Drug Development Counselling Consultants
Medical Advice and Clinical Development
CMC and Preclinical Development
- Anders Vagnø Pedersen
- Anders Christensen
- Kim Hejnaes
- Steen Gyldendal-Melberg
- Jørgen Lang Pedersen
- Anke Domdey
- Jørn Arnt
- Lars Mecklenburg
- Martin Munk
- Jens Bukrinski
- Jes Jacobsen
- Simon Bjerregaard
- Ingrid Brück Bøgh
Regulatory, QA, Patents, Statistics, Medical Writing
- Ira Hartling
- Hanne Jensen
- Tina Kjøller
- Roger Timewell
- Elisabeth Augustsson
- Tine Kronborg-Hansen
- Lars Bo Kjerrumgaard
- Bjarne Bodin
- Peter Bergqvist
Medical Advice and Clinical Development
Lars Jelstrup Petersen, MD DMSc CBA
Professor Lars J. Petersen received his MD and Doctor of Medical Science degree from the University of Copenhagen and his CBA from AVT Business School. He is board certified in nuclear medicine and functional imaging. He has published more than 140 peer-reviewed papers and received a number of scientific honours. Lars has been working in the pharmaceutical business for more than 15 years with medical research and clinical science. He has been Associate Medical Director, Genmab with responsibilities for phase I-II trials in oncology, hematology, and immunology, and Medical Director, Abbott. Since 2005 he has provided part-time consultant services to a variety of small to medium sized biotech and pharmaceutical companies. At KLIFO, Lars provides mainly advice on early drug development in oncology and haematology, including the use of biomarkers and imaging. He also prepares executive summaries in these areas covering guidelines, existing and emerging competitors, medical need, target profiles, and clinical requirements for regulatory approval.
Peter Damsbo, MD
Clinical Development of Drugs and Devices + Technology Transfer. Peter has more than 25 years of experience from life science industry and science,including 3 years in the United States heading up clinical development of diabetes products for Novo Nordisk. Key positions include Chief Development Officer at Zealand Pharma, Vice President Clinical Drug Development at Novo Nordisk HQ, Medical Director Diabetes at Novo Nordisk USA, and Research Fellow at the Steno Diabetes Center, author and co-author of more than 20 peer reviewed papers.
Drug Development expertise: Has carried 3 projects from preclinical phase through to worldwide registration from a clinical perspective, including writing the expert reports and presented at meetings and hearings with FDA and EMA. He has experience in medical device development and conducted numerous drug concept evaluations and been involved in drug licensing deals and due diligence processes.
Therapeutic areas: Diabetes, Obesity, Metabolic Diseases and inflammatory diseases
NCE and Medical Devices*
Examples of deliveries:
Clinical and regulatory guidance for reporting of clinical trial on medical device (Medical Device company).
Post approval - compilation and evaluation of medical documentation to support marketing strategy (International Pharmaceutical Company).
Literature reviews and Clinical evaluation reports for CE marking of medical devices.
Stig Waldorff, MD, Clinical Pharmacology
Main area: Pharmaceutical Medicine with 23 years of experience from
AstraZeneca, locally and globally as member of Clinical Development Board. Broad
experience as lecturer in pharmacology, internal medicine and clinical trial
methodology. From 2009 he has been working as consultant to the pharmaceutical
industry and authorities.
- Drug Development expertise
from Coorporate Board membership.
- Therapeutic areas:
Respiratory, Gastroentorology and Cardiology.
- Technology expertise:
Pharmacokinetics, Statistics, Ethics, Applied IT solutions and Implementation
Examples of deliveries:
- Designed development programs
- Designed implementation programs form knowing to doing.
- Evaluated developmentand regulatory strategies.
Leif Lang Jensen, MSc Pharm, MD
Leif Lang Jensen has a degree as medical doctor as well as pharmacist. He has worked with medical advice, medical affairs and clinical development in the pharmaceutical industry for 27 years in Lundbeck A/S and in Janssen-Cilag. In Janssen-Cilag Leif Lang Jensen was Medical Director from 1988-2007. His key areas of competence in clinical development phase II-IV in the therapeutics areas Pain, Psychiatry and CNS. In addition to this Leif has worked with haemotological indication.
Leif's motivation to work in the Drug Development Counselling team is the opportunity to use his 27 years experience from the pharmaceutical industry by focusing on advise in clinical trials strategies and evaluations of clinical trials, primary within pain, psychiatry and CNS.
Mikael Thomsen, MS. (Pharm and Human Biology), PhD
Mikael Thomsen has worked in the pharmaceutical area for close to 20 years within different major pharmaceutical companies including Novartis Pharma, Basel, Switzerland, Novo Nordisk, Copenhagen, Denmark as well as at the U.S. Food and
Drug Administration. He is co-founder of the Biotech company OSI Prosidion Ltd, Oxford, UK where he acted as the VP of Development for more than three years bringing several drug candidates from Research to clinical Phase IIa. He has functioned as Chief Development Officer in the German biotech, Probiodrug AG as well as Chief Scientific Officer and Head of R&D in Bridge BioResearch, a UK/Danish based biotech. He co-founded the Danish biotech company Sound Biotech as well as the two recent started biotechs in Denmark, Concit Pharma and Conrig Pharma. He is an experienced Clinical Pharmacologist where he was responsible for planning and conduction of Phase I/II activities (clinical development plans and trials) as well as he has managed several projects through the regulatory pre-clinical and CMC phase leading to clinical activities. Recent roles at major pharmaceutical companies and biotech companies include Senior Clinical Pharmacologist, Clinical Pharmacologist, Head of Clinical Pharmacology, VP Development, Chief Development Officer and Chief Scientific Officer, where he managed departments organizing all the activities leading a drug from late Discovery to Phase I/II. In all the named positions he has focused on achieving early fast track drug development. He has taken numerous compounds from Research/pre-clinical into Phase I/IIa (in several disease areas but predominantly in the area of Metabolism as well as inflammation/pain) and has been involved in several product filings as well as interactions with authorities from EMEA/CHMP, FDA and KIKO (Japan). Mikael Thomsen has two M. Sc. degrees (Pharmacy and Human Biology; from University of Pharmaceutical Sciences, Copenhagen and University of Copenhagen, Medical Faculty) and has a PhD in Pharmacology and Toxicology (University of Copenhagen and FDA site, Arkansas, US) and a degree in Pharmaceutical Medicine (ECPM, Basel, Switzerland). He is a member of several pharmaceutical societies and has authored or co-authored more than 50 publications/abstracts related to early drug development as well co-author of several patents.
CMC and Preclinical Development
Anders Vagnø Pedersen, Chemical Engineer / Biochemistry
Anders brings to the table more than 30 years background in product development, quality and project management within Biotech and Pharma. Anders has experience ranging from lead candidate identification, CMC development, process technology and documentation from operational and managerial positions in small, mid-sized as well as large organization.
Anders is overview oriented with deep respect for the details and for the people involved. One of his focus points is including all relevant competencies already available in order to optimize balance between risks and progress.
Anders Christensen, MSc, PhD
Anders B. Christensen has an MSc in cell biology (immunology) and a PhD in biotechnology. Anders Christensen has worked for 25 years with many aspects in the field of biotechnology and biologics. After an academic career he spend 7 years as a development Scientist with Novo Nordisk A/S, 4 years as CMC Consultant with KLIFO A/S and 4 years as a Principal Scientist with CMC Biologics A/S. From 2015 he has served as Senior CMC Consultant. Anders Christensen is the founder of Abionex development and BioCMC Consult ApS.
Kim Hejnaes, MSc
Kim Hejnaes holds an MSc in biochemistry from University of Copenhagen, Denmark. He spent 20 years (scientist, project director, principal scientist) with Novo Nordisk, Denmark. Kim Hejnaes has over the past 18 years been representing clients outsourcing biopharmaceutical projects to contract manufacturers and has for 5 years worked for CMC Biologics (a major contract manufacturer based in Copenhagen, Denmark) as Director, Project Management.
Kim Hejnaes served as an adjunct professor in biotechnology at University of Aalborg, Denmark for 10 years. He has founded 6 biotech companies over the past 18 years.
Steen Gyldendal-Melberg, MSc PhD, Quality Assurance and Quality Management Systems
GMP, GDP, CMC, Aseptic production, Visual inspection, Batch documentation, Handling and approval of deviations, Release of medicinal products, Risk Management, Validation/Qualification, Stability protocols and reports
Quality Management Systems:
ISO 9001, ICH Q10, Quality manual, Develop and maintain Quality Management Systems (QMS), SOP (ghost) writer
Training and audit:
GMP, GDP, Internal and external audits
The last 2-3 years Steen has worked as a senior consultant in pharmaceutical companies and been involved in design, development and implementation of QMS and final approval by Danish Health and Medicines Authority. He has been quality responsible person and is currently QP (Qualified Person). In addition,he has been deeply involved in design and qualification of temperature controlled storage and transportation facilities, visual inspection of injectable products, risk management, deviation and product release.
Prior to the years as consultant, Steen has more than 30 years of experience from the pharma industry (mainly ALK-Abello and Novo Nordisk). Main areas of experience include research and development, product support functions, pharmaceutical production (API, aseptic, QC, packaging and QA), leadership, project management,inspections from authorities (FDA and DHMA), design and implementation of QMS, safety health and environment and Corporate Social Responsibilty.
Jørgen Lang Pedersen,
Anke Domdey, MSc (Pharm), PhD
Anke Domdey, MScPharm, PhD has extensive international experience in cross-functional management & leadership in business plan preparation and product development incl. GLP compliance from 25+ years in R&D and marketing in the global Biotech and Pharma industries (e.g. Bayer, Boehringer Ingelheim, BioXell, LEO Pharma) and advisory roles.
Anke is an expert in early product development of small molecules as well as biologics and vaccines. She has worked with development products covering a broad range of therapeutic areas, among them oncology, autoimmune diseases, CNS, infectious diseases, dermatology and cardiovascular diseases. She has remarkable scientific understanding and strong capabilities of working herself into new matters in due time. Anke has co-operated with KLIFO on several tasks. Among them non-clinical due diligence, non-clinical development programmes, regulatory documentation (IB, CTD) and participation in authority meetings, project management, outsourcing and outsourcing management, management of bioanalytics and GLP/ GCLP implementation.
Jørn Arnt, Ph.D, D.Sc.
Jørn Arnt's main area of expertise is preclinical pharmacology based on more than 30 years' industry experience from positions in H. Lundbeck A/S. Key positions have been Head of Department of Psychopharmacology, Divisional Director for In vivo Pharmacology and Senior Principal Scientist.
Within the area of preclinical pharmacology, Jørn Arnt provides particular competences in CNS pharmacology & animal models and translational science animal/human. Having worked in many different projects with an international scope and in various industry partnerships, Jørn Arnt also provide knowledge as to drug development strategy and regulatory strategies and Jørn Arnt is an experienced project team participant from discovery phase to launch.
Jørn Arnt has during his career been involved in discovery and global development of several CNS drugs (e.g. citalopram; escitalopram, sertindole, serotonin 5-HT2 and 5-HT6 antagonists). Further he has contributed to numerous in- and out-licensing evaluations, including several Due Diligences. Jørn Arnt has been speaker at numerous international launch and marketing symposia, author or co-author of more than 100 peer-reviewed papers and several review articles.
Lars Mecklenburg, DVM, PhD, Dipl ACVP
Lars Mecklenburg is a veterinary pathologist with 20 years of experience in toxicologic and experimental pathology and more than 15 years of experience in preclinical drug development. Lars received his DVM and PhD degree from the School of Veterinary Medicine in Hannover, Germany. He is board certified by the American College of Veterinary Pathologists (ACVP) and obtained accreditation as an advanced risk assessor by the EU Toxicologicial Risk Assessment Training Program (TRISK).
Lars has worked as a preclinical expert for companies such as ALTANA Pharma, Nycomed, Takeda, and Fresenius-Kabi. He has worked on a large number of projects in preclinical development from a large variety of indications and in various stages of development.
Lars main expertise is medical writing and the scientific combination of pharmacology, pharmacokinetics and toxicology. At KLIFO, Lars provides mainly advice on preclinical development, including the generation of strategic preclinical development plans and the generation of regulatory dossiers to support clinical trials and marketing authorizations around the world.
Martin Munk, MD, DMSc
Martin Munk graduated in medicine at the University of Rio de Janeiro, received his MSc at São Paulo Medical University and earned a MD in Immunology from the University of Ulm, as well as a DMSc (Habilitation) from the Humboldt University Berlin. Munk served in various academic research positions involved in immunology and infectious diseases including Assistant Professor, University of Ulm; Medical Researcher, Humboldt University; Senior Scientist, Max-Planck-Institute for Infection Biology Berlin; and Invited Professor and Senior Scientist, Statens Serum Institute Copenhagen.
He has published more than 50 peer reviewed manuscripts.
Since 2002, Munk has been working in the pharmaceutical industry within the preclinical and early clinical areas of immunology, infectious diseases, inflammation, cancer and diabetes as Principal Scientist at Genmab A/S, Copenhagen; as Director Preclinical Safety and Bioassays at Santaris Pharma A/S, Copenhagen; and as Global Medical Advisor (Principal Scientist) at Novo Nordisk A/S, Copenhagen. He participated in different stages of compound development from research, lead candidate selection, nonclinical planning, safety assessment and biomarkers into Phase I/IIa, consequently being involved in product filings and interactions with authorities. Munk has been successfully working as consultant the last 5 years in different drug development programs.
Jens Bukrinski, MSc, PhD
Jens has +20 years of experience from academic research and from the pharmaceutical industry working in CMC, regulatory affairs and as project manager. He has a strong background in multiple key aspects of the drug development process such as
Pre-formulation/formulation and biophysical characterization of proteins and peptides
Drug substance and drug product formulations for clinical trials
Identifying key stability indicating methods critical quality attributes
In-use and shelf-life stability assessment and comparability studies
Troubleshooting and root cause assessment
Regulatory requirements for the quality documentation
Due diligence, opportunity and risk assessment in CMC
Project management and business to business collaborations
Jens holds an MSc in Dairy Science and technology and a PhD in structural biology and bioinorganic chemistry. After his PhD he worked as a post doc at University of Copenhagen and later as a research associate professor at Carlsberg laboratory. After Carlsberg he worked 7 years at Novo Nordisk A/S. For the past 6 years he worked as a project manager at Novozymes A/S, Biopharma R&D, managing internal R&D projects and collaborations with major pharmaceutical companies.
Jes Jacobsen, MSc (Pharmacy)
Jes is a highly experienced drug development scientist with a background in more than 30 years of commitment to the pharmaceutical industry, mainly within Novo Nordisk A/S. Throughout his career, he has been engaged in almost all CMC related aspects of protein and peptide drug research and development. Jes has a particular strong background within
Analytical chemistry and characterization based on knowledge and experience from a broad range of techniques
Identification of stability indicating methods
Analytical method development, qualification and transfer
Pre-formulation and formulation development
Stability evaluation for APIs and various formulation concepts
Troubleshooting during process and product development as well as upscaling
Preparation and review of documentation for clinical and regulatory applications
Project coordination, incl. CMO interaction and management
In addition, Jes has on numerous occasions conducted fruitful collaborations in the interface between professionals within process and product development, pre-clinical, clinical, quality assurance (GLP and GMP), and regulatory affairs and has contributed to applications submitted for clinical trials and marketing authorizations in US and EU.
Simon Bjerregaard, PhD, MSc (Pharmacy)
Simon holds a Ph.D. in pharmaceutical sciences and has more than 15 years of experience from working with biologics in the pharmaceutical/biotech industry.
He has a strong background in drug delivery of biologics, covering oral, parenteral, transdermal, pulmonary, and nasal drug delivery concepts. His work has resulted in several patent applications. On top of this he has extensive insight into physicochemical stability of peptides and proteins.
Throughout his career, Simon has been responsible for early stage formulation and process development and characterisation of peptides and proteins. He has coordinated several project activities and has participated in focus groups scouting for external trends and opportunities within drug delivery.
Furthermore, Simon has experience with technology transfer, risk management/QbD and management of CMO/CRO collaborations.
Ingrid Brück Bøgh, DVM, PhD, DVSc, European Registered Toxicologist
Ingrid holds a veterinary degree (Justus-Liebig University, Germany), a PhD (Melbourne University, Australia) and a DVSc, University of Copenhagen, Denmark).
Ingrid has solid expertise within pre-clinical safety evaluation of new drug candidates from early development stages to marketing and post marketing commitments. Her experience embraces a large variety of non-GLP and GLP toxicology programs, outsourcing strategies and drug safety evaluation for NCEs and NBEs (peptides, mAbs, antibody drug conjugates, radioimmunotherapy). Her speciality lies in the field of reproductive, developmental and juvenile toxicology. Ingrid has overlooked 100+ non-clinical parts of INDs/IMPDs and marketing applications, with more than 30 drug candidates successfully reaching clinical trial stage and several new compounds obtaining approval for marketing in US/EU/worldwide.
Apart from her academic career, Ingrid has worked for more than 11 years in pre-clinical safety of drug development; this includes CiToxLAB Scantox (Study Director, 1 year), Novo Nordisk A/S (Head of Toxicology and Safety Pharmacology, 9 years) and IBB Consulting (Founder, CEO and Preclinical Safety Consultant, since 2017). Key positions include Professor of Veterinary Reproduction and Obstetrics at University of Copenhagen (2005-2008) and Vice President of Toxicology and Safety Pharmacology at Novo Nordisk (2015-2017).
Ingrid is a strong driver of cross-functional collaborations and has held various professional international membership positions with strategic representative or advisory functions. She is an experienced leader/manager with a track record of achieving ambitious goals in science-driven environments.
Her publication record counts author/co-authorship of >45 international peer reviewed publications, 3 books/book chapters and more than 60 abstracts.
Regulatory, QA, Patents, Statistics, Medical Writing
Ira Hartling, MSc Parm, Regulatory Affairs and Quality Assurance
XEVMPD Registrations Status Systems, eCTD, Document Handling Systems, Variations, SmPC/PL/Labelling, New applications
Develop and maintain Quality Management Systems, SOP (ghost) writer.
The last 7-8 years Ira has worked as a senior consultant in pharmaceutical companies and has for several years been deeply involved in XEVMPD/Registration Status System. Also, she has been product responsible, made strategic planning of variations, submitted applications, coordinated with the health authorities, worked with eCTD, EVMPD, EDMS, RIMS, GDP and has developed and maintained Quality Management Systems.
Prior to the years as consultant, Ira has more than 25 years of experience from the pharma industry (mainly Novo Nordisk) with Regulatory Affairs in both Head Quarter and Affiliates (Singapore, Austria). Also, Quality Assurance within Development, Marketing and in an affiliate. These years included common regulatory tasks, project management/department manager of new IT systems including LIMS and EDMS. Furthermore, released API for products for clinical trials and quality responsible in an affiliate.
Hanne Jensen, PhD
Hanne Jensen holds a PhD from the Technical University in Denmark. Hanne Jensen's key competences are regulation for medical devices (MDD, IVD, 21CFR820, CMDCAS, Taiwan) and Quality Management (ISO13485, GMP, GCP, GDP, GLP, ICH guidelines, ISO 9001, 21CFR11, TQM, ISO 17025, OSHA 18001).
Hanne Jensen has worked 20 years for Novo Nordisk, 3 years for biotech and 3 years at the Danish Medical Devices Certification (DGM).
As part of the KLIFO Drug Development Counselling team, Hanne Jensen has provided advise as to strategies for meeting documentation requirements for CE mark and Hanne has reviewed documentation intended for CE-mark.
During my time at Danish Medical Devices Certification (DGM) - the Danish notified body I have often thought: "If this company had just had proper counselling before submitting this application the chances of bringing this Medical Device to market would have been much "better", easier and a lot faster."
Therefore I want to use my expertise and competencies to help Medical Device companies reach their goals in a more efficient way by having the right documentation in place to document safety and efficacy and at the same time help them building and maintaining competencies within the companies.
Tina Kjøller, MSc Pharm
Tina Kjøller has more than 20 years international regulatory experience within US and EU. She holds a Diploma in regulatory affairs from the University of Wales. During her career she has worked in big pharmaceutical companies (Novo Nordisk, Lundbeck) as well as small biotech (Zymenex). She has had the project manager role and headed meetings with the EMA and the FDA. In addition she has experience with drug-device combination products as well as devices and orphan drugs. In a couple of years she was the Danish delegate in an ISO standardisation working group. Finally she has 5 years of experience from the quality assurance area with CAPA, auditing, QP (release of products ect.), narcotic product handling and accounting.
Accomplishments: Responsible for an IND that got FDA approval; in cooperation with the regulatory team approval of an anti epileptic product via the EU Central Procedure; responsible for the CE-marking of an insulin pen-injector, responsible for the device part of several drug device combination products which got EU approval; responsible for the Orphan Drug Designation application for EMA and FDA (approval obtained in EU for the disease metachromatic leucodystrophy (MLD)).
For almost six years she has worked as an independent consultant with big and small pharmaceutical companies like Johnson & Johnson Consumer Nordic, Janssen-Cilag, Novo Nordisk, Ferring Pharmaceuticals, Grünenthal, Leo Pharma, Coloplast, Matas, CSL, Zymenex among others. In this period she has worked on site and remote with the clients dependent upon the need of the particular client. Some of the challenges have been to submit an application and later the responses to the questions from the EU authorites with regard to a generic product, which got the marketing authorisation last year. She has worked with both national and decentral regulatory procedures within the EU. Other type of tasks have been to prepare regulatory strategies for products, giving advice for companies who got stuck in the development of their products or in situations where a third party opinion was deemed necessary.
Elisabeth Augustsson, MSc Pharm
Consultant in regulatory strategy and communication.
Senior regulatory affairs professional with more than 20 years experience in drug development and regulatory affairs from both big pharma and smaller biotech companies. Special focus on clear and effective communication with regulatory authorities and problem solving. Project management experience.
Examples of drug development experience:
- Metabolic diseases
- Orphan Drugs
- Small molecules
Tine Kronborg-Hansen, PhD, Regulatory Affairs Cosmetic and Food
Compliance with national, Scandinavian and European legislation.
Evaluation of formulations, labelling, claiming, marketing materials on cosmetic, medical devices and food.
Advising on strategies for legal categorization of complex formulations. Strategic input and plans for placement of products which can be placed in more than one legal category.
Contact to other departments, i.e. legal, marketing, or attorneys and authorities as ghost writer or consultancy, in regards to claiming, notifications, granting exemptions, hearing letters and negotiations, safety and safety assessment.
Tines background is a M.Sc. in Dairy Science and Technology and a Ph.D. in Food technology and microbiology from the Royal Veterinary and Agricultural University (KVL), Department of Dairy and Food Science, (Current name: Copenhagen University, Faculty of Life Sciences, Department of Food Science).
Since 2005 Tine has worked as consultant with regulatory affairs - national and EU legislation on cosmetic, medical devices and food including food supplement, slimming products and PARNUT products. Tine has also been working with self-assessment programs and as an assessor at inspection by DVFA.
Prior to the years as consultant, Tine has worked as research scientist responsible for a microbiological QC-laboratory, GMP for API – culture cell bank and as a Research Assistant Professor on different microbiological/mycological research projects at KVL Author of several publications and book chapters on dairy mycology.
Lars Bo Kjerrumgaard, MSc, European Patent Attorney
Lars Bo Kjerrumgaard is a European Patent Attorney with 23 yours of industry experience from Lundbeck A/S, MAXYGEN, Novo Nordisk A/S and Ostenfeld Patent bureau A/S. Since 2009 he has worked as a consultant.
Lars is focusing on providing IP, in particular, Patent consulting to Pharmaceutical companies, Biotec companies having focus within the therapeutic area as well as start-up companies having focus within the therapeutic area. Lars also provides Patent consulting within the broader life science area and the chemistry area. Europe is the main area of competence, however, a broad network ensures a world-wide strategic focus.
Motivation for Drug Development Counseling:
"During my time of working in the pharma & biotec business I have gained a strong interest in the therapeutic field. I believe that my knowledge and understanding of intellectual property world-wide can be of significant value for drug development. I wish to ensure that my knowledge contributes to making the right decisions, and that it supports decision makers in understanding the complexity, strength, weakness and threats of their and their competitors' IP rights."
Bjarne Bodin, Statistic and Data Management
More than 25 years of experience working with DM and Stat in clinical research, Pharm and Device. Previous positions at Novo Nordisk and at CROs. Executive member of International Society of Clinical Biostatistics and founder of Danish Association of Data Management. Founder and CEO of BioStata.
Examples of deliveries:
- Statistical and DM advice in designing clinical trials, e.g. adaptive trial design, eCRF choice etc.
- Due diligence service with focus on compliance with ICH, GCP etc.
- Ensuring data quality and format in compliance with international standards
- Advise in statistical analysis modelling
- Advice in outsourcing issues (contract suitability, specifications and QC)
Peter Bergqvist, PhD
Peter holds a Ph.D. in Clinical Pharmacology (1997) from Lund University and has 18 years of combined experience within clinical trial management, medical writing, and management of medical writers.
Peter has substantial experience in authoring clinical trial outlines (including the design of clinical trials) and protocols, protocol amendments, clinical trial reports, clinical summaries and overviews, investigators brochures, abstracts, and manuscripts within the fields of uro-oncology, urology, endocrinology, and gastroenterology. Peter has been medical writer on various clinical trials, Phase 2 to 4. In relation to MAAs/NDAs, he has prepared clinical documents for submission and has been instrumental in Q&A processes with health authorities. Moreover, Peter has extensive hands-on experience in activities related to data transparency and public disclosure.
Before becoming a medical writer, Peter worked as International clinical trial manager on various projects within respiratory and CNS disorders which gave a solid experience with clinical research processes.
In addition, Peter has been an author of about 30 scientific papers, >10 book chapters and >60 abstracts as well as a presenter of scientific abstracts at >20 international conferences.
Alejandra Mørk, PhD, Pharm, CEO of KLIFO A/S
Alejandra Mørk joined KLIFO in January 2008 as CEO and main shareholder. Prior to that she worked for 18 years for Nycomed Pharma holding various management positions within drug development and life cycle management. In 1989 she joined Nycomed as project leader for development projects in pain. Shortly after that she moved into clinical development. For four years she worked with clinical development mainly in obesity and pain. After this she took on a position as director of regulatory affairs and became engaged in organizing product life cycle management across Europe. From 1999-2003 she was responsible for international project management in Nycomed, and part of this position was to organize and participate in evaluation of in-licensing opportunities. In 2003 she became overall responsible for drug development in Nycomed and a member of the senior management team. In this position she acted as Nycomed's representative in steering committees for partner projects with US biotech companies. After the merger between Nycomed and Altana in 2007, she was appointed senior vice president responsible for Portfolio, Project and Alliance Management.
Lene Schubert, MSc
Lene has worked with cross functional project management over the last +10 years. This includes project management at more detailed operational level as well as leading global teams (EU, US, JP) on a strategic level and evaluation of new drug opportunities (in-licensing). She has experience in working with various therapeutic areas (gastro intestinal/inflammation related diseases, bone/osteoporosis, pain) both in mid size (Alpharma, Nycomed) and big pharma (Takeda).
Lene has lead projects from early stage of development to global approval and life cycle management and has a proven track record with small molecules and biologics including orphan drug development.
Before Lene has worked within most areas of CMC Drug development, i.e. analysis, formulation and clinical supply. Her educational background is MSc in Organic Chemistry combined with education in project and line management and LEAN.
Thomas Matthiesen, MSc
Thomas originally has a CMC background in drug development, but has primarily worked with cross-functional project management over the last 10+ years. He has a science background combined with education in project management, LEAN, business/innovation management (SIMI) and has practical experience from a range of therapeutic areas (osteoporosis, blood products, diabetes, obesity) and has worked with all stages from early development to life cycle management.
Thomas has project and line management experience from big pharma (Novo Nordisk, Takeda), mid size (Nycomed) and also small scale companies and can manage complexity both on the detail level (e.g. writing an IMPD hands on), and on the strategic level (e.g. leading a team to define a product development strategy) and he has a proven track record with small molecules, biologics and medical device development projects that have been led to successful completion.
Torben Skarsfeldt, MSci, DSci
Torben Skarsfeldt is MSci and DSci from the University of Copenhagen. Before finalizing his major thesis he was recruited to H. Lundbeck A/S as research scientist.
During his 29 years' employment he served as Section Head in R&D, International Licensing Manager, Director of Business Opportunities (US) and Corporate Project Director.
He has been involved in the discovery and development of several CNS compounds, including antipsychotics (sertindole and tefludazine, antidepressants (citalopram and escitalopram, the M1 muscarinic agonist, Lu 25-109).
He was elected member of Lundbecks Supervisory Board for 16 years.
He is currently Board member of a Danish biotech company, scientific advisor for a US biotech company, Scandinavian Advisor for a US/UK investment banking group and Founder, CEO of Pharma Guidance ApS.
Michael Engsig, MSc, HD, EVP Drug Development Counselling
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.
Michael Gerstenberg, PhD, MSc Eng
Michael comes from a background in engineering and international academic research within condensed matter physics and chemistry, and biophysics. Michael moved to Novo Nordisk in 2002 to more closely help patients in need. He has mainly led device and drug projects from early inception past first human dose within diabetes and obesity, but has also experience in several other related areas (inflammation, CVD, encapsulation of stem cells, inhalation of drugs to the lung, continuous glucose monitoring and gut microbiota). A large part of Michael’s work has been centred on the early innovation portfolios identifying new targets with the responsibility for providing proof of principle in appropriate animal models. Lastly, Michael was appointed research project director with responsibility for driving projects past development lead selection towards phase 1 trials. As a specialist, he has held strategic positions in support of management combining research with business strategy. Within drug development, Michael can support your project with, e.g.,
- Project planning and execution bringing drug and/or device candidates from inception to lead candidate selection and clinical trials
- Optimization of peptides, proteins or Abs towards desired pharmacological properties
- Review of structure-activity-relationship, biophysical and pre-clinical data for development lead candidate selection
- Quality documentation for phase 1+ trials for drug and drug-device combinations
- Specifications and target product profile generation
- Challenge and generation of development strategies
- Facilitation of drug developmentprocesses and innovation
- Building a strong project winning culture
Michael has a MSc in Engineering from Danish Technical University and a Ph.D. in physics from Copenhagen University. He has later added pharma (Medicinal Product Consultant, LIF) and business acumen (CBS SIMI Executive Diploma). He has worked at Risø National Laboratory, Princeton University and Los Alamos National Laboratory.