編者按：“讓天下沒有難做的藥，難治的病”，是初心，更是愿景。自成立以來，藥明康德步履不停：從一間實(shí)驗(yàn)室，到覆蓋亞洲、歐洲和北美的全球網(wǎng)絡(luò)。從早期的化學(xué)合成服務(wù)，到貫穿研究（R）、開發(fā)（D）和生產(chǎn)（M）的一體化平臺。從第一位客戶，到全球三十多個(gè)國家的數(shù)千合作伙伴。不斷發(fā)展的，是規(guī)模與能力；始終堅(jiān)守的，是夢想與承諾。

致敬來時(shí)路，共譜新篇章！在這一系列訪談中，我們以“逐夢者”視角，回顧藥明康德成長發(fā)展的崢嶸歲月，回望賦能客戶創(chuàng)新的并肩往事，更以獨(dú)特的“藥明精神”展望未來新篇章。

張永斌博士始終記得那個(gè)瞬間，和當(dāng)天會(huì)議室里柔和的燈光。

那天，是一場與患者面對面的會(huì)議，一位曾患有產(chǎn)后抑郁癥的母親含著淚說：“我終于能笑著抱起我的孩子了。”

那時(shí)張永斌博士還是一位年輕的毒理學(xué)家，面對一款幾近被放棄的產(chǎn)后抗抑郁新藥，所有人都看到了藥物相關(guān)的安全性風(fēng)險(xiǎn)，但他還是選擇了再試一試——在數(shù)據(jù)深處，不放過任何一絲希望。他設(shè)計(jì)研究，反復(fù)驗(yàn)證，尋求機(jī)會(huì)為藥物正名。最終這款藥物活了下來，走向臨床，走進(jìn)了患者的生活。

當(dāng)獲得患者肯定的那一刻，他所有的通宵復(fù)核、所有質(zhì)疑與壓力，都變成了值得。

從毒理學(xué)家到賦能者

從早年的獸醫(yī)學(xué)到神經(jīng)科學(xué)，再到與新藥研發(fā)結(jié)緣，多年后掌舵藥明康德全球毒理業(yè)務(wù)，成為藥明康德副總裁，全球毒理業(yè)務(wù)負(fù)責(zé)人，這一路走來，張永斌博士始終相信：毒理學(xué)不只是識別危險(xiǎn)的信號，更需要為真正有價(jià)值的希望，披荊斬棘，照亮前路。

“是藥三分毒”，用藥的審慎古已有之。現(xiàn)代新藥研發(fā)中依然如此：療效可以優(yōu)化，但嚴(yán)重的副作用往往被“一票否決”。這背后的判定依據(jù)，就是毒理學(xué)。

人們常以為它只看“致癌、致畸、致突變”——三道生死線。但張永斌博士說，現(xiàn)代毒理遠(yuǎn)不止如此。它需要在藥物進(jìn)入人體前，全面排查藥物對肝、心、腎、神經(jīng)等器官的潛在傷害，評估劑量與風(fēng)險(xiǎn)，預(yù)測長期影響。

毒理學(xué)像是新藥的“哨兵”，守住安全底線，篩掉危險(xiǎn)分子，讓真正值得的藥物安心走向患者，避免臨床階段代價(jià)昂貴的失敗。

“毒理是研發(fā)中最令人敬畏的一環(huán)，卻也正是它的價(jià)值所在。”張永斌博士指出。

圖片來源：123RF

如今，張永斌博士帶領(lǐng)著一支超過千人的GLP毒理團(tuán)隊(duì)，在近百萬平方英尺的先進(jìn)設(shè)施內(nèi)，數(shù)千項(xiàng)研究同步運(yùn)轉(zhuǎn)。但他深知，真正的實(shí)力不僅僅在于規(guī)模，而在平衡——讓速度與質(zhì)量共生。

在生物醫(yī)藥的創(chuàng)業(yè)浪潮中，許多初創(chuàng)Biotech團(tuán)隊(duì)僅有十幾名成員，卻懷揣著改變疾病的愿景。然而，他們往往缺少毒理、DMPK或法規(guī)事務(wù)等關(guān)鍵職能，難以獨(dú)立推進(jìn)新藥進(jìn)入臨床。

對這些企業(yè)而言，藥明康德不僅是服務(wù)方，更是不可或缺的“研發(fā)基礎(chǔ)設(shè)施”。客戶往往只需要與一個(gè)項(xiàng)目組對接，即可推動(dòng)從研究設(shè)計(jì)、實(shí)驗(yàn)執(zhí)行、數(shù)據(jù)分析到IND申報(bào)的全鏈條工作。

“我們不僅僅是在提供服務(wù)，也是在幫客戶實(shí)現(xiàn)夢想。”張永斌博士說。

正因如此，團(tuán)隊(duì)常常主動(dòng)提速——有些項(xiàng)目比原計(jì)劃提前兩到三個(gè)月完成交付。“在生物醫(yī)藥領(lǐng)域，這幾月的差距，可能就是生與死的距離。”

“沒有質(zhì)量支撐的速度毫無意義。”他進(jìn)一步指出，“關(guān)鍵在于我們?nèi)绾我钥茖W(xué)、精確和透明的方式設(shè)計(jì)每一項(xiàng)研究，使結(jié)果能在全球范圍內(nèi)經(jīng)得起檢驗(yàn)。”

他的團(tuán)隊(duì)積累了對FDA、EMA和NMPA等監(jiān)管框架的豐富經(jīng)驗(yàn)。“報(bào)告不僅要出得快，更要無懈可擊，”張永斌博士始終堅(jiān)信。每一份方案都要經(jīng)過多層審查，每一組數(shù)據(jù)在提交前都要核驗(yàn)無誤，每一個(gè)結(jié)論都必須經(jīng)得起監(jiān)管問詢——因?yàn)楸澈螅且患壹页鮿?chuàng)企業(yè)的融資命脈，也是一位位患者早日用藥的希望。

高效的自動(dòng)化也正在改變毒理學(xué)的運(yùn)作模式。藥明康德構(gòu)建了自主研發(fā)的智能排程與可視化系統(tǒng)，如同一張敏銳的神經(jīng)網(wǎng)絡(luò)，實(shí)時(shí)追蹤每一項(xiàng)研究的進(jìn)展：從樣本流轉(zhuǎn)、設(shè)施使用，到人員調(diào)度與數(shù)據(jù)生成。系統(tǒng)在執(zhí)行海量的項(xiàng)目管理的同時(shí)，能有效提示并規(guī)避潛在風(fēng)險(xiǎn)。

“我們構(gòu)建了一個(gè)能在變量變成錯(cuò)誤之前就識別它的自動(dòng)化平臺，”張永斌博士說，“這讓速度與質(zhì)量得以兼顧。”

在這里，科學(xué)嚴(yán)謹(jǐn)與創(chuàng)新效率從來都并行不悖。

從分子到市場的全程伙伴

“藥明康德與客戶之間的合作，通常并不局限在單一環(huán)節(jié)，而是貫穿分子全生命周期的長期合作。” 張永斌博士笑著說，“我們更像是陪跑整個(gè)馬拉松的伙伴。”

在藥明康德的一體化生態(tài)系統(tǒng)中，毒理學(xué)服務(wù)并非孤立的安全審查節(jié)點(diǎn)，而是自項(xiàng)目早期就與DMPK、生物分析、生物學(xué)、CMC及法規(guī)事務(wù)等團(tuán)隊(duì)深度協(xié)同。上游研究中積累的經(jīng)驗(yàn)與洞察，能夠無縫傳遞至毒理設(shè)計(jì)環(huán)節(jié)，幫助有效決策。

“我們與上游的團(tuán)隊(duì)可能只隔著一條走廊，但這條走廊連接的是效率與精準(zhǔn)。”張永斌博士說。

在藥明康德CRDMO一體化平臺上，知識的連續(xù)性成為破局的關(guān)鍵。

在創(chuàng)新藥研發(fā)的前沿，傳統(tǒng)的毒理學(xué)“標(biāo)準(zhǔn)手冊”正逐漸失靈。對于許多分子，尤其是多肽、寡核苷酸或其偶聯(lián)體等新型藥物模態(tài)，傳統(tǒng)的毒性學(xué)“劇本”往往不再適用：每一種分子可能需要定制化的檢測法、專門的分析手段或不同的動(dòng)物種屬選擇。

“這些新分子，各有獨(dú)特之處。”張永斌博士指出，“從檢測方法到給藥方式，從靶器官分布到動(dòng)物種屬選擇，任何細(xì)節(jié)都可能影響安全性判斷。千篇一律的時(shí)代已經(jīng)過去。”

在實(shí)踐中，這意味著藥明康德提供的服務(wù)遠(yuǎn)不止實(shí)驗(yàn)執(zhí)行。當(dāng)客戶提交一個(gè)復(fù)雜或首創(chuàng)性的分子，尤其是缺乏既往毒理學(xué)參考時(shí)，毒理團(tuán)隊(duì)并不會(huì)只是接收并執(zhí)行現(xiàn)成的方案；他們會(huì)與客戶共同分析分子結(jié)構(gòu)、作用機(jī)制與潛在風(fēng)險(xiǎn)，共同制定檢測策略、確定合適的種屬與劑量遞增邏輯，并確保研究與既定的臨床路徑相一致。

幾年前，一家新興生物科技公司手握一款靶向RNA的創(chuàng)新藥——科學(xué)前沿，潛力驚人，但前路茫茫：該藥物在體內(nèi)的分布特征尚不明確，是否存在對正常組織的脫靶毒性？應(yīng)選用何種模型以更準(zhǔn)確地預(yù)測人體反應(yīng)？諸多關(guān)鍵問題缺乏成熟先例可循。

從初始的實(shí)驗(yàn)設(shè)計(jì)，藥明康德IND一體化項(xiàng)目團(tuán)隊(duì)即與客戶緊密協(xié)作，系統(tǒng)評估給藥途徑、模型選擇、分析方法適配性等關(guān)鍵技術(shù)路徑。

隨著項(xiàng)目推進(jìn)，一項(xiàng)核心挑戰(zhàn)浮現(xiàn)：該RNA藥物依賴脂質(zhì)納米顆粒（LNP）進(jìn)行遞送，而這類制劑的毒理評估，當(dāng)時(shí)還沒有成熟路徑可循。面對這一科學(xué)難題，藥明康德迅速整合內(nèi)部資源，聯(lián)動(dòng)藥物代謝與動(dòng)力學(xué)（DMPK）、制劑開發(fā)及毒理研究三大專業(yè)團(tuán)隊(duì)，構(gòu)建跨學(xué)科協(xié)同的快速驗(yàn)證機(jī)制。在不到三個(gè)月的時(shí)間內(nèi)，成功建立評估體系，并按時(shí)完成全套符合GLP規(guī)范的毒理學(xué)研究。

當(dāng)客戶如期向監(jiān)管機(jī)構(gòu)提交IND申請時(shí)，由衷地表示：“如果沒有藥明康德一體化的服務(wù)模式，我們不可能按時(shí)完成此次IND申報(bào)”。

圖片來源：123RF

這句認(rèn)可，正是對“一體化平臺”最生動(dòng)的注解——不是單點(diǎn)輸出，而是環(huán)環(huán)相扣；不是被動(dòng)執(zhí)行，而是主動(dòng)共創(chuàng)。科學(xué)無孤島，環(huán)節(jié)皆相連。在這里，毒理不是制動(dòng)，也可以是通往臨床的加速器。

這背后是客戶對質(zhì)量與信任的雙重依賴。張永斌博士強(qiáng)調(diào)，“他們選擇我們，不僅僅是因?yàn)槲覀兛欤且驗(yàn)槲覀兎€(wěn)。”他補(bǔ)充道，“溝通透明、質(zhì)量可靠，才能成為真正值得托付的伙伴。”

這種信任，歷經(jīng)時(shí)間淬煉。“有許多合作伙伴已經(jīng)與藥明康德合作過十幾年。”一家生物技術(shù)公司與藥明康德多年來始終并肩前行，最終將其分子推至美國獲批，成為同類首個(gè)上市產(chǎn)品。

“你們是唯一一家能在不走捷徑的前提下，比我們預(yù)期更快交付成果的合作伙伴。”客戶給出了這樣的評價(jià)。

為毒理學(xué)的未來做準(zhǔn)備

每一款新藥的研發(fā)都像一場未知的旅程，在毒理學(xué)的世界里，未知從未缺席。

“毒理學(xué)充滿復(fù)雜性，但正因如此，我們才更要用專業(yè)，讓未知變得可解，讓創(chuàng)新更有把握。”張永斌博士說。

毒理學(xué)領(lǐng)域正經(jīng)歷一場悄然卻深刻的變革。

長久以來，毒理評價(jià)依賴動(dòng)物模型——但其實(shí)沒有任何一種動(dòng)物，能完全復(fù)制人類的生理反應(yīng)。“理想與現(xiàn)實(shí)之間，始終存在差距。”張永斌博士指出。

而這道縫隙中，正生長出新的希望。監(jiān)管機(jī)構(gòu)鼓勵(lì)減少動(dòng)物使用，同時(shí)新型科研工具正走向成熟。張永斌博士并不視其為顛覆，而是一場科技的演進(jìn)。未來在于構(gòu)建多模式、人類相關(guān)的預(yù)測體系，讓動(dòng)物數(shù)據(jù)、體外數(shù)據(jù)與組學(xué)數(shù)據(jù)相互印證與強(qiáng)化。

張永斌博士并不認(rèn)為某種模型會(huì)取代另一種，他所預(yù)見的未來是由互補(bǔ)單元構(gòu)成的、更精確且更人性化的體系：某類模型負(fù)責(zé)承載最接近人類生物學(xué)的信息；其它研究則在最具預(yù)測力的環(huán)節(jié)被有選擇地應(yīng)用；所有產(chǎn)生的結(jié)果會(huì)不斷回流，用于方法的持續(xù)迭代優(yōu)化。

“一個(gè)更快、更準(zhǔn)、更以人為本的安全評估也許就在不遠(yuǎn)的將來。”張永斌博士充滿期待，“這場浪潮不會(huì)一蹴而就，依然會(huì)有很多挑戰(zhàn)，但方向清晰可見。而我們，也正站在這個(gè)潛力無限的十字路口。”

不放棄任何一個(gè)可能

身為藥明康德副總裁，全球毒理業(yè)務(wù)負(fù)責(zé)人，張永斌博士常說：“每一位患者，都應(yīng)獲得安全的療法。”

這句話聽起來簡單，卻重如千鈞。因?yàn)樵谒劾铮幟骺档露纠聿坎恢皇亲鰧?shí)驗(yàn)的地方，更是守護(hù)希望的一道防線。

在藥明康德的實(shí)驗(yàn)室里，每一個(gè)數(shù)據(jù)、每一份報(bào)告，都連著千里之外某個(gè)未曾謀面的人——一位患者，一場等待。

“讓天下沒有難做的藥，難治的病”——這不僅是藥明康德的愿景，也是他心中的信念。無論客戶是實(shí)力雄厚的大型藥企，還是初出茅廬的Biotech，只要帶著科學(xué)的夢想走來，藥明康德就會(huì)用專業(yè)和信任，陪他們跨過從實(shí)驗(yàn)室通往臨床的高山大海。

“我們不是在做項(xiàng)目，”他說，“是在為每一個(gè)可能被改變的生命爭取機(jī)會(huì)。”

正因如此，任何一項(xiàng)研究都應(yīng)該得到最專業(yè)嚴(yán)謹(jǐn)?shù)脑u判。哪怕是一款曾被認(rèn)為“沒希望”的藥物，在當(dāng)年那位年輕毒理學(xué)家堅(jiān)持追查下，最終發(fā)現(xiàn)其安全性可控——后來，才有機(jī)會(huì)幫助無數(shù)產(chǎn)后抑郁女性重新感知生命的美好。

在張永斌博士心中，所謂創(chuàng)新，不只是突破技術(shù)，更是不放棄任何一個(gè)可能。

“那就是我至今熱愛這份工作的原因。”他輕聲說，仿佛又回到了多年前那場決定一款藥物命運(yùn)的評審會(huì)議。

所愛隔山海，山海也可平。不放棄，成功才有可能；安全了，希望才能出發(fā)。

Guardians of Drug Safety

Editor’s Note: “Every drug can be made, and every disease can be treated.” Since 2000, from a single laboratory to a global network spanning Asia, Europe, and North America; from early chemical synthesis services to an integrated platform that connects Research (R), Development (D), and Manufacturing (M); from its very first customer to thousands of partners across more than 30 countries, WuXi AppTec has never stopped moving forward to realize its enduring vision.

In tribute to the journey, we look back through the eyes of our “dream-makers”: revisiting the stories of partnership that empowered global innovation, and the unique spirit that continues to guide us toward the next chapter.

The first time Dr. Robert Zhang realized the power of toxicology, it wasn’t in a textbook or a lab notebook, but in a conference room.

A small molecule for postpartum depression had just cleared its final round of review. Years earlier, the program had stumbled on toxicity data that nearly halted development. But Zhang, then a young toxicologist, saw a path forward. Through painstaking study design and reevaluation, his team helped the company reframe its safety data and prove the drug’s potential.

Months later, at a meeting with patients and their families, Zhang listened as new mothers described how the therapy had lifted them from the fog of depression. “Their gratitude,” he says, “made every late-night data review worth it.”

That moment crystallized for him what toxicology really means: not just testing for harm, but safeguarding hope.

From Toxicologist to Enabler

A veterinarian by training and a neuroscientist by passion, Zhang has spent more than two decades studying how medicines interact with biology.

Today, as Global Head of Toxicology at WuXi AppTec, Zhang brings that same scientific rigor and curiosity to an even larger landscape: a global, integrated CRDMO platform spanning research, development, and manufacturing.

“Toxicology is the sentinel of drug development,” he says. “We are the guardians at the gate, ensuring safety, accelerating progress, and preventing costly failures downstream.”

Image source: 123RF

At WuXi AppTec, Zhang leads one of Asia’s largest GLP (Good Laboratory Practice) toxicology networks, with state-of-the-art facilities totaling nearly a million square feet. Yet scale alone, he insists, isn’t what creates “WuXi Speed.”

“Speed without quality is meaningless,” he says. “What matters is how we design every study scientifically, precisely, and transparently, so that results can stand anywhere in the world.”

His teams draw on experience across regulatory frameworks from the FDA, EMA, and NMPA. Every protocol undergoes multi-layered review; every dataset is verified before submission. “A study report must not only be fast, it must be flawless,” Zhang explains. “That’s how our clients earn approvals faster and sleep better at night.”

Automation has also transformed how toxicology runs. WuXi AppTec’s proprietary scheduling and visualization system tracks hundreds of studies simultaneously, optimizing animal use, staff allocation, and data integrity. “We built an automated platform that sees every variable before it becomes an error,” Zhang says. “That’s what allows speed and quality to coexist.”

A Partner from Molecule to Market

Within WuXi AppTec’s integrated ecosystem, toxicology is not an isolated checkpoint: it is a connected arc of science that begins as early as molecule discovery.

“Our work is not a transaction,” Zhang says. “It’s a relationship that often spans the entire life of a molecule.”

WuXi AppTec’s toxicology teams work side-by-side with DMPK, bioanalysis, biology, CMC, and regulatory experts from the very first experiments. Results from early screening flow seamlessly into toxicology study design, minimizing rework, reducing handoff errors, and accelerating decisions.

This continuity, Zhang emphasizes, is one of the platform’s greatest strengths. For many molecules, especially novel modalities like peptides, oligonucleotides, or their conjugates, traditional toxicity playbooks may no longer apply. Each molecule may require customized assays, specialized analytical methods, or unique species selection. Having the biology team that helped discover the molecule only a hallway away from the toxicology team that will evaluate it creates a level of coherence few organizations can achieve.

In practice, this meansWuXi AppTec does far more than run studies.When a client brings in a complex or first-in-class molecule, particularly one without established toxicology precedents, the toxicology team shapes the assay strategy, determines the appropriate species and dose-escalation logic with the customer, and ensures the study is aligned with the intended development path.

Zhang recalls a recent program for a rare-disease molecule that offered few regulatory precedents to guide its development. To meet that challenge, WuXi AppTec assembled toxicology team leaders and senior pathology experts to design a tailored evaluation strategy grounded in the molecule’s structural features for the client. The result was a toxicology package that cleared FDA review smoothly, and within the client’s targeted submission window, demonstrating how finding the solution together accelerates progress without compromising rigor.

Image source: 123RF

“Clients choose us because our quality is consistent, our communication is transparent,” Zhang says. “Our collaboration is built on partnership.”

Trust, he adds, is earned over time. Zhang recalls one long-time partner, a biotech whose molecule, shepherded through WuXi AppTec’s non-clinical pipeline, became the first of its kind approved in the U.S. “They’ve worked with us for thirteen years,” he says with quiet pride. “At one point, they told us: ‘You’re the only partner who delivers faster than our expectations—without ever cutting corners.’”

Preparing for the Future of Toxicology

The field of toxicology is undergoing a quiet but profound shift. Regulatory agencies are encouraging reduction of animal use, and new scientific tools are rapidly maturing. Zhang sees this not as disruption, but evolution.

For years, toxicology relied primarily on animal models. But, as he notes, no animal can perfectly reflect human biology. The future lies in creating multi-model, human-relevant prediction systems, where animal data, in vitro data, and -omics data reinforce each other.

Rather than one model simply replacing another, Zhang envisions a more precise and humane system built from complementary parts: one type of model will anchor the most human-relevant biology; other studies will be applied selectively where they are most predictive, and results generated will continuously flow back to refine every model and assumption. “We are preparing for a world where safety prediction is faster, more accurate, and more human-centered,” he says. “That is where the field is going, and we are already preparing for it.”

Every Patient Deserves Safe Medicine

As the industry moves toward human-relevant testing, Zhang envisions WuXi AppTec’s toxicology unit as both innovator and bridge-builder, linking regulatory science with discovery, technology with humanity.

“Our vision, ‘Every drug can be made, and every disease can be treated,’ is not just a slogan,” he says. “For us, it means every program deserves a fair chance, and every patient deserves a safe medicine. If we do our job right, no therapy will be held back due to incomplete safety knowledge.”

He pauses thoughtfully, recalling that toxicology review meeting years ago and the women whose lives changed because a young toxicologist refused to give up on a risky idea.

“That,” he says softly, “is why I still love this work.”

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