Next-Gen Biotech Innovations- for Entrepreneurs

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Main Priorities for financing, Stages of rounds, needs & science expertise: 

Four Priorities rule the journey of the entrepreneur from idea to monetization,

within three preliminary steps (A B C) (prerequisites to start up ):

A)  Concept

1) The need for a second professional opinion and help (of high caliber) to confirm that the science is correct, and whether there is some proof it can become a commercially feasible, scalable process / product The concept and potential must be outstanding with high potential(1) for funders to take you seriously.

 
B)  The Coming Presentation to Funders 

2) The need for a) outside Review and authoritative endorsement*, of high caliber, and b) to refine the funding presentation;

3) The need for "proof of concept" and outside support of scientific viability, and Business a) feasibility, b) efficiency-scalability and c) niche size-demand

 
C)  Planning and Execution

4) The need for good planning and execution of the seed, start up and expansion Stages

 
Priorities 2) and 3)are about credibility in the funding presentation phase.

The planning part of 4) is usually part of the funding proposal.

 
Priority 4 is where your business becomes real and successful enough that

Funders don't take much of it away from you , or "cut you off" (or out).

 
Note (1) "potential" in commercial success = dominance of a niche or gap in the industry segment, a replacement for a leading product/process, or a new production efficiency (higher yield, purity) or feature (effectiveness, safety, ease of use, simpler or cheaper process).

The Stages:

A)  Idea and Creative Stage:

Scientists often must collaborate, review, study and discuss existing research (prior art) complex papers and methods... and decipher complex underlying principles... toward finding or "perfecting" a concept that is truly innovative, meets a major demand and is "do-able".

B)  Invention or proprietary trade secret perfection and proof stage:

Inventorsoften use "perfection assistants" to help cover the research, prior art and "embodiments" and to find the best "workable" version which serves a more lucrative market. 

Scientistsmay need more of a high-level collaborator and experiments design. All this is even more crucial in the high-tech biotech / life science sector.

There likely will also be pitfalls, dangers , hazards, interactions and purity issues which the helper scientist may discover or caution about.

Having a strong outside, unbiased PhD reviewer and brain-stormer to aid understanding and give an honest outside scientific opinion... is invaluable.

C)  Helping the Plan, Presentation and Funding:

A secret to funding successis having an A-school USA PhD top scientist with you--- confirming your theory, proof of concept and plan. 

There is nothing stronger for funding... than having another accomplished PhD expert standing beside youto verify your biotech or biochem theory, invention or concept (to the extent disclosure must be limited) and business plan.

An outside "A-School" PhD molecular biophysicist-biochemist and math expert 

confirming that "proof of concept" is possible (or done) ... meets the extreme need for credibility. Such validation in your presentation and requests for funds is key. We focus on that all-important proof of viability, feasibility.

Positive, helpful, constructive critiques-collaboration and assistance in life science hypothesis and proof assessment, business and funding/proposal assistance.  

  Helping science innovators and inventors with analysis, research and development-- from idea through funding presentation and execution (pre-seed, seed, startup, expansion & growth stages):

Entrepreneurs need a Second Opinion and credentialed endorsement*

--- and help and refinement of the science, proposals and business:

The key, before the financing stage, to be considered by a large funder--  is having competent independent outside scientific review--- to confirm feasibility, proof, proper design, proper emphasis and guidance on this difficult path to quality and commercial scalability.

A TopPhD-biotechConsultant-tm can help both venture funders and concept creators in these areas.

An entrepreneur scientist can not afford mistakes, and the science may be extremely difficult, to near-unfathomable. Various high-tech methods and instruments are typically selected, applied and cited.

A TopPhD-biotechConsultant helps hone the scientist's concept as a "perfection assistant", with an eye to what investors, funders, licensees and the market want. 

 Limited availability. 

Contact us early.   Reasonable Rates (See prices near bottom of Scientists page)

(See also Corporate R& D, innovation departments)

  Keeping Trade Secrets .. secret--- by Narrow Exposure and Partitioning

Government funders (grants) and academics may not fully appreciate the crucial requirement to limit disclosure; They suggest "collaboration". Academic grantors on the science side of a grant team proposal review may by habit look for publishing, partnering and collaboration, whereas

Private funders expect collaboration to be very limited, and NO publishing

Even Corporations can be naive on this.

The inventor and his one expert can NOT be naive on this. Efforts to conceal biotech trade secrets will raise you highly in esteem and better stead with venture capitalists, angels, lenders, royalty Licensees and investment bankers.

First questions will be "Whom have you talked to?" and "What did you tell them?" Remain cautious on exposing details.

 
For a public money grant, an entrepreneur may have to "fight back and challenge" suggestions of wider "collaboration" or "partnering". In answer to the grant team member that focuses on academic grants, you might tactfully defend that wider associations are completely against "trade secret" legal requirements, and cannot come in at the proof of concept and pre-seed stages. You might focus on availability of resources and promises to advise from professionals in your field.

Only when you have money, resources and some strength can limited disclosure 

be allowed under NDA's for vital team members or partnering.

On the other hand, the grant team may have found that "one person shows" tend to fail more often, by lack of depth, lack of perspective, or having no other resources (a lab of bench) to implement the stage. One other PhD scientist and an informal agreement to "barter" by a company (incubator) advancing resources (bench) for a future small royalty cut (1%?) from your main business revenues ($100 million)... could make the difference in covering the partnering concern of the grant team for the "proof" stage. (NOTE: This is not advice.)

Venture funders want you to have limited but strong expert input on your idea, as they review your Business Plan to monetize and scale your innovative concept and methodsThis is particularly true if your expert can help “cut Time and Risk”.

Speed to marketand scalability are always priority in venture capital and investor minds, because the market won't wait for laggards. 

Funders and Grantors alike want expert oversight (depth) and experience beside you on the journey to success or monetization. They know:

First in a market usually dominates for decades.

Your expert science and industry "perfection assistant" will help keep you focused on those goals in all you do: "Time is of the Essence"

So, there is a "fine balance" of factors requiring an outside life science expert to help you stay on the narrow path to both science and business success.

Choose a TopPhD-biotechConsultansttm as the biotech science expert beside you ...

Emphasizing Proof of concept, oversight, adherence to Plan, standards-quality (QC), 

Helping you through the project-venture steps of:

Proof ofconcept experiment design, research, development, strategy, planning, set up, project management, oversight, quality control, coordination, and even direct interim management ---

These are where life science / biotech Inventor and investors-funders needs align... they are exactly the same.

* "endorsement" would be opinion, not a guarantee 

  Strategic business and technical consulting in biotech fields of: 

biochemistry, cell biology, disease mechanisms and progression, microbiology, molecular biophysics, biotechnology and bio-active products/ processes (bio-pharma, health therapeutics) 

Molecular biophysics  (our TopPhD-biotechConsultanttm ) underlies all cellular and biochemical processes and reactions-- what net energies, forces and enthalpy drive reactions and processes. Also many lab techniques and instruments operate under these molecular biophysics and biochemistry principles. Knowing what best works in the lab and business execution phases is essential.

You need this unbiased foundational science expertise helping you.

 A) First, foremost--- the Idea-Concept

Ultimately, it is the concept’s scientific viability, do-ability, potential and competitive advantages that determine whether the new product or process is

hugely disruptive (what investors, Licensees or Royalty holders want), to be successful. Funders want "proof" and may fund that as a "pre-seed" stage.

A TopPhD-biotechConsultanttm business degree, PhD science knowledge, math and biology majors, lab and industry experience--- will keep you focusedon "reality", the "end game" in competitive business or science peers shakeout.

That is the unique "competitive advantage" (unique education and skills) that

A TopPhDConsultanttm bringsto bear on your behalf.

Likewise, your concept must have "competitive advantage".

Such advantage can be a disruptive new product, or unique process or efficiency.

Your concept needs to focus on such key business concepts, to get funding.

A TopPhD-biotechConsultanttm builds on the key principle: -- “Ask the Right Question… the Right Way” -- (Einstein, Deming, Watson)

Validation proof comes from asking the right question [the right way]. 

On a problem, Einstein would first spend 1/2 his time formulating 

"decisive scientific questions".

Funders and Grantors look first for "proof of concept" by initial experiment(s), and a little depth (more than one person able, or a lab).

No significant funds ($500,000 to millions) will come before this first critical step, or at least a highly-knowledgeable outside expert opinion-evaluation.

The life-sciences entrepreneur must look for expert scientific critiquing, which foremost... critically examines scientific rationale. These are usually biochemistry, microbiology and bio-physics - related questions, on reactions, rates, bonding energies, molecular structures, etc. 

Other Key questions must be answered before jumping ahead. 

You must "front-run" critical questions to evaluate whether your concept has true economic and scientific potential:

What might prevent it from working? Will the main scientific principle prove out? What has been tried? Is it grounded in proven principles? 

Businesswise: Does your invention compete head-on with any market leaders? 

(existing research, methods and products). Are these leaders innovative and efficient? 

Can a preliminary "proof of concept" experiment actually be designed?

What are the key dispositive questions^ from the hypothesis?

Does it have high potential for efficiency scalability, purity and sales?

That requires a a TopPhDConsultant's skills, caliber and experience--- to ask the right questions on which to base the "proof of concept" experiment.

-- "A venture is pointless if the underlying product or process does not show large or "order of magnitude" improvement/ performance, for huge 'competitive advantage'. Incremental steps won't cut it." --  RS

A TopPhDConsultant assesses nnovation true validity-viability, feasibility and proof of concept by

a) review, critique & expert opinion

b) proper questions ^

c) expert experiment design for proof of concept

d) succinct Reports 

 ^ "dispositive" = disposes (decides) the issue (go, no go, same as in law)

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B) Pre-seed, Seed, and Startup & Development (Series A) Stages

A TopPhD-biotechConsultant aids pre-seed through start up, development & growth stages--- Formulating: strategy, design, testing, protocols, standards, plans, organizing ...

then vetting facilities, lab, instruments, staffing, systems, QA and procedures.

Setting up even small organizations, labs (or selection) and beginning more testing or early production--- are crucial to get right.

   The pioneer team and leaders must be coordinated on the goals, vision and methods. How well they work together and support teamwork and leaders is crucial to be observed by an expert (oversight, assessment, troubleshooting, coordination).

-- "Too often  'innovation groups' are not led by 'seasoned' leaders nor seeded with real experts or scientists in the field. You should 'seed' with seasoned management and an expert scientist --- or bring in outside expert oversight, even if not full time. 

A novice 'project manager' with lower science credentials than sthe cientists and technicians supervised-- will likely fail. PM's need to know or consult with a top scientist who understands the methods and hurdles to be overcome." -- CS

Project Managers are key and must have both science credentials and management training, and be proficient with PM software and methods. Only experienced in the field can set and estimate, the right tasks,  tasks duration, precedence and relationships AND understand the science.

Their job is to anticipate, coordinate, faciliate and HELP, not delay and hinder, as so often.

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C) Advising and assessing: development, expansion, growth, market penetration and scaling production. (Financing Rounds 1 - 3 or Series A, B offerings) (Seed stage or Series A may include "preferred stock" for start up, development)

A TopPhD-biotechConsultant-tm takes an advisory, assessment, standards and oversight role--- to help make sure methods, systems, staffing, and scientific and management resources are on the right track:

--- "This demanding execution phase is where many new organizations break down." -- CS

   We have  Consultant who do-- Planning, organizing and standards... and can oversee--adherence to standards, protocols, procedures, and Quality control programs (QA, QC). 

We aid company success by aligning R&D, technologies, therapeutics & markets. 

"Corporate partnering" success also requires strong planning, and coordination of companies, resources, teams & stakeholders. 

For success: -- “Do it Right, or don’t do it.” -- RS

Biotechnology bioprocess biochemistry microbiology therapeutics biopharmaceuticals molecular biophysics .

-- "If you are pursuing these projects without expert review and oversight...

you are asking for trouble." --- RS

Contact us early. Reasonable Rates (See near bottom, and Scientists page)

Our services cover: Scientific review, viability, design, strategy review, oversight, reporting in biotechnology, therapeutics (and suppliers) and biopharmaceutical companies' supply needs (enzymes, reagents). 

We evaluate or help find: New technologies for commercial realization of breakthroughs. 

Our main Consultant also does custom protein and enzyme engineering, and can help with production.

 
Our focus is: Intellectual property creation, management and protection, as key to success; We help create, license IP, and suggest ways to protect it.

Proposed ventures are evaluated as a whole: assessing viability and challenges, including SWOT Analysis (method-concept strengths, vulnerability, potential).

 
Execution strategies are proposed or critiqued. We provide forecasts for novel technologies, suggesting exploitation pathways, and assessing markets and potentials for those products. 

We aid presentations-funding proposals... for the scientist-entrepreneur, or critiquing for partners and funders.

You select services in accord your need.

Start-up and Early-stage Companies / 

New products-processes and production methods

· Concept evaluation, correction or tweaking.

· Strategic business consulting for new ventures or new products. 

· We offer strategic business advice with superior scientific-technical skills. 

· We canhelp entrepreneurs and funders identify high value markets, and risks. 

· We aid most areas of startup creation, from business plans, presentation (with protection), to team building and IP portfolio management, all vital to the funding process and beating competitors. 

· We help develop presentations and pitches, for customers, Directors, VC's, Angels and other investors, licensing and business negotiations. 

In Startup to Expansion: 

We can also perform active direct interim management (funders may require this). 

------>  CONTACT us now. Limited availability.

We do not advise on Specific Venture Finance or Funding Structures.

For innovation creators/entrepreneurs, we do not provide specific advicein venture finance or financial structures, other than helping review funding proposals versus funder demands and the schedule for equity, debt warrants or royalties, and whether milestones seem fair and realistic. We can discuss what some have done, or what we might do ourselves.

---"We can offer a few caveats." -- CS:

All financial investment or venture offering advice must come from a professional: a business or securities lawyer, investment banker, CPA, financial advisor, securities broker, etc. , This is especially true if you go the conventional offering route, even if your investors are sophisticated (in your field, experienced, knowledgeable of investing (the SEC definition varies by income, net worth, percent of worth invested, etc.)). Here is a comparisonof sophisticated vs accredited investors, and a discussion of "rounds".

Funders and concept creator-entrepreneurs should be realistic, fair and share risks equitably. or as the market will bear if your potential is large. 

A TopPhD-biotechConsultanttm can argue the case for either side, Funders or Creator.

We can offer some thoughts (not advice) on this crucial topic, in private discussion. You will likely need an existing sophisticated company already in your field, who may fund, or advance some of a Royalty (that you woud later pay) or resources, ... or a specialized intermediary, typically a botique investment banker (in biotech), or "Angels" group.

In exchange for a “first right of refusal” or an “option” on license for exclusive regional resale of your product(s), use of part of your process, or even straight small percent of your future sales, a start up might negotiate a loan of corporate stock or a partial loan guarantee, or outright grant or loan, or advance in form of lab space, instruments (even money for supplies). We are not recommending anything.

These arrangements may fall under the "pre-seed" stage of financing (very unique requirements and contrast with standard "VC, Angels and investment bankers approach).

CAUTION NOTE: Some of those may be "securities" (regulated).

Many possibilities exist. Consult a Financing, securities expert or lawyer in that field.

Financing of Research , Development and Pre-seed stage, introduction

We do not advise on specific means of Funding or Financing, but offer an overview. 

Depending on the size of the market and project, and the funders' expertise, the types of funding and funders--- may be different.

A few general observations are that private funders and investors like to be close to the project geographically. Of course, you must search for the few who may fund in your sub-field or niche.

There are many options and avenues, but the standard VC's may expect the highest returns and ownership (especially if you fail a milestone), usually within 3 to 4 years, of actual revenues and producing assets and IP properties.

There are smaller, and perhaps simpler approaches, but unlike larger investment bankers, the funds are much smaller ($300,000 to $5 million) yet the regulations may be even stricter as smaller investors are less "sophisticated". The biotech field is complex, so thereby there are fewer "sophisticated" investors, as defined by SEC and state regulators. 

Alternatives could be discussed when we are engaged, but all formal Funding advice must be from registered securities dealers,  investment bankers or securities lawyers. 

Such one or two alternatives to "offerings" are narrow and still have some restrictions, but always.. full risk disclosures remain required <------. 

You should study definitions and yourself become knowledgeable, and as to what a "sophisticated investor" is, as you likely become the main shareholder.

Know 3 things well: 

   1) Never publicly advertise an "investment"; That's illegal.

  2) The key definition is any projection of "passive income" (from Profits) or "part ownership (equity), to an investor who is not a partner involved in management or operations (hence, a passive investor); 

The mere suggestion of possible PROFIT creates a "Security" , highly-regulated.

Read some SEC broad definitions of "Securities". and Cornell

Landmark case SEC vs Howey, 1946 (good example)

  3) Profit vs Revenues-based part of SEC definition: A key word in stock (equity) and securities--- is whether a right to a fraction of "profits" (if any) is conferred. Conversely, Royalties, or advances on royalties from part of future revenues, and some short term (under 9 month) debt may not be a security. (The latter may be a security , if the lender is not "sophisticated", or not all risk is disclosed). Only a professional can advise you.

If you look to small equity offering,  a "Boutique Investment Banker" in your field, or a wealth advisor who has the right contacts, including lawyers for "deals", or a growth company seeking IP to re-sell.

Be aware: some lawyers are called "deal killers".

If going through an investment banker, expect to pay him/her and the lawyer about 18% of funds raised.

 
The possible other avenues, mentioned in 3) above, we can not advise on or recommend. 

But, Licenses and Royalties are typically based on "Revenues" (sales, not profits), so may have some regulatory advantages, particularly if the Royalty holder is sophisticated (in the field, wealthy, knowledgeable--- or might "participate" in a "non-passive" role).

We are adding a page on aspects of this pre-seed funding.

Caution:Do not expect investment bankers, angels, brokers or lawyers to suggest alternatives to conventional stock offerings. That's against their interests and specialties.

A TopPhDConsultant aids critical decisions and whom to seek, with feasibility, and time estimates for the selected Funders.

(NOTE: This is not a solicitation for any investment or offering, nor any specific advice. 

Nothing here is legal advice-- seek competent legal counsel specialized in the field)

The key before the financing stage remains,-- to be considered by a large funder-- is having competent independent outside scientific review , as above, for feasibility, proof, proper design, proper emphasis and guidance on this difficult path to quality and commercial scalability.

A TopPhD-biotechConsultantt  can help both venture funders and concept creators in these areas.

 
Funders want an outside scientist to confirm that your concept is viable and potentially very profitable and scalable. That is where we come in.

Contact Us early. Limited availability.

[1] These special structures for Pre-seed Research and proof of concept are outside of a TopPhDConsultant expertise.  Be aware that pre-seed is a very special stage with unusual demands on funders-investors who must have depth of investment success and knowledge in the sector,,, Plus reasons for some confidence from an expert outside scientific opinion.

Special Financing Structures for Pre-seed, Research, Proof phase.

NOTE about hazards of pre-eed phase:

In the finance of the "new venture" biotech innovation research and development stage, there are unique structures and requirements, due to possible lengthy times for the R & D (pre-seed) stage… having no revenue, no cash flow nor assets, needing expensive resources, with considerable uncertainty.

BUT ! .... 

"However, biotech investors pour millions into these projects, with some patience, when the innovation has a fair prospect to potentially scale to wide application, a strong market and a high price."  RS

As consultant , we aid that critical decision, supporting proof, with time estimates, and planning-projections.

The key is competent independent outside scientific review emphasizing quality, results, productivity and scalability.