Dr. Marika Crohns, MD, PhD, is a distinguished C-suite healthcare professional, renowned for her exceptional combination of medical expertise and substantial commercial insight.
Dr. Crohns holds an array of prestigious qualifications, including an MD, PhD, and Board Certification in Oncology and Radiotherapy.
Her impressive global career spans over three decades, with 10 years committed to academia and clinical practice as an oncologist and radiotherapist in leading European hospitals, and 20 years in International Commercial and Medical roles within the global pharmaceutical and MedTech industries.
Dr. Crohns has cultivated a vast network across top-ranked hospitals, healthcare institutions, and academic circles worldwide. Her professional connections include close relationships with renowned professors, experts, and numerous healthcare organizations globally.
In addition to her clinical and commercial achievements, Dr. Crohns is actively involved in various international companies and foundations at the Board of Directors level. Notably, she played a pivotal role as a founding member and Vice-President of the NGO Global Society for Nutrition, Environment, and Health (GSNEH).
Dr. Crohns is recognized for her strong leadership and management capabilities and has served as a mentor to medical and business leaders across the United States, Europe, Australia, and Latin America. She is also an award-winning global keynote speaker, honored with “Outstanding Leadership” awards.
Dr. Crohns has authored a groundbreaking book titled “Antioxidants, Cytokines, and Markers of Oxidative Stress in Lung Cancer Patients: Associations with Adverse Events, Response, and Survival.”
Dr. Marika Crohns exemplifies transformative leadership, unwavering dedication, and strategic brilliance within the healthcare sector. Her commitment to advancing standards in science, healthcare, and visionary leadership leaves an indelible impact. She is an ambitious, dynamic, and strategic visionary mentor and lecturer, possessing excellent leadership, communication, and listening skills, complemented by a profound presence.
Sami Makelainen is a leading strategic foresight professional with an emphasis on the mindful adoption of emerging technologies, including Artificial Intelligence.
His career began in the development of online commerce and banking platforms, transitioning to mobile technology research at Nokia. In Australia, he held pivotal roles at Telstra Corporation and founded its Strategic Foresight practice, where he specialized in harnessing long-term technology trends and their business implications, including in the implementation of AI governance.
He also has extensive experience in innovation program management and driving corporate innovation initiatives to success. Currently affiliated with the Institute for the Future and running Transition Level, his own consulting entity, Sami is a key influencer in ethical AI & GenAI governance and implementation.
With an MSc in Computer Science, Sami also serves as an Adjunct Senior Industry Fellow at RMIT FORWARD, on the steering committee for University of Melbourne’s Centre for AI and Digital Ethics (CAIDE), and as an expert member in the Royal Aeronautical Society’s Flight Operations Group (RAeS FOG).
His work centers around teaching the mindful application of generative AI and other emerging technologies, their societal impact, and their role in building resilient systems and facilitating capability uplift for organizations.
He has facilitated foresight projects globally and enabled organizations in various domains to adapt to a rapidly evolving technological landscape. Sami is the authority for organizations seeking to integrate generative AI into both their strategic and operational planning.
Professional Summary:
Dr Williams is an experienced drug developer with experience of large pharma, small start-ups and consulting for equity groups (especially in due diligence) in all areas of drug development in oncology, infectious disease (including launch activities), vaccines and orphan drugs.
Physician executive and researcher with extensive experience in oncology, infectious disease (including launch activities), vaccines and orphan drugs and global pharmaceutical protocol and clinical development including clinical, medical, and regulatory monitoring and operations. Expert in Phase 1-4 study development and oversight, regulatory affairs (NDAs, INDs, and SPAs), orphan and breakthrough drug applications, medicine innovation, strategic planning, due diligence and business development from a development angle.
He has managed medical, clinical, and regulatory operations and protocol development in the US/EU as well as for orphan and breakthrough drug applications. Medical monitoring and oversight of studies (preclinical and Phases 1-4); proof-of-concept studies; potential target review; PI relations including chairing medical advisory committee; management of SAWG, IMPD, NDAs, INDs, and SPAs; clinical program troubleshooting; and product commercialization and launch. Study site recruitment and acceleration. Strategic advice on developing novel breakthrough products (vaccines, antibiotics, oncology supportive care therapies) and new dosage formats.
He has been chief medical officer in start-ups and established companies and has provided:
Skilled at using clinical and executive expertise to increase productivity and success, gain funding, and boost stock prices.
He has overseen medical and clinical FDA/EMA regulatory process and interactions including advice on end-of-phase meetings, NDAs, INDs, and SPAs. Medical/regulatory expertise in protocol adherence and safety reporting, SAWG, IMPD, and study set-up in the EU and US. Expert in novel and orphan/breakthrough product designations. Advisor on FDA meetings regarding post-marketing commitments. Responsible for the clinical portion of a successful 505(b) (2) application for Rifater.
He has worked on hereditary angioedema (ecallantide), CF and oncology orphans.
He was part of the team that took Hepacare® through CPMP (hepatitis B mammalian cell recombinant vaccine), acellular pertussis, travel vaccines and annual influenza vaccines.
Having read medical sciences at the University of Cambridge at a time of biological advances that have transfigured medicine and studying experimental pathology (immunology, bacteriology, and virology), he learnt of the importance of understanding and implementing translational medicine. Following qualification as a physician at University College Hospital (UCH), London, he worked in oncology (solid and haematogical) at Charing Cross Hospital and UCH London, and spent some years working in laboratory medicine, mostly infectious disease, gaining an appreciation of the need for a seamless integration of patient care and laboratory studies to ensure the best outcome for the patient.
Since pursuing a career in drug development, he has continued to integrate novel approaches to patient care (such as monoclonal antibodies) and innovative approaches to diagnostics, such as circulating tumor cell assays, NGS, and changes in the understanding of imaging data in a period where immune checkpoint inhibitors have given rise to the concept of pseudoprogression and using this to produce clinical data that satisfies current and likely future regulatory needs. He is also interested in patient reported outcomes, which has become important in decisions involving dose escalation in early oncology clinical studies.
He is a Fellow of the Royal College of Physicians, London, based on his work in clinical pharmacology. Currently he splits his time between the USA and London. He is slowly pursuing an MBA at UCL.
A physician scientist with over a decade of progressive medical affairs experience with demonstrated leadership in demanding situations.
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Other Competencies:
Global Medical Team Lead, Global Medical Affairs: Daiichi-Sankyo, USA 2022
Senior Director, Global Medical Affairs: Kite Pharma, USA 2020 – 2022
Medical Director, Global Medical Affairs: Sanofi Genzyme, USA 2016 – 2020
Associate Director: Zipher Medical, USA 2014 – 2016
Healthcare Consultant: Align 2 Action, USA 2012 – 2013
Physician Scientist 2000 – 2009
9 years of academic clinical and medical research experience in leading institutes
Post-Doctoral Fellow: Brown University; Visiting Scientist: Charité, Germany; Ph.D. Fellow (Genetics): Palacký University, Czech Republic
Experience: Genetics, Emergency Medicine, Cardiovascular, Infertility, and Ophthalmology
17 scientific peer-reviewed publications – list available on request
Doctor of Medicine (MD) Guru Nanak Dev University, INDIA
Doctor of Philosophy (PhD) Palacký University, CZECH REPUBLIC
Master of Business Administration (MBA) Queen’s University, CANADA
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An energetic Translational Medicine and Clinical Biomarker Leader with excellent cross-functional management and communication skills forged through demonstrable leadership of global matrix teams at pre-clinical, clinical, operational, and business levels over 30 years. Extensive industry experience initiating, developing, driving, and evolving translational science and biomarker strategies in oncology and multiple other therapeutic areas with preclinical and clinical partners for implementation in commercially sustainable clinical areas. Demonstrable evidence driving biomarker discovery, validation, and translation into diagnostic capability and patient population stratification utility. Key opinion leader in clinical drug development and disease biology as evidenced by current inclusion on the Scientific Advisory Board and as Industry Advisor for various companies. Unique breadth and depth of industry R&D expertise straddling preclinical, translational science, clinical, regulatory filing, and post-approval drug pricing, covering modalities from small molecules, large molecules to gene therapy, and wide management experience covering academia, management consultancies, small biotech, CROs, and big pharma.
Visionary, strategic, and trustworthy decision-maker. Safe pair of hands. Trusted to lead, trusted to deliver.
1 April 2020 to Present – Independent Pharmaceutical Consultant, CGS Precision Medicine Consultancy Limited, Letchworth, UK
January 2019 to 31 March 2020 – Life Sciences Expert, Management Consultant, PA Consulting, London, UK
September 2016 to January 2019 – Independent Pharmaceutical Consultant, CGS Precision Medicine Consultancy Limited, Letchworth, UK
October 2013 to September 2016 – Director of Personalised Medicine, Proteome Sciences plc, Cobham, Surrey, UK
2011 to 2013 – Independent Pharmaceutical Consultant, CGS Precision Medicine Consultancy Limited, Letchworth, UK
2006 to 2011 – Clinical Biomarker and Experimental Medicine Leader, Roche Products Limited, Welwyn, UK
1995 to 2006 – Genomics Technology Operations Director, GlaxoSmithKline, Stevenage, UK
1985 to 1995 – Post-doctoral Research Fellowships and additional information
1992 to 1995 – Post-doc at University College London, UK. Human Genome Mapping Project, Team X-Chromosome
1989 to 1992 – Post-doc at University of Birmingham, UK. Transgenic crop plants
1985 to 1989 – PhD at Queen Mary & Westfield College, University of London
GCP/ICH certificate. Basic proficiency in German. UK citizen.
