Posts Tagged asthma
Jobs – July, 2015
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on July 13, 2015
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I have new opportunities in California and Texas; many of them are in in engineering in Quality, Manufacturing, and Mechanical and other job openings in Biochemistry, Physiologist with animal surgery experience and in manufacturing and document control of drug delivery type of medical devices. I will post details as and when I get full descriptions. All opportunities are for candidates located in the United States. When sending your resume, please include details on your current compensation and compensation expectations. Also, include in the email a short summary of your background and your key strengths. Please send resumes to wd_darshana at hot mail dot com. See below a list of additional opportunities.
Post-docs – Engineering – ME, EE, Biochemistry, Pharmaceutical Sciences – CA & TX
Requires excellent and proven problem solving skills.
Clinical Trial Manager/Sr CTM – Asthma (12-Month Contract) – Berkeley, CA
Overview: Responsible for managing the full scope of proper study conduct including, but not limited to, protocol development to final report, regulatory filing and/or publications, coordinating cross functional efforts in the administration and progress of Phase 1 to 4 clinical trials. Additional responsibilities include trial start-up, conduct, and close-out activities in order to achieve program objectives and goals.
The incumbent will use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways. May determine methods and procedures on new assignments. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Responsibilities:
* Lead clinical trial project execution for asthma programs to ensure that trial timelines, costs, and quality metrics are met.
* Serves as primary contact for functional area representatives in managing protocol execution.
* Manage the financial aspect of clinical trials to ensure accuracy and timeliness of service provider and site payments.
* Forecast and oversee clinical supplies, e.g. study drug.
* Manage study milestones to ensure accurate tracking and reporting of study metrics.
* Oversee ongoing service provider management (e.g., CROs, IVRS, Central Labs), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
* Create and manage clinical trial budgets in collaboration with manager and the Vice President of Clinical Operations.
* May provide study-specific direction and mentoring to CRAs and CTAs.
* Collaborate with Clinical Quality Assurance to maintain quality standards in compliance with regulatory requirements/guidance’s and adherence to SOPs and ICH/GCPs; participate in ongoing process improvement initiatives.
* Manage adherence to ICH/GCP/local regulations.
* Participate in clinical operations initiatives and programs.
* Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
* Other duties as assigned.
Qualifications:
* Bachelor’s Degree with at least 5 to 8 years of CRA experience for the manager level with at least 1 year of staff management experience. The senior manager level requires 10+ years of combined CRA and CTM experience and 3 years direct staff management experience is required.
* Experience in inflammatory diseases, specifically Asthma and/or Chronic Obstructive Pulmonary disease (COPD) is required.
* Excellent communication skills to effectively disseminate information within clinical as well as other functional areas as appropriate.
* Experience developing trial plans including developing creative strategies for site monitoring, risk mitigation, trial budgets, site selection, and clinical supplies management.
* Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology.
* Excellent organizational and negotiation skills. Proven ability in creative problem-solving and possess sound judgment.
* Team oriented and collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners.
* Proficient computer skills, specifically with Microsoft Office Suite that includes Word, Excel, PowerPoint, and Outlook.
* Working knowledge of MS Project for development and update of clinical study timelines.
* The incumbent in this position must be able to remain in stationary position 50% operating a computer and other office equipment and needs to occasionally move about the office for meetings, to access files, and other office equipment.
* Willing to travel – anticipate up to 25%.
Senior Mechanical Engineer – San Jose, CA
12+ years of Class III medical device is required, with experience in machining, injection molding etc.
Biochemist – San Jose, CA
Senior Electrical Engineer – Austin/ San Antonio – TX
A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience. Experience with closed loop, analog design hardware, microcontrollers, actuators and ultra low power consumption circuit design highly desired.
Key Responsibilities
* Lead Electrical Engineering, primarily for long-term implantable drug delivery devices:
* on R&D- design and development of implantable and associated wearable and external hardware using mixed signal- analog and digital techniques, sensors and actuators and closed-loop control systems
* Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation esp for implantable electronics
* Develop Class III implantable electronics to be compliant with regulatory and QA standards (FDA and ISO), as well as be power-efficient, reliable for multi-year operation and pass EMI/RFI, be hermetically sealed and packaged and interface with rest of electronics systems for developed products
* Establish reliable suppliers and partners for manufacturing
* Work in a matrixed and multidisciplinary organizational structure to support multiple projects and technologies following appropriate QA system for each segment
* Document work output and use project and organizational documentation systems, including electronic systems
* Plan for and support existing and projected growth of the company.
Key Qualifications
* Designed and implemented electronics mixed-signal hardware, firmware and software for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. 10-15 15 years desirable
* Bachelor’s degree in Electrical Engineering or in an equivalent field required
* Led and grown EE groups with a hands-on, leadership- by-example approach
* Demonstrated working experience and accomplishments with electronics hardware and software- analog/digital, sensors/actuators. Developed, selected and qualified sensors for both implantable device function and for measuring physiological parameters
* Familiarity and experience with other implantable device components such as connectors, leads, cables, interconnects, headers, electronics packaging, communication protocols and standards. Real-time microcontroller programming a plus.
* Excellent and demonstrated grasp and use EDA tools: sensor/circuit design, simulation, layout. Hands-on re: circuit and system prototyping and development
* Developed and implemented manufacturability, and related process flows and controls. Selected and qualified vendors for manufacturing Class III implantable device electronics.
* Working knowledge of biomaterials, drugs, drug delivery, and mechanical technologies in support of multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Strong technical and hands-on skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator
* Supported multiple complex projects in a start-up environment: able to prioritize.
Key Job Parameters
* Full-time position located near Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development
Senior Mechanical Engineer – San Jose, CA
This is an exciting opportunity to work at grounds level with a veteran leader, in innovative drug delivery space. Minimum 10 years of medical device experience is required.
Opportunities in Berkeley, CA
If you are interested in any of the opportunities below in Berkeley, CA then send me an email with resume and I will be happy to share more details.
On “Building a Pearl” – Story of Pearl Therapeutics from Concept to Acquisition by Astra Zeneca for $1.15B
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on March 17, 2014
Pearl Therapeutics is a huge success story in the biotech world. At www.bio2devicegroup.org event, Dr. Sarvajna Dwivedi, co-founder of Pearl Therapeutics talked about his own professional journey and about Pearl team, technology and products, that brought the company to pearly stunning $1.15 Billion exit. Pearl Therapeutics was acquired by Astra Zeneca in June, 2013.
Dwivedi began the talk by paying tribute to his mentors, his father, Professor Rewa Prasad Dwivedi, his first role model and a reknowed Sanskrit scholar and poet, his professor Dr. Alan Mitchell at University of British Columbia who imparted important lessons on staying true to fundamentals and understanding the properties of nature, and Silicon Valley’s prolific inventor Mr. Mir Imran, who told him long before he needed to raise money, “don’t ever take investor’s money, unless you can treat it as your own”. Dwivedi said he carried all those valuable lessons in his professional journey.
After his education where he worked on tablets, Dwivedi was invited to join Glaxo to work on inhalation products. When he was concerned about making a jump from tablets to inhalation products, he was told “you know how to keep particles together, you would know how to keep them apart too”. From Glaxo, he went on to Dura, where he worked on an electromechanical inhaler system, a complex 50 part device. Then at Alkermes, Dwivedi put together a team which designed a device with a precessing capsule inside. Each of these opportunities contributed to giving him a stronger grounding into fundamentals.
Eventually, his career journey brought him to Nektar Therapeutics. Nektar was focusing on systemic conditions like diabetes, to be treated by inhalation delivery of drugs like insulin, and on anti-infective therapies for lungs. Dwivedi and his colleagues were looking at delivering drugs uniformly into the lungs for diseases such as asthma and COPD, and especially make drug combinations with standard metered dose inhalers. Global COPD or chronic obstructive pulmonary disease and asthma market is projected to reach $47 billion, by 2017. These were compelling clinical problems that Dwivedi and his colleagues were trying to solve, but Nektar chose to stay focused on other opportunities. Eventually, Dwivedi and his co-founder Adrian Smith formed Pearl Therapeutics and spun it out as a separate company.
Image via CrunchBase
Pearl Therapeutics has combined two bronchodilator drugs in one inhaler, and put it into Phase III. Pearl has now demonstrated that it can also combine three drugs, to treat the fatal lung condition, COPD. These drugs typically do not mix well together in a common inhaler and that leads to less than ideal distribution of the drugs in the lungs. Pearl’s secret is its proprietary technology. Dwivedi said the lessons he learned earlier in life regarding staying true to fundamentals and to not fight nature, were most useful in navigating these challenges. The nature of particles is to coalesce, and therefore it’s very difficult to keep them separate for aerosolization purposes. This can be achieved easily with liquid propellant suspensions, such as those in commonly used metered dose inhalers. Pearl creates these suspensions with a proprietary technology utilizing specially engineered phospholipid porous particles. When these inhalers are actuated then the porous particles go back from liquid to vapor, facilitating consistent and uniform inhalation delivery. The porous particles traverse the back of the throat easily and spread aerosols throughout the lung. Astra Zeneca saw the tremendous promise in this technology, the product progression achieved by Pearl, the value of the product pipeline at Pearl, and the Pearl team assembled by Dwivedi and his co-founder, Smith. AZ forked over $1 B+ and acquired Pearl, with a promise to enable Pearl to continue to operate independently. This was very interesting talk and generated a great deal of discussion.
Role of Lipid Mediators in Metabolic Diseases & Malignant Tissue Growth – Two Distinct Diseases, One Common Denominator
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on April 21, 2013
Dr. Ayala Luria, scientist in the Department of Urology and Institute for Regenerative Cures at UC Davis Medical Center, and a Consultant in a startup company, Adipocyte Therapeutics, discussed about the role of lipid mediators in various diseases, at www.bio2devicegroup.org event.
Diabetes is a disease of glucose homeostasis. We need glucose for brain activity, energy for muscles etc. But too much glucose can cause osmosis and affect the vessels and organs. Under normal circumstance, the body can balance the amount of glucose, or sugar, in the blood with the amount of glucose that the cells need for fuel. The hormone insulin, produced by the pancreas, helps transport the glucose into the cells. However, under diabetic conditions, the insulin secretion is not sufficient or is not working properly. There is a strong correlation between obesity, particularly abdominal fat and diabetes. Adipose tissue is implicated in the development of a systemic inflammatory state that contributes to obesity-associated coronary heart disease.
Dr. Luria’s research project relies on the concept of small lipid mediator, the autacoids that are metabolites of arachidonic acid. About 40% of the drugs in the market targeted towards treatment of inflammatory diseases, asthma and allergy are based on the a class of chemical compounds or small molecules of the archidonic acid pathway. This small molecule can be diverted to prostaglandins and thromboxanes to treat inflammation and blood clothing. It can also be diverted to leukotrienes to target asthma, allergies and so on. There is however, yet another pathway through epoxyeicosatrienoic acids (EETs). Luria’s research indicated that increasing EETs either pharmacologically or through genetically modified animals, helped obese mice regulate glucose levels.
Luria then discussed her work in angiogenesis. Angiogenesis refers to the formation of growth of blood vessels, which is at the core of sustaining life. Without blood, without oxygen, we cannot survive. In diabetics, impaired wound healing, retinopathy etc. are caused due to impaired angiogenesis. Insufficient angiogenesis also is considered to be one of the causes in stroke, CHS and so on. Whereas in cancer, excessive angiogenesis causes malignant tumor growth and many drugs on the market are targeted towards killing angiogenesis. Luria’s collaboration research indicated that (EETs) stimulate angiogenesis, although the mechanisms involved are not entirely understood. She tried to use angiogenesis as a vehicle for chemotherapy drugs in low doses. Combining EETs with inhibitors, led to stark decline in tumors. She arrived at the conclusion that it might be interesting to target diabetes treatment as benign tumor growth by inhibiting angiogenesis and further use angiogenesis as a vehicle to target tissue growth.
This interesting talk generated lot of response and was followed by Q&A.
Please join us on this Tuesday, April 21, 2013 for continuing discussion on metabolic diseases. Next week’s talk is titled “Obesity 360” and panelists include – Dr. Darshana Nadkarni, Dr. Alex Nedvetsky, and Mr. Nat Bowditch – http://bit.ly/ZExFfQ
2013 J P Morgan Healthcare Conference – Pharmaceutical & Biotech Company Presentations
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 20, 2013
2013 J P Morgan Healthcare Conference – Pharmaceutical & Biotech Company Presentations
Disclaimer – Below is my best attempt to capture highlights from company presentations, at 2013 J. P. Morgan Healthcare Conference, in San Francisco, CA. Please check details against more authentic sources, before making any financial decisions. My writeup on the overview of the conference can be found at this link – http://bit.ly/UY1Cpk . My article on the highlights from some of the medical device company presentations can be found at this link – http://bit.ly/WfhGmU . Big Pharma industry historically enjoyed growth rates in double digits and 20% operating margins with growing demand and big profits. But times are changing for big pharma with challenging healthcare environment, cost pressures, and patent expirations. Many firms responded to initial challenges by investing heavily in next-generation drugs, often based on biotechnology. Though promise of biotech has not panned out, many pharma companies have done restructuring, initiated serious cost containment and have nurtured the pipeline by investing in some promising molecules. See below, highlights from some of these companies.
Amgen – 2011 & 2012 were solid years and advanced pipeline offers promise for 2013
Both 2011 and 2012 were solid years for Amgen, with revenue growth of 11%, said COO and CEO elect, Bob Bradway. He credited the growth largely to the newly launched products, particularly denosumab franchise that include XGEVA and Prolia. In first year in market, Amgen has recouped over $500M of revenues from this new franchise. Amgen has returned 36% back to the shareholders. Prolia accounts for $1B in sales in the US.
Besides growth in its core franchise and advanced footprint, Amgen also has exhibited strong commercial execution with solid performance in the US and international markets, said Barclay. Sales of Neulasta grew and 40% of patients receive it during first chemo. Enbrel is Amgen’s leading molecule in rheumatoid arthritis and psoriasis space and is steadily growing. Sensipar, Nplate, and Vectibix also have strong and steady momentum. There was 18% growth in 2011 on these new products.
Additionally, there is a late stage pipeline emerging that looks promising. It includes, molecules AMG 145, an antibody PCS K9 for hyperlipidemia for high cholesterol, AMG 785 antibody for post menopausal osteoporosis, AMG 827 (in collaboration with Astra Zeneca) for psoriasis, AMG 416 for secondary hypothyroidism, and several oncology molecules, including AMG 102 for gastric cancer and AMG 386 for ovarian cancer.
Amgen will continue collaborations with other significant players. Recent acquisitions that are advancing its pipeline include Micromet, decode, and finally Mustafa Nevzat to help establish a presence in Turkey, an emerging market for Amgen. Amgen will continue to return significant capital to shareholders and in 2013, Amgen will focus on growing revenue, operating efficiencies, advance its pipeline, and focus on ROI.
Bristol Myers Squibb – will its promising portfolio deliver in 2013?
While 2012 was a year of transition, BMS is now poised to deliver by driving growth of key brands, executing on new product launches, and driving late stage pipeline said, CEO, Lamberto Andreotti.
BMS’s diversified portfolio includes key brands Eliquis, Yervoy, forxiga, Orencia, Sprycel and so on. Acquisition of Eliquis for stroke prevention and systemic embolism for Afib, offered a significant global opportunity and it was launched in Europe, US, Canada, and Japan. BMS has a broad portfolio targeting diabetes, in partnership with Astra Zeneca and it includes Amylin, onglyza, forxiga, and Byetta. A robust late stage portfolio targeting HCV includes some promising molecules. Finally, immuno-oncology continues to remain an exciting portfolio. Yervoy is showing encouraging 5 year survival data for melanoma patients, Nivolumab is in broad stage III program, and Elotuzumab phast III studies are looking promising, said Andreotti.
BMS is committed to 3% increase in dividend for 2013 versus 2012, has completed initial $3B share repurchase program and has announced additional $3B share repurchase program, and will continue to focus on business development through licensing, acquisition, and partnerships. BMS is well poised to deliver with improved decision making, more efficient operations, and greater collaboration, said Andreotti.
Merck – Exciting Pipeline & Plans to Expand Geographic Footprint
Celebrating first year as a combined company, following the merger of Schering-Plough and Merck, the company is well poised to outperform the broader healthcare market, said Ken Frazier, President & CEO of Merck. Its broad portfolio includes market leading medicines and vaccines, Merck has expanded geographic footprint in key markets, and has a strong exciting late stage pipeline.
While sales force was reduced in the US by 10%, in emerging markets like China, Brazil, and Russia, Merck was increasing the presence. Despite 2012 being a year of maximum disruption, with blending sales forces, training reps on new products etc., the company maintained top line growth with 7 of the top 10 products growing at a steady pace, said Frazier. The current late stage pipeline includes 55% legacy Merck compounds and 45% legacy Shering-Plough compounds, affirming the scientific productivity of both organizations, said Frazier. Growth strategy going forward includes plan for geographic expansion in Japan and emerging markets, delivering on the pipeline, and expanding broader portfolio of business that include Merck BioVentures and animal health business. Some significant brands include, Simponi which is launched in 18 countries, with great success. There are five new drug approvals including Dulera in the US, and Brinavess, Daxas, Elonva and Sycrest in Europe.
While strongly focusing on internal innovation, Merck has also signed 46 significant outside deals with external partners including most recently the SmartCells deal in diabetes. Merck has over 20 drugs in Phase III incuding Vorapaxar, Tredaptive, Anacetrapib, and Odanacatib. Merck will continue to remain committed to cardiovascular space, with currently over 100,000 patients in outcome studies and though costly now, the eventual aim is that these will lead to drugs that will reduce cardiovascular events, heart attacks, and strokes. Vorapaxar is the largest study with 40,000 patiens and Tredaptive has 25,000 patients. While Merck is number two pharmaceutical company, globally, it is number five in emerging markets and going forward, plans to expand presence in these markets from current 18% total sales to 25% by 2013, said Frazier. The plan is to grow the current portfolio in oral antibiotics and vaccines, as well as in women’s health. Additionally, given the rise in chronic diseases, Merck plans to grow in respiratory, cardiac, and diabetes space. Januvia is already number one oral diabetic product in emerging markets. Merck acknowledges that countries like China are surrounded by strong science and innovation in those markets can be a huge contributor. Merck aims to grow through value creating partnerships in those markets that would help in issues like pricing, reimbursement, market access, and low cost manufacturing.
Gilead – In addition to targeting Hep C, also continues to grow & remain a Leader in HIV Treatment
2012 has been a busy year for Gilead, said Chairman and CEO, John Martin. Gilead’s current commercial portfolio includes HIV, liver, respiratory, cardiovascular and other areas. The biggest part of revenue generation has been HIV. Truvada, the single regimen pill is steadily growing and is made available in low and middle income countries at steeply discounted prices or through generic licensing partners. In 2012, Gilead launched single table regimens, Atripla and Completera for HIV, distributed through join ventures with Merck and Janssen Therapeutics. Also in 2011, Gilead extended licenses to Indian partners to grant them future rights to produce generic versions of single table regimen, Stribild. Stribild was approved by US FDA, in August, 2012 and approval in Europe is expected in 2013.
Gilead’s pipeline includes Tenofovir, delivered directly to lymph nodes and showing greater efficacy, Sofosbuvir for Hep C, and Simtuzumab targeting Ideopathic Pulmonary Fibrosis. While much of the focus in 2012 had been on Gilead’s Hep C pipeline, it seems the company’s HIV franchise may emerge as a strong growth driver, than previously anticipated. The number of people in developing countries receiving Gilead antiretroviral therapy has increased from less than 30,000 in 2006 to over 3 million in 2012 and one-third of people treated for HIV in developing countries receive Gilead medicines.
Eli Lilly – Poised to deliver with 13 molecules in Phase 3, and 20 molecules in phase 2
Chairman, President, and CO John Lechleiter shared that Lilly’s total revenue is over $20B, with gross margin of revenue, approximately 78%, $3 billion in net income with at least $4 billion in operating cash flow. Lilly will continue to stay the course and implement the strategy that includes, replenishing and advancing the pipeline, driving growth in countercyclical growth areas, and increasing productivity to fund R&D.
In 2008, Lilly made the largest acquisition in Lilly’s history, by acquiring ImClone, to advance its oncology pipeline. In 2012, Lilly launched Amyvid in US, got approval for Erbitux and Jentadueto. Cymbalta and Zyprexa are approved for new indications in Japan and Cialis is approved in Europe for once daily use for BPH. Some of the setbacks included slower emerging market growth, due to patent expirations. Growth is expected from dulaglutide in collaboration with Boehringer Ingelheim to target diabetes, launch of Tradjenta in 30+ markets, and from Lilly’s animal health division Elanco’s acquisition of Janssen Pharmaceuticals animal health business. Lilly is poised to deliver with rich pipeline that includes 13 molecules in Phase 3, and 20 molecules in phase 2, said Lechleiter.
Glaxo Smith Kline – Refocused on Science & Revamped R&D Engine
Patrick Vallance, President of Pharmaceutical R&D opened the presentation with assurances that GSK has re-engineered its drug discovery organization, has built a late stage pipeline, restructured its commercial and manufacturing to support the pipeline and will deliver value. Given where GSK was a year ago, there seemed to be a marked progress in terms of its late stage pipeline.
Six new drugs that completed phase III studies in 2012 include dabrafenib and trametinib in oncology, albiglutide targeting diabetes, dolutegravir targeting HIV and Relvar and UMEC/VI for respiratory diseases. In oncology, combination therapy with both molecules is indicating more complete blockade of critical pathway and ability to prevent or delay emergence of resistance. For type II diabetes, albiglutide, first once-weekly fully humanized GLP-1RA regimen that can be administered with a pen device, is indicating opportunity to delay use of basal insulin and no weight gain. For HIV, current trials indicate dolutegravir to be statistically superior to Atripla at week 48. GSK has a broad portfolio targeting respiratory diseases. Relvar/Breo for asthma and COPD, appears well tolerated and efficacious at lower doses and shows significant improvement in lung functions compared to FF or FP. UMEC/VI for COPD, once daily, is potentially first in class in the US and indicates statistically significant improvement over placebo. GSK has more advanced portfolio in respiratory disease space. GSK has reengineered to deliver sustainable pipeline flow with visible multiple waves of pipeline delivery, said Vallance. It seems that GSK has refocused on science and has revamped its R&D engine. Will it deliver?
Baxter – Diverse Core Portfolio, Robust R&D Pipeline, Targeted Acquisitions – (stock worth watching)
Baxter CFO, Robert Hombach began the presentation with a reminder that this $38 billion healthcare company is one of the most diversified companies presenting at this conference. Baxter focuses on acute and critical care business and on treatment of chronic diseases. Emerging markets account for 20% of sales. Baxter has a diverse core portfolio, a robust R&D pipeline, and engages in targeted acquisitions.
BioScience accounts for $6.1 billion business and represents vaccines, bio surgery and hemophilia. Baxter is advancing pipeline of novel recombinant proteins. Bio surgery business continues to be double digit growth driver. Advate, a targeted therapy for hemophilia A, which affects approximately 1 in 5,000 males, is also a strong growth driver, showing to be very safe and efficacious and remains a gold standard of therapy. Investors believe Advate sales will continue higher, on account of FDA’s recent approved a higher dosage strength of the drug, in 2012. The higher dose allows patients to be treated only once every three days, which is a first in the hemophilia market and gives Baxter a sustainable advantage. Medical products business account for $7.8 billion in sales in 2011. Its key renal business accounted for 32%. Baxter acquired Swedish-based Gambro, a kidney and liver dialysis company, for $4 billion, in late 2012, to integrate end stage renal market and enhance worldwide reach.
Baxter’s late stage product pipeline in 2012, includes 18 molecules in phase 3. SubQ self-administration therapy of Gamnagard Liquid for Primary Immunodeficiency is showing favorable tolerability pipeline including low infusion site reaction and is advancing label indications. A possible future blockbuster drug, Baxter has multiple data releases of Gamnagard for Alzheimer’s disease this year. There is a probability that Baxter receives FDA approval for Gammagard Liquid in mild/moderate Alzheimer’s in coming years. Baxter’s expanding portfolio to new therapeutic areas include, CD34+ stem cells as a possible treatment for chronic myocardial ischemia, anti-MIF antibody targeting MIF protein that influences tumor growth, and Rigosertib, a novel targeted anti-cancer compound. Baxter has partnered with Momenta Pharmaceuticals, in a $452 million deal, to tap into the biosimilars market. Baxter is continuing the innovation in home dialysis, with over 30 new products in the pipeline and has potential to contribute up to $250 million to its top line. This is one of the richest pipeline in Baxter’s history, said Hombach.
Abbott – New Diversified Healthcare Company with Focus on Nutrition, Established Pharma, and Medical Devices
Abbott is a large cap diversified healthcare company and is now separate from new company, abbvie, a large cap biopharmaceutical company, said CEO, Miles White. The new Abbott Laboratories is strongly position with $5.9 billion sales in medical devices and $5.4 billion in sales in established pharma market, in 2011. Diagnostics accounted for an additional $4.2 billion in sales and nutrition accounted for $6 billion in sales, in 2011. There is an increasing emerging market presence with sales targeted to approach 50%, by 2015.
Abbott enjoyed leadership position in large markets in several industry sectors. In diagnostics, Abbott hold number 1 place in immunoassay diagnostics and in blood screening and has a leading point of care platform. In nutrition, it is number 1 in adult and pediatric nutrition and is a leading science based nutrition company. In medical devices, Abbott is number 1 in DES, BMS, BVS, and number 1 in Lasik and number 2 in cataract, said White. Diabetes and vision care is driving growth in emerging markets. Abbott also has robust vascular pipeline and in 2012, launched Absorb, a bioresorbable vascular scaffold for treatment of CAD, in Europe, Asia, and Latin America. In established pharmaceuticals, Abbott is a leader in branded generics, with a broad portfolio that includes, 500+ branded generics, a strong development pipeline, and 60% presence in emerging markets.
AbbVie – Will other products pick up slack from Humira’s patent expiration for more agile new company?
AbbVie is the new spinoff company, from Abbott Laboratories, focused on “research-based pharmaceuticals.” It is a global biopharma company, with focus and agility of a biotech, said CFO, Bill Chase. AbbVie has revenues of about $18 billion and Humira, a prescription drug for rheumatoid arthritis, is its best asset. Humira is a huge product, generating about $9 billion in sales. There is a concern with Humira’s pending patent expiration in 2016, but Chase outlined some future plans. AbbVie will focus on achieving Humira’s full potential through new indications, maximizing product portfolio, advancing pipeline, and leveraging global footprint.
Humira has recently been approved for ulcerative colitis. Beyond Humira, other growth brands and durable performers include, Andro Gel, leading in testosterone replacement, Lupron, Synagis1, Creon, Synthroid, Kaletra, Norvir and Zemplar. Humira faces stiff competition, in addition to patent expiration. Will AbbVie’s other products easily take up the slack?
Bausch & Lomb – Only Global Company Focused on Eye Care Focused on Future Growth & New Products
B&L is the only global company found on caring for the eyes, said, President & CEO Brent Saunders. B&L is an iconic brand with 160 year history. The company manufactures and markets eye health products that include contact lenses and lens care products for Astigmatism, Presbyopia, Nearsighted/Farsighted, and cataract patients. The company also provides intraocular lenses and delivery systems, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals; vision shaping treatment products; dry eye products; allergy/redness relief products; eye wash products; eye vitamins and so on. Three important worldwide trends, the aging population, higher diabetes prevalence, and emerging middle class more interested in eye care, will lead to increased demand, said Saunders.
At B&L, 80% of business is in cash market. Some of the upcoming B&L products to watch are, BioTrue, one day lenses made from a next generation, bioinspired material called HyperGel, Victus Fentosecond Laser platform for enhanced performance across cataract and corneal procedures, and enVista, new glistening free, hydrophobic acrylic IOLs. What is in its future? Will there be a buyer willing to offer multi-billion dollar deal or will this private equity firm turn to an initial public offering (IPO)? Following the company presentation, Saunders mentioned that the company is focused on future growth and also “aspiring to return to public markets”.
Cerulean Pharma – Private Company with Nanoparticle Based, Dynamic, Targeted Drug Delivery Platform
Cerulean Pharma develops and markets novel, intelligently designed, nanoparticle based technology to target tumor agents, in fight against cancer, said CEO Oliver Fetzer. Tumor is targeted via leaky vasculature, used at entry portals into the tumor tissue. Cerulean nanoparticles are are small enough to penetrate these tumor blood vessels but are too large to enter health tissue. These nanoparticles are transported through the tumor tissue up into tumor cells and then the drug is gradually released within tumor cells. The drug is covalently bound and dynamically releases within tumor cells and the nanoparticles eventually disintegrate over time.
While chemo works well in getting the tumor cells, it also harms the healthy tissue. History of oncology is somewhat gloomy. With surgery, radiation, combination therapy, chemo, personalized medicine, immunotherapy etc., 5 year survival is still only 50%. This kind of dynamic tumor targeting has two important benefits. By focusing on tumors and sparring healthy tissue from unwanted exposure, Cerulean nanopharmaceuticals leads to limited side effects, while also enhancing therapeutic results. The linker that attached the drug to the nanoparticle is selected to provide optimal intra-tumor drug release, by gradually breaking apart inside the tumor and releasing the drug payload over time. The current trials indicate significantly lower toxicity and higher effectiveness with drugs with high adverse profile, like Docetaxel, Erlotinib, and Pemetrexed. Cerulean’s own small molecule oncology product pipeline in trials, includes CRLX101, CRLX301, and siRNA delivery platform. Cerulean develops products with partners by marrying their molecules, marketed or in development, with their nanopharmaceutical platform.
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