Advocate

We advocate for sound public policies designed to improve the business environment for biotech companies by encouraging investment in innovation and ensuring that legislation and regulation focus on timely, science-based, and patient-focused outcomes.

Issues

2017 New York State Policy Agenda

As the only statewide association in New York dedicated solely to the issues of the bioscience industry, NewYorkBIO urges legislators to support the industry by focusing on issues that will create a better business climate that will allow companies at all stages of development to grow and succeed. NewYorkBIO is committed to policies that ensure patient access to the innovative therapies, devices and diagnostics that are being developed by the many bioscience companies across New York.

TOP PRIORITIES

1) Oppose Efforts to Mandate Price Controls On Biopharmaceutical Products

NewYorkBIO strongly opposes Part D of the Health and Mental Hygiene Article VII budget proposal.  This proposal would allow the state to impose draconian price controls on all pharmaceuticals sold in New York and thereby disincentivize innovative drug makers from offering their products in the New York market. Most importantly, it would stifle the development of innovative therapies that target some of the most challenging and debilitating diseases in our lifetime.   Unfortunately, this proposal represents one of the most aggressive interventions into the functioning of the bioscience industry.  Ironically, the State of New York stands to lose the most from such a proposal because it has one of the largest bioscience sectors in the country.  It would be akin to the State of Iowa passing legislation that would harm the corn industry nationwide.

CLICK HERE TO DOWNLOAD THE MEMO IN OPPOSITION

2) Support Gov. Cuomo’s New York Life Science Initiative

NewYorkBIO welcomes the Governor’s support for the life sciences, and since the announcement of this initiative has solicited feedback from our membership regarding how the various provisions within the proposal would affect our ability to research, develop, and commercialize life-saving technologies in the Empire State.

CLICK HERE TO DOWNLOAD THE MEMO IN SUPPORT

3) Support Smart Biosimilar Legislation Promoting Patient Safety

NewYorkBIO believes that a sound policy in New York outlining parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to high-quality, safe, and effective biologic medicines. NewYorkBIO’s core concerns are to safeguard patient safety and the primacy of the physician-patient relationship, recognizing that treating physicians and their patients are in the best position to determine appropriate therapies. We believe that the FDA will develop appropriate standards for the approval of safe biosimilar and interchangeable biologic products in order to best protect patient safety. To ensure transparency and communication between patients and their treatment teams, however, NewYorkBIO also believes that certain safeguards should guide substitution policies for interchangeable biologics under state law as well.

4) Protect Patient Safety and Foster Access to Innovative Therapeutics and Devices

Patients in the U.S. are offered the latest and best medicines because our national policies have fostered innovation and ensured that patients can benefit from this innovation. This is not the case in many countries. It is important that New York reflect this commitment to innovation by ensuring that State programs and policies do not unduly limit a patient’s ability to receive, in consultation with their doctors, the best therapies and devices for him or her.  For instance, NewYorkBIO supports legislation that would set forth parameters regarding the safe substitution of interchangeable biologics.

5) Support Full Funding of Innovation Investment Fund

Several years ago, New York created a state-sponsored fund to make monies available to selected investment entities to increase the amount of seed stage investment capital available to high technology small businesses in New York.  We urge full funding and continued support of this strategic program.  Moreover, New York should look for other ways to encourage investment in pre-commercialization-phase startup companies in New York.

6) Maintain a Supportive Regulatory Environment in New York State

In order to maintain leadership as a location for the bioscience industry to flourish, NewYorkBIO recommends that the Legislature refrain from passing legislation that adds unduly burdensome regulation to the bioscience industry.  In particular, we oppose state regulation of matters that are ultimately governed by an existing federal regulatory structure.  Moreover, NewYorkBIO opposes measures that inhibit the ability of researchers to perform clinical trials in the state, restrict marketing, or proscribe continuing medical education programming.  Similarly, NewYorkBIO opposes price controls or similar measures, and supports fair reimbursement rates for drugs and devices that are the result of bioscience research. NewYorkBIO also opposes any weakening or elimination of drug re-importation laws.

Price Controls

Link to New York State Price Controls Proposal 

 

MEMORANDUM OF OPPOSITION TO THE HEALTH AND MENTAL HYGIENE ARTICLE VII BUDGET PROPOSAL S.2007/A.3007, PART D:

“Pharmaceutical-related Medicaid Redesign Team Recommendations”

 

NewYorkBIO strongly opposes Part D of the Health and Mental Hygiene Article VII budget proposal.  This proposal would allow the state to impose draconian price controls on all pharmaceuticals sold in New York and thereby disincentivize innovative drug makers from offering their products in the New York market. Most importantly, it would stifle the development of innovative therapies that target some of the most challenging and debilitating diseases in our lifetime.  

This Proposal Creates an Unprecedented Price Control Scheme in the State of New York

In short, the proposal would allow the Department of Health to arbitrarily force certain biopharmaceutical companies to report trade secrets and proprietary information regarding costs associated with the research, development and production of treatments.  The Department of Health would send that information to a Drug Utilization Review Board, which would then capriciously decide a “fair price” for that treatment.  Any amounts paid over that price would either be reimbursed back to the state (in the case of treatments paid for by Medicaid) or taxed at a confiscatory rate (for treatments paid for in the commercial marketplace).      

This Proposal Could Cripple Bioscience – New York’s Homegrown Industry 

NewYorkBIO brings together over 250 of New York’s bioscience companies, universities, research institutions, and others dedicated to advancing life science research and commercialization.  The New York area is the largest and richest bioscience community in the world:  Among other assets, the region boasts over 60% of Big Pharma national or global HQs; supports more than 75,000 direct biotechnology jobs and has been named Genetic Engineering News’s #1 region in the US to find a biotech job three years running; graduates more life science PhDs than any other region in the US; is home to over 25% of the cancer clinical trials in the US; and lays claim to the world’s largest concentration of academic medical centers.

The State of New York has long supported the bioscience industry, and a significant factor in the development of this sector in New York has been the state’s unwillingness to pass legislation that negatively affects innovation.  Unfortunately, this proposal represents one of the most aggressive interventions into the functioning of the bioscience industry.  Ironically, the State of New York stands to lose the most from such a proposal because, as discussed above, it has one of the largest bioscience sectors in the country.  It would be akin to the State of Iowa passing legislation that would harm the corn industry nationwide.   

    This proposal would be especially burdensome on the engine of biotech innovation – the small emerging companies with few or no marketed products.  These companies must use their limited resources as efficiently as possible to speed the discovery of treatments that can improve the lives of patients, ensure patients maintain access to these therapies once available, and to reinvest in future innovation.  Reporting requirements contained in this proposal would divert scarce resources to accounting and compliance activities that could be better used on developing therapies that patients need.

    Some might argue that the interventions permitted by this proposal would only be used against large biopharmaceutical companies, which could presumably afford the additional expenses associated with compliance.  Such a sentiment is a misunderstanding of how the dynamic bioscience industry operates.  The large publicly traded companies are some of the most significant investors in and partners to the small bioscience research companies that drive growth. Inflicting harmful price controls on those companies will in turn affect how they can invest in the growth of the industry generally.  And again, because New York has one of the most vibrant ecosystems for biomedical innovation, it stands to bear a disproportionate amount of the cost of enacting a proposal such as this. Indeed, in 2016 New York State medical schools alone spun out over 30 new bioscience companies, many of whose research and development was funded at least in part by large biopharmaceutical companies.

 

This Proposal Would Limit Future Patients’ Access to Innovative New Therapies in Return for a Speculative and Meager Cost Savings Today

    Harming the state’s bioscience sector is certainly ill-advised, but tragically, the group most harmed by a proposal such as this are the patients who will face reduced access to innovative treatments.  The U.S. marketplace fosters robust competition, which helps to control costs while allowing for development of innovative new therapies.  This ecosystem allows patients in the U.S. to enjoy more timely and robust access to innovative therapies than patients in countries that employ government-imposed price controls.

    The proceeds from the rebates the State expects to extract from the bioscience industry would not, in turn, be returned by the state to further research or to help patients, but would instead be deposited into a “High Priced Drug Reimbursement Fund.”  Funds collected would be paid out to health insurers and the state Medicaid system.  In other words, the state would do double harm by extracting potential research and innovation investment out of the system in order to redirect it into the state’s Medicaid system or to insurance companies in a fanciful attempt to lower the cost of premiums in New York.  Of course, all of this would have the effect of disincentivizing investors and researchers alike from doing business here.    

    Artificial interventions like price controls have such a devastating impact because the innovation ecosystem for new treatments is relatively fragile.  According to researchers at Tufts, bringing just one drug to market costs nearly $2.6 billion and takes 10-15 years.  In fact, of those rare treatments that proceed to phase-1 human clinical trials, only 12% win approval from the FDA.  Only 2 of every 10 treatments on the market ever earn back enough money to match the costs of research and development and the FDA approval process before their patent expires;  and only 1 in 10 biotech companies ever makes any profit at all. The incremental costs of failed drugs comes to many times the profits from any one successful therapy—these costs are not included in the state’s proposed pricing analysis, and therefore imposing additional costs and setting artificial price controls will only worsen those figures.

    In the past few years, many of the world’s leading research organizations have looked to New York specifically to access the talent, research, and technology being created here: the Pfizer Center for Therapeutic Innovation; the Roche/Genentech Translational Research Center; and the Johnson & Johnson Innovation’s JLABS have all come to access and bring to patients New York technologies. Further, growth companies from Europe and Asia such as France’s Cellectis and China’s WuXi have come here to build research alongside home-grown research companies like Regeneron, Acorda, and Intra-Cellular Therapies—all companies working to bring life-changing therapies to New York patients. And in the past year two years, Versant Ventures and Accelerator Coro, two leading venture capital firms without a previous presence in New York, moved into New York City to invest in early stage development opportunities and have together already launched four new biotechs based on New York technolgoy. Together, this constitutes a wave of innovation that could easily be snuffed out by the state’s pricing controls.

Conclusion

While there is great pressure to respond to passions temporarily inflamed by the recent actions of one or two bad actors in the industry, such sweeping interventions into the marketplace cause much more harm than good.   And as stated above, this proposal would specifically harm New York because we have fostered such a strong bioscience sector in this state.  Indeed, many of the advanced therapies that New Yorker have access to have been discovered at New York academic institutions, commercialized by small New York companies (who take on the full investment weight of bringing these therapies to market), and dispensed by New York doctors and hospitals.  Critically, it is the citizens and patients of New York that most benefit from a healthy, innovative bioscience marketplace. 

It is for these reasons that NewYorkBIO strongly opposes this proposal.  If you have further questions regarding this issue, please contact Joe Tortorice, VP, Operations & Business Development, at joe@newyorkbio.org or 212-433-2623.

Biosimilars

Memorandum in Support A.7509(Gottfried); S.4788(Hannon)

 

Relates to interchangeable biological products

NewYorkBIO strongly supports A.7509 and S.4788, which would establish requirements for pharmacies to substitute and dispense interchangeable biological products.  This legislation updates New York’s laws regarding the substitution of generic drugs to reflect the more complex nature of emerging biologic therapies.  This update is necessary both to allow for the substitution of biologics in New York (which should lead to cost savings for consumers and to provide safeguards for patients to ensure they receive the most efficacious treatment possible.    

Biologics are cutting-edge therapies that are manufactured in a living system (like a plant or animal cell).  Most biologics are very large, complex molecules produced using recombinant DNA technology. These are drugs that target spinal cord injury, kill cancer cells and treat inflammatory diseases; attack Alzheimer’s, diabetes and heart failure; and address genetic disorders, addiction, and even alopecia.

Biologics differ from tradition drug therapies that are manufactured through chemical synthesis.  A traditional drug can be analyzed with specificity to ensure that it was manufactured with the exact chemical composition intended.  Thus, once a brand drug has lost its patent protection, the FDA can determine if a proposed generic version of that drug is “bioequivalent” to the brand drug.  Analogously, New York law provides a fairly straightforward process by which pharmacists can substitute generic drugs for name brand drugs.

Fundamentally, the present legislation ensures patient safety and access to innovative treatments by creating a pathway to bring biosimilars to consumers.  Addressing difficult maladies with biologics requires absolute certainty with regard to a treatment’s interaction with a patient’s system.  This legislation would update the New York law regarding drug substitution to require that a substitute biologic be “interchangeable” with a prescribed biologic.  Federal law defines whether a biologic meets the standard of “interchangeable” – a different standard that reflects the more complex nature of biologic products.  

Moreover, it contains transparency provisions which are critical to both prescribers and patients.  It is for this reason that 18 health care advocacy groups support this legislation, including the American Cancer Society – Cancer Action Network, the Global Healthy Living Foundation, the Latino Commission on AIDS, the Lupus and Allied Diseases Association and the Scleroderma Foundation Tri-State Chapter.  

In recent years, 31 other states have updated their substitution laws to reflect the distinction between traditional drugs and biologics, including California, Pennsylvania, New Jersey, Ohio, Washington, and Oregon

Conclusion

For the reasons set forth above, NewYorkBIO strongly supports this proposal.  For further inquiries, please contact Joe Tortorice, VP, Operations & Business Development at joe@newyorkbio.orgjoe@newyorkbio.org or (212) 433-2623

About NewYorkBIO

NewYorkBIO is the leading trade association for the life sciences industry in New York City and New York State, representing more than 250 biomedical companies, universities, research institutions, and others dedicated to advancing life-saving research. New York is the largest and richest bioscience community in the world. With the largest concentration of academic research centers in the world, New York graduates more PhDs than any other region in the country and is responsible for a quarter of all cancer clinical trials. The life sciences employ more than 75,000 New Yorkers at companies ranging from very small start-ups that rely on incubator space to the largest pharmaceutical companies in the world.

New York State Life Science Initiative

Link to New York State Life Science Initiative

 

Memorandum in Support of Gov Cuomo’s New York State Life Science Initiative

In mid-December 2016, Governor Cuomo announced an ambitious plan to support and grow the state’s life science sector through various tax incentives, direct investments, and policy initiatives. Those proposals were also included in the Governor’s budget, delivering a total investment of more than $650 million to New York’s life science sector over the next 10 years with the aim of creating 25,000 jobs in New York State. In particular, the Governor’s proposal examines the shortage of affordable lab space for researchers and pre-commercial companies; increasing access to capital for early research; and the critical problem of attracting and retaining scientific talent.

NewYorkBIO welcomes the Governor’s support for the life sciences, and since the announcement of this initiative has solicited feedback from our membership regarding how the various provisions within the proposal would affect our ability to research, develop, and commercialize life-saving technologies in the Empire State. Our findings and thoughts regarding the Governor’s Life Science Initiative are below, separated by subject area. 

Addressing the Lack of Affordable Lab Space

NewYorkBIO is enthusiastic about the Governor’s proposal to provide $200 million of capital funding for lab space, equipment, and technology. Several of our start-up companies have secured space at the SUNY Downstate incubator, the University of Buffalo Biotech Incubator, and other StartUp sites, and many more have identified this is a primary development concern.

While the availability of affordable lab space is a key, a high value is also placed on the density of life science companies where they locate. Accordingly, we also support the restructuring of the StartUP NY program to make it easier for companies to find tax-free space and to aid in the development of life science clusters tied to institutions of higher education. We strongly feel that these provisions can help offset the high cost of built out lab space, while at the same time encouraging co-location. 

Increasing Access to Capital for Early and Growth Stage Companies

Several of our members expressed the challenges that they have with the refundability of existing tax credits. Other states have addressed this problem by establishing an incentives exchange market. However, the refundable corporate tax credit contemplated in this initiative goes a step further to help early-stage companies access capital. In doing so, New York is demonstrating an astute understanding of the drug development lifecycle while at the same time providing capital to the companies that need it most among our membership. 

NewYorkBIO applauds this provision and encourages the state to consider expanding its eligibility requirements and revisiting the refundability of other existing tax credits for early and growth stage companies. Should the Governor expand the eligibility for Excelsior job credits, as proposed, we would strongly encourage those credits to be refundable for early and growth stage companies as well. We are additionally pleased with the proposal to provide a tax credit for angel investors, as well as to award promising early and growth stage companies through a quarterly launch competition.

Attracting and Retaining Top Scientific Talent

NewYorkBIO represents many of the state’s leading research universities, and they have expressed that it is difficult to attract and retain top talent, particularly in the downstate region where the cost of living creates an additional burden. The pressures are additionally pronounced for early and growth stage companies that must contend with the high costs of the New York metro area without being able to offer any of the advantages or resources that come with a large-scale research university.

The Governor’s plan acknowledges these challenges and seeks to implement a life sciences researcher recruitment program in conjunction with the academic medical colleges. Additionally, the Governor envisions creating an Entrepreneurial Advisory Panel that matches mentors with emerging innovators that can help them maneuver the various challenges that early and growth stage companies face. NewYorkBIO has a wide array of experts within our membership who are enthusiastic about these opportunities to increase the connectivity of our industry while helping the next generation of innovators succeed. 

Conclusion

NewYorkBIO strongly supports the Governor’s Life Sciences Initiative, and we welcome the opportunity to be an active partner in bringing it to fruition. As the state’s leading association for the life sciences, we look forward to further discussion with the Governor and his administration to make New York the premier destination for life sciences innovation and research. For more information, please contact Joe Tortorice, VP, Operations & Business Development, at joe@newyorkbio.org or (212) 433-2623.

About NewYorkBIO

NewYorkBIO is the leading trade association for the life sciences industry in New York City and New York State, representing more than 250 biomedical companies, universities, research institutions, and others dedicated to advancing life-saving research. New York is the largest and richest bioscience community in the world. With the largest concentration of academic research centers in the world, New York graduates more PhDs than any other region in the country, and is responsible for a quarter of all cancer clinical trials. The life sciences employ more than 75,000 New Yorkers at companies ranging from very small start-ups that rely on incubator space to the largest pharmaceutical companies in the world. For more information, see www.newyorkbio.org.

New York City Life Science Initiative

Link to LifesciNYC

 

Memorandum of Support for Mayor Bill de Blasio’s LifeSciNYC Initiative

In mid-December 2016, Mayor Bill de Blasio announced an ambitious plan to support and grow the city’s life science sector through various tax incentives, direct investments, and policy initiatives. Those proposals aim to deliver a total investment of more than $500 million to New York City’s life science sector over the next 10-25 years with the aim of creating 16,000 jobs for New Yorkers. In particular, the Mayor’s proposal examines the shortage of affordable lab space for researchers and pre-commercial companies; developing a robust pipeline of researchers and entrepreneurs; and increasing access to capital for early research. 

NewYorkBIO welcomes the Mayor’s support for the life sciences and, since the announcement of this initiative, has solicited feedback from our diverse membership regarding how the various provisions within the proposal would affect our ability to research, develop, and commercialize life-saving technologies in New York City. Our findings and thoughts regarding the LifeSciNYC are below, separated by subject area. 

Addressing the Lack of Affordable Lab Space

NewYorkBIO supports the targeted tax incentives designed to spur the creation of additional commercial lab space in New York, as well as the direct investment to fund incubators and innovation centers. Aside from the space constraints facing start-up companies, access to expensive common core equipment (flow cytometers, microscopy, sequencers, etc.) is a major hurdle for early researchers outside of the academic setting. As the City drafts the legislation to enact these proposals, we hope that equipment dedicated to life science research is also eligible for the tax incentives and direct investment contemplated here.

The proposals to create a new life sciences campus and to expand the network of life sciences R&D facilities for existing academic medical centers is exciting as well, with one caveat. We hope that the City will endeavor creative solutions for how private start-ups (which account for some 70% of life science research activity) can access the resources invested in these two projects. In doing so, we are confident that the investment will further spur the commercialization of opportunities discovered within these not-for-profit centers while leveling the competitive playing field for start-up companies that do not have the world-class resources within the City’s premier academic institutions. 

One of our start-up companies recently secured space at the SUNY Downstate Incubator. While the availability of affordable lab space is a key concern for start-ups, a high value is also placed on the density of life science companies where they locate. We strongly feel that these provisions will help offset the high cost of built out lab space, while at the same time encouraging co-location – not only among companies but among companies and their academic partners. 

Developing a Pipeline for Scientific Talent

NewYorkBIO represents many early-stage companies in the City who face significant headwinds as they try to get their companies off the ground in one of the most expensive metropolitan areas in the country. Talent development is a key challenge, and we applaud the Mayor for his acute focus on not only attracting talent to New York but also cultivating it through our world-class academic institutions. Our member companies have already committed to increasing the number of internships and post-doc opportunities, as well as writing curricula that will introduce real-world drug development perspective to local colleges and universities. This, in addition to expanding the ELabNYC and SBIR Impact programs, will provide useful resources for our emerging researchers and entrepreneurs. 

We are excited about the proposed Life Sciences Management Corps and the Mayor’s Life Sciences Advisory Council. Hiring seasoned entrepreneurs in New York is a time consuming and expensive undertaking; the Life Sciences Management Corps will go a long way to facilitating that process. We also hope that the Mayor’s Life Sciences Advisory Council can go a step further to investigate how smaller companies may begin to pool some shared services – such as human resources and benefits – so that they can more effectively compete with academic institutions and more established companies for talent. 

Conclusion

NewYorkBIO strongly supports the Mayor’s LifeSciNYC Initiative and welcomes continued discussion about the feedback we have presented for individual proposals here. As the state’s leading association for the life sciences, New York City is our home base and we envision an active role in working to ensure that City funding is used judiciously to create jobs and discover life-saving technologies. 

For over 20 years, NewYorkBIO has worked closely with life science associations and clusters across the US to identify and assess best practices in life science economic development and we have developed a broad and deep library on the subject. We believe that NewYorkBIO can be an expert resource for these proposals, and can facilitate their implementation. 

We look forward to further discussion with the Mayor and his administration as we all work to make New York City the premier destination for life sciences innovation and research. 

For more information, please contact Joe Tortorice, VP, Operations & Business Development, at joe@newyorkbio.org or 212-433-2623.

Patent Reform

Congress will shortly consider patent litigation reform legislation.  The legislation in the Senate (S. 1137, the PATENT Act) contains a number of changes to the patent litigation process but, at this time, does not contain needed reforms to the PTO’s administrative patent challenge system known as Inter Partes Review (IPR).  NewYorkBIO is working with BIO to engage with the bill’s key sponsors on the Senate Judiciary Committee (Senator Grassley, Senator Leahy, Senator Cornyn, and Senator Schumer) with the goal of gaining their agreement to include these needed reforms in any package considered by the Committee.  As part of this process, BIO has made it clear that, without a balanced bill which meaningfully reforms the IPR system, BIO will oppose this legislation.

 

  • House and Senate patent litigation reform legislation MUST INCLUDE provisions to balance the inter partes review (IPR) proceedings at the Patent and Trademark Office (PTO) by harmonizing the PTO standards and processes with those used in court to provide a fair mechanism for patent owners to defend their patents, and by imposing some restrictions on what IPRs can be filed and by whom. 
  • IPR is a relatively new procedure, created in the America Invents Act, where any person (not just a competitor or accused infringer) can challenge and invalidate patents at the U.S. Patent & Trademark Office (USPTO). The process was meant to be a faster and cheaper alternative to district court litigation, but in implementation, it has become a much easier system under which to invalidate patents. 
  • This is so because the PTO uses substantive and procedural rules that systematically disfavor patent owners and favor patent challengers ? including lesser standards than used in district court.
  • As a result, about 80% of patents that are challenged and accepted by the PTO are invalidated. This is much higher than the district court rate of 43%, and has created disturbing trends and abuses within the IPR. 
  • Recently, a large hedge fund investor Kyle Bass announced plans to short the stocks of more than two dozen biotech companies and then go after their key patents using the IPR procedure, and we are seeing other efforts by IPR-filing entities attempting to extort very large payments from biotech companies in exchange for not filing the petitions on the key patents that protect their most valuable products. 
  • We are deeply concerned about these and other implications of the IPR procedures on the biopharmaceutical industry ? both what that means for future innovation and ultimately the ability of patients to have access to new therapies in the future. Unless we balance the overall IPR system, these abuses will only continue to morph and grow. 
  • Congress created the IPR system to provide a more efficient and less expensive patent dispute resolution process. Congress did not intend for the PTO administrative system to function in a way that kills off many patents that otherwise would be deemed valid in district court, thus undermining the fundamental ability of investors to rely on patents to protect their investments in innovation. 

 

 

BIO Comments on the Draft National IPR Policy

Statement Regarding the Introduction of Senate Patent Reform Legislation