Jefferson’s Innovation Pillar: who we are and what we do

Heather Rose PhD, JD; Director of Technology Licensing

Robert DeHaven; Innovation Management

Thomas Jefferson University

Outline

Commercialization

– What is “tech transfer”

– Why does “tech transfer” exist? (University’s interest in commercialization)

– Ways the Innovation Pillar can partner with you to accelerate commercialization of your work

– Pharma partnerships interests on the rise

What is Tech Transfer?

Technology Commercialization Offices work with faculty, students and staff to identify novel technologies discovered and developed at the University, secure intellectual property protection for them and help get the technologies to the people that need them.

-transitional work advice and funding-corporate partners -supporting start-ups

But please remember TJU does not have a tech transfer office per se, we are the Innovation Pillar and we really do much more than this!

- Help with the development of ideas- Strategize for getting work to market (building it backwards and trying to

help with finding funding.)

The Bayh-Dole Act: A Real Life Example of the Value of Patents

• Everything was worse in the 80’s!– discoveries made at Universities with federal funding lay fallow

because the federal government embraced a policy of taking title to all such inventions and licensed them on a non-exclusive basis.

– In other words, anyone was welcome to make and use them but could not exclude others from doing the same.

• Because they had no protection against competition, companies could not justify investing significant amounts of time and money into developing University innovations.

• The federal government held title to approximately 28,000 patents, of which fewer than 5% were being used for development of commercial products.

Bayh-Dole Act (P.L. 96-517, Patent and Trademark Act Amendments of 1980)

Enacted December 12, 1980• Created a uniform patent policy among the many federal

agencies that fund research, enabling small businesses and non-profit organizations, including universities, to retain title to inventions made under federally-funded research programs.

• Especially instrumental in encouraging universities to participate in technology transfer activities.

“Possibly the most inspired piece of legislation to be enacted in America over the past half-century... More than anything, this single policy measure helped reverse America’s precipitous slide into industrial irrelevance.”

– Economist Technology Quarterly, Dec. 14, 2002

Enter Innovation Pillar

In response to Bayh Dole, many Universities created offices dedicated to translation of their technologies to market

“Translation” describes the formal transition of academic innovations resulting from scientific research and clinical experience at universities and non-profit research institutions to the commercial sector for public benefit.

Jefferson’s Innovation Pillar works with our faculty, students and staff to identify novel technologies discovered and developed at the University, secures intellectual property protection for them, and licenses the inventions to corporate partners.

The Impact of Bayh Dole; Large and Growing

Since enactment in 1980:• More than 5,000 new companies formed around university

research. • 153 new FDA approved vaccines, drugs and/or new

indications for existing drugs were discovered.• According to MIT, about 30 billion dollars of economic activity

per year and 250,000 jobs can be attributed to technology born in academic institutions.

In 2012 alone:• $36.8 billion of net product sales were generated and startup

companies started by 70 academic institutions employed 15,741 full-time employees.

• 591 new products originating from university research were introduced to the marketplace by companies.

According to the former President of the NASDAQ, an estimated 30 percent of the US stock Market has its value is rooted in university-based, federally funded research results, which might never have been commercialized had it not been for the Bayh-Dole Act.

https://www.autm.net/AUTMMain/media/Advocacy/Documents/BayhDoleTalkingPointsFINAL.pdf

The Key Elements of Innovation Programs

$

Submissions of Ideas and Inventions at TJU

• http://innovation.jefferson.edu/innovators.html

• Formal “Report of Invention” for inventions funded by government or fully developed from your research

• “Fast Track Your Idea” for inventions or ideas that are less developed or outside your area of research

• Links to invention disclosures, CDA and MTA information

Partnering with pharma: working with the enemy?

Rumor that pharma and academics natural enemies but have been building quite synergistic relationships.

• Driver is the growing difficulty and expense of identifying novel drugs and getting them to market

The Rising Cost of Drug Development

In 1975, the pharmaceuticals industry spent the equivalent of $100 million in today’s dollars for research and development of the average drug approved by the FDA.1

– By 1987, $300 million.2

– By 2005, $1.3 billion. 2

– Today R&D spending from the 12 leading pharmaceutical companies from 1997 to 2011 was $802 billion to gain approval for just 139 drugs: $5.8 billion per drug. 2

(Other authors offer their own estimate of between ~$870M and $1.8 billion )3

1 Tufts Center for the Study of Drug Development.2 Forbes: How the FDA Stifles New Cures, Part I: The Rising Cost of Clinical Trials Online:4/24/2012.3 Paul, S et al. Nature Reviews Drug Discovery 9, 203-214 (2010); DiMasi, et al. Journal of Health Economics 22 (2): 151–185 (2003); Brantner A Health Aff(Millwood) 25 (2): 420–8 (2006).

Why Has the Cost of Drug Development Risen so Much?

Attrition Rates:The overall attrition rate for developing a drug is currently calculated to be 10,000:1. The averages breakdown roughly as follows:• Chemistry (10,000 compounds) Pharmacology and

Safety (1000 compounds) Clinical Trails (10 compounds) NDA Submission and Approval (1 compound)

This has been somewhat favorable for Universities. Cos admitting they need to be better at in silico screening. Less R and more D.

Stratmann, Dr. H.G. (September 2010). "Bad Medicine: When Medical Research Goes Wrong". Analog Science Fiction and Fact CXXX (9): 20.

Why Has the Cost of Drug Development Risen so Much?

Clinical Trial Cost:

Due to increasing regulations, Phase III clinical trials have become far larger and more complex than they were in the past.

From 1999 to 2005. • The average length of a clinical trial increased by 70%.1

• The average number of routine procedures per trial increased by 65%.1

• The average clinical trial staff work burden increased by 67%.1

• Increasingly stringent enrollment criteria led to 21 % fewer volunteers being admitted into trials.1

– Overall, Phase III trials now represent about 40 percent of pharmaceutical companies’ R&D expenditures.2

This has been generally bad for Universities. The value of a technology at the most developed stage an academic can get it too is still quite low because carries such high risk.

1 Tufts Center for the Study of Drug Development.2 When this analysis is confined to those drugs that actually get approved, Phase III clinical trials typically represent 90 percent or more of the cost of developing an individual drug all the way from laboratory to pharmacy.

• In 2017, a total of 22 drug patents are estimated to lose patent protection.

– That happens to exactly match the number of new drugs approved in 2016, a more than 50 percent decrease on approvals the year before.

http://medcitynews.com/2017/01/infographic-drug-patents-expiring-2017/?rf=1

Many Drug Patent Expirations vs. Few New Drug Approvals

Rising Drug Development Costs & Patent Expirations, Fewer Drug Allowances Driving Huge Change in

Pharma

• 2009 to 2013- U.S. biopharma eliminated at least 156,000 American jobs, including scaling back R&D departments, slashing sales teams, and eliminating redundancies in post-merger workforces.

• At the end of 2016 five massive pharma companies with a combined market cap of more than $228 billion announced more major restructurings and layoffs.– With most pharma groups slashing internal R&D, many big

pharma companies’ needs for keeping their pipelines supplied with hot new science has sent them to academic where more and more they are contributing to funding discovery and early R&D work.

FiercePharma http://www.fiercepharma.com/tags/pharmaceutical-layoffs#ixzz2So2H4m00

http://fortune.com/2016/12/12/big-pharma-big-job-cuts/

Rising Drug Development Costs, Patent Expirations Driving Change: New Partnerships

Johnson & Johnson & Queensland University Focus: Chronic pain- Collaboration calls for research of spider venom peptides to find novel treatments for chronic pain.

Eli Lilly, Merck and Pfizer & University of Hong Kong, National University of Singapore, National University Health System in Singapore and the Genome Institute of Singapore Focus: Cancers impacting Asian populations

Elan & Cambridge University Focus: Alzheimer's

Novo Nordisk & Oxford University Focus: Rheumatoid Arthritis- The collaboration will study diseased human tissue to validate drug targets and identify biomarkers of autoimmune and inflammatory diseases.

UCB & Oxford University Focus: Immunology- UCB will lay down £3.6 million to fund the three-year agreement, consisting of between 5 and 10 specific projects for UCB and Oxford researchers.

Novo Nordisk & JDRF Focus: Type I diabetes

Bristol-Myers Squibb & Vanderbilt University Focus: Parkinson's disease- The Vanderbilt Center for Neuroscience Drug Discovery received an upfront sum and the promise of more money in the form of milestone payments and potential royalties from the drug giant to look for new treatments that target the mGluR4 receptor.

Novartis & University of Pennsylvania Focus: Personalized T-cell therapy- The collaboration involves a new research center for novel cancer immunotherapies, which Novartis is supporting with $20 million.

Sanofi & Brigham and Women's Hospital/Harvard Medical School Focus: Diabetes

Merck & California academic researchers Focus: Disease progression- Merck struck a partnership with academia and the biotech entrepreneurs of California to create the California Institute of Biomedical Research (Calibr). The institute will be located in San Diego, with close proximity to University of California, San Diego, the Scripps Research Institute, and the Salk Institute. Merck will provide $90 million for the creation of the institute over the next 7 years and aims to fund programs there through preclinical proof-of-concept studies, at which point industry can decide whether to pick up the assets and advance them into the clinic.

http://www.fiercebiotech.com/slideshows/20-major-pharma-academic-alliances-2012

Rising Drug Development Costs, Patent Expirations Driving Change: New Partnerships

GlaxoSmithKline & Yale University Focus: Disease progression

AstraZeneca & The Broad Institute Focus: Infectious diseases- The Broad Institute's 100,000 compound library will be tapped for weapons against drug resistant strains of bacteria. AstraZeneca plans to take responsibility for the development of potential treatments discovered at the Broad.

AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen Pharmaceutica (J&J), Merck Serono and Pfizer & University of Dundee Focus: Multiple disorders-The university will be provided with £14.4 million in core support from the consortium. The collaboration will consist of 15 research teams stationed at the university investigating multiple diseases such as arthritis, cancer, hypertension, lupus and Parkinson's.

Abbott, AstraZeneca, Bayer, Eli Lilly, GlaxoSmithKline, Merck and Sanofi Partners: Texas A&M University, Weill Cornell Medical College, the Bill & Melinda Gates Foundation Focus: Tuberculosis- The Bill & Melinda Gates Foundation has donated $20 million for the TBDA, which "aims to develop five new preclinical drug candidates with treatment-shortening potential within 5 years and proof-of-concept for a one-month three-drug regimen within 10 years,"

AstraZeneca, Genentech and Merck & University of Washington Focus: Drug Transporters

Roche, Eli Lilly, Servier, Janssen Pharmaceutica and Pfizer & Multiple academic centers led by King's College London Focus: Autism spectrum disorders -One of the largest efforts of its kind ever to tackle the growing problem of ASDs with the full force of pharma giants, academic powerhouses and other advocates behind it. The groups combined resources to back the 5-year effort with $38.7 million.

Accuray & University of Heidelberg Focus: Oncology- The partnership will consist of radiation oncology research, looking to advance treatment technologies.

AstraZeneca & Weill Cornell Medical College, Washington University School of Medicine, The Feinstein Institute for Medical Research and the University of British Columbia. Focus: Alzheimer's disease- new drug targets associated with a key risk factor for Alzheimer's known as apolipoprotein E4 genotype (ApoE).

Bayer HealthCare & Academic researchers/entrepreneurs Focus: Foster biotech startups-- Bayer HealthCare has opened facilities in the Mission Bay area in hopes of housing innovative new companies and perhaps partnering with them as their programs mature. Called "CoLaborator."

http://www.fiercebiotech.com/slideshows/20-major-pharma-academic-alliances-2012

The Problem

Universities

Early R & D-targets!

Development $$$

Formulation, dosing, safety, approval,

manufacturing, quality control, marketing,

sales, and distribution

Early R&D

Pharma

development

The Solution

Universities

Research

Development $$$

Formulation, dosing, safety, approval,

manufacturing, quality control, marketing,

sales, and distribution

Pharma

In Summary

• Work with Innovation to get your work to the people who will benefit from it!

• We do patents and so much more– Building out early stage stuff (even ideas)– Building it backwards– Translational funding opportunities– Corporate partnerships– Licensing technologies– Supporting start-ups– Sales of research materials

• More that just biotech too, please contact us about ANY GREAT IDEAS AT ANY STAGE FOR ANY SECTOR!!! We want to hear your ideas and support you in getting them to the people who need them!

Answers to frequently asked questions can all be found at: http://innovation.jefferson.edu/innovators.htmlThomas Jefferson University Patent Policy can be viewed at: https://tjuh.jeffersonhospital.org/policy/index.cfm/universitypnp/view/id/10335