દ્રષ્ટિકોણ 102: એન્ટિબાયોટિક દવાની મહત્વપૂર્ણ શોધ અને તેનો ગેરઉપયોગ

મિત્રો, શનિવારે પ્રકાશિત થતી દ્રષ્ટિકોણ કોલમ ઉપર હું દર્શના વારિયા નાડકર્ણી તમોને આવકારું છું. અત્યારે કોરોનાવાઈરસ ખુબ ચર્ચાઈ રહ્યું છે ત્યારે આપણે એન્ટિબાયોટિક દવા ઉપર થોડી ચર્ચા કરીએ। સૌથી પહેલા તો એ કે કોઈ પણ વાઇરસ ઉપર એન્ટિબાયોટિક દવા કામ કરતી નથી. એન્ટિબાયોટિક દવા માત્ર બેકટેરિયા ઉપર કામ કરે છે. તેથી જ એન્ટિબાયોટિક્સ ને એન્ટિબેકટીરિઅલ તરીકે પણ ઓળખાય છે કેમ કે તે ખાસ બેકટીરિયા ઉપર કામ કરે છે. આ શક્તિશાળી દવાઓ શરીર ના ખરાબ બેકટીરિયા નો નાશ કરે છે અને બેકટીરિયા દ્વારા શરીર માં થતા રોગો ઉપર કાબુ લાવે છે. વાઇરસ થી થતા રોગો (જેમકે શરદી, ઘણી જાતની ઉધરસ અને ફલૂ) ઉપર એન્ટિબાયોટિક્સ કામ નથી કરતી।

એલેક્ષાંડર ફ્લેમિંગ નામના વૈજ્ઞાનિકે પહેલ વહેલી પેનિસિલિન નામના એન્ટિબાયોટિક ની શોધ 1928 માં કરી. દાક્તરી ભણ્યા પછી સ્ટેફીલોકોક્સ નામના બેકટીરિયા ઉપર કામ કરતા ફ્લેમિંગે નોંધ કરી કે એક વાર કોઈક ફૂગ વળવાથી પેટ્રી ડીશ માં ના બેકટીરિયા નો નાશ થયો. બીજા કોઈ હોય તો કામ બગડી ગયા નો અફસોસ કરે અને વધુ સાફ કરીને કામ શરુ કરે. પણ ફ્લેમિંગે આ ફૂગ બીજા બેકટીરિયા ની ડીશ ઉપર લગાડી અને તેમાં પણ બેકટીરિયા નો નાશ થયો. તેણે ત્યાર બાદ કરેલું કે બીજા દિવસે તે ઉઠ્યા ત્યારે તેણે એમ તો વિચારેલ જ નહિ કે બેકટીરિયા જે શરીર માટે કાતિલ બને છે તેને નાશ કરવાની દવાની તે શોધ તે ખુદ કરશે. પણ થયું તેવું જ. તેણે આ ફૂગ ને નામ આપ્યું પેનિસિલિન જીનસ।

બીજા વિશ્વયુદ્ધ દરમ્યાન ફ્લેમિંગ ના વિદ્યાર્થીઓ એ આ દવાનું સામુહિક ઉત્પાદન શરુ કર્યું। અને 1945 માં ફ્લેમિંગ ને આ શોધ માટે નોબેલ પ્રાઈઝ આપવામાં આવી. ટાઈમ મેગેઝીને તેને 20મી સદીના સૌથી મહત્વપૂર્ણ માણસ નું બિરુદ આપ્યું અને તેને 30 હોનારરી ડિગ્રીઓ અને કેટલાય ઇનામો આપવામાં આવ્યા છે. તે પછી તો બીજા ઘણા વૈજ્ઞાનિકોએ બીજા ઘણા એન્ટિબાયોટિક્સ જે જુદા જુદા બેકટીરિયા ઉપર અસર કરે છે તેની શોધ કરી છે.

હું નાની હતી ત્યારે મને ઘણી વખત ગળા માં દુખાવો થતો અને ડોક્ટર એન્ટિબાયોટિક નું પ્રિસ્ક્રિપશન આપતા. તે વિષે વધુ વાતો કરતા પહેલા કહીશ કે, એન્ટિબાયોટિક ની શોધ થતા પહેલા તેવા નાના નાના રોગ માં કેટલાયે બાળકો નાની ઉમર માં જ ખલાસ થઇ જતા. 20મી સદી ની શરૂઆત પહેલા ચેપી રોગો બાળકોના અને વૃધ્ધોના મૃત્યુ માટે જવાબદાર ગણાતા। સરેરાશ આયુષ્ય તે સમયે 47 આસપાસ હતું અને વધુ ગંદકી વાળી રહેવાની જગ્યાઓમાં ખુબજ ઓછું સરેરાશ આયુષ્ય હતું। પરંતુ ફ્લેમિંગ ના સંશોધન પછી તે વાસ્તવિકતા બદલાય ગઈ. ધીમે ધીમે અમેરિકા જેવા દેશોમાં સરેરાશ આયુષ્ય 80 ને પહોંચવા આવ્યું અને ચેપી રોગોથી મરવાને બદલે બિન ચેપી રોગો દ્વારા મૃત્યુ થવાનો દર વધી ગયો.

મેં આગળ કહ્યું તે પ્રમાણે હું સમજી ગઈ હતી કે મને ગાળામાં દુખાવો થાય ત્યારે મને એન્ટિબાયોટિક લેવાની જરૂર પડે છે. તે પછી તો મેં ડોક્ટર પાસે જવાનુંજ છોડી દીધું। ઘરમાં મારી મમ્મીને પણ કહેતી નહિ. ગાળામાં દુખે એટલે નીચે ચાલીને હું એન્ટિબાયોટિક ની બે ચાર ગોળી લઇ લેતી અને સારું લાગે એટલે લેવાનું બંધ. અજ્ઞાનતા માં રહીને આ રીતે એન્ટિબાયોટિક રેઝિસ્ટન્સ વધારીને મેં મારા શરીરને જ અતિશય નુકશાન નથી પહોચાડ્યું પરંતુ તે સાથે સાથે દુનિયાભર માં નુકશાન કર્યું છે અને ઘણા લોકોએ અજ્ઞાનતામાં રહીને જે રીતે આવા શક્તિશાળી એન્ટિબાયોટિક્સ નો ગેર ઉપયોગ કર્યો છે તેથી દુનિયાભરમાં મોટી સમસ્યા ઉપસ્થિત થઇ રહી છે. તે એન્ટિબાયોટિક રેઝિસ્ટન્સ વિષે અને સેપ્સિસ વિષે આવતા અઠવાડિયાઓ માં વધુ વાતો કરીશું।

મારો બ્લોગ ગમે તો 3200 વ્યક્તિઓ જોડે તમે પણ ફોલો કરી શકો છો અથવા બ્લોગ ની નીચે લાઈક નું બટન પ્રેસ કરો અથવા બ્લોગ ની ઉપર 5 સ્ટાર લાઈટ થયા પછી પ્રેસ કરીને બ્લોગ ને 5 સ્ટાર રેટિંગ આપી શકો છો. તમારી કોમેન્ટ પણ જરૂર મુકશો. હું બધીજ કોમેન્ટ્સ ખુશી થી વાંચું છું.

Speedy identification of pathogens: Reduces sepsis, saves lives, cost & lowers antibiotic resistance problem

At a recent Bio2DeviceGroup (www.bio2devicegroup.org) event, Kevin Hacker, CEO of BioAffinity Sciences talked about their new technology that when fully developed will identify pathogens more than 100 times faster than the traditional blood culture and related technologies currently in use.

Sepsis Problem

Every year, in the US, 500 thousand people die due to sepsis related complications. Sepsis is a final common pathway for many infections, particularly when an individual’s immunity is low. Body normally releases chemicals into the bloodstream to fight an infection. When the body’s response to these chemicals is out of balance, it results in Sepsis. That is when body’s immune system launches a massive counter attack that harms body’s own tissues and organs. The triggering changes begin to damage body’s vital organ systems that results in dramatic drop in the blood pressure, ultimately leading to death.

Sepsis and septic shock are more common if the individual is very young or very old, have a compromised immune system, have diabetes or cirrhosis, is already sick and frequently in a hospital intensive care unit, have wounds or injuries or severe burns, have invasive devices inserted into the body, and have previously received antibiotics or corticosteroids. Often people can recover from mild sepsis. However, if the body goes into septic shock, the average mortality rate for septic shock is about 40%. Additionally, an episode of severe sepsis may place a person at higher risk of future infections.

Given that widespread infections can progress to Sepsis and Sepsis shock in a matter of few hours, it is imperative that such infections be treated immediately with antibiotics. When given the right antibiotics, there is often a dramatic improvement and speed of cure.

Problem with speedy identification of pathogens

Given that early treatment of sepsis is associated with vastly improved outcomes, rapid diagnosis is essential. However blood culture work is slow and often takes 1-3 days. The diagnosis of sepsis in critically ill patients, housed in hospitals is also challenging because it can be complicated by the presence of inflammation resulting from other underlying diseases and from prior use of antibiotics, making cultures negative. Most testing is done through mass spectrometry that gives mass to charge ratio of ions. Since culture-dependent diagnosis of infection is slow, sometimes patients are given antibiotics, before the results of the culture are available. Patients are given broad spectrum antibiotics and 40% are not effective. In such instances, antibiotics are withdrawn after one cycle of treatment, when the cause of the illness is found to be something else and this can lead to antibiotic resistance.

Bioaffinity Sciences solution will be able to identify pathogens within 10 minutes, 430 fold faster than blood culture. This is cell affinity based, low cost technology. Pathogens are run through microchannels comprising of a surface- grafted scaffold of reactive polymer onto which affinity molecules (sugars, aptamers, vancomycin, and methicillin) have been bio-conjugated. High capacity of the channels allows low numbers of microbes to be quickly identified. The unknown pathogen’s pattern of binding to the channels is recorded, and this pattern is compared to a library of known pathogens. When a match is made, the identity of the pathogen is reported. In addition to speed, this is also more sensitive in terms of the number of different pathogens detected than blood culture.

Disease burden to the healthcare system in the US due to Sepsis

Sepsis management is a major challenge and results in disproportionately high burden in terms of hospital utilization. The average length of stay for sepsis patients in the US is approximately 75% greater than for other conditions. The cost of sepsis management ranks highest among hospital admissions for all disease states. The cost is estimated to be between $25 billion and $27 billion, and represents 13% of total US hospital costs.

Considering that poor sepsis outcomes are directly tied to the delay in diagnosis and treatment, such a dramatic improvement in speed and accuracy of diagnosis leading to speedy and accurate treatment can not only dramatically improve outcome and quality of patient care but also significantly reduce cost of care for hospitals.

The talk was followed by Q&A.

 

Life Sciences Industry Outlook for 2018: Post BiotechShowcase & JPM

JPM 2018 and concurrent events just ended with what may be one of its biggest draws.  As many as 10,000 people from life science industry and its related sectors are likely to have descended upon the city, during last four days.  In addition to JPM event itself, everything health was under review and up for discussion at various conferences including at EBD Group & Demy Colten’s #BiotechShowcase #DigitalMedicine #BTS18 and #WuXiGlobalForum2018 . Networking and deal making continued late in the nights at various receptions held across the city. Receptions by legal firms like #WilsonSonsini #MoFoLLP #ReedSmithLLP attracted some of the biggest crowds.

Overall the tone for 2018, seemed highly optimistic.  BiotechShowcase held a media roundup and echoes of optimism were heard from almost all panelists @barbara_ryan12 @TriangleInsight @CarolineYLChen @adamfeuerstein @statnews @SFBIZronleuty @BrittanyMeiling @endpts @juliet_preston @medcitynews @ldtimmerman .

There is a general agreement that the pace of #innovation in biotech greatly accelerated in 2017 and is likely to continue. According to Luke Timmeerman, “sheer velocity of news in healthtech innovation is fascinating”. Transformative therapies across huge and diverse range of diseases are increasingly focusing on cures and going beyond the short term treatment focus. The surge of innovation has been led by focus on oncology although concern was also raised in one of the panels that we still continue to get stymied and realize how friggin smart the disease of cancer is and if we will truly crack the code on cancer in the immediate upcoming years. All signs are however, that next year we may see critical data from some clinical trials in immuno-oncology space that can cause market spikes.

Here are some areas of concern raised in some of the panels. In 2017, a slight dip was observed in the areas of orphan and rare diseases. Also there seemed to be a general consensus that we need smart policies that incentivize new anti microbial drugs and other treatments for infectious diseases. Due to increasing resistance of antibiotics, there is an ongoing and real fear for some of the infectious diseases to turn into pandemics. These are areas that bold entrepreneurs may focus on. Also medical devices continues to remain somewhat underfunded. Discussions around accelerating healthcare costs and drug pricing issues creeped over into many panels. Entrepreneurs with disruptive pricing innovation in product development as well as healthcare can easily have a tremendous leverage. It can’t be overstressed that finding effective pricing solutions holds key to continued and sustainable growth in healthcare sector.

Discussion in one of the panels focused for a few minutes around large investments in life sciences and if that indicated a healthtech bubble that may be due for a crash.  Indeed, some experts observed that pace of 2017 is unlikely to continue and there may well be a slight dip in 2018. But overall the consensus seemed to be, that a steep and deep pipeline of innovation in R&D is likely to prevent a crash, and the venture funding blizzard is likely to continue. Overall, the feeling among investors and healthcare experts was that among the industry, there is a strong focus on science and people are pursuing innovation with discipline that will ensure unprecedented mechanisms and novel medicines. All this activity is taking healthcare to a new level of cures and sustainability and stability from temporary treatment focus. Exciting indeed to be living in this era of amazing healthcare innovation.

 

 

Biotech Showcase 2018 Preview: What it will mean to be living in the era of cures & more VC money

Lunch plenary sessions are always a huge draw at Biotech Showcase and are very exciting. On day one, a panel moderated by Sara Radcliff from CLSA will take a 60,000 feet view and will discuss what the future holds for biotechnology and life science sector. Biotechnology is increasingly going beyond treatment to focusing on cures. Day 2 panel moderated by Alice Valder Curran from Hogan Lovells with Eric Aguiar from Aisling, Philippe Lopes-Fernandes from Merck and Camille Samuels from Venrock will discuss “what it means to be in the era of cures”. The panel will discuss how public and private markets are still catching up with new policies on coverage, pricing, and liability issues, making it even more challenging to decide what product candidates to pursue.  Lunch panel on day 3 moderated by Ellen Corenswet from Covington & Burling LLP and populated by prominent VCs and industry experts will reflect on 2017 surge of venture capital.

Besides all day information packed sessions focused on key diseases that are getting attention http://bit.ly/2pA45B7 , there are interesting panels and sessions on treatment modalities that are the garnering attention of investors and entrepreneurs http://bit.ly/2CjET4G .  And then there will be panels discussing investment in healthcare, what to expect in 2018 from investment perspective and what are likely to be new drivers of innovation in drug development, and new targets, new trends and new combinations in treatment.

Besides three action packed days, the evenings will be packed with countless receptions and networking will continue late into the night. Concurrent 36th annual J P Morgan Healthcare Conference is expecting 400+ public and private companies to deliver presentations to over 8000 attendees. San Francisco will be taken over by everything health for three days, from January 8th through 10th, 2018.  

While JPM conference is by invitation only event, registration is open for Biotech Showcase at conferences@ebdgroup.com or at https://ebdgroup.knect365.com/biotech-showcase/agenda/1

 

Biotech Showcase 2018 Preview: Treatment focus on microbiome, regenerative medicine, gene & immuno therapies

Biotech Showcase taking place concurrently with the J P Morgan event in San Francisco, will host more than 3,500 attendees and 900+ investors. This event considered to be a critical strategic benchmark for business development activities in biotech, medtech, pharma and digital health, is regarded as among the year’s most important investor meeting place and sets the tone for financial health in these sectors, for the coming year.  Speakers and attendees at Biotech Showcase, will participate, network and listen to over 400 company presentations. Over 2,100 companies from 50+ countries will participate.  Besides 7000+ one on one meetings, general sessions will focus on a number of topics that are significantly expected to impact the healthcare arena. Here are some of the treatment modalities that are getting interest from both investors and entrepreneurs.

A panel moderated by Joseph Gulfo, Executive Director at Lewis Center for healthcare innovation and technology with Thomas Hallam, CEO of Leading Biosciences, Arpita Maiti, Senior Director, ES&I at Pfizer, Glenn Nedwin, CEO of Second Genome, will start day one. Microbiome refers to internal ecosystem of bacteria, widely believed to be residing in the gut. By some researchers estimates, over 90% of all diseases can be traced to the gut and health of the microbiome. However, new research on lung, skin, inflammation, immunology, and neuro microbiome is bringing together experts in neuroscience, gastroenterology, microbiology and more to unlock even larger role that microbiota plays in interacting with itself and its human host, in understanding disease and health and better understand possible treatment modalities.

A panel moderated by Janet Lambert, CEO at Alliance for Regenerative Medicine will discuss next gen cell based immunotherapies with panelists Robert Preti from Hitachi, Bob Azelby from Juno Therapeutics, Manuel Litchman from Mustang Bio, James Noble from Adaptimmunie, Pascal Touchon from Novartis and Scott Walchko from Fate Therapeutics.  Immunotherapies use body’s immune system’s natural capacity to detect and destroy abnormal cells. Immmunotherapies have generated great deal of interest, specifically for treatment of cancers because these regimens present fewer side effects and have less potential for creating resistance when treating microbial diseases.

Gene therapies using genes to treat or prevent diseases, indicate promising though yet risky treatment options. What does the future hold for gene therapies, specially beyond rare diseases?  Bill Lundberg from CRISPR and Geoff Nichol from Biomarin will discuss outlook for gene therapies.  

PS: Here is link to my earlier blog on disease areas that will generate interest and renewed attention in some of the panels http://bit.ly/2pA45B7 . Registration is open for Biotech Showcase at conferences@ebdgroup.com or at https://ebdgroup.knect365.com/biotech-showcase/agenda/1