June 2009 Dr. Archana Shekher, Dr. Valérie Pimpaneau, Dr. Rajashree Devarakonda and Anne-Virginie Eggimann recently attended Bangalore Bio 2009, India's premier Biotechnology event with the focal theme, ‘Biotechnology beyond boundaries – the promise of India’. Dr. Valérie Pimpaneau gave a lecture on ‘Tracking the effect of process changes – BioMolecule Characterisation & Analysis’. Bangalore Bio 2009 attracted more than 650 delegates and 5,000 visitors. June 2009 Dr. Emmanuelle Voisin and Dr. Anne Dupraz recently attended the ILSI-Biomed 2009 in Tel Aviv, the leading International Conference covering the fast-growing field of innovation in the Biomedical, Health Care and Life Sciences Industries. Biomed 2009 hosted 6,500 participants from 35 countries. During Biomed, Voisin Consulting, with partners, organized and participated in a satellite workshop entitled “Convergence: One-Stop-Shop to access the European Market”. Convergence is a network of companies in drug and medical device development creating a virtual European Company. For more information on Convergence click here. June 2009 Dr. Carolyn Tucek-Szabo recently chaired and presented the session “A Hard PIL To Swallow: Design And Testing Of The Consumer Medicine Information (CMI) Leaflets” at the 18th ARCS Australia Scientific Congress in June 2009 in Sydney, Australia. The expert panel discussed CMI user testing from an industry and regulatory perspective taking into account mandatory European legislation. This was followed by a lively discussion with much participation from the audience. The session attracted the interest of over 150 people. June 2009 EU and U.S. Integration Strategy, to find out more on how regulatory agencies on both sides of the Atlantic are working toward transatlantic harmonization please see an article authored by Stuart Mudge and Christiane Fertig here. June 2009 Eric Lawson, Project Director at Voisin Consulting Inc. chaired the Companion Diagnostics Working Group opening meeting on June 10, 2009. This working group was established to address novel regulatory affairs practices and compliance issues associated with diagnostic tests linked to or developed in conjunction with specific therapeutic drugs, biologics, or devices. It is sponsored under the Association of Medical Diagnostics Manufacturers. This working group aimed at addressing inconsistencies between drug and diagnostics, improving the timing of drug and IVD submission to approval, and eventually bringing personalized medicine effectively to the healthcare market. The group will start with providing FDA’s Office of In Vitro Diagnostics (OIVD) of the Center for Devices and Radiological Health (CDRH) with comments and suggestions for incorporation into any future FDA Guidance documents which may be forthcoming. May 2009 The recently released Australian Federal Budget reveals that there is significant impact for R&D companies, including offshore companies. The new R&D tax credit system greatly improves the attractiveness of Australia to emerging technology companies and will support the growth of maturing biotechs. The budget delivers a 45% refundable tax credit for companies developing their products in Australia and with an annual turnover of less than $20 million, including companies in tax loss. The BioMelbourne Network press release is available here. May 2009 Anne-Virginie Eggimann attended the FDA Cellular, Tissue and Gene Therapies Advisory Committee on May 14 and 15, 2009 (Meeting ID: 2009-4436). The following three topics were addressed at that meeting: 1. Potential for Chlamydia trachomatis and Neisseria gonorrhoeae transmission by human cells, tissues, and cellular and tissue-based products that are recovered from the reproductive system, gestational tissues, or other sources; 2. Animal Models for Porcine Xenotransplantation Products Intended to Treat Type 1 Diabetes or Acute Liver Failure; 3. Clinical issues related to the FDA draft guidance “Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. May 2009 A workshop at the EMEA in London gave an important insight into the implementation of the European regulation on advanced therapy medicinal products. A report on this workshop, by Dr. Anne Dupraz-Poiseau and Dr. Valérie Pimpaneau, was published in the May issue of RAJ Pharma and May/June issue of RAJ Devices. The article is available here. May 2009 Dr. David Uguen and Dr. Marie Deneux, respectively Voisin Consulting’s Project Director and Project Leaders for Pediatric Investigation Plans, recently published in the May 2009 issue of the Regulatory Rapporteur journal (TOPRA) on the key steps to define and prepare a pediatric investigation plan for a new medicinal product. The article is available here. April 2009 The FDA waives the application fee (NDA/BLA) for the first human drug application that a small business or its affiliate submits for review. A small business is defined as an entity that has fewer than 500 employees, including employees of affiliates, regardless it is based within or outside the USA. This NDA fee is currently up $1,178,000.