Dr Phil Lavin, PhD, FASA, FRAPS
Dr Philip Lavin brings over 40 years of expertise in clinical trials, regulatory affairs and product development planning, having collaborated with world class investigators and sponsors since 1974.
Phil founded Boston Biostatistics (renamed Averion and now part of ICON plc) in 1983 and Boston Biostatistics Research Foundation (BBRF) in 1988, whilst being a Biostatistics faculty member at the Harvard School of Public Health. BBRF is a 501(c)(3) research foundation focused on the design, analysis and reporting of clinical studies involving public health. He is also the principal of Lavin Consulting LLC which he founded in 2012 to support commercial ventures in the development of drugs, devices, diagnostics, and biologics.
He has authored or co-authored 180 peer-reviewed publications and is internationally recognised for his methodology contributions in analysing biomarkers, assessing prognostic factors using multivariate models, developing longitudinal models to detect shifts and trends, standardising efficacy and safety for oncology studies, innovating non-inferiority designs, devising composite endpoints to assess multiple aspects of efficacy and extending labelling claims through a closed testing procedure. He is the only person to be named a Fellow of the American Statistical Association (ASA) and Regulatory Professional Society (RAPS).
Phil has also used his clinical and statistical experience to contribute to developing biomarkers (CA-125 and PSA), establishing the importance of performance status and weight loss for planning GI cancer studies, utilising tumour dimensions to more efficiently assess new oncology agents, employing cardioplegia during open heart surgery, optimising kidney transplants through tissue matching, defining composite endpoints for periodontology and orthopaedic studies, devising a more efficient way to classify infertility, and identifying the value of limited weight loss to reverse morbidities associated with obesity. He has won awards for his work in infertility and periodontal disease. He brings board experiences across many disease settings.
He has successfully supported many IDEs and INDs and has represented clients for >40 years, leading to 80 FDA product approvals/clearances to date, including the blockbuster drug, Lipitor. Phil has been the senior biostatistician for over 40 PMA approvals. He is regarded as a world leading expert in clinical product development.
To date, Phil has helped increase the value of companies by over $30B following regulatory approval.
He co-founded Melior Capital Management with Mickael Marsali, with whom he has worked for 10 years to identify worthy investee candidates.
Mickael Marsali is a French national, with a degree in Economics and Management.
He started his professional career within the Private Wealth Management Practice of the Lincoln Financial Group, where he worked for three years. Following the sale of Lincoln FG to inter-alliance, Mickael joined Allied Dunbar Assurance Plc, now part of the Zurich Group, and was part of what was arguably the most successful practice in the history of Allied Dunbar.
Mickael then joined the AIM Listed Lighthouse Group Plc in 2003, as a Senior Investment Consultant where he was formally recognised as their top producing advisor for five consecutive years.
In 2008 Mickael joined Centurion Capital as a senior partner, advising UHNW individuals on sophisticated investment opportunities. Mickael resigned from Centurion Capital in April 2011, in order to become a senior consultant of a Guernsey based private equity firm.
During his career Mickael has advised many ultra-high-net-worth and high-profile clients on sophisticated investment opportunities, successfully raising in excess of £1bn. His work has focused primarily on the alternative investment space, such as derivatives, FX, real estate, media, green projects, bio-ethanol and life-science.
Mickael is a founding member of Melior Capital Management, where he brings his in-depth knowledge of the financial market and his outstanding experience in dealing with professional intermediaries who represent both private and institutional investors.
Professor Suzanne D Turner, PhD
Dr Suzanne Turner is an acknowledged world expert in cancer cell biology at the University of Cambridge, UK.
She obtained her PhD in oncology from the world-renowned Paterson Institute for Cancer Research and the Christie Hospital in Manchester where she examined the potential toxic side effects of chemoprotective gene therapy in collaboration with AstraZeneca. Suzanne then worked at the AstraZeneca Central Toxicology Labs before moving to the Babraham Institute in Cambridge where she began to investigate mechanisms of lymphomagenesis, a subject that she has pursued to become a world-expert in paediatric lymphomas. For the past 17 years Suzanne has been leading an academic research group at the University of Cambridge with backing from various organisations with research funding of over £10m including GSK, the European Union, Blood Cancer UK, the Little Princess Trust, Neuroblastoma UK and CRUK. She also teaches and examines aspects of the medical, veterinary and natural science tripos at the University of Cambridge and is chair of graduate education. Suzanne has been a fellow of Hughes Hall, a Cambridge College since 2015 where she is also a tutor.
In 2005, Suzanne was awarded the prestigious Leukaemia and Lymphoma Research (LLR) Bennett Fellowship and in 2010 an LLR lectureship.
Amongst her many achievements are the inception and establishment of the European Research Initiative on ALK related malignancies, the coordinator of ‘ALKATRAS’, a European Union Marie Curie innovative training network encompassing 14 research groups across 7 EU countries, the non-clinical chair of the European Inter-Group for Collaboration into Childhood Non-Hodgkin Lymphoma (EICNHL), co-chair of the Cancer Research UK (CRUK) Cambridge Centre Paediatric Programme and the biological lead for the National Cancer Research Institute (NCRI) paediatric lymphoma Clinical Study Group (CSG).
Suzanne is an invited member of the MHRA Devices Independent Expert Advisory Group; Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) as well as the European Union scientific committee on health, environment and emerging risks (SCHEER) and has served as an advisor to Allergan and Cephalon Oncology. She also serves on the International grant panel of the World Cancer Research Fund and the Swedish research council for medicine and health.
She is an accomplished speaker having been invited to speak by the American Association for Cancer Research, the Medical University of Vienna, the Necker Institute Paris, University of Edmonton, Perelman School of Medicine Philadelphia and University of Hail, Kingdom of Saudi Arabia among many other esteemed academic institutes.
Amongst her other interests, Suzanne is the scientific advisor to the Alex Hulme Foundation and the Francesca Richardson Research Fund. She is also a member of a number of professional societies including the American, European and British Associations for Cancer Research, the Children’s cancer and leukaemia group and the international society for paediatric oncology.
Dr. Chris Rundfeldt
Dr. Chris Rundfeldt offers over 30 years of expertise in drug development and regulatory affairs. His hands-on experience includes target discovery, experimental pharmacology and regulatory toxicology as well as regulatory affairs, always focussing on risk and time optimized drug development. As board certified pharmacologist and toxicologist, he contributed significantly to numerous first in human drug development projects and to new drug approvals.
Chris has co-founded in 2000 elbion AG as management buy-out, a biotech company based in Dresden, Germany, focussed on drug development in CNS and inflammatory diseases. In 2007, he left elbion AG and founded his current company, Drug-consulting network, a drug development expert network, aiming at bringing development and translational medicine as well as regulatory affairs expertise to clients from biotechnology and pharmaceutical industry worldwide. He recently also co-founded PrevEp LLC, a biotech company based in Bethesda, USA, dedicated to cure epilepsy by preventing epileptogenesis in patients at risk. As a faculty member and Professor of Pharmacology and Toxicology, he is teaching students the principles of drug development at the University of Veterinary Medicine, Foundation, in Hannover, Germany.
He has authored or co-authored 87 peer-reviewed publications and book chapters and served as editor for one book project. He submitted nearly 20 patent applications. He is recognised for his expertise in nonclinical drug development, serving as expert and problem solver in diverse projects including biotechnology and nanomedicine projects. Based on his experience in patent applications, he helped clients to identify patentable assets and to optimize patent strategies.
While he had discovered a novel target for treatment of epilepsy and pain leading to an approval of a first in class antiepileptic drug and to numerous development projects worldwide, his focus has been for many years now on nonclinical drug development, aiming at translating ideas into clinical results. His project-specific optimized toxicology strategies have been accepted by FDA and by European national agencies leading to cost, time and risk optimized drug developments and rapid translation of preclinical data into human proof of concept. As a nonclinical regulatory affairs expert, he has authored numerous regulatory documents including Investigators Brochures for clinical trial application and nonclinical expert reports for new drug applications in EU and US.
Dr Cécile M. Perrault
Cécile holds a PhD in Biomedical Engineering from the University of Florida, where she worked in the emerging field of microfluidic cellular devices. In addition, she was a postdoctoral fellow at McGill University, working on developing a high-precision microfluidic probe for immersed environments and was a senior researcher at the Institute for BioEngineering in Catalonia, an institution renowned for its innovation in cellular biomechanics. Cécile has also authored and co-authored over 40 peer reviewed papers.
Between 2012 and 2018 Cécile led the “microfluidics and cellular mechanics” laboratory at the UK’s University of Sheffield, creating a bridge between mechanical engineers and medical clinicians, with funding from the British Heart Foundation, UK Research Council and H2020.
In 2018, Cécile was awarded a prestigious Marie Curie fellowship from the European Commission, and is now based in Paris specialising in microfluidics.
Her work has led to important insights on medical stent design, materially contributing to patient recovery and operating theatre decisions during stent placement in patients with aneurysms. Other credits include identifying a new therapeutic target to reduce the risk of restenosis (closure of the vessel) after stent implantation, leading a collaboration with a Vietnamese institute, and a low-cost dengue fever diagnostic device.
In addition, Cécile has been a key advisor to three successful start-ups, namely, Loop Medical (a spin-out of QloudLab), Eden Microfluidics and BlackHole Laboratories. She is an acknowledged expert at the European Commission, UK Research Council, the British Council and the French Ministry of Sciences. She is also the monitor of two large H2020 proposals, and consultant for innovation actions at the European Commission.
Robert is a 25+ years global pharmaceutical “hands on” cross-functional senior leader with a keen sense for the business, a strong track record of building pipelines, and globally launching products with top talent teams across specialty and primary care disease areas.
Executive strategic & operational leadership are at the core of his competencies, consistently driving alignment for results. He has led multiple therapeutic area teams that generated a combined 18 POC’s and phase III programs and driven the global and local launches of more than 10 products. Albeit not a scientist, he is seen as someone who “gets the science”, can work with scientific colleagues and top KOL’s to shape pipelines. Having also worked in consulting and banking Robert developed strong analytical skills that enable him to quickly define opportunities, risks and financial implications for an investment. In 2016 Robert established REBes Consulting, LLC his own biotech consultancy practice. His practice is focused on defining strategies and the optimal investable paths and implementing high impact solutions to achieve the set goals. REBes Consulting draws on a network of highly experienced consultants that has been cultivated over 25 years, and is able to act as a supportive management SWAT Team.
Robert holds a B.A. in Economics from Case Western Reserve University, and a Master of International Management from the Thunderbird School of International Management. Robert is fluent in English, German, Spanish, and conversant in Dutch, French.
Dr. Irina Kulinets
Dr. Irina Kulinets brings more than 30 years of experience in regulatory affairs and clinical research of medical devices, biologics with special expertise in combination products. She is recognized for her expertise in regulatory affairs, clinical research, clinical studies conduct (Phase I through IV).
Irina utilizes her regulatory and clinical expertise to contribute to developing and launching medical products in multiple therapeutic areas, such as neurovascular, cardiovascular, oncology, orthopedics, dermatology, gynecology, aesthetics, biologic implants, and drug/device/biologic combinations. She worked for major US and international life science corporations such as Johnson & Johnson, Boston Scientific, Terumo Medical as well as smaller organizations. Irina led multiple teams to the approval and conduct of numerous multi-national clinical studies and approval/clearance of more than 50 different medical products in numerous therapeutic areas; her winning regulatory and clinical strategies contributed to the expansive growth of the companies in the US and international regulatory approvals and product launches. Irina provided executive strategic and operational leadership to research and launch new products in the US, EU, China, Japan, and many other Asian and Latin American markets.
Irina also has extensive experience as a regulator and worked for TUV Product Service and Food and Drug Administration to review, assess and approve new technologies.
She is the principal of Regulatory and Clinical Consulting Group, LLC which she founded in 2006 to support the development of medical devices, biologics, and combination products. Her life-science consulting practice is focused on regulatory and clinical strategies to identify highly efficient solutions to launch medical products in many markets.
Irina holds MS in Mechanical Engineering from Belarus Polytechnic Academy, MS in Quality Systems from California State University, and a Ph.D. in Health Science as International Practitioner from Trident University. She is RAPS certified and Board Certified in Medical Affairs.
Irina has strong ties to Academia. She served as a Faculty Director and lecturer for the Master of Science in Regulatory and Clinical Affairs Program at Northeastern University, Boston, and designed a Master of Science in Regulatory Science and Clinical Research program in Georgetown University, Washington DC
She has authored or co-authored 3 books and peer-reviewed publications in areas of her expertise.
During the last 30 years, Joseph led the research, design, and development teams doing the development of electronics systems, semiconductor chips including specialized chips for medical device applications, and provided his leadership, expertise, and strategic thinking in the development of finished medical devices for the US and international markets. The therapeutic areas where Joseph was working include front-end devices for computer tomography, glucometers and glucose monitors, hospital medication distribution system, drug patch-pumps, wireless ECG devices, surgical tools management system, and a device for the treatment of neurological disorders.
Joseph also provided a system and technical support for multiple investment projects.
Joseph authored and co-authored more than 30 US and international patents and has extensive experience in system design, patent development, and patent analysis and defense in medical device areas. Joseph is a co-founder of several startup companies.
Joseph holds a BSc with Honor in Electrical Engineering, MSc with Honor in Computer Science, and continued his education with post-graduate studies at the Belorussian Academy of Sciences.
Arthur Ware MSc, FRIC
Arthur Ware has extensive experience in design and construction in the petrochemical industry, civil works and mechanical handling facilities as a contracts and project manager in the Far East, Middle East, Africa, Soviet Union and the US over a 32-year period. His expertise is in diplomacy in these roles dealing with many nationalities, familiarity with contracts and the legal provisions of FIDIC conditions of contract, tender negotiations and claims settlement. He’s now involved in residential construction in the London area.
Eric is a Dutch national and a Bachelor in Business Economics. He has over 26 years of experience in investment sales and business development. In addition to Dutch, he also speaks fluent German and English.
Eric started his professional career in 1993 with the ABN AMRO Bank followed by the Rabobank in the Netherlands, where he was a senior investment consultant, advising Ultra High Net Worth Individuals on complex investment solutions.
In the year 2000 Eric started his investment banking career at the Raiffeisen Bank International in Austria. He joined the Austrian- and CEE (Central- and Eastern European) equity sales desk as an institutional sales manager. With Raiffeisen International Bank he was able to successfully built a large client book of European based institutional clients and in the year 2005 he was promoted to desk head Central- and Eastern European equity sales and trading. During his time with Raiffeisen he also had an important role in the capital raising for several initial- and secondary public offerings and private placements of equity.
Since 2007 Eric has been living in Switzerland and he worked for several specialized Swiss (alternative) investment boutiques. He was an asset management sales director with Azemos Partners AG (a Zurich based renewable energy manager), Watamar Asset Management AG (a Zurich based systematic fund manager owned by a Geneva based single family office) and Anaxis SA (a Geneva based corporate credit and high-yield manager).
Over the years Eric gained a lot of valuable experience and knowledge about traditional-, alternative- and private market investment solutions and also about the European family office- and wealth management investor market.
During his career in equity- and asset management sales, Eric successfully raised significant amounts of capital with a focus on European Family Offices and Wealth Managers.
Eric joined Melior Capital Management in 2019 as a Managing Director Origination.
John has over 30 years of experience in corporate finance and business development. He received a BA with high distinction in economics including advanced studies in mathematics and econometrics from Indiana University. He holds a MALD from the Fletcher School of Law and Diplomacy along with a Diplôme in economics and trade law from The Graduate Institute of International and Development Studies (IHEID) in Geneva.
John started his banking career with Citibank in their World Corporation Group. From 1994 to 2006 he held various senior posts with Paribas Switzerland (later BNP Paribas) where he acted successively as: Head of Financial Institutions, Head of Corporate Banking Geneva, Head Acquisition Finance, and Head Corporate Restructurings. In 2006 he became COO of Erickson Capital Management – a JV in alternative funds with Merrill Lynch. In late 2008 he joined Lloyds International Private Bank as Head of Credit and Member of the Executive Committee. There he created an innovative and highly successful Credit Origination Team to work with UHNV private banking clients.
In 2011 John founded his own company as a senior independent consultant. He has acted as a trusted advisor to a number of corporate and UHNW family clients. He has worked on a range of projects in banking, real estate, clean energy, agro-tech and especially medical technology – in particular radio-oncology. He has a special enthusiasm for medical science.
John has extensive international business experience including working on projects between Switzerland and China. He is a Swiss national and resides in Geneva. John speaks maternal English. He is fluent in French and German, and speaks intermediate level Mandarin.
John has joined Melior Capital Management as Senior Executive – Origination.
Françoise is a French national with over 20 years’ experience in financial services. Françoise holds a Bachelor of Science in Psychology, passed the Level 1 examination of the CFA Program and was awarded the CFA Society of the UK’s Certificate in Investment Management (IMC). In addition to her mother tongue, she speaks English and German fluently.
She started her investment banking career at Goldman Sachs Frankfurt, working on their listed and OTC equity option sales desk to service large German and Austrian asset management and insurance companies. She then transferred to Goldman Sachs’ equity trading floor for institutional clients in London. It was her outstanding ability to handle clients with complex needs that led to her being chosen to contribute to the successful launch of Goldman Sachs’ new Global Products sales desk, offering a full range of financial products (from equities from all over the world to commodity futures and bonds) to hedge funds and selective financial institutions.
Françoise’s experience in selling a broad range of financial products to institutions during her 8 years at Goldman Sachs paved the way for her subsequent move to Morgan Stanley’s Private Wealth Management Division and then to a six-year tenure at Crédit Suisse London’s Private Banking Division where she looked after the portfolios of high net worth individuals.
In 2008, Françoise left Crédit Suisse to become a founding member of Crossbridge Capital, a private wealth management firm based in London and Singapore. During her 6 years at Crédit Suisse and 5 years at Crossbridge Capital, Françoise gained extensive exposure to complex derivative products such as structured notes as well as alternative investment offerings such as hedge funds and private equity.
Dumitru holds a First-Class Honours degree in Finance and Accounting.
He previously worked at Citigroup within the investment banking division. Prior to Citigroup, he was at IBM where his notable success included the re-engineering of the EMEA Financing annual plan. Dumitru has also worked for an investment firm specialised in the life-science sector, where he assisted in the negotiations of investment deals and has elaborated the Marketing Strategy Plan, as well as, coordinated the implementation of a number of projects.
More recently, Dumitru was invited to join the executive team of a microfinancing organisation in his native country, Republic of Moldova, where he is developing a new comprehensive marketing strategy and advises on the business strategy. The mission of the organisation is to empower economically the impoverished, particularly from the rural regions of Moldova, the poorest country in Europe.
Dumitru is a passionate volunteer, and throughout the years, has participated in and led teams for causes such as education, economic empowerment, politics and social action.
Dumitru joined Melior Capital Management to capitalise on his experience and knowledge, as well as, employ his enthusiasm about life-science, in order to identify the breakthroughs of tomorrow and the best investment opportunities of today.
Dumitru is fluent in Romanian, Russian, French and English.
Marinela graduated in Business Management & Economics with Distinction. She completed an MSc studies in Biotechnology, Bioeconomy & Law with a full scholarship granted by the Hellenic Biosafety Society at the International Hellenic University. Marinela who is an MBA candidate at the University of Birmingham (UK) specializes in Digital Strategy, Pharmaceutical & Biotechnology Drugs Marketing and Value-Based Healthcare (VBHC).
With over a decade of experience in the global life science industry, Marinela has held various International Marketing and Digital Strategy positions before joining Roche Diagnostics International – Roche Diagnostic Solutions (RDS) in the Global Marketing & Customer Insights Chapter and the Healthcare Transformation Initiative. She started her career in a multinational molecular diagnostics company in 2012, where she spent 7 years leading the International Marketing & Digital Strategy department before deciding to relocate in Zurich, Switzerland and further advance her career in the biopharmaceutical sector. Furthermore, she has been leading the digital transformation of a Swiss-domiciled non-profit company focused in global health and the implementation of the Sustainable Development Goal (SDG) 3 – “Quality Healthcare” in Switzerland and globally, having managed to digitize the end-to-end company’s activities and establish novel partnerships during the period of the pandemic.
As a former prominent professional athlete, Marinela is a passion-driven and committed personality who has a great interest in innovation and fulfilling unmet needs in modern healthcare.
Moreover, Marinela is the co-founder of the EMHS Society, an initiative created to raise public awareness around ethics in global health and nourish international collaborations to foster the value-based transformation of global health and improve patient lives globally.
Last but not least, Marinela is providing continuous voluntary support to wellness, education and global health causes and is a volleyball player and coach.
Marinela joined Melior Capital Management in 2020 as a Marketing & Digital Strategy Manager and appointed as an Executive Director in 2022.