OpenBook Executive

𝗦𝗮𝗺𝘀𝘂𝗻𝗴 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗹𝗮𝘂𝗻𝗰𝗵𝗲𝘀 𝗘𝘅𝗲𝗹𝗹𝗲𝗻𝗦™ – 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝗶𝘀𝗶𝗻𝗴 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 𝘄𝗼𝗿𝗹𝗱𝘄𝗶𝗱𝗲 Samsung Biologics unveiled ExellenS™, a unified framework that standardises equipment, processes and functional specifications across its global biomanufacturing network. This approach improves consistency, accelerates tech‑transfer and regulatory review, and enables multi‑plant production to strengthen supply chains. The company’s total capacity is already 784,000 L across five plants. 🔍 𝗦𝗼 𝘄𝗵𝗮𝘁? Harmonisation across sites reduces variability and ensures clients receive the same quality regardless of location. With regulatory agencies focusing on quality‑by‑design and global supply reliability, frameworks like ExellenS could become a competitive differentiator. Smaller CDMOs might need to invest in similar standardisation to remain attractive. 💬 𝗤𝘂𝗲𝘀𝘁𝗶𝗼𝗻: Do you view global standardisation as essential for CDMOs competing on the world stage? How can smaller players replicate such systems without breaking the bank?

I'm hiring. This time for OpenBook Executive I would be interested in speaking to recruiters who want to be part of something a bit different from your normal exec search/rec companies. I'm open to different seniorities, but indeed help on sourcing would be top of my list. What makes OpenBook Executive different? • 𝗠𝗼𝘀𝘁 𝗿𝗲𝗰/𝗲𝘅𝗲𝗰 𝘀𝗲𝗮𝗿𝗰𝗵 𝗳𝗶𝗿𝗺𝘀 𝗵𝗮𝘃𝗲 𝗮 𝘀𝘁𝗿𝗼𝗻𝗴 𝗰𝘂𝗹𝘁𝘂𝗿𝗲 𝗮𝗿𝗼𝘂𝗻𝗱 𝗶𝗻𝘀𝘁𝗮𝗻𝘁 𝗴𝗿𝗮𝘁𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻, especially involving drugs and alcohol, here, if we have a company meet-up or party, it's going to be a hike or a yoga retreat!    • 𝗖𝗮𝗻𝗱𝗶𝗱𝗮𝘁𝗲 𝗮𝗻𝗱 𝗰𝗹𝗶𝗲𝗻𝘁 𝗳𝗲𝗲𝗱𝗯𝗮𝗰𝗸 𝗶𝘀 𝘁𝗵𝗲 𝗺𝗼𝘀𝘁 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗞𝗣𝗜. Happy candidates and clients equal high sales. That means delivering, no lying and deception and being a true long-term partner for companies and candidates.    • 𝗕𝗲𝗶𝗻𝗴 𝗮 𝗱𝗶𝘀𝗿𝘂𝗽𝘁𝗼𝗿. We don't follow the traditional Exec search firm structure or model. This is reflected both in our rates, our terms, our branding our marketing and speed of delivery. The industry needs a shake-up up and we want to be a big part of that.    • 𝗛𝗮𝘃𝗶𝗻𝗴 𝗱𝗶𝗿𝗲𝗰𝘁 𝗮𝗰𝗰𝗲𝘀𝘀 𝘁𝗼 𝗶𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗲𝘅𝗽𝗲𝗿𝘁𝘀 such as our current board members, as well as external coaches with very impressive credentials (People you normally wouldn't have access to) What I'm looking for. • People who are on long-term self-improvement, this is a non-negotiable. • Ideally, recruitment experience, but may consider outside of this case-by-case Location: • Ideally Czech Republic, but may also consider remote in Europe I'll be fully honest that as this would be employee No1 (Excluding board members), I'm still learning and getting a feel for what will work best, so please be mindful/patient with me on this. Interested or know someone? DM me or email [email protected]

The FDA’s New Pilot Could Reshape Generic Manufacturing The FDA just launched a pilot program to fast-track approvals for generics fully manufactured and tested in the U.S. It’s a small policy change with big implications. Less than 10% of global API capacity sits in the U.S., yet over 80% of finished drugs depend on foreign supply. This pilot signals a shift — not just for safety, but strategy. For CDMOs and generics manufacturers, “Made in USA” may soon mean faster reviews, smoother approvals, and more stable contracts. If supply-chain resilience becomes a competitive differentiator, where will your next facility be?

Here are some of the roles we are working on in order of seniority: 𝗦𝗩𝗣 𝗚𝗹𝗼𝗯𝗮𝗹 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗔𝗣𝗜- We are limited on what can be shared here, but if you are a commercial leader in API based in Europe, a conversation can be had.  Location flexible. 𝗚𝗹𝗼𝗯𝗮𝗹 𝗛𝗲𝗮𝗱 𝗼𝗳 𝗤𝗔 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀- This role manages the QA ops for 10 large-scale sites globally. We are looking for someone who's managed large sites (ideally multiple) who comes with strategic thinking and a flair for digital. Location ideally Switzerland or Germany. 𝗖𝗢𝗢- We are looking for someone with significant experience in supply chain in the generics industry. Location can be Switzerland but other locations can be considered. We are limited on what we can share publicly for this, sadly. 𝗕𝗗 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿 𝗔𝗣𝗔𝗖- We are looking for an experienced BD who has a strong track record in generics for the APAC region. We can be flexible on location for the right person. 𝗕𝗗 𝗟𝗶𝗰𝗲𝗻𝘀𝗶𝗻𝗴 𝗗𝗶𝗿𝗲𝗰𝘁𝗼𝗿- Keen to speak with candidates strong in generics licensing (in or out). Must have a strong deal sheet and experience across multiple countries. Location can be flexible for the right candidate. 𝗕𝗗 𝗮𝗻𝗱 𝗔𝗰𝗰𝗼𝘂𝗻𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗿. Similar to above, a commercially savvy BD who can account manage as well as negotiate prices and initiate new business. If you might know someone (Keep in mind they do not need to be looking), please feel free to share. The typical profile we look for is the type of person whose company will be very upset with us for headhunting them from their business.  (Us being super honest) You can contact Matt at [email protected] We do pay for successful referrals.

𝗘𝘂𝗿𝗼𝗽𝗲’𝘀 𝗔𝗣𝗜 𝗕𝗼𝗼𝗺 𝗮𝗻𝗱 𝗪𝗵𝗮𝘁 𝗜𝘁 𝗠𝗲𝗮𝗻𝘀 𝗳𝗼𝗿 𝗚𝗲𝗻𝗲𝗿𝗶𝗰𝘀 Europe’s active pharmaceutical ingredient (API) market is entering one of the most dynamic growth phases in decades. Valued at roughly $49 billion in 2024, it is projected to reach about $80 billion by 2033—an annual growth rate close to 6%. Few other healthcare segments can point to that kind of sustained expansion. Several forces are converging to drive this boom: • 𝗣𝗮𝘁𝗲𝗻𝘁 𝗲𝘅𝗽𝗶𝗿𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗟𝗢𝗘𝘀 are creating fresh opportunities for generic entrants across therapeutic areas. • 𝗚𝗼𝘃𝗲𝗿𝗻𝗺𝗲𝗻𝘁 𝗰𝗼𝘀𝘁-𝗰𝗼𝗻𝘁𝗮𝗶𝗻𝗺𝗲𝗻𝘁 𝗽𝗼𝗹𝗶𝗰𝗶𝗲𝘀 are pushing substitution and tendering, placing APIs at the center of national healthcare strategies. • 𝗧𝗵𝗲 𝗿𝗶𝘀𝗲 𝗼𝗳 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗮𝗻𝗱 𝗯𝗶𝗼𝘀𝗶𝗺𝗶𝗹𝗮𝗿𝘀 is adding demand for far more complex APIs, with regulators already approving dozens of new biosimilars annually. • 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝗶𝗰𝗮𝗹 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝗼𝗻—from single-use bioprocessing to continuous manufacturing—is reducing costs and enabling flexible, multi-product facilities. • 𝗣𝗼𝗹𝗶𝗰𝘆 𝗶𝗻𝗰𝗲𝗻𝘁𝗶𝘃𝗲𝘀 are supporting local and regional production to reduce reliance on imports.    For CDMOs and generics companies, this moment requires a strategic rethink. Owning capacity is no longer the only way to win; orchestration of flexible networks and specialized technologies is just as valuable. Those who invest in adaptable manufacturing platforms and forge smart partnerships will be best positioned to capture share in a market that is not just growing, but becoming structurally more sophisticated. The message is clear: Europe’s API market is no longer a volume play. It is evolving into a value-driven ecosystem where quality, complexity, and resilience are decisive.

𝗖𝗮𝗻 𝗖𝗼𝗺𝗺𝗲𝗿𝗰𝗶𝗮𝗹 𝗠𝘂𝘀𝗰𝗹𝗲 𝗕𝗲𝗮𝘁 𝗣𝘂𝗿𝗲 𝗦𝗰𝗮𝗹𝗲? Biosimilars are no longer a niche corner of pharma. The European Commission’s approval of USYMRO®, a Stelara® biosimilar developed by Bio‑Thera and commercialised by Gedeon Richter, is one example. Yet the more interesting story is Richter’s reinvention: a company once known for generics now combines CNS royalties, women’s‑health innovation and a growing biologics arm. The strategy is asset‑light – Bio‑Therra builds and manufactures while Richter focuses on what it does best: commercial execution. Its pipeline stacks denosumab, tocilizumab, teriparatide and now ustekinumab in a steady cadence of launches. At the same time, the biosimilar space is getting crowded; Sandoz, Amgen, Samsung, Biocon, Celltrion, Stada and new Chinese players are all chasing the same off‑patent biologics, squeezing margins. This raises a question: can smart partnering and commercial muscle outcompete sheer scale? Richter believes the answer is yes – and USYMRO® will be the test case.

𝗗𝗶𝘃𝗲𝗿𝘀𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻 𝗮𝘀 𝗮 𝗛𝗲𝗱𝗴𝗲 𝗶𝗻 𝗩𝗼𝗹𝗮𝘁𝗶𝗹𝗲 𝗠𝗮𝗿𝗸𝗲𝘁𝘀 In the ongoing debate over where generics companies should focus, STADA’s revenue split offers food for thought. About 40 % of its business comes from consumer health products, 40 % from generics and 20 % from specialty pharma. This mix illustrates how branded consumer health can underpin value just as much as scale in generics. The next question for STADA’s owners is whether to push further into consumer health for brand‑led resilience or into specialty pharma for margin expansion. Investors are rewarding diversification; consumer brands act as a stabiliser in volatile generics markets. For leaders in the sector, diversification isn’t about abandoning the core business. It’s about adding steady, brand‑driven cash flows that buffer volatility while still leveraging scale in generics. Where does your current portfolio leave you exposed, and what adjacent areas could hedge that risk?

𝗪𝗵𝗲𝗻 𝗚𝗲𝗻𝗲𝗿𝗶𝗰𝘀 𝗕𝗲𝗰𝗼𝗺𝗲 𝗮 𝗩𝗲𝗻𝘁𝘂𝗿𝗲 𝗖𝗮𝗽𝗶𝘁𝗮𝗹 𝗔𝗿𝗺 Teva has been known for its generics cash engine, but the company is quietly transforming into a biopharma growth story. The pipeline it’s building has $11–13 billion in peak sales potential, and the most innovative assets carry gross margins north of 90 %, compared with a company average of 54 %. What’s striking is how Teva is using its generics business as both a cash generator and a venture capital arm. With more than 25 biosimilar assets and GLP‑1 generics in development, the company can fund innovation while limiting capital expenditure through disciplined partnerships. For leaders in generics and CDMOs, this is a reminder that a strong base business can be the platform – not the obstacle – for innovation. When does your “cash engine” shift from a commodity business into a growth catalyst?

Amneal opens up competition in sleep disorder treatment Amneal has secured the 𝗳𝗶𝗿𝘀𝘁 𝗔𝗡𝗗𝗔 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹 for a 𝘀𝗼𝗱𝗶𝘂𝗺 𝗼𝘅𝘆𝗯𝗮𝘁𝗲 oral solution, opening U.S. competition to Jazz Pharmaceuticals’ Xyreminsight. Previously the market faced only an authorized generic. This approval signals that regulators are willing to green‑light complex generics when the data are solid. 𝗪𝗵𝘆 𝗶𝘁 𝗺𝗮𝘁𝘁𝗲𝗿𝘀: New entrants can lower costs and improve access for patients with narcolepsy and other sleep disorders. For generics developers, it underscores the value of pursuing difficult‑to‑make liquids and controlled substances. Expect more demand for formulation scientists and regulatory strategists. 𝘏𝘢𝘷𝘦 𝘺𝘰𝘶 𝘸𝘰𝘳𝘬𝘦𝘥 𝘰𝘯 𝘢𝘯 𝘈𝘕𝘋𝘈 𝘧𝘰𝘳 𝘢 𝘤𝘰𝘮𝘱𝘭𝘦𝘹 𝘰𝘳𝘢𝘭 𝘴𝘰𝘭𝘶𝘵𝘪𝘰𝘯? 𝘞𝘩𝘢𝘵 𝘩𝘶𝘳𝘥𝘭𝘦𝘴 𝘥𝘪𝘥 𝘺𝘰𝘶 𝘦𝘯𝘤𝘰𝘶𝘯𝘵𝘦𝘳?

𝟭𝟬𝟬% 𝗧𝗮𝗿𝗶𝗳𝗳𝘀: 𝗕𝗿𝗮𝗻𝗱𝗲𝗱 𝗣𝗵𝗮𝗿𝗺𝗮 𝗨𝗻𝗱𝗲𝗿 𝗦𝗶𝗲𝗴𝗲. 𝗚𝗲𝗻𝗲𝗿𝗶𝗰𝘀 𝗘𝘅𝗲𝗺𝗽𝘁. The U.S. will impose a 𝟭𝟬𝟬% 𝘁𝗮𝗿𝗶𝗳𝗳 𝗼𝗻 𝗶𝗺𝗽𝗼𝗿𝘁𝗲𝗱 𝗯𝗿𝗮𝗻𝗱𝗲𝗱/𝗽𝗮𝘁𝗲𝗻𝘁𝗲𝗱 𝗱𝗿𝘂𝗴𝘀 𝗳𝗿𝗼𝗺 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭. 𝗚𝗲𝗻𝗲𝗿𝗶𝗰𝘀 𝗮𝗿𝗲 𝗲𝘅𝗲𝗺𝗽𝘁. Waivers apply if a company is 𝗮𝗰𝘁𝗶𝘃𝗲𝗹𝘆 𝗯𝘂𝗶𝗹𝗱𝗶𝗻𝗴 𝗨.𝗦. 𝗺𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴. 𝗪𝗵𝗮𝘁 𝗶𝘁 𝗺𝗲𝗮𝗻𝘀 • 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗼𝗿𝘀: Margin shock. Rapid supply-chain rewiring. Trade frictions with EU/Japan incoming. • 𝗚𝗲𝗻𝗲𝗿𝗶𝗰𝘀 & 𝗖𝗗𝗠𝗢𝘀: Tailwind. U.S. access improves for low-cost players and domestic contractors. • 𝗕𝗼𝗮𝗿𝗱𝗿𝗼𝗼𝗺𝘀: Localize or pay. Plant announcements move from optional to necessary. 𝗧𝗮𝗸𝗲𝗱𝗮’𝘀 $𝟯𝟬𝗕 𝗨.𝗦. 𝗰𝗼𝗺𝗺𝗶𝘁𝗺𝗲𝗻𝘁 𝗹𝗼𝗼𝗸𝘀 𝗽𝗿𝗲𝘀𝗰𝗶𝗲𝗻𝘁. 𝗪𝗵𝘆 𝘁𝗵𝗶𝘀 𝗺𝗮𝘁𝘁𝗲𝗿𝘀 • Tariffs + exemptions create a two-tier market: 𝗯𝗿𝗮𝗻𝗱𝗲𝗱 𝘀𝗾𝘂𝗲𝗲𝘇𝗲𝗱, 𝗴𝗲𝗻𝗲𝗿𝗶𝗰𝘀 𝗽𝗿𝗼𝘁𝗲𝗰𝘁𝗲𝗱. • Expect accelerated 𝗼𝗻𝘀𝗵𝗼𝗿𝗶𝗻𝗴, JV/CDMO deals, and API redundancy plans. • Watch Section 232 challenges and WTO noise; policy durability is the wild card.    𝗔𝗰𝘁𝗶𝗼𝗻 𝗳𝗼𝗿 𝗼𝗽𝗲𝗿𝗮𝘁𝗼𝗿𝘀 1. Map SKUs by origin, tariff exposure, and U.S. onshoring feasibility. 2. Lock peptide/sterile capacity with U.S.-based CDMOs where possible. 3. Prepare fast-track MA transfers and dual-source APIs.     What do you think about this?