Gerry, a molecular biologist, has twenty years’ experience
in the biotechnology and pharmaceutical industries,
in regulatory affairs, clinical development and
business development.
He has worked with large and medium pharma companies
(Almirall and Glaxo) and was Regulatory & Scientific
Affairs Director of The Liposome Company, a US
biotechnology firm.
He founded the European regulatory
affairs and product development consultancy company,
GMG BioBusiness Ltd, which was sold to a top 5
CRO in 2005. He also set up and was CEO of the
Catalan biotechnology development agency, Biocat.
Gerry has worked directly with over 30 client organizations
on projects ranging from early stage regulatory
strategy and complex biotechnology products, to
MAAs for novel healthcare products.
Gerry has excellent
relationships with top level business, science
and governmental executives. Gerry
is a member of TRI Cap, a group of independent
investors, through which he invests in biotech
/ pharma and other companies.
After starting his biopharmaceutical career
in Regulatory Affairs at Almirall in 1987, and
thereafter in Palex (both Spain), Martin was head
of EU Regulatory Affairs for Convatec (UK), a device
subsidiary of BMS, responsible for lobbying the
company position on wound care products during
the development of the Medical Devices Directive
93/42 EEC.
He subsequently joined the board of
MTC Europe, the largest specialist medtech regulatory
firm in the EU. He then set up and managed the
European operations of Biomatrix Inc., a successful
US biomaterials company subsequently acquired by
Genzyme.
He has significant regulatory and commercial
experience with borderline & combination products as well as devices incorporating
human and animal tissues, and a unique understanding of how the regulatory positioning
of such products can help or hinder their commercial success.
Elaine is a chemist with 16 years experience
in the pharmaceutical and biotechnology industries.
She has worked in Regulatory Affairs with Cortecs,
an emerging biotechnology company, Chugai, a medium
size Japanese pharma firm, and was Regulatory Director
of BMS in UK.
She was a principal partner with Gerry in their consultancy firm,
GMG BioBusiness Ltd, where she oversaw the successful running of a range of projects
and general management of the organization, including regulatory strategy, clinical
trial applications, orphan drug designations, legal status changes, and major MAAs.
Elaine has contributed to the successful development of small molecules
and biotechnology agents in the fields of respiratory, oncology, haematology
and GI diseases, and has particular expertise in biotechnology CMC issues. Elaine
has excellent relationships with regulatory authorities as a result of the wide
range of projects she has handled.
Emma Holmes has 13 years experience in Regulatory
Affairs both in UK and on mainland Europe. Emma
started out with the pesticide company, Rentokil,
subsequently moving to Bristol Myers Squibb. At
BMS she was initially responsible for regulatory
submissions to Central and Eastern Europe based at the UK office in London.
Emma then moved to the BMS European headquarters where she handled a number of key
European regulatory projects. She returned to UK in 2003 to join GMG BioBusiness
Ltd as Director, Regulatory Affairs. In this role she managed a team of regulatory
professionals and controlled the company’s project management system. Emma’s
experience covers all stages of drug development.
She has lead CMC, Nonclinical
and Clinical projects across a range of therapeutic areas, including oncology,
CNS, anti-infectives and metabolism / endocrinology. Emma maintains excellent
relationships with European regulatory authorities.
