Genesis, an annual event, celebrated 10 years of success on Thursday 9^th December 2010 with over 700 delegates and 81 exhibitors in attendance maximising on existing relationships and building new relationships through extensive networking. Genesis is reputed to be the leading biotechnology networking event in Europe.

Global Regulatory Services (GRS), GP-TCM non-beneficiary partner, was an integral part of Genesis 2010 by hosting the Botanicals/Natural Products Stream. Their involvement was the result of a successful pilot they ran in December 2009, where feedback confirmed that people wanted this Stream to be a permanent feature of all future Genesis events. Interestingly, in the UK, botanicals and natural products are rarely included in biotechnology events. In other parts of Europe, however, this is definitely not the case so the Directors of GRS are delighted to raise the profile of this area of the industry at such a prestigious event.

The Directors, Bobby and Greer Deal, were delighted with the range and expertise of the speakers they had invited. They were keen to provide the delegates with an overview of the industry from harvest to finished product and were pleased to include case studies not only from the UK but also from a Canadian delegation who had arranged their visit to coincide with Genesis.

Prof. Peter Hylands (GP-TCM WP4 Coordinator), Kings College London, acted as Chair making sure that speakers kept to time and asked pertinent questions along the way. The Stream opened with Robert Haslam of Somerset Consultants Limited talking about quality control placing emphasis on how important this is particularly in relation to the European Traditional Herbal Medicines Product Directive which is effective as from 1^st May 2011. This was to be followed by Holly Mash, a holistic vet, but unfortunately due to the severe snowy conditions she was unable to join us. In fact, she couldn’t even get out of her driveway! Fortunately, Prof. Monique Simmonds (GP-TCM WP1 Coordinator) was able to step in at the last minute and entertained the attendees with the wonderful work, which Kew Gardens is undertaking in cataloguing plants and their genus.

Of course, safety is another extremely important aspect in the development and marketing of any medicinal product. Ben Rees of PharSafer Associates spoke about “Compliant Safety Reporting” particularly in relation to Small and Medium sized Enterprises (SMEs). It was clear that the audience hadn’t appreciated the extent of these requirements with many questions being raised at the end.

Next was the first of the case studies with Andrew Davies of STI Pharmaceuticals speaking about some of his experiences. Even though the product he is developing is a synthetic its origins are from the naturally occurring compounds of cannabis. This captured the attention of several delegates, who have maintained contact with Andrew post conference.

A representative from the MHRA provided the agency’s perspective of the Traditional Herbal Medicines Product Directive with statistics to show how many applications had been submitted and approved under the scheme. Later on, Greer Deal of GRS gave an overview of the regulations which could apply to botanicals and natural products in the UK. Both of these presentations caused a few frowns especially from the Canadian delegation, who admitted afterwards that they hadn’t realised how complex the regulations are in the UK and commented that “thank goodness there are expert consultants who can help”!

Three more case studies were presented by the Canadian delegation: Bill Cheliak of Neurodyn Inc discussed the regulatory strategy for Ginseng and then there was to be a ‘double act’ from Dr. Russ Kerr and Don Ridley of Nautilus Biosciences Canada Inc presenting on “Natural Product Discovery from Marine Microbes”. Unfortunately, Dr. Kerr and Mr. Ridley had been delayed in Paris due to the extreme wintery weather, which closed the Charles de Gaulle airport. They did manage to get to the venue for the afternoon only to discover that the Queen Elizabeth II Conference Centre was in “lock down” because of the student riots taking place at the same time and right outside the front door! So despite their best efforts, they were unable to gain entry. Fortunately, one of their colleagues, Rory Francis of BioAlliance, was able to represent them admirably.

The session was concluded by Jim Furniss of Bridgehead International who enlightened the audience on Pricing and Reimbursement, a very crucial part of a product’s success.

It was a challenging and eventful day. When the date for the event was chosen no one could have predicted that Europe would suffer one of its hardest winters in years with all travel coming to a virtual standstill and that students would be rioting directly outside the venue demonstrating their anger about the UK Government’s decision to implement high tuition fees. The presenters and delegates managed to remain unperturbed despite the roar of the crowds outside, the sound of charging horses, the constant buzz of helicopters overhead and fireworks going off at every opportunity. It was a bit of an adventure and we all went away with some unusual memories! Most importantly, however, we learnt a lot about the challenges being faced by botanical and natural product companies and how those challenges can be overcome. It’ll be interesting to see if much has changed for the industry by the time the next Genesis conference takes place.

For further information, please visit www.genesisconference.com. Genesis 2011 will be taking place on Thursday 1^st December and, again, GRS will be hosting the Botanicals/Natural Products Stream.

Author: Greer Deal, Director, Global Regulatory Services (GRS)

Email: [email protected]

Web: www.globalregulatoryservices.com