC, which eventually became Appian International Research, Inc. Dr Harris' expertise include designing and conducting international, multi-center clinical trials. Perform clinical management, consulting and project planning functions, including creation of clinical development plans for ANDA and NDA projects and preparation of study designs and pricing quotes for clinical trials. Prepare and review protocols, bids and quotes and negotiate contracts with pharmaceutical sponsors and vendors. Provide technical information for Phase I-IV projects, including study design, pharmacokinetics, pharmacology, regulatory affairs and clinical toxicology. Perform hazard assessments and Quality support services for pharmaceutical manufacturers. His clinical expertise include toxicology, oncology, cardiology, diabetes, general medicine, infectious disease, special populations such as pediatrics, geriatrics, pregnancy/lactation, and hemostasis/anticoagulant management. He has presented and published extensively. D Harris is Licensed as Registered Pharmacist (North Carolina) since August 1991. He is also a Board Certified Specialist in Poison Information since July 1996.
William Huang, PhD
Dr Huang has over 25 years of experience in the pharmaceutical industry, including directing biometrics efforts in NDA, BLA, PMA and ANDA submissions. His experience includes working on a number of submissions requiring FDA advisory committees and European submissions, all leading to successful approvals. Prior to joining PGS PharmaServ, Dr Huang served as Head of Biometrics and Programming at several major pharmaceutical and biotech companies. In his previous roles, Dr Huang was responsible for preparing briefing documents, data presentations and data submissions in e-CTD format to the FDA, and representing company to various FDA meetings such as end of Phase II, pre NDA, and FDA advisory meetings. Additionally, Dr Huang provided strategic input and biometrics oversight to U.S. and EU development and commercial efforts. Dr Huang also played a key role in business development discussions that resulted in successful collaborations with other companies. Dr Huang holds a PhD in Statistics from the University of Iowa.
Ashraf Islam, PhD
Dr Ashraf Islam is an analytical chemist with 18 years of management experience in the pharmaceutical industry. He began his pharmaceutical career by leading an analytical group at Par Pharmaceuticals for complete revalidation of the analytical methods to current compliance standard and satisfying FDA's concerns and warning letters. Most recently, he was a director of analytical research and development at Teva Pharmaceuticals (formerly Barr Laboratories) where he was responsible for comprehensive analytical method development, validation and analytical support of more than 30 ANDA projects including many PIV first-to-file opportunities as well as 3 NDA projects involving advanced analytical tools. He worked extensively with products that included solid dosage forms tablets and capsules of immediate and modified release (delayed and extended), vaginal cream and gel, lyophilized product for injection, inhalation solution, ophthalmic suspensions and vaginal gel in addition to traditional solid dosage products. He is an expert in women's heath products including estrogenic HRT products and APIs such as conjugated estrogens and other complex natural API for which he established the analytical testing standards for pharmaceutical equivalence and quality control. He has extensive experience in filing ANDA's. NDAs, INDA's and DMF's that involved preparation of the CMC sections for ANDA submission, the Quality Overall Summary (QOS) modules and Product Development Reports (PDR) and assisting in Pre-Approval Inspections (PAI) and responding to Major, Minor and telephone Amendments. He has extensive knowledge of 21CFR Part 210 and 211 cGMP regulations as well as Part 11 compliance for electronic records and signatures. Dr. Islam earned his Ph.D. in Physical/Analytical Chemistry at Southern Illinois University in 1985 did postdoctoral research at Rice University. Before joining the Pharmaceutical Industry he was a visiting faculty member at the University of Missouri (Columbia and St Louis) and Saint Louis University for 5 years where he taught general, organic and quantitative/instrumental analytical chemistry.
F C Phillips, MD
Dr Phillips, board-certified in Occupational Medicine, has extensive administrative and research experience working for the US Army, General Motors, Boeing Corporations, and at the NASA - Kennedy Space Center. She has retired as a Major of the Medical Corps of the US Army in 1997. Before opening her own center, she worked as an investigator at other CRO/SMO organizations, first at Comprehensive Neurosciences (CNS), later at Accelovance. Under her guidance, CRS has consistently been a top-enrolling site in large number of studies undertaken. Dr Phillips has been involved as an investigator in more than 100 clinical trials. During her career, she has presented extensively and received numerous awards. Dr Phillips earned her MD in 1990 and MPH in 1997. She is also a certified Medical Review Officer.
Abdur Rashid, PhD
Dr Rashid has more than 11 years of experience working in the CRO industry specializing in the bioavailability studies. Over a duration of eight years PharmaKinetics, he had conducted and supervised most activities pertinent to phase 1 clinical trials. He was responsible for the implementation of new procedures/techniques, and he developed and conducted the first topical corticosteroid skin-blanching bioequivalence studies, based on the freshly published guidances. After PharmaKinetics, Dr Rashid joined PAREXEL International to help build PAREXEL's flagship Clinical Pharmacology Research Unit (CPRU) in Baltimore. At PAREXEL, Dr Rashid was responsible for protocol development, clinical data management, data analysis, and study report writing. Dr Rashid eventually joined Barr Laboratories, a large pharmaceutical company manufacturing generic and proprietary products, as a Director of Scientific Affairs. At Barr, Dr Rashid managed the clinical development of a large portfolio of pharmaceuticals. These included nasal spray suspension products for seasonal allergies, products that needed pharmacodynamic studies, and generic products that needed pharmacokinetic studies to be conducted in patients. Finally, Dr Rashid joined Clinical Research Solutions, where he currently manages the administration of the facility and developing CRS into a niche clinical trial center with a focus in prototyping clinical trials. Dr Rashid has a Master's in pharmaceutical sciences and a PhD in pharmacokinetics.
Foma Rashkovsky, MS
Foma Rashkovsky is a Regulatory Affairs Professional with over 25 years of experience in the pharmaceutical industry. He has successfully filed 12 NDAs, one eBLA and numerous ANDAs, INDs and DMFs. During his career in the regulated industry, he acquired thorough knowledge of drug development and approval process. His responsibilities include strategic planning, due diligence, submission preparation, identifying and solving regulatory and technical issues. A significant part of his career was at Forest Laboratories with progressively responsible positions. Most recently, he was a Senior Director of Regulatory Affairs at Savient Pharmaceuticals, Inc. Foma earned his BS in Analytical Chemistry and MS in Industrial Pharmacy.
Leonard T Solas, MBA
Len Solas is a Quality Assurance professional with 45 years of working experience, 39 years of which is in quality assurance area in regulated industries. His experience includes working for the US Air Force, Schering-Plough, Superfarm, Barr Laboratories, and Teva Pharmaceuticals. Most recently, he was a Director of Quality Assurance at Barr Laboratories, Inc. which became a subsidiary of Teva. His expertise includes, process controls, operating procedures, documentation management systems, change management, failure investigations, as well as corrective and preventive actions. His quality assurance experience includes GMPs, GCPs and GLPs that are associated with the development and manufacturing of new products, including generic and innovative. Len has a BS in Marketing/Business Management and a MBA in Pharmaceutical Business.
Shabbir Ahmed, MBA
Shabbir Ahmed is an entrepreneur and corporate executive with 25 years of international senior level experience with major global corporations. As an MD and CFO, during his extended international career, he has established several start-up ventures as well as led and completed numerous mergers and acquisitions throughout the world in the chemical, healthcare and manufacturing industries. His extensive due diligence experience as well as strong track record of ethics and compliance though the implementation of processes such as Sarbanes Oxley at the various entities brings critical expertise to the team and ensures practices without conflict of interest. Prior to his current position as managing partner of Princeton Global Synergies, Mr. Ahmed was CFO (Chief Financial Officer) for region EMEA (Europe, Middle East, Africa) of Stanley Works (SWK), based at the European head offices in Brussels, Belgium. Before joining Stanley Works, he was Managing Director and CFO for region EMEA of Johnson Controls (Battery Division), based at the European head offices in Hannover, Germany. Prior to that Mr. Ahmed held the position of CFO of Linde Healthcare North America, based at the North American head offices in Cleveland, USA. During his career, he has held several other international management positions in different countries of the world. He has extensive global experience, multilingual skills as well as excellent international network and contacts. He holds a MBA from Austria.
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