Management Team & Partners
Terry Carmichael, M.Sc.
Managing Director; Marketing and Sales
Terry holds a Master’s degree in Molecular Medicine and Genetics from Wayne State University School of Medicine. After beginning his career in a genetics laboratory, his entrepreneurial spirit quickly took him beyond research and into the business world.
In 1997, Terry founded GeneTree Inc., marking the start of a pioneering journey in biotechnology and consumer health. One of his most notable achievements was conceptualizing and leading the launch of the first-ever retail DNA testing product—initially available online and later reaching the shelves of major U.S. pharmacy chains, including Walgreens, Rite Aid, and CVS.
Over the years, Terry has expanded his expertise across multiple industries, gaining valuable leadership and management experience in consumer retail, medical devices, life sciences, and professional training. His forward-thinking approach has driven innovative solutions, from creating novel eLearning delivery platforms to integrating physician-managed, point-of-care medical devices with electronic health record (EHR) systems.
Today, Terry is focused on building and scaling Biopharma Institute, where his vision is centered on streamlining the delivery of high-quality regulatory and compliance training. His mission is to empower professionals in the pharmaceutical, clinical research, and medical device sectors with the knowledge and tools they need to ensure safety, quality, and compliance in highly regulated industries.
Algis Rajeckas, Ph.D.
Director of Training
Dr. Rajeckas earned his Ph.D. in Organic Chemistry from the world-renowned Massachusetts Institute of Technology (MIT), establishing a foundation of scientific excellence that has fueled his distinguished career. With a unique blend of technical expertise and business acumen, he has built a strong track record in marketing management and business development across a range of highly regulated and innovative industries—including clinical diagnostics, medical devices, life sciences, and biotechnology research.
In addition to his corporate achievements, Dr. Rajeckas is deeply committed to education and mentorship. He serves as a professor of chemistry at both Cerritos College and Golden West College, where he inspires the next generation of scientists by bringing real-world industry insights into the classroom. His dual role as an educator and industry leader underscores his dedication to advancing both scientific discovery and professional growth in the life sciences.
Mark Walker, B.S., M.A.
Director of Training Business Development
Mark is an accomplished Sales and Training Development Executive with extensive experience serving the pharmaceutical, biotech, medical diagnostics, and academic sectors. Over the course of his career, he has specialized in delivering critical solutions that accelerate time to market, reduce development costs, and ultimately support the advancement of innovative therapies that change lives. Recognized as a true Rainmaker in the biopharmaceutical marketplace, Mark is driven by a commitment to creating value for clients while helping them achieve meaningful impact through cutting-edge biotherapeutics.
His expertise spans the full spectrum of drug development and commercialization, with deep knowledge of regulatory requirements, drug discovery, and the technical complexities of scaling from process development to fill–finish. Mark possesses a strong acumen for engineering and validation requirements and is well-versed in both small molecule and biologics manufacturing, including classical approaches and modern single-use technologies.
In the realm of training and development, Mark has distinguished himself by championing Cognitive Training methodologies over traditional behavioral models. He views training not as a cost, but as a strategic investment that strengthens organizations. By conducting comprehensive gap analyses, aligning with client goals, and tailoring programs to achieve management’s desired outcomes, Mark ensures that every training initiative delivers measurable value and long-term proficiency.
With a passion for collaboration and a results-oriented mindset, Mark looks forward to partnering with clients to understand their objectives and to help them achieve excellence in an increasingly competitive and regulated industry.
Christina T. Carmichael, B.S., CCRA
Director of Clinical Projects
Christina launched her clinical research career in 1995 and has since built a distinguished track record of excellence across a wide range of roles, including Clinical Research Coordinator, Regional Clinical Research Associate, In-House Clinical Research Consultant, and Project Manager. This extensive hands-on experience has provided her with a comprehensive understanding of the clinical research landscape—from site-level operations to global project oversight.
Today, Christina serves as the Director of Clinical Projects at Biopharma Institute, where she plays a pivotal role in shaping the next generation of industry professionals. In this leadership position, she is responsible for designing, implementing, and managing high-quality clinical research training programs tailored to the needs of professionals in regulatory affairs, clinical research, laboratory sciences, medical devices, drug manufacturing, and drug safety.
With nearly three decades of experience, Christina is recognized for her ability to bridge practical expertise with strategic vision, ensuring that the training solutions she oversees not only meet regulatory standards but also empower professionals to advance their careers and contribute to innovation in life sciences. Her commitment to excellence and professional development continues to have a lasting impact on the regulated healthcare industry.
Steffen A. Kaplan, B.A.
Social Media & Visual Strategist
Steffen is an award-winning Supervising Photo Editor at The New York Times and a dynamic multimedia strategist whose work spans leading organizations, non-profits, and high-profile professionals. With a rare combination of visual artistry and strategic insight, he crafts compelling narratives that captivate audiences and drive meaningful engagement across digital platforms.
As a seasoned live stream producer and digital campaign strategist, Steffen brings unmatched expertise in written and visual storytelling—transforming complex ideas into accessible, shareable content that attracts and inspires thousands online. His leadership extends beyond the newsroom, where he has built a reputation for developing innovative cross-platform brand strategies, editorial roadmaps, and audience growth initiatives that strengthen organizational impact.
A true global connector and collaborator, Steffen specializes in community building, communication, and digital engagement, helping brands not only reach but resonate with their audiences. With his passion for storytelling and talent for forging lasting relationships, he empowers organizations to build vibrant communities, elevate their voice, and create enduring value in today’s fast-paced media landscape.
Vincent Cirimele, Ph.D.
Director of Laboratory – Laboratoire ChemTox
Dr. Cirimele earned his Ph.D. in Biochemistry and Pharmacology from the prestigious Louis Pasteur University of Strasbourg in 1996, laying the foundation for a career dedicated to advancing forensic and analytical toxicology. In 2003, he founded ChemTox, a laboratory specializing in toxicological analysis, and by 2009 he was appointed both Scientific Director and CEO, guiding the organization’s growth and international reputation for scientific excellence.
Recognized for his expertise, Dr. Cirimele was appointed as an Expert by the Cour d’Appel de Colmar in 2007 and later by the Cour de cassation in 2012. His areas of specialization include forensic and analytical toxicology, blood alcohol analysis, detection of drugs of abuse, and identification of doping substances.
An active contributor to the global toxicology community, Dr. Cirimele is a longstanding member of numerous professional societies, including TIAFT, SFTA, and STC. He has also been involved with the Society of Hair Testing (SoHT) since its founding in 1995 and has served as a board member since 2012. His leadership, scientific rigor, and commitment to advancing toxicological sciences continue to influence research, practice, and policy worldwide.
Instructors, Auditors, & Subject Matter Experts (SMEs):
Sandra SAM Sather, M.S., B.S.N.
Clinical Research GCP Quality Consultant
With more than 25 years of experience in clinical training and research, [Name] is a seasoned Performance Improvement Consultant dedicated to advancing the highest standards of clinical quality systems and program development for Sponsors, CROs, and Investigators/Research Institutions. She holds a Bachelor of Science in Nursing and a Master of Science in Education with a specialization in Training and Performance Improvement, combining clinical knowledge with a deep expertise in instructional design and organizational development.
SAM’s credentials include dual certification from the Association of Clinical Research Professionals (ACRP), having served over a decade as both a Certified Clinical Research Associate (CCRA) and Certified Clinical Research Coordinator (CCRC). SAM is also a past Chair of the ACRP CCRA Exam Committee, a member of the ACRP Academy Board, and currently co-chairs the ACRP Regulatory Affairs Committee. A frequent and respected speaker at industry conferences, she has authored more than 50 courses for clinical research training programs, making significant contributions to professional education in the field.
In 2002, SAM co-founded Clinical Pathways (CP), a clinical research consulting firm offering services in monitoring, auditing, training development, mentoring, systems analysis, and performance improvement. In addition to her role as a subject matter expert, she serves as CP’s Acting CFO and Business Development Officer, helping guide strategic growth and operational excellence. Over the years, she has successfully managed and monitored projects across a diverse client base, ranging from small-scale studies to large, complex research programs.
Through her leadership, expertise, and passion for quality and performance, she continues to shape the future of clinical research by empowering organizations to achieve compliance, efficiency, and innovation.
Carl M. Selavka, Ph.D.
Expert Witness – Toxicology, Explosives and Arson
Carl Selavka is a distinguished forensic scientist with deep expertise in esoteric toxicology, explosives, and arson investigation. Throughout his career, he has collaborated with operational, academic, and legal institutions to strengthen forensic service infrastructures, elevate quality standards, and expand scientific capabilities in the pursuit of justice.
His toxicology work has focused on advancing specialized methodologies in hair, urine, and oral fluid drug testing, as well as pioneering applications of hair and blood alcohol biomarkers. Renowned for his innovative approach, Carl has been instrumental in applying non-traditional forensic techniques to uncover critical evidence when conventional testing methods prove inadequate.
With a career defined by scientific rigor, creativity, and service, Carl Selavka has consistently pushed the boundaries of forensic science—transforming complex challenges into actionable solutions that deliver probative value in even the most difficult cases.
David Markovitz
cGMP In-Plant Training
David is the Founder and President of GMP Training Systems, Inc., bringing over three decades of leadership and management expertise within FDA-regulated industries. His career journey includes pivotal roles such as Manufacturing Laboratory Manager, Packaging and Filling Manager, Pilot Plant Manager, Manufacturing Engineer, Technical Training Manager, and Corporate Director of Education and Training. Through these positions, he gained invaluable hands-on experience in navigating operational complexity, optimizing limited resources, and driving organizational excellence. His corporate background spans industry leaders such as Nutrilite Products, SmithKline Beckman, Organon Diagnostics, and Ortho Diagnostics.
David had the rare honor of working alongside Dr. W. Edwards Deming, the legendary quality pioneer of the 20th century, assisting him in several of his renowned Four-Day Seminars. Building on this mentorship, David went on to establish and lead the Deming Roundtable—a year-long collaborative initiative uniting eight diverse organizations to implement Deming’s groundbreaking quality principles.
A highly sought-after international speaker, trainer, and workshop leader, David has inspired audiences worldwide with his insights on quality systems, regulatory compliance, and organizational performance. His contributions to professional education and public speaking have been recognized with numerous awards, including the Gold Microphone Award from the National Speakers Association and the prestigious Connie Award for Professionalism on the Speaking Platform in 2004.
Today, David continues to be recognized as a visionary in GMP training and quality systems, combining technical expertise, practical industry knowledge, and a passion for teaching to empower professionals and organizations around the globe.
Allan Dewes, M.A.
Onsite GMP Training Instructor
Allan brings more than 30 years of expertise in identifying organizational training needs and developing practical, cost-effective solutions to achieve and maintain CGMP compliance. Over the course of his career, he has successfully trained thousands of employees—ranging from front-line personnel to executive leadership—across a wide spectrum of international industries and cultures.
As a compliance consultant, Allan is known for blending regulatory expectations with current industry best practices, while always tailoring his recommendations to align with client capabilities. His balanced approach ensures that compliance strategies are both effective and sustainable.
An internationally recognized training and development consultant, Allan has earned a reputation for delivering dynamic, creative, and highly participative training programs. Whether presenting at global conferences, leading on-site courses, or facilitating workshops at national conventions, he focuses on solving real-world business and compliance challenges with engaging and actionable solutions.
In addition to his consulting and speaking work, Allan is also a prolific author and publisher of influential e-learning resources. His works include the GMP Training Instructor Guide for Pharmaceuticals, GMP Training Instructor Guide for Medical Devices, and innovative interactive training tools such as The GMP Challenge, Inspection Detection, and The GMP Trainer’s Survival Kit. These materials have become trusted resources for organizations striving to strengthen their compliance culture.
The Biopharma Institute is proud to collaborate with Allan, whose knowledge, creativity, and dedication continue to elevate GMP training standards worldwide.
Content Partners:
SeerPharma (seerpharma.com)
SeerPharma is a trusted team of consultants dedicated to strengthening Quality Assurance and GMP compliance across the pharmaceutical, medical device, and life science industries. For more than 25 years, SeerPharma has partnered with organizations throughout the Asia-Pacific region—operating from offices in Melbourne, Sydney, and Singapore—and extends its reach into Europe through an affiliate in the United Kingdom.
With decades of combined expertise, SeerPharma’s consultants have guided companies of all sizes—whether entering the therapeutic product supply chain for the first time or optimizing existing operations—to achieve and maintain compliance with global regulatory standards. Their expertise spans FDA, PIC/S, TGA, WHO, ISO, and ICH frameworks, ensuring that facilities, equipment, quality systems, and processes consistently meet the highest standards of safety and effectiveness.
The firm provides comprehensive support across the entire product lifecycle, from Research and Development through Manufacturing, Logistics, Warehousing, and Post-Market Surveillance. SeerPharma consultants not only deliver expert training and tailored advice but also perform inspections on behalf of the Australian Government (APVMA) and international organizations reliant on Asia-Pacific suppliers.
Complementing their compliance and consulting services, SeerPharma’s IT Solutions team specializes in implementing electronic Quality Management Systems (eQMS) that streamline processes, drive efficiencies, and strengthen quality oversight. Additionally, companies regularly engage SeerPharma to supply short-term Quality Assurance professionals, providing flexible access to specialized expertise without the commitment of full-time hires.
With a reputation built on integrity, knowledge, and results, SeerPharma continues to be a leading partner for organizations striving for excellence in compliance and quality management worldwide.
grapl ltd. (grapl.co.uk)
Zenosis®, a brand of Grapl based in Dundee, Scotland, is a premier web-based eLearning library dedicated to regulatory affairs and compliance in the medicinal products sector. Designed to meet the rigorous demands of a highly regulated industry, Zenosis® courses deliver accessible, authoritative, and continually updated training for professionals across the pharmaceutical, biotechnology, and healthcare fields.
All Zenosis programs are accredited for Continuing Professional Development (CPD) by the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom. Learners not only gain critical knowledge but also earn CPD points proportionate to course length. Certificates of completion formally recognize these points and are awarded upon successful completion of each course’s assessment.
The Zenosis library offers a comprehensive range of courses covering every stage of product development and compliance:
- Regulatory Affairs – in-depth training on submissions required for medicinal product development and marketing in both Europe and the USA.
- Clinical Trials – practical modules on trial design, set-up, monitoring, auditing, and inspection.
- Good Manufacturing Practice (GMP), Quality Assurance, and Quality Control – essential training for manufacturing personnel working within pharmaceutical and biotech industries.
- Drug Safety and Pharmacovigilance – focused instruction on meeting the critical and evolving requirements in drug safety oversight.
By addressing these key areas, Zenosis equips learners with the knowledge needed to navigate complex regulations, meet compliance obligations, and contribute to organizational success in an increasingly demanding global marketplace.
Zenosis is available as both a stand-alone remote learning solution and as an integrated training platform for organizations of any size. With its rapid deployment, scalability, and continuous updates, Zenosis provides vital knowledge that empowers teams to remain compliant, enhance productivity, and maintain a culture of regulatory excellence.
Clinical Pathways, LLC (clinicalpathwaysresearch.com)
The Clinical Pathways team is composed of seasoned clinical research professionals who bring together decades of expertise in both nursing and clinical research. With team members who are Registered Nurses boasting more than 30 years of direct patient care experience—and an additional 30 years dedicated to clinical research—Clinical Pathways has built a strong foundation of knowledge, insight, and adaptability that allows the organization to successfully support a wide variety of projects across multiple therapeutic areas.
This depth of expertise enables Clinical Pathways to deliver high-quality services throughout every phase of the clinical trial process. The team is highly skilled in the design, oversight, and execution of both pediatric and adult clinical drug and medical device trials. Their experience spans a diverse range of therapeutic fields, including oncology, schizophrenia, multiple sclerosis, and orthopedic interventions such as joint replacement.
By combining clinical expertise with a proven track record in research, Clinical Pathways offers clients a trusted partner capable of navigating the complexities of clinical development while ensuring the highest standards of quality, compliance, and patient care.
LearnAboutGMP (learnaboutgmp.com)
Learnaboutgmp, a trusted name in regulatory compliance training for life sciences, was acquired by Veeva Systems in mid-2021.
Veeva Systems is the global leader in cloud-based software for the life sciences industry, serving more than 1,000 customers worldwide—from the largest pharmaceutical enterprises to fast-growing biotechs. As a Public Benefit Corporation, Veeva is uniquely committed to balancing innovation, product excellence, and customer success with its broader responsibility to stakeholders, including employees, shareholders, and the industries it supports.
Since its founding in 2006 and headquartered in Ireland, Learnaboutgmp has partnered with life sciences companies to ensure workforce qualification, compliance, and job readiness through its extensive online training library. As a leading provider of accredited training content, Learnaboutgmp offers the most comprehensive portfolio of regulatory compliance courses for professional certification and continuing education (CEU) credits.
With a focus on flexibility and engagement, Learnaboutgmp delivers interactive, best-in-class eLearning through traditional course formats, accredited programs, and innovative microlearning videos. Its customer base spans top global pharmaceutical companies, leading medtech innovators, emerging biotechs, and other organizations across the healthcare landscape.
Together with Veeva, Learnaboutgmp continues to elevate training standards worldwide, empowering life sciences professionals with the knowledge and skills to meet compliance demands and drive innovation in a regulated industry.
