Senior Specialist Technical Account

West Pharmaceutical Services

In-person

Dr. Ana Marques Kuschel, Sr. Specialist Technical Customer Support Europe As Sr. Specialist
Technical Account, Dr. Ana Kuschel is providing technical support relating to West’s packaging
components and delivery systems for injectable drugs and healthcare products. This is comple–
menting her previous role as Manager Material Development, where she worked with existing and
on the development of new rubber formulations.

Ana holds a PhD in macromolecular chemistry from the Universities of Coimbra, Portugal and
Wuppertal, Germany.

Group Leader – Human Health/Toxicology

In-person

Susanne is a regulatory toxicologist at knoell with more than 14 years experience and member of the German Society of Toxicology and Pharmacology and certified as European Registered Toxicologist (Eurotox). She gained broad experience in the human safety assessment of substances and products of different regulatory areas. The toxicological characterization of extractables and leachables of medical devices is a key topic, in which she applies standard as well as scientific state-of-the-art approaches for human hazard and risk assessment.

Group Leader – Human Health

In-person

Marco Costante is a biological safety professional at knoell. He helps manufacturers to navigate through the intricate regulatory requirements to evaluate the biocompatibility of their devices. He has large experience in submitting medical devices worldwide, dealing with notified bodies, national agencies and ethics committees.  He has a background of materials science and postgraduate education in toxicology, he is an active member of the ISO TC 194 following the development of ISO10993-1, ISO10993-17 and ISO10993-18.  His membership to the international tables makes him a valuable source of information for manufacturers seeking for advices on strategies anticipating future trends and requests.

Research Scientist

Baxter International

Virtually

Steve Zdravkovic is currently a Research Scientist II at Baxter Healthcare, which he joined in
February 2021. Prior to joining Baxter, he worked for 16 years in the E/L team at PPD, Inc.
In these roles, Steve has been responsible for all aspects of E/L studies with a focus on the design
and execution of screening studies using mass spectrometry-based techniques. Steve has
published nine peer reviewed journal articles, which pertain to various areas of research within
the E/L field, and is a member of the editorial board of the PDA Journal of Pharmaceutical Science
and Technology. Steve holds a Bachelor of Science degree in chemistry and mathematics from the
University of Wisconsin – Whitewater.

Science Lead

Drug Development Solutions

In-person

Mike Ludlow is Science Lead for the Analytical and Materials Science division within Drug
Development Solutions (formerly LGC). He is an analytical chemist with over 25 years’ experience
in chromatographic and spectroscopic techniques, specialising in the area of extractable and
leachable testing and impurity characterisation.
Mike Ludlow, Science Lead, Drug Development Solutions
In his current position Mike provides technical support to operational and commercial colleagues
and to an extensive client base, primarily focused on the pharmaceutical and consumer healthcare
sectors. He has presented at numerous international events on topics including extractables and
leachables, genotoxic impurity analysis and experimental design.
Mike is currently on the Register of Specialists for the UK Government Office of Product Safety
and Standards (OPSS). He previously worked for ICI Chemicals and Polymers division where he
was responsible for the NMR area providing support to the research function at Runcorn in the UK.
Mike holds a BSc Hons in Applied Chemistry, an MSc in Analytical Chemistry, and an MBA from
Warwick Business School.

Laboratory Supervisor and Manager Extractables

Sartorius Stedim Biotech

In-person

Dr. Roberto Menzel has a Ph.D. in Chemistry from the FSU University Jena.
Roberto started his career as an assistant editor in the natural science book section at Wiley
followed by a position as group leader for the organic trace analysis in the environmental analytical
division at Eurofins Scientific. In 2015, he joined Sartorius Stedim Biotech where he is heading
the internal analytical laboratory and Extractables group. The main working areas are material and
product qualification studies for single-use (SU) systems and components for the biopharmaceutical
industry. He authored several articles on the characterization of SU devices and is a regular speaker
at various E&L conferences.

Vice President Regulatory and Clinical Services

MED Institute

In-person

Theodore (Ted) Heise has three decades of experience in regulatory and clinical affairs, and
currently serves as Vice President Regulatory and Clinical Services at Cook MED Institute. In this
capacity, Dr. Heise leads efforts to develop scientifically robust regulatory and clinical study
strategies for successful development of new medical products that improve patient well being.
Graduating Magna Cum Laude with a B.S. in chemistry from the University of Nebraska at Omaha,
Dr. Heise went on to earn a Ph.D. in analytical chemistry from Iowa State University. He has
been a member of the Regulatory Affairs Professionals Society since 1993, and the American
Chemical Society since 1988. For the past 15 years Dr. Heise has been a U.S. delegate to
ISO TC 194, the technical committee for international consensus standards that govern bio–
compatibility evaluations and clinical investigations of medical devices. He currently serves as
convenor of TC 194/WG 14. As convenor, Dr. Heise led the process of re-writing ISO 10993-18
to reflect current best practices in chemical characterization, including evaluation of extractables
and leachables from medical devices. He is also a member of the USP expert committee on
packaging, and is supporting revisions of the chapters on biocompatibility.

Principal Scientist

Novo Nordisk A/S

In-person

Carsten Worsøe is a principal scientist within extractables and leachables (E&L) at Novo Nordisk.
In over 24 years his main responsibility has been to analytical E&L documentation for container
closure systems (vials, cartridges and pre-filled syringes), production materials and devices.
Within Novo Nordisk Carsten has been one of the main actors to bring relevant people in
packaging materials, production, toxicology, formulation, regulatory and analytical together to
perform risk assessments and strategies for E&L testing in development projects. In addition to
that work, Carsten is a member of the E&L industry groups BioPhorum (BPOG), executive
committee member in ELSIE (Extractables and Leachables Safety Information Exchange) and
member of the EfPIA and Pharma ICH Q3E support groups.

Team Manager / Business Development Manager R&D

SGS INSTITUT FRESENIUS GMBH

In-person

Andreas studied organic chemistry at the University of Bielefeld in Germany with the main focus on
mass spectrometry and computational chemistry. Since the date of his PhD/doctorate in 1997, he
worked in different scientific and managerial positions ranges from head of laboratory to GMP QA
site manager in Life Science industry prior he proceeds with his carrier at SGS in 2007. From 2007
to 2010 he was responsible for project management and regulatory consultancy at the customer
service Pharma at SGS Institute Fresenius GmbH. Andreas introduced Extractables & Leachables
testing services for both medical devices and pharmaceutical applications at SGS in 2008 and got
his current position of an business development manager in 2010. Andreas applies technical and
regulatory knowledge, scientific experience and expert judgment to address solutions for a broad
range of difficult problems. He troubleshoots and directs the resolution of QC method issues by
fostering effective interdepartmental and cross-functional partnerships with clients from pharmaceu–
tical and medical industry. With over 25 years’ experience in Life Science segment he is a frequent
speaker at events and international conferences (PDA, A3P, ECA, VDI, BioInnovation, CPHI, Smithers
RAPRA, IQPC, Vonlanthen Group, Chinese Medical Device Association, Dipartimento di Scienze del
Farmaco in Pavia and others) in the fields of Medical Device, Single Use Systems and Finished
Packaging safety evaluation. Companies in regulatory controlled industries are challenged by
on-going regulatory systems. Changes must be set in practice and cross-functional teams with
different functional expertise must be organized to work toward a common goal. Andreas wants to
motivate experts from Life Industry or organizations working together to realize or achieve a better
and effective cross departmental collaboration in order to improve regulatory requirements for safety
testing of plastic materials that are used to produce the medical product.

E&L European Strategic Director

Hall Analytical

In-person

Andrew is an experienced analytical chemist with over 20 years’ experience in the field of trace
organic analysis, where he predominantly focussed on extractables and leachables. He has become
a leading authority on extractables and leachables, presenting in over 15 countries including India,
Japan, China, and the USA. Andrew was also co-chair of the ELSIE group and was a scientific
advisor to IPAC-RS. His previous work experience includes 2 key roles;
Operations director at a contract research organisation – where he grew the size of the group
and passed audits by the FDA, MHRA, and UKAS
Senior scientist at a large pharma corp. – where he worked on numerous dosage forms and
wrote regulatory documents including NDAs, IMPDs, and INDs.
He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of
Chemistry and is the inventor of two patents. Using his vast experience and knowledge, Andrew
is an invaluable addition to the Hall Analytical team, benefitting our customers equally.

Head of Sales and Consulting Specialist Extractables & Leachables

Intertek

In-person

Dr. Tino Otte is the Head of the Sales and Consulting Department at Intertek in Switzerland.

He joined the company in 2016. Tino is an expert in extractables & leachables studies, impurity
characterization and analytical method development.

He has more than 13 years of experience in pharmaceutical analysis and polymer characterization.

Tino is a chemist by training with a PhD in Analytical Polymer Chemistry from the Technical
University of Darmstadt, where he graduated in 2010.

Prior to joining Intertek, he worked at different service providers for pharmaceutical industry and
analytical Instrument manufacturers in Switzerland and Germany.