Lesson Plan Rationale Template Five Important Facts That You Should Know About Lesson Plan Rationale Template

Dennis P. Schafer explains how in-licensing drugs can be a action for growing a biotechnology startup bound and cheaply.



lesson plan rationale template
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Book trailer Lesson Plan Project – lesson plan rationale template | lesson plan rationale template

Scientist–entrepreneurs generally ask how adventure capitalists appraise their new technologies and business plans. Optimistically, the bioentrepreneur hopes that the broker will set abreast all ageism and analyze the abstraction with beginning and acquisitive eyes, thereby acquainted the arresting abeyant of the opportunity. In reality, however, investors attending at a new befalling in abundant the aforementioned way as scientists attention a new discovery—with concern and absorption but additionally through the filters of acquaintance and preference. In this context, broker preferences about “business models” additionally apply. Here we altercate one business archetypal that currently finds favor with investors—in-licensing.

Venture capitalists favor assertive business models over others, application these as templates aback evaluating new plans. An broker adeptness acumen as follows: “In my experience, archetypal A can assignment if you do it right, but archetypal B never works. And this plan looks like B—so, balloon it.” What the administrator needs is an broker who will say, “These guys are a bit abashed about their strategy, but if you change a few things this accord could attending a lot like A, and A works if you do it right.” The broker will afresh be able-bodied on his way to autograph a check.



Much like accurate theories, business models go in and out of fashion. Aback Genentech (S. San Francisco, CA) led the industry in the aboriginal 1980s, investors were absorbed alone in companies that could become absolutely chip biologic companies (FIPCOs). Aback the bazaar angry sour, FIPCOs went from Holy Grail to fool’s gold. But today, FIPCOs are already afresh aback in favor.



Indeed, business models can acceleration in acceptance with arresting speed—consider the contempo affection for “tool-kit” companies and any aggregation whose technology had an “-omics” appendage. But models can additionally appear added gradually, defective to prove themselves at every turn.

And the in-licensing archetypal fits the additional description. Apathetic to become popular, in-licensing is now fashionable with some investors, mainly because of its adeptness to advance the accumulated development process. However, the archetypal has been apathetic to mature, because it is difficult to accretion articles acceptable for in-licensing, and best scientists still ask, “Why bother?”

Although adventure capitalists began authoritative cogent investments in in-licensing companies during the mid-1990s, the archetypal has a added admirable history. On the artefact accumulation ancillary of the in-licensing transaction, ample biologic companies accept for some time exchanged both launched and development-stage articles with one another, swapping them in affairs that rationalize the companies’ artefact portfolios and development pipelines. For example, a aggregation with business backbone in cardiovascular articles adeptness bandy late-stage articles with a aggregation able in, say, endocrinology, should a artefact appearance added affiance in one analytic breadth than the other. Alternatively, a aggregation that has added applicable preclinical projects that it can fund, but a abridgement of artefact candidates at the appearance 3 balloon stage, adeptness barter one or added of the preclinical projects as fractional advantage for a applicant in appearance 3.

The ascent course of mergers aural the biologic industry has accelerated this trend (see Fig. 1). Aback two companies merge, accordingly acceptable projects are annulled and the development of assertive articles is halted. Indeed, in some ample research-based biologic companies, out-licensing has become a academic function. Although aloof a few years ago best sellers would alone accede licensing to added multi-national biologic companies, today they accept to stoop lower in the “food chain” to accretion accommodating partners. This provides an befalling for startups.

© Bob Crimi

Source: CenterWatch, In Vivo.

On the appeal ancillary of the transaction, the roots of the in-licensing business archetypal are aloof as abysmal but conceivably beneath able-bodied understood. Put simply, it is far easier to body a aggregation (around absolute products) than it is to attend a accurate assay bottomward the continued and cher aisle to acceptable a bankable product. Architecture a aggregation is centered on the about low-risk action of recruitment, which is no altered for biotechnology than for any added industry. Developing new articles from basal discoveries is a long, aerial action abounding with risk. Indeed, this is attempted in few industries, and it about fails added generally than it succeeds in companies both big and small.

lesson plan rationale template
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Unit Lesson Plan Template – 8+ Free Sample, Example .. | lesson plan rationale template

In fact, abortion is accustomed and assured in the biotechnology industry—both technically and commercially. But companies abort beneath frequently than products. As the biotechnology industry has matured, a growing cardinal of accustomed and acknowledged companies accept emerged, which are able-bodied staffed, scientifically accomplished, able-bodied managed, and able-bodied funded—but which accept bootless articles or technologies. Aloof like the emperor in his new clothes, some of these companies strut appreciative as peacocks bottomward Wall Street until their banal amount crashes amidst snickers of acceptance by investors that they accept no actuality and their banknote affluence dry up. Some companies, abbreviate of cash, advertise themselves, generally aloof for pennies on the invested dollar. However, the astute and able-bodied adjourned reinvent themselves: acquainted that their aboriginal technologies bootless through the abrasion accustomed to such a chancy industry, they admission new technologies or accustomed articles and alpha again.

The in-licensing business archetypal originates from this action of reinvention. Typically, aback companies ability this crossroad they are managed by accomplished exiles of the biologic industry. These admiral appearance this bind as artlessly addition adaptation of the action botheration faced by the biologic industry, and so they accept addressed the botheration in absolutely the aforementioned way, accepting articles from the area of the industry with which they were accustomed (and sometimes alike from their antecedent employer).

Early examples of companies that acquired launched articles beneath these affairs accommodate Athena Neuroscience (S. San Francisco, CA), Gensia (Irvine, CA), and Dura Pharmaceuticals (San Diego, CA). These companies now abatement into the chic of alleged “specialty pharmaceuticals”—companies that admission and bazaar articles in specific ameliorative areas such as dermatology, neurology, or respiratory medicine. Today, leaders in specialty pharmaceuticals accommodate King Pharmaceuticals (Bristol, TN), Elan Pharmaceuticals (Dublin, Eire), and Forest Laboratories (New York), which accept absolute revenues and ample bazaar capitalizations. Biologic sales and business are axial apparatus of this strategy—which is of little absorption to scientists starting biotechnology companies—and specialty biologic companies are not discussed added in this article.

The additional solution, to admission one or added articles still in preclinical or analytic development, is the abettor of the in-licensing model. Companies congenital on this action may alpha with articles adequately avant-garde in development, and their focus is on artefact development and launch. The abilities complex are accordingly medical and clinical, rather than apropos to discovery. Typically, however, in-licensing companies do not advance sales and business skills, and will seek ally to commercialize their products.

The aboriginal aggregation to accomplish a above success of this strategy, which some adeptness altercate happened accidentally, was Agouron Pharmaceuticals (San Diego, CA). A protein crystallography aggregation founded in 1984, Agouron formed a affiliation with Eli Lilly (Indianapolis, IN) to ascertain antiviral drugs. In 1994, Lilly concluded the partnership, which larboard Agouron the buyer of a Lilly admixture that it afterwards avant-garde as its advance analytic candidate. The constant drug, Viracept, has become a accepted assay for AIDS, and its success led to the accretion of Agouron by Pfizer in what still stands as one of the bigger mergers in the history of the biotechnology industry.

The amount of in-licensing

So what are the bread-and-butter allowances of in-licensing? Table 1 outlines academic estimates of what it adeptness amount to advance a artefact to appearance 2 trials, which is not alone a key date of validation for the artefact but additionally a acute anniversary for the appraisal of the aggregation for investors.

The abstracts appearance that a aggregation can admission a artefact for a bashful up-front fee, conduct basal tests in bodies (to appearance 2) for the ambition indication, and ability an adorable banking position rapidly and (relatively) inexpensively (column 3 of Table 1). Reaching this date costs more, and takes longer, for a startup (column 2 of Table 1). The key aberration amid the two is accumulated build-out—the amount of putting an alignment in place. Bodies charge be recruited, which takes time, and they charge be paid during the process, which takes money. Nevertheless, architecture organizations is article that adventure capitalists are acceptable at, authoritative it a adequately low-risk activity. Although the amount of any basal can be debated, it is bright that in-licensing is a cheaper, faster way to alpha a biopharmaceutical aggregation than architecture one about a new technology.

More importantly, in-licensing is a faster way to ability “payoff.” In adventure investing, the adjustment about consistently occurs aback the aggregation goes accessible at a appraisal that produces a ample acknowledgment on the aboriginal investment. The appraisal for a set of accessible biotechnology companies advised adjoin their date of artefact development is apparent in Figure 2. The assignment is simple: the bazaar rewards advance in analytic development, and until analytic development begins, aggregate is account about the same—not actual much.

© Bob Crimi

Source: Burrill & Co., and Ernst & Young, 1997.

The accord amid amount and date of artefact development has afflicted little over time, with slight accouterment depending on bazaar sentiment. However, the blueprint highlights the goals for the aggregation architect and, critically, the founding adventure capitalist: they charge get to the articulation believability of the ambit as fast as they can and with as little advance as possible.

Today, the big articulation believability are (i) antecedent appearance 2 results, which advance ability (ii) avant-garde appearance 3 trials, which advance to a New Biologic Application (NDA), and (iii) bazaar launch. The catechism is which articulation point should a architect aim for? This accommodation is afflicted by how able-bodied adjourned the aggregation is. Best aboriginal date companies and aboriginal date investors are affected to apply on the aboriginal articulation point—phase 2, affidavit of concept. At this stage, a aggregation can activate to action a accurate artefact applicant to abeyant partners, and can activate to allocution to underwriters of the antecedent accessible alms with a beeline face. At this stage, a aggregation can additionally aggrandize its clandestine financings from a scattering of aboriginal date adventure capitalists to balustrade and crossover investors, who address bigger checks and will advance at college valuations.

Most investors would rather ability the articulation point at appearance 2 afterwards 1–2 years at a amount of $3–4 actor than afterwards added than 4 years at a amount of $15 actor (Table 1). And that—in a banking nutshell—is the account for the in-licensing archetypal for biopharmaceutical startups.

And that, no doubt, is area abounding scientists will allotment aggregation with this analysis. The scientist will altercate that the amount of a technology startup is in its change and adroitness and not its low cost. Afterwards all the time and investment, a scientist–entrepreneur wants a aggregation that is added than an in-licensing endeavor. Why bother if all there is to activity is developing the bootless articles of biologic giants?

It is a accurate perspective, and a arduous question. One acknowledgment is that in-licensing is a acknowledged agency to an end. If in-licensing speeds progress, and if it is constant with the accurate goals of the founders, it can be a apparatus for allotment innovation, rather than an addition to innovation.

Esperion (Ann Arbor, MI) provides an apt analogy (Table 2). Founded in 1998 with baby investments by Oak Ventures and Scheer and Company, Esperion recruited a administration aggregation with accurate success in developing lipid-lowering drugs and acquired a accordant late-stage preclinical biologic applicant fabricated accessible by the alliance of Pharmacia and Upjohn. By the time Esperion went accessible in 2000, it had amorphous analytic trials on its aboriginal product, had additionally accustomed its own analysis programs, and acquired several added cardiovascular biologic candidates and technologies, some added agitative than the aboriginal candidate. By starting with a accountant artefact in development, Esperion fabricated faster advance and aloft added money to armamentarium its own atypical programs than acceptable would accept been accessible had the aggregation started with able analysis programs but no biologic in development.

The ultimate allure of the in-licensing archetypal is that, done right, artefact accretion brings accelerated advance in artefact development, which allows fundraising above that accessible for best technology startups. In turn, balance funds aloft can abutment added advancing development of atypical technologies.

In-licensing is absurd to become a ascendant archetypal for biotechnology startups, because such ventures are consistently serendipitous, actuality abased on the availability of artefact candidates. Nonetheless, the cardinal of in-licensing businesses is increasing, and it is accessible to action a few applied believability for those because adopting this business model.

1. You charge to actualize an in-licensing business about bodies with medical and analytic development expertise, and not, as with acceptable start-ups, about bodies focused on basal research. Ability in biologic artefact development and analytic development (at atomic acceptable to administer these functions through a arrangement analysis organization) are critical. Indeed, some in-licensing companies, conspicuously The Medicines Aggregation (Parsippany, NJ), accept arisen to backpack out analytic development faster and added cheaply than a product’s originators. In-licensing companies charge recruit agents from analytic development experts at ample biologic companies and arrangement analysis organizations, a awful aggressive area of the application market.

2. A additional botheration could be acceptable a biologic behemothic to authorization its artefact to your little startup “gnat”; abounding biologic companies accretion it easier to beat the gnats away. You can accomplish yourself a added adorable partner, however, by advertent amount in the artefact that the biologic behemothic did not recognize. For example, in 1999, Assay Therapeutics (now Aderis Pharmaceuticals, Hopkington, MA) acquired a discontinued appearance 2 anti-asthmatic abettor from Bayer (Leverkusen, Germany). Assay had abstracts suggesting that the artefact adeptness be of amount for alleviative branch disease, which was added accustomed by the believability of the company’s awful admired set of medical advisors.

3. The breeze of articles accessible for licensing is neither abiding nor predictable. One way to atom abeyant candidates for in-licensing is to hover about anew alloyed companies, attractive for discontinued projects or disenchanted activity leaders. One aggregation that acquired in this address is Viropharma (Exton, PA). Pleconaril, a assay for RNA viral diseases, was discontinued afterwards Sanofi acquired Sterling Winthrop in the aboriginal 1990s. The scientists complex in pleconaril’s development founded Viropharma, and acquired the biologic in 1995, demography it into appearance 3 trials. The aggregation now has a admired antiviral assay program. In addition example, Novartis (Basel, Switzerland), which was formed by the alliance of CIBA-Geigy and Sandoz in 1996, accustomed a academic out-licensing affairs and a accumulated adventure basic armamentarium (Novartis Adventure Fund) to abutment above CIBA and Sandoz advisers gluttonous to alpha new companies. To date, Novartis has accountant technologies to added than a dozen start-ups.

An addition admission for anecdotic abeyant biologic candidates is to coin relationships with clinicians at medical schools, who may accept insights into new articles that their artist lacks. Academic physicians generally get admission to new classes of biologic agents during actual aboriginal analytic development. These experts, with their affectionate ability of both ache and patients, may be bigger positioned to see how a new analytic account will accessible new markets than are the biologic company’s business administration analysts.

4. To accommodate an in-license successfully, a startup charge accretion a way to arch the gap amid the disparate ethics placed on the artefact by the licensor and licensee. Abounding ample biologic companies set bartering hurdles afore advancing a new admixture into the final stages of analytic development (such as projected anniversary sales of $250 actor or higher), which are appreciably college than those that adeptness be hailed a success for the start-up (as little as $50–100 actor annually). Moreover, for the startup, the primary focus is not on acquirement but on aggregation value, which is apprenticed by success in analytic development (see Fig. 2) alike afore the company’s aboriginal artefact is launched. Those are the differences that accomplish affairs work.

Schafer, D. In-licensing as a business model. Nat Biotechnol 20, BE36–BE39 (2002). https://doi.org/10.1038/nbt0602supp-BE36

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Lesson Plan Rationale Template Five Important Facts That You Should Know About Lesson Plan Rationale Template – lesson plan rationale template
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