Posts Tagged entrepreneurs
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on January 12, 2018
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.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on November 20, 2014
Recently, Karl Handelsman, Founder, Codon Capital, talked about the Lean LaunchPad Entrepreneurship program, at www.bio2devicegroup.org event. Handelsman, with Allan May (Managing Director at Life Science Angels), are instructors in the Lean LaunchPad for Life Sciences program at UCSF and also will be teaching at NIH, in the future. Handelsman is the Therapeutics cohort and May is the Medical Device cohort.
It is a mistake to assume that pre-clinical programs are risky and they need to focus on easier low hanging fruit or they must take 10+ years and a billion dollars to create value, said Handelsman. We have a duty to search for the path to unlock the value of the idea as industrially relevant innovation, and there are examples of biotech startups reaching that point in 18-30 months, said Handelsman. Lean LaunchPad program teaches scientists and clinicians in startups to do a real world assessment of their idea or technology, before plunking down millions of dollars, in an idea. Entrepreneurs receive training in determining their product’s market viability, regulatory risk, potential clinical utility, and also likely financing vehicles before making big dollar investments in research, design, and manufacturing.
Entrepreneurs need good operational models that build a context of value creation, said Handelsman. Investors like value, not milestones. “Investors want to invest money and they want to hear a business case, and operational milestones don’t get you there”, stressed Handelsman.
Big things often have small beginnings and start with contributions from many small pockets. Sharing the case of a company that started with collaboration and became the behemoth, Genentech, Handelsman said, entrepreneurs need to start thinking about collaboration, not competition, and begin to look at models of collaboration that would create true value. After all, strategic alliances built the Silicon Valley and there are many diverse and creative ways of creating partnerships. Entrepreneurs need to talk with others and be really good listeners.
Successful entrepreneurs are not thoughtless risk takers, but approach problems in a disciplined way. Value creation for therapeutics begins with thoughtful consideration of who would benefit from solving a certain problem; patients, payers, insurances companies or any other entity? Once entrepreneurs can figure that out, they can go to a VC and explain the business case. Value creation, after all, is not what entrepreneurs think or believe, but an idea or concept that gets external validation from the customer. “Do not constantly worry about keeping the concept in the stealth mode, and talk to a lot of people”, advised Handelsman. VCs do not count, they are not potential customers. In the end, one could have a sexy product, but if it does not solve a pressing problem then it is not creating value. Real answers to key commercialization questions, in the case of therapeutics, lie outside the lab, and entrepreneurs need to actively engage and talk with customers, partners, regulators and so on to figure out the value of their product. Lean LaunchPad methodology therefore, helps to validate the product, before commercial strategy is considered, saving time, money, resources and in some cases, helping guide the change in the trajectory, for more meaningful outcome.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on March 23, 2014
Dr. Akhil Saklecha, General Partner at Artiman Ventures talked about understanding the challenges of physician adoption of new technologies and discussed ways of overcoming resistance and enable adoption of new medical and heatlhcare technologies by physicians, at www.bio2devicegroup.org event. (See below, at the end of the article, more info on bio2devicegroup, EPPICon, TiEcon, & HTF conf.)
Entrepreneurs in the health technology sector, must first understand physicians, the environment they work in, and the nature of the work flow. Physicians have to be patient advocates, they often control the purse strings and make decisions on allocation of scare resources, and there is a potential to impact their adoption of new technologies by exercising influence upon them. Physicians generally have competitive, type A personalities and they do not want to lag behind in adoption of useful technologies, said Saklecha.
So what are drivers for adoption of new technologies? Technologies that solve problems that drive doctors crazy, get their attention. Entrepreneurs with “must have” technology, will find it easier to get it adopted. Entrepreneurs must focus on solving their problems, said Saklecha. In addition to understanding physician’s work challenges, it is also important to understand every single stakeholder, in the healthcare setting. For instance, Saklecha said he has seen some GI tools that solve a smaller problem but take up additional time of the scrub technician, general nurse, and GI nurse. All this would add to the expenses and if the technology does not offset the cost, it will be rejected. In fact, there is an early shift towards disposable colonoscopy devices because it saves set up and clean up time.
When it comes to money, “ignore it at your own peril”, said Saklecha. His advice was that entrepreneurs must map out the flow of money, very early on. They should get an understanding of where the revenue is generated and who makes the money and who loses the money. Given the tremendous pressure to save costs, it is extremely important that new technology does not add costs to the system, unless it is a huge value add in terms of quality of health. Entrepreneurs must know the flow of the money, direct and indirect costs and savings and they should understand CPT codes and reimbursement rules. Obtaining CPT code does not necessarily translate into reimbursement, warned Saklecha.
Entrepreneurs must focus on enhancing quality and patient safety, said Saklecha. Quality drives revenues and safety keeps patients alive and providers’ revenues are increasingly tied to performance. A thorough understanding of work flow and how it impacts all various service providers including nurses, physicians, clerks etc. is very important.
One of the valuable advice Saklecha gave was with regard to timing and specific point of insertion of new technology. Find a point of least friction for insertion of new techology, said Saklecha. With regards to timing, it is important to keep in mind that no benefits will be seen during the first month, and instead there may be adverse effects. Most inefficiencies will dissipate in the following 3-6 months and only then will the benefits begin to appear. So this may be a time to keenly observe and understand the impact and every little nuance of the new technology on the work flow. In the past decade, electronic medical records or EMR has been all the rage. However, data entry and management takes physicians’ time away from patient care. This is a challenge that is not yet effectively tackled, said Saklecha. Voice recognition and scribes are used but the both have challenges of cost and errors.
Saklecha gave examples of several medical technologies and how they overcame physician adoption challenge by solving their key pressure point. For instance, iRhythm cardiac monitoring device allows for remote monitoring of minimally “at risk” patients and it enables ER doctors to read the data and generate revenues. Insurance companies also like it because instead of sending the patients over for hospital stays, they can be sent home and patients enjoy the convenience. Minimally invasive blood test offered by Cardio Dx replaces cardiac stress test and it was a great improvement in saving costs. The company directly marketed it to primary care physicians. However, they misjudged and found that these doctors were slow to adopt because they were looking for validation from the cardiologists. That was an important lesson in physician adoption of new technologies. Now the company has pivoted and changed their marketing strategy and they are finding traction.
Another example is GI Dynamics which has a medical device that targets obesity. Bariatric surgery is complex and there is high morbidity population. The company has a fairly simple procedure that was found to simultaneously solve issues around hypertension and diabetes, while treating obesity. GI physicians loved the technology since it offered them a whole new class of patients. Just like GI physicians, cardiologists are also a competitive and procedure driven specialty, and they are quickly adopting new technologies in cardiac stents and percutaneous valves. The talk was highly interactive and generated lot of discussion.
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Please mark 3 great conferences focused on life science, medtech, & healthcare, in the next two months, in San Francisco Bay Area, on your calendar, & see info on life science networking group that meets every week.
www.eppicglobal.org EPPICon annual conference is on March, 29, at Westin, SF and it features a panel on “Neglected & Rare Diseases” http://bit.ly/1c1vvTR, on “Point of Care”, on “Innovations in Clinical Development of Novel Agents” and more. Excellent event to network with VCs, panelists, speakers & other professionals.
www.tiecon.org is on May 16 & 17 at Santa Clara Convention Center. On day 2, May 17th, it will feature a Life Science track with keynote and a distinguished panel on “Disruptions in Healthcare”. Great to network with entrepreneurs working inside and on the boundaries of various disciplines.
www.healthtechnologyforum.com annual conference is on May, 20 at Parc 55, Wyndham, SF and it has excellent lineup of speakers and panels with a broad focus on “pathways to sustainable health”. More specific panels will focus on patient engagement, medical ethics, IoT, health apps, building resilient communities and more. Excellent to network with physicians, non profits & other entrepreneurs.
www.bio2devicegroup.org meets every Tuesday & covers a broad range of topics pertaining to biotech, medical device and pharmaceutical industries. On Tuesday, March 22, at 8:30am Johannes Schweizer, Arbor Vita will talk on OncoE6™ Cervical Test that Predicts Development of Cervical Cancer www.bio2devicegroup.org – Free event, all are welcome. Become a member and network with diverse range of life science industry professionals.
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on February 5, 2014
Mahendra Shah, Partner with Vivo Ventures & Ravi Mistry, President of EPPICGLOBAL (www.eppicglobal.org) talked about how to take a biotech company from idea to launch, at www.bio2devicegroup.org event. Here is some of the comments made by Shah and Mistry.
Entrepreneurs starting a biotech company must start with a disease target, said Shah. First and foremost there should have a good understanding of the disease and at which stage in the disease progression is the biotech seeking to interfere. Second, one should have a good understanding of the market opportunity and about existing treatments. Entrepreneurs need to ask the hard question regarding “clinical meaningfulness”; and whether or not the possible treatment developed by the biotech will lead to significant enhancement in patient care. Payers will not pay for little improvements, said Shah. Companies need to identify gaps in the treatment, and find a niche market. Patients need to be identified for who the prescribed treatments do not work well and that could be a niche market for entrepreneurs, said Shah. Shah said that during his career, he found such niche markets through repurposing, taking old drugs and finding new indications. He also cautioned about the importance of ensuring secure Intellectual Property to protect the proposed solution. With currently available internet tools and database resources, that is not hard to do. Even speed browsing on Google can give you a quick idea of who owns the IP and if there are ways to get around it, said Shah. Biotechs based on developing Orphan drugs are a great opportunity for a new startup, because once approved, you cannot have competition for up to 7 years in the US, and up to 10 years in Europe.
In terms of drug development, one needs to also get clarity on development pathway to determine whether it will require 10 thousand patients or few hundred, since that can make a huge difference in the amount of financial capital that will be required to bring the product to market. Companies need to identify how quickly one can progress to phase 2 and bring it to a meaningful endpoint. Also it is important to get an understanding if the endpoint is subjective or objective. A subjective endpoint will have significant placebo effect and will require much higher number of patients, said Shah. In order to do successful fund raising, companies need to have approximate idea of time and costs of bringing the product opportunity to a meaningful endpoint. Companies also need to have clarity on the various product development milestones and inflection points. Finally, an experienced Team is extremely important to bring the idea to fruition. However in this, two members of the team are particularly important; the CEO and the Medical Director. Other members of the management team can be hired as consultants but these two team members of the team need to be identified early and brought on board and should be people one can trust and those who feel passionate about the technology and who buy into it.
A biotechnology company requires significant money for its operations, so it is important to make sure that the first time investors have deep pockets, very sane advice from Shah. He told the budding entrepreneurs to be careful and make sure they have synergy with the investors. “Some of the investors’ money is not good, it will give you ulcers”, warned Shah, since money can have many strings attached to its return on investment. Referring to reimbursement, Shah emphasized that the payer is very important and entrepreneurs should do a quick survey of physicians and Key Opinion and Thought Leaders and get a clear idea about existing and current modes of treatment and who will be paying for the new product opportunity.
Mistry shared some statistics on activity in the life science space. 2013 has been a banner year for life science IPOs. Out of a total of 82 total IPOs in 2013, 46 were in the life science industry. Life science industry also enjoyed a substantial investment of dollars. The increase was certainly more significant in biotechnology, while medical device industry actually saw fewer dollars invested. Mistry talked about how to prepare for an M&A exit and provided some advice to entrepreneurs to keep diligent documentation with respect to company’s IP. He also commented that when it comes to negotiation, there is no “one size fits all” and best deals can be made if entrepreneurs remain can remain flexible throughout the process.
At the start of the talk Mistry put in a plug for EPPICGlobal and their upcoming annual conference, on March 29, 2014. The conference has an exciting lineup of speakers and panels addressing neglected and rare diseases, point of care diagnostics, and innovations in clinical development of novel agents. The talk ended with Shah sharing information on exciting speed pitch session, at the EPPIC conference, where entrepreneurs will have an opportunity to pitch their company to a panel of VCs and receive real-time feedback.
I would encourage my readers to attend the EPPICon 2014 conference, and avail of the opportunity to listen to various industry renowned speakers. To register for the conference and/or register for the speed pitch, please go to www.eppicglobal.org.