Contact person: Michael Hildebrand

CMC is the basis for every new medical entity on its way to the market. Our expertise covers all challenges which customers may encounter with their compound during development and later on the market.

CONELIS Experts offer Consultancy and Support for:

• API synthesis, Formulation development and QC-analytics
• Process development and manufacturing for Biologicals
• Due diligences and other project evaluations
• CMC development and manufacturing strategy incl. life-cycle management and contract manufacturing
• Submissions to authorities
• Interdisciplinary workflows to ensure appropriate communication and documentation for life-cycle management

Each project has its specific CMC aspects due to the different nature of compounds. We tailor our consultant work to your individual needs to safeguard the selection and development of most promising candidates and formulations in a successful, time and cost efficient manner.

Experts:

	Michael Hildebrand Expert for CMC, Biopharmaceuticals and QP topics • CMC support from research to life cycle management • Formulation development and Quality Control • GMP and Qualified Person support hildebrand@conelis.org
	Georg Roth Expert for Biotech Process Development and Manufacturing • Process development (emphasis on cell line and USP) • CMC compliance support • Due Diligence, CMO selection and evaluation assistance roth@conelis.org
	Werner Skuballa Expert for all aspects of Chemical Synthesis • Medicinal Chemistry and Drug Development • Synthesis of drug compounds and - candidates • Synthesis of natural compounds skuballa@conelis.org
	Monica Unger-Bady Expert for CMC Regulatory and Compliance • Provide practical experience for Regulatory Compliance • Development of databases for Regulatory Affairs • Develop workflows between RA and Production/QC unger-bady@conelis.org
	Heiner Zindel Expert for Biotech Process Development and Manufacturing • Business Development and Support for CMO/CRO’s • Process Development (USP and emphasis on DSP) • Qualifications / Validations (DQ, IQ, OQ, PQ based on an FMEA approach) zindel@conelis.org

Contact person: Jens Hoffmann

CONELIS Experts offer Consultancy and Support for:

• Disease specific Target Identification, Validation and Drug Candidate Evaluation of data for strategic decisions
• Drug Discovery Project
• Design of Preclinical Drug Development Programs and Project Management
• Pharmacodynamic Studies in relevant Disease Models (Primary Pharmacology)
• Safety and Pharmacokinetics in vitro and in animal studies (Secondary Pharmacology)
• Toxicology Studies (Chronic Toxicity, Cancerogenicity, Embryonic Toxicity)
• Scientific and Medical Writing of Clinical, Scientific and Regulatory Documents
• Support in grant application writing and project management of funded projects

Experts:

	Matthias Bräutigam Expert for drug research and preclinical development • Imaging agents • Imaging technologies • Medicated devices braeutigam@conelis.org
	Hans Hendriks Expert for R&D programmes in Oncologyx • Scientific and Medical Writing • Preclinical anti-cancer R&D • Grant applications and project management hendriks@conelis.org
	Michael Hildebrand Expert for Pharmacokinetics and CMC • Biopharmaceuticals and CMC • Pharmacokinetics in animal and man • Development of drug substances and formulations hildebrand@conelis.org
	Jens Hoffmann Expert for Research and Drug Discovery in Oncology • Validation and characterization of oncology targets • Tumor models, stem cells • Biomarker identification, translational research hoffmann@conelis.org
	Pascal Piller Expert for Project Management and Contract Research • Full range Test Laboratory Service for REACH/Preclinic • Regulatory Affairs Service / Material Safety Data Sheets • Product safety-tests, in-vitro tests and SVHC analyses piller@conelis.org
	Wolfgang M. Roßberg Expert for non-clinical drug safety and development • Research toxicology • Regulatory toxicology • Evaluation of in-/out-licensing candidates rossberg@conelis.org
	Werner Skuballa Expert for CMC and Medicinal Chemistry • Medicinal Chemistry, Synthetic Chemistry • Development of drug substances • Chemistry and biological activity of Natural Compounds skuballa@conelis.org
	Frank S. Zollmann Expert for Pre-/ Clinical Drug Development • Safety pharmacology, toxicology, pharmacogenomics • Integrated preclinical & clinical development up to PoC • Clinical pharmacology zollmann@conelis.org

Contact person: Astrid Schott

All clinical testing needs planning and all available data needs to be interpreted. Clinical drug development is very expensive and if you want to find the right path to approval, you need the best target product profile, development plan and study design.
If you are considering to invest in a drug or are preparing a strategic decision inside your company you want to evaluate the quality of the available data and estimate how and when this product could get to the market. Let us introduce you to our team of independent experienced consultants who can support you with medical, scientific and statistical expertise, experience and know how.

CONELIS Experts offer Consultancy and Support for:

• Clinical program and study design Phases I-IV
• Evaluation of data for strategic decisions
• Safety risk management
• Interim Management
• Support of submissions to authorities
• Conduct of Expert Meetings, advice on biomarker programs

Experts:

	Johannes Lampe Expert for Clinical Research & Development • Clinical development, Phase I-IV (Neurology, Immunology) • Medical regulatory strategy • Due diligence lampe@conelis.org
	Wolf-Stefan Richter Expert for Clinical Development • Study design and imaging biomarkers • Medical need assessment • Medical regulatory strategy richter@conelis.org
	Astrid Schott Expert for Clinical Research & Development • Clinical Development planning, Phase I-III • Interim management • Due Diligence, licensing schott@conelis.org
	Carsten Schwenke Expert for Biostatistics • Statistical planning of Clinical Development, Phase I-IV • Submissions for marketing authorization • Health economics and outcomes research schwenke@conelis.org
	Daniel Sehrt Expert for Early Clinical Research & Development • Scientific concept & design of Phase I-IIa trials • Clinical pharmacology (PK/PD and pharmacogenomics) • Clinical trial applications sehrt@conelis.org
	Mark Waring Expert for Safety Risk Management • Safety risk management strategy and plans • Epidemiological study design • Operational support in pharmacovigilance waring@conelis.org
	Christian Wolf Expert for Clinical Development & Life Cycle Management • CNS indications (MS, epilepsy, stroke) • Strategy, operations and interim management • Business development wolf@conelis.org
	Frank S. Zollmann Expert for Pre-/ Clinical Drug Development • Safety pharmacology, toxicology, pharmacogenomics • Integrated preclinical & clinical development up to PoC • Clinical pharmacology zollmann@conelis.org

Contact person: Bernd-Günter Schulz

Development and testing of drugs and medical devices is a complex process, which is highly regulated by Health Authorities. This also requires being compliant with authority requirements in production of a device or medicinal product throughout its life cycle. We provide our expertise to navigate the regulatory maze with its large number of guidelines, to stay compliant and to propel your project forward as fast and efficient as possible. Our goal is to develop and protect your projects' value.
Based on our extensive knowledge and experience with numerous development projects, successful submissions and marketed products we offer pragmatic proposals and solutions for your project:

CONELIS Experts offer Consultancy and Support for:

• Practical experience for Regulatory Compliance
• Design and implementation of Regulatory Strategies
• Customer oriented project management for most cost effective analyses and tests according GLP and ISO

Experts:

	Siglinde Dürr Quality Assurance • Implementation of Quality Systems according to GMP, GCP or ISO regulations • Conduct quality audits (GMP/GCP/GLP) • Develop and implement Standard Operating Procedures duerr@conelis.org
	Birger Kintzel Expert in Regulatory Affairs for the EU, USA and International territories, covering both pharma and biotech products • Regulatory strategy and submissions • CTAs und Scientific Advice preparation • Life-cycle management kintzel@conelis.org
	Pascale Piller Expert for GLP-Compliant Analyses and Tests • GLP compliant regulatory analyses and tests • In-vitro concepts for efficient product development • Project management and study monitoring piller@conelis.org
	Bernd-Günter Schulz Drug Regulatory Affairs • Regulatory strategy and submissions • Clinical Trial Application • Scientific advice preparation schulz@conelis.org
	Mónica Unger-Bady Expert for Regulatory Compliance • Development and implementation of workflows and SOPs • Development of databases for regulatory affairs • Mediation between regulatory affairs and production services unger-bady@conelis.org
	Michael Zimmermann Regulatory Affairs and Medical Devices • Expert for conformity assessment according to EU directives • Medical device quality management • Medical device clinical affairs zimmermann@conelis.org

Contact person: Sebastian Tegethoff

Besides providing help for all stages of product development until market approval, CONELIS also offers a wide range of expertise to support commercial insight, strategy, and success. Life science companies and investors in the field have the regular task of evaluating the commercial prospects of products or portfolios, which requires a sound understanding of market dynamics. Our consultants will help to thoroughly assess the facts and minimize risk. We are experienced to serve the pharmaceutical, biotechnology and medical device industry and offer external or hand-on support for business development, product commercialization strategies, financing or partnering deals, portfolio planning, and due diligence. We are internationally networked to facilitate transaction needs. In addition, we offer advice on the entire range of intellectual property rights to cope with the competitive challenges of development, manufacturing and commercialization of life science products throughout the world. We also offer services related to corporate design with the goal of clearly communicating the company's values and products, attracting attention, and creating recognition and trust.
Whatever it is you are looking for it is our intention to provide you with our competent knowledge as a basis for your strategic decisions and commercial success. Some of our experts are also available to fill executive positions as interim managers who can hit the ground running.

CONELIS Experts offer Consultancy and Support for:

• Commercial Assessment and Market Research
• Portfolio assessment and corporate strategies
• In- and Outlicensing Support
• Due Diligence Support
• Financing Support
• Intellectual Property Law
• Corporate Design

Experts:

	Andreas Hey Expert for Interim Management • Sales & Marketing (world-wide) • Business Development • General Management (CEO & COO) hey@conelis.org
	Moritz Hillgenberg Expert for Commercial Assessments and Market Research • Commercial Opportunity Evaluation • Product Positioning and Forecasting • Primary and Secondary Market Research hillgenberg@conelis.org
	Claas Junghans Patent Attorney • Strategies for IP protection, IP portfolio due diligence • Patent application drafting and prosecution • Licensing negotiation, term sheets and contracts junghans@conelis.org
	Christian Nagelstrasser Expert for Visual Strategy • Corporate Design, Brand Development • Webdesign, Social Media • Graphic Design, Medical Drawing nagelstrasser@conelis.org
	Sebastian Tegethoff Expert for Intellectual Property Law • Patent prosecution, litigation, due diligence and Freedom to operate analysis • Trademark and Design prosecution and litigation • Licensing and German Law relating to employee invention tegethoff@conelis.org
	Kerstin Waterloh Expert for Growth Strategies and Market Access • Due Diligence and Commercial Valuation • Product Positioning and Pricing • Fund Raising waterloh@conelis.org