Management Team & Partners
Terry Carmichael, M.Sc.
Managing Director; Marketing and Sales
Terry earned a Master’s degree in Molecular Medicine and Genetics from Wayne State University School of Medicine. After working in a genetics laboratory for a couple years, Terry’s ambitions led him into the entrepreneurial world. Founding GeneTree Inc. in 1997, Terry embarked on what has become an interesting journey. One adventure along the way was envisioning and spearheading the launch of the very first retail DNA testing product, first from the Internet, then from the shelves of major US pharmacy chains, Walgreens, Rite-Aid, and CVS. Terry has since gained management experiences in the consumer retail, medical device, life sciences, and training industries. Terry has been a visionary for many unique solutions within these industries, from the novel delivery of e-Learning modules to connecting physician managed point-of-care medical devices to electronic health record (EHR) systems. Terry’s focus is now on growing Biopharma Institute by streamlining the delivery of high-quality regulatory and compliance training solutions for the regulated drug, clinical, and medical device industries.
Algis Rajeckas, Ph.D.
Director of Training
Dr. Rajeckas earned a Ph.D. degree in Organic Chemistry from the Massachusetts Institute of Technology (MIT). He is a marketing management and business development professional with industry experience including clinical diagnostics, medical devices, life sciences, and biotechnology research.
Dr. Rajeckas is also an active professor of chemistry at both Cerritos College and Golden West College.
Christina T. Carmichael, B.S., CCRA
Director of Clinical Projects
Christina began her clinical research career in 1995, where she held positions as a Clinical Research Coordinator, Regional Clinical Research Associate, In-house Clinical Research Consultant, and Project Manager. Today, Christina holds the position of Director of Clinical Projects at Biopharma Institute. Her responsibilities include identifying and managing clinical research training for professionals in regulatory affairs, clinical research, laboratory, medical device, drug manufacturing, and drug safety.
Steffen A. Kaplan, B.A.
Social Media & Visual Strategist
Steffen is an award-winning supervising photo editor for The New York Times and multimedia strategist and live stream producer for many top organizations, non-profits, and professionals. Steffen brings a level of written and visual expertise to social media and digital campaigns that helps attract the interest of thousands online. He is a highly-skilled and passionate storyteller. Steffen has deep expertise in cross-platform brand strategy, editorial planning, audience development, and digital engagement. A true global connector and collaborator, highly specialized in community building and management, communication and engagement, Steffen helps brands develop lasting relationships
Vincent Cirimele, Ph.D.
Director of Laboratory – Laboratoire ChemTox
Dr. Cirimele studied biochemistry and pharmacology at the Louis Pasteur University of Strasbourg and received his Ph.D. in 1996. In 2003, he founded ChemTox and became Scientific Director and CEO of this laboratory in 2009. He was listed as Expert by the Cour d’Appel de Colmar in 2007 and by the Court de cassation since December 2012 for forensic and analytical toxicology, blood alcohol determination, drugs of abuse and doping substances. He is member of several scientific societies (TIAFT, SFTA, STC) including the Society of Hair Testing (SoHT) since its creation in 1995, and became SoHT board member in 2012.
Instructors, Auditors, & Subject Matter Experts (SMEs):
Sandra SAM Sather, M.S., B.S.N.
Clinical Research GCP Quality Consultant
To promote the highest Clinical Quality systems and program development for Sponsors, CROs, and Investigators/Research Institutions. Performance Improvement Consultant. Over 25 years of clinical training and research experience; Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. Dual certified by Association for Clinical Research Professionals (ACRP) 10+ years CCRA and CCRC and past chair for the ACRP CCRA Exam Committee; ACRP Academy Board Member; co-chair of ACRP Regulatory Affairs Committee. Frequent speaker for industry conferences and authored over 50 courses for clinical research training programs.
In 2002 co-founded Clinical Pathways (CP), a clinical research consulting firm providing many services including: monitoring, auditing, content expert, training development, mentoring, performance improvement systems analysis and more. CP’s current acting CFO and business development officer. Multiple monitoring and project management experiences with diverse client base, size, and objectives.
Carl M. Selavka, Ph.D.
Expert Witness - Toxicology, Explosives and Arson
Carl Selavka is a forensic scientist specializing in esoteric toxicology, explosives and arson. His career has been spent working with operational, academic and legal agencies to enhance forensic service infrastructures, quality and capacities. His toxicology specialties have been focused on hair, urine and oral fluid drug testing, hair and blood alcohol bio-markers, and the application of non-traditional forensics to harvest probative scientific information when normal tests would fail.
cGMP In-Plant Training
Founder and President of GMP Training Systems, Inc., has over three decades of leadership and management experience in the FDA regulated industries. Having held positions as Manufacturing Laboratory Manager, Packaging and Filling Manager, Pilot Plant Manager, Manufacturing Engineer, Technical Training Manager, and Corporate Director of Education and Training, he has hands-on experience in effectively managing complexity with limited resources. David’s corporate experience was acquired at Nutrilite Products, SmithKline Beckman, Organon Diagnostics, and Ortho Diagnostics.
David had the rare privilege of assisting Dr. W. Edwards Deming, the 20th century’s leading quality guru, in several of his famed Four-Day Seminars. David created and led the Deming Roundtable, an intensive year-long cooperative effort involving eight different organizations working to implement Deming’s teachings. An internationally recognized and award winning speaker and workshop leader, David has been invited to present at conferences and meetings throughout the world. He is the recipient of the Gold Microphone Award (National Speakers Association) and the 2004 winner of the prestigious Connie Award for Professionalism on the Speaking Platform.
Allan Dewes, M.A.
Onsite GMP Training Instructor
Allan possesses more than 30 years of experience in identifying training needs, and developing and delivering practical, cost-effective training solutions for CGMP compliance. He has trained thousands of employees from all levels of the organization, from line personnel to executive staff, and in a variety of international cultures.
As a compliance consultant making recommendations, Allan applies current knowledge of the regulatory expectations along with current industry best practices balanced with client capabilities. As a conference presenter and course facilitator, he, is an internationally recognized training and development consultant, solving real business/compliance problems with practical, cost-effective solutions. Allan delivers exciting, creative, and participative training and workshop sessions through public seminars, on-site courses and national conventions.
Allan is also the author and publisher of various E-learning materials: the GMP Training Instructor Guide for Pharmaceuticals, GMP Training Instructor Guide for Medical Devices, and interactive training tools such as the GMP Challenge and Inspection Detection, and the GMP Trainer’s Survival Kit. The Biopharma Institute is proud to have built a strong alliance with Allan.
The team of consultants has extensive experience working with clients supplying or looking to enter the supply chain of a therapeutic product. They work with organizations looking to ensure that their facilities, equipment, quality systems and processes are compliant with FDA, PIC/S, TGA, WHO, ISO, ICH and other regulations and standards that apply to their product(s). Their consultants actively train and provide advice to companies on matters of compliance from Research and Development through to Manufacturing, Logistics, Warehousing and Post Market Surveillance. They regularly inspect organizations on behalf of the Australian Government (APVMA) as well as Pharmaceutical and Medical Device organizations relying on suppliers in the Asia-Pacific region. Their IT Solutions team routinely implement electronic Quality Management Systems to help improve process efficiencies within organizations. Companies also turn to SeerPharma to provide short term Quality Assurance contractors to help with projects that do not warrant hiring a full or part time employee.
Through their work they aim to "Advance Quality and GMP Best Practices in the APAC region" for the Pharmaceutical and Medical Device Industry.
grapl ltd. (grapl.co.uk)
Zenosis is available as a remote or integrated eLearning solution for any number of users requiring access. This eLearning provides a rapidly deployable training solution and is continually updated, providing vital knowledge that will enable your staff to comply with regulatory requirements and increase productivity.
Clinical Pathways, LLC (clinicalpathwaysresearch.com)
Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.
Customers include top pharma companies, leading medtech companies, emerging biotechs, and other brands. Founded in 2006, Learnaboutgmp is headquartered in Ireland.