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New head of Bayer’s U.S. pharmaceuticals business

Bayer has appointed Habib Dable as president of Bayer HealthCare Pharmaceuticals, the U.S.-based division of the global company’s pharma business. Dable reports to Philip Blake, who assumed the role of head of region Americas for Bayer HealthCare Pharmaceuticals and continues leading U.S. corporate functions as senior Bayer rep in the United States, a position he has held since 2012.

“Habib Dable is a highly respected leader at Bayer, and I’m thrilled to have someone with such a wealth of experience step in to lead the company’s largest pharmaceuticals market worldwide,” Blake says. “Having spent more than two decades at Bayer in a range of key roles with increasing management responsibility, Habib will be a critical asset as we look to build on our positive momentum in the U.S. to create long-term growth.”

Previously, Dable was global head of specialty medicine for Bayer HealthCare Pharmaceuticals, a role he held since 2013 and in which was responsible for overseeing four therapeutic areas for the company – hematology, oncology, ophthalmology, and neurology. He began his career at Bayer in 1994 as a sales representative and moved on to hold a number of senior roles in Canada, Japan and the U.S., focusing on strategic planning, sales management, and global product marketing including successfully leading global product launches.

Dable earned a master’s of business administration from the University of New Brunswick in Canada, where he also completed his undergraduate study. He is married with two children, and resides in New Jersey.

Martin Shkreli picked as new CEO of KaloBios

The man popularly dubbed “Pharmabro” by mainstream media because of his price-hiking actions at Turing Pharmaceuticals AG has been appointed CEO of another company. Martin Shkreli became CEO of KaloBios Pharmaceuticals Inc. after Turing acquired 70 percent of its outstanding shares. Shkreli is now also chairman of KaloBios.

KaloBios further announced that David Moradi, Tony Chase, and Marek Biestek have been elected to the board of directors. In connection with these developments, the former directors resigned, effective immediately.

KaloBios has received a commitment from Shkreli and other investors for an equity investment of at least $3 million. In addition, Shkreli and the group of investors have committed to a $10 million equity financing facility, subject to applicable shareholder approval.

“We believe that the KaloBios’ lenzilumab is a very promising candidate for the treatment of various rare and orphan diseases,” Shkreli says. “This monoclonal antibody neutralizes soluble granulocyte-macrophage colony stimulating factor, a central actor in leukocyte differentiation, autoimmunity, and inflammation. Lenzilumab has particular promise in chronic myelomonocytic leukemia (CMML), a disease with no FDA-approved treatment options and a three-year overall survival rate of 20 percent.”

An IND for a Phase I/II CMML monotherapy study of lenzilumab has been cleared by the Food and Drug Administration. Preclinical studies have shown lenzilumab can be used to cause apoptosis in CMML cells by depriving them of GM-CSF. Lenzilumab may also have clinical utility in other rare autoimmune and inflammatory disorders. A 31-patient Phase I/II clinical trial of lenzilumab was to begin enrollment at eight leading oncology clinical trial sites by year-end 2015 with interim results possible as soon as the first half of 2016.

Shkreli will continue as CEO of Turing Pharmaceuticals, and the two companies will operate independently.

Purdue Pharma appoints new senior VP of R&D

Alan W. Dunton, M.D., has been named to the position of senior VP of R&D, reporting to CEO Mark Timney. In this role, Dr. Dunton will serve as the company’s lead scientist and will oversee the Medical Research, Drug Safety, Clinical Pharmacology, Virtual Discovery, Project Management, and Pharmaceutics & Analytics teams.

“At a time of transformation for Purdue, Alan brings the right skills and experience to diversify and grow our portfolio,” Timney says. “We look forward to his contributions in optimizing our existing pipeline, while strengthening our presence in other therapeutic areas.”

Dr. Dunton is responsible for spearheading the company’s overall scientific development strategy. This includes management of the pipeline, early clinical development programs, and setting the scientific direction for the company.

“Purdue Pharma has a well-established record of innovation in pain medicine that makes a positive impact on patient lives. I look forward to helping the company continue its pioneering research in pain medicine, as well as innovative research in other areas of unmet need,” Dr. Dunton says.

Dr. Dunton has devoted his 33-year career to the discovery and development of new prescription and over-the-counter (OTC) drug products. In 2006, he founded Danerius LLC, a biotechnology and pharmaceutical consulting business, which he led until joining Purdue. Before starting Danerius, Dr. Dunton held executive-level positions in the pharmaceutical and biotechnology industries, including president and CEO of Panacos Pharmaceuticals and Metaphore Pharmaceuticals. He was also the president and managing director of the Janssen Research Foundation, the R&D arm of the pharmaceuticals division at Johnson & Johnson. During his career, Dr. Dunton has been responsible for the approval of more than 20 prescription and OTC products.

Dr. Dunton received his medical doctorate from New York University School of Medicine, where he completed his residency in internal medicine. He was a fellow in Clinical Pharmacology at the New York Hospital/Cornell University Medical Center. Dr. Dunton is also a diplomat of the American Board of Internal Medicine and currently licensed to practice medicine in New Jersey and New York. He received his bachelor of science degree in biochemistry, magna cum laude, from State University of New York at Buffalo. Dr. Dunton was awarded The Nellie Westerman Prize from the American Federation for Clinical Research for his research in medical ethics.

Pharma Companies

• Thierry Volle has become president of Europe, Middle-East & Africa (EMEA) at Lupin Ltd. Volle joined Lupin from Vifor Pharma, where he was the head of EU & International business operations.

• Joseph Leveque, M.D., has been named chief medical officer of EMD Serono Inc., the U.S. biopharmaceutical business of Merck KGaA. Most recently, Dr. Leveque was at Bristol-Myers Squibb, where he served as the head of U.S. medical for oncology. Scott Filosi became senior VP of managed markets. Filosi was with UCB Pharma as the head of U.S. market access and pricing and the head of established brands in the United States. He also led business operations for Canada and Mexico.

• Peter Sandor is now VP, head of oncology therapeutic area in marketing strategy at Astellas. He reports to Yukio Matsui, senior VP and head of Marketing Strategy. Most recently, Sandor served as VP, global marketing therapeutic area head oncology at Amgen.

• Laszlo Radvanyi, Ph.D., has been appointed senior VP, head of research in immuno-oncology at Merck KGaA. Before joining Merck KGaA, Dr. Radvanyi served as chief scientific officer at Lion Biotechnologies.

Biopharma/Biotech Companies

• James B. Breitmeyer, M.D., Ph.D., has become president and CEO of Tokalas Inc. Dr. Breitmeyer was president of Bavarian Nordic Inc.

• Miri Ben-Ami, M.D., has been appointed president and executive VP, oncology, of Immune Pharmaceuticals Ltd. (Israel), a wholly owned subsidiary of Immune Pharmaceuticals Inc. Monica E. Luchi, M.D., has been named executive VP, global drug development, and chief medical officer. Dr. Ben-Ami was CEO of Aposense Ltd., a clinical-stage public biotech company. Before joining Immune, Luchi held senior immunology and inflammation positions at Novartis, Incyte, and most recently, Mesoblast.

• Harry Lander, Ph.D., has been appointed president of Regen BioPharma Inc. Dr. Lander has strong experience as both a researcher and administrator, having served in these positions at Cornell University as well as at the Sidra Medical and Research Center in Qatar.

• Patricia Henahan was named chief financial officer of Array Biopharma Inc. Henahan has been VP of finance for Hospira. During her tenure, Hospira delivered double-digit profit growth and achieved its highest-ever U.S. market share and revenue level.

• Steve E. Krognes has joined Denali Therapeutics Inc. as chief financial officer. Krognes was with Genentech, where he served as chief financial officer and as a member of the Genentech executive committee since 2009.

• Lawrence A. Kenyon has become chief financial officer of Oncobiologics Inc. He was chief operating officer and chief financial officer of Arno Therapeutics Inc.

• Jeffrey Su, Ph.D., is now executive VP and chief operating officer, Sorrento Therapeutics Inc. Dr. Su previously was chief scientific and development officer at Cytovance Biologics Inc.

• Richard Gulino is now senior VP, general counsel, and secretary of Vanda Pharmaceuticals Inc. Before joining Vanda, Gulino served as VP and general counsel of Ameritox Ltd. Vanda Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders.

• Robert Kleinfield, Ph.D., is now chief development officer of Arvinas LLC. Dr. Kleinfield was with Takeda Pharmaceuticals, leading global programs for a number of oncology assets, including kinase inhibitors, immuno-stimulators and protein-modifying enzymes.

• Dr. Neil Brewis has been named chief scientific officer of F-star. Dr. Brewis joins F-star from GlaxoSmithKline (GSK) where he was VP, head of biopharmaceutical research. At GSK, he led a global team of 300 scientists who advanced numerous monoclonal antibodies, antibody fragments, and protein therapeutics from target validation into early clinical development.

• Yong-Jiang Hei, M.D., Ph.D., has become chief medical officer of Ambrx, reporting directly to the CEO, Tiecheng “Alex” Qiao. Prior to Ambrx, Dr. Hei worked at Amgen for more than nine years as an executive medical director in global development where he led cross-functional teams to define product development strategies and clinical development plans for several late-phase oncology projects in various solid tumors.

• Georgia Erbez has been appointed to chief financial officer at Asterias Biotherapeutics Inc. Erbez was chief financial officer, secretary, and treasurer of Raptor Pharmaceutical Corp.

Specialty Pharma/Specialty Biopharma Companies

• Mark Strobeck, Ph.D., has been promoted to executive VP and chief operating officer of Egalet Corp. He was chief business officer. Egalet is a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments.

• Ranjan Ray Chaudhuri has been named global commercial lead of Mylan’s over-the-counter business. Chaudhuri reports to Rajiv Malik, president of Mylan. He joins Mylan from GlaxoSmithKline Consumer Healthcare.

• Anders Martin-Lof has been appointed chief financial officer of Wilson Therapeutics AB. Martin-Lof reports to CEO Jonas Hansson, and has joined the company’s management team. Before joining Wilson Therapeutics, he served as chief financial officer of Extenda, a privately held software company. Wilson Therapeutics is a privately held biopharmaceutical company focused on improving the lives of patients with Wilson’s disease through the development of new treatment options and increased awareness and education.

• Michaela Celano is now chief financial officer of Makindus Inc. Celano was chief financial officer for Drugscan Inc. Makindus is a privately held, specialty pharmaceutical development company focused on ophthalmology and rare diseases.

• Craig Paterson, M.D., was appointed chief medical officer at Endo International Plc. Dr. Paterson was senior VP, Medical and Clinical Development for Salix Pharmaceuticals. Endo develops, manufactures, markets and distributes quality branded pharmaceutical and generic pharmaceutical products as well as over-the-counter medications though its operating companies.

• Stephen Richardson has become chief scientific officer of IGI Laboratories. Richardson was a principal consultant for Lachman Consultant Services Inc. IGI Laboratories is a specialty generic pharmaceutical company.

• Catherine C. Turkel, Pharm.D., Ph.D., has been named to the position of senior VP, clinical research and development, and chief development officer of OticPharma Inc. Dr. Turkel joins the company from Allergan Inc. where she was most recently VP of clinical development for the neurology and pain franchise. OticPharma develops differentiated therapeutic products for the treatment of Ear, Nose, Throat (ENT) disorders.

• Gina Ford, R.Ph., has been made VP of commercial strategy at AcelRx Pharmaceuticals Inc. Ford worked with AcelRx as a consultant from 2013 to the present. AcelRx Pharmaceuticals is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain.

Service Companies

• Donald B. Hawthorne has been appointed president and CEO of Daktari Diagnostics Inc. He was most recently president and CEO of AdvanDx. Daktari Diagnostics is a healthcare solutions company that enables enhanced disease management in both developed and developing countries.

• George L. Miller is now senior VP, general counsel and corporate secretary of West Pharmaceutical Services Inc. Miller was senior VP, general counsel and secretary for Sigma-Aldrich Corp. Annette Favorite became senior VP and chief human resources officer. Favorite served as VP, global talent management at IBM Corp. West Pharmaceutical Services is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products.

• Dr. James Clark has been appointed VP of Clinical Laboratory Operations at Inivata Limited. Dr. Clark brings U.S.-based CLIA lab experience to Inivata, having held executive roles in a number of oncology companies including VP, Research and Development at MDx Health, and chief operating officer at Response Genetics. Inivata is a clinical cancer genomics company.

• Dave Lasecki is now chief commercialization officer of GenomOncology. He most recently served as president of CompanionDx Labs. GenomOncology is a healthcare technology company enabling precision medicine by transforming genomic data into actionable information.

• Kevin Sly is now senior VP, marketing and commercial strategy, at Paragon Bioservices Inc. Sly was VP, business and corporate development, at Aeras. Paragon Bioservices is a contract development and manufacturing organization.

• Kristine Senft has become VP sales and marketing at Hovione. Senft was most recently with DSM Biomedical as a business unit director. She reports to Guy Villax, CEO. Hovione is an international company that manufactures active pharmaceutical ingredients and drug product intermediates.

• Greg Reh was named vice chairman, Deloitte LLP, and leader of its national life sciences sector practice. A principal with Deloitte Consulting LLP, Reh brings to the role significant experiences in both client service and practice management. Deloitte offers a distinctive menu of professional services delivered in an integrated approach that address all segments of the health plan, health care provider and life sciences industries.