PharmaSource Podcast

Dr. Reddy’s Laboratories, the global pharmaceutical company headquartered in Hyderabad, India, has been a key player in the industry since its establishment in 1984.

Committed to ensuring access to affordable and innovative medicines, the company operates under the mantra, ‘Good Health Can’t Wait’. Dr. Reddy’s offers a comprehensive range of products and services, encompassing APIs, generics, branded generics, biosimilars, and OTC medications.

Ahead of CPHI 2023 we interviewed Kalpesh Kumar Modi, VP and Head of Europe API Sales, Dr. Reddy’s to explain their priorities.

“We manufacture more than 200 APIs and specialise in complex APIs, including peptides, oncology, cardiovascular, and all other therapeutic categories.” says Kalpesh.

“Dr. Reddy’s is a vertically integrated pharma companies that can support customers with formulation expertise, improving development processes and timelines, and have global regulatory teams facilitating filings and early market launches..” 

In 2023, the company recently became a ‘Water Positive‘ company, beating their 2025 target by two years.

“We were among the first Indian companies to build a zero liquid discharge infrastructure into all our facilities. We are delighted to say that we are not sending a single kilogramme of waste to any landfill.”

Dr Reddy’s is committed to ESG principles, employing ‘green chemistry’ to make API processes sustainable and work with suppliers who contribute to sustainable supply chain performance.

Kalpesh explains API Plus, an initiative for emerging markets where customers don’t have their own formulation facilities.

“The core objective of API Plus is to ensure that patients of those countries can access high-quality, affordable medicines. We cooperate with local partners and support them with expertise, formulation, and technology.”

Digitalisation is another major focus for Dr. Reddy’s, says Kalpesh. “We are leveraging Industry 4.0 technologies to streamline operations and enhance data accuracy.”

As an example of this, the company has created a platform called XCEED that enables customers to manage the complete inquiry and procurement process of Dr. Reddy’s APIs in real-time. 

“We are a small company but very innovative. I have confirmation from our customers that despite our relatively small size, we are at the leading-edge of digital transformation in packaging” says Christoph.

“We were one the first contract packaging partners to introduce traceability technology into our processes and have more than 12 years experience in this area.”

allpack group ag already deliver e-leaflets and e-patient information packs in Japan, a demanding market where leaflets are now mandatory.

“We provide dashboards to our customers that allows them to directly feed business-relevant information into our operations and also to monitor their products within our operations”

Why work with a dedicated Contract Packaging Organisation?

Christoph explains the benefits of working with a dedicated Contract Packaging Organisation, compared to a CDMO that includes a packaging service:

"The big challenge for a CMO is to balance two very different elements of business and technology. The business acumen between manufacturing and packaging are two different animals. It’s a challenge to keep up with the market in both areas”.

“Our experience is that if you focus exclusively on packaging, you can have much more competence in areas such as traceability, brand protection, sustainable packaging materials. Furthermore, you can be much more effective in high demanding sub-segments such as orphan drugs and highly individualised products lines."

"The classical #CDMO usually has a preference to run larger batches than what we do as a pure and focused packaging contract partner.”

🎧 Listen to the full episode here: https://pharmasource.global/content/supplier-spotlight/allpack-group-a-passion-for-digital-transformation-in-packaging/

Pfizer CentreOne, is a global contract development and manufacturing organisation (CDMO) and a prominent supplier of specialised APIs with a manufacturing network spanning over 35 sites across six continents

Ahead of CPHI Barcelona 2023 we asked Karen Lauxmann, Global Head of Marketing, Communications and Training, Pfizer CentreOne, to explain how being part of the Pfizer group makes them a different type of partner.

Karen explains how the scale and expertise within Pfizer enables CentreOne to support partners in a unique way. Whether a customer is developing complex biologics or oral solid dosage (still the lion’s share of prescriptions), they can tap into Pfizer’s network of experts.

“Pfizer is big and we’re used to making courageous decisions, if needed, to bring innovations to market.” says Karen. The Pfizer network brings substantial technical proficiency, worldwide regulatory assistance, and supply capabilities.

Finding the right contact manufacturing partner of your business is a balance between a number of factors, including price, quality and reliability to deliver on time.

“If you’re a small biotech and want to bring a breakthrough to market fast, you need to manage finance and cashflow carefully, but you also need someone you can rely on to think and plan ahead. It can’t just be about price” says Karen.

Here are her tips for finding the right CDMO for you:

“All these will ultimately save you time and money in the long run.”

One such leader is David Ward, Procurement Director at Catalent, who has leveraged his extensive experience from senior procurement roles at AstraZeneca and MSD/Merck to help guide the CDMO through challenging times. 

Catalent, along with other CDMOs, has been instrumental in the fight against COVID-19. The company played a significant role in vaccinating approximately 70% of the United States population through its partnerships with AstraZeneca, Moderna, and Johnson and Johnson. This massive undertaking saw Catalent’s largest vaccine manufacturing site in Bloomington, US, expand its workforce from around 1,500 employees to around 3,500 in just a few weeks.

David Ward describes this period as a “huge ramp up,” followed by a plateau and now a phase of ‘right-sizing.’ Throughout these stages, procurement has played a crucial role. 

In the latest episode of the PharmaSource podcast, David shares his insights on how procurement teams should operate differently during lean times and why he believes that “Procurement is the organisational Swiss Army Knife.”

The contract manufacturing sector is navigating through turbulent times as Gil Roth, Founder and President of the Pharma & Biopharma Outsourcing Association (PBOA) explains.

Caught between the after-effects of the pandemic, changing legislation, and the still-to-be fully realised promise of groundbreaking new treatments, CDMOs are showing real resilience.

“We saw the CDMO rise up heroically to help with vaccine and therapeutic production. While there was a lot of government support on the build-up side, there's been none on the drop-off". Many contract manufacturers had to scale significantly to cope with the demand but "now that things are receding, they are on their own. That's been a real challenge."

Gil says this has been a disappointing for the industry that achieved so much over the pandemic to rush out successful vaccination programmes as part of 'Operation warp speed'.

"A lot of those lessons seem to be forgotten. People start complaining about budgets, and government support starts to dissipate. "They're still arguing over reauthorizing the long standing pandemic and all hazards preparedness act here in the US." says Gil.

“R&D pipelines have been hurt, both by COVID itself or the lockdown period where a lot of research and clinical trials were disrupted. The global interest rate rises post-COVID has also led to some R&D funding drying up."

"The Inflation Reduction Act (IRA) in the US is meant to permit Medicare to begin negotiating prices on certain drugs. Some drug companies have said this is going to stymie their R&D efforts, so are leaving fields X, Y, and Z, which is also impacting funding."

“The CDMO sector is dependent on things making their way through the innovator side, so the R&D drought becomes the CDMO drought”

Cell and Gene Therapy, an area that is predominantly outsourced to startups - has experienced slower than expected growth due to speed of getting treatments approved.

“They're an incredibly promising set of technologies but building up to accommodate it is going to be tough” says Gil.

“The FDA is still working to build up the regulatory framework for a lot of the cell and gene therapies. They are in the process of hiring reviewers, build up that infrastructure and issuing guidance.Protocols that are still being developed for how to do these sorts of trials. The regulatory framework for them is still evolving.”

Gil explains some of the ways that contract manufacturing can adapting and thrive during these challenging times.

“I think they're they're in position, they're adapting. Capital is still accessible when it comes to making new investments. “

"It's worth remembering that Oral solid dosage drugs are still mighty important. In the US 90% of prescriptions are generic, small molecule drugs. That's a big savings on the US healthcare system and one that we helped contribute to by manufacturing for them.”

The onshoring movement is also creating opportunities for CDMOs based in North America and Europe. “There's more to be done for companies are looking for more supply chain security, but there's also geopolitical considerations that licence holders have and they might be interested in moving manufacturing to particular regions that aren't currently served, that might create opportunities for CDMOs in those sectors in those particular geographic regions."

There is still huge opportunities on the horizon with new treatments. “Nobody was predicting a $50 billion market in diabetes drugs that happen to cause weight loss. "

While it can be a gamble to ramp up capacity at an early stage "treatments like this create gigantic demand for certain types of manufacturing that just wasn't there before."

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Larger pharma companies are renown for spending a large amount on management consultants and other professionals services, due in part to the pharma industry's unique and high-risk business model.

There is a real opportunity to managing professional services better in life sciences, but it is far from straightforward, as Cameron Smith, Procurement Senior Partner for Professional Services at Novartis explains in the latest episode of the PharmaSource podcast.

“Procurement is constantly evolving” says Cameron “I don't think we're anywhere near close to scratching the surface of the value that procurement can bring.“

Professional services meets life sciences

The pharma business model comes with significantly greater risks than industries as "Pharma has to take a long-term view" says Cameron.

"If we're doing a deal with a strategy house, that strategy should help define what the business looks like for medium term, tie-in with the drug development pipeline and look at growth opportunities in market".

Another challenge is that the high-margin nature of big pharma means that a "mindset shift" is sometimes needed before stakeholders are prepared to consider alternatives to their existing suppliers.

Procurement professionals supporting business leaders is these decisions have to be aware of the importance, and politics, of these business issues. "If you're not, you're going to be left behind very quickly. Stakeholders are going to take a fairly dim view of what sort of value you can bring to the table."

7 strategies for transforming professional services procurement

Cameron details his recommendations for how procuerment professionals can manage professional services in the pharma industry.

1. Know your data down to the cent

2. Segment the existing supplier base

3. Find the category experts

4.Benchmark against the market

5. Align with your stakeholders

6. Consolidate your supply base without compromising quality

7. Measure only what is useful

Read the full article here: https://pharmasource.global/content/podcast/how-to-get-more-value-from-professional-services-in-pharma/

The pharmaceutical supply chain is undergoing major change, driven by advances in science, technology, and evolving patient expectations. 

To keep up will require fresh approaches to supply chain logistics, says Fernanda Teles, Head of Global Clinical Logistics for DHL Supply Chain. In the latest PharmaSource Podcast she explains some of the key trends from their recent report Delivering Next-Level Healthcare, and shares advice on how supply chain leaders must adapt including:

Read more here: https://pharmasource.global/content/podcast/pharma-supply-chain-transformation-how-to-adapt-to-the-new-era-of-healthcare/

“One of the challenges we face is trying to recruit talent in a market that is short on the skills we require.  There’s a major shortage of talent,"

Neil Kelly, founder of Vector Partners, has two decades experience in talent acquisition within life sciences, including high-growth period at Thermo Fisher and Patheon.

In the latest episode of the PharmaSource podcast Neil explains some key strategies to help bridge the talent gap in life sciences.

The great lesson from the pandemic was been the successful continuation of business through remote working.

“The supply chain is becoming more and more global - the ability to source product from anywhere in the world is just a reality now. As you think around talent and your workforce globally, then you then start realising that  it's not so much about where the product is that’s important but it's where you can source that talent, because the certain talent around the world that is really short."

However, this has presented a real challenge for HR functions and talent functions to understand which roles can go remote versus those that simply can't - such as  manufacturing or supply chain roles that physically handle products.

“Don't think about physical distance as a limitation to trade or to doing business together." says Neill.

"Start to look at your landscape globally for where do you source talent, versus where do you need to produce the product.”

If it's challenging to find someone who is an exact fit, go look deeper into candidate's strengths, says Neil.

“There are very few dedicated Academic courses for sourcing, procurement and supply chain, and those that are are very dated in terms of the content that's delivered to students.  So, we have to look elsewhere."

“If particular talent doesn't exist in the market we have bypass what the label of the degree says on their resume and really start to look at who they are as an individual and their behaviours.”

3. Invest in skills development

“Skills development will continue to be paramount for organisations moving forward, certainly for the next two to three years minimum. It's not only a great retention tool, but the second is that it also allows you to create more skills within your existing resources. “

"If you take an average procurement function or supply chain function, very often, they will have a defined set of skills and a defined boundaries in terms of where they operate. 

Training can help you to get "more all-rounders in your business", says Neil, which will increase your productivity. Training "is a good thing for the employee, and a good thing for the business. "

"You can't train the science" says Neil, but enabling functions such as Procurement and Supply Chain - like HR and Finance - have transferable skills which you can look for outside of the pharma industry. 

"In supply chain, we look for agility, we look for speed, we look for sharpness around commerciality that generally has not come from within the pharma industry. “

"We source that talent from those industries that are really lean - telecoms, third-party logistics.These are industries that really sharpen their pencil around some of these skills. We go into these industries and pluck out the very best."

Take the opportunity to use pay and benefits as way to attract talent from other industries.

"Compensation is generally lower within these industries (such as telecoms and third-party logistics) so you're able to attract the talent, so you've got a commercial or a compensation advantage of attracting someone.”

Listen to the full podcast for the full interview.

We spoke to Alessandro Agosti, Senior Director of Scientific Operations about how they partner with customers, and some of the ways they are unique. 

The CRO was founded 1986, before being acquired by Olon SpA in 2017.   Now part of the wider Olon Group, Alessandro explains that "clients can tap into a 'One stop shop' taking them from early phase work to scaling up into full commercial manufacturing - leveraging Olon's technologies and the centre of excellence."

Speed of development is a top requirement, says Alessandro, providing the example of a recent collaboration with a US-based pharma company to develop an oncology drug. They escalated from a very early phase to full GMP manufacturing within one year.

"It was a quite a big jump in terms of scale. It was made possible because of the continuous interaction between the different teams fine-tuning the process, the analytical work, as well as the process engineering that is inevitably needed when you go from a few 100 grammes to manufacturing batches on on large scale on a chemical on a chemical plant."

"A trend that that we are seeing from many clients is the requirement to move research and manufacturing away from the Far East" says Alessandro.

While acknowledging this comes with a higher price tag, moving research to the United States is "has clear advantages in terms of control and interaction with customers", adding that it's more important than ever "to deliver first time and keep to the timeline in these very challenging times."

"We like to provide clients with a roadmap for their development, partnering from a very eary stage. This includes the way we write the proposal, the way we try to understand the client's most immediate needs. That will drives and impact the way we do the process development."

"We want to think that there might be a much larger scale, scale up required further down the road, and we believe that establishing a partnership and providing a process package rather than selling a product is the key to a successful working relationship."

“You can’t develop medicines without an ecosystem. Suppliers are probably one of the most neglected sections of the ecosystem.”

Tanya Momtahen, Vice President of Integrated Product Solutions at Thermo Fisher explains how understanding your supplier ecosystem is how to make an impact.

“The amount of money that's spent in the supplier world is daunting, to say the least” says Tanya  “yet too often key suppliers are treated transactionally.” While this attitude might make sense when procuring something that already exists “if it's services that are supporting research and development of a medicine it is crazy.”

Tanya spent nearly two decades at Sanofi, over which time she moved from research and development to becoming VP of global scientific and clinical procurement. 

She explains that she moved to procurement with a mission to champion the “neglected supplier world and truly partner with suppliers. That's how I convinced myself to go to into procurement.”

Moving to procurement Tanta faced “ many naysayers” but for her, changing how to partner with suppliers came with a moral responsibility

“I had a mission and the mission was:  if I work on a couple of products (in R&D), those are the only ones I can impact. But if I go and take over outsourcing and drive the suppliers to bring better solutions forward, I can affect many more medicines.” 

 “We owe the responsibility to the world not to waste money that can be spent on additional medicines.   It’s frustrating to see people killing products that may work because there's just not enough money to go around to develop them. Some of the products that are not so publicly known are the easiest ones to kill internally. But they also may be the ones that may work.“

Now working at Thermo Fisher and PPD, her role is to help sponsoring biopharma companies  get the most out of the wide range outsourcing services they offer. This has given her a broad perspective on how to make outsourcing work from both sides of the table.

Advice for negotiating transformational supplier partnerships

Here is Tanya’s advice for sourcing and procurement professionals to get more from their supplier ecosystem.

1. Understand the supplier’s business model

2. Move from transactional to strategic partnerships

3. Identify what’s really important for your business

4. Aim for a Win-Win 

5. Practise negotiations

6. Change come from the top