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Transitioning from Bench to Pharma – Face to face with Dr. Sourav Sarkar, Senior Scientist, AstraZeneca, UK

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Dr. Sourav Sarkar (SS) shares his academic journey with Nida Siddiqui (NS) and describes the factors that led to his transition into the industry. He also provides some invaluable pointers for future “transitioners”.

NS: Could you tell us about yourself?

 SS: I am an experienced research scientist with broad knowledge and understanding in cell biology and biochemistry. I did my masters in Biochemistry from Calcutta University, India followed by PhD in Genetics and cell biology from Bose Institute, Kolkata, India. After completion of PhD, I joined University of Warwick, UK to pursue postdoctoral research in understanding molecular mechanism of chromosome segregation in normal and cancerous cells. Currently I am working in AstraZeneca, Cambridge, UK as a senior scientist where my role is to screen different classes of compounds to find candidates that are effective, as well as selective against targets in different cancer types, and to gain a better understanding of the molecular mechanism of action of specific compounds against a target.

 NS: What were some of the exciting projects that you worked on during your PhD/Postdoc?

SS: I have mainly worked on understanding the molecular mechanism of chromosome segregation during mitosis and meiosis, and how genetic alterations affect this process in cancer cells.

I have been involved in several projects during my research career and most of them have been very interesting, but if I must choose then I would say that the following projects have been particularly exciting.

  1. a) To understand the role of fusion gene(s) in chromosome segregation, and its contribution towards development of aneuploidy, and consequently cancer. There is considerable evidence that suggests potential links between fusion gene(s) and cancer, so it is very important to understand the molecular basis of this association.
  2. b) To understand how cells respond to nutritional status in the environment, and trigger entry into quiescence/gametogenesis program for their survival.

NS: Did you have any dilemma after your PhD, to choose between a postdoc/industry position?

SS: After completion of PhD, I decided to continue my research work in an academic setting. Frankly speaking, I never had any thoughts of moving to the industry after my PhD.

NS: When did you decide it was time to move on and transition to the industry?

SS: To consider moving to the industry was not an easy decision for me. However, successful scientific research is not a product of ideas alone. Other factors, such as research funding play a crucial role, and I have personally experienced research getting affected due to the lack of funds. It was during my postdoc that I realised that staying in academia was not going to be an easy task. There is constant pressure of publishing articles, getting grants etc. and this to some extent I believe led to a situation where “publish or perish” became a harsh reality.  Considering all these factors, I thought it would be a good time for me (after my second postdoc) to move to the industry, where I could still be involved in science, and address relevant scientific questions. Moreover, I felt that joining a pharmaceutical industry would give me the perfect opportunity to work more closely with experts from different fields towards a common goal of developing new medicines and improving human health. 

NS: What are the skills that helped you crack your current position?

SS: My research experience during PhD and postdoc gave me the invaluable opportunity to learn various technical skills ranging from cell and molecular biology to protein biochemistry. In addition to my technical skills, I also got the chance to develop my inter-personal skills over this period. Interacting with researchers from various fields of expertise has helped shape my research career. The set of skills I acquired from these communications turned out to be highly valuable towards obtaining my current position in this company.

 NS: How has PhD Career Support Group (PhDCSG) played a role during your transition period?

SS: PhDCSG is a great initiative and I must thank all the people who are behind this. CSG has helped me better prepare myself during the transition stage. The vast variety of posts by people from different areas, starting from CV writing to preparing for a job interview etc. are very useful. One learns a lot from CSG as people share their personal experiences on topics relevant to early-career scientists, which to me is extremely valuable.

 NS: What would you advise PhD students and postdocs, looking to transition to the industry?

SS: I would suggest few points to work on before making the move.

  1. First ask yourself whether you are prepared for the move.
  2. Be honest, be prepared to take risks, and believe in yourself.
  3. Continue to learn and develop skills in your area of specialization, but also keep your mind open to picking up new skills in other areas, as and when an opportunity presents.
  4. Understand your subject very well and develop the quality to address pertinent questions.
  5. Both, technical and inter-personal skills are key during transition.
  6. Don’t hesitate to interact with people, reaching out to them, and making yourself visible in the job sector.
  7. Attend conferences, meetings, networking events etc. where you would get an opportunity to meet people from different industries.
  8. If possible, attend courses on career development.

And most importantly, remember, employers won’t come and knock on your door; you will have to create opportunities for yourself.

 

About Dr. Sourav Sarkar

Dr. Sourav Sarkar is a senior scientist at AstraZeneca, Cambridge, UK. He completed his PhD from Bose Institute, Calcutta, India followed by two postdoctoral stints at the University of Warwick, UK.

 

About Nida Siddiqui

Nida Siddiqui is currently pursuing final year PhD at the Centre for Mechanochemical Cell Biology, University of Warwick, UK. Follow her on LinkedIn and Twitter @siddnida

Editor: Arunima Singh

About: Arunima obtained her PhD in Computational chemistry from the University of Georgia, USA, and is currently a postdoctoral researcher at New York University. She enjoys traveling, reading, and the process of mastering a new cuisine. Her motivation to move to New York was to be a part of this rich scientific, cultural, and social hub.

 Cover image: Pixabay

The contents of Club SciWri are the copyright of PhD Career Support Group for STEM PhDs (A US Non-Profit 501(c)3, PhDCSG is an initiative of the alumni of the Indian Institute of Science, Bangalore. The primary aim of this group is to build a NETWORK among scientists, engineers and entrepreneurs).

This work by Club SciWri is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

MedNess: FDA Approvals, Label Expansions and International Market

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Hello and welcome to MedNess. This edition of MedNess covers the latest from small and big biotech and pharma companies. Stay tuned for MedNess Asco Coverage. In the meantime, please subscribe to ClubSciWri for our other articles and blog posts!

Celgene supports Dragonfly in enhancing NK-cell based immunotherapy

The discovery-stage company, Dragonfly Therapeutics, aims to enhance immunotherapy using Natural Killer (NK)  cells. Dragonfly aims to harness the power of body’s innate immune system to vastly improved patient outcomes. They plan to stimulate NK cells so that these cells can attack tumors directly with support of T and B cells. This strategy has attracted the attention of a leading global pharmaceutical company, Celgene along with the Duke of Bedford, Disney family members and other organizations.

Celgene bagged the option on four NK cell based cancer therapeutics to treat myeloid leukemia, multiple myeloma and other hematological cancers by investing over $33 million in Dragonfly. This collaboration by Celgene shows that they saw immense potential in this discovery stage biotech to develop innovative therapies for cancer patients (Dragonfly Therapeutics, Fierce Biotech).

MedNess: Celgene recently reported positive data from Lupus trial. Its shares have been soaring with an overall gain of 19.8% in the last one year. As per Zack’s index, Celgene stocks are a strong hold. At the present, the shares are sold for $124.82 (Zacks).

Europe, US, and Japan joins hands to boost antibiotic development

The three drug regulators of the world; European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA,) and the Food and Drug Administration (FDA) participated in the tripartite meeting in Vienna, Austria  to consider a robust response to boost antibiotic development.

They agreed to align their data requirements for certain aspects of the clinical development of new antibiotics so that the new meds can come in the global market. Also, in the meeting, they discussed in detail clinical trial recommendations for certain types of bacterial infections, including infections caused by multi-drug resistant organisms. Even the areas of differences were talked about in this meeting, and an effort to work together to minimize them was discussed.

While all three of them are now working on updating their respective guidance documents, they are also willing to provide suggestions to the individual biopharma companies. The next meeting is scheduled for October 2017 ( Fierce biotech, EMA).

Astrazeneca terminates the plan for NASH drugs with SoCal’s Regulus

California based biopharmaceutical company, Regulus aims to discover and develop innovative medicines targeting microRNAs. They recently announced their pipeline updates and advancement in which a major setback was when Astrazenenca terminated the clinical development program for AZD4076 (RG-125) which is involved in the treatment of nonalcoholic steatohepatitis (NASH) in Type 2 Diabetes/Pre-diabetes.

Regulus also planned to discontinue clinical development of RG-101 for Hepatitis C Virus (HCV) upon completion of the one remaining clinical study, which is expected to occur in July 2017. Now, the company is majorly focussing on keeping the plans of the Phase II clinical programs for RG-012 which is used for the treatment of Alport syndrome on track. Also, the IND for RGLS4326 for autosomal dominant polycystic kidney disease (ADPKD) is on track for filing by year end 2017 (Regulus, Fiercebiotech).

AstraZeneca’s Lynparza slows breast cancer progression, now a potential precision drug against prostate cancer

AstraZeneca announced statistically significant positive results from Phase 3 OlympiAD tested against breast cancer patients with BRCA gene mutations. The results demonstrated a clinically-meaningful improvement in progression-free survival (PFS) for patients treated with Lynparza (olaparib) tablets (300mg twice daily), compared to chemotherapy. In addition, a 42% reduction in disease worsening or death (HR 0.58; 95% CI 0.43-0.80; p=0.0009; median 7.0 vs 4.2 months) was observed in patients treated with Lynparza when compared to those who received chemotherapy. The results were reported in New England Journal of Medicine. Lynparza was earlier approved for ovarian cancer that is caused by BRCA. Now, in another study being carried out at the Institute of Cancer Research, London, Lynparza is showing a potential towards precision drug in prostate cancer. According to the researchers, the test designed by them, could distinguish the disease severity, treatment response and if prostate cancer is evolving genetically and can potentially become drug resistant. The results of these tests were reported in Cancer Discovery (AstraZeneca, Reuters)

MedNess: AstraZeneca has a strong pipeline of drug candidates.  The stock has a market capitalization of $87 billion. Lynparza generated $218 million in sales in 2016. The current share price is a little over $34 with overall gain of 0.26% (Forbes, CNNMoney).

Clovis Oncology announces positive results from late stage ovarian cancer trial

Clovis Pharma’s, Rubraca, met its primary endpoint and a key secondary endpoint. The company is planning to request label expansion for Rubraca and gain approval for second line treatment and maintenance treatment for women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. Clovis Pharma’s drug is directly in competition with Tesar Inc’s Zejula and AstraZeneca Plc’s Lynparza. All the drugs belong to the class of PARP inhibitors, that blocks enzymes poly ADP ribose polymerases. These enzymes are involved in repairing damaged DNA (Clovis Oncology).

MedNess: Clovis Pharma’s shares are soaring. It shutdown at $59.97 on Friday, June 15. The stock opened at $87.73 (~ 50% surge in price) on Monday, June 19.

MedNess Asia:

Promising addition in cancer therapy from Chi-Med with a huge investment from U.S. partner Eli Lilly

Last week, Hutchison China MediTech Limited (Chi-Med) has submitted its New Drug Application (NDA) to China Food and Drug Administration (CFDA) for fruquintinib, developed jointly with Eli Lilly to treat advanced cases of colorectal cancer (CRC). In addition, fruquintinib is being tested to treat non-small cell lung cancer and gastric cancer. The drug selectively inhibits vascular endothelial growth factor receptor and helps preventing angiogenesis, i.e. development of new blood vessels essential for tumor growth and metastasis.

Chi-Med aims to break the Active Pharmaceutical Ingredient (API) manufacturer’s stereotype of Chinese pharma companies, and establish itself in bringing innovative and modern drugs in international market. The other drug that the company is evaluating at phase II trial for cancer research is sulfatinib, that also targets tumor angiogenesis and immune evasion. (Reuters, Chi-med press releases)

MedNess: CRC is the second most common cancer with 380,000 cases in China and 1.5 mn cases globally. Reports suggest that the number of new cases of CRC will increase by 13% over the next three years by 2020. Hopes are that fruquintinib can be used in combination with chemotherapy and targeted cancer therapy. Since the application of NDA for the drug on 12th June, Chi-Med has seen a surge of 2.6% in its stock prices (within two days).

Market for internationally manufactured aesthetic medicine in China

Austria-based Croma-Pharma becomes the only second European producers of intradermal fillers approved in China. Intradermal fillers (biodegradable – like different forms of collagen and hyaluronic acid, semi-permanent – like different polymers and permanent – like silicone) help in skin aging management by restoring facial volume or treating wrinkles.

Croma-Pharma (CP) has registered Princess® VOLUME, a hyaluronic acid based filler in China by joining hands with Sihuan Pharmaceutical (SP)  – CP brings in its products, experience and related intellectual property rights, whereas SP will provide its multi-channel distribution and marketing knowledge, being one of the largest pharma corporations and drug franchises in China. This joint venture aims to compete against the local manufacturers in the country and increase the quality of beauty products in China. (Croma news, Bloomberg)

MedNess: China has the largest market for aesthetic medicine in Asia-Pacific region growing at 20% annually, with its aging population, increasing awareness about aesthetic treatment and rise in disposable incomes. By taking advantage of a Chinese company’s distribution channels, Croma-Pharma hopes to reach a considerable market share, by competing against local manufacturers – an issue that has been bothering most foreign manufacturers in China.

Generic anticoagulant launched by Dr. Reddy’s Laboratories for US market

Indian multinational pharma company Dr. Reddy’s Laboratories launched bivalirudin, a therapeutic equivalent generic version of Angiomax® by the Medicines Company. Approved by US-FDA, it is to be used for injection as a blood anticoagulant.

Angiomax, a direct thrombin inhibitor (DTI) structurally similar to hirudin, is used for acute cardiovascular care. DTIs show a higher specificity in reaction with thrombin and lesser complications arising from its use, and hence are preferred over indirect thrombin inhibitors like heparin . Angiomax and its generics registered US sales of around $198 mn over the last year till March 2017. (Dr. Reddy’s Laboratories press release, The Medicines Company)

MedNess:  The anticoagulants market is expected to grow at a CAGR of more than 6% by 2020. Within a week after the launch (on 6th June) by Dr. Reddy’s its stock prices went up by 4.5%.

 

Featured Image: Vinita Bharat

About the Authors:

 Imit Kaur, Ph.D. is a freelance scientific advisor, medical writer, editor, and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development. Follow Imit on LinkedIn (Imit Kaur) or Twitter (@imit_kaur)

Somdatta Karak, PhD is interested in pharma and healthcare sector in Asia. She also works with PhD Career Support Group / Club SciWri as its project coordinator. She aims to make a more and better informed world for all, and hence experiments with making effective platforms of education. She can be reached here.

Vinita Bharat Ph.D., is currently a postdoctoral research fellow at European Neuroscience Institute, Göttingen, Germany and had been an International Max Planck Research School (IMPRS) student here. Her research area focuses on cellular and molecular neuroscience. Other than enjoying ‘being a scientist’, she has also been working on science education. Presenting science in easy and fun way is what she loves doing through her platform “Fuzzy Synapse” (one can find fuzzy synapse on Facebook, Instagram and Twitter). She is a fun, enthusiastic and curious person, passionate about traveling, loves celebrations and bringing smiles around her.

 

 

MedNess- March Mania

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Hello and welcome to yet another exciting week of MedNess. In this March mania, we bring the news from medicine and healthcare with the greatest impact.

Tom Price justifies NIH’s “indirect” budget cuts

Secretary of Health and Human Services (HHS) defended Trump’s administration proposed National Institute of Health’s budget cuts. The Trump administration proposed $5.8 billion, about 18% cut for the fiscal year 2018. In addition to that, an addendum proposed an additional $1.2 billion cut for the current fiscal year. When questioned by both democrats and republicans about the nature of budget cuts, Price explained to reduce the “overhead” costs to streamline the system. According to the Secretary of HHS, the “indirect” cost takes up about 30% of the grant money, which could otherwise be available for research.
This came in as a second blow to the medical research community. Earlier this year, Trump administration pushed deregulation of FDA to accelerate the drug approval process. The research community did not welcome this proposal. Also, both pharmaceutical companies and insurance companies did not approve of the proposition (STAT and Science).

 

March for Science, a scientist’s view:  For our readers, “overhead” or “indirect” costs constitute of anything required for carrying out research safely, smoothly and efficiently! Some of the “indirect” costs include lab equipment, electricity, custodial services and other utilities. The list is not inclusive but clearly, emphasizes the importance of overhead charges. The budget cuts will not only affect the advancement of research but will also impact jobs and outreach of science. For non-science professionals, say, politicians, the overhead cost will include, electricity, custodial services, security, dinner, travel, etc. Again, the list is not inclusive! Of course, these expenses are required for the smooth functioning of the government. Before I wrap up the section, just a thought: yes, we need the stronger military to defend the country, but we need to ask this question, who are we protecting; the people and the Mother Nature. Therefore, we need an effective EPA and NIH. We need the healthy and clean environment and disease-free children and adults.

Amgen’s LDL-lowering drug Repatha: effective drug with good data for a bad price?
Amgen presented Phase III FOURIER results on Repatha (Evolocumab) at the 2017 American College of Cardiology conference. Repatha is an LDL-lowering PCSK9 inhibitor. Repatha targets PCSK9 proteins in the blood stream thus preventing it from binding to and breaking down LDL cholesterol receptors in the liver. The trial results were impressive. This wonder drug is believed to break down the most stubborn cholesterol. The FDA approved drug marketing in 2015 after the drug’s addition to statins reduced the LDL levels by about 63%. At the ACC, Amgen reported the outcome of long-term FOURIER trial and the results showed that Repatha reduced the risk of heart attack and stroke by 15% or more. Repatha met both its primary and secondary composite endpoint in the secondary prevention trial demonstrating superiority to statin therapy. However, analysts are not too impressed with the data and question the high price of the drug. Earlier, analysts with BioPharmInsight suggested that the high price of Repatha could be justified if the cardiovascular event risk reduction is at least 35%. Repatha has been price tagged for $14,000 annually. The trial findings and analyst’s reports will also affect insurance coverage of the drug (MedPage Today).

MedNess: PCSK9 is the hottest target in the field of cardiovascular research. While Amgen’s drug can crush the most stubborn cholesterol molecules, the investors were not impressed, or at least the stock market trend did not concede with it. After the results had been announced, Amgen’s stock price went down by 10%. However, a lot of analysts are still keeping their faith in Amgen’s stocks and considering this temporary dip as an opportunity for investment. On the contrary, the competition from other biosimilars is getting fiercer, and the dip in stock price might not be temporary after all. Other contenders in this area with Amgen, are the drugs from Sanofi and Regeneron. Both the companies are locked in a patent battle with Amgen. Another drug in the race is The Medicine’s Company’s inclisiran. Unlike Amgen’s, Sanofi’s and Regeneron’s drug, inclisiran interrupts PCSK9 synthesis. The analysts look at this drug as efficacious as Repatha but with fewer annual doses. If this assumption is correct, Amgen will have a hard time convincing insurance companies for their drug price. The best bet might be therefore to either wait or invest wisely (The Motley Fool and Seeking alpha).

FDA approves Roche MS drug Ocrevus after 3-month delay

The FDA approved Roche MS drug Ocrevus after initial delay caused by regulator’s concerns over manufacturing issues.
Ocrelizumab, becomes the first U.S.-approved medicine for the primary progressive multiple sclerosis. It has also been approved for relapsing-remitting multiple sclerosis (RRMS). Biogen’s MS drug has been used to treat RRMS. Biogen will receive up to 24% royalty on U.S. sales of Ocrevus. According to the pharmaceutical giant; Ocrevus is expected to be available for use to people within two weeks.

 

MedNess: Analysts forecast annual sales exceeding $3 billion by 2021 as reported by Reuters. After the approval news, Biogen stock fell by 2%, and Roche stock rose by a fraction. Novartis’s drug for MS treatment, BAF312, for secondary progressive MS is expected to receive regulatory approval in the first half of 2017. Until then, Roche can bask in glory  (Reuters, Investor’s Business Daily, FiercePharma).

FDA approves Tesaro Inc’s Niraparib for the treatment of Ovarian Cancer

Tesaro’s Niraprib (Zejula) gained an early approval by FDA for the treatment of recurrent ovarian cancer. Zejula is a PARP inhibitor causing DNA damage. It is a first drug in the class that can be used to treat all women with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer without requiring BRCA mutation or biomarker evaluation. This is unlike the rival drug Lynparza by AstraZeneca. In addition, Zejula acquired orphan drug designation for its use in the treatment of recurrent epithelial ovarian cancer.

MedNess: According to EvaluatePharma, Zejula is one of the top drug launches of 2017 with 2022 sales expectations of $1.9 billion. Tesaro Inc’s shares were up 7.78 percent after the drug gained FDA approval (FiercePharma and BusinessInsider).

Illustration: Ipsa Jain

About the Author

Imit Kaur is a freelance medical writer, editor and an active science blogger. She pursued her PhD in Pharmaceutics and Pharmaceutical Chemistry from University of Utah. She is experienced in the field of oncology, hematology, pharmacology, nanotechnology and drug development.

The week that it was – 20th to 26th March, 2017

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  • 894856_10151596530946703_1017119723_o.jpg?fit=2048%2C1379

CSG is now a platform with 6000+ members and CSG-Europe has started to bloom. Among the wide variety of information shared on the platform daily, I decided to bring you the opportunities to shape your future (of course, I know how you love to see them), help to deal with them and some refreshing foods for thought.

Time is ripe to attack the predatory science journals under the pretext of open access publishing, as researchers from Sussex carry out sting operation to expose 48 of them.

While Harvard Medical school scientists propose revising guidelines around genetic engineering, Nobel laureate Harold Varmus, Cornell Weill Medicine voices concerns around NIH budget cuts proposal.

Director of IISER Thiruvananthapuram, Prof. V. Ramakrishnan faces scrutiny for plagiarism; many academicians had objections to his appointment in the first place.

While CSIR lost enough of tax-payers money in filing non-revenue generating patents, researchers from IIT-Madras suggest possible solutions.

The market always loves and grooms the ones with exciting ideas –

  • Startup India brings free online extensive 4 weeks program for entrepreneurs to learn from the leading names in the country
  • Falling Walls lab, an initiative by German Centre for Research and Innovation, New York is looking forward to hear your research/ entrepreneurial idea to sponsor your meeting with other bright minds in Berlin, Germany
  • JoVE offers exciting prizes for filming equally exciting research work
  • And do not miss the opportunity to get connected with the pioneers in biotechnology in New York via the GRO BioPharma conference on 5th April

Illumina takes Next Generation Sequencing (NGS) techniques to fisheries; promises its help in increasing fishing yield.

Grab the openings-

With this mighty a list of openings, chances are high one of them interests you. Get started with the application then. Here are some tips on excelling your postdoc application, writing the perfect resume and cover letter. We don’t want to take chances here!

About the author:

Somdatta Karak works with Club SciWri as a project co ordinator and Corporate Liaison. She is a doctorate in neuroscience from Georg August University, Göttingen, Germany and has been a Teach for India fellow (2014-16). She loves putting her analytical skills to build newer and more sustainable solutions, enjoys traveling and communicating and takes every opportunity to expand her horizon.

You can reach her here.

 

 

MedNess- Immuno Oncology, Precision Medicine and more….

in SciBiz/Uncategorized by

Picture Illustration: Ipsa Jain

CAR-T therapy- a step closer to precision medicine?

Kite Pharma’s CAR-T candidate axicabtagene ciloleucel (previously referred to as KTE-C19) might be the first gene therapy to gain approval from FDA. The candidate therapy attained primary endpoints in a major study. The study encompassed patients with chemorefractory aggressive B-cell non-Hodgkin lymphoma. The study showed that out of 101 patients enrolled in ZUMA-1 trial, 82% had their cancer shrunk at least by half after six months. In addition, 41% had partial response while 36% of patients went on complete remission. The therapy comes with its own share of risks. 3 patients in the study died and 2 of the deaths were attributed to the treatment.

CAR-T therapy, one of the most controversial treatments involving gene therapy, utilizes reengineered patient’s T cells. These T cells (immune system’s killer cells) are filtered from patients blood and altered in the lab and injected back intravenously making it a “living drug”.

Novartis and Juno Therapeutics are also in the race for CAR-T therapy. However, Juno Therapeutics announced the discontinuation of their experimental product early this month. This is because thirteen percent of patient deaths were reported, majorly due to cerebral edema and brain swelling. Kite Pharma’s CART-T cell product is safer in this regard. Kite Pharma’s axicabtagene ciloleucel was granted Breakthrough Therapy Designation status for diffuse large B cell lymphoma, transformed follicular lymphoma, and primary mediastinal B-cell lymphoma by the FDA and by the Food Priority Medicines (PRIME) regulatory support for DLBCL in the EU.

MedNess: Although Kite Pharma has not presented formal results of the trial and is expected to present their report at the annual conference of American Association of Cancer Research in April this year, the reports of axicabtegene ciloleucel meeting primary endpoints raised the stock prices by 13% of this California-based biopharmaceutical company. Kite Pharma’s CAR-T product might be first in line to gain approval from FDA by the end of this year leaving behind the products from its competitors. Therefore, stocks of Kite Pharma hold a lucrative future. However, a lot can change in further studies and it all comes down to safety and efficacy of the final product (FiercePharma, STAT).

Barclays analyst’s stern advice to Gilead Sciences

Geoff Meacham, Barclays senior analyst apparently lost patience with Gilead Sciences, urging it to “do something”. He sent an open letter to the management prompting the company to either make an acquisition or take strict measures to improve sales and profit growth. Meacham suggested measures including Gilead’s orphan drugs diversification, cost cutting in Hep-C business due to declining market, HIV franchise clarification and/ or in-licensing deals in order to gain trust of its investors (Seekingalpha)

MedNess: Gilead Sciences sales and profit growth have eroded as its hepatitis C franchise has declined, the shares have slipped by 1% and profits have declined in each of the past five quarters.

Scott Gottlieb to lead FDA under Trump administration

Scott Gottlieb who has served as a practicing physician, clinical assistant professor at New York University and health information technology adviser for the department of Health and Human Services, has been selected as Trump’s nominee to lead FDA. The president’s selection is expected to yield support from biopharma industry. Gottlieb, if confirmed, is likely to hasten the drug approval process that might have earned him Trump’s support. He was a former deputy commissioner for medical and scientific affairs at the FDA under George W. Bush (FiercePharma).

Earlier this month, Club SciWri initiated a new section on Science and Policy, emphasizing on the involvement of scientists in the healthcare policy decisions. Gottlieb’s nomination to lead FDA will serve as a perfect example, underscoring the relevance of this sensitive subject.

BMS appoints Thomas Lynch as its new Chief Scientific Officer

BMS has been in news for quite a while now and that too for all the wrong reasons. Amongst the turmoil and speculations of its buyout, BMS appointed Thomas Lynch as its new Chief Scientific Officer (CSO) while the former CSO Francis Cuff made the exit this Wednesday. Thomas Lynch, an oncologist, was a former board member of BMS. With the new appointment, hopes are high on the Opdivo front as well. Recently, Opdivo fell short in a major clinical trial when tested on previously untreated lung cancer patients. Opdivo is PD-L1 checkpoint inhibitor and therefore its efficacy is expected to be better in patients with higher levels of this biomarker. However, BMS lost its non-small cell lung cancer lead to rival Merck’s Keytruda that succeeded in patients with a PD-L1 score of 50% or more. Also, earlier this year, BMS decided to not to seek accelerated approval for their Opdivo-plus-Yervoy combination in lung cancer. These two events combined with new checkpoint inhibitors expected from Roche, AstraZeneca, Merck and Pfizer have put BMS’s shares down. However, analysts suggest, BMS share might still be a great bargain if the drug succeeds in other arms of the trial, testing Opdivo as a monotherapy in first-line lung cancer. The company also awaits readouts from Phase 2 and Phase 3 studies evaluating Opdivo and Yervoy in other types of cancer (FiercePharma, The Motley Fool).

 

MedNess-Pill for Alzheimer’s?

in ClubSciWri/SciBiz/Uncategorized by

Hello and welcome to yet another exciting week of MedNess. We bring the news from medicine and healthcare with greatest impact. It seems like; year 2017 will be the year of neurology! It is just the second month of the year and treatment strategies for various neurological disorders are making headlines.

Merck halts Phase 3 study on Alzheimer’s drug- another setback for amyloid theory

Clinical trials on Verubecestat- a small molecule BACE 1 and BACE2 inhibitor were called off after an interim analysis on Phase 2/3 studies did not show promising results. The analysis team concluded that there was “virtually no chance of finding a positive clinical effect”. However, another trial on patients with early symptoms of Alzheimer’s will continue. It has been speculated that the drug was too weak, or was dosed inadequately or the disease had progressed too far in patients for the drug to show concrete effect. The failure of this trial is another blow to the famous “amyloid theory”. According to this theory, the amyloid plaques are believed to be cause of the disease. Verubecestat is a beta secretase inhibitor. This disappointing cessation of clinical trial came months after Eli Lilly’s Alzheimer’s drug; Solanezumab failed in Phase 3 clinical trials in November last year. Unlike Verubecestat, Solanezumab targets plaque rather than beta secretase enzyme. This brings in disappointment not only for the patients but also for the researchers. The evidence suggests that once the disease has advanced and patients have established dementia, the removal of amyloid plaque might not yield effective outcome.

                              Do we have a pill to cure Alzheimer’s? Some quick facts:

  • Alzheimer’s is an irreversible brain disorder causing cognitive impairment
  • More than 5 million Americans are expected to suffer from Alzheimer’s
  • Sixth leading cause of death in the USA
  • No new drug has been introduced to provide symptomatic relief or to halt its progression since last decade

Picture source: https://unsplash.com/search/brain?photo=rmWtVQN5RzU

There are couple of drugs at various stages of trial that are being tested under the amyloid plaque hypothesis. These drugs either act on the plaque or beta secretase enzyme (BACE inhibitor) or available as amyloid immunotherapy. These candidate drugs are from Biogen, AstraZeneca, Eli Lilly, Amgen and Novartis. Apart from BACE inhibitors, hopes are also high for Axovant’s intepirdine. Intepirdine is believed to improve cognitive symptoms by targeting receptor 5-HT6 that stimulates the release of a neurotransmitter. Interestingly, intepirdine was abandoned by GSK in 2010. The drug failed when compared to placebo. However, one study showed tangible effect on cognitive symptom when intepirdine was paired with the approved Alzheimer’s drug Aricept.

MedNess: Merck’s stock suffered severe blow after the announcement of cessation of clinical trial. On the contrary, shares of Eli Lilly, AstraZeneca, Biogen and Roche, the fellow Alzheimer’s drug makers, increased. (Fierce Biotech, Business Insider, STAT news, The Boston Globe)

Axovant’s nelotanserin passes phase 2 study for Lewy body dementia

Axovant Sciences declared successful completion of phase 2 study of nelotanserin. The company is now setting its foot forward for phase 3 study that is expected to initiate later this year. Axovant Sciences reported preliminary results from the first small group of 11 patients.

Lewy body dementia or LBD is the second most common form of dementia. The hallmark characteristic of this form of dementia is the build up of abnormal proteins i.e. Lewy bodies thus affecting cognition, movement, behavior and alertness.

The study included patients with either LBD or Parkinson’s disease dementia. These patients experienced frequent hallucinations as assessed by mini mental state examination (Pharmaceutical Business Review)

CRISPR battle of patents: The Broad institute and MIT wins!

The scientists who first demonstrated the use of most powerful gene editing technology in biotech suffered a major blow on Wednesday, February 15, 2017, in their fight to gain exclusive rights on their invention. CRISPR gene editing system has revolutionized the field of biotechnology enabling scientists to make changes in DNA. Jennifer Doudna, a UC Berkely biochemist and her European collaborator Emmanuelle Charpentier first published this gene editing technology in prokaryotic system (type of bacterial system) in 2012 in Science. UC Berkely and University of Vienna filed for U.S. patent in March 2013. There were 155 broad claims to the CRISPR-Cas9 technology. Feng Zhang, a biologist at the Broad Institute, demonstrated the use of this technology in eukaryotic cells (type of plant cells, animal cells and human cells). The Broad Institute filed their patent in 2013; months after Berkeley group filed their patent. Since the patent claims by Broad Institute were fewer than Berkeley’s, the Broad Institute’s patent was issued on April 15 2014 through accelerated approval while Berkeley group is still awaiting their approval. After the Broad Institute was granted their patent, UC Berkeley filed an interference claiming that the Broad Institute should not have been granted the patent since Doudna’s and Charpentier’s CRISPR research outlined in 2012 paved the way for Zhang’s research in eukaryotic system. The Broad Institute argued that the research was not obvious and the patent claims from both the institutes were different. The federal Patent Trial and Appeal Board ruled out UC Berkeley’s claims and sided with the Broad Institute. With this decision, UC Berkeley plans to move forward with their patent application, which if approved, will provide them right on the use of CRISPR on all cells. This would also mean that if the technology will be employed commercially, the companies would have to get licenses from both the Broad and the Berkeley group.

MedNess: The patent decision in the favor of the Broad institute increased the stocks of Editas Medicine by 30%. Editas Medicine licenses Broad’s patents for human genetic disorders. (Fierce Biotech, STAT News, The LA Times, NPR, Wired)

Are pharmaceutical industries in favor of Trump’s FDA pick? The story so far….

Donald Trump is pushing deregulation of FDA in order to accelerate the drug approval process. His ideology: drug costs are higher, drug approval process through FDA takes forever, drug companies are involved in “unfair foreign trade”, drugs should be manufactured in the USA and finally, drug companies should add the innovation factor for the better cure of the diseases. This recipe will work in favor of patients to bring the overall drug costs down and patients can have quicker access to the newer agents. Not to forget, drug manufacturing in the USA brings back jobs and the “fair trade” promotes revenue generation. This all sounds good, except, the pharmaceutical industries have opposing views. The most common complaint of every patient and every healthcare researcher is the never-ending drug approval process by the FDA. So suddenly, when we might be able to overcome this hurdle, why is everyone (read the researchers, pharmaceutical companies and informed patients) so anxious? The truth is bitter sweet. Even though we rant over the FDA, we still knew, the FDA has best interests at heart and such a tight screen is probably important for the safety of the patients. In addition, a 2011, study found that the FDA usually approves cancer drugs before Europe does. Moreover, the researchers at Yale found the FDA’s drug review is at least a month faster than Europe’s or Canada’s.

The pharmaceutical industries on the other hand are concerned about the high drug costs. In addition to the limited patient safety, deregulation in the FDA might not provide enough time for pharmaceutical companies to justify high costs of the drugs to patients and to insurance companies. The pharmaceutical companies will not be able to account for high costs of the drugs owing the limited safety and efficacy analysis that ultimately affects both the patients and the companies. President Trump said last month he has a “fantastic person” lined up for the role of the FDA commissioner. A survey conducted by Mizuho Securities of drug company executives indicated that 72 percent agreed Scot Gottlieb should be Trump’s pick to head the FDA. Until then, we all wait! (Reuters, The New York Times, Forbes)

 

              

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