Contributing Writers
Site last published: 08/28/08
Alison Macpherson - The Road to Pharmacopolis
Alison Macpherson has been involved in the pharmaceutical industry since 1988. She is the President/Owner of Bright Pharmaceutical Services and Bright Media Services, which were founded in 2002. Ms. Macpherson speaks regularly on topics related to entrepreneurship and the pharmaceutical industry. In addition to her published scientific articles and abstracts, she contributed to “From Inspiration to Realization”, volume II. She serves on the Boards of Diversity Alliance for Science and Women’s Business Enterprise Council – West as well as Big Brothers Big Sisters. She resides in Los Angeles.
Woody Woodaman - My Father, My Hero
About
the Author:
Woody Woodaman is the President/CEO and co-founder of Synergy Clinical Research Centers in San Diego, National City and Escondido, California. He is also founder of Brainstorm, a research consulting company. Woody has worked in healthcare in San Diego for 38 years with an emphasis on research for the past 15. He has consulted with numerous companies with a focus on business development, marketing, networking and patient recruitment & retention.
Woody Woodaman is the President/CEO and co-founder of Synergy Clinical Research Centers in San Diego, National City and Escondido, California. He is also founder of Brainstorm, a research consulting company. Woody has worked in healthcare in San Diego for 38 years with an emphasis on research for the past 15. He has consulted with numerous companies with a focus on business development, marketing, networking and patient recruitment & retention.
Jean L. Fourcroy - Reflections on the Inclusion of Women in Clinical Trials
Dr. Fourcroy received her M.D. from the Medical College of Pennsylvania and her Ph.D from the University of California at San Francisco. Her surgery and urology residencies were completed at George Washington University Medical Center with Board Certification in Urology in 1981. In 1999 she received her Masters in Public Health from the Medical College of Wisconsin. She retired as a Medical Officer with the Food and Drug Administration having been involved with many aspects of the regulatory process within the entire agency. Currently, she is a regulatory consultant in areas of urology and endocrinology. She has been appointed to the Board of the U.S. Anti-Doping Agency and is an active member of the American Urological Association, the American Society of Andrology, and Past President of the American Medical Women's Association.
Mona Homyk - If you STILL don’t know what you want to be when you grow up…
About
the Author:
Mona Homyk, PhD, RAC has over 30 years of experience working in the pharmaceutical industry, biotechnology and academic research. She has expertise in all phases of clinical trials, in which she participated in various capacities, including clinical operations, regulatory writing, due diligence and as trainer in regulatory compliance.
Dr. Homyk is a Regulatory Affairs consultant in Charlottesville, VA, providing consulting services for submissions to regulatory agencies worldwide, compliance in clinical trials, regulatory intelligence, and medical writing.
Mona Homyk, PhD, RAC has over 30 years of experience working in the pharmaceutical industry, biotechnology and academic research. She has expertise in all phases of clinical trials, in which she participated in various capacities, including clinical operations, regulatory writing, due diligence and as trainer in regulatory compliance.
Dr. Homyk is a Regulatory Affairs consultant in Charlottesville, VA, providing consulting services for submissions to regulatory agencies worldwide, compliance in clinical trials, regulatory intelligence, and medical writing.
Edyta Frackiewicz - Teach to Learn
About
the Author:
Edyta Frackiewicz, PharmD has over a decade of pharmaceutical industry experience and is currently an independent consultant. Dr. Frackiewicz has extensive expertise in conducting clinical drug trials and additional experience in drug development and marketing. She has authored scientific papers and book chapters on schizophrenia, depression, anxiety, and women's health as well as the book: Ethnicity in Drug Development and Therapeutics. Over the years she has provided lectures to physicians, nurses, health-care professionals and university students on a wide variety of topics. Dr. Frackiewicz received her BS in Biochemistry from UCLA and her PharmD from the USC. She lives in Los Angeles with her husband and two sons.
Edyta Frackiewicz, PharmD has over a decade of pharmaceutical industry experience and is currently an independent consultant. Dr. Frackiewicz has extensive expertise in conducting clinical drug trials and additional experience in drug development and marketing. She has authored scientific papers and book chapters on schizophrenia, depression, anxiety, and women's health as well as the book: Ethnicity in Drug Development and Therapeutics. Over the years she has provided lectures to physicians, nurses, health-care professionals and university students on a wide variety of topics. Dr. Frackiewicz received her BS in Biochemistry from UCLA and her PharmD from the USC. She lives in Los Angeles with her husband and two sons.
Andree K. Bates - How to Add Muscle to Patient Adherence Program Measurement and Results
Dr. Andrée Bates is the CEO of Eularis– a company that provides
mathematical systems for measuring the current sales impact of specific
sales and marketing mix components, as well as recommending optimal
allocation and activities for future measurable results. Dr. Bates has
gained wide recognition within the international healthcare industry in
the area of ‘Return on Investment’ measures in pharmaceutical marketing.
She has lectured on ROI for the Pfizer MBA program at INSEAD Business
School and the Executive Pharmaceutical MBA program at Erivan K. Haub School of Business in Philadelphia. She is the author of many
publications on this topic in peer-reviewed journals as well as the
author of several chapters in books on this topic.
Marie H. Tartaglio - The ABCs of Effective Communication
About
the Author:
Marie H. Tartaglio, MEd, is the Manager of Training, Medical Compliance,
Policy and Process at sanofi-aventis in Bridgewater, New Jersey.
Focusing on the unique needs of adult learners, Marie has more than 15
years of corporate healthcare experience in instructional design,
learning strategy, program development, project management, training
delivery, and program evaluation. She graduated from The Pennsylvania
University with a master’s degree in instructional systems. Her
undergraduate degree is in sociology from Millersville University.
Marie H. Tartaglio, MEd, is the Manager of Training, Medical Compliance,
Policy and Process at sanofi-aventis in Bridgewater, New Jersey.
Focusing on the unique needs of adult learners, Marie has more than 15
years of corporate healthcare experience in instructional design,
learning strategy, program development, project management, training
delivery, and program evaluation. She graduated from The Pennsylvania
University with a master’s degree in instructional systems. Her
undergraduate degree is in sociology from Millersville University.
Janet B. W. Williams - How to Deliver a Sensational Scientific Talk
About
the Author:
Dr. Williams is Vice President, Clinical Development at MedAvante, Inc.
Previously, she was Professor of Clinical Psychiatric Social Work in the
Departments of Psychiatry and Neurology at Columbia University College
of Physicians and Surgeons. Dr. Williams is the author of over 230
scholarly publications and was made an Honorary Fellow of the American
Psychiatric Association for her contributions to the development of
DSM-III, DSM-III-R, and DSM-IV. Dr. Williams holds a BS in biology, an
MS in marine biology, and an MS and DSW in social welfare.
Dr. Williams is Vice President, Clinical Development at MedAvante, Inc.
Previously, she was Professor of Clinical Psychiatric Social Work in the
Departments of Psychiatry and Neurology at Columbia University College
of Physicians and Surgeons. Dr. Williams is the author of over 230
scholarly publications and was made an Honorary Fellow of the American
Psychiatric Association for her contributions to the development of
DSM-III, DSM-III-R, and DSM-IV. Dr. Williams holds a BS in biology, an
MS in marine biology, and an MS and DSW in social welfare.
Al O. Pacino II - Trial Drift Phenomena
Al O. Pacino II is a senior executive with more than 18 years experience in the healthcare and clinical research industry. He has held multiple positions with well-established CRO and clinical technology companies. He is the founder and current president of TrainingCampus.com. Mr. Pacino is the current vice-chair of education for the ACRP Data Management and Technology forum and a frequent speaker and educator on the trial phenomena. Mr. Pacino has extensive experience in centralized training using web-based technologies and has helped pioneer the standardization and the delivery of clinical content and clinical scales which are commonly used in clinical trials such as the NIH Stroke Scale and many others.
TL Clarkgerman - A Case Study in Preventing “Trial Drift”
About
the Author:
TL has over 16 years experience in clinical trials starting as a coordinator, becoming a Certified Clinical Research Associate in 1996, and finally moving into Regulatory and Clinical Audits in 2004. He is the founder and one of the senior auditors of Clinical Research Audit Associates. His unique experience and approach to the audit process has provided many investigator site's with a formulaic foundation that encompasses on-line training (CRAA.trainingcampus.net) specific education/training based on contemporaneous audits, and sound Corrective Action Plans (CAP) that address areas of non-compliance. In 2007, Mr. Clarkgerman was instrumental in facilitating 7 separate FDA audits at investigator sites, multiple sponsor offices, and vendor locations. Of the 7 separate audits none received warning letters.
TL has over 16 years experience in clinical trials starting as a coordinator, becoming a Certified Clinical Research Associate in 1996, and finally moving into Regulatory and Clinical Audits in 2004. He is the founder and one of the senior auditors of Clinical Research Audit Associates. His unique experience and approach to the audit process has provided many investigator site's with a formulaic foundation that encompasses on-line training (CRAA.trainingcampus.net) specific education/training based on contemporaneous audits, and sound Corrective Action Plans (CAP) that address areas of non-compliance. In 2007, Mr. Clarkgerman was instrumental in facilitating 7 separate FDA audits at investigator sites, multiple sponsor offices, and vendor locations. Of the 7 separate audits none received warning letters.
Elias Nyberg - Regulatory, Clinical Trials and Welsh Farmers!
About
the Author:
Elias Burr Nyberg was born and raised in Connecticut, but left at an
early age for Europe, then the Middle East (Iraq and Saudi Arabia), New
Zealand and Australia, Africa and back to Europe where he joined the
pharmaceutical industry after 10 years in private practice. In Europe he
joined industry, first in Switzerland, followed by the UK, Sweden and
then returned to the USA after more than 30 years overseas. Currently
Elias is working at Novartis Pharmaceuticals in Global Regulatory
Affairs. He is married with three children, the eldest in university in
Australia, one in high school and one in middle school. He is an avid
skier and golfer and has a keen interest in parrots, Scottish highland
cattle, grandfather clocks and antique cars. DVM Areneta University
Philippines, BVSc(hons) University of Pretoria, South Africa, MBA,
Henley Management College, Brunnel University, England MRCVS, Member
Royal College of veterinary Surgeons, England MACVS, member Australian
College of Veterinary Scientists
Elias Burr Nyberg was born and raised in Connecticut, but left at an
early age for Europe, then the Middle East (Iraq and Saudi Arabia), New
Zealand and Australia, Africa and back to Europe where he joined the
pharmaceutical industry after 10 years in private practice. In Europe he
joined industry, first in Switzerland, followed by the UK, Sweden and
then returned to the USA after more than 30 years overseas. Currently
Elias is working at Novartis Pharmaceuticals in Global Regulatory
Affairs. He is married with three children, the eldest in university in
Australia, one in high school and one in middle school. He is an avid
skier and golfer and has a keen interest in parrots, Scottish highland
cattle, grandfather clocks and antique cars. DVM Areneta University
Philippines, BVSc(hons) University of Pretoria, South Africa, MBA,
Henley Management College, Brunnel University, England MRCVS, Member
Royal College of veterinary Surgeons, England MACVS, member Australian
College of Veterinary Scientists
Vaira Altergott - Climbing the Ladder with a Chronic Illness
Vaira started her career in medical technology working in Illinois
hospitals for 10 years. After graduating NIU, she worked at Searle as a
Research Chemist. Her career has brought her employment in Data
Management at Parexel, Fujisawa, Baxter, Kos Life Sciences in Florida
and she is currently employed at i3 Statprobe Data Services. In
December 2001, a ski accident profoundly affected her life.
Fortunately, after long periods of therapy and intensive medical
treatments, she is now leading a productive work life once more.
Susie Szembek - Embracing Change
About
the Author:
Susie Szembek is an Independent Clinical Research Contractor currently
residing in North Carolina. Tapping into her entrepreneurial spirit,
she now works exclusively out of her home office and loves every minute
of it. She is continuing to play multiple roles in the Pharmaceutical
and Biotech Industry, including roles in Regulatory, Clinical, Data
Management and Drug Safety.
Susie Szembek is an Independent Clinical Research Contractor currently
residing in North Carolina. Tapping into her entrepreneurial spirit,
she now works exclusively out of her home office and loves every minute
of it. She is continuing to play multiple roles in the Pharmaceutical
and Biotech Industry, including roles in Regulatory, Clinical, Data
Management and Drug Safety.
Mary Elizabeth Roarke - You work from home ~ I am so jealous!
Mary Elizabeth Roarke is a remote study manager for Pfizer & Execu Pharm. She has worked from home for almost 10 years now. Her research career started in 1989 as a study coordinator in an AIDS clinical trial unit. In 1998 Mary Elizabeth started working cross therapeutically as a regional monitor in Phase I-IV clinical trials for Merck and in the same capacity for K force & Pfizer since 2001. She is considered a subject matter expert in HIV and provides therapeutic area training for new monitors, as well as giving organizational tip presentations at team meetings. She is available to give talks on these topics. She graduated with a BSN from Molloy College, NY. Mrs. Roarke is currently writing a book about traditions and parenting tips
Christina Atwood - Got OCD?
Christina Atwood is the President of CenteRxperts and Clinical Trial Manager of Northwest Clinical Trials both located in Boise, ID. CenteRxperts delivers on-site training to industry professionals and boasts an online training campus. By implementing the outstanding CenteRxperts training techniques, Christina has helped to build a premier site, Northwest Clinical Trials, in her community. This wife and mother of three growing sons strives to produce and promote excellence in the industry while balancing a family.
Nadina C. Jose - It’s all about the Attitudes and the Relationships!
Nadina C. Jose, MD, CPI, MBA, has 20 years’ experience in the clinical research industry. She has conducted hundreds of clinical trials in various capacities, phases, and therapeutic areas. In September of 1996 she founded Research Strategies Incorporated, designed and envisioned to facilitate simple, cost efficient delivery of quality clinical trial support services. Aside from being the President/CEO of RSI, Dina enjoys training and teaching research professionals and being actively involved with APPI and ACRP.
Roger Rignack - Clinical Trials Marketing
Roger Rignack has worked in the clinical trial and pharmaceutical industry for over 12 years, most of which was spent at California Clinical Trials (CCT). In 2005, Roger joined CBS Radio/KFWB News 980 in Los Angeles where he is currently employed. Roger is a member of the Board of Directors for the Parkinson’s Resource Organization and continues to do consulting work for various clinical trial sites. He received his BFA degree in Communications, Minor in English from Emerson College, and his MBA in Marketing from the University of Phoenix.
David Vulcano - Terrorists Can’t Open Ziploc® Bags…
David was born and raised in New Orleans, Louisiana. He has a Masters degree in both Social Work and Business Administration from Louisiana State University. He is currently the Chief Research Officer for Psychiatric Solutions, Inc. overseeing the research efforts of 75 facilities in 29 states. Among other roles, he was formerly the Chief Research Officer for Ardent Health Services/Behavioral Healthcare Corporation where he oversaw research the efforts in both medical and psychiatric hospitals, as well as the operations of 2 in-house IRB’s. He is on the Board of Trustees for the Association of Clinical Research Professionals. Additional duties in this role include sitting on their Finance Committee and chairing the Ethics and Public Policy Committee (which he co-founded as the Ethics and Human Subject Protection committee). David is a Certified IRB Professional; a judge in the Health Improvement Institute’s Annual Award for Excellence in Human Research Protections and former Human Subject Protection Program accreditation surveyor for both the National Committee for Quality Assurance and Partners for Human Research Protection. David has been a speaker for many organizations on topics related to the clinical trials industry. On a lighter note, he was the Regulatory Jeopardy! Champion at the DIA in the contest’s first two years (2004 and 2005). He is married with 2 children and has lived in the Nashville area since 1999.
Jack Minster - Travel Tips for the Road Warriors
Jack Minster serves as VP of Sales for DSG, a clinical pharmaceutical software company headquartered in Malvern, PA. Electronic data capture technology for the Life Sciences industry has kept Jack on the road, educating pharma, biotech, and medical device companies about the benefits of EDC software, since 1999. Jack graduated with a Bachelor of Science degree in Business Administration from Villanova University, and shortly thereafter began a career involving global travel, every week, since 1987.
Luis Torres - There’s always potential to grow
Born (1977) and raised in Bayamon, Puerto Rico, Luis E. Torres traveled in 1988 to Philadelphia, Pennsylvania with his mother, brother and sister. Luis graduated from high school and attended Community College in Pennsylvania. He is now employed as a Programmer by Omnicare Clinical Research. In December, 2007, he will reach a ten-year milestone with the company. Married to his lovely wife, and the father of three beautiful children, he enjoys the many challenges that life brings. Luis is a Board member and serves as an assistant to the Financial Director in his local church, Iglesia Evangelica Bautista where he has attended for more than 15 years.
Kelly Clonan - Blonde Ambition
Kelly Clonan has worked in the pharmaceutical and biotechnology industry for over 4 years. Prior to joining Peninsula Pharmaceuticals, Kelly was a Marketing Manager at Lucent Technologies, Inc. Prior to Lucent, she was employed at AT&T for over five years. She started at Peninsula as the Manager of Business Operations. Kelly was able to move into a Marketing position while Peninsula was in the process of potentially going public. During the Johnson & Johnson buyout, Kelly successfully moved into a Clinical Operations position with them. Kelly Clonan received her BA from San Diego State University and her Masters in Business from the University of Phoenix.
Sandy Putirka - So, you want to start your own Biotech Company?
About
the Author:
Sandy Putirka has a Bachelor’s degree in Biochemistry and a Masters of Science in Molecular Biology. She has managed Phase I-III clinical studies for both device and small-large molecule pharmaceutical companies, and has participated in the early stages of a “potential” start-up biotech company. Sandy has actively participated in the local San Diego Chapter Association of Clinical Research Professionals and was its co-founder and inaugural president in 2000.
Sandy Putirka has a Bachelor’s degree in Biochemistry and a Masters of Science in Molecular Biology. She has managed Phase I-III clinical studies for both device and small-large molecule pharmaceutical companies, and has participated in the early stages of a “potential” start-up biotech company. Sandy has actively participated in the local San Diego Chapter Association of Clinical Research Professionals and was its co-founder and inaugural president in 2000.
Charlene Dark - Tomorrow’s Landscape Can Be a Dramatic Change from Today’s Garden
Charlene Dark has seized entrepreneurial opportunities throughout her entire career in the pharmaceutical research industry. Ms. Dark's experience has been focused in the CRO industry, where she began as a statistician and quickly grew to a leader of operations, strategic planning and business development. Ms. Dark has been instrumental in developing new departments and enhancing current divisions within existing organizations as well as leading the launch of new ventures for global and regional CROs. She currently services as the director of clinical development for Clarkston Consulting, a management and technology consulting firm focused solely on the consumer products and life sciences industries.
Jaz Whittington - Downsized But Not Down-and-out!
Jaz Whittington has spent 20 years in Pharmaceutical Development holding positions of increasing responsibility ranging from CRC, CRA, Regional Manager and Associate Director in academia, CROs and most recently a major pharmaceutical setting. Since leaving the pharmaceutical industry she has expanded her dog training business, RaisingK9 Companions. She lives in Maryland with her husband and their five dogs.
Leah Brown - Uncles Make the World Go-round
Leah Brown, President & CEO
Leah Brown serves as co-founder and President of ATEN Solutions, Inc (A10). A10 provides leading-edge professional services in the clinical research, clinical data management, statistical programming, and biostatistics space. A10 is one of only a handful of certified woman and minority owned firms that provide support for phase I-IV clinical trials that contribute to the FDA approval of therapeutic products for global biotech and pharmaceutical companies.
Ms. Brown earned her Juris Doctorate from the University of Kentucky and was admitted to the North Carolina Bar in 1992. Moreover, she possesses the distinguished designation of Certified in Healthcare Compliance (CHC).
Born and raised in Northern New Jersey, Leah has been settled in Raleigh, North Carolina for past 15 years and enjoys skiing and tennis with her two sons; Christopher, 16 and Clayton, 13.