Tag: Novo Nordisk

Company News: Anergis Appoints Kim Simonsen as Chief Development Officer

– Senior Biotech Executive brings over 25 years of drug development expertise

Anergis, a company developing novel and proprietary ultra-fast allergy immunotherapeutics, today announced the appointment of Kim Simonsen, MD, as Chief Development Officer. Mr. Simonsen will head Anergis´ global product development from preclinical development to registration, including CMC, clinical development, regulatory affairs and global project management.

Kim Simonsen joins Anergis from Ablynx NV, where he was Chief Operations Officer. Prior to that, he was Senior Director, Global Clinical Development, at ALK Abello A/S, where he led the clinical development of Grazax®, the first marketed grass pollen allergy immunotherapy tablet. From 2000 to 2005, Mr. Simonsen was Chief Executive Officer of the CRO Medicon A/S after having held various clinical development roles at big pharmaceutical companies, e.g. as Medical Director of Novartis Healthcare A/S, Director of Clinical Operations at Novo Nordisk A/S, and as Medical Director and Clinical Expert at Sandoz A/S.

Prior to joining the biopharmaceutical industry in 1986, Mr. Simonsen trained as an MD at Copenhagen University and worked for five years at two different clinics in the Copenhagen area, focusing on internal medicine (gastroenterology, respiratory, cardiology). During his career, Mr. Simonsen has gained extensive experience in clinical drug development, including regulatory affairs, clinical pharmacology, and the design and management of clinical trials and pharmacovigilance. His expertise covers an extensive range of disease indications, incl. allergy immunotherapy, immunology, oncology, rheumatology, and cardiovascular and pulmonary diseases.

Company News: InDex Pharmaceuticals Expands Management Team

– InDex Pharmaceuticals Names Pernilla Sandwall Head of Clinical Operations and Thomas Knittel Chief Medical Officer –

Stockholm, April 11, 2012 – InDex Pharmaceuticals today announced two additions to its management team: Pernilla Sandwall has been appointed as Head of Clinical Operations and Thomas Knittel as Chief Medical Officer. Pernilla Sandwall will lead the company’s clinical development team, with the main focus being the ongoing phase III clinical trial of Kappaproct® in patients with treatment-refractory ulcerative colitis. Thomas Knittel will serve as the company’s lead medical expert and provide leadership in medical and marketing affairs.

Pernilla Sandwall has more than 20 years of experience in clinical research operations. She joins InDex Pharmaceuticals from Merck & Co. Inc. (MSD), where she has worked both in the Swedish subsidiary and the U.S. headquarters, as well as regionally in Europe. She has experience in the field as CRA and project manager, as well as strategically as Clinical Research Manager. Her focus over the last years has been global patient recruitment, site selection strategies and execution. She also has experience in change management and Lean Six Sigma methodology.  She has a Master of Science in Pharmacy from Uppsala University.

Thomas Knittel has over 15 years of clinical experience within gastroenterology as well as 13 years of experience in medical affairs and marketing management. Before joining InDex Pharmaceuticals, he held positions as Business Unit Director and Director of Sales and Marketing at Novo Nordisk for central Europe, as General Manager Pharmaceuticals at Harlan Laboratories, and as Vice President Corporate and Medical Affairs at Develogen AG. He has a Medical degree from the University of Mainz with a specialist training in internal medicine and gastroenterology. He is an Associate Professor in Internal Medicine and Gastroenterology at the University Clinic Goettingen. In addition, he has an MBA from Kellogg School of Management/WHU.

Food for Thought: Weekly Wrap-Up

In Forbes, Matthew Herper this week deals with the failure of Bydureon eventide, the once-a-week anti-diabetes shot developed by Eli Lilly and Amylin Pharmaceuticals. In a head-to-head Phase III trial Bydureon was not superior to Victoza, the once-a-day drug by Novo Nordisk, in terms of lowering blood glucose levels. Both are synthetic versions of glucagon-like peptide-1, or GLP-1. In another article, Herper looks at the biotech busts and breakthroughs of Februay, from KV Pharmaceuticals (shares up 400%) to Orexigen (shares down 64%). Herper concludes that the rejection of the Orexigen drug Contrave by FDA – the third rejection of an obesity drug in a row – “killed the obesity drug field.”

Wired this week features a story by John Timmer who describes experiments, in which the introduction of engineered viruses boost memory recall in rats. The improment is brought about by a viral protein kinase, but the exact mechanism ist still not understood.

In Germany, Sascha Karberg in Frankfurter Allgemeine Zeitung (FAZ) revisits the attempts to cure AIDS by removing the gene for the receptor protein CCRS, which serves as the entry door for the AIDS virus, from the T cells of HIV-infected patients . Humans lacking the CCRS gene show natural resistance to the disease. The genetically modified T cells are then reinjected into the patients’ blood stream (see akampioneer, January 17). In a Phase I trial of this approach by Sangamo Biosciences, preliminary results have been encouraging, leading to a significant and durable increase of CD4+ T- cell counts in the patients.

Magnus Heier in Frankfurter Allgemeines Sonntagszeitung (FAS) deals with the ignorance of medical doctors in Germany regarding therapy guidelines and attempts to solve the problem by publishing patient versions of the guidelines in the internet.

Richard Stone in Sueddeutsche Zeitung (SZ) features an epidemic in Bangladesh caused by the Nipah virus, which was discovered only in 1998. The virus is spread by bats via raw palm tree juice, a delicacy for both bats and humans. Christina Berndt, also in SZ,  deals with the replacement of members in Germany’s federal “German Standing Vaccination Committee” (STIKO) responsible for handing out advice on vaccination practices. Berndt claims that some of the newly appointed members are too close to industry because they participate in vaccine studies sponsored by vaccine manufacturers.

In a five-part series, Kai Kupferschmidt in German weekly magazine Die ZEIT deals with synthetic biology, this week introducing companies developing synthetic fuels and novel ways to produce drugs. Surprisingly, the article does not feature a single German synthetic biology company but US companies only.

Food for Thought: Weekly Wrap-Up

Matthew Herper of Forbes this week takes up the issue whether a DNA sequencer can get FDA approval and quotes Jay Flatley, president and CEO of Illumina as saying the company is in talks with FDA to get regulatory clearance to use its technology for medical diagnostics. He also writes about the late Adriana Jenkins, who worked for Celgene and Third Rock Ventures, among others, and died of breast cancer earlier this month. Having been treated as one of the first patients with one of the first personalized drugs, Herceptin, which gave her a decade of life, she calls for a new law that would give drug companies extended monopolies for developing personalized medicines. Her  own last article explaining her plea for supporting personalized medicine by a legislation similar to the Orphan Drug Act  is featured in Forbes, too.

Also in Forbes, Robert Langreth explains  why Novo Nordisk decided to abandon development of diabetes pills and to ramp up insulin production instead – a move highly successful so far.

Dealing with green energy, the Economist reports on the latest efforts to develop artificial leaves for the synthesis of carbohydrate fuels directly from sunlight, carbon dioxide and water. The article features efforts by the Joint Centre for Artificial Photosynthesis (JCAP) in California, Massachusetts-based Sun Catalyx and a group at Massey University in New Zealand lead by Wayne Campbell.
For those of us who already are short-sighted and need reading glasses on top, the New York Times has good news about a new gadget that already hit the US market. Anne Eisenberg reports that with the new device the days of bifocal spectacles may be over soon. The new emPower electronic spectacles have liquid crystals inserted at the bottom of the lens which change refraction by simply touching the frame. As a result, reading power can be easily switched on and off.

Hannah Waters in The Scientist features a new pathway that may be used to develop novel antibiotics, e.g. to combat Staphylococcus infections.  The trick is done by blocking RNA degradation via a small molecule inhibiting the enzyme RNAse P found in gram-positive bacteria. This leads to accumulation of RNA transcripts and their encoded proteins so that the bugs die from chaos.

In Frankfurter Allgemeine Zeitung (FAZ), Jörg Altwegg reports about a baby that opened up a fierce ethical debate in France. The boy was conceived after preimplantation diagnosis made clear that he not only did not carry beta thalassemia but that he also was suited as a blood donor for his older sister suffering from the disease. Another ethical debate around human genetics is taken up by  Volker Stollorz in a Frankfurter Allgemeine Sonntagszeitung (FAS) article not yet online. In the US, researchers have developed a universal gene test able to uncover the genes for hundreds of severe, rare genetic diseases. The test is going to be used for family planning, and couples at risk of conceiving a child with one of those conditions can opt to perform preimplantation diagnosis. However, while some human geneticists warn that the results might overstrain the expertise of human genetic councelors, others already are crazy about using such tests to eliminate all recessive alleles for genetic diseases from the human gene pool.

Finally, Alison McCook in The Scientist claims researchers are punks, because just like in punk music, as they are typified “by a passionate adherence to individualism, creativity and freedom of expression with no regard to established opinions.” To get a taste, she recommends listening to Minor Threat and Nomeansno for a start.