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BIRAC

Biotechnology Ignition Grant

From Ideas to Startups


BIRAC’s
Biotechnology Ignition Grant
Call-14

A p p l i c a t i o n p e r i o d : 1 st J a n u a r y - 1 5 th F e b r u a r y
(17:30)
The BIG Philosophy
• S u p p o r t H i g h R i s k Te c h a t I d e a t i o n t o E a r l y S t a g e

• Foster generation of ideas with commercialization


potential

• P u r s u e P r o m i s i n g Te c h w i t h I m p a c t f u l ! d e a

• E s t a b l i s h , U p s c a l e a n d Va l i d a t e P r o o f o f C o n c e p t ( P o C )

• Encourage researchers >> take technology closer to


market through Product / Service Start -Up / Spin-Out

• Stimulate enterprise formation

• Generate Industrially and Market relevant IP


What is BIG?

• Supports research based business


ideas to proof of concept and
validation
• Grant in aid up to INR 50 Lakhs
• Duration: Full time 15 -18 months
max.
• Not research grant, fellowsip ,
What is Supported?
A pr ocess / pr oduct innovation w ith significant
societal im pact or commercial potential

 C l ear technol ogy objectives

 Establishing or validating proof -of-concept ( PoC )


for technology i dea

 Technology de -r isking i.e., reducing uncertainties in


technol ogy

 Generating and providing scientific data needed to


demonstrate idea to potential licensors / i nvestors
etc.
Financial Support provided
 Pure Grant -i n-aid of up to INR 50 Lacs into applicant CR A/c

 Milestone based fund disbursement over 18 months

 F o r t e c h n o l o g y c o m m e r c i a l i z a t i o n o f s a l e a b l e ( i m p l e m e n t a b l e ) L S , B T,
Bioengg. technology / products / services

 N o R o y a l t y, i n t e r e s t e t c . c h a r g e d

 Ty p i c a l b u d g e t h e a d s a r e :

 - Equipment - Incubation services/ rentals

 - Manpower - Tr a v e l a n d r e l a t e d c o s t s

 - Consumables - Outsourced services

 - IP costs - Contingency
Technical Support provided
 B I R A C ’s a n d S I I C a s a B I G p a r t n e r p r o v i d e , a r r a n g e :

 Mentoring / advisory / referrals support

 Periodic learning, visibility events and networking


opportunities

 IP Cell can assist BIG grantees with IP related services


on need and availability basis

 T h e B I G P r o j e c t R e v i ew, M o n i t o r i n g a n d E v a l u a t i o n
process

 P r o v i d e a p p l i c a nt s , g r a n t e e s w i t h v a l u a b l e f e e d b a c k
comments and inputs from networks of experts
Who can apply?

• Individuals: Any Indian with a minimum

BSc or equivalent upwards: Final year any

stream

B . Te c h / M . Te c h / M S c / M P h i l / P h D / B . P h a r m a /

MBBS/BDS/MDes/MPH/MSW/MBA etc.

• ICA Registered Indian S&T Startups /


Themes supported
• Healthcare : Diagnostics, Medical Devices
• Lifesciences
• B i o P h a r m a : D r u g s , Va c c i n e s , D r u g f o r m u l a t i o n s ,
Delivery systems
• Industrial Biotechnology
• Agriculture and secondary agriculture
• Wa s t e m a n a g e m e n t
• Clean energy and related areas
Why BIG?
• Pure grant in aid support

• Realise your entrepreneurial dream

• Assured follow on BIRAC funding:

SBIRI, BIPP & Angel/VC/PE funding

• Apply as many times with as many ideas


How to apply?
• Register
Selection process

• Round 1: Preliminary eligibility screening by SIIC IITK

• Round 2: Online review by SIIC IITK

• Round 3: Presentation at SIIC IITK

• Round 4: Final presentation at BIRAC’s office, New Delhi


Selection process

• Round 1: Preliminary eligibility screening by SIIC IITK

• Round 2: Online review by SIIC IITK

• Round 3: Presentation at SIIC IITK

• Round 4: Final presentation at BIRAC HQ, New Delhi

A f t e r s e l e c t i o n , Yo u m u s t p h y s i c a l l y I N C U B AT E
Call for Proposals
1 Jan 1 July
Opens

Call for Proposals ~14


~ 14 Feb
Closes August

• Basic eligibility
BIG Partners assigned • Topics relevant to
proposals to review biotech/biomed
• POC project for tech vs.
basic research

Preliminary screening
by BIG Partner Proposal
not
eligible
BIG Partner requests
reviewers to
evaluate Application
process
Slide 1 of 4
• Novelty or unmet need
• Technical feasibility of idea;
do-ability; any prelim
indication that it might work
Receipt of • Can the team deliver?
reviewers Proposal Technical capability. Project
comments mgmt experience
not
• Potential to create IP or
eligible existing IP; Estimate of FTO
2 neg/ 2 based on reviewer’s
Proposal 2 neg/ 3 experience.
recommended to • Can the project achieve
impt goals in 18 months and
BIRAC Rs 50 lakhs? Are budget and
2 pos/ 2; 2 pos/3 timelines realistic?

1 April 1 Sept • Does the topic fit within


BIRAC screening scope of BIG?
• Does BIRAC concur with
Proposal reviewer’s comments?
not • Some prior art search is
eligible reqd?

BIRAC shortlists
applicants for
presentation to
TEP in Delhi Application
process
Slide 2 of 4
• Novelty or unmet need
• Technical feasibility of idea
• Technical credibility of PI
Presentation in • Proposal budget/timelines
Delhi to TEP. realistic
Decision by ESC
Proposal ~ 15 May ~ 15 Oct
not
selected
In principle
approval decision ~ 1 June ~1 Nov
by ESC

Due diligence by BIG


Partner; site visit; ~ 1 July ~1 Dec
detailed discussion Proposal Delays possible
not here if applicant
needs time to
eligible
produce
• Company legal and financial documents
BIG Partner documents
provides due • Project milestones/budgets;
diligence report quotes
to BIRAC • Commitment of incubator
• Adequacy of facility Application
available process
• Tech transfer agreement;
scientific support contracts Slide 3 of 4
• All scheme requirements met

BIRAC does final


review
Proposal
not
BIRAC okays final selected
terms and signing
of agreement by ~ 1 Aug ~ 1 Jan
BIG Partner

Agreement
signed between
Grantee and
BIG Partner

First installment
~ 1 Sept ~1 Mar
released by BIG
Partner.
BIG Project can Application
begin. process
Slide 4 of 4
Evaluation Criteria
Criteria Percentage (%)
Te c h n i c a l F e a s i b i l i t y 10
Novelty 20
Potential Impact 15
Commercialization Strategy 15
Te a m 20
Barriers 10
BIG project plan 10
Indicative Evaluation Criteria: !dea to Commercialization
• Cur r ent f ield k nowledge : pr elim inar y data
• >1 significant novel component
• Cogent tec hnic al ar gum ents , pr opos al - - -
- Reduce a national dependence
Reas onabl e tec hnic al c laim s
- PO C dem o s trateg y s c ientif ic m ethod on a monopoly producer
- Meets important national
priorities
Technical - New IP creation potential
feasibility Novelty
of the idea (20%)
(10%)

• - Significant commercial
• End- produc t/s erv ic e -
Potentia l c us tom ers -
Importance and/or - environmental impact
Commercialization
strategy (15%) and potential P. - Potential solution for
Value ac c r uing to
impact (15%)u outstanding mark et / society ne
c us tom er
- Need
- Value pr opos itio n vs
other of f er ings availab l e
- Large Mark et addressed

- Plan to tak e tec hnolo g y to - Mark ets / industry / technology

f inal goal of c om m er c ializat i on


landscape disrupting potential
I n d i c a t i ve E va l u a t i o n C r i t e r i a : A - T E A M , B I G P l a n ,
Barriers
• T ec hnic al bac k ground, es s ential ex per tis e • Barriers to execution such as:
o Regulatory
f or pr oj ec t ex ec ution o Ethical and EHS
- Mem bers who c an c om m unic ate value o Investment needs
o Key expertise gaps
pr opos iti on Cus tom er f ac ing team
o Lack of k ey facility
- T ak e proj ec t to c om m er c ializa ti o n o Patents and lack of FTO
Experienc e d s c ientif ic advis ors
/ m entors to f ill ex per tis e gaps Barriers and
Te a m Strategies to
(20%) overcome
(10%)

• End- produc t/s er v ic e


- Potentia l c us tom er s • - Sufficient details to
- Value ac c ruing to c us tom er Entrepreneurial BIG Plan proposal to evaluate
- Value propos itio n Vs Spirit (100% ) (10%) - Project execution and
other of f erings availab l e
path forward after project
- Plan to tak e the tec hnolo g y to duration
its f inal goal of c om m er c ializat i on R - Reasonable project time lines
- Objectives achievable with
INR 50 Lacs funding cap
Budget Breakup
Budget Head Percentage
Equipment <=30%
Manpower <=30%
Consumables Flexible
Contingency Flexible
IP/Patent 1.5 Lakhs
Tr a v e l 2-3 Lakhs
Outsourcing <=20%
BIG Success stories
• Therapeutics: Venom based drug against MDR
TB, Adipocyte derived stem cell isolation kit,
Single site protein labelling
• Devices and diagnostics: Dermascope, Hand
h e l d D e f r i b i l l a t o r, N e o b r e a t h e , S m a r t b l o o d b a g
• Agriculture: Immunity booster for shrimp
aquaculture
• Industrial Biotechnology: Biofungicide,
bioalgal fuels, fermentation processes
BIG Success stories : IITK
• BIG12:
- Early stage cervical cancer detection
- NIR based handheld device:
brain hemorrhage detection

• BIG13:
-Dengue detection strip,
- M i c r o T u m o r Te k ,
-Intrinsic fluorescence based cancer
diagnostic
- Bioleather from flower waste
Basic needs of any startup venture

Fund
Mentor
Prototyp
e
Network
Funding
• Business Mentors

Dr. Arjun Surya Mr. Ajit Gill Mr. Biplab Mr. Srikant Dr. Saurabh
Chief Scientific Pharmaceutical Paul Sastri Srivastava
Officer, CuraDev Development Founder Founder Chairman CA
Biopharma Pvt. Executive Naireeta crayondata, India
Ltd Director, NeKtar services Angel Founder
Therapeutics (Bhungroo), investor NASSCOM,
Scientific Angel Investor crayondata,
Advisor, LAXAI Angel
investor

Mentoring
• Business Mentors

• Academic Mentors/IITK Faculty

• Intellectual Property Cell

• Technology Transfer Cell

Mentoring
• Alumni Network…
• Angels Investors
• Ve n t u re c a p it a lis t s
• Management firms
• Government administration
• Medical Colleges
• Clinical validation
• Design alpha
• D-Rev

Networking
Biodesign
Clinical Immersion Program
IITK KGMU Joint Initiative
Doctor Talk Series
Contact Us:

bioincubator@iitk.ac.in

udayanc@iitk.ac.in

9899091984
C e r v i s c o p e TM Te c h n o l o g y D e s c r i p t i o n
• Trust Worthy (96% Specific & 91% Sensitive)

• Minimal Missed and Overcall cases

• Objective, Quantitative same day test results

• NO BIOPSY NEEDED: Minimally invasive

• Cost Effective (INR 70K for 100 units)

• Accessible -> Portable, compact, hand held probe

• Indigenously developed medical device

• A P P L I C AT I O N :

• Early stage in body detection of cervical cancer

• Using intrinsic fluorescence of upregulated biomarkers

• Minimise mortality by pre cancer stage detection

• Useful for regular rapid screening of cancer

• Effective future biopsy guidance tool



Need of early detection of cervical cancer
Estimated Incidence, Mortality and Prevalence (WHO, 2012 ):

➢ Wo r l d w i d e 4 th m o s t c o m m o n c a n c e r i n w o m e n
➢ estimated 5,28,000 new cases
➢ 2,66,000 deaths, accounting for 7.5% of all female cancer
deaths.
➢ India: estimated 1, 23, 000 new cases & 67, 000 deaths.
➢ A l m o s t 9 / 1 0 ~ ( 8 7 %) c e r v i c a l c a n c e r d e a t h s o c c u r i n t h e
less developed regions.
➢ If cervical cancer can be detected at early stage, it can be
cured.
➢A c o s t - e ff e c t iv e indigenous technology for early stage
detection that minimizes mortality due to cancer is
imperative. http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
N E E D O F T H E H O U R – M AR K E T S

C e r vi c a l c a n c e r s t a t i s t i c s

E a r l y c a n c e r d i a g n o s i s i s c r i t i c a l f o r s u c c e s s f u l c u r a t i ve
treatment
Need in India in the context of diagnostic devices:
• Affordable diagnostic devices
• Robust diagnostic techniques
• Accessibility in rural and far -flung areas
• B2G (CGHS, ECGHS) ; B2B (Hospitals, Pathology chains)
1. Bruni L, Barrionuevo-Rosas L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S. ICO/IARC Information Centre on HPV and Cancer (HPV Information Centre).
Human Papillomavirus and Related Diseases in India. Summary Report 27 July 2017. [Date Accessed]
2. http://cancerindia.org.in/wp-content/uploads/2017/11/Head_and_neck.pdf
MARKET INTEREST : M E D I C A L D E V I C ES I N I N D I A

Indian Medical Device Market

Diagnostic Imaging: largest segment within Indian


medical device market in 2015
• https://rbtereport.com/head-and-neck-cancer-diagnostics-market-2018-2023-analysis-by-regional-development-status-
market-size-market-dynamics-applications/
• Make in India report(2018)
• http://www.digitaljournal.com/pr/3967880
P R E S E N T S TA N D A R D C A N C E R D I A G N O S T I C T E C H N I Q U E S

Conventional methods Limitations of conventional methods

CERVICAL CANCER

• Low sensitivity (55%) ; high specificity


Pap (Papanicolaou) (97%)
test • Many abnormal cases missed
• 7-10 days for test results

• High sensitivity (94%) ; low specificity


Colposcopy directed (50%)
Biopsy test • Many cases overcalled
• Results may take 25 to 35 days

These tests are subjective with accuracies


d e p e n d e n t o n t h e s k i l l s o f t h e e x a m i n e r.

Scully C, Bagan JV, Hopper C, Epstein JB. Oral cancer: current and future diagnostic techniques. Am J Dent.
2008 Aug 1;21(4):199-209.
Ad v a n t a g e s o f t h e d e v i c e o v e r c o n v e n t i o n a l t e c h n i q u e s
Conventional method Limitations of conventional method Advantages of our device
Due to low sensitivity (55%) and high High sensitivity (91%) and specificity
specificity (97%) many abnormal (96%), minimizes either missed or
cases missed. overcalled cases.

1. Pap (Papanicolaou) Extra tests: HPV test, colposcopy or Pathology being a gold standard may
test repetition of Pap test may be required
be required in the initial trials.
.
Presently on the same day. Final
Generally it takes 7to 10 days to get
product results will be available
test results
immediately
High sensitivity (94%) and low High sensitivity (91%) and specificity
specificity (50%) indicates that many (96%), minimizes either missed or
cases are overcalled. overcalled cases.
2. Colposcopy If results are abnormal biopsy
directed Biopsy test No biopsy needed.
required.
Presently on the same day. Final
Colposcopy directed biopsy results
product results will be available
may take 25 to 35 days.
immediately
These tests are quantitative and not
These tests are subjective, with
subjective, and a medical person can
accuracies varying as per the skills of
comfortably use this set up with some
the examiner.
amount of training.
If a Pap test, colposcopy, and cervical
No biopsy needed to detect early stage
biopsy show different results, then
of cervical cancer.
COMPETITIVE LANDSCAPE
Cervical cancer devices in the market Our Device(Cervical cancer probe)
Truscreen (Polartechnics Ltd., Australia)
• Patented device • Intrinsic fluorescence based
• Opto-electrical technique optical technique
• Available in India
• Sensitivity (CIN-1: 75.8%, CIN-2/3: 77.3%) & • More objective result compared to
Specificity(normal : 85.1%) visual examination based results of
• Price: Rs. 4,50,000/- most of the devices available in
Testing cost per patient: Rs. 4000/- market
LuViva (Guided Therapeutics, Inc, USA)
• Cost effective and portable device
• Patented device
• Reflectance and fluorescence spectroscopy technique
• Sensitivity (~ 80 %) & Specificity(~ 60%) CANCER SENSITIVITY SPECIFICITY
GROUPS
• Not available in India.
Normal vs 91% 96%
Sascan Meditech Pvt. Ltd, India CIN I/ CIN II
• Imaging device for oral cancer
• Fluorescence and Diffuse reflectance technique
• Testing going on in hospital
• Not yet available in market.

Conventional techniques
• Pap Smear: Sensitivity (55%) and specificity (97%)
• Colposcopy: Sensitivity (94%) and specificity (50%)
Development Status
Ex-vivo on hystorectomy and in-vivo studies
done

Beta Research Prototype at present clinically


tested on 51 patients

Positive feedback from Medical experts

In 18 months ; at INR 50 Lacs:

Semi Commercial prototype will be ready after


testing on 100 patients

10 such devices to be manufactured and sent to


Medical research college hospitals

Earlier version made with Aluminium Currently being used for in-vivo
measurements in GSVM medical
college (Made with stainless steel)
Core IP of the Product
• Intrinsic Fluorescence

technique
Block diagram of the patented device
• A l g o ’s d e v e l o p e d a n d v a l i d a t e d
Diode laser (405nm)

• D e v i c e b a s e d o n M L / AI Al g o ’s

• Te c h n i q u e a n d d e v i c e p a t e n t e d Xe-lamp

• Invention title: System Method

And Device For Diagnosis Of

Cancer Based On Polarized • Certifications for the device:


• Ethical clearance from IIT Kanpur:
Fluorescence • IEC communication number:
IITK/IEC/2016-17/2
• Ap p l i c a t i o n n u m b e r :
( recommended up to 5 years from 30/09/2016)
3052/DEL/2015 • Clinical Trial Registry(CTRI) India:
• Trial Number: REF/2017/09/015283
• Publication on in-vitro testing
RISKS & BARRIERS
Universal Calibration on scaling
Differential Diagnosis b/w infection and cancer
Genetic variation of cervical cancers b/w population sets
Patent Pending ; Student, Faculty Entrepreneurship Policy

P R I C E E S T I M AT I O N Price estimation over


increasing no of units
Estimated price per unit Fixed cost
120000

Estimated price in Per unit


PRODUCTION
100000
COST(per unit)
~ Rs 95000 80000

60000

40000
Hardware Software Manpower 20000
~ Rs 60000 ~ Rs 20000 ~ Rs 15000 0
10 20 40 50 100
No of units produced
T E A M S TAT U S

➢ IIT Kanpur Professor with 25+ years experience in


Biomedical Imaging heading Research Group.

➢ Associate Professor in Instrumentation supporting


academic expertise

➢ Project Engineering Lead : Optical Spectroscopy


Expert

➢ Te c h n i c a l E n g i n e e r i n g L e a d :
M e d Te c h D e v i c e D e v e l o p m e n t

➢ Business Development Executive: Market Research &


Intelligence

➢ 2 Advisors: Electronics Data Processing & Analytics

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