Who we are
Founded in Denmark 1994, KLIFO provides clinical trial services for medical products, devices and nutritional products. We have grown into a drug development consulting company with an international client portfolio.
We provide a wide range of consultancy, strategic and operational services within all areas of clinical research, pharmacovigilance, clinical trial supply, regulatory affairs, the development of pharmaceutical and biotech products and the development of medical devices.
Our solutions meet each client’s specific needs.
KLIFO’s vision is to contribute to efficient product development by:
- Drawing on broad and solid international industry experience
- Designing solutions that meet industry standards and the requirements from authorities, and comply with each client’s targets and requirements
- Building trust and motivating collaboration with clients.
KLIFO has a strong management team representing our different competencies and areas of expertise.
Alejandra Mørk, (Ph.D., Pharm.), CEO: KLIFO A/S
Alejandra Mørk joined KLIFO in January 2008 as CEO and main shareholder. Previously, she worked for Nycomed Pharma for 18 years, in various management positions in drug development and lifecycle management.
In 1989 she joined Nycomed as project leader for development projects within pain, and was then moved to clinical development. For four years she worked with clinical development, mainly within obesity and pain, after which she became director of regulatory affairs and became engaged in organising product lifecycle management across Europe.
From 1999 to 2003, she was responsible for international project management at Nycomed, organising and participating in the evaluation of in-licensing opportunities. In 2003, she was made responsible for drug development at Nycomed, in senior management.
Alejandra chairs the Danish Pharmaceutical Society, is a board member of Danish Biotech and a member of the Danish Academy of Technical Sciences. She is also part of the EUCROF Paediatric Working Group.
Michael Engsig, (MSc Biotech, GDBA) EVP Drug Development Counselling & Business Development
Michael Engsig is a broadly anchored pharmaceutical professional with more than 19 years of experience and successful track record in R&D and commercial functions.
He has a background as Civil Engineer (M.Sc.) in chemistry specialized in biotechnology from the Technical University of Denmark 1998, followed by a Graduate Diploma in Business Administration (HD) - Organization and Leadership from Copenhagen Business School 2001.
Michael Engsig’s career began as a researcher in Nordic Bioscience in Copenhagen, followed by a position in ABN AMRO/Alfred Berg Investment Bank, working with commercial assessment of biomedical products as well as pipeline and company valuations of pharma and biotech.
In 2003 he joined Nycomed as Project Manager for late stage projects, and later Head of R&D Business Support and Portfolio Management. In 2006 when Nycomed acquired Altana Pharma, Michael Engsig was appointed Head of R&D Integration Office, holding the overall project lead of the integration of Nycomed’s and Altana’s R&D divisions. In 2011 Takeda Pharmaceuticals acquired Nycomed, and Michael Engsig was appointed Head of Russian Innovation Centre, Takeda Pharmaceuticals Russia/CIS, Moscow, until 2015. When joining KLIFO in January 2017 he came from a position in PPD as Head of Central and Eastern Europe Clinical Management.
Michael Engsig’s broad international experience is now focussed on supporting KLIFO’s clients. He strives to understand client needs and to supply the utmost experienced drug development experts to always match these needs.
Lisbet Vandvig, (MD),Vice President, Clinical Trial Services & Pharmacovigilance Services
Lisbet Vandvig joined KLIFO in July 2016 as VP Clinical Trial Services & Pharmacovigilance Services. Prior to joining KLIFO Lisbet worked 13 years within Clinical Development at Ferring. Before this she worked 12 years in marketing positions in GSK, Novo Nordisk and ALK and 5 years as Account Director at a CRO.
Lisbet was Senior Director, Clinical Operations, Clinical R&D at Ferring and in this position she was heading a group of approx. 30 people, conducting phase II-III clinical trials within Women’s Health, Urology, Endocrinology and Gastroenterology. The main part of the practical conduct of the trials were outsourced while core areas such as trial management including centralized monitoring, TMF quality review, protocol development and clinical trial reporting was managed internally.
As Director of Vendor Management at Ferring, Lisbet established this as a new department. The main achievement was an outsourcing strategy and in line with this to initiate the selection of preferred suppliers. Furthermore systems and processes were developed and implemented successfully under her management.
Lisbet gained her marketing and sales experience from working in both the pharma and CRO industry, where she was involved in developing marketing campaigns and strategies and in meeting clients and vendors and presenting proposals and budgets for various projects.
Christina Vinum, Vice President: Clinical Trial Supply Services
Christina joined KLIFO in February 2011 as Senior Clinical Trial Supply Coordinator and became Director of Clinical Trial Supply in January 2012 and VP: Clinical Trial Supply in 2014.
Christina has 15 years’ experience with clinical trial supplies, first at Nycomed from 2001 as Clinical Trial Supply Coordinator and, from January 2009, as Head of Clinical Supply for Nycomed CTS departments in Denmark and Germany.
Before Clinical Trial Supply, Christina worked as a Production Leader at Nycomed’s Commercial Operation site for 10 years.
Christina has worked with all aspects of handling clinical trial supply services in-house, as well as outsourcing of these activities to CMOs worldwide.
She has also worked closely with several large CROs, which have given her a good understanding of the GCP area.
Through many years of management and cooperation, across borders and between different cultures, Christina has a sound understanding of the daily procedures and challenges related to handling investigational medicinal products in clinical trials.
Anne Tingsgård, (M.Sc. Pharm.), Vice President: Regulatory Affairs Services
Anne joined KLIFO in September 2014 as VP: Regulatory Affairs Services. She has 28 years’ regulatory affairs experience, 15 years in pharma and 13 in a consulting company.
In 1987 she joined Eli Lilly Denmark as Regulatory Affairs Officer. After three years, she moved to Novo Nordisk Pharma Denmark, working for the company’s own products as well as for in-licensed products.
In 1994 Anne joined Novo Nordisk Headquarter Regulatory Affairs. Here, she worked in the CMC area, participating in updating the CMC sections of the dossiers for FDA and EU agencies. She was then asked to establish a team to support regulatory affairs in the emerging markets. During this period, Anne was also Project Manager for the development and implementation of a regulatory information management system.
In 2002, Anne joined A-consult, where she initially worked as a Regulatory Affairs Consultant and gradually moved into management and business tasks. In 2011, she was appointed CEO & COO, reporting directly to the board. In this capacity, she also gained experience in the financial and business strategy areas.
Lars Bo Nielsen, (M.Sc. Pharm.), Director: Quality Assurance and Qualified Person, GMP
Lars joined KLIFO in April 2015 as Director: Quality Assurance and QP. After his graduation as Pharmacist in 1984, he has worked in different pharmaceutical companies in Denmark. He has more than 30 years’ experience in the pharmaceutical industry, of which more than 20 is as QP.
Most recently Lars has worked for Ferring Pharmaceuticals A/S, first as Director: Global QA, responsible for manufacturing compliance at Ferring’s manufacturing sites. He then became Director: Global R&D QA and QP in development projects (CMC teams).
Lars is a GMP specialist and has conducted many audits as lead auditor. He also has GCP knowledge.
Lars has mainly worked in the QA/QC area and has gained much knowledge in the analysis and sterile and non-sterile manufacturing processes, of APIs and different types of products (e.g. small molecules, peptides, biologics and biotech products).
Michael Krak, (Graduate Diploma in Business Administration, Financial and Management Accounting), CFO
Michael joined KLIFO in February 2016 and is responsible for KLIFO’s financial management. He has a solid financial experience from 25 years in positions as Controller, Finance Director and CFO in companies such as Accenture, Nycomed and Takeda.
KLIFO’s board supervises the company’s performance, management and organisation on behalf of the shareholders. It also helps to determine strategy.
Mette Kirstine Agger, Chairman, Executive Director, Head of LFI Life Science Investments, LUNDBECKFONDEN / LFI A/S
Mette Kirstine was previously co-founder and CEO of 7TM Pharma A/S and has a broad international experience within biotech/life science covering business development and licensing, management and financing. Prior to founding 7TM Pharma, Mette was part of the management team of NeuroSearch A/S responsible for business development and licensing. She started her career as Patent Agent and has over the years co-founded several biotech companies. Mette has been appointed to numerous board positions both in private and public companies. Mette Kirstine Agger graduated as Biologist from the University of Copenhagen and has an MBA.
Morten Nielsen, CEO, Medicom Innovation Partner A/S
Morten has more than 20 years of experience across various industries and have obtained extensive executable experience within fast-track turnaround, management consulting, business development, product innovation, regulatory affairs and performance management.
Today, Morten heads up Medicom Innovation Partner A/S as CEO and has been a major driver in the turnaround of Medicom.
Prior to Medicom, Morten was partner in PA Consulting Group being responsible for the Nordic life sciences technology business. Before that Morten has held various leadership positions within Procata Consulting (e-business consulting), Lawson/intentia (ERP software), Olicom (computer network systems), DGM (Regulatory affairs) and S&W Medico Teknik (Emergency case medical devices). Morten has a master degree in electrical engineering.
Kerstin Valinder Strinnholm, Business Development Advisor and Board Member
Kerstin Valinder Strinnholm has more than 30 years experience from leading positions in sales, marketing and business development from AstraZeneca and Nycomed Takeda.
During her 12 years as EVP Business Development of the Nycomed Group she played a key role in ten folding the company’s turnover – primarily through M&A activities and in-licensing.
Currently, Kerstin works as strategic advisor through her own consultancy firm, Cavastor AB. She is also active as member of the boards of Camurus AB, Corline Biomedical AB and Immunicum AB.
Kerstin was born in 1960 and holds a degree in Journalism from the University of Gothenburg.